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VOLUME 13 NO. 21 — SPRING
WINTER 2009
2009
500 NE Multnomah St, Suite 100
Portland, Oregon 97232
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Permit No 1452
Spring 2009
Volume 13 No. 2
A peer-reviewed journal of medical science,
social science in medicine, and medical humanities
Original Articles
4 Short- and Long-Term Antireflux and Asthma
Medication Use in Children After Nissen
Fundoplication
12 The Falling Rate of Positive Penicillin Skin
Tests from 1995 to 2007
20 Developing Minimally Invasive Surgery
Centers Within Kaiser Permanente
THE PERMANENTE JOURNAL
31 An Exploratory Case Study: Effects of a
Physician Organizational Socialization
(Enculturation) Program
Lawrence Patient Safety Awards — 2008
37 Northwest Simulation Center
44 Ohio Safety Action Teams
Review Article
50 Incidental Gallstones
Clinical Medicine
55 An Unusual Presentation and Etiology of
Hypotension Seen in Nephrotic Syndrome
58 An Unusual Cause of Elevated Values on Liver
Function Tests in a Liver Transplant Patient
61 Early and Accurate Diagnosis of Sudden
Sensorineural Hearing Loss
Commentary
65 Statement to US Senate Committee
Investing in Health IT: A Stimulus for a
Healthier America
71 Marketing, Media, Wishful Thinking, and
Conflicts of Interest: Inflating the Value of
New Medical Technology
80 Dealing With Change: Using the Conditional
Change Model for Clinical Research
The Permanente Journal
Spring 2009
Volume 13 No. 2
ISSN 1552-5767
Printed on recycled paper.
www.kp.org/permanentejournal
Spring 2009/ Volume 13 No. 2
Original Articles
Mission: The Permanente Journal is
published for physicians, practitioners,
and nurses to create and to deliver superior
health care through the principles and
benefits of Permanente Medicine.
Permanente Medicine is preventive,
innovative, evidence-based, population
care practiced by a multispecialty group,
using an electronic health and medical
record, and focused on patient
relationships and outcomes.
Circulation: 25,000 print readers per
quarter, and accessed by 501,000 unique
Web readers in 2008 from 164 countries
of the world.
On the cover:
“Brothers on the
Fourth” by Patrick
Kusek, MD, is a photograph taken two
days after the birth of
his second son. Calvin, now 9 years old,
is holding his newborn baby brother Alexander,
now 6 years old. Dr Kusek is an avid photographer
and especially enjoys photographing his family and
favorite places they travel. A highlight of his photography career was photographing Notre Dame
football games from the sidelines as photo editor
for the University newspaper.
Dr Kusek has been a Pediatrician at the Westminster Medical Offices in Westminster, CO for the
past 11 years and is the Area Operations Chief for
the four clinics in the Metro West Region.
92 Book ReviewS
95 CME EVALUATION FORM
4 Short- and Long-Term Antireflux and
Asthma Medication Use in Children
After Nissen Fundoplication.
Steven L Lee, MD, FACS, FAAP
31 An Exploratory Case Study: Effects of a
Physician Organizational Socialization
(Enculturation) Program.
Richard Pitts, DO, DABEM, DABPM
Compelling study data—filling a
literature void—shows that comprehensive enculturation improves physicians’ effective entry into a medical
group. Themes include: developed
a strong sense of belonging; gained
improved communication skills; gained
multiple resources for success at home,
and work; and developed friends
called on later for clinical advice.
Overall, study findings demonstrated a slight decrease in antireflux medication use after Nissen fundoplicaton. With respect
to asthma medications, only
older, neurologically healthy
children decreased use in the
short term (one year).
12 The Falling Rate of Positive Penicillin
Skin Tests from 1995 to 2007.
Eric Macy, MD; Michael Schatz,
MD, MS; CK Lin, PhD; Kwun-Yee
Poon, MS
Data on the rate of positive penicillin skin test (PenST) results
over time in large populations
are rare. Of 3469 individuals,
255 had positive PenST. The rate
declined from >10% to <5% (13
years studied) accounted for by
the year of testing without contribution from patient’s age or
time since reaction. Route and
frequency of outpatient antibiotic
use may explain this.
20 Developing Minimally Invasive
Surgery Centers Within Kaiser Permanente: The Integrated Multidisciplinary Experience of Los Angeles.
Gary W Chien, MD; Maher A
Abbas, MD, FACS, FASCRS
Although there are unique issues
for each specialty, many common
issues, such as anesthetic considerations, organizing operating room
teams, standardization of disposable products and electrosurgical
units, testing and implementation
of new equipment, postoperative
care, education, simulation, training, and research are effectively
and efficiently addressed through
a multidisciplinary approach and
complete integration.
2008 David M Lawrence, MD:
Chairman’s Patient Safety Award
37 Northwest Simulation Center—
Sharpens Clinical and Communication
Skills for Individuals and Teams.
Georgina Ottaviano, BSN, RN-BC; Carl
Washington, MT, PSO, CPHQ
Many authorities have suggested that
some variant of team training is likely
to reduce human error in operating
rooms, Emergency Departments, resuscitation teams and other settings
within health care—where human
interaction is common and where
breakdowns in communication and
teamwork can have critical consequences. The Kaiser Sunnyside Medical Center Regional Simulation Center
achieves this end.
2008 Lawrence Patient Safety Award
44 Ohio Safety Action Teams.
Cindy Ebner, RN, MSN, CPHRM, FASHRM
Following the implementation of a
new process—“Images-to-OperatingRoom”—a survey of all Safety Action
Team (SAT) participants showed they
knew more about building a reliable
process, their job satisfaction increased,
patient safety was improved, and the
gains were sustained. The plan is to
continue SATs which are readily transferable to other areas and facilities.
Review ARTICLE
50 Incidental Gallstones. Jeffrey K Wang,
MD; Shannon M Foster, MD; Bruce G
Wolff, MD, FACS
Gallstones develop in approximately
10% to 15% of the US population.
Complications arise at 1% per year in
asymptomatic patients and 2% per year
in symptomatic patients. Laparoscopic
cholecystectomy has quickly become
the gold standard in the US. The literature also advocates cholecystectomy
for gallstones found incidentally during
other abdominal procedures.
The Permanente Journal
500 NE Multnomah St, Suite 100
Portland, Oregon 97232
www.kp.org/permanentejournal
ISSN 1552-5767
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Books published by
Permanente authors:
Health Care Reform Now!
By George C Halvorson
San Francisco, CA:
Jossey-Bass; 2007
ISBN-10:0787997528
ISBN-13: 978-0787997526
Hardcover: 384 pages
$27.05
Clinical Emergency
Medicine Casebook
By Joel T Levis, MD, PhD,
FACEP, FAAEM and Gus M
Garmel, MD, FACEP, FAAEM
Cambridge, UK: Cambridge
University Press; 2009
ISBN-13: 9780521719643
Paperback: 512 pages
$75.00
Birth Day: A Pediatrician
explores the science, the
history, and the wonder
of childbirth
By Mark Sloan, MD
New York: Ballantine Books;
2009
ISBN-10: 0345502868
ISBN-13: 978-0345502865
Hardcover: 384 pages
$25.00
Now available
The Story of
Dr Sidney R Garfield
The Visionary Who Turned
Sick Care into Health Care
$19.95*
Prostitution and
Trafficking in
Nevada: Making
the Connections
By Melissa Farley, PhD
San Francisco, CA:
Prostitution Research
& Education; 2007
ISBN-10: 0615162053
ISBN-13: 978-0615162058
Paperback: 326 pages
$24.95
This book tells the story of
Dr Sidney Garfield’s long and
eventful career in turning his
desert dream into a thriving
and enduring reality that continues to offer a practical
model for the future of American health care.
To order a copy of this Permanente Press title, visit The Permanente
Journal Web site at: www.kp.org/permanentejournal.
* Discount price for Kaiser Permanente employees: $12.00.
Case Studies
Commentary
55 An Unusual Presentation and
Etiology of Hypotension Seen
in Nephrotic Syndrome.
Anna-Maria Panagiotides, MD;
Aviv Hever, MD; John J Sim, MD
S tatement on behalf of the Kaiser Permanente Medical Care Program before the
Committee on Health, Education, Labor,
and Pensions; United States Senate on
January 15, 2009
65 Investing in Health IT: A Stimulus
for a Healthier America.
John H Cochran, MD, FACS
The case discussed illustrates
an unusual presentation of
hypotension due to amyloid
infiltration of the vasculature,
leaving the patient susceptible
to acute kidney injury even
from what is generally considered mild diuresis. The kidneys
are the most frequently affected
organs in approximately 80% of
patients with the disease. Cardiac dysfunction is the second
most common presentation.
58 An Unusual Cause of Elevated
Values on Liver Function Tests
in a Liver Transplant Patient.
Ankur Jain, MD; Amandeep Sahota, MD; Najeeb S Alshak, MD;
Jim K Tung, MD
Biliary obstruction and rejection
are two of the most common
causes of abnormal findings
on liver function tests (LFTs)
in patients who have already
undergone liver transplantation.
Here a post-transplant patient
with jaundice, not previously
vaccinated, had hepatitis B as
the cause of his increased values on LFTs.
Congress should explore investing in the nation’s health care
delivery system. KP HealthConnect securely connects 8.7 million people to their physicians,
their health care teams, their personal health information, and the
latest medical knowledge, leveraging the integrated approaches
to health care available at KP. It’s
not just about digitizing the visit:
it’s about using visit data to inform and ultimately to transform
care delivery.
71 Marketing, Media, Wishful
Thinking, and Conflicts of
Interest: Inflating the Value
of New Medical Technology.
Richard A Deyo, MD, MPH
“Advances”—autologous bone
marrow transplantation, Vioxx,
arthroscopic debridement—
were expensive, marginal treatments that became widely used
without adequate scientific
evaluation or comparison to
competing treatments. “Newly
approved” does not necessarily mean new and improved.
Marketing, politics, media, and
advocacy sometimes trump scientific considerations. “Jumping
the gun” before rigorous evaluation makes it hard to practice
evidence-based medicine.
Clinical Medicine
orridor Consult C
61 Early and Accurate Diagnosis of
Sudden Sensorineural Hearing
Loss. Barry Rasgon, MD; Luke
James Schloegel, MD
Sudden Sensorineural Hearing
Loss is defined as a 30-dB hearing loss in three consecutive
frequencies whose onset is less
than three days. Most researchers agree it is likely to be of
vascular, immunologic, or viral
origin, and is regarded as an
otologic emergency.
EDITORIALS
77 Isn’t it Time to Stop Accepting
Handouts for our Educational
Efforts? KM Tan, MD
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Commercial support for continuing education risks distorting
educational content, invites bias,
and endangers professional
commitment to evidence-based
decision making. The Permanente Medical Groups are
leading a ban on commercial
support for accredited organizations that provide continuing
education, especially because
it is not the size of the gift, but
the gifting itself that creates the
desire to reciprocate.
80 Dealing With Change: Using the
Conditional Change Model for
Clinical Research.
Mikel Aickin, PhD
Virtually all clinical medicine
is about change. In clinical
research one of the most frequently used approaches—to
compare changes in a treated
group with corresponding
changes in a control group—
fails to include the baseline
measurement value in the
analysis. Reasons to prefer the
conditional change model over
the t-test are: smaller error, similar groups, and less artifact.
he Merging of the Work of Two
T
Pioneers: Dr Weed & Dr Berwick
85 Attaining Comprehensive Health
Care Improvement is Imperative.
Lee Jacobs, MD
Two physicians are on journeys to improve health care.
Lawrence Weed, MD (problemoriented medical record)
explores how practitioners
process and apply information,
using “knowledge couplers”
for decisions based on quality
data input rather than on recall.
Donald Berwick, MD believes
that the key to higher quality is
understanding and improving
100 core work-flow processes
covering 95% of all patient care.
We need both approaches.
CME credits are available
online to at www.kp.org/
permanentejournal and the
mail-in CME form can be
found on page 95.
Soul of
the healer
Original Visual Art
19 “Thriving at 20 till 7”
John Davenport, MD
30 “Spherical Tea Set”
and “Spiral Tea Set”
Patrick Ting, MD
49 “Modern Woman Torso”
Evany Zirul, MFA, DO
64 “School Days”
Josh Schechtel, MD
Narrative Medicine
88 A Fatal Form of Contentment.
Catherine Hickie, MBBS
A 19th-century query in The
Lancet into mass train travel
noted vagrants as enjoying the
pleasure of travel without having earned it through work—a
“fatal form of contentment.” The
Internet has come with anxieties
and fears just as the trains did.
A 21st-century psychiatrist wonders if our hopes for new technology are that different from
the hopes of the Victorians.
Book Reviews
page 92
1
PermanenteJournal
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The Permanente Journal/ Spring 2009/ Volume 13 No. 2
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The Permanente Journal/ Spring 2009/ Volume 13 No. 2
3
credits available for this article — see page 95.
Original article
Short- and Long-Term Antireflux and Asthma
Medication Use in Children After Nissen
Fundoplication
Steven L Lee, MD, FACS, FAAP
Abstract
Purpose: We sought to determine antireflux and asthma medication
use after Nissen fundoplication (NF).
Methods: We performed a retrospective study using hospital discharge
and pharmacy data from 1996 through 2005. A total of 342 pediatric
patients had ≥1 NF; 336 of those had complete medication data. Use of
antireflux medications and asthma medications were reviewed before
and after NF.
Results: Short-term (one year after NF) use of antireflux medications decreased (odds ratio [OR] = 0.35; 95% confidence interval [CI],
0.26–0.45). During the entire study period, the decrease in antireflux
medication use after NF remained in place (233 to 197 patients; OR
= 0.63; 95% CI, 0.47–0.84). Use of antireflux medications decreased
in neurologically healthy patients (n = 186) after NF but remained the
same in neurologically impaired patients. Short-term use of inhaled
and systemic asthma medications did not change (OR = 1.16 [95%
CI, 0.89–1.51] and 0.90 [95% CI, 0.69–1.18]), respectively. During
the entire study period, inhaled and systemic asthma medication use
increased after NF (OR = 2.11 [95% CI, 1.63–2.74] and 1.85 [95% CI,
1.43–2.41]), respectively. Inhaled and systemic asthma medication use
increased in both neurologically healthy and impaired children. In older
children (age >5 years), short-term use of inhaled and systemic asthma
medications decreased after NF (OR = 0.39 [95% CI, 0.25–0.60] and
0.31 [95% CI, 0.19–0.53]), respectively. However, during the entire
study period, inhaled and systemic asthma medication use in older
children remained the same.
Conclusion: NF decreased antireflux medication use in the short and
long term, particularly in neurologically healthy children. Inhaled and
systemic asthma medication use increased after NF in neurologically
healthy and impaired children. NF provided a short-term decrease in
inhaled and systemic asthma medication use in older children but showed
no change in the long term.
Introduction
Excellent symptomatic results
after Nissen fundoplication (NF)
in children have been shown in
large retrospective studies.1,2 Furthermore, laparoscopic NF has also
been shown to be safe in children as
small as 1.2 kg and as young as five
days.1 However, few studies have
demonstrated long-term objective
outcomes after NF in children. We
previously looked at the number
of hospitalizations for complications related to gastroesophageal
reflux disease (GERD) to determine long-term effectiveness after
NF.3 There was no change in the
number of patients hospitalized for
pulmonary symptoms and failure
to thrive before and after NF.3 We
also showed that long-term use of
antireflux medications decreased
by 37% in children after NF.4 However, these studies were criticized
because patients of all ages were
grouped together regardless of
neurologic status. Many believe
that reflux disease in a young child
with an underlying neurologic disorder and repeat hospitalizations
for pneumonia or failure to thrive
may be different from the disease
in an older, neurologically healthy
child with significant reactive air-
Steven L Lee, MD, FACS, FAAP, is Chief of Pediatric Surgery, Associate Program Director of General
Surgery, and Education Chair for the Department of Surgery at the Los Angeles Medical Center and
volunteer faculty at the Harbor-UCLA Medical Center in Los Angeles, CA. E-mail: [email protected].
4
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
ORIGINAL Article
Short- and Long-Term Antireflux and Asthma Medication Use in Children After Nissen Fundoplication
way disease. Thus, endpoints after
NF may be different in such vastly
dissimilar patient populations. The
purpose of this study was to address this criticism by analyzing the
short- and long-term effects after
NF in children. Specifically, this
study analyzes the use of antireflux
medication and asthma medication
on the basis of patient age and
neurologic status.
Materials and Methods
The Southern California Kaiser
Permanente (KP) Discharge Abstract Database (PDAB) was used
to identify pediatric patients (those
<19 years old) hospitalized in 12
acute-care hospitals with diagnosed
GERD that was treated with NF
between January 1, 1996, and December 31, 2005. Surgical therapy
was determined according to the
guidelines for the Current Procedural Terminology, fourth edition
(CPT)5 procedure code for NF. This
study was approved by the institutional review board of KP Southern
California, protocol numbers 3934
and 5040.
Patients’ data were then analyzed
using the KP Southern California
Pharmacy database for use of
antireflux medications. Specifically, use of antireflux medication
(H 2-blockers and proton pump
inhibitors) and asthma medication (systemic steroids, inhaled
β-agonists, and inhaled steroids)
were analyzed. The pre-Nissen
period was defined as the period
from birth to first NF, and postNissen period was defined as the
time from first NF to death or to the
end of the study, whichever came
first. The number of patients using
antireflux and asthma medications
was recorded before and after NF
at six-month intervals. Short-term
use was defined as restarting medication within one year of NF. Long-
term use was defined as restarting
medication at the end of the study
period, with a mean follow-up
period of 4.5 years.
The data from PDAB were exported to SAS statistical software
(version 9.13, SAS Institute, Inc,
Cary, NC, USA) for subsequent
analyses. Use of antireflux and
asthma medication before and after
NF was compared using χ2 analysis.
Odds ratios (ORs) were calculated
using logistic regression. In addition to NF, age and underlying neurologic disorder were also included
in the regression model. Estimates
were considered statistically signifi-
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
cant if the 95% confidence interval
did not overlap 1.0 and if p values
were <0.05.
Results
A total of 342 patients were
identified as having undergone NF
during the study period. Medication
data were available for 336 of those,
and 154 (45%) patients had an associated neurologic disorder. Mean
patient age at time of NF was 3.9
± 4.8 years (median age, one year;
range, 0–17 years) with a maleto-female ratio of 1.19 to 1. Mean
duration of follow-up monitoring
was 4.5 years.
Table 1. Short-term and long-term use of antireflux medication
after Nissen fundoplication in children
All children in study
All ages (n = 336)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
<1 year (n = 140)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
1 year ≤ age < 5 years (n = 99)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
≥5 years (n = 97)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
OR (95% CI)
p value
0.35 (0.26–0.47)
0.63 (0.47–0.84)
<0.0001
0.0015
0.59 (0.37–0.95)
1.06 (0.67–1.69)
0.0282
0.7995
0.18 (0.10–0.34)
0.28 (0.15–0.51)
<0.0001
<0.0001
0.23 (0.13–0.42)
0.49 (0.28–0.87)
<0.0001
0.0136
CI = confidence interval; OR = odds ratio; NF = Nissen fundoplication.
Table 2. Short-term and long-term use of antireflux medication
after Nissen fundoplication in neurologically healthy children
Neurologically healthy children
All ages (n = 186)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
<1 year (n = 82)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
1 year ≤ age < 5 years (n = 50)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
≥5 years (n = 54)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
OR (95% CI)
p value
0.22 (0.15–0.34)
0.38 (0.26–0.57)
<0.0001
<0.0001
0.45 (0.25–0.81)
0.82 (0.46–1.43)
0.0084
0.4791
0.11 (0.04–0.26)
0.15 (0.06–0.35)
<0.0001
<0.0001
0.09 (0.04–0.21)
0.17 (0.07–0.40)
<0.0001
<0.0001
CI = confidence interval; OR = odds ratio; NF = Nissen fundoplication.
5
Original article
… longterm use of
antireflux
medication
after NF
[remained
the same] in
neurologically
impaired
children.
Short- and Long-Term Antireflux and Asthma Medication Use in Children After Nissen Fundoplication
Antireflux Medication Use
After Nissen Fundoplication
Table 1 summarizes short- and
long-term use of antireflux medication after NF in all patients. Overall
short-term use of antireflux medication decreased in children after NF.
With respect to age, short-term use
of antireflux medication decreased
in children of all ages after NF.
Overall, long-term use of antireflux
medication remained decreased for
all patients (233 to 197 patients). Of
the 233 patients requiring antireflux
medication before NF, 150 required
medication after NF; 75.6% of all patients who restarted antireflux medi-
cation did so within one year after
NF. An additional 47 patients with
no prior requirement of antireflux
medication were given medication
after NF. With respect to age, longterm use of antireflux medications
remained decreased in children one
year of age and older.
Table 2 summarizes short- and
long-term use of antireflux medication after NF in neurologically
healthy children. Overall shortterm use of antireflux medication
decreased in neurologically healthy
children after NF. With respect to
age, short-term use of antireflux
medications decreased in neuro-
Table 3. Short-term and long-term use of antireflux medication
after Nissen fundoplication in neurologically impaired children
Neurologically impaired children
All ages (n = 150)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
<1 year (n = 58)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
1 year ≤ age < 5 years (n = 49)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
≥ 5 years (n = 43)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
OR (95% CI)
p value
0.58 (0.37–0.90)
1.09 (0.71–1.68)
0.0145
0.6961
0.87 (0.41–1.86)
1.56 (0.71–3.43)
0.7149
0.2735
0.33 (0.17–0.73)
0.62 (0.30–1.29)
0.0061
0.2028
0.52 (0.22–1.20)
0.1230
1.10 (0.49–2.48)
0.8185
CI = confidence interval; OR = odds ratio; NF = Nissen fundoplication.
Table 4. Short-term and long-term use of inhaled steroids after
Nissen fundoplication in children
All children in study
All ages (n = 336)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
<1 year (n = 140)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
1 year ≤ age < 5 years (n = 99)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
≥5 years (n = 97)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
OR (95% CI)
1.31 (0.95–1.80)
3.24 (2.34–4.49)
0.1056
<0.0001
11.80 (4.36–31.94)
4.96 (1.90–13.00)
<0.0001
0.0011
1.31 (0.80–2.13)
3.69 (2.15–6.35)
0.2842
<0.0001
0.67 (0.38–1.17)
1.73 (0.99–3.03)
0.1557
0.0562
CI = confidence interval; OR = odds ratio; NF = Nissen fundoplication.
6
p value
logically healthy children of all
ages and long-term use remained
decreased in neurologically healthy
children one year of age and older.
Overall, long-term use decreased
in neurologically healthy patients
(140 to 101).
Table 3 summarizes short- and
long-term use of antireflux medication after NF in neurologically
impaired children. Overall shortterm use of antireflux medication decreased in neurologically
impaired children after NF. With
respect to age, short-term use of
antireflux medication decreased in
neurologically impaired children
between the ages of 1 and 5 years.
Long-term use remained the same
in neurologically impaired children
of all ages (93 to 96).
Asthma Medication Use
After Nissen Fundoplication
Table 4 summarizes short- and
long-term use of inhaled steroids
after NF in all patients. Overall
short-term use of inhaled steroids
remained unchanged in children
after NF. With respect to age,
short-term use of inhaled steroids
increased in children younger than
one year and remained unchanged
in children older than one year
after NF. Overall, long-term use
of inhaled steroids increased for
all patients (44 to 109). Of the 44
patients requiring inhaled steroids
before NF, 31 required medication
afterward; 50.5% of all patients
who restarted inhaled steroids did
so within one year after NF. An additional 78 patients with no prior
requirement of inhaled steroids
were given medication after NF.
With respect to age, long-term use
of inhaled steroids increased in
children younger than five years
and remained the same in children
older than five years.
Table 5 summarizes short- and
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
ORIGINAL Article
Short- and Long-Term Antireflux and Asthma Medication Use in Children After Nissen Fundoplication
long-term use of inhaled steroids
after NF in neurologically healthy
children. Overall short-term use
of inhaled steroids remained the
same in neurologically healthy children after NF. With respect to age,
short-term use of inhaled steroids
increased in neurologically healthy
children younger than one year and
remained the same in children older
than one year, and long-term use
increased in neurologically healthy
children younger than five years
and remained the same in children
older than five years. Overall,
long-term use of inhaled steroids
increased in neurologically healthy
patients (29 to 59).
Table 6 summarizes short- and
long-term use of inhaled steroids
after NF in neurologically impaired
children. Overall, short-term use of
inhaled steroids increased in neurologically impaired children after
NF. With respect to age, short-term
use increased in neurologically impaired children younger than five
years and remained the same in
children older than five years, and
long-term use increased in neurologically impaired children younger
than five years and remained the
same in children older than five
years. Overall, long-term use increased in neurologically impaired
patients (15 to 50).
Table 7 summarizes short- and
long-term use of inhaled β-agonists
after NF in all patients. Overall
short-term use of inhaled β-agonists
remained unchanged in children
after NF. With respect to age, shortterm use of β-agonists increased in
children younger than one year and
decreased in children older than five
years after NF. Overall, long-term
use of inhaled β-agonists increased
for all patients (162 to 219). Of
the 162 patients requiring inhaled
β-agonists before NF, 131 required
medication after NF; 79.0% of all
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Table 5. Short-term and long-term use of inhaled steroids after
Nissen fundoplication in neurologically healthy children
Neurologically healthy children
All ages (n = 186)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
<1 year (n = 82)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
1 year ≤ age < 5 years (n = 50)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
≥ 5 years (n = 54)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
OR (95% CI)
1.04 (0.67–1.62)
2.69 (1.77–4.09)
p value
0.8476
<0.0001
5.60 (1.57–19.91)
10.53 (2.78–39.96)
0.0078
0.0005
0.73 (0.31–1.73)
2.41 (1.10–5.31)
0.4804
0.0282
0.63 (0.35–1.14)
1.73 (0.93–3.21)
0.1281
0.0844
CI = confidence interval; OR = odds ratio; NF = Nissen fundoplication.
Table 6. Short-term and long-term use of inhaled steroids after
Nissen fundoplication in neurologically impaired children
Neurologically impaired children
All ages (n = 150)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
<1 year (n = 58)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
1 year ≤ age < 5 years (n = 49)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
≥5 years (n = 43)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
OR (95% CI)
p value
1.80 (1.08–3.02)
4.54 (2.57–8.01)
0.0254
<0.0001
4.77 (0.98–23.25)
15.08 (3.36–67.62)
0.0533
0.0004
2.05 (1.19–3.55)
5.42 (2.65–11.10)
0.0102
<0.0001
0.78 (0.21–2.85)
1.74 (0.52–5.83)
0.7054
0.3677
CI = confidence interval; OR = odds ratio; NF = Nissen fundoplication.
Table 7. Short-term and long-term use of inhaled β-agonists after
Nissen fundoplication in children
All children in study
All ages (n = 336)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
<1 year (n = 140)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
1 year ≤ age < 5 years (n = 99)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
≥5 years (n = 97)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
OR (95% CI)
p value
1.14 (0.88–1.49)
2.04 (1.57–2.64)
0.3129
<0.0001
3.34 (2.10–5.32)
5.72 (3.45–9.49)
<0.0001
<0.0001
0.81 (0.49–1.32)
1.43 (0.89–2.31)
0.3976
0.1412
0.42 (0.27–0.66)
0.84 (0.56–1.25)
0.0001
0.3927
CI = confidence interval; OR = odds ratio; NF = Nissen fundoplication.
7
Original article
Short- and Long-Term Antireflux and Asthma Medication Use in Children After Nissen Fundoplication
Table 8. Short-term and long-term use of inhaled β-agonists after
Nissen fundoplication in neurologically healthy children
Neurologically healthy children
All ages (n = 186)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
<1 year (n = 82)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
1 year ≤ age < 5 years (n = 50)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
≥ 5 years (n = 54)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
OR (95% CI)
p value
0.80 (0.57–1.13)
1.78 (1.27–2.49)
0.2106
0.0008
2.11 (1.23–3.64)
3.87 (2.15–6.99)
0.0069
<0.0001
0.57 (0.29–1.12)
1.18 (0.61–2.27)
0.1037
0.6165
0.29 (0.16–0.55)
0.92 (0.55–1.54)
0.0001
0.7629
CI = confidence interval; OR = odds ratio; NF = Nissen fundoplication.
Table 9. Short-term and long-term use of inhaled β-agonists after
Nissen fundoplication in neurologically impaired children
Neurologically impaired children
All ages (n = 150)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
<1 year (n = 58)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
1 year ≤ age < 5 years (n = 49)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
≥ 5 years (n = 43)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
OR (95% CI)
p value
1.79 (1.20–2.66)
2.44 (1.61–3.70)
0.0042
<0.0001
6.53 (2.78–15.35)
11.07 (4.09–29.97)
<0.0001
<0.0001
1.20 (0.59–2.44)
1.80 (0.88–3.69)
0.6168
0.1053
0.68 (0.37–1.23)
0.74 (0.39–1.41)
0.2013
0.3631
CI = confidence interval; OR = odds ratio; NF = Nissen fundoplication.
patients who restarted β-agonists
did so within one year after NF. An
additional 88 patients with no prior
requirement for inhaled β-agonists
were given medication after NF.
With respect to age, long-term use
of inhaled β-agonists increased in
children younger than one year
and remained decreased in children
older than one year.
Table 8 summarizes short- and
long-term use of inhaled β-agonists
after NF in neurologically healthy
children. Overall short-term use
increased in neurologically healthy
children after NF. With respect to
age, short-term use increased in
8
neurologically healthy children
younger than one year and decreased in children older than five
years, and long-term use increased
in neurologically healthy children
younger than one year and remained the same in children older
than one year. Overall, long-term
use increased in neurologically
healthy patients (85 to 111).
Table 9 summarizes short- and
long-term use of inhaled β-agonists
after NF in neurologically impaired
children. Overall short-term use increased in neurologically impaired
children after NF. With respect to
age, short-term use increased in
neurologically impaired children
younger than one year and remained the same in children older
than one year, and long-term use
increased in neurologically impaired children younger than one
year of age and remained the same
in children older than one year.
Overall, long-term use increased
in neurologically impaired patients
(77 to 108).
Table 10 summarizes short- and
long-term use of systemic steroids
after NF in all patients. Overall
short-term use remained unchanged
in children after NF. With respect
to age, short-term use increased
in children younger than one year
of age and decreased in children
older than one year after NF. Overall, long-term use increased for all
patients (102 to 150). Of the 102
patients requiring systemic steroids
before NF, 70 required medication
after NF; 63.3% of all patients who
restarted systemic steroids did so
within one year after NF. An additional 80 patients with no prior
requirement of systemic steroids
were given medication after NF.
With respect to age, long-term use
of systemic steroids increased in
children younger than one year
of age and remained the same in
children older than one year.
Table 11 summarizes short- and
long-term use of systemic steroids
after NF in neurologically healthy
children. Overall short-term use
remained the same in neurologically healthy children after NF.
With respect to age, short-term use
increased in neurologically healthy
children younger than one year
and decreased in children older
than one year, and long-term use
increased in neurologically healthy
children younger than one year
of age and remained the same
in children older than one year.
Overall, long-term use increased
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
ORIGINAL Article
Short- and Long-Term Antireflux and Asthma Medication Use in Children After Nissen Fundoplication
in neurologically healthy patients
(59 to 75).
Table 12 summarizes short- and
long-term use of systemic steroids
after NF in neurologically impaired
children. Overall short-term use
remained the same in neurologically
impaired children after NF. With
respect to age, short-term use increased in neurologically impaired
children younger than one year of
age and decreased in children older
than one year, and long-term use increased in neurologically impaired
children younger than one year and
remained the same in children older
than one year. Overall, long-term
use of systemic steroids increased
in neurologically impaired patients
(43 to 75).
Revision Fundoplication
and Mortality
Twenty-six (7.6%) patients had
more than one fundoplication
operation performed. Fifty-one
patients (14.9%) died during the
study period. The causes of death
included aspiration pneumonia for
one patient, other pneumonia for
one patient, and respiratory distress
for two patients. All other deaths did
not appear to be associated with
GERD-related complications.
Discussion
Antireflux surgery has been a
mainstay in the treatment of GERD
for many decades. However, with
new and more potent antireflux
medications available, the long-term
outcome after antireflux procedures
has recently come into question.6
Previous studies have shown that
antireflux procedures are successful in relieving reflux symptoms in
children.4 In a multi-institutional
review of 7467 patients, good to excellent resolution of symptoms was
reported in 95% of neurologically
healthy children and 85% resolution
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Table 10. Short-term and long-term use of systemic steroids after
Nissen fundoplication in children
All children in study
All ages (n = 336)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
<1 year (n = 140)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
1 year ≤ age < 5 years (n = 99)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
≥ 5 years (n = 97)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
OR (95% CI)
p value
0.90 (0.69–1.18)
1.85 (1.43–2.41)
0.4630
<0.0001
3.19 (1.99–5.12)
6.04 (3.66–9.97)
<0.0001
<0.001
0.57 (0.38–0.87)
1.23 (0.79–1.92)
0.0089
0.3520
0.31 (0.19–0.53)
0.77 (0.50–1.19)
<0.0001
0.2377
CI = confidence interval; OR = odds ratio; NF = Nissen fundoplication.
Table 11. Short-term and long-term use of systemic steroids after
Nissen fundoplication in neurologically healthy children
Neurologically healthy children
All ages (n = 186)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
<1 year (n = 82)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
1 year ≤ age < 5 years (n = 50)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
≥5 years (n = 54)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
OR (95% CI)
p value
0.77 (0.54–1.11)
1.46 (1.03–2.06)
0.1567
0.0343
2.44 (1.34–4.43)
3.68 (1.97–6.87)
0.0034
<0.0001
0.39 (0.21–0.71)
0.92 (0.51–1.66)
0.0023
0.7814
0.32 (0.16–0.63)
0.73 (0.40–1.34)
0.0011
0.3152
CI = confidence interval; OR = odds ratio; NF = Nissen fundoplication.
Table 12. Short-term and long-term use of systemic steroids after
Nissen fundoplication in neurologically impaired children
Neurologically impaired children
All ages (n = 150)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
<1 year (n = 58)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
1 year ≤ age < 5 years (n = 49)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
≥ 5 years (n = 43)
Short-term (within 1 year of NF)
Long-term (>1 year after NF)
OR (95% CI)
p value
0.77 (0.54–1.11)
1.46 (1.03–2.06)
0.1567
0.0343
2.44 (1.34–4.43)
3.68 (1.97–6.87)
0.0034
<0.0001
0.39 (0.21–0.71)
0.92 (0.51–1.66)
0.0023
0.7814
0.32 (0.16–0.63)
0.73 (0.40–1.34)
0.0011
0.3152
CI = confidence interval; OR = odds ratio; NF = Nissen fundoplication.
9
Original article
Short- and Long-Term Antireflux and Asthma Medication Use in Children After Nissen Fundoplication
in neurologically impaired children
after NF.2 However, these subjective
outcomes were not clearly defined,
and there were no objective outcome measures in that study.
Few studies have documented
objective endpoints after NF in children. Conversely, in adult patients,
long-term follow-up monitoring
that compared medical and surgical
management of GERD showed no
difference in grade of esophagitis,
frequency of treatment of esophageal stricture, scores on the Medical
Outcomes Study 36-Item Short-Form
Health Survey, and overall satisfaction with antireflux therapy.7 Such
endpoints after NF are difficult to reproduce in children because not all
children being treated for
GERD routinely undergo
… it is unlikely
endoscopy to document
that asthma
esophagitis or stricture.
medication
Furthermore, existing
use will be
quality-of-life surveys
eliminated after
used in adults are not apNF, but there is
plicable to children.
a trend toward
In an attempt to prodecreased
vide
objective follow-up
use of rescue
after
NF, we previously
asthma
looked
at the number
medications …
of hospitalizations for
GERD-related complications to determine long-term effectiveness after NF. There was no
change in the frequency of hospitalizations, number of hospitalizations,
or number of patients hospitalized
for pulmonary symptoms and failure to thrive before and after NF.3
Similar results were seen in a population-based study.8 In another attempt to look at objective outcomes
after NF, we studied the long-term
use of antireflux medications after
NF and showed that NF decreased
use of antireflux medications by
37%. 4 However, both of these
studies were criticized because all
patients were grouped together.
Many suggested that GERD may af-
10
fect children differently depending
on age and underlying neurologic
status. In addition, the goals of
treatment may also be significantly
different because of age and associated comorbidities. It is well
known that patients with underlying
neurologic disorders have a higher
complication rate after NF, including a higher reoperation rate for
wrap disruption and increased risk
of hospitalization for GERD-related
complications after NF.3,8–11 Thus,
to address these issues, we specifically looked at short- and long-term
use of antireflux medications and
asthma medications on the basis of
age and neurologic status.
Antireflux medication use significantly decreased in both the short
term and the long term for all patients. Only neurologically healthy
children older than one year had
significant long-term decrease in
medication use. Children with associated neurologic impairment and
who were younger than one year
of age demonstrated a short-term
decrease in antireflux medication
use, but this trend did not continue over the long term. Although
these findings are significant and
provide valuable information to
better counsel parents regarding
antireflux medication use in their
children after NF, we still have not
answered the question of whether
the goals of the antireflux procedure, as determined by the parents
or caregivers, were met. It may be
that parents of children younger
than one year or children with
associated neurologic impairment
consider NF to be successful despite
the need to restart antireflux medications as long as other benefits of
NF, such as improved weight gain or
administration of bolus feedings, are
achieved. Further study is needed to
develop and validate quality-of-life
indicators and surveys specifically
for parents of these children.
An obvious goal for performing NF in patients with GERD and
severe reactive airway disease is
to eliminate or decrease the use
of asthma medications. Our study
showed that use of inhaled steroids
increased in the long term for all patients. This increase was seen more
in neurologically healthy children
younger than one year of age and
neurologically impaired children
younger than five years of age.
With respect to inhaled β-agonists,
there was a decrease in use in the
short term for older, neurologically
healthy children. Similar findings
were seen with respect to systemic
steroids use. These findings indicate that it is unlikely that asthma
medication use will be eliminated
after NF, but there is a trend toward
decreased use of rescue asthma
medications (systemic steroids and
inhaled β-agonists) in the short
term. These findings further support
the belief that outcomes after NF
vary with patient age and neurologic status.
Our study had several limitations.
Our data came from a discharge
abstract database, and the CPT
coding or coding according to
the International Classification of
Diseases, ninth revision (ICD-9), of
each diagnosis and procedure was
not independently validated. Thus,
we were not able to determine
the exact indications for NF. Some
patients with underlying neurologic
or cardiac anomalies underwent NF
because of their perceived risk of
developing GERD. Also, technical
details of the procedure were not
available, such as length of wrap,
crural approximation, or open versus laparoscopic. Another limitation
of this study was that indications
for administration of antireflux
and asthma medications were not
reviewed and are not known.
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Short- and Long-Term Antireflux and Asthma Medication Use in Children After Nissen Fundoplication
Previous studies have shown that
antireflux medications may be overprescribed in children;12,13 they have
been prescribed without adequate
workup and without documented
GERD. Although not previously
studied, this may also be the case
with respect to asthma medications.
In our study, we also did not know
how compliant patients were in
taking the antireflux and asthma
medications. Our pharmacy database represents dispensed medications, so we cannot be sure that
the patients were taking what was
prescribed.
Overall, our findings demonstrated a slight decrease in antireflux
medication use after NF. In children
with neurologic impairment, there
was no decrease in antireflux
medication use after NF. Thus, NF
should not be performed with the
expectation that patients will no
longer need antireflux medications.
Furthermore, with respect to asthma
medications, it appears that only
older, neurologically healthy children may potentially benefit from
NF. These findings suggest that
GERD and GERD-related complications may be significantly different
depending on age and associated
neurologic status. Finally, endpoints
indicating successful NF may also
be different depending on age and
neurologic status. v
Disclosure Statement
The author(s) have no conflicts of
interest to disclose.
Acknowledgment
Katharine O’Moore-Klopf, ELS, of KOK
Edit provided editorial assistance.
References
1.Rothenberg SS. The first decade’s
experience with laparoscopic
Nissen fundoplication in infants
and children. J Pediatr Surg 2005
Jan;40(1):142–7; discussion 147.
2.Fonkalsrud EW, Ashcraft KW, Coran
AG, et al. Surgical treatment of
gastroesophageal reflux in children:
a combined hospital study of 7467
patients. Pediatrics 1998 Mar;101(3
Pt 1):419–22.
3.Lee SL, Shabatian H, Hsu JW, Applebaum H, Haigh PI. Hospital admissions for respiratory symptoms and
failure to thrive before and after Nissen
fundoplication. J Pediatr Surg 2008
Jan;43(1):59–63; discussion 63-5.
4.Lee SL, Sydorak RM, Chiu VY,
Hsu JW, Applebaum H, Haigh PI.
Long-term antireflux medication
use following pediatric Nissen
fundoplication. Arch Surg 2008
Sep;143(9):873–6; discussion 876.
5.Current Procedural Terminology:
CPT 2002, 4th edition. Chicago (IL):
American Medical Association; 2001.
6.Hassall E. Outcomes of fundoplication: causes for concerns,
newer options. Arch Dis Child 2005
ORIGINAL Article
Oct;90(10)1047–52.
7.Spechler SJ, Lee E, Ahnen D, et al.
Long-term outcome of medical and
surgical therapies for gastroesophageal reflux disease: follow-up of a
randomized controlled trial. JAMA
2001 May 9;285(18):2331–8.
8.Goldin AB, Sawin R, Seidel KD,
Flum DR. Do antireflux operations
decrease the rate of reflux-related
hospitalizations in children? Pediatrics 2006 Dec;118(6):2326–33.
9.Pearl RH, Robie DK, Ein SH, et al.
Complications of gastroesophageal
antireflux surgery in neurologically impaired versus neurologically
normal children. J Pediatr Surg 1990
Nov;25(11):1169–73.
10. Dedinsky GK, Vane DW, Black T,
Turner MK, West KW, Grosfeld JL.
Complications and reoperation after
Nissen fundoplication in childhood.
Am J Surg 1987 Feb;153(2):177–83.
11. Spitz L, Kirtane J. Results and
complications of surgery for gastrooesophageal reflux. Arch Dis Child
1985 Aug;60(8):743–7.
12. Khoshoo V, Edell D, Thompson A,
Rubin M. Are we overprescribing
antireflux medication for infants
with regurgitation? Pediatrics 2007
Nov;120(5):946–9.
13. Diaz DM, Winter HS, Colletti RB,
et al; NASPGHAN/CDHNF Scientific
Advisory Board. Knowledge, attitudes and practice styles of North
American pediatricians regarding
gastroesophageal reflux disease.
J Pediatr Gastroenterol Nutr 2007
Jul;45(1):56–64.
All States of Life
The first fit of the asthma has been experienced at all times, from the earliest
infancy to extreme old age, and in every intermediate stage of life.
— Commentaries on the History and Cure of Diseases, William Heberden, 1710-1801, English physician
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
11
Original article
The Falling Rate of Positive Penicillin Skin Tests
from 1995 to 2007
Eric Macy, MD
Michael Schatz, MD, MS
CK Lin, PhD
Kwun-Yee Poon, MS
Abstract
Background: Data on the rate of positive penicillin
skin test (PenST) results over time in large populations
are rare. The factors that influence positive PenST
results are incompletely understood.
Objectives: We sought to correlate demographic variables to the rate of positive PenST results over time in a large
group of patients with a history of penicillin allergy.
Methods: Results from the first test for all patients
tested for penicillin allergy in the Kaiser Permanente
Health Care Program in San Diego County, CA, between 1995 and 2007 are reported. All patients were
tested with penicillin, penicilloyl-poly-lysine, penilloate, penicilloate, and amoxicillin.
Results: There were 255 positive PenST results in
3469 individuals. The rate of positive PenST results declined from >10% to <5% during the 13 years studied.
The positive PenST result rate could be accounted for
by the year of testing (R2 = 0.56; p = 0.003) without
any significant contribution from the patient’s age or
the time since reaction (TSR). If the TSR was ≤13 years,
the relative risk of a positive PenST result was 2.1 (95%
confidence interval = 1.6–2.8). If the study subject’s
age was ≤38 years, the relative risk of a positive PenST
result was 2.1 (95% confidence interval = 1.6–2.7).
Females reported higher rates of penicillin allergy
history than males did (11% compared with 6.6%; p
< 0.0001), but there were no significant sex differences
in the rate of positive PenST results.
Conclusions: There has been a steady decline in
the proportion of positive PenST results between 1995
and 2007, independent of study subject age and TSR.
Increasing age and increasing TSR were associated
with a lower rate of positive PenST results.
Introduction
Penicillin skin testing has been done in advance of
need in large groups of people since penicilloyl-polylysine (PPL) became commercially available in the 1970s.1,2
There have been higher rates for positive penicillin skin
test (PenST) results reported in recent studies from Europe
and the Middle East compared to most recent studies
from the US.3–7 The literature on IgE–mediated penicillin
allergy has become increasingly difficult to analyze8 for
the following reasons: 1) reports of PenST results are
marked by differences in populations studied, testing
criteria, reagents, and testing methods; 2) some studies
have very small sample sizes and include individuals with
histories of reactions to nonpenicillin β-lactams;9 3) there
are significant disagreements on the concentration of native amoxicillin that should be used for testing;10–12 and
4) there is no international consensus on what constitutes
an appropriate panel of PenST reagents.
Another factor contributing to this confusing state is
that there may be population variation in the rate of
positive PenST results over time. The positive PenST
result rate in children in the US has markedly declined
since the early 1990s.7 We present data here that was
derived from a large population, including both children
and adults, studied by a single group of investigators for
more than 13 years using the same method of skin testing with a extensive panel of chemically well-defined
PenST reagents. In addition to determining variation
over time of positive PenST results, we identified clinical
predictors of positive results in this population.
Methods
This study was reviewed and approved by the Kaiser Permanente (KP) Southern California institutional
review board. All PenSTs were performed by registered
Eric Macy, MD, (top, left) is an Allergist in the Department of Allergy at the San Diego Medical
Center and Assistant Clinical Professor of Medicine at the University of California San Diego
School of Medicine. E-mail: [email protected].
Michael Schatz, MD, MS, (top, right) is an Allergist and Chief of the Department of Allergy
at the San Diego Medical Center. He is a Clinical Professor in the Department of Medicine,
University of California San Diego School of Medicine. E-mail: [email protected].
CK Lin, PhD, (bottom, left) is a Project Manager at the Allergy and Immunology Laboratory
at the Los Angeles Medical Center in Los Angeles, CA. E-mail: [email protected].
Kwun-Yee Poon, MS, (bottom, right) is an Analyst in the Research and Evaluation
Department for Kaiser Permanente in Pasadena, CA. E-mail: [email protected].
12
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
ORIGINAL Article
The Falling Rate of Positive Penicillin Skin Tests from 1995 to 2007
nurses from the KP San Diego Allergy Department.
Patients were tested either in the outpatient setting or
in the hospital. The KP Health Care Program maintains
a single comprehensive medical record for each member. The medical records since 2007 are completely
electronic. This report complies with the position paper
of the European Academy of Allergology and Clinical
Immunology on nomenclature for allergy.13
Oral Challenges
An oral amoxicillin challenge was given to 215
individuals tested between November 16, 1994, and
May 28, 1996, who had negative results on PenSTs,
as previously reported.12,15 Almost all patients with a
negative result after July 16, 2006, were given an oral
amoxicillin (250 mg) or penicillin (500 mg) challenge
and observed for one hour.
Penicillin Skin Test Reagents
All patients were tested with penicillin (0.01 molar),
penicilloyl-poly-lysine (PPL) in the form of Pre-Pen or
self-produced PPL (6 × 10–5 molar), penicilloate (0.01
molar), penilloate (0.01 molar), and amoxicillin (0.01
molar).12 Commercially produced PPL (Pre-Pen) became
unavailable in the US after September 2004. Penicillin skin testing was done between October 2004 and
October 2006 using outdated Pre-Pen, as previously
reported.14 All penicillin skin testing done after October 2006 was done with PPL produced and assayed
in the KP Southern California Regional Immunology
Laboratory, as noted in the Sidebar: The production of
penicilloyl-poly-lysine.
Inclusion and Exclusion Criteria
Patients were offered a PenST if they had a history
of a penicillin-associated adverse drug reaction and if
it was thought that knowing whether they had positive
or negative test results on PenSTs would help in their
future clinical treatment. Most patients were tested in
advance of acute need for a penicillin-class antibiotic.
Patients were not offered a PenST if they had any of
the following exclusion criteria: Stevens-Johnson syndrome, toxic epidermal necrolysis, hemolytic anemia,
nephritis, hepatitis, or oral and/or skin blisters associated with or attributed to previous penicillin-class antibiotic use. Patients who had a history of anaphylaxis,
respiratory problems, hives, local swelling at the site
of injection, other rashes, gastrointestinal symptoms,
unknown index symptoms, and other mild symptoms
not specifically excluded by already-mentioned criteria
were tested.
Medical history data were obtained from each study
subject at the time of the PenST by the nurse performing the test or the physician treating the patient. Study
subjects were asked the following questions, and their
medical records were reviewed to confirm or add additional information that the patient could not provide:
1.How long has it been since your last adverse reaction to a penicillin-class antibiotic? The result was
recorded as the time since reaction (TSR) in years.
2.How long after the first dose of penicillin associated
with the last adverse reaction did it take for the first
adverse reaction symptom(s) to be noticed? The five
choices given were as follows: less than 1 hour, 1
to 24 hours, 25 to 72 hours, 73 or more hours, unknown.
3.What type of adverse reaction occurred? Because
this was an open-ended question, the answers were
sorted into the following eight categories:
a.Anaphylaxis—if the word anaphylaxis was offered, if shock occurred, or if more than two organ
systems were involved
b.Hives—if a pruritic rash occurred, where individual
lesions making up the rash lasted <24 hours; angioedema could also occur with the hives
Penicillin Skin Test Method
A buffered saline negative control and a histamine (1
mg/mL for prick tests and 0.1 mg/mL for intradermal
tests [ID]) positive control were placed at the start of
each round of tests. Drops of each reagent were placed
on the outer surface of the upper arm and pricked using a different Duotip-Test device (Lincoln Diagnostics,
Inc, Decatur, IL, USA) for each drop. After a 15-minute
waiting period, skin prick reactions were read and
recorded. The mean diameter of the wheal over the
mean diameter of the flare or surrounding erythema was
measured in millimeters. Positive responses consisted
of a wheal of ≥5 mm in diameter with surrounding
erythema greater than the wheal, a negative response
to the control solution, and a positive response to histamine. If all test responses were negative by skin prick,
then ID testing was performed using the outer surface
of the other upper arm. Using the same reagents, we
administered 0.02 mL of each reagent intradermally
through individual 27-gauge tuberculin syringes. ID test
results were also read and recorded after 15 minutes.
Positive responses consisted of a wheal of ≥5 mm in
diameter with surrounding erythema greater than the
wheal, a negative response to the control solution, and
a positive response to histamine. If any puncture test
result was positive, no ID tests were done with any of
the remaining negative reagents.
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
13
Original article
The Falling Rate of Positive Penicillin Skin Tests from 1995 to 2007
c.Local swelling—if only an area around an injection
swelled
d.Other rashes—if some other nonhive rash occurred
e.Gastrointestinal—if only abdominal pain, nausea,
vomiting, and/or diarrhea occurred
f. Pulmonary—if shortness of breath occurred in
isolation
g.Other—if any other mild symptoms occurred that
were not in categories a through f or in the exclusion criteria noted above
h.Unknown—if the patient did not know what
happened and if the reaction type could not be
determined by medical-record review.
We also attempted to collect data on patients’ recollections of the index reaction-associated infection,
the specific type of penicillin-class antibiotic used,
and the route of penicillin administration. Health Plan
demographics were obtained for 2007. Data from all
Health Plan patients who had at least one outpatient
Table 1. Study subject demographics
Study subjects tested
Age (mean years ± SD)
Time since reaction
(mean years ± SD)
Positive findings on
penicillin skin test
Positive findings on
penicillin puncture test
Males
1068 (30.8%)
44.0 ± 26.3
21.9 ± 19.5
Females
2401 (69.2%)
48.2 ± 21.7
20.7 ± 18.1
p value
<0.0001
0.09
79 (7.4%)
176 (7.3%)
0.95
8 (10.1%)
13 (7.4%)
0.47
Table 2. Penicillin skin test results by year of test
Time
period
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
Total
14
No. of
subjects
tested
Positive
(%)
Age (mean
years ± SD)
25
253
196
250
219
171
150
231
330
492
435
358
168
176
3469
10 (40.0)
39 (15.4)
18 (9.2)
20 (8.0)
21 (9.6)
7 (4.1)
13 (8.7)
25 (10.8)
29 (8.8)
23 (4.7)
21 (4.8)
16 (4.5)
7 (4.1)
6 (3.4)
255 (7.3)
30.7 ± 25.3
38.8 ± 22.3
39.4 ± 23.0
39.8 ± 21.3
38.9 ± 20.9
45.0 ± 20.5
40.1 ± 21.6
43.9 ± 25.4
56.5 ± 22.0
52.9 ± 21.2
50.9 ± 22.5
50.9 ± 24.3
47.9 ± 22.4
46.8 ± 22.7
46.9 ± 23.3
Time since
reaction
(mean years
± SD)
13.6 ± 15.9
13.8 ± 15.8
15.0 ± 15.6
14.9 ± 14.8
13.9 ± 15.7
16.5 ± 16.4
14.2 ± 16.7
18.3 ± 17.1
28.9 ± 18.6
24.1 ± 17.8
26.2 ± 19.3
26.3 ± 20.5
20.7 ± 18.6
23.9 ± 19.6
21.1 ± 18.6
Average
Health Plan
patient age
(years)
35.7
35.8
35.6
35.6
36.0
36.5
37.0
37.4
37.9
38.3
38.4
38.4
38.5
visit in 2007 were reviewed. Patient-reported drug
allergy and intolerance was tabulated.
Statistical Analysis
Hypothesis testing for continuous variables was by
means of Student’s t-test (two groups) and analysis
of variance ([ANOVA] more than two groups) and for
categoric variables by χ2. Relationships between year
of study and rate of positive results on skin tests, and
between year of study and mean patient age were
determined by simple linear regression. Results were
expressed as the average change per year on the basis of the regression coefficient, with the adjusted R2,
ANOVA, F, and p value of the models also presented.
Independent predictors of positive findings for skin
test reactivity were determined by means of stepwise
multiple linear regression. In this model, the dependent
variable was the percentage of positive penicillin skin
test results, and the independent variables were mean
age of skin-tested patients, mean TSR, and year tested.
Because of potential colinearity, a forward stepwise
algorithm was used. Nominal statistical significance was
set at p = 0.05. All statistical analyses were performed
using SAS version 9.1 statistical software (SAS Institute,
Inc, Cary, NC, USA).
Results
Penicillin skin testing was performed on 3469 unique
individuals between November 16, 1994, and January
21, 2008, including 3158 previously reported on.12,14–19
Study cohort demographics are reported in Table 1. Of
3469 study subjects tested, 255 had positive results on
PenSTs. Of 411,543 Health Plan patients seen during
2007, 37,059 (9.0%) reported a history of penicillin allergy. More females, 11.0%, than males, 6.6%, reported
a history of penicillin allergy (p < 0.0001). Males accounted for 33.2% of the Health Plan patients with a
history of penicillin allergy in 2007 and 30.8% of the
patients undergoing PenST over the course of the study
(Table 1). The proportion of positive PenSTs, including
the subgroup with positive results on penicillin puncture, was not significantly different between females
and males (Table 1). TSR data was not available for
355 (10.2%) study subjects.
There were 36 adverse reactions, both subjective
and objective, during testing, 13 (5.1%) in the group
with positive PenST results and 23 (0.72%) in the group
with negative PenST results (p < 0.001). In the former
group, there were 21 (8.2%) who had positive results
on penicillin puncture. There were 4 (19.0%) adverse
reactions in the PenST group with positive findings on
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
ORIGINAL Article
The Falling Rate of Positive Penicillin Skin Tests from 1995 to 2007
puncture and 9 (3.9%) in the PenST ID group with positive findings (p = 0.0024). None of the testing-associated
reactions were severe. Fewer than half received any
treatment. Seven were treated with epinephrine and
antihistamines, five were treated with antihistamines
only, two received ammonia inhalant, and the rest
received no treatment.
The percentage of positive findings on PenSTs by
year of test, along with mean age of tested study subject, TSR, and mean age of Health Plan patients, are
shown in Table 2. There was a significant decrease in
the rate of positive findings on PenSTs with time (R2
= 0.561; F = 14.069; p = 0.0032). Study subjects were
progressively older at an average rate of 1.18 years per
year over the 13 years studied (R2 = 0.556; F = 13.783;
p = 0.0034). The average age of Health Plan patients
increased by only 0.22 years per year. After 2001, a
greater emphasis was placed on testing hospitalized
individuals who were older than average Health Plan
patients (data not shown).
The prevalence of positive findings on PenSTs was
highest in younger patients and decreased significantly
(p < 0.0001 χ2 for trend) with advancing age, as displayed
in Table 3A. Nearly 70% of patients with positive findings
on PenSTs were ≤50 years old. Half of the study subjects
with positive findings on PenSTs were ≤38 years old.
If a patient reported an age of <38 years (median), the
relative risk of a positive finding on a PenST was 2.1
(95% confidence interval [CI] = 1.6–2.7).
The relationship between the TSR and the preva-
lence of positive findings on PenSTs is displayed in
Table 3B. Patients with positive findings on PenSTs
had shorter TSRs (13.3 ± 15.4 years) than patients with
negative PenSTs (21.7 ± 18.7 years; p = 0.0001). Half
of the study subjects with positive findings on PenSTs
had a TSR ≤6 years. One quarter of the study
subjects with positive findings on PenSTs had
The prevalence of
a TSR ≤3 months. Ten percent of the study
positive findings on
subjects with positive findings on PenSTs
PenSTs was highest
had a TSR ≥38.2 years. If a patient reported
in younger patients
a TSR ≤13 years (mean) the relative risk of
and decreased
a positive finding on a PenST was 2.1 (95%
significantly … with
CI = 1.6–2.8).
advancing age …
Given that both study subject age and TSR
correlated to PenST results and the overall
population studied was older as the study progressed,
a stepwise linear regression was performed to see if
the year of testing had an independent effect on the
proportion of patients with a positive finding on a
PenST in a given year. The rate of positive findings
could be accounted for by the year of testing (R2 =
0.56; p = 0.003) without any significant contribution
from the patient’s age or the TSR.
The relationships among the type of index reaction
to proportion of positive findings on PenSTs, patient
age, and TSR are displayed in Table 4. Time to onset
of the index adverse reaction to penicillin was not
significantly associated with PenST outcome (n = 2279;
χ2 = 4.05; p = 0.26). The index reaction type was
related to a positive result for a PenST (Table 3; n =
Table 3A. Relationship of subject age (by quartile) to the prevalence of positive findings on penicillin
skin tests
Study subject age
quartile (years)
<30
30–50
51–65
>65
No. of study
subjects
tested
866
884
844
875
Percentage of study subjects in
that quartile who had positive
findings on penicillin skin testa
11.3
9.1
5.2
3.8
Percentage of study subjects who had
positive findings on penicillin skin test
who are in that quartilea
38.4
31.4
17.2
12.9
p < 0.0001 χ2 for trend.
a
Table 3B. Relationship of time since reaction to the prevalence of positive findings on penicillin skin
tests
Time since reaction
category (years)
<1
1–10
11–20
>21
No. of study
subjects
tested
944
609
366
1455
Percentage of study subjects in
that category who have positive
findings on penicillin skin testsa
10.4
9.5
7.9
4.6
Percentage of study subjects who have
positive findings on penicillin skin tests
who are in that categorya
38.9
33.0
11.5
26.6
p < 0.0001 χ2 for trend.
a
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
15
Original article
The Falling Rate of Positive Penicillin Skin Tests from 1995 to 2007
3029; χ2 = 34.28; p < 0.0001). There was a significant
relationship between age and the index reaction type
(ANOVA; F = 40.85; p < 0.0001). The most pronounced
difference was noted between individuals reporting
hives (mean age, 40.7 years) compared with those
reporting local swelling (mean age, 60.4 years). There
was also a significant relationship noted between the
TSR and the index reaction type (ANOVA; F = 35.72; p
< 0.0001). Again, the most pronounced differences were
seen between study subjects reporting hives (mean TSR,
15.5 years) and those reporting local swelling (mean
TSR, 30.7 years). Subjects reporting anaphylaxis were
intermediate (mean TSR, 21.6 years).
Patient recollection of the infection associated with
the index reaction and the specific penicillin-class
antibiotic used were too poor to produce a meaningful analysis.
Oral challenges with amoxicillin or penicillin were
given to 311 individuals with negative results on PenSTs
after July 16, 2006. Data on study subjects given oral
challenges after testing before July 16, 2006, have been
previously reported.12,15 There were six (1.9%) acute
subjective reactions reported; five patients noted itching, but no visible rash was present; and one patient
reported chest tightness but had completely normal
spirometry results while symptomatic. There were also
5 (1.6%) delayed-onset reactions reported, all rashes
starting from 5 to 30 hours after the oral challenge.
Several were treated with oral antihistamines, and there
were no severe reactions.
Discussion
We find in a large, well-characterized group of individuals with a history of penicillin allergy that the rate
of positive results on PenSTs has decreased since 1995.
The rate of positive findings on PenSTs was lower in
older patients and in those with longer TSRs, but the
decreasing rate of positive findings on PenSTs was
independent of these variables. A partial explanation
for these observations may lie in the changes over
time in the route and frequency of outpatient antibiotic
use. Parenteral antibiotic use has become rare in the
outpatient setting, where most antibiotic use occurs.
Consistent with this, patients with histories of local
reactions to penicillin injections were the oldest group
of patients studied. Overall outpatient oral antibiotic
use has also decreased significantly in our Health Plan
(data not shown). Reduced use of antibiotics over time,
especially by the parenteral route, could help explain
the overall decrease in positive results on PenSTs over
time as well as the relationship between positive results
on PenSTs and both older age and longer TSRs.
Even though the rate of positive findings on PenSTs
is decreasing and is lowest in older patients, positive
test results still occur. Thus, the PenST is a very useful
clinical tool in older individuals who are more likely to
be hospitalized and, when in the hospital, much more
likely to require antibiotics.18
We did not see higher rates of positive findings on
PenSTs in women, as reported recently by Park et al.6
We did see overall similar low rates of positive findings
on PenSTs in adults. For patients undergoing penicillin
skin testing between June 2, 2002, and June 30, 2004,
Park et al reported 64 (3.7%) positives from 1722 valid
test results. When they reanalyzed their data using 5
mm as the threshold for a positive finding on a PenST
as we did in this study, they did not see a significant
difference between males, 8/724 (1.1%) and females
19/988 (1.9%) (Miguel Park, MD personal communication, September 2008).a
Penicillin skin testing as we describe is safe.20 However, a few individuals with positive results on PenSTs,
7% to 10%, also have positive results on PenST puncture
tests and thus are extremely allergic. These individuals
Table 4. Relationship between the type of index reaction to the proportion of positive findings on
penicillin skin tests, study subject age, and time since reaction
Type of index
reaction
Pulmonary
Anaphylaxis
Hives
Local swelling
Gastrointestinal
Other rashes
Other
Unknown
Total
16
No. of subjects
(%)
59 (1.7)
148 (4.3)
1539 (44.4)
242 (7.0)
91 (2.6)
782 (22.5)
168 (4.8)
440 (12.7)
3469 (100)
No. of positive
findings on penicillin
skin tests (%)
8 (13.6)
20 (13.5)
143 (9.3)
15 (6.2)
5 (5.5)
36 (4.6)
4 (2.4)
24 (5.5)
255 (100)
Study subject age
(mean years ± SD
years)
54.0 ± 19.3
51.2 ± 17.4
40.7 ± 23.9
60.4 ± 18.4
50.2 ± 21.9
49.3 ± 23.9
55.7 ± 17.0
50.4 ± 20.2
46.9 ± 23.3
Time since reaction
(mean years ± SD years)
20.7 ± 19.5
21.6 ± 18.0
15.5 ± 16.9
30.7 ± 17.8
19.5 ± 17.8
22.9 ± 18.7
25.9 ± 18.4
36.6 ± 14.3
21.1 ± 18.6
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
ORIGINAL Article
The Falling Rate of Positive Penicillin Skin Tests from 1995 to 2007
The Production of Penicilloyl-poly-lysine
Penicilloyl-poly-lysine (PPL) was produced as follows: All
chemicals were obtained from Sigma Chemicals (St Louis,
MO; www.sigmaaldrich.com). A solution of 2 mmol of lysine
(0.25 g) in the form of poly-l-lysine hydrobromide (Sigma
Chemicals P0879; molecular weight, 1–5 kDa) in 50 mL of
sterile deionized water was made by stirring until everything
was completely dissolved in the water. An equal molar amount
of potassium penicillin G (Sigma Chemicals P8721), 2 mmol
(0.0746 g), was slowly added into the solution during continuous stirring. The pH was adjusted to 11.5 with 5N NaOH. The
mixture was continuously stirred at room temperature for 90
minutes. A three-times molar excess of succinic anhydride
(Sigma Chemicals 28-5500), 6 mmol (0.06 g), was slowly added
to the solution with continued stirring. The pH was maintained
at 11.0 for 1 hour while stirring continued. Another 0.6 g of
succinic anhydride was added into the solution. Stirring continued as pH was maintained at 9.5 for 1 hour. The last 0.6
g of succinic anhydride was added into the solution. Stirring
continued as pH was maintained at 9.5 for a final hour. The
mixture was transferred into a Spectrum/Por #6 MW cutoff 1K
dialysis tubing (Spectrum Laboratories, Inc; Rancho Dominguez,
CA; www.spectrapor.com). The PPL was dialyzed against 4-L
baths at 4°C, with daily buffer changes, for 7 days. On days
1 and 2, 0.002 M Tris, at a pH of 8.5, with 5 g of BioRad
50W-X2 resin was used. On days 3 to 7, 0.15N NaCl with no
resin was used. The dialyzed solution was filtered through a
0.22-µm Millipore (Billerica, MA, USA) filter. The PPL solution
was placed into sterile tubes and lyophilized to obtain PPL
powder. The PPL was assayed using the penamaldate (HgCl2
titration) method to determine the moles of penicillin bound.1
The molar concentration was calculated using an extinction
coefficient of 22.325 for the penicilloyl moiety at 282 nm, pH
= 7.6. The penicilloyl-bound concentration (M) = 500{[Amax
(3 + 0.02N)/3] – Aini}/22.325 b, where Amax is the maximum
absorbance observed at 282 nm, Aini is the initial absorbance
at 282 nm, N is the number of 20-µL portions of 0.007% HgCl2
solution (3.5 mg of HgCl2 in 50 mL water) added, and b = the
width of the cuvette. A dilution factor of 500 was chosen on
the basis of the transfer of 10 µL of the PPL test solution into
5 mL of phosphate-buffered saline (PBS) at a pH of 7.6. The
assay was performed using 3 mL of the penamaldate-PPL-PBS
mixture in a standard 3-mL quartz cuvette, b = 1 cm. Samples
were then tested for endotoxin. Sterility was verified using
blood agar plates and a BBL-enriched thioglycolate anaerobic
broth (Becton, Dickinson and Company, Franklin Lakes, NJ,
USA). The PPL was then diluted with sterile PBS to the desired
concentration of 6 × 10–5 molar. The PPL was stored at 4°C
until ready for skin testing. The PPL solution has been found
to be stable for >2 years at 4°C.
1
United States Phamacopeia and National Formulary 2004.
Rockville, MD: United States Pharmacopeial Convention, 2003
Nov. p 228.
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
are likely to have a testing-associated reaction and
may benefit from an oral antihistamine given as
soon as the positive puncture finding is apparent.
This is also the reason we do not perform any ID
tests on an individual with any positive puncture
results.9,21 Our use of amoxicillin at about 2 mg/mL
or 0.01 molar, compared with the 20 to 25 mg/mL
used by some other investigators, helps explain
two findings. First, it may explain the very high
rates of false positive results on PenSTs recently
noted by Goldberg and Confino-Cohen,5 where
only 6.6% of individuals with positive results on
PenSTs responded to an oral challenge, only mild
rashes were seen, and no severe reactions to the
oral challenges occurred. Second, it might explain
the relatively high rates of systemic testing reactions
reported by some European investigators.21 If 0.02
mL of a 25-mg/mL solution of amoxicillin is used
for ID testing, it results in 0.5 mg of systemic antibiotic exposure, which may be enough to cause a
reaction. Additionally concentrated amoxicillin solutions have to be very basic because the solubility of
amoxicillin in water at physiologic pH is only about
4.0 mg/mL, which may contribute to a nonspecific
irritant effect. The use of a mean wheal diameter
of 5 mm with erythema greater than wheal as the
positive test result cutoff reduced the rate of false
positive results on PenSTs in our study.
The use of an oral challenge after a negative
skin test result is safe. Our oral challenge reaction
rates after a negative PenST result are about an
order of magnitude lower than recently reported
by European investigators.10,22 About 3% of individuals with a history of penicillin allergy and a
negative finding on a PenST will report some sort of
adverse reaction, generally mild, after a therapeutic
course of a penicillin-class antibiotic. Some of these
delayed-onset reactions may be T-cell mediated.
In our study, only rarely did an individual report
a delayed-onset reaction—one to two days later—
at the site of ID tests with negative findings. Our
rates of delayed-type hypersensitivity reactions after
PenSTs are also about an order of magnitude lower
than seen by European investigators, who used
much higher amoxicillin concentrations.10,22 Their
rate of positive findings on PenST puncture was
higher than ours, but their overall rate of positive
findings on PenSTs was very similar to ours.
Penicillin skin testing as we describe with oral
challenge is an effective way to allow the majority
of individuals with a history of penicillin allergy to
17
Original article
Penicillin skin
testing as we
describe with
oral challenge
is an effective
way to allow
the majority
of individuals
with a history
of penicillin
allergy to
subsequently
take penicillinclass antibiotics.
The Falling Rate of Positive Penicillin Skin Tests from 1995 to 2007
subsequently take penicillin-class antibiotics. The longer
an allergic individual goes without exposure to an allergen, the more likely an allergy is to become clinically
insignificant. This was demonstrated well with latex allergy starting in the late 1980s through the early 2000s.23
The inverse relationship demonstrated in our current
study between TSR and the rate of positive results on
PenSTs is consistent with this paradigm as well.
In summary, our data suggest that true penicillin
allergy, as defined by medical history, positive results
on a PenST, and clinically significant reactions with reexposure may be decreasing over time. We believe that
this makes it even more important to identify the increasing majority of patients who have a history of an adverse
reaction to penicillin but are not currently allergic. We
thus encourage the use of penicillin skin testing and oral
challenge as we describe to improve patient safety. We
encourage the pharmaceutical industry to provide PPL,
penilloate, and penicilloate to use in testing worldwide.
Our data suggest that testing would be particularly helpful for older individuals, who are more likely to benefit
from the use of penicillin-class antibiotics and less likely
to have positive results on a PenST. v
a
Department of Medicine, Division of Allergic Diseases, Mayo
Clinic, Rochester, MN.
Disclosure Statement
The author(s) have no conflicts of interest to disclose.
Acknowledgment
Katharine O’Moore-Klopf, ELS, of KOK Edit provided editorial
assistance.
References
1.Green GR, Rosenblum AH, Sweet LC. Evaluation of penicillin hypersensitivity: value of clinical history and skin testing
with penicilloyl-polylysine and penicillin G. A cooperative prospective study of the penicillin study group of the
American Academy of Allergy. J Allergy Clin Immunol 1977
Dec;60(6):339–45.
2.Mendelson LM, Ressler C, Rosen JP, Selcow JE. Routine elective penicillin skin testing in children and adolescents: study
of sensitization. J Allergy Clin Immunol 1984 Jan;73(1 Part
1):76–81.
3.Palma-Carlos ML, Palma-Carlos AG, Medina M. “In vivo”
and “in vitro” tests in the diagnosis of Beta-lactams allergy.
Eur Ann Allergy Clin Immunol 2007 May;39(5):157–61.
4.Matheu V, Pérez E, González R, et al. Assessment of a new
brand of determinants for skin testing in a large group of
patients with suspected beta-lactam allergy. J Investig Allergol Clin Immunol 2007;17(4):257–60.
5.Goldberg A, Confino-Cohen R. Skin testing and oral penicillin
challenge in patients with a history of remote penicillin allergy. Ann Allergy Asthma Immunol 2008 Jan;100(1):37–43.
18
6.Park MA, Matesic D, Markus PJ, Li JT. Female sex as a risk
factor for penicillin allergy. Ann Allergy Asthma Immunol
2007 Jul;99(1):54–8.
7.Jost BC, Wedner HJ, Bloomberg GR. Elective penicillin skin
testing in a pediatric outpatient setting. Ann Allergy Asthma
Immunol 2006 Dec;97(6):807–12.
8.Torres MJ, Blanca M. Penicillin allergy. Allergy
2003;58(5):452.
9.Nolan RC, Puy R, Deckert K, O’Hehir RE, Douglass JA.
Experience with a new commercial skin testing kit to
identify IgE-mediated penicillin allergy. Internal Med J 2008
May;38(5):357–61.
10. Bousquet PJ, Kvedariene V, Co-Minh HB, et al. Clinical
presentation and time course in hypersensitivity reactions to
beta-lactams. Allergy 2007 Aug;62(8):872–6.
11. Solensky R. Hypersensitivity reactions to beta-lactam antibiotics. Clin Rev Allergy Immunol 2003 Jun;24(3):201–20.
12. Macy E, Richter PK, Falkoff R, Zeiger R. Skin testing with
penicilloate and penilloate prepared by an improved
method: amoxicillin oral challenge in patients with negative
skin test responses to penicillin reagents. J Allergy Clin Immunol 1997 Nov;100(5):586–91.
13. Johansson SG, Hourihane JO, Bousquet J, et al; EAACI (the
European Academy of Allergology and Clinical Immunology)
nomenclature task force. A revised nomenclature for allergy.
An EAACI position statement from the EAACI nomenclature
talk force. Allergy 2001 Sep;56(9):813–24. Erratum in: Allergy 2001 Dec;56(12):1229.
14. Macy E, Lin CK, Goldberg B. Penicilloyl-polylysine stability
and clinical use over time. Perm J 2007 Fall;11(4):10–1.
15. Macy E. Elective penicillin skin testing and amoxicillin challenge: effect on outpatient antibiotic use, cost, and clinical
outcomes. J Allergy Clin Immunol 1998 Aug;102(2):281–5.
16. Macy E, Burchette RJ. Oral antibiotic adverse reactions
after penicillin testing: multi-year follow-up. Allergy 2002
Dec;57(12):1151–8.
17. Macy E, Mangat R, Burchette RJ. Penicillin skin testing in
advance of need: multiyear follow-up in 568 test result–
negative subjects exposed to oral penicillins. J Allergy Clin
Immunol 2003 May;111(5):1111–5.
18. Macy E, Roppe L, Schatz M. Routine penicillin skin testing in
hospitalized patients with a history of penicillin allergy. Perm
J 2004 Summer;8(3):20–4.
19. Macy E. Penicillin skin testing in pregnant women with
a history of penicillin allergy and group B streptococcus colonization. Ann Allergy Asthma Immunol 2006
Aug;97(2):164–8.
20. Macy E. Risks of penicillin skin testing. Ann Allergy Asthma
Immunol 2000 Nov;85(5):330–1.
21.Co Minh HB, Bousquet PJ, Fontaine C, Kvedariene V,
Demoly P. Systemic reactions during skin tests with betalactams: a risk factor analysis. J Allergy Clin Immunol 2006
Feb;117(2):466–8.
22. Bousquet PJ, Pipet A, Bousquet-Rouanet L, Demoly P. Oral
challenges are needed in the diagnosis of beta-lactam
hypersensitivity. Clin Exp Allergy 2008 Jan;38(1):185–90.
23.Reunala T, Alenius H, Turjanmaa K, Palosuo T. Latex allergy and skin. Curr Opin Allergy Clin Immunol 2004
Oct;4(5):397–401.
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
soul of the healer
“Thriving at 20 till 7”
photograph
By John Davenport, MD
John Davenport, MD, is a Family Medicine Physician
at the Lakeview Medical Center in Anaheim, CA.
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
19
Original article
Developing Minimally Invasive Surgery Centers
Within Kaiser Permanente: The Integrated
Multidisciplinary Experience of Los Angeles
Gary W Chien, MD
Maher A Abbas, MD, FACS, FASCRS
Abstract
Minimally invasive surgical therapies are growing in type and volume
of interventions. As one of the largest health delivery organizations in the
US, Kaiser Permanente staff must be aware that the proliferation of these
technologies has occurred in parallel within many surgical specialties, with
a large variation in level of implementation between different regions and
even within regions. In Los Angeles, we have developed the Minimally
Invasive Surgery Center, encompassing a multidisciplinary, integrated
approach. It unites the effort and expertise of many outstanding practitioners within the organization and consolidates the achievements of many
surgical specialties. It also brings together the elements needed to provide
the highest level of care to our patients in a safe, efficient, cost-effective
environment, with minimal morbidity and best long-term outcome.
Introduction
Surgical procedures and interventions remain an important
cornerstone of modern health care
and contribute to the care of millions of individuals in the US every
year. Surgery is invasive and often
requires large soft-tissue incisions to
gain access to diseased organs and
compartments of the human body.
Although the morbidity of a procedure is determined by its nature and
that of its target organ (eg, bone,
brain, bowel, urologic tract, gynecologic organs), the invasiveness
and magnitude of the soft-tissue
incision is one of the determinants
of postoperative recovery, complications, length of hospital stay, pain,
and eventual resumption of normal
daily activities.
Since the 1980s, the surgical
fields have been in a revolutionary phase with the development
and implementation of new technologies and procedures that have
provided surgeons across many
specialties with an armamentarium
of less-invasive therapies. Many
conditions traditionally approached
with open surgery are now treated
by alternative means.1–22 Minimally
invasive surgery (MIS) can address
many disease processes by allowing the surgeon access to the area
of interest through smaller incisions
that are at lower risk of morbidity.
The advantages and benefits as-
sociated with MIS have translated
into fewer complications and less
morbidity for the patient without
compromising the principal goal
of surgical therapies, which is the
eradication or control of disease
(eg, removal of an inflamed gallbladder, ablation of endometriosis,
excision of colon cancer, repair of
an aortic aneurysm, evacuation of a
herniated vertebral disc, elimination
of gastroesophageal acid reflux). As
experience with MIS has evolved—
and is still evolving—there has
been rapid growth in both the
types and volume of such surgeries
performed, with a shift from simple
procedures such as hernia repair
to more complex and advanced
procedures such as gastric bypass
and radical prostatectomy, partial
nephrectomy, and cystectomy.7–12
Many MIS techniques have now
become the standard of care (eg,
cholecystectomy for cholecystitis,
splenectomy for hematologic disease, adrenalectomy for adrenal
tumors, transsphenoidal resection
for pituitary tumors, arthroscopic
shoulder surgery for rotator cuff
injuries, endovascular therapy for
aortic disease), but other procedures
increasingly compete with open surgery for percentage volume of cases
and a growing number of indications
Gary W Chien, MD, (left) is the Director of the Minimally Invasive Urology/Endourology Fellowship
Program at the Los Angeles Medical Center in Los Angeles, CA. E-mail: [email protected].
Maher A Abbas, MD, FACS, FASCRS, (right) is an Assistant Clinical Professor of Surgery at UCLA;
the Chief, Colon and Rectal Surgery and Chair, Center for Minimally Invasive Surgery at the Los
Angeles Medical Center in Los Angeles, CA. E-mail: [email protected].
20
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Developing Minimally Invasive Surgery Centers Within Kaiser Permanente: The Integrated Multidisciplinary Experience of Los Angeles
(eg, colectomy for diverticulitis
or colon cancer, hysterectomy for
fibroids or malignancy).1,3,4,14
Several new, advanced MIS techniques are being implemented, are
under development, or are being
investigated for technical feasibility
and results.15–26 Research is currently
underway to evaluate the results of
MIS for oncologic disorders such as
rectal cancer.15,16 Robotic surgery is
gaining momentum in the US and
other countries as more data are
collected on short- and long-term
outcome and its potential role in
and impact on pelvic surgery for
urologic, gynecologic, and colorectal conditions as well as foregut and
thoracic surgery.6,18–22 Kaiser Permanente (KP) recently introduced
robotic surgery in its Southern and
Northern California Regions and is
closely monitoring the effects of
this evolving technology. Finally,
active investigation is underway
to assess the technical feasibility,
safety, and outcome of single-port
surgery (accessing the abdominal
cavity and performing abdominal
surgery assisted by a device through
a single 2-cm umbilical incision)
and of natural orifice transluminal endoscopic surgery ([NOTES]
accessing the abdominal cavity
through a puncture in the stomach,
rectum, or vagina and performing
abdominal surgery through a flexible endoscopic device).17,23,24 Research in these emerging areas will
yield innovations, new technologic
advances, and new tools.
Rapid Growth in Volume
of Advanced Minimally
Invasive Procedures
KP embraced the MIS revolution from the beginning. Some KP
hospitals got involved with the
introduction and implementation
of these new procedures early in
their development. For example,
the San Diego facility in Southern
California pioneered some of the
MIS procedures to advance the care
of patients with intestinal and abdominal conditions.27 Since the early
1990s, surgeons at the KP San Diego
Medical Center have performed
numerous laparoscopic colonic
resections. Their surgical skills have
benefited not only KP San Diego
patients but also patients across the
US through their contributions as
surgery educators at many symposia
and conferences. More recently, the
West Los Angeles Medical Center in
Southern California implemented
robotic surgery for radical prostatectomy. Within a short time, our group
of urologists has performed one of
the largest series of patients at both
the national and international levels.
Our collaboration has yielded comprehensive short-term outcomes
and a model of efficiency for future
expansion of robotic surgery within
KP. Although noting all MIS advances at a regional or national level is
beyond the scope of this article, we
note that KP physicians both inside
and outside the Southern California
region are responsible for many MIS
achievements.
Across KP nationally, the growth
of advanced MIS procedures was
gradual in the 1990s, but there has
been a rapid surge in volume in the
first decade of the 21st century. This
phenomenon stems from several
factors: influx of a large number of
fellowship-trained surgeons with
advanced MIS skills, the increasing
availability of surgical tools and
technology to perform such operations, proliferation of outcomes
data demonstrating the benefits
of MIS, patients’ demands, and an
institutional commitment to provide
state-of-the-art care to patients.
Our own experience at the Los
Angeles Medical Center (LAMC) illustrates the growth in MIS practices
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
ORIGINAL Article
within KP. Our institution serves
as the regional tertiary center for
all hospitals within Southern California and occasionally provides
extraregional care to patients from
the Hawaii and Northwest regions.
Since 2003, we have witnessed
swift growth in the number of MIS
procedures across many specialties
at LAMC: for instance, the volume
of advanced laparoscopic urologic
procedures has increased more
than tenfold, and the percentage
of colorectal excisions performed
with laparoscopic or endoscopic
techniques has increased from <5%
in 2003 to >60% in 2008. Currently,
pediatric surgeons perform 40% of
their procedures in children using
MIS techniques; a few years ago,
none of them used MIS. Orthopedic
MIS procedures for upper-extremity
conditions such as rotator cuff injury, unstable joints, and contractures represent >60% of the total
volume of cases. Within the field
of neurologic and spine surgery,
approximately 100 MIS procedures
are performed at LAMC every year.
Finally, there has been a major shift
in the MIS training and expertise
of the staff in the various surgical
subspecialties at our medical center.
Within the Department of Surgery
(general surgery and its subspecialties), for example, the percentage
of surgeons offering advanced MIS
procedures (laparoscopic, endovascular, endoscopic) grew from 18%
(2 of 11 surgeons) in 2003 to 71%
(12 of 17 surgeons) in 2008.
The Need for
Multidisciplinary
Minimally Invasive
Surgery Centers
The implementation of new
technology and growth in MIS procedure volume has benefited both
patients and the health care system
but has also presented many chal-
21
Original article
Developing Minimally Invasive Surgery Centers Within Kaiser Permanente: The Integrated Multidisciplinary Experience of Los Angeles
lenges. Different procedures have
been established at different times
and have been implemented at different rates within KP because of the
gradual evolution of the technology.
Furthermore, the introduction and
promotion of MIS procedures within
KP has been driven by individual
surgeons in various specialties
according to their interest level, training,
… we have
and expertise. In most
reached a point
instances, the implein the history of
mentation of these new
surgery where
procedures has been
an infrastructure
fragmented, with large
is needed that
variation in practice
can both support
patterns among surexisting practices
geons in the different
and accommodate
regions and even withthe proliferation of
in the same region or
future technology.
medical center. Despite
We must evolve
leadership support and
from a surgeoncommitment to MIS,
driven process to a
there has not been a
team- and systemsystemic approach to
based process.
MIS implementation
at a local, regional, or
national level. Medical
centers have not optimized the introduction of these new procedures.
Furthermore, each subspecialty has
its own learning curve. Often, the
different surgical subspecialties do
not share resources, consolidate
accumulated experiences, or exchange information on best practices to make the learning curve less
steep and resolve the challenges of
developing and implementing new
technology. Although there are
unique issues for each specialty,
many common issues, such as
anesthetic considerations, organizing operating room teams for
MIS, standardization of disposable
products and electrosurgical units,
testing and implementation of new
equipment, postoperative care,
education, simulation, training,
and research, could be effectively
22
and efficiently addressed through a
multidisciplinary approach.
There are numerous unresolved
issues, at KP and elsewhere, surrounding the care of patients treated
with MIS procedures: There is an
ongoing debate of how to best train
residents, fellows, and practicing surgeons not proficient in advanced MIS
techniques. Additionally, there is no
consensus as to how best to proctor
or credential physicians requesting
privileges for MIS procedures.28–30
Also, changes in the operating
room environment are particularly
stressful for surgeons and supporting nursing staff. The majority of
practicing scrub and circulating
nurses are skilled at assisting in
open procedures. For more than
100 years, surgical nurses and
technicians have received extensive
training on how to best assist surgeons to perform traditional procedures. The nursing surgical heritage
and knowledge of instrumentation
and equipment have been transmitted from one generation to the next
in nursing and technical schools and
perfected in operating rooms everywhere. Therefore, many support
personnel lack the skills set necessary to effectively assist surgeons
with MIS techniques. Our experience has been that most operating
room nurses and technicians have
been acquiring the necessary experience on the job, a process that is
often stressful and frustrating to the
surgeon and costly to patients and
institutions because of decreased
efficiency, increased duration of
surgery, and thus increased fees.
Furthermore, labor regulations and
considerations affect staffing and
logistical issues. Finally, a shortage
of nurses in the US has affected the
operating room at several levels.
However, unlike surgeons, who
have increasingly taken up subspecialties, with focused expertise
in, for example, shoulder, spine,
or sinus surgery, the majority of
nurses are expected to assist with
all subspecialties of surgery. The
discrepancy in level of expertise
between the surgeon performing
an advanced MIS procedure and
supporting personnel can often affect both patient well-being and the
efficiency of the operating room.
In addition to these human factors, the physical environment in
which we practice can also contribute to some of the daily difficulties
encountered. Our group practices in
high-quality, well-equipped hospitals, but many of our facilities were
designed and built before the MIS
revolution. Existing operating rooms
have plenty of space to allow for the
conduct of traditional open procedures but not for MIS procedures,
which require additional equipment
(eg, monitors, electrosurgical units,
fluoroscopic machines, robotic
equipment) that in turn requires
additional time for setup, retrieval,
and troubleshooting.
Clearly a system-based approach
is needed to maximize the efficient
and safe integration of advanced
MIS technology within health care
systems such as KP. Although
individual surgeons can make significant contributions to the process
of establishing MIS programs, we
have reached a point in the history
of surgery where an infrastructure
is needed that can both support
existing practices and accommodate
the proliferation of future technology. Collaboration is needed at all
levels: surgeons, anesthesiologists,
nurses, technicians, administrators,
and educators. A new platform
needs to lay the foundation for
addressing the continuing and
emerging needs of MIS. We must
evolve from a surgeon-driven process to a team- and system-based
process. The value of an operating
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Developing Minimally Invasive Surgery Centers Within Kaiser Permanente: The Integrated Multidisciplinary Experience of Los Angeles
room team approach has been well
established and validated in several
studies,31–36 but it is important to
keep in mind that operating room
teams are only one of the critical
elements necessary to successfully
support MIS practices. MIS Centers
are required to serve as umbrella
structures to address the needs of
MIS at several levels.37
Organizing Minimally
Invasive Surgery
Centers Within Kaiser
Permanente: The Los
Angeles Experience
The changing nature of surgical
practices at our tertiary referral
center at LAMC and the increasing
number of practitioners offering
advanced MIS procedures have
led us toward a multidisciplinary
approach to address challenges.
To fulfill the needs of surgeons
providing MIS and patients seeking it, LAMC launched an MIS
Center. Originally we set up an
MIS committee to address the
implementation of new technology at our facility. Recognizing
that this endeavor addressed only
one aspect of MIS, we expanded
the focus to a multidisciplinary
MIS Center that would tackle all
facets of MIS care at our institution
and might also serve as a regional
and national integrated model of
MIS within KP. The mission of our
Center of excellence is to support the clinical practices of MIS
surgeons, to offer state-of-the-art
care for our patients, to provide
education opportunities through
residency and fellowship training
programs, and to advance the science of MIS through research and
innovation. To fulfill this mission,
we have assembled a team of experienced surgeons and nurses to
guide the development, growth,
and direction of the Center.
It is important to point out that
there has been a rapid proliferation of MIS Centers of excellence
within the US since the mid-1990s.
Unfortunately, many of these centers are driven by marketing and
financial considerations and rarely
represent collaborative efforts to
address the needs of MIS. Although
some of these centers have clinical
value, most are promoted by an
individual practitioner or a small
group of same-specialty surgeons
as a vehicle to increase practice revenues. Whether for gastric bypass
for obesity, spine surgery for disc
disease, or radical prostatectomy for
cancer, advertisements for such centers are ubiquitous on the Internet,
on television, in newspapers and
magazines, and on radio. In reality,
there are few comprehensive multidisciplinary MIS Centers nationally
or internationally.37
KP’s “secret” for success is its complete integration. Using this platform,
LAMC has developed and integrated
a multidisciplinary approach to MIS.
Our multispecialty group practice,
collaborative nature, institutional
resources, large patient population, and commitment to provide
ORIGINAL Article
the best possible care without any
financial incentive provide us with
all the elements necessary to pursue
this endeavor. In Los Angeles, we
invested in these unique features of
KP to successfully launch and grow
our MIS Center at a local, regional,
and national level (Figure 1).
Clinical Practice Initiatives
A significant contributor to the
volume and quality of advanced
MIS procedures is the expertise and
skills of surgeons. At LAMC, the
chiefs of surgery and other surgical subspecialties have actively
recruited new fellowship-trained
surgeons proficient in the delivery
of the latest technology. As mentioned earlier, the percentage of
MIS-trained surgeons has grown
rapidly, paralleled by an increasing amount of collaboration and
exchange between the different
subspecialties to tackle issues
universal to all surgical specialties. The MIS Center at LAMC has
served as a forum for exchange
of information on best practices
and of technical skills. Interpersonal relationships among MIS
surgeons have enhanced patient
Figure 1. Schematic diagram showing the multidisciplinary integration model
of an Minimally Invasive Surgery center.
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
23
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Developing Minimally Invasive Surgery Centers Within Kaiser Permanente: The Integrated Multidisciplinary Experience of Los Angeles
care, especially when combined
specialty procedures are necessary.
Furthermore, the lack of financial
incentive within our organization
has fostered a collegial collaborative
atmosphere.
The MIS Center has actively
engaged the Anesthesiology Department to encourage an open
dialogue to improve the delivery of
MIS care within the institution. For
instance, an anesthesia colleague
serves on our general committee to
represent that aspect of MIS care.
Several cardiopulmonary and physiologic considerations come into play
with MIS techniques such as laparoscopy. Preoperative factors such as
baseline comorbidities and body
habitus can have a direct impact on
intraoperative events (eg, carbon
dioxide metabolism, difficulty with
ventilation in extreme positions
such as severe Trendelenburg for
low pelvic surgery). Guidelines for
selective preoperative cardiopulmonary testing and evaluation are
now being delineated. Surgeons
often select a patient for an MIS
procedure on the basis of technical feasibility and outcome, which
in turn depend on surgical history
(eg, presence of scars or adhesions) and disease process (ie, benign, inflammatory, or malignant).
Input from anesthesia colleagues as
to the fitness of a patient to withstand a prolonged MIS procedure is
critical. Many of these procedures
require additional considerations
such as more time in the operating
room, extreme positioning, and
physiologic changes. We have solicited their direct feedback through
personal interactions, group discussion, and educational activities such
as grand rounds on MIS topics led
by LAMC surgeons.
As mentioned earlier the increased volume of MIS procedures
has affected support personnel as
24
much as it has affected surgeons.
With that in mind, we have approached nursing staff at several
levels, from nursing administrators
to frontline nurses, to raise awareness about the changing nature of
our practices and to solicit their
thoughts about ways to enhance
operating room efficiency. Several
of our MIS surgeons have conducted educational activities for our
nurses. In-service training sessions
have been conducted regularly
with refreshers by surgeons, nurse
educators, and industry representatives to review instrumentations and
equipment. We have welcomed several nurses as members of our MIS
Center and have encouraged their
participation in all of our meetings
to guide policy. This overture has
been much appreciated, and the
presence of nurses as partners in the
process of advancing MIS at LAMC
has been critical. These efforts have
culminated in the realization of the
importance of the team approach to
MIS. Jointly we have created specialty lead positions that oversee the
Center’s day-to-day clinical activities. The nursing leads are seasoned
nurses who provide support to our
nursing staff by guiding the setup
of cases and being available during
procedures should a scrub nurse
or circulator need additional help.
This has improved operating room
efficiency and increased nursing
expertise and familiarity with MIS
procedures.
Hospital and Equipment
As already discussed, most KP
facilities were designed or built
before the era of MIS. The equipment needed for the conduct of
most advanced procedures has outgrown the physical space needed.
In the spring of 2009, LAMC was
scheduled to inaugurate its new
state-of-the-art tertiary hospital.
The new facility was designed to
accommodate current and emerging technologies. All rooms are
spacious and fully equipped to
support the delivery of advanced
MIS. Many of the issues faced in
the older generation of operating
rooms, such as space constraints,
the requirement of extra time to
wheel in and retrieve equipment,
and maximization of working space,
have been addressed. The move
into the new hospital will constitute
a major milestone in the continuous
evolution of the Center.
The delivery of MIS care has
been driven by the introduction
of new tools and devices that
have enabled surgeons to refine
and advance their techniques.
There has been a steady stream
of new technology, most of which
has clinical merit. However, the
explosion in number of products
available on the market has posed
many problems: escalating cost,
variable efficacy and quality, the
added burden of maintaining a
larger inventory of products on
the shelf, compliance issues with
national contracts, and training
issues and familiarity of supporting staff with a wide spectrum
of disposable instruments. The
Center’s policy is to support the
needs of each individual surgeon
within the framework of the organization. Members of the MIS
Center are actively involved with
the operating room committee and
the regional and national product
council. Although we encourage
being at the forefront of surgical
care delivery, we critically evaluate requests for new products and
take into consideration available
scientific data, cost, volume of use,
niche specialty need, and existing
approved products. All products are
approached from a multidisciplinary
angle. When conducting trials with
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Developing Minimally Invasive Surgery Centers Within Kaiser Permanente: The Integrated Multidisciplinary Experience of Los Angeles
a new product, surgeons from various specialties are invited to participate and to provide feedback.
Residency and Fellowship
Training Programs
Members of the MIS Center are
active faculty at several postgraduate training programs at LAMC. MIS
has played an increasing role in
the education of future surgeons,
urologists, and gynecologists.
In addition to these three residency programs, LAMC offers an
endourology fellowship and is
awaiting regulatory approval for a
fellowship from KP and the University of California, Los Angeles
(UCLA) in pelvic floor and female
genitourinary tract reconstruction.
Both of these fellowship programs
entail MIS training. Residents and
fellows are eager to acquire MIS
skills. Accreditation and licensing
organizations, such as the American Council on Graduate Medical
Education and American Board of
Surgery, have established graduating requirements that include a minimum number of MIS cases. In 2008,
the American Board of Surgery established an additional requirement
for all graduating surgeons seeking
board certification: certification
in fundamentals of laparoscopic
surgery (FLS). FLS is a training
program jointly developed by the
Society of American Gastrointestinal Endoscopic Surgeons and the
American College of Surgeons. FLS
entails acquiring the basic knowledge and skills required to safely
and effectively provide MIS care.
FLS education is provided through
a Web-based training program and
skill practice on training boxes.
Certification is obtained by passing
a written examination and taking
a technical skills test. The purpose
of FLS certification is standardization of MIS care within the US and
ensuring that surgeons offering MIS
care are qualified to do so. The FLS
program has been validated through
numerous studies. 38–42 There is
ongoing discussion within several
national organizations to make FLS
certification a hospital credentialing
requirement for surgeons seeking
privileges for MIS procedures. Eight
members of our LAMC MIS Center
have already obtained the certification or are seeking it to provide the
training needed to our residents
and fellows.
Simulation Center
There is increasing evidence
of the importance of simulation
in training physicians to acquire
new skills. 43–47 Simulation can
provide many of the necessary
skills in a stress-free environment
at a comfortable pace and without
jeopardizing the safety of a patient.
Accordingly, we have designed and
developed an MIS Simulation Center at LAMC that is equipped with
seven training stations, including a
state-of-the-art virtual simulator that
provides trainees with various tasks
appropriate to their level of training and expertise. Several surgeons
have set up a multidisciplinary curriculum that is task oriented (eg,
suturing, dissecting, manual dexterity, visualization, trocar placement)
rather than procedure oriented (eg,
how to perform a hysterectomy). In
addition to providing skill acquisition and refinement, the program
offers a series of didactic lectures
at regular intervals. Finally, performance data and testing are provided
as feedback to trainees.
Local, Regional, and National Educational Endeavors
To foster exchange of ideas,
knowledge, and expertise of MIS,
the Center has launched several
educational endeavors. A multidis-
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
ORIGINAL Article
ciplinary lecture series has featured
KP surgeons from throughout the
Southern California region as well
as academic surgeons from institutions such as the Mayo Clinic and
UCLA. Diverse topics have been discussed, including instrumentation in
spine surgery, operating in a liquid
environment such as the knee, endovascular therapies, evolution of
robotic surgery, and laparoscopic
pelvic surgery. We have invited
several visiting professors from
prestigious academic institutions to
join us for a two-day visit to share
with them our work and to benefit
from their expertise in MIS.
In 2009, the Center, in conjunction with surgical colleagues from
other regions, held the first annual KP National Multidisciplinary
Minimally Invasive Surgery Symposium. It addressed the current
and future developments within
the field of MIS, including those
in the arenas of surgical education,
simulation, natural orifice surgery,
single-port surgery, and robotics.
Leaders in academic surgery joined
us from such institutions as the
Mayo Clinic, the Cleveland Clinic,
and the Lahey Clinic.
In addition, the Center is launching MIS Web-based education in
2009. The Web site will feature
the range of services offered by
expert surgeons, patient-education
information on pre- and postoperative care, MIS publications by
members of the LAMC MIS Center,
active research, and a video library
of MIS procedures performed by
KP surgeons. The Web site will
be a venue for all KP surgeons
at LAMC, in Southern California,
and in other regions to share
their expertise. All KP physicians,
regardless of geographic location,
are encouraged to submit videos
and write-ups of their work to the
Web site. The contact person is the
25
Original article
Developing Minimally Invasive Surgery Centers Within Kaiser Permanente: The Integrated Multidisciplinary Experience of Los Angeles
author of this article, Gary Chien,
MD ([email protected]). The
Web site will also be linked to The
Permanente Journal Web site.
Research and Publications
Many LAMC surgeons are actively
involved in scientific research and
serve on committees of national
scientific organizations. Numerous
recent publications and presentations at the regional and national
level have been delivered by members of the MIS Center.13,23–26,48–97
These scientific contributions have
included developing or refining
new techniques, reporting the outcome of MIS procedures, appraising
emerging technologies, and establishing treatment and management
algorithms.
The MIS Center has played an
important role in surgical clinical trials. This involvement established KP
as a leading organization at
the forefront of scientific
[Recent] scientific
research and one of the
contributions [by
largest contributing centers
members of the
to the American College of
MIS Center] have
Surgeons Oncology Group
included developing
trial ACOSOG Z6051 evaluor refining new
ating open versus laparotechniques, reporting
scopic rectal excision for
the outcome of
cancer. The LAMC MIS cenMIS procedures,
ter is currently the only KP
appraising emerging
center nationally enrolling
technologies,
patients in this trial. The
and establishing
results and data generated
treatment and
by this study will guide the
management
future care of thousands of
algorithms.
KP patients.
Conclusion
As KP is one of the leaders in
health care delivery, it strives to
provide state-of-the-art care to its
patients in several geographic areas
of the US. Surgical interventions
represent a significant portion of
rendered care and contribute to the
well-being of thousands of patients
26
within the different regions every
year. Within KP, MIS therapies are
growing in type and volume of
interventions. The proliferation of
these technologies has occurred
in parallel within many surgical
specialties, with a large variation in
level of implementation between
different regions and even within
regions. A multidisciplinary approach to MIS unites the efforts
and expertise of many outstanding
practitioners within the organization
and consolidates the achievements
of many surgical specialties. Organizing centers for MIS within KP will
bring together the elements needed
to provide the highest level of care
to our patients in a safe, efficient,
cost-effective environment, with
minimal morbidity and best longterm outcomes. We hope that the
integrated multidisciplinary model
implemented in Los Angeles will
guide the future development of
MIS Centers within KP at the national level. v
Disclosure Statement
The author(s) have no conflicts of
interest to disclose.
Acknowledgments
We thank the following physicians for
their continued effort and support in
making the Center of Minimally Invasive
Surgery at LAMC a success: Roman Sydorak, MD; Malcolm Munro, MD; Steven
Lee, MD; Talar Tejirian, MD; J Craig Collins, MD; Michael Pearl, MD; John Lim,
MD; Kevin Patel, MD; Scott Lentz, MD;
Brian Miyazaki, MD; Andrew DiFronzo,
MD; and Harsimran Brara, MD.
Katharine O’Moore-Klopf, ELS, of KOK
Edit provided editorial assistance.
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Weiss MH. Predictive value of serum
prolactin levels measured immediately after transsphenoidal surgery. J
Neurosurg 2002 Aug;97(2):307–14.
75.Chen JC, Amar AP, Choi S, Singer
P, Couldwell WT, Weiss MH. Transsphenoidal microsurgical treatment
of Cushing disease: postoperative
assessment of surgical efficacy by
application of an overnight low-dose
dexamethasone suppression test. J
Neurosurg 2003 May;98(5):967–73.
76. Kuo JS, Chen JC, Yu C, et al. Gamma
knife radiosurgery for benign
cavernous sinus tumors: quantitative
analysis of treatment outcomes. Neurosurgery 2004 Jan;54(6):1385–93;
discussion 1393-4.
77.Chen JC, Girvigian M, Greathouse H,
Miller M, Rahimian J. Treatment of
trigeminal neuralgia with linear accelerator radiosurgery: initial results.
J Neurosurg 2004 Nov;101 Suppl
3:346–50.
78.Rahimian J, Chen JC, Rao AA,
Girvigian MR, Miller MJ, Greathouse
HE. Geometric accuracy of Novalis
stereotactic radiosurgery system for
trigeminal neuralgia. J Neurosurg
2004 Nov;101 Suppl 3:351–5.
79. Pearl ML, Edgerton BW, Kazimiroff
PA, Burchette RJ, Wong K. Arthroscopic release and latissimus dorsi
transfer for shoulder internal rotation
contractures and glenohumeral deformity secondary to brachial plexus
birth palsy. J Bone Joint Surg Am
2006 Mar;88(3):564–74.
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Developing Minimally Invasive Surgery Centers Within Kaiser Permanente: The Integrated Multidisciplinary Experience of Los Angeles
80. Pearl ML. Arthroscopic release of
shoulder contraction secondary to
birth palsy: an early report on findings and surgical technique. Arthroscopy 2003 Jul-Aug;19(6):577–82.
81. Pearl ML, Edgerton BW, Kon DS,
et al. Comparison of arthroscopic
findings with magnetic resonance
imaging and arthrography in children
with glenohumeral deformities
secondary to brachial plexus birth
palsy. J Bone Joint Surg Am 2003
May;85-A(5):890–8.
82. Sydorak RM, Albanese CT. Minimal
access techniques for fetal surgery.
World J Surg 2003 Jan;27(1):95–102.
83. Harrison MR, Sydorak RM, Farrell JA,
Kitterman JA, Filly RA, Albanese CT.
Fetoscopic temporary tracheal occlusion for congenital diaphragmatic
hernia: prelude to a randomized
controlled trial. J Pediatr Surg 2003
Jul;38(7):1012–20.
84. Sydorak RM, Nijagal A, Albanese
CT. Endoscopic techniques in
fetal surgery. Yonsei Med J 2001
Dec;42(6):695–710.
85. Danzer E, Sydorak RM, Harrison MR,
Albanese CT. Minimal access fetal
surgery. Eur J Obstet Gynecol Reprod
Biol 2003 May 1;108(1):3–13.
86. Sydorak RM, Albanese CT. Laparoscopic repair of high imperforate
anus. Semin Pediatr Surg 2002
Nov;11(4):217–25.
87. Sydorak RM, Albanese CT. Laparoscopic antireflux procedures in children: evaluating the evidence. Semin
Laparosc Surg 2002 Sep;9(3):133–8.
88. Sydorak RM, Feldstein V, Machin
G, et al. Fetoscopic treatment for
discordant twins. J Pediatr Surg 2002
Dec;37(12):1736–9.
89. Fowler SF, Sydorak RM, Albanese CT,
Farmer DL, Harrison MR, Lee H. Fetal
endoscopic surgery: lessons learned
and trends reviewed. J Pediatr Surg
2002 Dec;37(12):1700–2.
90.Albanese CT, Sydorak RM, Tsao K,
Lee H. Thoracoscopic lobectomy for
prenatally diagnosed lung lesions. J
Pediatr Surg 2003 Apr;38(4):553–5.
91. Sydorak RM, Shaul D. Laparoscopic
partial nephrectomy in infants and
toddlers. J Pediatr Surg 2005
Dec;40(12):1945–7.
92.Glass KB, Tarnay CM, Munro MG.
Intraabdominal pressure and incision
parameters associated with a pyramidal laparoscopic trocar-cannula
system and the EndoTIP cannula. J
Am Assoc Gynecol Laparosc 2002
Nov;9(4):508–13.
93.Glass KB, Tarnay CM, Munro MG.
Randomized comparison of manipulation on incisional parameters asso-
ORIGINAL Article
ciated with a pyramidal laparoscopic
trocar-cannula system and the EndoTIP cannula. J Am Assoc Gynecol
Laparosc 2003 Aug;10(3):412–4.
94. Munro MG. Endometrial ablation
with a thermal balloon: the first 10
years. J Am Assoc Gynecol Laparosc
2004 Feb;11(1):8–22.
95. Munro MG, Tarnay CM. The impact
of trocar-cannula design and
simulated operative manipulation on
incisional characteristics: a randomized trial. Obstet Gynecol 2004
Apr;103(4):681–5.
96.Rosenbaum S, Fried M, Munro,
MG. Endometrial hydrothermablation: a comparison of short-term
clinical effectiveness in patients with
normal endometrial cavities and
those with intracavitary pathology. J
Minim Invasive Gynecol 2005 Mar–
Apr;12(2):144–9.
97.Cunningham E, Barreda L, Ngo M,
Terasaki K, Munro MG. Uterine artery
embolization versus occlusion for
uterine leiomyomas: a pilot randomized clinical trial. J Minim Invasive
Gynecol 2008 May-Jun;15(3):301–7.
The Greater Satisfaction
As I sat by the side of this great surgeon [Lawson Tait], a question suggested
itself … Which would give the most satisfaction to a thoroughly humane and
unselfish being, of cultivated intelligence and lively sensibilities: to have written
all the plays Shakespeare has left as an inheritance for mankind, or to have
snatched from the jaws of death more than a hundred fellow-creatures …
and restored them to sound and comfortable existence?
— Our Hundred Days in Europe, Oliver Wendell Holmes, Sr, 1809 – 1894, poet, physician, and essayist
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
29
soul of the healer
“Spherical Tea Set”
“Spiral Tea Set”
Pottery sculpture
By Patrick Ting, MD
Patrick Ting, MD, is a General Surgeon at the Rock Creek Medical Center in Lafayette, CO.
Here, we see four photos of two complete tea sets. In “Spherical Tea Set,” the top photograph demonstrates the tea set in exhibition mode with the teacups and the teapot forming a
spherical sculpture. In service mode (bottom photograph), the teapot and cups are completely
functional and the lid of the sphere forms the lid of the teapot. In “Spiral Tea Set,” the top
photograph demonstrates the tea set in exhibition mode with the teacups and the teapot
forming a cylindrical sculpture. In service mode (bottom photograph), the teapot and cups are
completely functional. The tea sets are made of earthenware clay, initially formed through a
slipcasting technique, then hand glazed.
More of Dr Ting’s work may be seen at his Web site: www.tingteas.com.
30
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
credits available for this article — see page 95.
Original article
An Exploratory Case Study: Effects of a Physician
Organizational Socialization (Enculturation) Program
Richard Pitts, DO, DABEM, DABPM
Abstract
This article presents compelling data supporting a
comprehensive enculturation program for physicians
entering a medical group practice and fills a void in the
literature about improving the process whereby physicians can more effectively enter a medical group. As far
back as 1999, a study noted that physicians joining the
Mayo Clinic physician group took five years to be fully
integrated into the medical group. Further research was
called for, yet no studies on enculturation of physicians
into a medical group have been reported. Unlike medical science, in which double-blind studies are the gold
standard for proving a hypothesis of care, double-blind
studies are essentially impossible to conduct in the social sciences. However, what can sometimes be identified are patterns of behavior that although they fail the
test of a double-blind study can be helpful in decision
making when it comes to individual and group behavior. It is in that spirit that I conducted a social science
exploratory case study. In the midst of a challenging
year of conversion to an electronic medical record, the
survey had a 40% response rate with compelling comments on the effects of the program. The study suggests
that the enculturation program provided those queried
a clearer understanding of the complexities of a large
integrated medical group, with much earlier integration into a large medical group in contradistinction to
the Mayo Clinic study. This study is important because
of the lack of research in the area of enculturation of
physicians into large medical groups.
Introduction
Why should an organization care about what happens when a newcomer joins the organization? It seems
obvious that companies invest time, energy, and money
in recruiting and trying to retain workers that a company values. However, do organizations try to discern
the newcomer’s perspective on what happens when
a newcomer joins a company? Some newcomers set
personal work goals, and these frequently are centered
around job satisfaction.1 Yet what if these goals are not
achieved or are deemed unachievable by the newcomer?
The newcomer’s commitment to the organization may
either falter or simply not develop at all.2
Schein3 shook up the management world with his
thoughtful article on what happens when someone
joins an organization. For better or worse, a newcomer
receives an informal or a formal introduction to the organization in which the newcomer learns what it means
to belong to the organization. Schein3 coined the term
organizational socialization to describe the process
whereby newcomers learn how to get things done in an
organization in an acceptable manner while remaining
welcome there. It seems that achieving mutual expectations is what organizational socialization is all about. Yet
organizational socialization that is too formal risks making the newcomer a conformist to such an extent that
creativity and fresh ideas are smothered. Conversely,
too little of a socialization process in an organization
may result in the newcomer being disruptive. Perhaps
even worse, if no formal organizational socialization
occurs, informal socialization may occur, resulting in a
default culture. Companies may be reluctant to invest
time and money in an organization socialization program. Yet can the dollar value of a loyal and committed
organization member be calculated?
“In effect, we must teach our students to become
change-agents, whatever their disciplinary specialty
turns out to be. We must teach them how to influence
their organizations from low positions of power without
sacrificing their professional values in the process. We
must teach them how to remain creative individuals in
the face of strong organizational pressures.”3p10
Of all professions, medical groups may have the most
difficult time socializing newcomers.4 After US medical students complete college, they must complete an additional
7 to 11 years of technical education (specialty dependent)
to become licensed and achieve board certification. Al-
Richard Pitts, DO, DABEM, DABPM, is Chief of Occupational Medicine
and an Assistant Area Medical Director at the Orange County Medical
Center in Anahiem, CA. E-mail: [email protected].
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
31
Original article
… the loss
of a single
physician from
[the] Colorado
Permanente
Medical Group
resulted in
approximately
$300,000 in
expenses not
related to
direct health
care as well as
unnecessary
utilization
of medical
resources …
An Exploratory Case Study: Effects of a Physician Organizational Socialization (Enculturation) Program
though the technical training is intense and comprehensive, physicians in general do not receive training in group
dynamics or learn how to become an effective member
of a medical group. In this study, I investigated the effects
of formal organizational socialization on a six-year cohort
of new physicians entering a medical group.
Bender et al5 found that it could take up to five years
for a physician to reach the highest level of group function
at the Mayo Clinic. They posited that it is common sense
that whatever must be done to integrate new physicians as
quickly as possible into a health care organization should
be done. As a result of their findings, Bender and et al
called for research in the area of physician socialization
into health care organizations.5
Besides trying to make medical groups function more
effectively, what about reducing physician attrition from
medical groups? Cooper-Thomas and Anderson1 established that newcomer acquisition of information improves
job satisfaction and commitment to the organization and
decreases intention to leave an organization. Also, patient
satisfaction relates directly to physician satisfaction, which
in turn relates to being tightly bonded to the medical
group. Hence, satisfaction for all three—medical group,
physician, and patient—is highly interdependent.6,7
Purpose
This study was conducted as a preliminary attempt
to understand the effects of a formal organizational
socialization program for physicians who enter a large
medical group practice.
Significance
Effective organizational socialization assists with
at least three facets of an organization member’s life:
improved job satisfaction, improved commitment to the
organization, and decreased likelihood of leaving the
organization.8 At the time that I conducted my study,
the most recent data on health care costs in the US
were from 2004. According to the Centers for Medicare
and Medicaid Services, 2004 US health care costs approached $1.9 trillion. Estimates were that these costs
would rise an average of 7.2% per year, resulting in an
estimated cost for health care of $4.0 trillion by 2015.9
In an attempt to decrease overhead costs, physicians
tend to practice in groups instead of alone.10 Yet little
has been written about how to integrate physicians
into a group environment. The knowledge generated by this research may have wide applicability to
the medical profession as it transitions to more of a
group-practice environment from solo entrepreneurial
practices. Also, those medical groups that continue to
32
add new physicians may also benefit from understanding the importance of rapid organizational socialization
of newcomers. This research may help to establish
recognition that rapid organizational socialization may
help stem the loss of physicians from a medical group
as well as help physicians reach their full potential
within the group earlier than the five years suggested
in the study by Bender et al.5
Background
I conducted my study at Kaiser Permanente (KP) Orange County, which had approximately 340,000 patient
members at the time. The county is a mixed urban and
suburban community. KP is a partnership between two
entities, an insurance plan—the Kaiser Foundation Health
Plan—and the Permanente Medical Groups. The KP program provides comprehensive care to almost nine million
individuals and has an annual budget of more than $25
billion. One of KP’s core values is to spend as much of
the premium dollar on health care as possible and as little
as possible on nondirect patient care11 (Kenneth Bell, MD,
personal communication,December 2003).a
The Colorado Permanente Medical Group (CPMG)
determined that the loss of a single physician from [the]
CPMG resulted in approximately $300,000 in expenses
not related to direct health care as well as unnecessary
utilization of medical resources (Kenneth Bell, MD,
personal communication, December 2003).a
Corroborating the CPMG study, Buchbinder et al12
reported similar results. Included in the costs were the
expense of recruiting a new physician to replace the one
who left, training costs of integrating the new physician
into the culture of the organization, increased Emergency
Department visits because of lack of familiarity by the
patient with substitute physicians, and an increase in the
use of laboratory and radiology studies.
Literature Review
What are the dimensions of organizational socialization? In a seminal article, Chao et al13 identified a lack
of precision in terms of the dimensions of organizational
socialization. In 1994, literature on the topic was focused
on either the process of socialization or its content.
However, Chao et al noted that there was little if any
actual research to verify the content of organizational
socialization. They designed and completed a five-year
longitudinal study that set out to confirm six content dimensions of organizational socialization through the use
of a self-reporting questionnaire that used a Likert scale
for reporting. Their research supports the idea that organizational socialization is a dynamic state depending on
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
An Exploratory Case Study: Effects of a Physician Organizational Socialization (Enculturation) Program
what is going on in an individual’s life at the time a survey
is completed. The results of their study support the idea
that job performance, proficiency, company politics,
language unique to the organization, organization goals
and values, and organization history are six conceptual
dimensions of organizational socialization.
The beginnings of organizational socialization as a
science can be traced to the mid-1900s. At that time,
anthropologists started to explore the commonalities
found in groups of people and, more specifically,
how these groups of people or collectives behaved.14
What evidence is there of the significance of the first
year in a new organization? Chatman15 found that the
socialization process of new members of an accounting firm was especially active during the first year of
employment.
What about rapidity of organizational socialization?
Cooper-Thomas and Anderson1 identified a gap in the
literature with respect to how quickly organizational
socialization takes place. They constructed a longitudinal
study over eight weeks in a group of British army recruits.
Although this study was admittedly in a very intense military environment, significant adjustment was found in the
newcomers at the end of two months of training.
How is the idea of success measured in organizational socialization programs? Typically, researchers
have adopted three items to measure that correlate with
success: job satisfaction, organizational commitment,
and intention to quit.16
Research Design Methodology
Unlike medical science, for which double-blind
studies are the gold standard for proving a hypothesis
of care, double-blind studies are essentially impossible
to conduct in the social sciences. However, what can
sometimes be identified are patterns of behavior that
despite failing the test of a double-blind study can be
helpful in decision making when it comes to individuals’ and groups’ behavior.
Currently KP offers a health care program in eight
regions: Mid-Atlantic (Washington DC, Virginia, and
Maryland), Ohio, Georgia, Colorado, Southern California,
Northern California, Northwest (Oregon and Southwest
Washington), and Hawaii. At the time that I carried out
my research, these eight regions combined served approximately nine million members. In each region, a
regional Permanente Medical Group (PMG) is partnered
with the Health Plan to provide integrated health care.
The PMGs are discrete corporations with physician shareholders. In Southern California, the PMG is organized as
a partnership of approximately 4500 physicians called
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
ORIGINAL Article
the Southern California Permanente Medical Group
(SCPMG). There are many subdivisions of the Southern
California Region of KP, one of which is KP Orange
County, CA. KP Orange County has approximately 400
physician partners serving approximately 340,000 Health
Plan members and is one of the fastest-growing medical
service areas in the KP program.11
The population for this study was physicians new to
SCPMG Orange County. These new physicians completed a formal nine-month organizational socialization
program. The program was designed in accordance with
the work of Chao et al.13 The program met approximately
every two weeks for nine months. Each meeting was approximately 90 minutes long. Teaching methods stressed
small-group interactions followed by reports to the larger
groups from the small groups.
Study Subject Selection
Permission was sought and granted by the Walden
University institutional review board and by the medical
director of the KP Orange County Medical Service Area
to conduct the proposed case study research.
Great care was taken to avoid selection bias of study
subjects. Six years of physician-participant archival
logs were used to determine data for physician participants, including what year each one participated in
the program. A random-number generator was used in
the selection of names to take part in the study. Three
candidate participants were randomly identified from
each of the six-year cohorts of participants, yielding a
total of 18 possible participants.
A letter of invitation approved by the institutional
review board, was e-mailed to the 18 potential participants, along with the initial study questions. Seven
of the 18 invitees were willing to participate in the
study, and 11 formally declined, citing current intense
work conditions because of the implementation of
an electronic health record. Originally, the study was
envisioned as using face-to-face interviews. However,
with workplace conditions changing because of the
implementation of an electronic health record, virtually
all of the candidates preferred to answer the questions
in writing at their convenience.
Data Collection
Participants were asked to fax the completed questionnaire to a secure fax. On arrival, the faxes were
photocopied and separated into two batches, which
were securely stored at two separate physical locations.
As each fax arrived, the participant list was updated to
reflect completion of the questionnaire.
33
Original article
An Exploratory Case Study: Effects of a Physician Organizational Socialization (Enculturation) Program
Data Analysis
The purpose of this exploratory case study was to
gain an initial understanding to serve as a platform
for a more comprehensive case study of the effects
on participants of a formal organizational socialization
program. The initial analysis of the data began with
data loaded into an Excel (Microsoft, Redmond, WA,
USA) spreadsheet. Color-coded data cells were used
to identify patterns of responses. Usefulness of the
questions was also evaluated.
Limitations
The purpose of an exploratory study before a more
in-depth study is in essence to see whether the researcher
is on the right track in planning a more detailed study.
Hence, inherent in an exploratory study is incompleteness.
However, important information may still be obtained, as
is presented here. An additional limitation is that because
data collection was done through self-reporting, the data
have the potential for reporting bias and/or recall bias.
Results
Of the 14 questions in this exploratory study, six
questions were simply gathered data. Eight of the
questions were substantive and generated a total of
84 potential response cells on the data spreadsheet.
Seventy of the 84 cells could be populated with data,
yielding an 83% cell-completion rate.
Color-coding of the 70 data cells suggested four major
areas of confluence or themes with respect to answers.
Sample responses in support of these themes are:
1.Developed a strong sense of belonging: “Having
the history/philosophy of KP gave me a sense of
belonging and understanding. I feel like I belong
rather than just [show] up for a job.”
2.Gained improved communication skills: “It was
a great venue [in which] to meet my fellow colleagues, and my interaction with them was enhanced by the program. We now usually page
each other first for advice because we have such
a great relationship.”
3.Gained multiple resources for success at home as
well as at work: “I am more patient with others. I
also see that my husband is more patient with me,
and we try to understand each other’s point of view
on a personal and a professional level.”
4.Gained information in the program that will produce
better function within the organization: “I feel that
doing the enculturation program allows me to appreciate how complex yet organized our system is
and how I can work best within this system and what
is expected of me.”
Questions and Sample Responses
The following key questions were used in the
survey; I have included some of the compelling
Table 1. Common themes found in responses to questions
Themes
Developed a strong sense of
belonging
Benefit to organization
Physicians’ confidence in organization improved
Gained improved communication
skills
Physicians able to advocate on behalf of organization
Gained multiple resources for
success at home as well as at work
Gained information in the program
that will produce better function
within the organization
Physician-to-physician communication for consults
improved via direct informal personal communication
channels established at program meetings
Physicians can function more effectively because they
understand organization’s culture
Improved function inside the organization
Physicians understand change parameters
Physicians have an understanding of just how
complex the organization is
Physicians less disruptive when frustrated with
change issues
Physicians clearly know what is expected of them
34
Benefit to physician
Physicians have a sense of belonging—of being
part of a community
Physicians have a sense of a support system
Physicians are more open-minded
Physicians developed cross-specialty friendships
Physicians developed a sense of ownership of
problems
Less use of formal on-call schedule for advice in
managing patient specialty care
Physicians understand organization’s culture
Less frustration
Physicians understand change parameters
Physicians understand that change is possible
Physicians have a more realistic understanding
of the complexities of the organization
Physicians confident that change can be enacted
within certain parameters
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
An Exploratory Case Study: Effects of a Physician Organizational Socialization (Enculturation) Program
responses from the cohorts sampled:
• Engaged in workplace? (All responded yes.)
• Can you cite examples in your work at KP where you
used principles that you learned in the enculturation
program to help you solve your problems?
- “Daily dealings with patients, staff, colleagues.”
- “Learning about the process of change in a large
organization. We have successfully acquired more
psychiatric space at Euclid after reviewing the
data, working collaboratively and problem-solving
instead of making hasty decisions.”
- “Be ‘proactive, not reactive.’ With angry patients,
I try to hear what they are saying and listen to
them, and they are very appreciative.”
- “Doing group and team activities in the enculturation program has assisted me tremendously in
[understanding] how our other specialties operate,
and to develop friendships.”
- “There was a situation in which a patient was
belligerent to the staff and support staff. Instead
of directly confronting the patient, I recruited the
ombudsman (KP ombudsman presented during the
enculturation program) to serve as a liaison, and
everyone was happy.”
- “With the enculturation program, I have become
more open-minded, appreciative, creative, patient,
efficient, and knowledgeable about our organization—which has resulted in better patient care.”
- “The four (clinical) habits program showed me
how to better interact and respond to my patients.
It has definitely helped me in situations when I
had to deliver bad news to my patients, [such as
a] diagnosis of colon cancer.”
• Have you seen behavior in either yourself or others
as a result of the enculturation program? If yes, what
behavior?
- “Being leaders/role models in the workplace.”
- “From the way my colleagues operate, it appears
that they have also completed the enculturation
program, so I have not noticed that they don’t
demonstrate these principles.”
• Are you happy with your position at KP Orange
County? (All responded yes.)
- “I feel much satisfaction in my work.”
- “I feel like I belong and can do what is best for my
patients without worrying about the cost. Generally, there are very few egos to deal with.”
- “I like helping my patients. I enjoy being with my
coworkers …. I don’t enjoy the stress of too much
indirect work.”
- “Wonderful partnered and associate physicians will-
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
ing to work together for the needs of our members.
Good working relationships with ancillary staff.”
- “Indirect work difficult at times.”
- “I have been very satisfied and happy with my
position [here]. I enjoy my job, my peers, my work
environment, and the way patients are receiving
good quality care.”
- “I enjoy working with my patient population. It is gratifying. I also enjoy working with my colleagues.”
- “Happy, strong group of colleagues.”
• What aspects of the enculturation program contributed to either your job satisfaction or dissatisfaction?
- “Helpful to understand culture of organization.
Helpful to know that change can be accomplished.
Specific physician examples discussed at sessions.”
- “Understanding the culture of SCPMG. Enabling
me to have the tools necessary to make change
if change was needed. Created a sense of community with peers in different specialties. Seven
Habits course in retrospect [was] invaluable [for]
interacting with patients and peers.”
- “I think the most important factor was the friendships that I developed. This goes a long way each
day in making my job fun and challenging.”
ORIGINAL Article
“Doing group
and team
activities in the
enculturation
program has
assisted me
tremendously in
[understanding]
how our other
specialties
operate, and
to develop
friendships.”
Discussion
This preliminary study prepares for a more comprehensive study, as is often the case in both the medical
sciences and social sciences. It can save valuable time
and resources later by fleshing out unforeseen issues
in designing a comprehensive study or by confirming
preliminary assumptions regarding the more comprehensive planned study. On occasion, an exploratory
case study may uncover compelling information of
interest to the larger community, as in this study.
Overwhelmingly, the respondents agreed that the
enculturation program provided them with valuable
information and tools to better do their jobs at KP
and to a certain extent in their private lives as well.
Their clearer understanding of the complexities of the
organization resulted in earlier integration into a large
medical group, in contradistinction to the Mayo Clinic
study. Substantial effort was undertaken to avoid selection bias, which suggests that the broader group may
provide similar results.
As already mentioned, the four major areas of confluence or themes from physicians’ responses were
as follows: 1) developed a strong sense of belonging;
2) gained improved communication skills; 3) gained
multiple resources for success at home as well as at
work; 4) gained information about the program that will
35
Original article
An Exploratory Case Study: Effects of a Physician Organizational Socialization (Enculturation) Program
produce better function within the organization.
An unsolicited comment from John Davenport, MD,
JD, Chief of Family Medicine for KP Orange County,
supports the positive effects of the enculturation program
as reported here. Dr Davenport noted that when asking
for physician volunteers for projects or committees, he
received a higher percentage of positive responses to his
call for help from the physicians who had completed the
enculturation program than from those who had not. This
observation is consistent with information on citizenship,
ownership, and partnership responsibilities presented
during the new-physician enculturation program.
One final observation with respect to the enculturation
program at KP Orange County: The physicians who complete the program are frequently heard to say that they
have formed lifelong friendships that cross geographic
and specialty boundaries. Many physicians comment
that when they need advice on how to manage a case,
instead of using a call list to get help, they will simply
call one of their friends in that particular specialty—a
friend made during their participation in the enculturation program. Does this confirm the idea that first comes
a relationship, then comes ease of communication? What
value can be placed on ease of communication when
asking for help in a large organization?
Improved understanding of the complexities of the
KP organization, along with improved understanding
of expectations in the areas of citizenship, ownership,
and partnership, plus earlier engagement in the group
role as physicians in a multidisciplinary medical group,
are compelling reasons for a robust and competently
administrated enculturation program early in a physician’s entry in to a medical group. v
a
Former Medical Director, Kaiser Permanente Orange County.
Disclosure Statement
The author(s) have no conflicts of interest to disclose.
Acknowledgments
I would like to acknowledge the following individuals as sources
of encouragement for this work: Jeff Weisz, MD, Medical Director
SCPMG; Mark Klau, MD, Physician Director-Leadership Development SCPMG; Nancy Spiegel, Manager-Leadership & Organization
Leadership SCPMG; Lucia Soh, Director-Physician Leadership and
Performance SCPMG; Karen Olson-Coordinator Physician and
Graduate Education KP Orange County; Edward Ellison, MD, current Associate Area Medical Director for KP Orange County; and
Kenneth Bell, MD, former and long-time Associate Area Medical
Director for KP Orange County. And, a very special thank you and
acknowledgment to Ruth Maurer, PhD, my faculty chair and men-
36
tor at Walden University. Dr Maurer’s help and guidance were key
in successfully completing this exploratory study.
Katharine O’Moore-Klopf, ELS, of KOK Edit provided editorial
assistance.
References
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The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Original article
2008 David M Lawrence, MD: Chairman’s Patient Safety Award
Northwest Simulation Center—Sharpens Clinical and
Communication Skills for Individuals and Teams
Georgina Ottaviano, BSN, RN-BC
Carl Washington, MT, PSO, CPHQ
Abstract
Many authorities have suggested that some variant
of team training is likely to reduce human error in operating rooms, Emergency Departments, resuscitation
teams and other settings within health care­—where
human interaction is common, and where breakdowns in communication and teamwork can have
critical consequences. The Kaiser Sunnyside Medical
Center Regional Simulation Center achieves this end.
In particular, simulation prepares people for errorprone, high-risk, or unusual situations. Here, we will
cite several scenarios and two actual protocols; five
principles for managing critical events; results (2006
People Pulse favorability, 2007-2008 postsimulation
survey favorability); Kaiser Permanente Northwest
departments trained; strategic initiatives supported
including service internalization; collaboration with
local and regional community programs; and process
transferability.
Introduction
Many authorities have suggested that some variant of team training is likely to reduce human error
in operating rooms, Emergency Departments (ED),
resuscitation teams and other settings within health
care—where human interaction is common, and where
breakdowns in communication and teamwork can have
critical consequences.1 These authorities cite the work
done in aviation’s crew-resource management; recommendations made by the Institute of Medicine’s landmark
report, To Err is Human: Building a Safer Healthcare
System,2 released in 2000; and the Joint Commission’s
comprehensive Patient Safety Plan.1 Because of the
success of the Kaiser Permanente Northwest (KPNW)
Region’s Perinatal Patient Safety Projecta in training teams
in standard communication—how to respond in critical
patient events—and the need to practice these situations
in a controlled environment, Kaiser Sunnyside Medical
Center (KSMC) leadership approved and created a Regional Simulation Center (RSC). Here multidisciplinary
teams sharpen their clinical and communication skills
and practice managing escalating scenarios such as:
mock codes, infant resuscitations, and malignant hyperthermia. Team communication skills are reinforced by
using human factors tools such as Situation Background
Assessment and Recommendation (SBAR) and Assertion
and Situational Awareness. Simulation addresses individual technical performance and important elements
of teamwork—listening, leadership, communication,
respect, role clarity, and Crew Resource Management
(CRM). In particular, simulation prepares people for
error-prone, high-risk, or unusual situations.3
Objectives
Preventive measures to increase patient safety are
grounded in scientific literature on team training, CRM,
and critical thinking.4 Because KPNW has specifically
trained individuals and teams in Human Factors communication, reliable design, and managing escalating
patient events, they reduced birth-related, potentially
compensable events, claims, and lawsuits between
2002–2007. KPNW meets the key objectives of simulation training—reduce medical errors and improve patient safety—by using the RSC and by adding simulation
mannequins as training tools (Table 1).
Table 1. Training activities to meet objectives
Staff work together and communicate more effectively
Teams simulate and debrief high-risk events
Realistic practice for emergencies
Disciplines train together
Areas identified for improvement
Georgina Ottaviano, BSN, RN-BC, (left) is the Coordinator of Regional Simulation Operations at
Kaiser Sunnyside Medical Center, in Clackamas, OR. E-mail: [email protected].
Carl Washington, MT, PSO, CPHQ, (right) is the Regional Manager for Patient Safety for the
Northwest Region in Portland, OR. Email: [email protected].
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
37
Original article
Northwest Simulation Center—Sharpens Clinical and Communication Skills for Individuals and Teams
Methodology
The RSC, constructed in fall 2006 by adjoining two
small conference rooms into the Sim-Lab, is coordinated
by one full-time Registered Nurse (RN), (trained in
simulation), one part-time RN simulation nurse educator, and one full-time trained simulation operations
specialist. The RSC team work with department staff,
managers, clinical experts, and educators to construct
simulation scenarios relevant to individual teams. The
RSC team use a four-tiered approach in reaching their
objectives with staff (Figure 1).
1. Simulation Mannequins and Clinical Scenarios:
Simulations occur on one of four simulation
mannequins—SimMan, SimBaby, (Laerdal Medical,
Wappinger Falls, NY; www.Laerdal.com); Birthing
Mother Noelle (and fetus), wireless Newborn HAL,
and wireless Adult HAL (Gaumard Scientific, Miami
FL; www.gaumard.com). The simulation nurse manages the scenario from a control booth, adjusting
the mannequin’s change in condition dictated by
the scenario and the participant’s interventions. Sim
Man can mimic most any condition; his heart can
emit 2500 different sounds, he has bowel sounds,
pulses, temperature, blood pressure and he can
speak through a wireless microphone system. The
other mannequins have similar functions. RSC also
has an inventory of low-fidelity mannequins for
task training listed on their Web site (http://internal.
or.kp.org/simlab; password protected) including:
Standardized patient
supports role play as
a family member.
Simulation can have
its fullest effect with
the use of mannequins
and equipment.
Actor
Mannequins
and Equipment
Scenarios guide
the nurse educator
controlling the
mannequins
Clinical Scenarios
Debrief
Foundation of simulation is the scenarios and debrief where human factors
and communication can be emphasized.
Figure 1. Four-tiered approach.
38
Debriefing
supports
team
development
Table 2. RSC simulation scenarios in 2007
ACLS and BLS Codes
Medical-Surgical Adult Sepsis
Malignant Hyperthermia in the PACU
MD, RN, RT Neonatal Resuscitation Team Training
OB/GYN Hemorrhage and Code
Emergency Department Neonatal and ACLS Code
Emergency Department Pediatric Code
Acute Coronary Syndrome
ACLS = Advanced Cardiac Life Support; BLS= Basic Life Support;
PACU = Post Anesthesia Care Unit
Table 3. Advantages of simulation training 1
Presentation of uncommon but critical scenarios in
which a rapid response is needed, and where there
are few means other than simulation to conduct
systematic training to manage such critical events (eg,
malignant hyperthermia, which occurs in every 40,000
anesthesia cases).
Errors are allowed and reach their conclusion so participants can see the results of their decisions and actions.
With mannequin-based simulators, clinicians can use
actual medical equipment, exposing limitations in the
human-machine interface.
Complete interpersonal interactions with other
clinical staff can be explored in training for teamwork,
leadership, and communication.
Ashish J, Gaba DM. Incident reporting. In: Making health care safer:
a critical analysis of patient safety practices AHRQ Publication No.
01-E058 [monograph on the Internet]. Rockville, MD: US Department
of Health and Human Services, Agency for Healthcare Research and
Quality; 2001 July [cited 2009 Mar 24]. Available from: www.ahrq.
gov/clinic/ptsafety/chap4.htm.
1
airway management, Neonatal Resuscitation Program recertification, and ED technician training. RSC
Simulation Scenarios in 2007 are listed in Table 2,
and two actual simulation protocols are detailed in
the Sample Simulation Scenario Sidebars: Malignant
Hyperthermia (MH) in the Post-Anesthesia Care Unit
(PACU) and Precipitous Delivery in the ED and the
Neonatal Resuscitation Program. Advantages of
simulation training are noted in Table 3, and five
principles for managing critical events are noted
in Table 4.
In a number of fields, simulation has been used in
crew resource management training where the focus is
on behavioral skills such as interteam communication
during critical incidents.
The RSC provides an incredible opportunity for clinicians and staff to learn by experience. Poor critical event
management often results in delayed diagnosis and ineffective treatment processes, even when clinical knowledge
and skills are adequate. According to the Center for
Medical Simulation,5 effectively managing a critical event
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Northwest Simulation Center—Sharpens Clinical and Communication Skills for Individuals and Teams
Table 4. Five principles for managing critical
events
Role Clarity: An event manager delegates
responsibilities to the team members while paying
attention to workflow. Other team member(s) define
their role responsibilities and do not change roles
without an explicit discussion with the event manager.
Communication: All communication flows through the
event manager who reliably repeats all information for
the benefit of the entire team. All verbal communication
should be closed-looped—the teller gives information
to the listener who repeats what s/he heard and understood; the teller then confirms that information. All communication is directed to an individual by name.
Personnel Support: The event manager is responsible
for calling for help when needed. Because task loading
tends to cause one to forget to call, it is important to
summon help early in the event evolution.
Resources: Team members must be familiar with all of
the equipment and supplies necessary to manage the
event. Understanding the infrastructure of the environment and institutional systems is also important.
Global Assessment: Frequent verbal status reports,
reviewed by the event manager, is the best mechanism
for avoiding fixation, promoting clarity of a situation,
and prompting new ideas.
requires attention to five principles (Table 4) in addition
to timely diagnosis and appropriate medical treatment.
These principles relate to clinicians’ individual behaviors and to the group dynamics of the clinicians and
their individual behaviors.
2. Equipment and Materials: The RSC is outfitted with
medical equipment, which includes a code cart with defibrillator. Cabinets and the control booth were recycled
from a recent remodel of the KSMC ED. The control
booth allows the simulation educator to monitor and
control the patient’s vital signs in line with the scenario
and in response to the actions of the clinical team. S/
he may advance the scenario or recover the patient
on the basis of team responses. Supporting equipment
includes: a video camera, computers to preprogram
and run the scenarios, and a television monitor used
to immediately replay completed scenarios to the team
during debriefing (Table 5).
3. Standardized Patient: The “standardized patient” is
an actor who often plays a role as a family member
of the patient (mannequin). The standardized patient
reacts in real time to the patient’s clinical signs and to
the actions of the health care team. This person will
ask and answer questions, and make observations
and comments to the team. There are times when the
standardized patient adds tension to the simulation,
increasing what could be an already stressful situation.
For example, a “standardized patient” often plays the
ORIGINAL Article
role of the distraught parent in a pediatric or newborn
resuscitation simulation. The objectives of including a
“parent” or “family member” is to increase awareness
of family-centered care principles, to illustrate the effects of distractions on clinical care, and to use crew
resource management concepts to meet the family
members’ needs.
4. Debriefing: All participants of each videotaped simulation debrief directly after the simulation. Topics
discussed are: communication, leadership and roles,
crisis resource management, system improvements,
highly reliable team characteristics, handoffs and
SBAR, human factors and situational awareness, and
best clinical practices and standards.
After simulation and debriefing, individuals complete
an evaluation, noting its value and relevance, the value
of the debriefing, and improved patient-care skills.
Surveys from the first year of the RSC, were analyzed
compared to baseline measurements.
Results
Poor critical
event
management
often results
in delayed
diagnosis and
ineffective
treatment
processes,
even when
clinical
knowledge
and skills are
adequate.
2006
A 2006 job satisfaction survey (People Pulse) question
asked: “Do you receive the training necessary to do
your current job well?” to which 71% of respondents
Sample Simulation Scenario: Malignant
Hyperthermia in the Post-Anesthesia Care Unit
Intended Audience: PACU RNs, CRNAs, MDs, other
PACU personnel
Brief Description of Scenario: Postoperative patient post-transurethral
bladder tumor resection arrives in PACU. Patient then has a laryngospasm, is given succinylcholine for emergent intubation, which triggers a
malignant hyperthermia (MH) crisis. MH crisis is treated and the patient
is transferred to the ICU.
Scenario Objectives: Participants will demonstrate:
1. Knowledge of MH triggering agents
2. Recognition of a symptoms and appropriate interventions for MH
3. Effective communication using SBAR
4. Effective Crisis Resource Management
5. Effective Dantrolene preparation and administration
6. Effective hand-off procedure
7. Knowledge of current transfer policy of patients from PACU to ICU
Description of patient: In surgical gown with foley catheter in place
with small amount of dark urine, IV LR infusing, patient moaning, just
arrived in PACU postprocedure.
Pertinent Medical History: Post-transurethral bladder tumor resection, smokes one pack per day, family history of death during surgery
in Russia.
ICU = Intensive Care Unit; MH = malignant hyperthermia; PACU = Post-Anesthesia Care Unit;
SBAR = Situation Background Assessment and Recommendation
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
39
Original article
Northwest Simulation Center—Sharpens Clinical and Communication Skills for Individuals and Teams
responded favorably. This encouraged further development of the RSC.
2007
In November of 2006, the RSC moved into a conference room formerly used for storage and created a
fully operational, high-fidelity simulation laboratory.
Approximately 666 physicians, nurses, respiratory
therapists (RTs), CRNAs, CNAs, students and technicians
trained using simulation in 2007.
The postsimulation survey used by the RSC for the
period February 2007—January 2008 evaluated four
components (Table 6). Using a ranking methodology
of 1-5, poor to excellent, a numerical value was substituted for analysis (poor = 1 and excellent = 5). Six
hundred sixty-six participants were surveyed about the
scenario in which they were involved. Overall, teams
felt the most positive about the value of the debriefing
session—4.6 average, in 8 of 11 scenarios (Table 7).
Many comments gathered from the KPNW RSC post-
Table 5. Regional Simulation Center equipment list
Human patient simulators
(Mannequins—includes
warranty)
SimMan – 1
$42,000.00
SimBaby – 2
One in lab and one portable
$46,000.00 for each
Megacode Kid Advanced
$6700.00
HAL Mobile Team Trainer
$28,000.00
A completely wireless adult computerized mannequin. HAL has the capabilities similar to
SimMan, and can be used in the actual clinical environment. Scenarios using HAL can be
controlled with a computer tablet at distances up to 300 meters.
Noelle
$17,000.00
Noelle S575 with newborn
$43,000.00
A wireless, full-sized adult mannequin that gives birth and can display a range of potential
delivery complications.
A wireless, full-sized adult mannequin that features obstetrical scenarios controlled by a
computer tablet. Mother and fetus each have patient monitors and can mimic a variety of
normal and complicated intrapartum and postpartum situations, including cesarean section.
Wireless, has its own patient monitor and is the approximate length and weight of a newborn.
Baby HAL has features similar to SimBaby, with the addition of an umbilical pulse, and
umbilical access.
Features
Right leg of a one-year-old for intraosseous access practice. Also has a simulated femoral artery
and vein in the upper thigh.
A realistic anatomical model complete with internal landmarks, allows practice of subclavian,
supraclavicular, and interjugular access techniques. The tissue responds to ultrasound imaging
for needle guidance.
Baby HAL S3010
$24,000.00
Task trainers
Pediatric intraosseous leg
$600.00
Central Line Man System
$4800.00
Trauma Man System
$21,000.00
Airway management
task trainers
Gaumard S312
$550.00
Gaumard S315
$1600.00
Laerdal Deluxe Difficult
Airway Trainer
$2400.00
Laerdal Airway Management
$1600.00
Other equipment
40
Features
Adult, advanced patient simulator with realistic anatomy and clinical functionality, including
intubatable airway, multiple ECG rhythms, defibrillation and pacing capabilities, IV fluid and
drug administration, and interactive voice.
A computerized advanced patient simulator the approximate size and weight of a nine-monthold infant. It features realistic intubatable airway, cyanosis, several ECG rhythms, intraosseous
and IV access.
Used for training in a wide range of advanced pediatric emergencies. Includes realistic
intubatable airway, multiple ECG rhythms, defibrillation and pacing capabilities, intraosseous
access and drug administration.
An anatomical human body form designed to practice surgical procedures including
cricothyroidotomy, chest tube insertion, pericardiocentesis, diagnostic peritoneal lavage and
IV cutdown.
Features
One-year-old pediatric upper torso-airway trainer with anatomically accurate, intubatable
airway.
Adult upper torso-airway trainer with anatomically accurate, intubatable airway
Adult upper torso mannequin, capable of multiple difficult airway scenarios, including
laryngospasm.
Trainer mounted on a practice board, this mannequin can be used to demonstrate and practice
intubations, ventilation, suction, and bronchoscopy.
Birthing bed, hospital bed, infant warmer, code cart with defibrillator, wardrobes for
mannequins, video cameras and television monitors, control booth.
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
ORIGINAL Article
Northwest Simulation Center—Sharpens Clinical and Communication Skills for Individuals and Teams
Table 6. Survey questions
1. The value of the simulation exercises for you
2. The relevance of the simulation scenario to your
clinical practice
3. The value of debriefing session(s)
4. Our success at providing a “safe learning
environment”
simulation evaluation supported the personal value of
simulations. Examples include: “These exercises were
really helpful, I feel more comfortable handling the
initial 241 scenarios,” (participant of a 241 code, which
indicates a newborn in distress). Another responded,
“The SimMan made things so real that I almost forgot
he wasn’t a real patient.” Many others expressed more
confidence in speaking up in code situations if there
is unclear leadership or direction given. Participants
said they valued the experience of participating in
simulations, the ability to become more focused in
their jobs and to relieve anxiety about certain escalating situations prior to practicing their drill. A newly
graduated nurse commented, “Simulation may be the
next or only time a nurse gets to practice something
s/he learned in nursing school.”
2008
Approximately 864 clinicians and staff trained using
simulation in 2008.
In support of the KPNW internalization efforts in Cardiovascular Services and Behavioral Health and Addiction Medicine services, teams from both disciplines used
or planned to use the RSC to conduct scenario sessions
to test readiness prior to “go-live” opening. Five such
scenario sessions were conducted for Brookside—a freestanding residential treatment facility. These simulations
included a cardiac arrest in a group therapy session, an
anaphylactic reaction to a medication, a patient leaving
against medical advice, admission procedures, and an
escalating behavioral situation. Simulations were also
conducted in the new Cardiac Catheterization Laboratory
to test systems prior to opening.
Objective data was gathered during the cardiac resuscitation drill. The scenario used a patient exhibiting signs
of shortness of breath and tightness of chest during a
group therapy session in one of the Behavioral Health
unit’s group therapy rooms. As the staff became aware of
the medical emergency, and a Code 99 was announced,
support staff from KSMC responded. Many opportunities for system improvements were identified during the
debrief session: correcting emergency response time,
staff finding their way to the emergency site, signage,
locked security doors, equipment needs, and physical
plant adjustments. Finding these challenges during the
simulation allowed them to be addressed before the
Residential Treatment Facility (RTF) opened.
In July and August 2008, KSMC completed a massive
training endeavor with over 25 Mock Code 99 drills involving 100 people from the inpatient critical care units,
medical-surgical units, and the entire Code 99 team. The
goal was to involve as many of the staff as possible, on
the various units. This endeavor facilitated the highest
level of teamwork within a true Code 99 situation.
As of March 31, 2009, 403 staff have participated in
simulation.
Discussion
Quality of Care and Patient Safety
An RSC serves an essential function in the creation,
maintenance and improvement of quality of patient
care and patient safety by providing training opportunities for staff. Comments and scores on evaluation
surveys obtained during postsimulation self-assessment
demonstrated that staff feel the simulation training is
of definite value in improving their job performance
and their confidence in performing a procedure and
in providing patient care.
KSMC staff experiences confirm other reports in the
scientific literature, for example in simulation-based
orientation training for first-year pediatric critical-care
fellows in the US, students viewed simulation training
for common pediatric critical care management as effective for improving self-efficacy.6
Table 7. Average survey scoresa
Scenario
Average of all
questions in
each survey
General
team
4.5
ACLS
mock
code
4.5
Med-Surg
septic
mock
code
4.6
RN,
RT,
MD
team
4.4
Malignant
hyperthermia
4.5
MD, RN,
RT neonatal
resuscitation
4.7
OB/
GYN
mock
code
4.7
ED
neonatal
and ACLS
mock code
4.5
ED
peds
code
4.6
Acute
coronary
4.5
MedSurg
mock
code
4.4
a
on a scale of 1-5 (1 = poor; 5 = excellent)
ACLS = Advanced Cardiac Life Support; ED = Emergency Department; RT = Respiratory Therapist
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
41
Original article
Northwest Simulation Center—Sharpens Clinical and Communication Skills for Individuals and Teams
Regional Initiatives
The use of the RSC is connected to regional goals
and supports regional and national strategic initiatives. In particular, the RSC supported the KPNW
internalization efforts in Cardiovascular Services and
Behavioral Health and Addiction Medicine services,
and for the new RTF prior to opening. Simulations
were conducted in the new Cardiac Catheterization
Laboratory to test systems prior to its opening. Simulation sessions have occurred in preparation for the
opening of the Cardiovascular Intensive Care Unit,
planned for 2009. Finally, more simulation scenarios
are being developed for use by surgical teams involved
with the Highly Reliable Surgical Team project and the
Reliable Emergency Departments projects.
Additional Activites
The RSC and its staff provide educational opportunities for organizations and groups throughout the
greater Portland, OR and Vancouver, WA areas, such as
simulation activities for local nursing programs allowing student nurses to practice what they are learning
in the classroom and provide a systems approach to
real-time clinical learning. KPNW also hosts a bimonthly
simulation roundtable to provide opportunities for area
simulation educators to network. The roundtable is
supported by grants from the state of Oregon. In addition, the KSMC Coordinator for Regional Simulation
Operations is a member of the governing council of
the Oregon Simulation Alliance (OSA). Activities of the
OSA include providing simulation training courses and
apprenticeships, increasing public awareness of the
value of simulation, and hosting an annual Sim Summit Conference. Participants from Oregon, Washington,
and Idaho attend this conference to learn multidisciplinary approaches to simulation. Clinical teams on
the KSMC campus often use the RSC as action items
of Sentinel Event Root Cause Analysis work to improve
team communication. Because the Sim Lab is mobile
it regularly travels to KP medical and dental offices for
staff emergency preparedness training. Sim Lab staff
also participate in citywide disaster training, providing
mannequins, and standardized patients for the drills.
Transferability
Because the RSC was built on a “shoestring” budget
with the costs for furniture controlled by recycling furniture and materials from areas undergoing remodels
Sample Simulation Scenario: Precipitous Delivery in the Emergency
Department and Neonatal Resuscitation Program
Intended Audience: ED Consortium, new graduate RNs
Brief description of scenario: G4P3, age 34 years, presents in ED in active labor, SROM clear fluid, bloody show,
states strong urge to push. Spontaneous vaginal delivery occurs on ED stretcher without maternal complications.
Infant requires stimulation and PPV, and recovers.
Scenario Objectives: Participants will demonstrate:
1. Recognition of signs of impending birth
2. Appropriate skill in delivering baby
3. Appropriate Neonatal Resuscitation Program skills
4. Appropriate care and safety for mother and baby following delivery
5. Resource management, teamwork, and communication skills.
Description of Patient: Patient is in labor, wearing street clothes, in active labor. Patient is unaccompanied. SROM
obvious, positive bloody show on towel between legs.
Pertinent Medical History: Normal prenatal course, no problems. Baby has been active. Labor began several hours
ago, SROM within the last hour, clear fluid. UCs now every three to four minutes, getting stronger, patient has urge
to push, has bloody show.
Progressive Outline:
Noelle – Initial State: Head is crowning – prior to scenario, let head deliver until “Turtle sign.” Wet towel with
bloody show inside underpants.
Baby HAL – Initial State: Cyanotic, HR = 80, RR = 0, limp. After about 20 seconds of PPV, baby recovers: Pink,
HR = 120, RR = 40, active, crying.
ED = Emergency Department; G4P3 = Gravida 4, Para3 (gravida is number of pregnancies, para is number of live births); HR = heart rate;
PPV = positive pressure ventilation; RR = respiratory rate; SROM = spontaneous rupture of membranes; UCs = uterine contractions.
42
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Northwest Simulation Center—Sharpens Clinical and Communication Skills for Individuals and Teams
and from the Region’s surplus warehouse, it is a model
for low-cost start-up. RSC also gained momentum from
the Perinatal Patient Safety Reliability project and now
can serve as an added demonstration of simulation
value. Space, staff wages, and the mannequins are the
true costs of developing such a “laboratory”; however,
KP is also investing in the resource of human patient
simulators. The staff of the KPNW RSC is available to
consult with any KP Region or hospital looking to add
their own simulation center. Their internal KP Web site
is on the KP Northwest homepage: http://internal.or.kp.
org/simlab (password protected). v
a
For more information about the Perinatal Patient Safety
Project, please see: Nunes J, McFerran S. The Perinatal
Patient Safety Project: New Can Be Great! Perm J 2005
Winter;9(1):25-7; Nunes J, McFerran S. 2004 Lawrence New
Project Award Winner: Perinatal Patient Safety Project. Perm
J 2005 Spring;9(2):28-33; Sandoval J, McDonald J, Graham
S. 2005 Lawrence Transfer Award Winner: The Southern
California Perinatal Patient Safety Project. Perm J 2006 Summer;10(2):29-36.
Disclosure Statement
The author(s) have no conflicts of interest to disclose.
ORIGINAL Article
References
1.Musson DM, Helmreich RL. Team training and resource
management in health care: current issues and future directions. Harvard Health Policy Review 2004 Spring;5(1):25-35.
2.Institute of Medicine, Committee on Quality of Health Care
in America. Kohn LT, Corrigan JM, Donaldson MS, editors.
To err is human: building a safer health system [monograph
on the Internet]. Washington (DC): National Academy Press;
2000 [cited 2009 Jan 15]. Available from: www.nap.edu/
openbook/0309068371/html/.
3.Botwinick L, Bisognano M, Haraden C. Leadership guide
to patient safety. IHI Innovation Series white paper
[monograph on the Internet]. Cambridge, MA: Institute
for Healthcare Improvement; 2006 [cited 2009 Jan 14].
Available from: www.ihi.org/IHI/Results/WhitePapers/
LeadershipGuidetoPatientSafetyWhitePaper.htm.
4.Making health care safer: a critical analysis of patient safety
practices. Summary [monograph on the Internet]. AHRQ Publication No. 01-E057. Rockville, MD: Agency for Healthcare
Research and Quality; 2001 July [cited 2009 Jan 14]. Available from: www.ahrq.gov/clinic/ptsafety/summary.htm.
5.Welcome to the Center for Medical Simulation© (aka
Harvard Hospital). Cambridge (MA): HarvardMIT Center for
Medical Simulation; 2007.
6.Nishisaki A, Keren R, Nadkarni V. Does simulation improve
patient safety? Self-efficacy, competence, operational
performance, and patient safety. Anesthesiol Clin 2007
Jun;25(2):225-36.
Attend to the Details
Even a trained student should attend to every
detail, if he wishes to master with assurance
and speed each aspect of his profession which
he has already learned by the general method.
— On the Affected Parts, Galen of Pergamum, 129-200,
Roman physician and philosopher of Greek origin
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
43
Original article
2008 Lawrence Patient Safety Award
Ohio Safety Action Teams
Cindy Ebner, RN, MSN, CPHRM, FASHRM
Abstract
Ambulatory care presents many challenges for implementing
a risk management and patient safety program. In addressing
a perceived problem about inadequate response to reports in
the Kaiser Permanente Ohio Region, interdepartmental Safety
Action Teams (SATs) were created and activated in 2005-6.
The Kaiser Permanente (KP) Ohio Region includes various
locations widely separated through northeast Ohio. Team Lead
Registered Nurses, Managers, and Directors are responsible for
primary care, specialty care, and other services that are located
across the Region rather than in one building. Physicians and
allied health professionals practice in more than one location.
Practice variations in affiliated hospitals with which the Ohio
Permanente Medical Group (OPMG) contracts—only some of
which have OPMG Hospitalists—add to the challenges.
To improve the process, the SATs mapped the current process
and ran Plan-Do-Study-Act cycles to test the new process prior
to implementation. Nineteen SATs have been implemented
since inception and eleven are completed. In a post-SAT survey,
participants showed they knew more about building a reliable
process, their job satisfaction increased, patient safety was
improved, and the gains were sustained. The plan to continue
SATs is felt to have a solid future and is readily transferable to
other areas and facilities.
Introduction
Ambulatory care presents many challenges for implementing a risk management and patient safety program.
A random sample of employees throughout the Kaiser
Permanente (KP) Ohio Region revealed that staff had
become discouraged and no longer reported incidents
or issues because of a perceived lack of response,
either in the form of feedback or of action to address
issues. In response to this and because the KP Ohio
Region includes various locations widely separated
throughout northeast Ohio, a Safety Action Team (SAT)
(See sidebar: Glossary of abbreviations) program was
developed. At that time, the Ohio Region did not have
an active performance improvement mechanism and
the Risk Management Patient Safety (RMPS) commit-
tee was composed of staff and managers without the
authority to implement change. Additionally, in 2006,
an annual employee satisfaction survey (People Pulse)
indicated that only 71% of staff felt encouraged to speak
up about errors.
Safety Action Teams:
Construction and Implementation
In 2005-2006, to address these challenges, several building blocks were put into place to create the foundation
for an RMPS program. The program’s goal is to do the
right thing right the first time, which is consistent with
the Region’s strategic plan. A strategy was created to
establish a culture of safety and to build a highly reliable
organization. The six most important activities were: 1)
to create a just culture using David Marx’s Just Culture
Model and Just Culture Algorithm1,2 in collaboration with
human resources; 2) to implement an anonymous electronic incident reporting system; 3) to restructure the RMPS
committee with department chiefs and managers who can
review critical events and trends and drive improvement;
4) to bring safety to the forefront through education,
executive walkarounds, senior leadership support, and
safety fairs; 5) to implement SATs to improve systems
and processes by engaging frontline staff, managers,
and leadership who touch the system/process; and 6)
to build relationships through fostering collaborations
between departments on the SATs, Quality Resource
Management Committees and RMPS committee.
Glossary of Abbreviations
SAT – Safety Action Team
RMPS – Risk Management Patient Safety
PIPS – Performance Improvement and Patient Safety
QRPS – Quality and Risk and Patient Safety
PIPPRO – Performance Improvement and Provider
and Practitioner Review and Oversight
PDSA – Plan-Do-Act-Study cycle
ASC – Ambulatory Surgery Center
PAR – Preadmission Requisition
Cindy Ebner, RN, MSN, CPHRM, FASHRM, is Director of Risk Management and Population Care
Management for Kaiser Foundation Health Plan in Cleveland, OH. E-mail: [email protected].
44
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
ORIGINAL Article
Ohio Safety Action Teams
Methodology
The SATs began in the third quarter of 2006 and were
designed to engage frontline staff, physicians, and leadership to improve the systems and processes. Issues are
identified as noted in Table 1. The goals were to make
the processes error free, to eliminate waste, to decrease
steps, and to standardize where applicable, thus creating
processes that are highly reliable and decrease costs and
resource utilization. SATs are composed of frontline staff,
managers, directors, and executives of each department
the issue touches. A Performance Improvement and
Patient Safety (PIPS) Department (Table 2) staff member
leads and facilitates the team and records the team’s
progress. PIPS Department includes staff from the Quality
and Risk and Patient Safety Department (QRPS).
When an issue arises, it is presented to the RMPS Committee who determines if a SAT is warranted. Members
of the SAT follow the process detailed in the following
example of the images-to-operating-room process. The
average time to complete a SAT is five to seven months.
Department managers are responsible for incorporating the new processes into department policies and
procedures, communicating regularly on team progress,
involving staff in Plan-Do-Study-Act (PDSA) cycles, soliciting feedback from physicians and staff, and monitoring
the process after implementation.
Safety Action Team Example:
The Images-to-Operating-Room Process
An example to best illustrate using a SAT was the one
formed to improve transferring KP radiologic images
to affiliated hospital operating rooms (ORs) in a timely
fashion prior to surgery.
Identifying the Problem
A surgeon referred this issue to the RMPS Committee, insisting that scans were rarely in the OR prior to
scheduled surgery, which led to cancellations, delays,
repeated scans, and surgeries performed without
scans. Upon investigation, it was discovered that the
process had a long history of challenges, which had
led to several workarounds being developed, which
included patients being responsible for the delivery of
their own scans, physicians bringing the films, scans
being reprinted by the file room, the use of STAT courier services, and repeated scans. All of these led to
increased costs and delays for the affiliated hospital,
for KP, and for the patient (Table 3).
A SAT was assembled (Table 4). PIPS Department
staff and the courier manager visited each department
involved to map the current process. Microsoft Office
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Table 1. Methods through which issues for
referral to Safety Action Teams are identified
Executive patient safety walkarounds
Incident reports
Peer-review cases
Staff and physician referrals
Customer complaints
Consumer Assessment of Healthcare Providers and
Systems surveys (patient satisfaction)
Various committees
Lawsuits and demand for payment
Employer group complaints
Table 2. Performance Improvement and Patient
Safety Department team
Kerry Dease, RN, BSN, Regional Patient Safety Lead
Justine Wells, RN, BSN, CPHRM, Clinical Risk Manager
Sharon Zahtilla, RN, BSN, Quality Consultant
Bonnie Lackey, RN, Quality Consultant
Virginia Mooney, RN, BSN, Quality Consultant
Visio Professional 2003 (Redmond, WA) process mapping software was used to identify issues and sent to
the SAT for review and revision.
Defining the Goals
At an initial teleconference, the findings were discussed and goals and possible metrics were outlined.
The group-defined goal was to get the images to the OR
24 hours prior to each surgery. Possible metrics included
monitoring the number of STAT courier deliveries.
Developing a Solution
The process map developed clearly showed how
departments interact and where challenges arise. The
map removed hierarchies, allowing participants to feel
comfortable voicing their opinions, and created opportunities to build relationships between departments and
staff. After mapping the process, one of the surgeons
pointed out that surgeons were not completing the
Preadmission Requisition (PAR). This set the tone for
sharing and collaboration. If key decisions are made at
a higher level, it avoids the trickle down effect to the
lowest level of staff who is blamed when the process
fails. In this case, the file room clerks were blamed by
hospitals and surgeons when scans weren’t in the OR
as expected. Because the surgeon identified this problem, made obvious from the process map, it removed
barriers and the reluctance to be forthright.
Surgeons suggested creating templates of the scans
consistently necessary for particular surgeries, which
The process map
developed clearly
showed how
departments
interact and
where challenges
arise.
45
Original article
Ohio Safety Action Teams
were then developed by the ASC Medical Director and
other Department Chiefs. The OR Manager and schedulers collaborated with the affiliated hospitals to obtain
OR schedules and to brainstorm efficient file room
notification for additional scheduled surgeries.
Implementing and Refining
One team surgeon attended a Surgery Department
meeting to share the SAT goals and to explain the
need to complete the PAR. The surgeon explained the
importance of the project and its potential benefits. To
build trust and to address concerns raised by physicians,
a safety net was created in which the file room sent
a text page to the physician the night before surgery
verifying the scans were at the hospital. This was extremely successful and within one month was no longer
necessary. Any surgeon not completing the PAR was
contacted by the ASC Medical Director and persuaded
to try the process. Two surgeons preferred to review
their scans the day before surgery in their offices and
an accommodation was developed for them.
Biweekly one-hour SAT teleconferences—to develop
Table 3. Improving the process for delivering images to the Operating Room project summary
Safety Action Team
Challenge: Images
were often not
available at the time
of surgery in our
contracted facilities.
There were multiple
failure modes in the
system that led to
workarounds and
an inefficient and
unreliable process.
This led to delayed
or cancelled
surgeries, repeat
x-rays, additional
copies of images
produced, STAT
courier deliveries,
and dissatisfaction
from everyone
involved in the
process.
Goal
Delivery of images
to the hospital
24 hours prior to
surgery for 100%
of scheduled
cases.
Team Members:
Medical Director
and Manager ASC;
KP file room staff
and manager;
three contracted
hospital file room
staff and managers
and OR managers;
courier manager
and staff; three
KP surgeons; KP
OR schedulers;
system telephone
operators
Improvements
1. All surgeons must fill out the
PAR delineating the films and/
or reports requested
2. PARs are sent to the file
room by OR schedulers with
schedule
3. Template developed by
surgeons for standard films
needed per type of surgery
4. Blue index card with specific
information required by
hospital to get the film to the
OR put in front of film jacket
5. Daily schedule obtained
from contracted facilities to
identify add-ons and sent to file
room
6. Courier delivery schedule
changed
7. File room calls hospitals prior
day to verify films are there
Time to
complete project
Start Date: 11/06
Completion
Date: 3/07a
Metrics
1. Number of STAT
courier deliveries on
scheduled surgeries.
2. Number of times
films not in OR on
time.
Results
1. Not tracked until
3Q07. No STAT
courier deliveries to
date.
2. Five times since
project completed
(one because a
physician did
not fill out PAR,
three because staff
distraction occurred
on same day with
same person; one
because the image
was not the right one:
the physician did not
want the default view
but another view.
Cost Savings and Benefits
Cost avoidance:
soft dollars
Average cost per
lawsuit: $350,000
Surgeon turnover
because of job
dissatisfaction
File room turnover
because of job
dissatisfaction
Damage to KP’s
reputation
Capacity
Increased
surgeries
scheduled in
hospital OR
because of
avoidance of
delays and
cancellations
Increased
productivity for
file room staff
Dollars saved:
hard savings
1. Processing additional films
-$1.05/filmb
2. $25.17 per minute for delays
in the ORb
3. Number of additional x-rays
taken at hospitals x $500b
4. STAT courier delivery from
contracted company -$12/
deliveryb
Time saved
• Minutes to
recopy x-rays
• No additional
courier deliveries
• No delays in
surgery because
of missing images
Patient benefits
• Surgeries take place
on time
• No additional
radiation exposure
• Surgeon has
necessary information
to perform surgery
• Expenses involved in
delays or cancellations
for surgery
• Potentially avoid
complications because
of performing surgery
without images
Other departments
affected
Radiology does STAT
films at contracted
facilities
OR has to delay or
cancel surgeries at
contracted facilities
Contracted couriers
doing STAT
deliveries to hospitals
a
Original process completed and extended to contracted referral office visits at Cleveland Clinic Foundation. Pink index card created for their specific needs. Designated delivery and
pick up places and delivery times changed to improve reliability.
b
Unable to quantify volumes since it was not tracked before implementation of this project. According to the surgeons, missing films happened frequently.
ASC = Ambulatory Surgery Center ; KP = Kaiser Permanente; OR = operating room; PAR = Preadmission Requisition
46
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
ORIGINAL Article
Ohio Safety Action Teams
Table 4. Safety Action Team participants
Affiliated hospital personnel
Operating Room personnel
File Room staff
Kaiser Permanente Ohio personnel
Courier manager and staff
Ambulatory Surgery Center manager
Operating Room schedulers
Radiology file room staff and manager
Radiology Director
Medical Director of the Ambulatory Surgery Center
Surgeons
actions with a completion goal based on the findings
from previous meetings—continued until the project was
completed. For example, the electronic routing form was
confusing because it listed the information to return the
scan to KP. The courier manager and the PIPS staff worked
with each hospital file room to determine how to best
organize the information needed to get the scan to the OR
on time. A surgeon suggested using an index card on the
front of the file jacket with the required information—a
simple and elegant solution. The PDSA cycle was completed to determine the potential success of this solution;
the evaluated process was implemented.
Transfer
The first phase of the project was completed in three
months and a trial for the clinics was developed and
tested in the Cleveland Clinic Foundation offices for
consultations. The process was again successful and,
with minor changes, was implemented.
Results
In addition to improving the process, this project
built relationships with people in affiliated hospitals
and KP shared the learnings about building reliable
processes and performance improvement. The staff
at hospitals readily participated, excited that KP was
proactively addressing failed processes. Ultimately, the
project will improve KP’s reputation in the community
through continued patient safety initiatives.
From a survey created and sent to all SAT participants
feedback was obtained and used to identify areas for
improvement. The response rate was 50% (n = 20) and
of those who responded 100% agreed that they knew
more about building a reliable process as a result; 97.4%
agreed that it increased their job satisfaction; and 100%
believed that patient safety was improved and the gains
were sustained (Figure 1).
Discussion
Ambulatory care presents many challenges. The KP
Ohio Region’s Safety Action Team program has proved successful in addressing some of these. Following implementation of the program, participants agreed that patient safety
was improved and they acknowledged that the gains made
through the program were sustained. They also agreed that
they knew more about building a reliable process and that
the program increased their job satisfaction.
100%
90%
80%
48%
48%
42%
37%
39%
37%
30%
20%
Strongly agree
Agree
Disagree
Strongly disagree
70%
60%
45%
50%
40%
30%
43%
52%
58%
58%
56%
65%
63%
20%
30%
10%
0%
10%
I know more
Process
about building increased
a reliable
efficiency in
process
work area
Patient
safety
improved
6%
5%
Built
relationships
with other
departments
Improvement
increased
work
satisfaction
5%
We were
able to
sustain
the gains
5%
Could
KP member
do small
would be
improvement valuable asset
project
to team
Figure 1. Safety Action Team Survey—Ohio Region; January, 2009
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
47
Original article
Ohio Safety Action Teams
Table 5. Requirements for a Safety Action Team
Method to identify dysfunctional systems
Processes and referral system for process improvement
Quality, patient safety, and risk professionals trained in process improvement
One hour every two weeks for meetings
Teleconference line
Visio or other process map software
Adobe Acrobat Professional (San Jose, CA) to convert the Visio map to a
readable format
Administrative assistant to set up initial meeting
Oversight committee to evaluate the progress of SATs and to assist with
project barriers
Frontline staff, managers, administrators, and physicians willing to participate
Template for tracking team progress
E-mail communication system
Information Technology (IT) support for data and to assist on teams
Brainstorming tools
Program Transferability
SATs can be implemented in any region for inpatient/
ambulatory care and can be customized for smaller
performance improvement projects. The Ohio Region
is committed to working with any region or facility
interested in implementing this process. Requirements
for a SAT have been developed (Table 5).
Where We Are Now
In 2008, to each new committee we added KP
nonemployee patients who participate in team activities, provide feedback, and drive some changes. For
instance, patients and families in Oncology were interviewed for input regarding their experience in the
Infusion Center for the Oncology SAT. Patients kept a
time log to identify delays and inefficiencies in their
treatment process. Patients and families were enthusiastic and willing to help us. An added benefit is that
staff has the opportunity to interact with patients in a
different relationship.
Improvements planned for 2009 include tracking
the outcomes, costs, and benefits for each new team
in the Performance Improvement record; working
with unit-based teams with a scaled-down version of
the SAT approach; educating department staff on how
to use the process algorithms; incorporating Webinars
or shared desktop for meetings; and developing a
one-page monthly update for all department staff not
involved in the program for feedback.
Conclusion
Since the inception of SATs, 19 teams have been
implemented and 11 are completed. The teams run
48
simultaneously and are led by different members of the
PIPS team (Director, regional safety lead, and/or three
quality consultants). All goals were met and the gains
are sustained within each team. New workflows were
developed and policies and procedures were changed
where applicable. Staff and leaders in the department
monitor the new process for 6-12 months. Any failures
are investigated by the staff in collaboration with the PIPS
team leader and adjustments to the process are made as
appropriate. When issues are brought to the RMPS, they
are investigated with consideration to the level of risk to
patients before a project is undertaken. The Senior Quality Council receives quarterly SAT reports and all staff is
updated quarterly per the PIPS Department newsletter.
Future plans are being made to offer assistance in
improving processes for issues identified by affiliated
clinicians. This will build collaboration, increase reliability, and further develop a culture of safety. This initiative
will include education, alerts, recalls, implementation of
The Joint Commission National Patient Safety Goals,3 and
creating a just culture. The overall goal will be to improve
patient outcomes by making it easy for all of our clinicians
to do the right thing right the first time. v
Disclosure Statement
The author(s) have no conflicts of interest to disclose.
Acknowledgments
The author would like to thank Ruth Langstraat, MD, Vice
President of Health Systems Design and Performance for the
Ohio Permanente Medical Group; Charles Zonfa, MD, Interim
Physician Director of Risk and Safety for the Ohio Permanente
Medical Group; Oksana Bender, Manager Analysis/Projects
for Kaiser Permanente Ohio; Marcy Becker, Senior Consultant,
National Market Research for Kaiser Permanente Ohio; and all
staff, managers, and physicians who participated on the Safety
Action Teams at Kaiser Permanente Ohio.
References
1.Marx D. The Just Culture Community: Patient safety and
the “just culture” [monograph on the Internet]. Plano (TX):
Outcome Engineering, LLC; 2007 [cited 2009 Feb 16]. Available from: www.health.state.ny.us/professionals/patients/
patient_safety/conference/2007/docs/patient_safety_and_
the_just_culture.pdf.
2.Marx D. Patient safety and the “Just Culture”: A primer for
health care executives [monograph on the Internet]. New
York: Columbia University; 2001 Apr 17 [cited 2009 Feb
16]. Available from: http://dodpatientsafety.usuhs.mil/index.
php?name=Downloads&req=getit&lid=724.
3.2009 National Patient Safety Goals [Web page on the Internet]. Oakbrook Terrace (IL): The Joint Commission; 2009
[cited 2009 Feb 18]. Available from: www.jointcommission.
org/PatientSafety/NationalPatientSafetyGoals/.
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
soul of the healer
“Modern Woman Torso”
27”
bronze sculpture with pink ribbon, limited edition
By Evany Zirul, MFA, DO
Evany Zirul, MFA, DO, is a former Ear, Nose, Throat and Facial Plastic Surgeon for the former
Permanente Medical Group of Mid-America, (PMGMA) in Kansas City, Missouri. She has
retired from the medical profession and is now a full-time artist. She creates drawings and
bronze sculptures. She states, “My art is figurative. It is realism expressing the maleness,
femaleness, and emotional nuances mirrored by our bodies and our life experiences.”
“Modern Woman Torso” was created for the Pink Show in Fresno, CA.
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
49
credits available for this article — see page 95.
Review article
Incidental Gallstones
Jeffrey K Wang, MD
Shannon M Foster, MD
Bruce G Wolff, MD, FACS
Abstract
Gallstones develop in approximately 10% to 15% of
the US population and represent one of the most common and most costly of all digestive diseases. Studies
investigating gallstones’ natural history have shown that
gallstone-related complications arise at a rate of approximately 1% per year in asymptomatic patients and
2% per year in patients who already have symptoms.
Patients can have any of multiple presentations with
gallstone-related problems along a continuum of health
threats from intermittent biliary colic to septic shock
from ascending infections. In most clinical situations
in which the patient’s gallstone symptoms are either
recurrent or have caused complications, cholecystectomy remains the procedure of choice. Laparoscopic
cholecystectomy, first performed in the mid-1980s,
has quickly become the gold standard in the US. For
clinicians who perform abdominal procedures, the
literature is consistent in advocating cholecystectomy
for gallstones found incidentally during other abdominal procedures.
Prevalence and Demographics of
Gallstone Disease
Gallstones represent the most common and costly
of all digestive diseases, with an estimated overall
financial burden in the US of more that $5 billion.
From a consensus statement published by the National
Institutes of Health (NIH), approximately 10% to 15%
of the US adult population has gallstones.1 Epidemiologic studies estimate the number of gallstone patients
in the US to be approximately one million per year.
Since the 1980s, we have gained insight to major risk
factors for the development of gallstones, including
increasing age, female sex, obesity, pregnancy, rapid
weight loss, systemic illnesses such as liver disease or
hematologic disorders, a long list of medications, and
specific bowel surgery.
Historical Perspective on Gallbladder
Surgery
The first recorded surgery performed on the biliary
system was in 1867 in Indianapolis, IN, when John
Stough Bobb operated on a woman with massive
gallbladder hydrops. Bobb performed an open cholecystostomy, extracted the gallstones, and then sutured
the gallbladder closed. Approximately 15 years later in
Berlin, Carl Langebuch performed the first cholecystectomy on a patient with biliary colic. This became
the standard operation for patients with symptomatic
gallbladder disease for more than 100 years until Erich
Mühe revolutionized the field in 1985 in Boeblingen,
Germany by performing the first laparoscopic cholecystectomy.2 In less than one decade, >90% of cholecystectomies performed in the US were being performed
laparoscopically.
Since the early 1990s, continual improvement has
been made in both the instrumentation and optics
needed to perform the laparoscopic cholecystectomy.
With ongoing research on indications, methods, and
outcomes, a great deal of experience with laparoscopic
cholecystectomy has been amassed worldwide.
Natural History of Gallstones
Studies have shown that the vast majority of patients
with gallstones will remain asymptomatic throughout
life.3 The reason a subgroup of individuals will ultimately develop symptoms remains unknown; however,
once symptoms arise, the recurrence rate is high and
risk of progression to gallstone-related complications
is significantly increased.4 An article by colleagues
from the Kaiser Permanente Medical Care Program in
Oakland, California,5 reported that 289 patients with
documented gallstones were monitored for up to 25
years after diagnosis. Using life-table analysis, the
researchers found that complications developed in
approximately 1% per year of asymptomatic patients
with gallstones and in about 2% per year of symptomatic patients. These figures are similar to those in
Jeffrey K Wang, MD, (left) is a Resident in General Surgery at Mayo Clinic in Rochester, MN.
E-mail: [email protected].
Shannon M Foster, MD, (center) is a Fellow in Critical Care and Trauma Surgery at Mayo Clinic
in Rochester, MN. E-mail: [email protected].
Bruce G Wolff, MD, FACS, (right) is a Professor of Surgery at the Mayo College of Medicine and the Chair
of the Division of Colon and Rectal Surgery at Mayo Clinic, Rochester, MN. E-mail: [email protected].
50
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Review article
Incidental Gallstones
other published reports1 that ultimately conclude that
patients with symptomatic gallstones should be treated.
Because nearly two-thirds of asymptomatic patients
with gallstones remain symptom free, prophylactic
cholecystectomy is rarely indicated and performed only
under certain circumstances.
Spectrum of Presentation
Chronic Cholecystitis
As the NIH consensus statement notes,1 gallstone
patients present in one of three clinical stages: asymptomatic, symptomatic, and with complications. Approximately two-thirds of symptomatic patients present
with chronic cholecystitis characterized by pain that is
severe and episodic, epigastric or right upper quadrant
in location, that lasts one to five hours, and that often
wakes the patient at night or beginning after a fatty
meal. This pain is most often caused by a gallstone
obstructing the cystic duct, the sole biliary outflow tract
of the gallbladder. This leads to progressively increasing
gallbladder wall tension and thus to pain. Nausea and
vomiting are commonly associated symptoms.
The diagnosis of chronic cholecystitis or symptomatic
cholelithiasis is made when the typical symptoms are
present and gallstones are found using various imaging modalities. Abdominal ultrasonography remains
the gold-standard diagnostic test, capable of detecting
>90% of gallstones. Occasionally, gallstones are found
incidentally during abdominal radiographs or computed
tomography (CT) scans. In these cases, ultrasonography
of the formal right upper quadrant should be performed
before surgery.
After its introduction in 1987, laparoscopic cholecystectomy quickly became the standard of care for
symptomatic individuals. Long-term results have shown
that laparoscopic cholecystectomy eradicates symptoms
in approximately 90% of patients with typical biliary
symptoms.6
Acute Cholecystitis
Once a gallstone has obstructed the cystic duct for
an extended period of time, inflammation of the gallbladder wall causes it to become grossly thickened and
edematous and may lead to the formation of pericholecystic fluid. These findings represent the cornerstones
of diagnosing acute cholecystitis. If the obstruction
and contamination are not relieved, inflammation can
evolve into infection and abscess formation, creating
a gangrenous gallbladder. Uncommonly, this may lead
to free perforation of the gallbladder wall, causing
development of peritonitis, development of fistulas
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
into adjacent organs, or formation of intra-abdominal
abscesses. The symptoms of acute cholecystitis are
similar to those of chronic cholecystitis, but in contrast to typical biliary colic, the pain does not regress
and may last for several days if untreated. Associated
symptoms are broadened to include fever, chills, and
anorexia. Physical examination will often show focal
tenderness with guarding. A classic characteristic of
acute cholecystitis is the finding of Murphy sign, or an
inspiratory arrest on deep palpation of the gallbladder
in the right upper quadrant.7 Also in contrast to chronic
cholecystitis, in which laboratory study results are generally normal, leukocytosis with white blood cell counts
>12,000 cells/mm3 is commonly present. Levels of other
substances for which patients are tested, such as those
for liver function (alkaline phosphatase, transaminases,
and bilirubin), may be elevated.
Diagnosis is most often confirmed using ultrasonography, which may show gallstones, a thickened
gallbladder wall, and fluid next to the gallbladder. For
atypical cases or for those in which the diagnosis is
uncertain, biliary radionuclide imaging, such as hepatobiliary iminodiacetic acid scans, may be helpful. The
finding consistent with acute cholecystitis is the lack of
filling of the radionuclide into the gallbladder within
four hours, indicating obstruction of normal biliary flow
from the liver into the gallbladder.
Cholecystectomy, whether open or laparoscopic, is
the treatment of choice for acute cholecystitis.8 One
area of controversy in recent years has been the timing
of cholecystectomy in acute cholecystitis. A prospective, randomized study by Lo et al9 found that barring
patient-related factors that would rule out surgery,
early cholecystectomy (within two or three days of
initial symptoms) should be recommended to patients
because it offers a definite solution in one hospital
admission, results in quicker recovery times, and also
allows for earlier return to work. When patients present
after the initial window of opportunity for cholecystectomy (after three or four days of initial symptoms),
they can be treated with antibiotics and then scheduled
for interval laparoscopic cholecystectomy after six to
eight weeks. Of these patients, this therapy will fail in
approximately 20%, who will require surgery sooner.
The concern about attempting laparoscopic cholecystectomy outside of the initial or late windows is due
to the increased rate of conversion to an open procedure, which is associated with increased pain, longer
hospitalizations, and obvious cosmetic drawbacks.10
For patients unfit for surgery, drainage of the gallbladder using either a percutaneous approach through the
51
REVIEW article
Incidental Gallstones
liver or an open approach in conjunction with a tube
or drain can be performed. This tube can ultimately be
removed once a contrast study through the tube shows
a patent cystic duct. Laparoscopic cholecystectomy can
be performed after the tube has been removed.
The most
common cause
of cholangitis
is gallstones,
but any disease
process that
leads to
obstruction
may precipitate
cholangitis,
such as bile
duct strictures,
parasites,
external
compression,
and blocked
biliary stents.
52
Choledocholithiasis
Stones that are found within the common bile duct
arise in two ways: 1) secondary migration of gallstones
formed in the gallbladder down the biliary tree or 2)
primary formation within bile duct. The majority of
ductal stones in the US are formed secondarily within
the gallbladder.
The spectrum of clinical manifestations in choledocholithiasis is vast, from asymptomatic to complete
obstruction with resulting pain, infection, and pancreatitis. Patients report similar biliary colic–type symptoms,
with nausea and vomiting commonly associated. These
symptoms may be more temporal, causing pain and
jaundice as the gallstone temporarily obstructs the bile
duct, acting like a ball-valve mechanism. Because the
gallstone may completely obstruct the normal flow of
bile, patients may become jaundiced and levels of liver
function tests, including alkaline phosphatase, serum
bilirubin, and transaminases, may be elevated.
Ultrasonography is commonly the first test obtained
to document stones in the gallbladder as well as the
size of the common bile duct. A dilated common bile
duct (>8 mm in diameter) in conjunction with jaundice,
biliary colic, and appropriate elevations in levels of
substances measured by laboratory studies is suggestive of choledocholithiasis. Other noninvasive studies,
such as magnetic resonance cholangiography, may
also provide further details about the biliary system.
Endoscopic retrograde cholangiography (ERC) not only
is the gold standard for diagnosing common bile duct
stones but also is potentially therapeutic if stones are
extracted from the common bile duct or sphincterotomy
is performed to relieve an obstructing stone.11
Common bile duct stones can either be relieved by
sphincterotomy and ductal clearance through preoperative ERC or extracted via intraoperative common bile
duct exploration through the cystic duct or common bile
duct. ERC may also be performed postoperatively when
common bile duct stones encountered during routine
laparoscopic cholecystectomy. Choledochotomy or
common bile duct exploration can be performed laparoscopically or in an open fashion; in either case, a T-tube
drain should be left in place to drain bile and stones
to the level of the skin. In the case of an abnormally
dilated bile duct secondary to impacted stones in the
ampulla, anastomosing segments of bowel, such as in
choledochoduodenostomy or choledochojejunostomy,
may be the best option.
Cholangitis
Acute cholangitis occurs when a stone either partially
or completely obstructing the common bile duct causes
bacterial contamination and leads to an ascending infection of the biliary system. Immunoglobulins within the
bile and a continuous downward flow from the liver
normally keep bile sterile. The most common cause of
cholangitis is gallstones, but any disease process that
leads to obstruction may precipitate cholangitis, such
as bile duct strictures, parasites, external compression,
and blocked biliary stents. Cultures taken of the bile,
of stones within the common bile duct, and of stents
produce positive findings in >90% of cases. The most
common microbiologic sources are Gram-positives and
Gram-negatives: Escherichia coli (25%–50%), Klebsiella
pneumoniae (15%–20%), Enterococcus (10%–20%), and
Enterobacter (5%–10%).12
The spectrum of clinical presentation varies widely from
mild, intermittent pain to life-threatening septic shock.
The classic Charcot triad, consisting of fever, right upper
quadrant pain, and jaundice, is present in approximately
50% to 75% of patients with cholangitis.13 This triad may
progress to Reynolds pentad, which adds mental-status
changes and septicemia-associated hypotension to the
presentation. Physical examination findings are similar
to those for patients with acute cholecystitis.
Laboratory findings will often show leukocytosis
with elevation in serum bilirubin levels, transaminases,
and alkaline phosphatase. Ultrasonography is useful in
documenting the presence of gallstones as well as the
diameter of the common bile duct. The initial treatments
for acute cholangitis are intravenous broad-spectrum
antibiotics, aggressive fluid resuscitation, and ultimately
drainage of the infected bile, either externally through
the skin or within the duodenum through the ampulla
of Vater.14 Many patients will need intensive care unit
monitoring and temporary vasopressors.
Endoscopic retrograde cholangiopancreatography
(ERCP) is useful in both confirming the diagnosis and
with sphincterotomy or stone extraction relieving the
obstruction. A stent may have to be placed to allow for
drainage of bile. When ERCP is not available, percutaneous transhepatic cholangiography (PTC) may have to be
used. It can demonstrate the level of obstruction, allow
for bile culturing, and establish a route for drainage
of bile, removal of stones, and tube placement. When
neither ERCP nor PTC is available, open surgery to
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Review article
Incidental Gallstones
decompress the biliary system with T-tube placement
is the treatment of choice. Cholecystectomy can be
performed electively once the obstruction is relieved
and infection has been controlled.
Gallstone Ileus
Rarely, gallstones can cause a mechanical bowel
obstruction in the distal segments of the small intestine, known as gallstone ileus. It occurs in <0.5% of
patients with gallstones and is the cause of 1% to 4%
of all cases of bowel obstruction. There is a strong
female predilection, with gallstone ileus being 3 to
10 times more common in women than in men.15 The
most common mechanism of gallstones causing ileus
is a biliary-enteric fistula, which is created after local
inflammation causes adhesion formation between the
bile duct and intestine. Ongoing inflammation leads
to necrosis between the biliary system and the small
bowel, leading to communication between the two
organ systems. Presenting symptoms are related to
mechanical bowel obstruction that causes episodic
vague abdominal pain, nausea, and vomiting. The
diagnosis is confirmed through plain radiographs and
computed tomography scans that demonstrate signs
of mechanical bowel obstruction, air within the biliary
tree (pneumobilia), or sometimes even the offending
stone. Treatment of gallstone ileus remains controversial because there are various opinions regarding the
management of the biliary-enteric fistula. Those who
advocate a one-stage procedure, by removing the stone,
managing the fistula, and cholecystectomy, agree that
it is reserved for patients with low surgical risk.16 With
regard to the small bowel, a longitudinal enterotomy is
made to carefully remove the stone and is subsequently
closed transversely to prevent bowel stenosis.17
Incidental Cholelithiasis
Gallstones detected either before or at the time of
another gastrointestinal procedure present a difficult
and long-debated problem for surgeons. There are
arguments both for and against: the possibility of adding significant morbidity and mortality to the index
procedure versus the likelihood that biliary symptoms
and complications will develop in the future. Of utmost importance when dealing with this issue is an
understanding of the natural history of asymptomatic
gallstones. As already stated, the complication rate in
the US for asymptomatic patients with gallstones is
approximately 1% per year. Because of this low rate
of progression, prophylactic cholecystectomy as the
sole procedure, meaning performing cholecystectomy
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
for the purpose of removing the gallbladder and the
associated stones, is rarely indicated.
What does one do when a patient will receive
abdominal surgery and the gallbladder can be easily
removed? The authors of the 1992 NIH Consensus Statement wrote: “It remains controversial whether incidental
cholecystectomy during nonbiliary abdominal surgery
in asymptomatic individuals is beneficial.”1
Despite this statement, there are numerous reports
in the literature that support performing incidental
cholecystectomy in conjunction with another abdominal procedure, such as from vascular,18 colorectal,19
and thoracic20 surgeries. Juhasz et al19 reported on a
single-institution retrospective review over five years
that identified 305 patients who underwent colorectal
surgery. Of that cohort, 195 (63.9%) had incidental
cholecystectomy that was discovered before, during, or
within one month after surgery. Patients were excluded
if they developed biliary symptoms before surgery.
Using surgical morbidity and long-term complication
rates as outcomes, Juhasz et al concluded that incidental
cholecystectomy was not associated with increased
postoperative morbidity. Furthermore, they found that
14.6% of patients who did not receive cholecystectomy
despite having gallstones went on to develop biliary
symptoms after a median follow-up period of six years.
Twelve of those 16 patients ultimately underwent
cholecystectomy.
In a similar study examining patients who underwent
incidental cholecystectomy during laparoscopic antireflux surgery, Klaus et al20 had a much smaller cohort (67
of 1065, or 6.3%) who underwent combined surgery.
The goal of the study was to compare the outcomes
for patients who underwent cholecystectomy with
outcomes for those who underwent fundoplication
alone. Using questionnaires to gather information about
postoperative symptoms related to gallstones such as
abdominal pain, nausea, and vomiting, the authors
found no significant difference between groups. They
concluded that concomitant laparoscopic cholecystectomy did not influence the outcome of the index
surgery and is a safe procedure. The literature supports performing cholecystectomy in conjunction with
another abdominal procedure. As long as the surgeon
is comfortable performing it, doing so does not put
the patient at significant additional risk or significantly
increase the duration of the index procedure. v
Disclosure Statement
Jeffrey K Wang, MD, and Shannon Foster, MD, have no
conflicts of interest to disclose. Bruce Wolff, MD, FACS, is a consultant for Tranzyme Pharma, Roche, and Cenzone Tech, Inc.
53
REVIEW article
Incidental Gallstones
Acknowledgment
Katharine O’Moore-Klopf, ELS, of KOK Edit provided editorial
assistance.
References
1.Gallstones and laparoscopic cholecystectomy. NIH Consens
Statement 1992 Sep 14–16;10(3):1–28.
2.Mühe E. Die erste: cholecystektomie durch das laparoskop.
Langenbecks Arch Klin Chir 1986;369:804.
3.Gracie WA, Ransohoff DF. The natural history of silent gallstones: the innocent gallstone is not a myth. N Engl J Med
1982 Sep 23;307(13):798–800.
4.Thistle JL, Cleary PA, Lachin JM, Tyor MP, Hersh T. The
natural history of cholelithiasis: the National Cooperative
Gallstone Study. Ann Intern Med 1984 Aug;101(2):171–5.
5.Friedman GD, Raviola CA, Fireman B. Prognosis of gallstones with mild or no symptoms: 25 years of follow-up
in a health maintenance organization. J Clin Epidemiol
1989;42(2):127–36.
6.Soper NJ, Stockmann PT, Dunnegan DL, Ashley SW. Laparoscopic cholecystectomy. The new ‘gold standard’? Arch
Surg 1992 Aug;127(8):917–21.
7.Ralls PW, Halls J, Lapin SA, Quinn MF, Morris UL, Boswell
W. Prospective evaluation of the sonographic Murphy sign
in suspected acute cholecystitis. J Clin Ultrasound 1982
Mar;10(3):113–5.
8.Kiviluoto T, Sirén J, Luukkonen P, Kivilaakso E. Randomised
trial of laparoscopic versus open cholecystectomy for
acute and gangrenous cholecystitis. Lancet 1998 Jan
31;351(9099):321–5.
9.Lo CM, Liu CL, Fan ST, Lai EC, Wong J. Prospective
randomized study of early versus delayed laparoscopic
cholecystectomy for acute cholecystitis. Ann Surg 1998
Apr;227(4):461–7.
10.Sanabria JR, Gallinger S, Croxford R, Strasberg SM. Risk
factors in elective laparoscopic cholecystectomy for
conversion to open cholecystectomy. J Am Coll Surg 1994
Dec;179(6):696–704.
11. Pasanen P, Partanen K, Pikkarainen P, Alhava E, Pirinen A,
Janatuinen E. Ultrasonography, CT, and ERCP in the diagnosis of choledochal stones. Acta Radiol 1992 Jan;33(1):53–6.
12. van den Hazel SJ, Speelman P, Tytgat GN, Dankert J, van
Leeuwen DJ. Role of antibiotics in the treatment and
prevention of acute and recurrent cholangitis. Clin Infect Dis
1994 Aug;19(2):279–86.
13. Saik RP, Greenburg AG, Farris JM, Peskin GW. Spectrum of
cholangitis. Am J Surg 1975 Aug;130(2):143–50.
14.Tsuyuguchi T, Takada T, Kawarada Y, et al. Techniques of
biliary drainage for acute cholangitis: Tokyo Guidelines. J
Hepatobiliary Pancreat Surg 2007;14(1):35–45.
15.Clavien PA, Richon J, Burgan S, Rohner A. Gallstone ileus. Br
J Surg 1990 Jul;77(7):737–42.
16.Rodríguez-Sanjuán JC, Casado F, Fernández MJ, Morales
DJ, Naranjo A. Cholecystectomy and fistula closure versus
enterolithotomy alone in gallstone ileus. Br J Surg 1997
May;84(5):634–7.
17. Doko M, Zovak M, Kopljar M, Glavan E, Ljubicic N, Hochstädter H. Comparison of surgical treatments of gallstone
ileus: preliminary report. World J Surg 2003 Apr;27(4):400–4.
18.Sonpal IM, Schreiber H, Byramjee AM. The rationale for
incidental cholecystectomy during major abdominal vascular
surgery. Am Surg 1991 Sep;57(9):579–81.
19. Juhasz ES, Wolff BG, Meagher AP, Kluiber RM, Weaver AL,
van Heerden JA. Incidental cholecystectomy during colorectal surgery. Ann Surg 1994 May;219(5):467–72.
20. Klaus A, Hinder RA, Swain J, Achem SR. Incidental cholecystectomy during laparoscopic antireflux surgery. Am Surg
2002 Jul;68(7):619–23.
Stones of Various Shapes and Colors
Moreover I have taken out innumerable stones with my own hands,
with various colors found in the kidneys, in the lungs, in the liver,
in the portal vein … Also in the gallbladder … I found stones of various
shapes and of various colors and very many in some others.
— De re Anatomica Libri, Matteo Realdo Colombo, 1516-1559,
Italian Professor of Anatomy and Surgeon at the University of Padua, Italy
54
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
credits available for this article — see page 95.
Case study
An Unusual Presentation and Etiology of
Hypotension Seen in Nephrotic Syndrome
Objective and Clinical
Importance
An unusual clinical case of hypotension and acute kidney injury
seen in a patient with underlying
nephrotic syndrome is presented
with an emphasis on understanding
the differential diagnosis as well as
the pathophysiology of the underlying disease.
Case History
A woman, age 58 years, reported
having experienced presyncopal
dizziness for two weeks. During
her physical examination, her systolic blood pressure was found to
be approximately 70 mm Hg. She
reported that for two weeks, she
had taken 20 mg of furosemide daily
for lower-extremity edema. She said
that she had not had any chest pain,
palpitations, shortness of breath,
fever, or hypothermia and did not
have any history of bleeding, diarrhea, polydipsia, dysuria, seizures,
or abdominal pain. She did exhibit
gastrointestinal symptoms of nausea
and early satiety as well as urinary
symptoms of polyuria and nocturia.
Her medical history included hyperlipidemia and rheumatoid arthritis.
She had no history of diabetes, liver
disease, or cardiac disease. She
had at one time undergone a hysterectomy and an appendectomy.
She reported that she did not use
tobacco, alcohol, or street drugs.
Her prescribed daily dosages of
oral medications included 20 mg of
furosemide; 20 mg of simvastatin;
20 mg of omeprazole; 40 mg of
benazepril; 200 mg of Oysco 500;
and hydrocodone-acetaminophen,
which she had been taking for several months. She was not taking any
disease-modifying agents for her
rheumatoid arthritis. Her vital signs
were as follows: blood pressure,
70/30 mmHg; temperature, 98.6°F
(37°C); pulse rate, 96 beats per
minute; respiration rate, 18 breaths
per minute; oxygen saturation,
99%; weight, 75 kg. The physical
examination demonstrated bilateral
2+ pedal edema, several bruises
on her back and legs, and righteye subconjunctival hemorrhage.
Jugular venous pressure was not
elevated, and there were no rales.
The patient did not have any joint
deformities. The patient had negative results on guaiac testing.
Case Workup
Initial investigative workup produced normal echocardiography
findings, negative findings on tests
for cardiac enzymes, negative findings on blood cultures, a finding of
a low level of thyroid-stimulating
hormone, and a finding of a normal
level of free T4, the latter three of
which ruled out cardiac dysfunc-
Anna-Maria Panagiotides, MD
Aviv Hever, MD
John J Sim, MD
tion, septicemia, and hypothyroid-
ism, respectively. Her laboratory
testing also revealed acute kidney
injury, with a creatine level of 7.3
mg/dL (compared with a baseline
of 1.1 mg/dL). Dipstick urinalysis
revealed 2+ protein, no blood, and
1+ glucose, although her serum
glucose was 100 mg/dL with no
history of diabetes mellitus. A 24hour urine quantitation revealed
19 g of protein and a urine albumin level of 10 g in a collection
of 2.4 L. Her proteinuria, together
with her clinical presentation of
peripheral edema and later laboratory findings of hypoalbuminemia
and hyperlipidemia, indicated that
she had nephrotic syndrome. The
differential diagnosis included
primary glomerular diseases, such
as minimal-change disease, focal segmental glomerulosclerosis,
membranous nephropathy, and
membranoproliferative glomerulonephritis, as well as secondary
causes such as systemic diseases,
including diabetes, human immunodeficiency virus, hepatitis B or C,
myeloma, and amyloidosis.
The discrepancy between the total
urine albumin and total urine protein
quantitation suggested a paraproteinemic process. The chemistry
panel also revealed a nonaniongap metabolic acidosis with a
serum bicarbonate of 14 mEq/L.
Anna-Maria Panagiotides, MD, (left) is an Internist at the Los Angeles
Medical Center in Los Angeles, CA. E-mail: [email protected].
Aviv Hever, MD, (center) is a Renal Pathologist at the Los Angeles Medical
Center in Los Angeles, CA. E-mail: [email protected].
John J Sim, MD, (right) is a Nephrologist at the Los Angeles Medical Center
in Los Angeles, CA. E-mail: [email protected].
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
55
Case Study
An Unusual Presentation and Etiology of Hypotension Seen in Nephrotic Syndrome
A
The urinalysis also demonstrated
glucosuria despite a normal serum
glucose level, further suggesting
renal tubular dysfunction. A renal infiltrative process was suspected. The
decrease in blood pressure after the
patient began taking a low dose of
furosemide also suggested possible
vascular rigidity and involvement.
Renal ultrasonography demonstrated
normal kidney size and echogenicity
bilaterally. Urine and serum protein
electrophoresis produced negative
findings for any light chains (LCs)
or monoclonal spikes by immunofixation, respectively.
Diagnosis
B
C
D
Figure 1. A) Mesangial regions widened
by PAS (–), silver (–), amorphous, acellular
material. Similar material is in the walls of
capillaries, arteries, and arterioles, as well
as in tubular basement membranes. B)
Congo red (+). C) Apple-green birefringence when viewed with polarized optics.
D) As seen on electron microscopy, the
abnormal material consists of haphazardly
arranged fine fibrils, approximately 12 nm
in diameter and of indefinite length.
56
A renal biopsy was performed
and revealed both renal and vascular
amorphous material deposition in
the mesangium, capillary walls, interstitium, arteries, and arterioles (Figure 1). Congo red staining produced
positive results, and apple-green
birefringence was present on polar
spectroscopy. Immunofluorescence
demonstrated immunoglobulin A
([IgA] 4+), IgM (1–2+), and λ LCs
(3+) in the capillary walls and mesangial regions of all the glomeruli
in a diffuse pattern, in the interstitium, and in tubular casts. Electron
microscopy revealed fibrillary deposition in the mesangial regions
of the glomeruli, interstitium, and
walls of the arteries and arterioles.
The abnormal material consisted of
haphazardly arranged fine fibrils,
approximately 12 nm in diameter
and of indefinite length. The definitive diagnosis was primary systemic
(AL) amyloidosis.
Discussion
Amyloidosis, a multisystem disease, can manifest in different ways
with varying severity. Its major classifications are AL amyloidosis, composed of Ig LCs and arising from a
clonal B-cell disorder; familial (AF)
amyloidosis, most commonly due to
transthyretin; and secondary (AA)
amyloidosis, which is composed
of the acute-phase reactant serum
amyloid A protein that occurs in
the setting of chronic inflammatory
or infectious diseases. Clinically
relevant renal involvement mainly
occurs in AL or AA amyloidosis.1
AL amyloidosis is the most common type of systemic amyloidosis
in North America. It is estimated to
affect 5 to 12 people per million
each year, although autopsy studies
suggest that the incidence might be
higher.2 More than 90% of patients
have a serum or urine monoclonal
Ig protein that can be detected by
immunofixation electrophoresis or
free-LC assay.3 The standard serum
protein electrophoresis and urine
protein electrophoresis are not
useful screening tests because the
clonal Ig in AL amyloidosis, unlike
in multiple myeloma, is often not
present in sufficient quantity in the
serum to produce a monoclonal
“M spike” on these tests. 4 This
phenomenon was illustrated in the
patient discussed here whose urine
and serum protein electrophoresis
produced negative findings for any
LCs or monoclonal spikes by immunofixation, respectively. The clonal
Ig was detected in the patient,
however, by immunofluorescence
on the renal biopsy, revealing IgA
(4+), IgM (1–2+), and λ LCs (3+) in
the capillary walls and mesangial
regions of all the glomeruli in a
diffuse pattern, in the interstitium,
and in tubular casts.
AL amyloidosis is usually a
rapidly progressive disease that
presents with characteristic clinical
syndromes, recognition of which is
key to making the diagnosis. The
kidneys are the most frequently
affected organs in approximately
80% of patients with the disease.5
The paraproteinemia, proteinuria,
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Case study
An Unusual Presentation and Etiology of Hypotension Seen in Nephrotic Syndrome
hypoalbuminemia, and edema seen
in the patient discussed here were
the result of amyloidosis having
caused nephrotic syndrome with
tubular dysfunction and glomerular
injury. Cardiac dysfunction, which
the patient did not exhibit, is the
second most common presentation.
Involvement of the nervous system
can include peripheral sensory neuropathy, carpal tunnel syndrome,
and autonomic dysfunction with
gastrointestinal motility disturbances (early satiety, diarrhea, constipation) and orthostatic hypotension.
Our patient did exhibit certain clinical features suggesting the presence
of autonomic dysfunction, such as
dizziness, nausea, early satiety, and
polyuria; however, her hypotension
and dizziness quickly resolved after
minimal fluid resuscitation.
Occasional patients have a different renal presentation because
the amyloid deposits are primarily
limited to the vessels, leading to
narrowing of the vascular lumens.
These patients usually present with
slowly progressive chronic kidney
disease with little or no proteinuria.
Along with both glomerular and
tubular involvement, the patient discussed here had vascular involvement, illustrated by deteriorated renal function, with low-dose diuresis
causing further worsening of renal
function, which was aggravated
by the presence of angiotensinconverting inhibitor in the setting of
low blood pressure. As mentioned
earlier, the patient also had several
areas of ecchymosis on her back
and legs as well as subconjunctival
hemorrhage, further suggesting
the presence of peripheral capillary vascular compromise due to
amyloid infiltration. Vasculature
with amyloid infiltration cannot
respond normally with appropriate
vasoconstriction when presented
with slight hypovolemia due to
mild diuresis.6 As expected, the patient’s hypotension quickly resolved
after minimal fluid resuscitation,
given the increased vascular rigidity
caused by the amyloid infiltration.
This allowed for adequate perfusion
to the kidneys, resulting in the rapid
correction of the patient’s acute
kidney injury.
Conclusion
Amyloidosis is a multisystem disease that can manifest in different
ways with varying severity. The case
discussed here illustrates an unusual
presentation of hypotension due to
amyloid infiltration of the vasculature, leaving the patient susceptible
to acute kidney injury even from
what is generally considered mild
diuresis. Paraproteinemia and proteinuria were due to the amyloidosis
having caused nephrotic syndrome
with tubular dysfunction and glomerular injury. The patient’s hypotension and acute kidney injury, which
likely occurred because of the in-
creased vascular rigidity caused by
amyloid infiltration, did eventually
resolve with volume resuscitation.
It was planned for the patient to be
evaluated by a hematologist for a
more specific workup and therapy,
but she left and did not return. v
Disclosure Statement
The author(s) have no conflicts of
interest to disclose.
Acknowledgment
Katharine O’Moore-Klopf, ELS, of KOK
Edit provided editorial assistance.
References
1.Dember LM. Amyloidosis-associated
kidney disease. J Am Soc Nephrol
2006 Dec;17(12):3458–71.
2.Skinner M, Sanchorawala V, Seldin
DC, et al. High-dose melphalan and
autologous stem-cell transplantation
in patients with AL amyloidosis: an
8-year study. Ann Intern Med 2004
Jan 20;140(2):85–93.
3.Sanchorawala V. Light-chain (AL)
amyloidosis: diagnosis and treatment. Clin J Am Soc Nephrol 2006
Nov;1(6):1331–41.
4.Akar H, Seldin DC, Magnani B, et al.
Quantitative serum free light chain
assay in the diagnostic evaluation
of AL amyloidosis. Amyloid 2005
Dec;12(4):210–5.
5.Kyle RA, Gertz MA. Primary systemic
amyloidosis: clinical and laboratory
features in 474 cases. Semin Hematol 1995 Jan;32(1):45–59.
6.Modesto KM, Dispenzieri A, Gertz
M, et al. Vascular abnormalities in
primary amyloidosis. Eur Heart J
2007 Apr;28(8):1019–24.
Urine
All we know for certain about the kidney is that it makes urine.
— Homer William Smith, ScD, 1895 – 1962, American physiologist and advocate for science
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
57
Case study
An Unusual Cause of Elevated Values on Liver
Function Tests in a Liver Transplant Patient
Ankur Jain, MD
Amandeep Sahota, MD
Najeeb S Alshak, MD
Jim K Tung, MD
Introduction
Biliary obstruction and rejection
are two of the most common causes
of abnormal findings on liver function
tests (LFTs) in patients who have already undergone liver transplantation.
Here we present a post-transplant patient with jaundice. Tests showed that
he had no hepatitis B surface antigen
before transplantation; he received a
core antibody-negative liver. He was
not previously vaccinated against
hepatitis B, however, and acute
hepatitis B was found to be the cause
of his increased values on LFTs. His
case demonstrates the need to keep
a broad differential during laboratory workup of such patients and to
vaccinate those patients at risk for
acquiring hepatitis B or developing
complications.
Case Presentation
A man, age 25 years, taking
immunosuppressive medications
after orthotopic liver transplantation
(OLT) presented to our clinic and reported having had jaundice for four
days. The patient’s medical history
was notable for primary sclerosing
cholangitis, diagnosed three years
earlier, and for which he underwent
OLT a year later at a transplantation
center outside the Kaiser Permanente system. He had no prior history of
rejection, cytomegalovirus hepatitis,
biliary strictures, or hepatic artery
ischemia. He was admitted to the
hospital for further evaluation.
His post-transplant course was
complicated by pulmonary coccidiomycosis, which was treated with oral
fluconazole, resulting in symptomatic improvement and partial clearing,
as seen on chest radiographs. Several
weeks before admission, the patient
developed tacrolimus toxicity while
taking fluconazole, as manifested
by an elevated tacrolimus level. His
dosage of tacrolimus was reduced,
which ameliorated the toxicity, but
his dosage of mycophenolate mofetil
was maintained. All liver enzymes remained normal during this period.
The patient did well until admission, when he reported developing
icterus and jaundice over the preceding four days. He said that he had
not had fever, abdominal pain, or
pruritus, but he did report fatigue
and nausea over the last several
weeks. He reported no cough or
shortness of breath, which he had
previously reported having with
pneumonia. He said that he had
not recently traveled, eaten unusual
foods, or had contact with anyone
who was ill. He reported taking his
transplant medications as prescribed,
except for discontinuing fluconazole
one month earlier because he had
been feeling better. His physical
examination findings were normal
other than for jaundice.
Admission laboratory results were
as follows: aspartate aminotransferase (AST), 1369 U/L; alanine
aminotransferase (ALT), 921 U/L;
alkaline phosphatase, 402 U/L; total
bilirubin, 5.1 mg/dL. His international normalized ratio (INR) was
1.1, and his tacrolimus level was
slightly low. Epstein-Barr virus testing and cytomegalovirus polymerase
chain reaction were negative. A
Coccidioides immitis complement
fixation antibody titer also produced
negative findings. Ultrasonography
with Doppler showed no definite
stones or strictures. A chest computed tomography scan showed
nearly complete resolution of the
previous infiltrate.
Because of concern about acute
organ rejection, the patient’s tacrolimus and mycophenolate doses
were increased, but no steroids were
given. The patient’s total bilirubin
and INR began to rise (to a peak of
12.1 mg/dL and 1.3, respectively)
and a percutaneous liver biopsy was
performed (Figures 1A and 1B). Biopsy showed severe lobular inflammation with occasional ground-glass
hepatocytes. There was no evidence
of rejection or biliary obstruction.
Stains for hepatitis B sAg and cAg
were positive (Figures 1C and 1D).
The patient also tested positive for
hepatitis B sAg and hepatitis B cAb
immunoglobulin M (IgM) in the se-
Ankur Jain, MD, (top left) is a Gastroenterology Fellow at the Los Angeles
Medical Center in Los Angeles, CA. E-mail: [email protected].
Amandeep Sahota, MD, (top right) is a Hepatologist at the Los Angeles
Medical Center in Los Angeles, CA. E-mail: [email protected].
Najeeb S Alshak, MD, (bottom left) is a Chief of Pathology at the Los
Angeles Medical Center in Los Angeles, CA. E-mail: [email protected].
Jim K Tung, MD, (bottom right) is a Hepatologist at the Los Angeles
Medical Center in Los Angeles, CA. E-mail: [email protected].
58
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Case study
An Unusual Cause of Elevated Values on Liver Function Tests in a Liver Transplant Patient
rum, with a viral load of >20 million
IU/mL. Serology for hepatitis B eAg
was positive; serology for hepatitis
B eAb and hepatitis D IgM Ab were
negative. The diagnosis was thus
acute hepatitis B.
The patient had negative serologies for hepatitis B sAg and hepatitis
B cAb before transplantation, and
review of the patient’s transplantation records revealed that the donor
liver was hepatitis B cAb negative.
The patient had not been vaccinated
before transplantation. On further
questioning, the patient reported no
recent unprotected sexual activity
other than with his wife, whose test
results were negative for hepatitis
B. He also reported no intravenous
drug use, recent tattoos, or blood
transfusions. HIV and syphilis test
results were negative. The patient
was promptly given entecavir for
acute hepatitis B. AST, ALT, alkaline
phosphatase, and total bilirubin were
monitored throughout hospitalization
and began to trend downward. The
INR remained stable. Before being
discharged from the hospital, the patient was given fluconazole again and
his tacrolimus was again decreased to
maintain appropriate levels. Prednisone was not continued.
The patient was examined again
in our clinic two weeks after hospital discharge and reported feeling
much better, with decreased jaundice. He was no longer fatigued or
nauseated. After three months of
entecavir, his AST and ALT levels
were 59 U/L and 73 U/L, respectively, with an alkaline phosphatase
and total bilirubin levels of 183 U/L
and 1.8 mg/dL, respectively. His
INR was 1.1. He remains positive
for hepatitis B sAg, but his viral load
has decreased to 2079 IU/mL.
Discussion
An estimated 350 million people
worldwide are chronically infected
1A
1B
1C
1D
Figure 1A. Severe lobular inflammation with occasional ground glass cell hepatocytes. Hematoxylin and
eosin stain. Figure 1B. Ground glass hepatocyte (arrow). Hematoxylin and eosin stain. Figure 1C. Hepatitis B
surface antigen. Immunoperoxidase stain. Figure 1D. Hepatitis B core antigen. Immunoperoxidase stain.
with hepatitis B.1 In the US, approximately 1.25 million people
have chronic hepatitis B, of whom
20% to 30% acquired their infection
in childhood. The implementation
of effective vaccination programs
in many countries such as the
US has resulted in a significant
decrease in the incidence of acute
hepatitis B.2
The most common risk factors for
hepatitis B in adults include sexual
exposure (sexual contact with a person with hepatitis B, multiple sex
partners, or men having sex with
men) and use of injectable drugs.3
In addition to vaccinating these
high-risk populations, the Centers
for Disease Control and Prevention4
also recommends vaccinating all
patients with chronic liver disease
against hepatitis B. Immunity should
then be confirmed with a hepatitis
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
B surface antibody. Our patient was
not vaccinated before transplantation and, despite denying having
any risk factors, he developed
acute hepatitis B, which could have
resulted in serious consequences,
given his post-transplantation immunosuppression.
Hepatitis B may present with
constitutional symptoms, including
anorexia, nausea, jaundice, and
right upper quadrant discomfort,
but is often subclinical. AST and
ALT values of 1000 to 2000 U/L
are typically seen during the acute
phase, with ALT values being much
higher than AST values. The INR is
the best indicator of prognosis.
Treatment of acute hepatitis B
in otherwise healthy individuals is
mainly supportive, with close monitoring of the INR. Treatment of such
patients with nucleoside/nucleotide
59
Case Study
An Unusual Cause of Elevated Values on Liver Function Tests in a Liver Transplant Patient
therapy is controversial because the
likelihood of fulminant hepatitis B
is <1%, and in immunocompetent
adults, the likelihood of progression
to chronic hepatitis B virus infection
is <5%. A recent study of 71 patients
with acute hepatitis B randomized
to either lamivudine or placebo
showed no biochemical or clinical
benefit with lamivudine.4
Treating certain patients with
acute hepatitis B has been advocated, including those with a severe
or protracted course (coagulopathy
with an INR >5, symptoms that
persist for more than four weeks,
or marked jaundice with total bilirubin >10 mg/dL).5 Patients with
fulminant hepatic failure undergoing
transplantation evaluation and those
who are immunocompromised, have
coinfection or preexisting liver disease, or are elderly should also be
considered for treatment. Chronicity
from hepatitis B is known to develop
more frequently in immunocompromised patients and in up to 60% of
patients receiving dialysis.6 In most
cases, treatment can be stopped after
confirmation that the patient has
cleared hepatitis B sAg.
Liver transplant recipients who
develop acute hepatitis B represent
a special population of immunocompromised patients.7 They may
undergo reactivation of a previously
acquired infection. Alternatively,
those who were seronegative may
develop hepatitis B after transplantation (de novo) by acquiring it
through traditional risk factors or as
a result of receiving a liver testing
positive for hepatitis B cAb, which is
the most common means of acquisition.8 Rate of transmission from the
donor liver has been reported to be
between 43% and 78%.9,10 Combination therapy with lamivudine and
hepatitis B immunoglobulin has
been shown to prevent hepatitis B
infection in seronegative recipients
60
of hepatic allografts from donors
positive for hepatitis B cAb.11-14
Patients with de novo hepatitis B
after transplant have primarily been
treated with lamivudine alone or in
combination with adefovir. Long-term
use of lamivudine is limited by its
high rate of resistance, however, and
adefovir should probably be avoided
as well because of its slow onset of
action and potential for nephrotoxicity. Newer antivirals such as entecavir
and tenofovir are being evaluated
for their role in these patients. Our
patient’s hepatitis responded well
to entecavir. He will likely require
lifelong treatment because of his
immunosuppression and the risk of
reactivation of hepatitis B. v
Disclosure Statement
The author(s) have no conflicts of
interest to disclose.
Acknowledgments
Special thanks to the Departments
of Gastroenterology, Hepatology, and
Pathology at Los Angeles Medical Center,
Los Angeles, CA, for their assistance with
this article.
Katharine O’Moore-Klopf, ELS, of KOK
Edit provided editorial assistance.
References
1.Maynard JE. Hepatitis B: global
importance and need for control.
Vaccine 1990 Mar;8 Suppl:S18–23.
2.Lavanchy D. Hepatitis B virus epidemiology, disease burden, treatment,
and current and emerging prevention and control measures. J Viral
Hepat 2004 Mar;11(2):97–107.
3.Alter MJ, Hadler SC, Margolis HS,
et al. The changing epidemiology of
hepatitis B in the United States. Need
for alternative vaccination strategies.
JAMA 1990 Mar 2;263(9):1218–22.
4.FAQs for health professionals: Hepatitis B vaccination [monograph on
the Internet]. Atlanta (GA): Centers
for Disease Control and Prevention;
2008 Jul 8 [cited 2009 Feb 23]. Available from: www.cdc.gov/hepatitis/
HBV/HBVfaq.htm#vaccFAQ.
5.Kumar M, Satapathy S, Monga R, et
al. A randomized controlled trial of
lamivudine to treat acute hepatitis B.
Hepatology 2007 Jan;45(1):97–101.
6.Hoofnagle JH, Doo E, Liang TJ,
Fleischer R, Lok AS. Management of
hepatitis B: summary of a clinical research workshop. Hepatology 2007
Apr;45(4):1056–75.
7.Bruguera M, Vidal L, SanchezTapias JM, Costa J, Revert L, Rodes
J. Incidence and features of liver
disease in patients on chronic hemodialysis. J Clin Gastroenterol 1990
Jun;12(3):298–302.
8.Roche B, Samuel D, Gigou M, et
al. De novo and apparent de novo
hepatitis B virus infection after liver
transplantation. J Hepatol 1997 Mar;
26(3):517–26.
9.Wachs ME, Amend WJ, Ascher NL,
et al. The risk of transmission of
hepatitis B from HBsAg(-), HBcAb(+),
HBIgM(-) organ donors. Transplantation 1995 Jan 27;59(2):230–4.
10. De Feo TM, Poli F, Mozzi F, Moretti
MP, Scalamogna M; Collaborative
Kidney, Liver and Heart North Italy
Transplant Program Study Groups.
Risk of transmission of hepatitis
B virus from anti-HBC positive
cadaveric organ donors: a collaborative study. Transplant Proc 2005
Mar;37(2):1238–9.
11. Dickson RC, Everhart JE, Lake JR,
et al. Transmission of hepatitis B by
transplantation of livers from donors
positive for antibody to hepatitis B
core antigen. The National Institute
of Diabetes and Digestive and
Kidney Diseases Liver Transplantation
Database. Gastroenterology 1997
Nov;113(5):1668–74.
12. Dodson SF, Bonham CA, Geller
DA, Cacciarelli TV, Rakela J, Fung
JJ. Prevention of de novo hepatitis
B infection in recipients of hepatic
allografts from anti-HBc positive
donors. Transplantation 1999 Oct
15;68(7):1058–61.
13. Yu AS, Vierling JM, Colquhoun
SD, et al. Transmission of hepatitis
B infection from hepatitis B core
antibody­­—positive liver allografts
is prevented by lamivudine therapy.
Liver Transpl 2001 Jun;7(6):518–20.
14.Chen YS, Wang CC, de Villa VH, et
al. Prevention of de novo hepatitis
B virus infection in living donor liver
transplantation using hepatitis B
core antibody positive donors. Clin
Transplant 2002 Dec;16(6):405–9.
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Clinical Medicine
Corridor Consult
Early and Accurate Diagnosis
of Sudden Sensorineural Hearing Loss
Barry Rasgon, MD
Luke James Schloegel, MD
Case 1
An obese man, age 57 years, with a medical history
of depression presented to his primary care physician
with three days of sudden left-sided hearing loss.
He did not report pain, tinnitus, vertigo, or external
auditory canal discharge. He said that he had not
experienced any recent trauma, upper respiratory
infection, or loud noise exposure or taken any ototoxic medications.
His physical examination revealed normal-appearing external auditory canals and tympanic membranes.
The membranes exhibited good mobility with insufflation. Findings on the Rinne test with a 512-Hz tuning fork were consistent with air conduction greater
than bone conduction on the right side; the left side
could not be tested because of profound hearing loss.
Findings on the Weber test with a 512-Hz tuning fork
were lateralized to the right side. On the basis of the
patient’s medical history and physical examination
findings, the primary care physician suspected sudden
sensorineural hearing loss, prescribed oral prednisone, and referred the patient for urgent audiologic
and otolaryngologic examinations. At the four-week
follow-up examination, an audiogram showed return
of hearing to near baseline on the left side.
Case 2
A woman, age 54 years, with hypertension, presented to the urgent care clinic with two days of
right-sided hearing loss and right ear fullness. She
reported that she had recently had an upper respiratory infection. Physical examination revealed a normal
tympanic membrane appearance and mobility, so a
tuning-fork examination was not done. The physician
diagnosed eustachian tube dysfunction (ETD) and
gave the woman oral decongestants.
She was referred to the Head and Neck Surgery
Department when there was no change in her symptoms two weeks after onset. After a thorough medical
history was obtained and a physical examination,
tuning fork tests were performed showing lateralization to the left ear on Weber test. An audiogram was
obtained that showed severe right-sided sensorineural
hearing loss, and a diagnosis of sudden sensorineural
hearing loss was made. The patient was given oral
prednisone and acyclovir. Later, magnetic resonance
imaging (MRI) with gadolinium enhancement of the
internal auditory canals revealed no retrocochlear
lesion. A follow-up audiogram obtained two months
after initial presentation showed no improvement in
the patient’s hearing.
Discussion
These case presentations illustrate the difficulty of
accurate diagnosis of idiopathic sudden sensorineural hearing loss (SSNHL), treatment of patients who
present with it in the primary care setting, and the
variable prognosis for the disorder. Briefly, SSNHL is
defined as a 30-dB hearing loss in three consecutive
frequencies whose onset is less than three days. Its
incidence in the US has been reported at 5 to 20 cases
per 100,000 persons annually.1 Although numerous
etiologies and treatments have been considered, most
researchers agree that SSNHL is likely to be of vascular,
immunologic, or viral origin.
SSNHL is regarded as an otologic emergency, and
the time between symptom onset and treatment initiation is one of the most important prognostic factors.
Most studies report the greatest recovery of hearing
when corticosteroids are initiated within the first one
to two weeks after symptom onset and little if any
benefit when initiated four weeks or more after the
onset of symptoms.2 Ideally, corticosteroid therapy
should be started as soon as possible, with an audio-
Barry Rasgon, MD, (left) is a Head and Neck Surgeon at the
Oakland Medical Center in CA. E-mail: [email protected].
Luke James Schloegel, MD, (right) is a Head and Neck Surgeon at
the Oakland Medical Center in CA. E-mail: [email protected].
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
61
Clinical Medicine
Early and Accurate Diagnosis of Sudden Sensorineural Hearing Loss
gram performed within 24 to 48 hours to document
the hearing loss. The severity of the hearing loss at
presentation is directly proportional to the likelihood
of recovery. Those with mild losses usually obtain full
recovery, and those with profound loss rarely do so.1,2
Other poor prognostic indicators are the presence of
vertigo and age <15 years or >60 years.
Primary care physicians, in the Emergency Department, Urgent Care Clinic, or Outpatient Clinic, are
often the first clinicians consulted for sudden hearing
loss, making accurate diagnosis and treatment critical because delay can have serious consequences for
prognosis. A recent study that we conducted revealed
that 33 of 53 (63%) patients whose hearing loss was
eventually diagnosed as SSNHL were initially given an
incorrect diagnosis by the primary care physician. Most
often, that diagnosis was ETD. This led to an average
delay in referral for audiologic and otolaryngologic
examination of 20.8 days.3
As seen in the illustrative cases, the hearing loss is
incorrectly attributed to ETD and other diagnoses such
as otitis media with effusion, because many patients
with SSNHL have had a recent upper respiratory infection, and this acts as a red herring. Ear fullness is also
Figure 1. Clinical algorithm for evaluation of patients with suspected sudden
sensorineural hearing loss (SSNHL).
a common presenting symptom and often attributed
by patients and clinicians to impaction of cerumen or
congestion from allergies.2 Furthermore, monocular
otoscopy is the only option for otologic examination
by the primary care physician. Although it remains a
very important diagnostic tool, it decreases the ability
to accurately assess a normal tympanic membrane,
adequately clear the external auditory canal of cerumen, and insufflate to assess mobility as compared
with binocular otoscopy. Simple Weber and Rinne
tuning-fork tests are available yet are not routinely
performed by most primary care physicians.
Although there are a multitude of potential causes
of SSNHL, most cases are idiopathic; therefore,
focused history, physical, and ancillary testing are
essential. The first goal of evaluation is to rule out
conductive loss by a thorough examination of the
tympanic membrane and assessment of its mobility.
The most critical step may be the use of a tuning fork
to conduct the Weber and Rinne examinations. In the
Weber test, a 512- or 1024-cycle tuning fork is placed
on the forehead, on the premaxilla, or between the
incisor teeth. If the sound is localized by the patient
to the contralateral side of the involved ear, then the
hearing loss is sensorineural. In unilateral conductive
loss, the sound is localized to the involved side. The
Rinne test, which compares loudness of sound when
a tuning fork is placed on the skull versus near the
external auditory canal, may supplement the diagnostic information obtained from the Weber test.
Although they are not good independent tools for
screening for hearing loss, the Weber and Rinne tests
should be used primarily to differentiate sensorineural
from conductive hearing loss to accurately distinguish
SSNHL from other causes of sudden hearing loss such
as ETD and otitis media with effusion, which will not
cause the sound to be localized in the contralateral ear.
In our study, there was evidence for the efficacy of Weber and Rinne tests for patients with suspected SSNHL:
Nine of the ten patients who underwent a documented
tuning-fork examination performed by a primary care
physician were initially given an accurate diagnosis of
SSNHL, but of the 43 for whom no documentation of
a tuning-fork examination was found in the chart, only
11 were given accurate diagnoses.
The goal of the initial evaluation of patients with
suspected SSNHL is urgent referral to an audiologist
and head and neck surgeon so that further workup
can be conducted as necessary (see Figure 1). In patients who do not have contraindications to systemic
HNS = Head and Neck Surgery
62
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Clinical Medicine
Early and Accurate Diagnosis of Sudden Sensorineural Hearing Loss
steroid treatment, medical treatment with oral steroids
for 10 to 14 days should be carried out. There is no
agreed-on dose or duration of treatment; many clinicians recommend starting with 60 mg of prednisone
for five days, followed by a taper by 10 mg every two
days. Medical therapy remains controversial because
spontaneous recovery of hearing has been reported in
45% to 65% of patients with SSNHL and because good
clinical studies are lacking. Wilson and colleagues4
performed a double-blind clinical study and found
that steroids were effective in achieving at least partial recovery of hearing in 61% of patients, compared
with only 32% who achieved recovery with the use
of placebos. Intratympanic application of steroids to
the middle ear has proven to be effective in some
patients in whom SSNHL had been refractive to oral
steroids. New research is examining the efficacy of
intratympanic dexamethasone as first-line therapy. In
a recent study, Battaglia and colleagues5 showed that
intratympanic dexamethasone and high-dose prednisone taper (HDPT) used in combination resulted in
higher rates of hearing recovery and better quality
of hearing recovery than HDPT alone. In the future,
initial treatment with intratympanic steroids may be
indicated. At the conclusion of their study, Battaglia
and colleagues recommended that treatment be initiated as quickly as possible, ideally within ten or fewer
days of onset of hearing loss and that referral be made
to an otolaryngologist who is comfortable with transtympanic injection. This reinforces the algorithm of
accurately identifying SSNHL by using a tuning fork,
starting oral steroids when not contraindicated, and
providing urgent referrals to audiology and Head and
Neck Surgery Departments for further treatment.
There is no evidence that antiviral medications make
any difference in hearing outcomes. Two prospective,
randomized, double-blind, placebo-controlled, multicenter clinical trials showed that antiviral medication
was no better than corticosteroid alone in the treatment of SSNHL.5
A thorough discussion of all possible etiologies and
diagnostic tests for sudden sensorineural hearing loss
is beyond the scope of this article, but there are some
basics to be aware of: Gadolinium-enhanced MRI
examinations are routinely obtained in all patients
with asymmetric sudden hearing loss from which the
patient does not recover after four weeks, because
vestibular schwannoma rarely presents as sudden
hearing loss. Obtaining a thorough medical history
investigating possible causes, including autoimmune
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
diseases, inner ear trauma, ototoxic medications,
vasculopathies, and viral exposures, can eliminate the
need for exhaustive diagnostic testing. Some advocate
administering the fluorescent treponemal antibody
absorption test or the microhemagglutination test for
Treponema pallidum because syphilis is a potentially
treatable cause of SSNHL. Furthermore, Ménière disease can initially present with sudden hearing loss,
but the natural course usually defines these distinct
entities. In rare cases, sudden hearing loss can be the
initial presentation of multiple sclerosis, and MRI is
frequently diagnostic.
Conclusion
Because most times SSNHL is idiopathic despite extensive diagnostic testing, the focus of initial evaluation
of patients with sudden hearing loss is to distinguish a
sensorineural from a conductive loss. If this cannot be
reliably done with otoscopic examination, the use of the
Weber and Rinne tuning-fork tests can help differentiate
between the two. Once a sensorineural hearing loss is
confirmed or suspected, urgent referral for audiologic
and head and neck surgery evaluation should be made.
In patients who can tolerate systemic steroids and are
aware of the potential side effects, medical treatment
with oral steroids should be initiated. Accurate diagnosis
and early treatment has been shown to lead to better
hearing outcomes in SSNHL. v
Nine of the ten
patients who
underwent a
documented
tuning-fork
examination
performed by
a primary care
physician were
initially given
an accurate
diagnosis of
SSNHL …
Disclosure Statement
The author(s) have no conflicts of interest to disclose.
Acknowledgment
Katharine O’Moore-Klopf, ELS, of KOK Edit provided editorial
assistance.
References
1.Byl FM Jr. Sudden hearing loss: eight years’ experience and
suggested prognostic table. Laryngoscope 1984 May;94(5
Pt 1):647–61.
2.Rauch SD. Clinical practice. Idiopathic sudden sensorineural
hearing loss. N Engl J Med 2008 Aug 21;359(8):833–40.
3.Schloegel LJ, Rasgon BM. Early and accurate diagnosis of
sudden sensorineural hearing loss. Presented at the Western Section of the Triological Society, 2009 Jan 29–31;
Henderson, NV.
4.Wilson WR, Byl FM, Laird N. The efficacy of steroids in the
treatment of idiopathic sudden hearing loss. A double-blind
clinical study. Arch Otolaryngol 1980 Dec;106(12):772–6.
5.Battaglia A, Burchette R, Cueva R. Combination therapy
(intratympanic dexamethasone + high-dose prednisone
taper) for the treatment of idiopathic sudden sensorineural
hearing loss. Otol Neurotol 2008 Jun;29(4):453–60.
63
soul of the healer
“School Days”
48 x 48”
Acrylic on canvas
By Josh Schechtel, MD
Josh Schechtel, MD, is a hospital-based Pediatrician and Chief of Professional Staff Education at the Oakland Medical Center in Oakland, CA. He has been drawing, designing gardens, and fabricating tile mosaics for many years
and started painting about two years ago. Dr Schechtel says that his streetscapes attempt to address the interaction between the geological forces that have created the topography of San Francisco: the plants and other natural
elements of the environment, and the roads and buildings that humans have constructed on it. Although none of
these elements are unique to San Francisco, the whole is greater than the sum of its parts, creating a unique sense
of place, and it is this synergy that fascinates him. These relationships are not always comfortable or easy. They
contain many compromises and awkward situations, which make it a more interesting, vibrant place to work.
More of Dr Schechtel’s work may be seen at: www.joshschechtel.com.
64
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Commentary
Statement on behalf of the Kaiser Permanente Medical Care Program before the Committee
on Health, Education, Labor, and Pensions; United States Senate on January 15, 2009
Investing in Health IT:
A Stimulus for a Healthier America
John H Cochran, MD, FACS
Senator Mikulski (D – MD) and Senator Enzi (R – WY)
and other distinguished members of the committee,
thank you for the invitation to be here today. I am Dr
Jack Cochran, the Executive Director of The Permanente
Federation—the national umbrella organization for the
regional Permanente Medical Groups. The Permanente
Medical Groups employ more than 14,000 physicians,
who care for approximately 8.7 million Kaiser Permanente (KP) members. I appear today on behalf of the
national KP Medical Care Program, the nation’s largest
integrated health care delivery system.
The Promise of Health Information
Technology
As Congress considers ways to stimulate the
economy, it should explore investing in the nation’s
health care delivery system. I am delighted to be here
to discuss how promoting the effective use of health
information technologies can improve health care quality, efficiency, and literally save lives.
Medicine is far behind other industries in adopting
and leveraging information technologies. While other
industries have been quick to automate, the health
care industry has often been slow to adopt.
Individual medical records, medication lists, along
with the latest medical research and up-to-date information on applicable clinical trials must be available
for clinicians and patients at the click of a mouse.
Under appropriate patient confidentiality safeguards,
secure electronic health records (EHRs) should allow
various health care providers across vast geographic
spans to collaborate and coordinate care for their
patients based on current, comprehensive clinical
information. The economic stimulus package should
promote the development of effective, interoperable clinical information systems and the skills to
use them.
But it is important to link these improvements in processes with systemic changes in financial incentives to
continually advance the effectiveness and reliability of
health care delivery. As you know, our nation’s health
care delivery system is fragmented, disorganized, and
hampered by ineffective and perverse incentives for
quality and efficiency. Health information technology
(HIT) is one critical tool that can help move our system
toward a highly functioning, organized, patient-centered
one. However, it is important that these investments
be strategic and worthwhile. As one wise policymaker
quipped, “Making the wrong investments in HIT could
simply result in doing the wrong things faster.”
Kaiser Permanente
When she invited me to speak today, Senator Mikulski asked me to share some of the lessons we’ve
learned in developing what we believe is the world’s
largest civilian deployment of an EHR. As Senator
Mikulski knows, we are proud to serve members in
the state of Maryland. We also provide health care to
nearly nine million individuals in eight other states,
including California, Oregon, Colorado, Georgia,
Hawaii, Ohio, Virginia, Washington, and the District
of Columbia.
At KP, we have found strength and opportunity
through the fundamental and often unique partnerships within our organization: the physician and
patient relationship; the collaboration between labor
and management; the linkage of clinical research to
improved care delivery; our investments and involvement in the communities we serve; and the shared
coordination of care across inpatient, outpatient, ancillary services, and all the settings of care delivery.
In 2003, KP began the KP HealthConnectTM project.
KP HealthConnect is a comprehensive health information system that includes one of the most advanced
John H Cochran, MD, FACS, is the Executive Director of The Permanente
Federation in Oakland, CA. E-mail: [email protected].
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
65
Commentary
Investing in Health IT: A Stimulus for a Healthier America
electronic health records available. Our success with
this endeavor is the result of decades of work developing health records and training physicians and staff
to use them. This experience spanned most of our
operating regions. For example, the Colorado region,
where I practiced, had a complete electronic
health record beginning in 1997.
One of our
Today, KP HealthConnect securely congreatest lessons
nects 8.7 million people to their physicians,
has been
their health care teams, their personal health
how much KP
information, and the latest medical knowlmembers value
edge, leveraging the integrated approaches
the ability to
to health care available at KP. KP has made a
use online tools
huge investment in HIT, both financially and
to manage their
philosophically. We believe it has the power
health.
to transform the way we deliver health care
and improve patient health.
Physician Adoption
and Acceptance of HIT
In April 2008, we completed implementation of KP
HealthConnect in every one of our 421 medical office
buildings, ensuring that our 14,000 physicians and all
other ambulatory caregivers have appropriate electronic
access to their patient’s clinical information. In addition,
we have completed the deployment of inpatient billing; admission, discharge, and transfer; and scheduling
and pharmacy applications in each of our 32 hospitals.
Now, we are in the midst of an aggressive installation
schedule for bedside documentation and computerized physician order entry (CPOE). As of the end of
2008, we had 25 of our 32 hospitals fully deployed.
(An interesting anecdote: the new hospitals we are
building in California as a response to the seismic
upgrade requirements are being built without medical
record rooms.)
Now, you may ask, did this all happen easily? Did
our physicians and nursing staff immediately embrace
our EHR? The simple answer is, no. Any major transition
like this requires fundamental change in workflows. We
had to build in time for testing, training, and some belly
aching too. But if we tried to take KP HealthConnect
away from any of our doctors and nurses now, a riot
would ensue.
Implementing HIT in a clinical setting is tremendously disruptive. You have to expect about a 20% reduction
in productivity in the first three to six months, and you
should not expect immediate cost savings. You have
to go slow to go fast. Initial stages of implementation
must be well planned and tested. Patience is key, and
physician leadership is critical.
66
Change can cause apprehension and concern. If not
handled properly, it can also interfere with the quality
of care that is delivered. In an outpatient setting, you
can build in time for training by scheduling patients
differently or making sure you do not implement a new
IT system during flu season, for example. In an inpatient
setting, you simply do not have the same flexibility, so
the challenges are different.
At first, Permanente physicians were reluctant to
complete after-visit summaries as a written acknowledgement of everything that was discussed during
the visit. These after-visit summaries are stored in
each patient’s EHR. Because patients can access them
later, the summaries can help remind them about
what they and their doctors discussed regarding
medications, follow-up treatment, etc. Primary care
providers who give their patients an after-visit summary typically score an average of 14 points higher
on satisfaction surveys.
Since the deployment of our integrated medical record, we have begun to see major advances
in using health information systems as a diagnostic
tool (for identifying and understanding patients with
certain risk factors) as well as for appropriate therapeutic intervention (for encouraging adherence and
for intensification or moderation of therapy when
needed).
The EHR has allowed our physicians to be more
efficient by giving them better practice management
and communication tools that help them reduce unnecessary visits and phone calls. Today, our doctors
don’t ask, “How many patients can I see?” but rather,
“How many problems can I solve?” Data gathered
in three of our regions (Colorado, Hawaii, and the
Northwest) demonstrate how implementing an EHR
lowers both primary and specialty care office visit
rates by enabling the clinician to resolve certain issues for patients with fewer face-to-face contacts. For
example, a simple response to an e-mail may be all
that a patient needs from his or her doctor. Because
our system allows our physicians to view appropriate
medical information online, patients and physicians
can interact with each other when it’s most convenient
for both of them.
Patient Acceptance
and Adoption of HIT
One of our greatest lessons has been how much KP
members value the ability to use online tools to manage their health. Launched in 2005, our personal health
record, My Health Manager, now has more than two
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Commentary
Investing in Health IT: A Stimulus for a Healthier America
million active users. This represents the largest user base
of online personal health records (PHRs) in the US. Using
direct links to actual clinical and operational systems,
we are able to provide our members with access to
robust features, including access to lab test results,
appointment scheduling, prescription refills, and even
the ability to securely e-mail their doctors. To date, our
members have viewed over 56 million lab test results
online, sent over five million secure e-mail messages,
made over two million online visits to book and review
future appointments, and logged over one million online visits to view past office visit information.
With secure e-mail messaging, patients can communicate with their doctors at any time, from anywhere.
Demonstrating the growing consumer interest in
e-visits, our patients send more than 300,000 secure
e-mail messages each month to their doctors and care
teams. The average doctor’s visit takes three hours out
of an individual’s day, so members value the ability to
use My Health Manager on kp.org to handle routine
health care needs, including refilling their prescriptions, which can be delivered directly to their home
or a pharmacy. Results from a study published in the
American Journal of Managed Care1 showed an 8%
reduction in office visits and a 14% reduction in phone
calls among My Health Manager users. The study also
confirmed that secure messaging is used primarily for
nonurgent issues; nearly two-thirds were coded as
“brief” or lower.
Transforming Health Care Delivery
While we have documented some specific dollar
savings, our greatest benefits are improvements in
clinical and service quality. With 24/7 access to comprehensive health information, our care teams are able to
coordinate care at every point of service—physician’s
office, laboratory, pharmacy, hospital, on the phone,
and even online. Unlike the paper chart locked in a
physician’s office, an EHR can be shared among all
physicians caring for a patient. For example, when a
patient comes into the Emergency Department at 2
am: 1) there will be no duplication of effort to collect
data that already exists; 2) the insights of one physician are more easily available to others; and 3) care can
be better coordinated. Our early results demonstrate
what Crossing the Quality Chasm2 predicted: HIT helps
to make care safer, more effective, patient-centered,
timely, efficient, and equitable.
Through our experience with KP HealthConnect,
we have found that implementing the technology was
just the first step. A far more crucial endeavor is deter-
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
mining how to translate the data collected within the
system into useful information that will deliver value.
It’s not just about digitizing the visit—it’s about using
the data from that visit and other sources to inform and
ultimately to transform care delivery.
For example, our use of HIT and our comprehensive
approach (partnership of primary care providers, cardiologists, nurses, and pharmacists with accountability
across the continuum of care—preventive, chronic, and
acute) have significantly reduced Emergency Department visits and mortality. In Colorado, we have seen
a 76% reduction in cardiac mortality for those who
participated in our Collaborative Cardiac Care Service
compared with those who received regular treatment.3
Based on NCQA data, as compared to the national HMO
average, we prevent more than 280 cardiac events annually in Colorado. This improvement saves $2 million
in annual hospital costs. In Northern California, if you
are a member of KP, you have a 30% less chance of
dying of heart failure compared to a member of the
general population. In Oregon and Washington, by
using KP HealthConnect in a new Regional Telephonic
Medicine Center staffed with emergency room physicians and advice nurses, we have achieved an 11%
reduction in the number of members who need to
visit the emergency room between the hours of 12
noon and 10 pm. In Southern California, from 2004 to
2007, combining the power of our IT systems and our
integrated delivery model, we were able to increase
mammography screening rates for women aged 50-69
from 80% to nearly 90%.
This last example was highlighted for me by a recent
letter that puts a human face on these statistics:
Early last year, I came to your facility to have a
foreign body removed from my eye. I visited your
Ophthalmology Department, and your competent
staff dealt with this minor emergency.
What made this visit so meaningful was my interaction with your nurse after my visit with the doctor.
In addition to giving me some after-visit instructions,
she noticed in the computer that I needed a mammography exam. I had been reminded before, but
I tend to be too busy to take care of my own health.
This time the nurse was very insistent. She even made
me an appointment so I could walk in and get an
exam within the hour. Since I did not have to wait
too long, I had an exam done that day. Well, they
found a mass in my right breast, and it was cancer. I
have gone through chemotherapy and radiotherapy,
and today I am cancer free.
I am convinced that I am alive today because
67
Commentary
of your organization’s focus on my total health.
My interaction with your entire health care system
has been nothing but positive. I am especially appreciative to the young nurse who took the time to
convince a stubborn old lady to take responsibility
for my health.
Thank you for giving me many more years to
thrive.
This letter describes a simple act by one of our nurses
that was possible only because the nurse had access to
that patient’s information, acted on it, and was part of
an integrated health care system that encourages this
series of events.
KP HealthConnect also allows us to share content
across all regional facilities, providing the best technical platform to disseminate drug formulary changes,
best-practice alerts, and automated clinical guidelines to
the entire enterprise. Our members can move through
any facility within a given region, and their clinical and
administrative information will follow them.
As an example, during the 2007 wildfires in San Diego, when KP facilities within the fire lines closed, we
contacted members and directed them to open facilities. When our members arrived at these new facilities,
their new care teams had appropriate access to their
records via KP HealthConnect, ensuring continuity of
care in a time of crisis.
When we started down this path, KP faced
many of the same barriers that other health
KP and other
care organizations and providers face today
multispecialty
when they start to utilize HIT to improve
groups like
care delivery. These barriers involve both
Group Health
process (eg, complexity of health care is
Cooperative,
increasing, workflows will be disrupted,
Intermountain
end-to-end patient-centered view is not well
Healthcare,
known) and technology (eg, data is “locked
and Geisinger
away” in various paper files, applications,
can set the
and databases; data standards, interopergold standard
ability standards, usability standards must be
with a
integrated). I am here to tell you that these
sophisticated
issues can be overcome.
EHR and
KP and other multispecialty groups like
integrated
Group Health Cooperative, Intermountain
care delivery
Healthcare, and Geisinger can set the gold
systems.
standard with a sophisticated EHR and
integrated care delivery systems. Harder to
overcome are the misaligned incentives in systems
that are not vertically integrated, because these do
not encourage providers to redesign care delivery to
incorporate evidence-based care processes for improving quality and effectiveness. As a nation, we can
68
Investing in Health IT: A Stimulus for a Healthier America
decide to create payment incentives that reward health
professionals who share information, who learn from
each other, and who hold themselves and one another
accountable to generate the best health outcome at the
most reasonable cost for each patient.
An Interoperable HIT System
Congress has the ability to create a system that is truly
interoperable. Today, far too often, our systems speak
different languages. Even when electronic information
exists for patients, critical clinical information can be
lost during an emergency or when patients transfer from
one system to another because the different systems
simply cannot communicate with one another.
After discussing interoperability of medical records
for years, KP recently demonstrated successful data
exchange of health records involving our shared patient
population with the Veterans’ Administration. This demonstration project uses test data for fictitious patients, but
it also shows that privacy and security requirements will
work to protect real patient data. The demonstration uses
the national interoperability standards recognized by
the Department of Health and Human Services (HHS),
proving they work in the real world.
Sound HIT policy should stress the critical importance of standards-based interoperability to achieve
coordinated patient-centered health care. The ability of
separate HIT systems to interconnect with each other
depends on uniform adherence to strictly defined standards. Most of these standards exist today. KP supports
the HHS-adopted interoperability standards selected
by the Healthcare Information Technology Standards
(HITSP) and used in the National Health Information
Network (NHIN).
Only when these existing technical standards are
used consistently across the delivery system will HIT
be able to achieve its promise for both direct care of
individual patients and for population-based care.
Connected HIT will not be adopted by most clinicians and institutional providers without mandates or
a system of incentives and penalties that are materially more advantageous or costly to providers than
those outlined in current and previous proposals. For
instance, one approach could use Medicare conditions
of participation as a means to promote adoption, with
metrics for adoption of HIT, determined by the Secretary
and used by HHS as benchmarks. Achieving benchmark measures for HIT could trigger loan forgiveness
or incentive payments.
Above all, dollars should be attached to outcomes.
For example, organizations that receive HIT incentives
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Commentary
Investing in Health IT: A Stimulus for a Healthier America
could be required to adhere to certain clinical care
pathways or demonstrate that they have “functional
EHRs.” This may mean that their EHR must show it is
capable of sending and receiving lab, pharmaceutical, and other clinical information—not just payment
claims information.
HIT system functions and interoperability are essential cornerstones for policies such as primary
care-centered medical homes, coordination of care
for chronic conditions, value-based care, comparative effectiveness research, and pay-for-performance/
pay-for-quality initiatives. Some EHR-systems come as
“blank slates,” with functionality, but without built-in
clinical content or knowledge; these systems demand
tremendous amounts of time, skill, and energy to harness the tools to the purpose of actually improving
quality. Linking the implementation of HIT to health
system reforms is essential. To promote appropriate
and clinically effective uses of HIT over the mere acquisition of technology, the Secretary of HHS should
develop and implement measures for HIT connectivity
and data exchange as well as measures for EHR-based
quality reporting.
Privacy
All consumers should be able to rely on appropriate
and consistent minimum levels for privacy and security protections among all entities—both public and
private—that access or use individual health information. A high level of trust in these protections is crucial
for HIT to succeed. It will be important for Congress to
strike an appropriate balance between the competing
interests of protecting privacy concerns versus advancing HIT, EHRs, and public health initiatives. Both can
be achieved. Today, many state laws risk slowing down
the rate of progress by allowing consumers to opt out
of disease registries and other community health initiatives due to privacy concerns.
We believe that HIPAA should remain the basis of
new privacy rules. However, privacy policy also must
cover personal health data consistently, regardless of
what entity holds the records. Privacy requirements can
achieve better protection for consumers without adding
to the cost of HIT, changing the practice of medicine,
or creating medical liability issues.
There are good models in state law for guarding
against security breaches in ways that do not impede
access to health information by clinicians; it is important
to remember that the lack of appropriate and complete
health information for clinicians who are treating a
patient can also endanger that patient’s life.
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
In our experience, California law provides a model
for breach notification that is clear and consistent
across all types of entities, events, and circumstances.
We believe HIPAA disclosure accounting for treatment,
payment, or health care operations purposes would
add a significant amount to the total cost of HIT implementation and could harm the practice of medicine by
disrupting clinical workflows. HIT innovators should
not be penalized by regulations that force unnecessary or disproportionate system overhauls to achieve
compliance, especially when such modifications will
consume resources that could be spent to deliver
high-quality care. Efficiency should be a goal of new
investments and rules.
Improving Safety, Quality,
and Efficiency
The real objective of HIT in the economic stimulus
package should not be technology, but rather to improve safety, quality, and efficiency.
At KP, we believe the keys to the solution will be
health care led by clinicians, integrated with functional
IT systems, and staffed with innovative, enthusiastic,
computer-enabled health care professionals.
Having HIT and the means to exchange information will do us little good if we do not foster and
support better information about the effectiveness of
care, including the relative benefits, risks, and costs of
treatments and services. We need a robust federal commitment to comparative effectiveness research so that
health professionals can ensure each individual patient
gets the care that is right for him or her. Reforms must
also ensure that patient information can be used not
only to optimize care for one specific patient but also
to improve care for all patients through, for example,
the development of clinical care guidelines and disease
management protocols. These goals require the use of
patient information and appropriate access to patient
records, with privacy safeguards as currently required
under HIPAA rules.
Ultimately, however, to effect real change, provider
payment systems should be based on value rather than
the number of procedures, drugs, tests one orders—
regardless of whether the best evidence calls for such
action. To keep coverage affordable and to really fix
our broken health care system, we must change the way
we deliver and pay for health care. Financial incentives
must be changed so that plans compete on quality and
efficiency, providers are rewarded for quality and keeping their patients healthy rather than for the volume of
services delivered, and individuals are encouraged to
69
Commentary
Investing in Health IT: A Stimulus for a Healthier America
seek high-quality care and to be more actively involved
in maintaining their own health.
We believe a computerized care support system that is
well designed and implemented appropriately can help
restore and enhance the physician’s healing mission.
Maximizing information available to the clinician means
optimizing care for the patient. The right systems will
yield more time with patients, better information about
care, and less time with traditional paperwork. The
right systems also must focus on the patient’s need for
affordable, well-informed, customized, and compassionate care. We believe a new HIT system will support our
nation’s health care reform agenda and can help our nation fulfill its ethical responsibility to improve health care
access, reduce costs, and ensure quality care for all.
We look forward to working with you to achieve
these goals. v
References
1.Zhou YY, Garrido T, Chin HL, Wiesenthal AM, Liang LL. Patient access to an electronic record with secure messaging:
impact on primary care utilization. Am J Manag Care 2007
Jul;13(7):418-24.
2.Institute of Medicine (US) Committee on Quality of Health
Care in America. Crossing the quality chasm: a new health
system for the 21st century. Washington, DC: National
Academy Press; 2001.
3.Sandhoff B, Kuca S, Rasmussen J, Merenich J. Collaborative
Cardiac Care Service: a multidisciplinary approach to caring
for patients with coronary artery disease. Perm J 2008 Summer;12(3):4-11.
A Quantum Leap
America needs to move much faster to adopt information technology in
our health care system …. Electronic health information will provide a
quantum leap in patient power, doctor power, and effective health care.
We can’t wait any longer …. Health information technology can improve
quality of care and reduce medical errors, even as it lowers administrative
costs. It has the potential to produce savings of 10% of our total annual
spending on health care, even as it improves care for patients and provides
new support for health care professionals …. This plan sorts out the
myriad of issues involved in achieving the benefits of health information
technology, and it lays out a coherent direction for reaching our goals.
— Health and Human Services News Release, July 21, 2004: Thompson launches
“Decade of Health Information Technology,” Tommy Thompson, b 1941,
US Department of Health and Human Services Secretary
70
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Commentary
Marketing, Media, Wishful Thinking,
and Conflicts of Interest: Inflating the Value
of New Medical Technology
Richard A Deyo, MD, MPH
In 1991, Nelene Fox, a 38-yearold mother of three, was diagnosed
with breast cancer. She underwent
bilateral mastectomies and chemotherapy but nonetheless developed
bony metastases. Her physicians
said her only chance for survival
was high-dose chemotherapy and
autologous bone marrow transplantation. Her Health Maintenance Organization (HMO) refused to cover
the procedure (around $140,000) on
the basis that it was experimental.1
Her husband launched a successful fundraising effort, and Mrs Fox
received the procedure, but died
eight months later. Her brother,
an attorney, sued the HMO for the
delay in her therapy, and won $89
million in damages. Similar lawsuits
played out across the country with
similar awards.
For the media, this was an irresistible David and Goliath story: relatively powerless individual patients
were bringing insurance companies
and HMOs to their knees. Reporting
focused on access to the new technology, not questioning whether it
was effective. With the media frenzy
and lobbying, lawmakers began
requiring insurance coverage for
the new procedure. Insurers, facing
lawsuits, bad publicity, and new legal requirements, began to routinely
cover the new procedure.2
Physicians and hospitals were
generally enthusiastic, optimistic,
and sincere in supporting the new
regimen for late-stage breast cancer, and the new approach was a
financial windfall for physicians and
hospitals. Clinicians became vocal
advocates for the procedure, and
frequently were witnesses in court.
Many joined complaints against
insurers. Some hospitals built new
wings to accommodate patients
having the procedure.
However, as clinical trial results
rolled in, the story began to unravel. An early positive report from
researchers in South Africa proved to
be fraudulent. National Institutes of
Health (NIH)-sponsored trials, long
delayed, finally showed the new
treatment to be no more effective
than standard chemotherapy, but
more toxic. The trials were delayed
because women were convinced the
procedure was effective, and few
were willing to submit to randomization with a chance of receiving
standard therapy. By the time the
negative results became available,
42,000 women in the US had been
treated at a cost of $3.4 billion.2
The approach was rapidly abandoned, but, in retrospect, medical
theories, professional egos, wishful
thinking, financial incentives, and
the media helped disseminate a new
technology that decreased quality of
care and increased costs. Clinicians
sincerely believed the treatment was
effective, but theoretical advan-
tages and financial incentives may
have obscured the lack of sound
evidence. When access to care is a
problem for millions of Americans,
one may reasonably ask if there
were better ways to deploy $3.4
billion.
Other Technologies that
Increased Cost, but not
Quality
Other “advances” that increased
costs without improving quality
are easy to find. Rofecoxib (Vioxx)
was recalled after its association
with myocardial infarction became
apparent, but only after, by one
estimate, 140,000 avoidable heart
attacks.3 Most who took it would
have done as well with ibuprofen
because they had a low risk of gastrointestinal bleeding.4 Nonetheless,
rofecoxib resulted in expenditures
of nearly $2.5 billion per year while
it was on the market.
Arthroscopic debridement and
lavage for knee osteoarthritis has
been a popular treatment. However,
randomized trials suggest it is no
more effective than sham surgery or
rehabilitation.5,6 Nonetheless, costs
of the procedure were estimated at
$3 billion per year.5
The Antihypertensive and LipidLowering treatment to prevent Heart
Attack Trial (ALLHAT) suggested
that old-fashioned thiazides were at
least as effective as several newer
Richard A Deyo, MD, MPH, is the Kaiser Permanente Professor of Evidence-Based
Family Medicine, and Director of the OCTRI Community and Practice-Based Research
Program at Oregon Health and Science University, in Portland, OR. E-mail: [email protected].
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
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Commentary
Marketing, Media, Wishful Thinking, and Conflicts of Interest: Inflating the Value of New Medical Technology
drugs in preventing complications
of hypertension. 7 Nonetheless,
their use had declined over several
decades in favor of newer, more
expensive drugs. Some estimated
that greater use of diuretics might
have prevented 70,000 myocardial
infarctions and strokes per year8—
and saved $1.2 billion per year.9
These expensive, marginal treatments became widely used without
adequate scientific evaluation or
comparison to competing treatments. They demonstrate that new
treatments are sometimes less effective or less safe than alternatives, yet
we often learn this only after avoidable harm and expenditure.
These examples suggest that
marketing, politics, media, and
advocacy sometimes trump scientific considerations. Furthermore,
physicians are often eager to adopt
new technologies, hoping they will
overcome the limitations of current
approaches. However, “jumping
the gun” before rigorous evaluation
makes it hard for all of us to practice
evidence-based medicine. And the
resulting waste of resources occurs
at a time when health costs are soaring and fewer Americans can afford
insurance each year. Only recently
have policy makers begun to address the need for better assessment
of new technology and studies of
comparative effectiveness.
Although many stakeholders
share responsibility for disseminating marginal technology, an
important factor has been the
growth of industry-sponsored
research,10 sometimes focused on
getting the “right” results or masking the “wrong” results.11 Sometimes professional organizations
align with industry to suppress
unwelcome results.12 How do these
events happen and how might we
improve the trustworthiness of our
scientific base?
72
Industry Sponsorship of
Research: Getting the
“Right” Results?
A growing literature documents
that industry-sponsored research
produces results favorable to its
own products more often than independent research.13-18 For example,
90% of industry-sponsored trials
of antipsychotic drugs favored the
sponsor’s drug, sometimes producing contradictory results.19 Among
trials comparing olanzapine with
risperidone, those sponsored by
Lilly favored olanzapine five times
out of five. In contrast, trials sponsored by Janssen favored risperidone three times out of four.19
How can seemingly well-designed studies reach conflicting
conclusions? There are several strategies for making research results as
favorable as possible.
In designing a comparison group,
one might choose a high dose of
a competitor’s drug that produces
more side-effects than the sponsor’s drug, or a less-effective low
dose of the competing drug.19,20 In
some studies, oral antifungals were
compared to competitor drugs that
were poorly absorbed by the oral
route.21
Selective reporting of subgroups,
side-effects, or outcome measures
is another strategy. If just one subgroup shows an advantage for the
sponsor’s drug, it may be reported
without results for other groups.
Similarly, if one outcome measure
among several shows a favorable
result, it may be reported to the
exclusion of others.20
Another strategy is to publish
favorable results multiple times.
Authors of a systematic review on
risperidone found the literature
to be “vexing,” “bewildering,”
and “intolerably time consuming”
because of overlapping reports.22
They discovered that 20 articles
and several unpublished reports
actually represented only seven
small studies and two large ones.
One larger study was reported in
six publications with different authors and no reference to the others. Similar redundant reports have
been identified for ondansetron,
fluconazole, and nonsteroidal antiinflammatory drugs. In each case,
the duplicate data inflate apparent
drug efficacy.22-23
Ghost writing and guest authorship comprise another important
strategy for favorable publications.
In this situation, research reports,
editorials, or reviews are written
by a professional writer hired by
a drug company or a public relations firm. A medical authority is
invited to be named as the author,
and gives final approval to the article. The ghost writer’s name does
not appear, but s/he has already
framed the arguments in the most
favorable light. In “Whose article
is it anyway?” by Marilynne Larkin,
writer Ronni Sandroff described her
experience in writing two cancer
pain articles “for MD signatures”
intended for peer-review journals.
She was told exactly what the drug
company expected and given explicit instructions about what to play
up and what to play down.24 Recent
revelations regarding rofecoxib
demonstrate that dozens of articles
were prepared in this way.25
Suppressing
Unfavorable Results
Finally, unfavorable trial results
can be buried. Companies argue that
their data are proprietary and there
is no requirement that all results
be published. A recent examination of FDA-registered studies for
antidepressant drugs illustrated the
problem. Of 74 registered studies,
only 51% had a positive result for
the sponsor’s drug according to FDA
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Marketing, Media, Wishful Thinking, and Conflicts of Interest: Inflating the Value of New Medical Technology
review. However, 94% of published
trials favored the sponsors’ drugs.
Among 36 studies that the FDA
judged as negative or questionable,
22 were never published; 11 were
published with a positive spin to
the discussion; and only three were
published as negative trials.26
Company-sponsored research
conducted by university investigators may seem less susceptible to
manipulation. However, a recent
survey of university-industry agreements suggested that academic
institutions routinely participate
in clinical research that does not
adhere to recommended standards
(from medical editors) for accountability, access to data, and control
over publication.27
A striking example of suppressing
results occurred at the University of
California, San Francisco. In 1987,
Betty Dong, MD, was approached
by the predecessor to Boots pharmaceuticals, maker of Synthroid
(generic: levothyroxine), to compare its product with generic competitors. Synthroid had dominated
the market, thanks to concerns that
other thyroid preparations had less
consistent bioavailability. However,
Synthroid’s market share was eroding, so Dr Dong was approached
to compare Synthroid with three
competitor drugs.28
Dr Dong’s study, completed in
1990, unexpectedly found that the
four preparations of thyroid hormone were equivalent. Although
Boots had handpicked Dr Dong,
specified the study design, and
made frequent quality assurance
visits, executives suddenly objected
to nearly all aspects of the study,
and complained to university officials. Two investigations found
only minor and easily correctible
problems. One outside expert said,
“The Boots people were deceptive
and self-serving.”29
These events were a prelude to
legal threats that blocked publication of the results. The company
cited a clause in Dr Dong’s contract,
even though restrictions on publication were contrary to university
policy. This occurred in 1994, when
Dong’s paper was accepted at the
Journal of the American Medical
Association (JAMA). Two weeks
before scheduled publication, in
the face of legal threats, the authors
withdrew the manuscript.
While these events were unfolding, Boots was selling its drug division to a German company for $1.4
billion. Boots became part of Knoll
Pharmaceuticals, and analysts suggested that publication of Dr Dong’s
results would have been disastrous
for Boots and its sale value.29
Eventually, in the face of negative publicity and pressure from
the Food and Drug Administration
for possibly misleading claims, the
company relented. In April 1997,
JAMA published the article along
with Knoll’s cautious apology and
continued objections.28,30
Knoll subsequently faced a class
action lawsuit by consumers, alleging they were overcharged
for medication because data on
bioequivalence were unavailable.
Knoll denied efforts to suppress
publication but offered $135 million
to settle the suit. Knoll later paid 37
states another $41.8 million to settle
charges that it made deceptive statements about Synthroid.
Although this episode may seem
extraordinary, attempts to suppress
unwelcome news may be business
as usual. Herb Needleman, MD,
of Yale was attacked by the lead
paint industry for many years, after
demonstrating the neurotoxicity of
lead in children. In 2007, the makers of OxyContin, the brand name
for the time-released oxycodone,
pled guilty to fraudulent marketing
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Commentary
claims and agreed to $634 million
in fines, after hiding data on addictive properties of the drug.31 Similar
claims of suppressing bad news and
intimidating investigators appear
with alarming frequency.
Attacks on Funding
Agencies
Another strategy for minimizing
bad news is to attack research agencies that fund unwelcome research.
Examples included efforts to eliminate the Injury Prevention Branch
at the Centers for Disease Control
after it funded studies demonstrating a higher risk of gun violence in
the homes of gun owners. Attacks
came from the National Rifle Association and a group called “Doctors
for Integrity in Research and Public
Policy,” with views similar to those
of the NRA.32 The National Center
for Health Care Technology was
a government agency with a brief
lifespan in the 1970s, eliminated after
lobbying by the drug and medical
device industries.33 The Agency for
Health Care Policy and Research
(AHCPR) was almost eliminated after
lobbying by a physician organization
upset with research and
guidelines the agency
Another
sponsored.12
strategy
for
In this last examminimizing
ple, our research team
bad news
demonstrated in the
is
to attack
1990s that spinal furesearch
sion surgery was the
agencies
fastest growing type
that
fund
of back surgery in the
unwelcome
US. At the time, pedicle
research.
screws were a relatively
new technology for this
type of surgery, and were growing
in popularity. Our work challenged
the effectiveness and safety of fusion surgery for some common
indications, and recommended
that it be subjected to randomized
controlled trials.
73
Commentary
Marketing, Media, Wishful Thinking, and Conflicts of Interest: Inflating the Value of New Medical Technology
At the same time, a multidisciplinary panel sponsored by the
same agency was producing clinical
guidelines for acute low back pain.
On the basis of extensive evidence,
the panel recommended nonsurgical therapy for most acute back
problems, noting there were no
trials of fusion surgery for patients
with acute back pain.
These findings elicited
a backlash from the North
In effect, vested
American Spine Society,
interests may
a multidisciplinary group
determine the
dominated by orthopeacceptable
dic surgeons. The Society
research
organized a letter-writing
questions and
campaign to Congress,
results. … For
arguing for elimination of
the research
the AHCPR. A member of
enterprise, the
the Society’s board foundpeer review
ed an advocacy organizasystem must
tion dedicated to this aim.
resist external
Finally, a manufacturer of
influences in
pedicle screws sought a
grant review
court injunction to block
and publication.
release of the back pain
guidelines.12
These events unfolded during
Congressional controversy over the
Clinton health plan and leadership
of the AHCPR. The combination
resulted in a House bill in 1996
that eliminated the AHCPR. The
agency was restored by the Senate after strong support from other
professional societies, including the
American Medical Association and
the American College of Physicians.
Nonetheless, the AHCPR ended its
guideline work altogether and sustained a 25% budget cut, eliminating
new research for several years and
reducing existing grant budgets.
The story continues today. Several spinal device manufacturers
are currently under investigation
for alleged kickbacks to surgeons.
In 2006, one company paid $40 million to the US government to settle
accusations of “sham consulting
74
agreements, sham royalty agreements, and lavish trips,” without
acknowledging any wrongdoing.34
Consequences of
Inadequate Research
and Suppressing Data
Several important consequences
may arise from suppressing research results, influencing scientific
reports, or inadequately evaluating
medical innovations. First, patients
may be exposed to unnecessary
risks. Second, harassment discourages research in controversial areas,
exactly those most needing good
scientific study. In effect, vested
interests may determine the acceptable research questions and results.
Eliminating public peer-reviewed
scientific research funding may slow
the emergence of new knowledge
and push investigators to seek
funding associated with conflicts of
interests.12 Ultimately, disseminating
marginal or ineffective technology
increases costs of care without
increasing quality, complicating
health care reform.
Improving the
Evaluation and Value of
New Technology
What are some potential solutions to these problems? First, for
physicians, a renewed sense of
professionalism may be essential.
While we value the professional
attributes of altruism, service, selfgovernance, and deep knowledge,
the business ethos is quite different.
Here, the primary responsibility is
not to patients but to shareholders. The drug, device, and supply
industries create many jobs, and the
main focus of attention is return on
investment. This contrast between
professional and business priorities
led the Association of American
Medical Colleges to argue recently
that doctors, staff, and students in
medical schools should avoid certain entanglements with industry. It
recommended that individuals not
accept free food, gifts, or travel from
drug and device companies and
not accept ghost-writing services.
The report strongly discouraged
participation in company-sponsored
speakers bureaus.35
Practicing physicians should
become familiar with the rules of
evidence-based medicine, as a
safeguard against misleading claims.
A simple-minded definition of evidence-based medicine would argue
that it is not enough to know if a
treatment ought to work; if it makes
physiologic sense; if it is common
practice; if we learned it in medical
school; if we’ve always done it that
way; if an expert vouches for it; or if
it works in mice.36 Instead, we need
to ask what is the best evidence that
a new treatment extends lives or
improves quality of life, and what
are the risks?
In addition, regulatory reforms are
needed. Direct comparisons of competing drugs and devices are rarely
mandated by the FDA but would be
enormously valuable to physicians
and patients. Legislative proposals for
studying comparative effectiveness
deserve support. Most agree that the
FDA needs more resources and better
methods for post-marketing surveillance of drug and device safety. I
favor a requirement for randomized
trials for devices that are surgically
implanted in the body. The current
threshold for approval is far less
rigorous than for drugs, yet the need
for evidence of clinical efficacy and
safety is equally great. Both private
and government insurers could help
produce better evidence by supporting clinical trials as a condition of
coverage when the evidence for new
technology is weak.37
For the research enterprise, the
peer review system must resist
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Marketing, Media, Wishful Thinking, and Conflicts of Interest: Inflating the Value of New Medical Technology
external influences in grant review
and publication. This requires eliminating efforts to block publication,
reviewers with conflicts of interests,
and threats to editors from their
advertisers. In some cases, new
university policies may be necessary to support faculty who come
under attack from vested interests.
Public funding agencies should be
vigorously defended.
For investigators themselves, it
is essential to strive for impeccable
science, and to have thick skin.
Research on product effectiveness
is a contact sport, and investigators
should anticipate a backlash, including character attacks and intimidation, to unfavorable results.
Finally, we should foster more
realistic public expectations of new
medical technology. Americans,
more than Canadians or Europeans,
believe new technology can solve
all our serious medical problems.38
We sometimes foster such expectations with our own wishful thinking,
and because it is financially convenient to generate more procedures
and more care. However, the public
must understand now more than
ever that “newly approved” does
not necessarily mean new and improved.39 This understanding may
be critical to freeing resources that
facilitate better access to care. v
Disclosure Statement
Supported in part by Grant # 1 UL1
RR024140-01 from the National Institutes of Health (NIH)/National Center
for Research Resources (NCRR). The
opinions and conclusions expressed are
solely those of the author, and not necessarily those of the NIH or Oregon Health
and Science University (OHSU).
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2.Mello MM, Brennan TA. The
controversy over high-dose chemotherapy with autologous bone
marrow transplant for breast cancer.
Health Aff (Millwood) 2001 SepOct;20(5):101-17.
3.Graham DJ, Campen D, Hui R, et al.
Risk of acute myocardial infarction
and sudden cardiac death in patients
treated with cyclo-oxygenase 2 selective and non-selective non-steroidal
anti-inflammatory drugs: nested
case-control study. Lancet 2005 Feb
5;365(9458):475-81.
4.Dai C, Stafford RS, Alexander GC.
National trends in cyclooxygenase-2
inhibitor use since market release:
nonselective diffusion of a selectively
cost-effective innovation. Arch Intern
Med 2005 Jan 24;165(2):170-1.
5.Moseley JB, O’Malley K, Petersen
NJ, et al. A controlled trial of arthroscopic surgery for osteoarthritis
of the knee. N Engl J Med 2002 Jul
11;347(2):81-8.
6.Kirkley A, Birmingham TB, Litchfield
RB, et al. A randomized trial of
arthroscopic surgery for osteoarthritis
of the knee. N Engl J Med 2008 Sep
11;359(11):1097-107.
7.ALLHAT Officers and Coordinators for the ALLHAT Collaborative
Research Group. The Antihypertensive and Lipid-Lowering Treatment
to Prevent Heart Attack Trial. Major
outcomes in high-risk hypertensive
patients randomized to angiotensinconverting enzyme inhibitor or
calcium channel blocker vs diuretic:
The Antihypertensive and Lipid-Lowering Treatment to Prevent Health
Attack Trial (ALLHAT). JAMA 2002
Dec 18;288(23):2981-97. Erratum
in: JAMA 2005 Jan 8;289(2):178.
Erratum in: JAMA 2004 May
12;291(18):2196.
8.Langreth R. The new drug war.
Forbes 2003 Mar 31: p 84a.
9.Fischer MA, Avorn J. Economic
implications of evidence-based
prescribing for hypertension: can
better care cost less? JAMA 2004
Apr 21;291(15):1850-6.
10. Bekelman JE, Li Y, Gross CP. Scope
and impact of financial conflicts of
interest in biomedical research: a
systematic review. JAMA 2003 Jan
22;289(4):454-65.
11. Deyo RA. Stacking the deck? How to
get the “right” answer in clinical research. In: Deyo RA, Patrick DL. Hope
or Hype: the obsession with medical
advances and the high cost of false
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
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promises. New York: AMACOM;
2005. p 103-14.
12. Deyo RA, Psaty BM, Simon G,
Wagner EH, Omenn GS. The messenger under attack—intimidation
of researchers by special-interest
groups. N Engl J Med 1997 Apr
17;336(16):1176-80.
13.Lexchin J, Bero LA, Djulbegovic B,
Clark O. Pharmaceutical industry
sponsorship and research outcome
and quality: systematic review. BMJ
2003 May 31;326(7400):1167-70.
14. Kjaergard LL, Als-Nielsen B. Association between competing interests
and authors’ conclusions: epidemiological study of randomized clinical
trials published in the BMJ. BMJ
2002 Aug 3;325(7358):249.
15.Als-Nielsen B, Chen W, Gluud C,
Kjaergard LL. Association of funding
and conclusions in randomized drug
trials: a reflection of treatment effect
or adverse events? JAMA 2003 Aug
20:290(7):921-8.
16. Okike K, Kocher MS, Mehlman CT,
Bhandari M. Conflict of interest in
orthopedic research. An association
between findings and funding in
scientific presentations. J Bone Joint
Surg Am 2007 Mar;89(3):608-13.
17. Fenton JJ, Mirza SK, Lahad A, Stern
BD, Deyo RA. Variation in reported
safety of lumbar interbody fusion:
influence of industrial sponsorship
and other study characteristics. Spine
2007 Feb 15;32(4):471-80.
18. Friedman LS, Richter ED. Relationship
between conflicts of interest and
research results. J Gen Intern Med
2004 Jan;19(1):51-6.
19. Heres S, Davis J, Maino K, Jetzinger
E, Kissling W, Leucht S. Why olanzapine beats risperidone, risperidone
beats quetiapine, and quetiapine
beats olanzpine: an exploratory
analysis of head-to-head comparison studies of second-generation
antipsychotics. Am J Psychiatry 2006
Feb;163(2):185-94.
20. Bero LA, Rennie D. Influences on the
quality of published drug studies. Int
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21. Johansen HK, Gotzsche PC. Problems
in the design and reporting of trials
of antifungal agents encountered
during meta-analysis. JAMA 1999
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22. Huston P, Moher D. Redundancy,
75
Commentary
Marketing, Media, Wishful Thinking, and Conflicts of Interest: Inflating the Value of New Medical Technology
disaggregation, and the integrity of
medical research. Lancet 1996 Apr
13;347(9007):1024-6.
23.Tramèr MR, Reynolds DJ, Moore
RA, McQuay HJ. Impact of covert
duplicate publication on Metaanalysis: a case study. BMJ 1997 Sep
13;315(7109):635-40.
24.Larkin M. Whose article is it anyway?
Lancet 1999 Jul 10;354(9173):136.
25.Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest authorship and
ghostwriting in publications related
to rofecoxib: a case study of industry
documents from rofecoxib litigation.
JAMA 2008 Apr 16;299(15):1800-12.
26.Turner EH, Matthews AM, Linardatos
E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its
influence on apparent efficacy. N Engl
J Med 2008 Jan 17;358(3):252-60.
27. Schulman KA, Seils DM, Timbie JW,
et al. A national survey of provisions
in clinical-trial agreements between
medical schools and industry
sponsors. N Engl J Med 2002 Oct
24;347(17):1335-41.
28.Rennie D. Thyroid storm. JAMA 1997
Apr 16;277(15):1238-43.
29. King RT. Bitter pill: how a drug firm
paid for university study, then undermined it. The Wall Street Journal
1996 Apr 25, Sect A:1.
30. Dong BJ, Hauck WW, Gambertoglio JG, et al. Bioequivalence of
generic and brand-name levothyroxine products in the treatment of
hypothyroidism. JAMA 1997 Apr
16;227(15):1205-13.
31. Meier B. In guilty plea, OxyContin
maker to pay $600 million. The New
York Times 2007 May 10.
32. Kassirer J. A partisan assault
on science­—the threat to the
CDC. N Engl J Med 1995 Sep
21;333(12):793-4.
33. Perry S. Special report. The brief life
of the National Center for Health
Care Technology. N Engl J Med 1982
Oct 21;307(17):1095-100.
34.Abelson R. Medtronic will settle
accusations on kickbacks. The New
York Times, 2006 July 19.
35.Industry funding of medical education. Report of an AAMC task force
[monograph on the Internet]. Washington (DC): Association of American
Medical Colleges; 2008 Jun
[cited 2008 Nov 13]. Available from:
https://services.aamc.org/Publications/showfile.cfm?file=version114.
pdf&prd_id=232.
36. Deyo RA. For doctors: evidencebased medicine. Chapter 17 in: Deyo
RA, Patrick DL. Hope or Hype: the
obsession with medical advances and
the high cost of false promises. New
York: AMACOM; 2005. p 229-40.
37. Brenner M, Jones B, Daneschvar HL,
Triff S. New National Emphysema
Treatment Trial paradigm of Health
Care Financing Administration-sponsored clinical research trials: advances
and dilemmas. J Investig Med 2002
Mar;50(2):95-100.
38. Kim M, Blendon RJ, Benson JM. How
interested are Americans in new
medical technologies? A multicountry comparison. Health Aff (Millwood) 2001 Sep-Oct;20(5):194-201.
39.Anderson GM, Juurlink D, Detsky
AS. Newly approved does not always
mean new and improved. JAMA
2008 Apr 2;299(13):1598-600.
That Which Shrinks
It is error only, and not truth, that shrinks from inquiry.
— Thomas Paine, 1737-1809, philosopher and writer
76
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Editorial
Isn’t it Time to Stop Accepting Handouts
for our Educational Efforts?
KM Tan, MD
The drip-drip-drip method of torture mistakenly
attributed to the Chinese but more accurately Italian
in origin1 has proven pervasive and persuasive over
the past year as more and more reports of prominent
and preeminent physicians failing to report substantial
amounts of money from pharmaceutical and medical
equipment companies hit the media.
The raison d’être of drug companies is to maximize
profits for their shareholders. This has led to an ongoing
ethical conflict between marketing departments whose
sole purpose is to increase sales versus the pharmaceutical companies’ educational departments where distinct
separation of provided commercial support from the
intent and content of educational interventions is considered paramount.
Most highly paid speaking engagements offered
to internationally and nationally renowned physician
researchers at top universities appear, unfortunately, to
be paid from the marketing departments of pharmaceutical companies. It is becoming depressingly obvious
that large and substantial payments are conveniently
not reported to universities as policy requires. This
has, predictably, not only tainted their reputations but
also raised questions about the quality of the research
activities.
Consider the case of Charles Nemeroff, MD, Chair
of the Psychiatry Department at Emory University as
reported in the New York Review of Books. He failed
to disclose, per university policy, that for over 250
educational presentations to physician audiences he
had received more than $1.2 million between 2000 and
2006 from several pharmaceutical companies, primarily
GlaxoSmithKline.2 Dr Nemeroff was simultaneously the
principal investigator of a five-year $4 million grant
from the National Institute of Mental Health to study
several GlaxoSmithKline drugs. Federal rules call upon
him to report any amounts over $10,000 to the National
Institute, a regulation conveniently overlooked.
Particularly egregious was the fact that Dr Nemeroff
was investigated by Emory University in 2004 and was
cited for multiple policy violations as a result of which
he promised to report any remuneration in excess of
$10,000 from any one company. He reported $9999
from GlaxoSmithKline that year while, apparently,
actually receiving $171,031.3 In late December 2008,
Dr Nemeroff was permanently relieved of his position as Chair of Psychiatry at Emory. However, the
damage is done, raising questions about his research
activities, his multiple educational presentations, and
his influence worldwide as co-editor of the Textbook
of Psychopharmacology (Arlington,VA: American Psychiatric Press; 1998).
Dr Nemeroff’s case is not a study in isolation. Reported in The New York Times is another world-renowned
psychiatrist, Joseph Biederman, MD, of Harvard University, whose research has resulted in an exponential
increase in the use of powerful antipsychotic medications for children as young as two years of age. He also
failed to report more than $1.6 million in consulting fees
from pharmaceutical companies from 2000 to 2007.3,4
Two other colleagues in the same department failed to
report similar substantial income as well.4
That such preeminent and sophisticated scientists
apparently chose to cover up their conflicts of interest is a sad commentary on the state of ethics in our
medical profession.
Awareness of these episodes is a result of a congressional inquiry through the efforts of Senator Charles
Grassley (R-IA) of the Senate Finance Committee who
is now turning his investigation from psychiatrists to
cardiologists. There are already multiple examples of
questionable ethical behaviors involving cardiologists
and orthopedic surgeons where surgical device makers appear to have a cozy relationship with physicians
KM Tan, MD, is a retired Radiologist from The Permanente
Medical Group in Northern California. He is an Associate Editor with The Permanente Journal. E-mail: [email protected].
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
77
EDITORIAL
Isn’t it Time to Stop Accepting Handouts for our Educational Efforts?
promoting their products. I would venture no medical
specialty would be off limits.
Continuing education for physicians is a multibilliondollar enterprise generously supported by pharmaceutical and medical device companies historically,
amounting to approximately 60% of a total outlay of
$2.7 billion in 2007. Increasing fears that the firewalls
promulgated by the Accreditation Council
on Continuing Medical Education (ACCME)
… the social
are proving porous are buttressed by the
science literature
stories related above and have led to an
… supports the
increasing consensus for the complete
premise that it
separation of commercial support from
is not the size of
educational interventions.
the gift, but the
In November 2007, the Josiah Macy, Jr,
gifting itself that
Foundation
released a report5 on continucreates the desire
ing education in the health professions
to reciprocate.
reflecting the conclusions of a group of
preeminent medical educators that commercial support for continuing education risks distorting
educational content and invites bias, raises concerns
about the vows of health professionals to place patient
interests uppermost, endangers professional commitment to evidence-based decision making, validates
and reinforces an entitlement mindset among health
professionals that continuing education should be paid
for by others and impedes the adoption of more effective modes of learning. The report calls for a ban on
commercial support for accredited organizations that
provide continuing education and recommends that faculty of academic centers should not serve on speakers’
bureaus or as paid spokespersons for pharmaceutical
or device manufacturers. In addition, the report decries
the common practice of publishing articles, reviews,
and editorials under the names of prominent academics
that have been ghost written by industry employees
and recommends its prohibition.5
In April of 2008, a task force on industry funding of
medical education from the American Association of
Medical Colleges called on all medical schools to ban
drug company food and gifts and to strongly discourage
faculty from serving on speakers’ bureaus.6
Finally, the Council on Ethical and Judicial Affairs
of the American Medical Association recommended
the discontinuance of commercial support for medical
education,7 a heroic stand soundly defeated by the June
2008 House of Delegates, perhaps a reflection of the
entitlement mindset mentioned in the Macy report.
Stanford University, one of the leading providers of
radiology CME, has historically held elaborate vendorsupported receptions linked to large meetings, includ-
78
ing International Symposia on multidetector row CT,
PET/CT and molecular imaging, neuroradiology, etc.
These receptions have been noted for “full-sized CT
ice sculptures, ‘mad-scientist’-inspired hors d’oeuvres,
and dancers/acrobats in colorful costumes, futuristic
helmets, and roller skates,”9 A new policy (http://
cme.stanford.edu/documents/cme_commercial_support_policy.pdf), effective September 1 2008, changes
everything. Under this new policy, no exhibits are
allowed. According to Philip Pizzo, MD, “If company
support has been linked either directly or indirectly
to marketing goals, I expect that the funding support
will decline.”9 Stanford University has been a leader in
reforming interactions between industry and the medical profession, in research, in education, and in clinical
care, and has restricted commercial funding since 2006
with its Industry Interactions Policy (available at: http://
med.stanford.edu/coi/siip/), which addresses the issues
raised here. (Philip Pizzo, MD, personal communication. 2009 Apr 30).a
Cleveland Clinic has also started publicly reporting
the business relationships that any of its 1800 staff
physicians and scientists have with pharmaceutical
companies and device makers.9 This is an understandable reaction to the increasing and ongoing furor on
conflicts of interest that occur when physicians work
closely with pharmaceutical companies and device
companies in research and development, yet artfully
neglect to have appropriate financial disclosures available to all and sundry.
The Permanente Medical Group (TPMG) adopted a
strong revised conflict of interest policy for its physicians effective January 2005, whereby physicians are
prohibited from receiving anything from commercial
vendors; this includes funding for CME programs
directed at TPMG physicians. The medical group has
allocated sufficient funds to cover the shortfall resulting
from the loss of commercial support. Sharon Levine,
MD, Associate Executive Director, TPMG, faults the
assumption that if you cap the amount of money you
receive as a gift or a gratuity that somehow caps the
level of influence. Rather, she points out, the social science literature is replete with research that supports the
premise that it is not the size of the gift, but the gifting
itself that creates the desire to reciprocate.10
Because of the increasing scrutiny and with multiple
examples of questionable practices and given the risk
of eroding the trust of our patients, perhaps it is time
to consider whether all physicians and employees in
Kaiser Permanente will need to build on the foundation that TPMG and other medical groups, notably
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
EDITORIAL
Isn’t it Time to Stop Accepting Handouts for our Educational Efforts?
the Northwest Permanente Medical Group and the
Colorado Permanente Medical Group have started: the
separation of commercial support from our educational
endeavors nationwide would be a great start. v
a
Memo from Phillip A Pizzo, MD, Dean, Stanford University
School of Medicine.
References
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2.Harris G. Top psychiatrist didn’t report drug maker’s pay,
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4.Harris G, Carey B. Researchers fail to reveal full drug pay.
The New York Times, 2008 Jun 8; Sect A:1.
5.Fletcher SW. Continuing Education in the Health Professions:
Improving Healthcare through Lifelong Learning [monograph
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7.Industry Support of Professional Education in Medicine,
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Dec 3,2008; Sect B:1.
10.No free lunch: TPMG a leader with a conflict of interest
policy. TPMG forum [serial on the Internet]. 2008 Jul-Aug
[cited 2009 15 Apr];20(4):[about 3 pages]. Available from:
http://cl.kp.org/portal/site/ncal/template.FRAME/menuitem.edbcbd56bff107f8401fdf702a71eea0/?url=http%
3A%2F%2Fcl.kp.org%2Fpkc%2Fncal%2Fclib%2Fnews
%2Ftpmg_forum%2Fjul_aug_2008%2Findex.htm?epi_
baseMenuID=null&epi_menuItemID=null&epi_menuID=null.
(Password protected.)
Nothing to be Ashamed Of
Among those who call themselves pure scientists, whatever their particular
field, there are many who feel that they would demean themselves and
lose caste among their fellows should they engage in researches which
obviously point to some utilitarian purpose. This I have always regarded
as an academic pose; for in the disinterested pursuit of knowledge, to
stumble, as did Roentgen or the Curies or Banting, on something not only
of great scientific importance but which at the same time was immediately
applicable to human welfare, is certainly nothing to be ashamed of.
— Harvey Cushing, MD, 1869-1939, American neurosurgeon and pioneer of brain surgery
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
79
Editorial
Dealing With Change: Using the Conditional
Change Model for Clinical Research
Mikel Aickin, PhD
Introduction
Virtually all clinical medicine is about change. The
criteria for deciding whether a therapy has been successful nearly always include consideration of the
degree to which the patient’s initial condition has improved or to which a deteriorating condition has been
stabilized. Both criteria depend on change. In the first
case it is a rise in some measurement of benefit or drop
in some measurement of burden, whereas in the second
it is that a downward change has been prevented.
In clinical research, therefore, one of the most frequently used approaches is to compare changes in a
treated group with corresponding changes in a control
group. Perhaps the most notable pedagogic failing of
statistics courses and textbooks is that they do not present the appropriate way to analyze data coming from
this design, which explains why published analyses
are so often suboptimal, if not actually incorrect. The
purposes of this article are to explain what should
be the default method of analyzing change data and
to indicate how to compute and display the results
graphically.
Regression to the Mean
One of the earliest observations, by Sir Frances Galton (1822-1922), was the tendency of change scores
to be negatively related to baseline values. In fact, the
regression procedure got its name from this phenomenon, which Galton called “regression to the mean.”
The notion that regression to the mean was a real
biologic phenomenon supported the early 20th-century
eugenics movement, especially in Great Britain. The
great statistician RA Fisher (1890-1962) was an ardent
participant in that movement. Although it is possible
for there to be true regression to the mean, in most
cases the phenomenon is artifactual. It arises from the
fact that if, over time, a biologic quantity must remain
in a certain range, to ensure survival of the organism,
then it is automatic that high values at one time will
tend to be followed by smaller values a little later on,
and conversely low values at one time will tend to
be followed by larger values a little later on. Thus,
regression to the mean is an inevitable consequence
of a time sequence of measurements needing to stay
in some viable range. The fact that it is not a biologic
effect but only a statistical one does not diminish its
influence when one is looking at change.
Table 1. Glossary of terms and symbols
Term
y0
y1
x
x=0
x=1
β
β0
β0 + β1
β1
e
null
Meaning
Baseline measurement
Endpoint measurement
Indicator variable (treatment)
Control group
Treated group
Study parameter
Mean change (control)
Mean change (treated)
Difference (treatment effect)
Residual (patient-specific)
No treatment effect
The Conditional Change Model
The simple change design can be described as follows (Table 1): Each patient yields a measurement, y0,
at the start of the study, the so-called baseline measurement. At the end of the study, each produces another
measurement on the same scale, y1, the endpoint measurement. There is a further treatment variable x (such
as a drug) that takes the value 0 for each patient in the
control group and the value 1 for each patient in the
treated group. It is called an indicator because it points
to the treated patients. The purpose of the study is to
compare pre-post changes y1 – y0 between the treated
(x = 1) and control (x = 0) groups.
The most common advice in statistics texts is that
this comparison should be made by applying a two-
Mikel Aickin, PhD, is a Research Professor in the Department of
Family and Community Medicine at the University of Arizona in
Tucson, AZ. E-mail: [email protected].
80
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
EDITORIAL
Dealing With Change: Using the Conditional Change Model for Clinical Research
sample t-test to the change scores. The null hypothesis
is that the mean changes in the two groups are equal.
Although it is not particularly well-known, one can
carry out the two-sample t-test with a linear regression
program. Figure 1 shows the mathematical model for
a single patient.
y1 – y0
Change
(endpoint
– baseline)
b0 + b1x
=
Parameters
(control
and treated
groups)
b2y0
+
+
Baseline
(measured
value)
e
Residual
(patientspecific)
Figure 2. Analytic model extended to include baseline.
y1 – y0
Change
(endpoint –
baseline)
=
b0 + b1x
+
Parameters
(control and
treated groups)
e
Residual
(patientspecific)
Figure 1. Mathematical model for a single patient.
I do not intend to go into the computation or theory
behind this model—only to use it as a convenient
language for thinking about the analysis. The y and x
variables I have already defined. The β’s are “parameters,” which just means that they are imagined to be
constant throughout any given study. The whole point
of the model is to provide a way of interpreting and
estimating these parameters. The e term represents a
patient-specific variable, which accounts for the fact that
change (the left side of the equation) is more than just
a simple linear function of the treatment indicator. The
left side of a regression equation is always thought of
as the outcome, the result of some process, whereas
the right side provides a mathematical explanation for
the result. In textbooks the result is always written
as just y, but here we want to think of change as the
outcome, so the result is a difference: endpoint (y1)
minus baseline (y0).
The model equation says that there is one mean
change in the control group (β0) and another in the
treated group (β0 + β1). These can be deduced by
the simple but universal technique of substituting the
possible values of x on the right side of the equation.
Thus, β1 acquires its interpretation as the difference
between the two mean changes, which is the whole
point of the study.
In a remarkably useful but almost completely unknown book, Ian Plewis1 argued strongly that in studies
of change, one should include the baseline value in
the analysis. The way to do this is to extend the above
analytic model (Figure 2). The only difference between
the two analyses is that y0 appears on the right side of
the equation in Figure 2. The model above thus says
that changes (left side) are influenced by treatment (x)
and baseline value (y0).
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Analysis Steps
As a practical matter, the dataset for such a study
looks like Table 2. The steps involved in the analysis
are as follows:
• Compute the change as a new variable
• Subtract the mean baseline from the baseline values
(centering)
• Regress the change on the treatment indicator and
the centered baseline to produce Table 3.
Table 3 is a simplified version of what most statistical
programs provide. The names of the right-side variables
appear first, followed by effect estimates of their corresponding β’s (under the “coefficient” column). The
other two commonly displayed values are the standard
deviation of the sampling distribution of the coefficient
estimate (under the “SDE” column; most programs erroneously use SE, for “standard error,” for what I call
SDE, for “standard deviation of the estimate), and a pvalue for testing the null hypothesis that the coefficient
is in reality zero (so that the named variable would not
appear in the true model equation).
Table 2. Example form of a dataset for studying
change
Baseline
140
141
157
138
Endpoint
138
123
140
136
Treatment
0
0
1
1
Baseline is the value measured at the start of the study, and endpoint
is measured at the end. The treatment variable is 0 for a control and 1
for a treated patient.
Table 3. Example regression computer output
Variable
Treatment
Baseline
Intercept
Coefficient
–4.122
–.801
1.531
SDE
2.178
0.213
1.260
p
0.058
0.000
0.224
Variables are the explanatory (right-side) variables in the regression
equation. Coefficients are their estimated effects (β’s), SDEs are
their sampling standard deviations, and p are the p-values for the
corresponding null hypothesis tests. The intercept term corresponds
to β0.
81
EDITORIAL
Dealing With Change: Using the Conditional Change Model for Clinical Research
Baseline Differences
If the
relationship
between
baseline
and change
is different
in the two
groups, then
does it not
follow that
this might be
a consequence
of treatment?
We can interpret the coefficient estimates by referring
back to the model equation. To interpret β0, plug the
values x = 0 and y0 = 0 into the right side. Of course
x = 0 means “in the control group.” Because we centered the baseline values, y0 = 0 means “at the mean
on baseline.” Thus, β0 stands for the mean change in
a control patient who was exactly average at baseline.
By substituting x = 1 and leaving y0 = 0, we interpret
β0 + β1 to be the mean change among treated patients
who are exactly average at baseline. The β2 parameter
captures how much the mean changes differ, if we
compare two patients in the same group but who differ
by 1 unit at baseline. Usually β2 is not of interest, so it
is included in Table 3 only for completeness.
Single Regression Line
Because it will play a role in the following discussion, we can note that to interpret β1 we could have
substituted any fixed value for y0. That is, β1 represents the effect of treatment on mean change when
we compare any two patients in different groups but
who had exactly the same baseline value. It is in this
sense that we say the analysis has been “adjusted for
baseline.” This is connected to the fact that if we were
to graph the fitted regression equations in the two
groups, like this
 β + β 2 y0
y1 − y0 =  0
(β 0 + β1 )+ β 2 y0
(controls )
(treated )
then they would appear as parallel lines. The vertical distance between the two lines is always the same
and is equal to the estimated β1. Thus, β1 captures the
effect of treatment for any group of patients who have
the same baseline values.
Three Advantages: Smaller Error,
Similar Groups, Less Artifact
There are three primary reasons for preferring the
conditional change model over the t-test (Table 4). The
first is purely statistical: that the SDE of the effect of
interest (β1) is nearly always smaller under the conditional change model. This means that the estimate of
treatment effect is more precise, and it has implications
for the chance of detecting a real effect using null
hypothesis testing.
The second reason is that if there is an imbalance
between the control and treatment groups with respect
to baseline values, this undermines the whole logic of
82
the study, in that the comparison of treatment versus
control is not made across two “similar” groups. Statisticians frequently claim that randomization removes
this concern, but this is an argument based on largesample theory, which does not apply to small studies
and may apply inadequately to most studies. Thus the
conditional change model is seen as an attempt to
lessen, if not remove, baseline differences.
The third reason is related to both of the first two.
Although it is possible for there to be true regression to
the mean, in most cases the phenomenon is artifactual.
Thus, the final argument for the conditional change
model is that it tends to reduce the artifactual effect of
regression to the mean.
The Unavoidable Warnings
Outliers
Although the conditional change model should probably become the default for analyzing change, it is not
without its difficulties. First, badly outlying values on
the baseline measurement can cause serious damage
to the estimate of the treatment effect because regression is sensitive to outliers. This is not, incidentally, an
argument in favor of the t-test, because it is also unduly
affected by outliers. Thus, it is always wise to view the
baseline distributions graphically and perhaps to take
some evasive action. One method, formerly widely
used and now nearly abandoned, is Winsorization.
One picks the largest and smallest reasonable values,
and then those above the largest value are rounded
down to it and those below the smallest value are
rounded up to it.
Differing Regression Lines
The second potential problem is that if one separately
fitted regression lines (of change, on baseline) within
the two treatment groups, one might get quite different lines. In this case, the rationale for fitting a single
line to both groups, which is part of the conditional
change model, might seem unjustified. There is actually a deeper issue here than just model fitting. If the
relationship between baseline and change is different
in the two groups, then does it not follow that this
might be a consequence of treatment? For example,
suppose that in the control group there is the usual
negative relationship between change and baseline that
is predicted by regression to the mean, but there is no
relationship in the treated group. Part of the effect of
treatment may then have been to detach changes from
baseline values.
Regardless of the source, differing regression lines
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
EDITORIAL
Dealing With Change: Using the Conditional Change Model for Clinical Research
y1 – y0 = β0 + β1x + (β2 + β3x)y0 + e
at the conditional change model for raising such an
issue, if there are differential treatment effects then it
would seem important to report them, which would
never happen with the t-test approach.
Here the effect of baseline explicitly depends on
which group the patient is in. This is accomplished in
the analysis by adding an interaction term, xy0, to the
list of explanatory variables. Now if we consider two
patients, one treated and one control with identical
values of y0, the difference between their mean changes is β1 + β3y0. (This is again deduced by substituting
trial values on the right side of the equation.) This
says that the treatment effect depends on the baseline
value, so that there is no single well-defined treatment
effect. The statistical way around this is to center the
baseline, as I have recommended, so that the nominal
treatment effect on the computer output (β1) is the
effect of treatment at the mean of the baseline. This
is a reasonable convention, but it does not solve the
conceptual problem. Although one might be annoyed
Three Measurement Points
The third difficulty only arises if one extends the
conditional change model beyond the comparison of
baseline and endpoint values. For example, imagine
a design in which the outcome variable is measured
three times on each patient: baseline, midstudy, and
endstudy. To measure the early effect, the change from
baseline to midstudy might be subjected to conditional
change analysis. One might then go on to investigate
late changes by applying the same model to midstudy
and endstudy values, with midstudy values now playing
the role of baseline. The reason this can go awry can
be seen in terms of regression to the mean. If the treatment produces an early beneficial effect, then midstudy
values will be higher in the treated patients than in the
control patients. The midstudy values will not be com-
pose a real conceptual problem, which can be seen in
terms of the model:
Adjusting Data: Graphical Display of Conditional Change Results
After having presented a statistical analysis,
researchers may want to show the data graphically, to give a richer impression of the results.
The danger here is that the conditional change
anaysis adjusts for baseline but the graphed
data are unadjusted. The alert reader may see
from the graphs that the asserted treatment
effects are implausible, undermining the credibility of the presentation.
The solution to this problem is to adjust the
data before graphing. The procedure involves
two steps, adjusting the baseline and adjusting
the changes. To adjust the baseline:
• Fit the regression model y0 = α0 + α1x + e
• Compute the fitted values (α0 + α1x where
the parameters (α’s) are estimated)
• Compute the regression residuals (observed
minus fitted). All programs will do this
• Subtract α1x from each fitted value, and
add α1x0 (parameters are estimated, x0,
determined as below)
• Add the residuals to the values just computed. These are the adjusted baselines.
Although it may have gotten lost in the
recipe, the values computed are α0 + α1x0 + e,
where the parameters are estimated and e is
the computed residual. These represent values
that would have been observed if each patient
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
had had x0 in place of his or her treatment
indicator. Often x0 = ½ will be sensible, but
one can sometimes argue for other values,
such as the mean of x (that is, the treated
fraction).
The process is similar for the adjusted
changes:
• Fit the regression model y1 – y0 = β0 + β1x
+ β2y0 + e
• Compute the fitted values of change
• Compute the regression residuals
• Subtract β2y0 from each fitted value, and
then add β2y0
• Add the residuals to the values just computed. These are the adjusted changes.
If the baseline values were centered, then
their mean y0 will be zero. However, one can
choose some other value for this constant
(such as the median, for example).
These two procedures will give baseline
data adjusted for treatment, as if everyone had
treatment value x0, and changes adjusted for
baseline, as if everyone had baseline value y0
(or whatever baseline constant was chosen).
Thus, for the adjusted data, baseline will have
the same mean in the two treatment groups,
and change will correspond to the effects
obtained from the conditional change model.
Adjusted endstudy values are computed by
adding adjusted changes to adjusted baselines,
and are adjusted both for baseline treatment
group imbalance and the consequences of this
imbalance on change.
It must be emphasized that the adjusted
data are not to be used for statistical inference.
Their only purpose is to make it possible to
show tables of summary statistics or graphics, with the above effects adjusted for. The
reason is that in general, adjusted data have
less variability than the original data (this is
an inevitable consequence of removing variability due to the adjustment variable), and
so effect estimates based on adjusted data
will be artificially precise. It may be worth
mentioning that the conditional change analysis easily lends itself to adjustment for other
variables that might be thought to influence
the outcome. Gender, age, and comorbidities
are logical contenders. Data can be adjusted
for these as well. The only part that becomes
more complex is that the fourth step (as given
earlier) must be done for each adjustment
variable. One must then be careful to report
the constant value substituted for each variable, to avoid misinterpretation of the adjusted
tables or graphics.
83
EDITORIAL
Dealing With Change: Using the Conditional Change Model for Clinical Research
Table 4. Differences between Conditional Change model and t-test
t-Test
Conditional Change model
Primary reasons:
1. Less artifact of regression to the mean
2. Lessen baseline differences of two groups
3. Lower SDE (more precise)
Cautions:
1. Artifact of regression to the mean
2. Subject to baseline differences between two groups
3. Higher SDE
1. Baseline outliers producing bias
2. Assumes single regression line for both groups (should be
investigated)
3. Dangerous to use mid-study value as baseline for late change
1. Baseline outliers producing variability
2. Assumes no regression line in either group
3. Same issue
SDE = standard deviation of the estimate.
parable between the groups, and for an understandable
reason. The second (midstudy  endstudy) analysis will
thus try to remove real effects, some of which are just
regression to the mean (the high values in the treated
group tending to drop) and could actually result in the
treatment appearing to do worse in this second analysis,
even though continued treatment is continuing to benefit
the patients. The conclusion is that for the analysis of
change, one should do the baseline  midstudy and
baseline  endstudy analyses, because the conditional
change approach is equally valid in these cases and
questionable in the midstudy  endstudy analysis.
Conclusion
There is an ethical principle in biostatistics, which says
that the most powerful appropriate analysis should be used
in evaluating the results of biomedical studies. This emerges
not just from general scientific principles but also out of
respect for the human participants who allowed themselves
to be used in a medical experiment. For a rather long time
now, this ethical principle has not been followed as well
as one would like, in studies where the issue is to compare
mean changes between two treatment groups, one of the
most common of all clinical trial designs.
The benefits of the conditional change approach were
clearly put forward by Plewis more than twenty years
ago. The failure to heed Plewis’s advice may stem from
the virtual absence of supportive articles, even in the
statistics literature. Indeed, an otherwise excellent statistical article2 on the topic made misstatements about the
conditional change model that were rectified two years
later, but only in a letter to the editor.3 It is understandable that a vacuum in the literature would open the way
to statistics textbooks’ continuing to promote a weak
analysis. The purpose of this article has been to try to
change the situation. v
Disclosure Statement
The author(s) have no conflicts of interest to disclose.
Acknowledgment
Katharine O’Moore-Klopf, ELS, of KOK Edit provided editorial
assistance.
References
1.Plewis I. Analysing change: measurement and explanation
using longitudinal data. Chichester, UK: John Wiley & Sons;
1985.
2.Frison L, Pocock SJ. Repeated measures in clinical trials:
analysis using mean summary statistics and its implications
for designs. Stat Med 1992 Sep 30;11(13):1685–704.
3.Senn S. Repeated measures in clinical trials: analysis using
mean summary statistics and its implications for design. Stat
Med 1994 Jan 30;13(2):197–8.
A Peculiar and Perpetual Error
It is the peculiar and perpetual error of the human understanding to be more moved and
excited by affirmatives than by negatives, whereas it ought duly and regularly to be impartial;
nay, in establishing any true axiom, the negative instance is the most powerful.
— Aphorisms, Sir Francis Bacon, 1561-1626, English philosopher, statesman, scientist, lawyer, jurist, and author
84
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Editorial
The Merging of the Work of Two Pioneers: Dr Weed & Dr Berwick
Attaining Comprehensive Health Care
Improvement is Imperative
Lee Jacobs, MD
How about sitting with Lawrence
Weed, MD, and Donald Berwick,
MD, in the same week? Granted my
time with Dr Weed was one-on-one
for three hours in his living room in
Vermont and my time “with” Dr Berwick was as part of an audience of
6000 attendees at his National Forum
on Quality Improvement in Heatlh
Care in Nashville, TN (December,
2008). I felt privileged to listen to the
journeys of these two men who have
had such a dramatic effect on how
medicine is practiced today.
Dr Weed and Dr Berwick have
much in common. Both have a
passion for and a vision of how
to improve health care. Both have
played major roles in improving
health care over the past few decades. Both are pioneers and as
such have for years endured the
criticism of their skeptics and the
accolades of their followers. Both
are leaders of significant movements that have and will continue
to affect health care in the US and
around the world. Both provide real
solutions to waste in health care.
And, most importantly, both want to
increase the likelihood of a positive
outcome for each individual patient
encountering the health care system
while at the same time lessening the
chances of being harmed.
During my time with these two
physicians, I heard both describe
with similar language the state of
disrepair of our present health care
system; however, I found neither
was pessimistic about the future. I
was struck by the can-do attitude
voiced by both—the problem is
huge but there is a solution and
they optimistically believe it can
be attained.
In leaving their mark on how
health care is practiced, however,
these two physicians have taken
two very distinct paths on their
journey.
Lawrence Weed, MD
Dr Weed is an innovator in health
information management and is
best known as the champion for the
problem-oriented medical record.
Dr Weed described for me how his
journey started, when, after years
as a disciplined researcher, he was
asked to lead rounds on a medical
ward. [Full interview in the Summer,
2009 issue.] He was astonished that
the residents and students were
functioning in a most unscientific
manner making decisions on the
basis of fragments of information
from patients each of whom had
a complex array of problems. To
arrive at a diagnosis, the physicians put this sparse information
through a diagnostic filter that was
totally dependent on their recall of
possibly related facts. It was from
such encounters that Dr Weed saw
the need to link the medical record
with the care of the patient and so
in the late 1950s he developed the
problem-oriented record now used
worldwide.
Subsequently, Dr Weed saw the
need for computer assistance to
support a more systematic collection of patient data so physicians
could be certain they had all the
pertinent historical facts. I recall
as a medical student in the early
1970s at the University of Vermont
seeing patients inputting their own
history on computer systems developed by Dr Weed—years ahead of
any consideration of an automated
medical record.
However, the pioneering work of
Dr Weed did not end there. He saw
the need for major changes in how
medicine is practiced even beyond
the medical record. Over the past 30
years he has eloquently challenged
how medicine is taught (“Students
are recruited and advanced on how
well they memorize and regurgitate”
[Lawrence Weed, MD, personal
communication, 2008]a); how practitioners are licensed and very
importantly, how physicians make
decisions based on recall (“The unaided human mind is not a reliable
Lee Jacobs, MD, residing in Atlanta, GA, is the Associate Editor-in-Chief
of The Permanente Journal. E-mail: [email protected].
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
85
EDITORIAL
Attaining Comprehensive Health Care Improvement is Imperative
instrument for processing of information in the solution of patients’
problems.” [Lawrence Weed, MD,
personal communication, 2008]a).
The recognition of the fact that
the mind is not capable of managing complex data consistently is
not unique to Dr Weed. A recent
Harvard Business Review article
discussed just this in an analysis of
flawed decisions executives made
on the basis of two characteristics
of “brain hard wiring” —relying on
“pattern recognition” and “emotional tagging.”1
To address this need,
Dr Weed has led a team
It will take a
in developing “knowl“Weedian”
edge couplers,” comrevolution of
puterized tools to assist
practitioner
decision making that link
training and
patient history and finddecision making
ings to the complexities
PLUS dramatic
of possible diagnostic
“Berkwickian”
and management posrefinement of the
sibilities. “These powercare processes for
ful tools embedded in a
every patient to
well-defined system of
receive state-ofcare can lead to a better
the-art care.
science of medical practice.” [Lawrence Weed,
MD, personal communication,
2008].a Using computer tools such as
these enables practitioners to make
decisions on the basis of quality data
input rather than on recall.
In summary, Dr Weed is leading
a movement that addresses how
practitioners process and apply
information thereby challenging
how medical students are taught,
how practitioners are licensed and
how they make decisions.
Donald M Berwick, MD
Dr Berwick is the President, CEO,
and visionary leader of the Institute
for Healthcare Improvement (IHI)–
a quality improvement movement
that has had a significant impact
86
on care systems in the US and
throughout the world. The recent
2008 IHI meeting in Nashville, TN
was a celebration of the 20 years
of the National Forum gatherings
of “health care leaders and learners
who are passionate about improving care,”2 growing from a small
room of participants in 1989 to 6000
at this year’s meeting. IHI’s 2009
Progress Report summarizes well
the overall impact of this quality
improvement movement:
“We have traveled far since
the day, 20 years ago, when
287 people gathered for what
was to become IHI’s first annual National Forum on Quality
Improvement in Health Care.
Those groundbreakers could
not have imagined where the
path they charted would lead,
nor how many health professionals and quality leaders
would join them on the journey.
But now, with the benefit of
20/20 hindsight, we can see
how much has changed. Theirs
were among the first steps on a
journey that would change the
face of health care quality and
improve the lives of hundreds
of thousands of patients and
providers. What started as a
fringe philosophy for a few has
now moved to the mainstream.
Quality is on health care’s center
stage at last.”3
In Nashville, Dr Berwick stated
that he believes there are about 100
core work-flow processes that cover
95% of all patient care. The goal of
IHI’s quality improvement movement has been to instill health care
leaders with an awareness of the
need to understand the processes
involved in patient care and then
to improve each process by applying quality improvement principles
and tools.
In Summary, Dr Berwick is leading a movement that addresses the
broken work-flow processes in
health care systems to improve the
care to the patient.
Imperative: Merge
These Two Movements!
Yes, these two movements are
going the same direction—both
with the goal of improving the care
each patient receives. Although the
swathes that they are cutting are
broad, they are two very distinct
paths. I do not believe that significant transformation in the health
care system will be realized unless
and until health care professionals intentionally incorporate both
improvement approaches in their
quality improvement change map.
Specifically, dramatic quality improvement will only result if:
1.The culture of medical education
is changed to diminish the role
of memorization and increase
the understanding and use of
information technology
2.All practitioners have access to
these tools to assist in the diagnosis and the management of
patients
3.The care flow processes of health
care are well understood and
improved.
Although these two pioneers
are cutting separate paths on their
journeys, it is my opinion that in the
future their paths must intersect if,
in fact, they are to comprehensively
change the health care system. It
will take a “Weedian” revolution of
practitioner training and decision
making PLUS dramatic “Berkwickian” refinement of the care processes for every patient to receive
state-of-the-art care.
Even if the multitude of careflow processes were improved by
the approach that Dr Berwick and
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
EDITORIAL
Attaining Comprehensive Health Care Improvement is Imperative
his followers advocate, true improvement in health care will not
be realized if the initial input (practitioner decision making) into these
processes is flawed. For example, if
new operating room guidelines that
are proven to lessen preventable injury and death are implemented but
the patient didn’t need the surgery
in the first place, it would be difficult to say from a patient-centered
viewpoint that we have achieved
quality improvement.
Conversely, if medical education
and practitioner decision making
was overhauled to integrate an entirely new approach as advocated
by Dr Weed, but the patient then
enters into a flawed care process,
then again—the vision of improved
health care will not be attained.
Closing
References
After sitting in the living room
of one pioneer, and then the same
week sitting among thousands
listening to another pioneer, it was
clear to me that both movements
must be successful if in fact significant health care improvement is to
be attained. When considering the
movements of these two amazing
men, it is not a question of which
one—we need both!
In future articles, we will highlight
some of the work presented at the
2008 IHI meeting in Nashville as well
as articles from frontline physicians
using Dr Weed’s approach to decision making. We want to hear from
you. Let the dialogue begin! v
1. Campbell A, Whitehead J, Finkelstein
a
S. Why good leaders make bad decisions. Harvard Business Review 2009
Feb.
2. Brochure. Institute for Healthcare Improvement: National Forum
on Quality Improvement in Heatlh
Care, Nashville, TN (December 8-11,
2008). p i.
3.20/20 Vision: 2009 Progress Report
[monograph on the Internet]. Cambridge (MA): Institute for Healthcare
Improvement; 2009 [cited 2009 Apr
6]. Available from: www.ihi.org/NR/
rdonlyres/A8C4BFED-0204-4327B03E-13C5798F737B/0/2009IHIProgr
essReport.pdf.
Interview with Lawrence Weed, MD,
Underhill, VT. December 4, 2008.
Achievements Never Imagined
Radical Change
Significant performance improvement
will only be accomplished by tracking
dramatic, system-level changes.
The courageous among us will get
there first, achieving performance
levels never imagined by previous
generations.
The time has come to abandon the
wrong premises and inadequate tools
that underlie the current systems of
medical education and care. If we are
willing to adopt radical change, we
may find that productivity can improve
by an order of magnitude.
— 2004 Progress Report, Donald M Berwick, MD,
MPP, b 1947, President and CEO Institute for Healthcare Improvement
— Lawrence L Weed, MD, President and
Founder of PKC Foundation,
developer of Problem-Knowledge Couplers
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
87
Narrative medicine
A Fatal Form of Contentment
Catherine Hickie, MBBS
The medical humanities can be relevant to clinical
practice in unexpected ways. While researching an essay on mass tourism in Victorian England, I read about
the Grand Tour of Europe, a travel experience for the
select few, mostly upper class young men who travelled
from England officially to complete their education with
exposure to the great cultural experiences of Europe,
but unofficially to let loose away from home. I identified
with those young men and their freedom away from
scrutiny. Studying medical humanities was supposed to
broaden a narrow scientific education and reinvigorate
my work as a psychiatrist but it was tempting to take
courses as far removed from medicine as possible.
The history of travel seemed remote from 21st-century
medicine but as a virtual tourist to the study of history,
I found some surprising links.
In 19th century England with the Industrial Revolution and the subsequent rise of the middle class, travel
opened up. People flooded to Italy, France, Switzerland,
and further afield to Egypt and other exotic destinations.
In contrast to the Grand Tour, where ample money and
time allowed a young man to spend months in Florence
or Venice, many of the Victorian middle-class travellers
were on brief vacations from work. They came to Europe on package tours that had been organized for them
and travelled in groups along a beaten tourist track.
There were criticisms of these new tourists who flooded
the art galleries of Italy and trekked the mountains of
Switzerland clutching newly printed guidebooks. One
name was singled out for praise and blame in regard
to mass travel, Thomas Cook.
Thomas Cook­—Mass Travel
On the Internet there are thousands of references to
Mr Cook and his tours, but one stands out because of
its medical linkage: an obituary in The Lancet, published in July 1892.1 Every issue of The Lancet from
1823 till the present day is now available online.2 The
early issues are fascinating with their mix of London
medical politics and medical progress. But why would
a man who pioneered mass travel be eulogized in a
prominent medical journal? The obituary of Thomas
Cook reads, in part: “The death of Mr Thomas Cook of
Leicester, … the originator of excursions by land and
sea over the world, calls for a word of deep respect
and regret. We sometimes complain of the restlessness of the age and its locomotive tendencies. …
His [Thomas Cook’s] is the credit of having reduced
the evils and the discomfort of travel and of having
enormously contributed to the width of men’s ideas
of the world and of their fellow creatures.”1
Thomas Cook came from a working class background.
His father died before he was ten and he was apprenticed
to a gardener and later to a wood turner, both men were
alcoholics. Mr Cook became a committed member of
the temperance movement. He was a Baptist minister
and preached against alcohol. A medical journal might
eulogize a man who had crusaded against the harms of
alcohol, but there is no mention of this in The Lancet
obituary. Cook is remembered as “the originator of excursions by land and sea over the world ….”1
The first excursion Cook organized was to a
temperance rally in 1841. He made a deal with the
railway company for cheap tickets; he had meals
provided and a pamphlet printed. Five hundred and
seventy temperance campaigners travelled by train
to a rally eleven miles away.3 He organized a similar event the next year and the year after that. The
railways made it possible for large groups to travel
but Mr Cook saw the greater potential. In 1845, he
took a group from Leicester to Liverpool and made
a small profit. The next year he took a group from
Leicester for a tour around Scotland. Within ten years
he was arranging trips to France, Switzerland, and
further afield.3 What is the connection between The
Lancet (and the Victorian medical fraternity) and the
rise of mass travel?
Thomas Wakely—The Lancet
The Lancet is one of the world’s most respected scientific medical journals. The founder and first editor,
Thomas Wakely, was a London-based physician with
Catherine Hickie, MBBS, is a Psychiatrist and Director of Clinical Training at Bloomfield Hospital in
Orange, New South Wales, and a Conjoint Senior Lecturer in the School of Psychiatry at The University
of New South Wales, Sydney, Australia. E-mail: [email protected].
88
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Narrative medicine
A Fatal Form of Contentment
a political axe to grind. He believed medicine was
held at the throat by the Royal Colleges, dominated by
privilege and nepotism and lacking in standards. When
Dr Wakely founded The Lancet in 1823, he used the
journal to attack the medical leadership—particularly
the College of Surgeons—and to agitate for reform.4
He wanted a voice for ordinary practitioners within the
medical profession. He also wanted medical information to be in plain language so that anyone could keep
up with changes in medical knowledge. In the preface
of the first edition he set out the target audience for
the journal: London specialists, country practitioners
colonial practitioners and “every individual in these
realms.”5 To make The Lancet as accessible as possible,
Dr Wakely determined that his journal would not use
the “semibarbarous phraseology of the schools … [but]
we will adopt … plain English diction.”5
I see parallels between Mr Cook’s opening up
of travel and Dr Wakely’s dissemination of medical
knowledge. Whatever their personal agendas both men
were pioneers in loosening the upper-class grip on
learning and education: Mr Cook saw a way to make
travel accessible to large numbers and was vocal in
defending against elitist attitudes that “places of rare
interest should be excluded from the gaze of common
people.”3 The Lancet made medical science more accessible but Dr Wakely also used the journal to air his
strong political views.6 He argued against the status
and power of the London Corporations who charged
licensing fees of the small practitioners for the benefit
of their own cliques.4
The Evils of Travel
One sentence in the obituary holds a clue to the link
between Mr Cook and the medical fraternity: “His is the
credit of having reduced the evils and the discomfort
of travel.”1 The word “evils” is striking. Although The
Lancet evolved as a scientific medical journal, science
cannot be separated from the prevailing experiences,
fears, and beliefs of its practitioners. Train travel was
new in the 18th century; there were concerns about
safety. Early trains had frequent accidents and poor
suspension. With the introduction of signals and improvements in vehicle technology accidents became
progressively less frequent. But it was not just the accidents that were a focus of concern. Comforts were
minimal in the third class carriages where people sat
on wooden benches, initially in carriages that had no
roofs. Physicians were concerned about the effects of
this rough travel especially for vulnerable people who
were already sick or weak.
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
In 1861, The Lancet commissioned its own inquiry
into train travel, “Editors note: Influence of Railway Travelling upon Public Health.”7 Submissions were sought
from “interested parties” from individual specialists,
often London based, reporting on observations they had
made of their patients. In general, they reflected concerns about the body as a fragile machine: the motion of
the train being seen as a source of harm. For example,
on February 15th 1862, a London obstetrician wrote: “I
would wish to draw attention to one very important
point … the danger of excessive railway travelling to
newly married women,”8 attributing miscarriages to the
new habit of train travel. And further, “But I should
expect, from the impressionable state
of the nervous system in women, that
He wanted a
whatever is found to affect this system
voice for ordinary
in man, will do so to a higher degree
practitioners
[in women] ….”8 And this submission
within the medical
from a surgeon, Samuel Solly, MD: “I
profession. He also
was visited by a patient, aged 62, who
wanted medical
had been suffering from congestion of
information to be
the brain, which had been completely
in plain language
relieved by medicine and 24 leeches
so that anyone
to the temples …. He told me he had
could keep up with
felt perfectly well … until he travelled
changes in medical
up this morning by rail. … a brain
knowledge.
disturbed by congestion is injuriously
9
affected by motion on the rail.”
Not all the observations concerned injuries, some
wrote of protective factors: “… the stout, easy-going,
lethargic traveller, I notice, bears continuous locomotion
far better than the spare, nervous, irritable man.”10 This
author postulated a connection between temperament
and vulnerability to the effects of physical motion.
Many of the submissions viewed the motion of the
train, the shaking and the vibrations, as a source of
harm. And some parts of the body, such as the uterus
and the brain, were seen as more sensitive than others.
Pregnant women and sick people were thought to be
at greatest risk. Submissions made to The Lancet can
be read as an attempt to make sense of these anxieties.
What beliefs and anxieties cloud our current scientific
vision? One example from my own clinical practice
seems relevant.
A Train Ride
During the last four years I have worked in the psychiatric service of a rural district hospital in a town on
the main railway line between Sydney and Melbourne.
More than once a man has alighted from the train
(or been put off because of odd behaviour), found
89
Narrative medicine
the police station or the hospital Emergency Department and announced that he has a mental illness and
wishes to be admitted to the psychiatry unit. He gives
a sketchy account of recent travels, he has just come
from the outback or the coast where he has been for
several months. If pressed he will give a slim account
of a long psychotic history with bursts of treatment
and long gaps with no medical care. He has been in
other country psychiatric units. He may name a friend
or a family member, but probably not. The impression
is of persistent psychotic symptoms and a desire to
keep moving.
I recall one of these men in particular—he had
many years of psychotic symptoms and had been in
the ward for a week or more when he slipped out the
door of the hospital, got himself to the railway station
and rode the train to Sydney. At the Sydney terminus,
he approached a station guard, announced that he
was a “mental patient” and asked to be taken to the
hospital. When the overstretched inner-city Emergency
Department discovered he had a hospital bed waiting
for him in the country, transport was
quickly arranged. The round trip was
An editorial in
complete within 12 hours and the
The Lancet, in
man was very pleased with his day.
a report on an
When I asked him why he had gone
inquiry into
to all that trouble to end up where he
vagrancy,
started he said he just wanted to ride
called this
the train.
“a fatal
Patients who prefer to be itinerform of
ant present a problem to physicians.
contentment.”
When we treat patients who have
chronic conditions we emphasize the
benefits of wholistic care. For patients with enduring
mental illness we want to do more than prescribe medications; we aim for improvements in social function and
work, establishing accommodation and building social
networks. We can’t do our best work when people are
itinerant. Concerns about illness and itinerants have a
long history: a particular concern at the turn of the 20th
century was the rapid spread of infectious diseases.
Unemployed people could travel widely on foot and
by catching free rides on the trains; it was feared that
these people spread diseases like smallpox; concerns
were also for a perceived moral problem: enjoying the
pleasure of travel without having earned it through
work. The Lancet ran a number of articles on vagrancy
at the beginning of the 20th century. There was particular interest in those who chose to move freely
from town to town and refused to engage in the work
schemes that were established. The Lancet was critical
90
A Fatal Form of Contentment
of the charitable organizations that made this not only
possible “but pleasant and attractive. They enabled the
idle to live either by mendicancy or by crime or by both
without any need to work and the example of men and
women leading indolent, self-indulgent lives without
responsibility or restraint is a constant temptation to
others to adopt the same course.”11 An editorial in The
Lancet, in a report on an inquiry into vagrancy, called
this “a fatal form of contentment.”12
I wonder if contentment is the motivation to leave
town soon after hospital discharge, opting to ride the
train rather than to accept accommodation and community treatment. Or is it to be in control, coming for
treatment, then slipping away. Do the trains symbolize
freedom? Adventure? Or is it something about the movement of the train itself? Were the Victorians right about
the rocking and the vibrations but wrong in their conclusions? Could it be soothing or even therapeutic?
Or perhaps it is the anonymity of the train, where a
traveller can be in company without pressure to communicate. Where a person who lives with schizophrenia
can step out of the persona of patient and become a
traveller like everybody else. Trains can offer a social
mixing that is both exciting and threatening.
In the 21st century, we have our own new technology
that takes us on anonymous rides, mixes up the social
order, and challenges the establishment. The Internet
has come with anxieties and fears just as the trains did
a century and a half ago. We are all familiar with the
concerns: the speed at which a child can be on a pornography site; the anonymous chat rooms as a place of
social intercourse; ciber bullying and stalking. And, like
The Lancet of the 19th century, the Internet presents
an information revolution for health. Knowledge is no
longer the exclusive domain of the expert, up-to-theminute medical facts can be found on the Internet in
plain language for all to read. Any amateur can set up
a Web site. In some ways we are back in the unregulated age, where quacks are flourishing. This makes us
nervous. We warn of the dangers of unregulated Web
sites, false information, and global cons. The Internet
is changing our relationships as health professionals.
We may have a looser hold on knowledge but there are
benefits. There are good Web sites hosted by reliable
providers; and Web-based therapies may offer some
solutions to unmet needs in mental health care.13
In the university library, a virtual tourist to the study
of history, I wondered if our hopes for new technology
were so different from the hopes of the Victorians.
Perhaps The Lancet eulogized Thomas Cook for the
same reason that people set aside their fears and
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
Narrative medicine
A Fatal Form of Contentment
embraced the train, the opening up of possibilities
(risks and all) to people who were previously shut out.
This, after all, was one of The Lancet’s original aims.
As our anxieties subside we are embracing information technology to improve health care as well as for
pleasure and private exploration. An essay on mass
travel in the 19th century proved far from irrelevant
to a 21st century psychiatrist. v
Disclosure Statement
The author(s) have no conflicts of interest to disclose.
Acknowledgment
My thanks to Megan Hickie for her thoughtful reading and
comments on an early draft of this paper.
References
1. Obtituary. Death of Mr Thomas Cook. Lancet 1892 Jul
23;140(3595):215.
2. Hutchinson M. How The Lancet made medical history
[monograph on the Internet]. London: BBC News. 2003
Oct 6 [cited 2009 Mar 7]. Available from: http://news.bbc.
co.uk/2/hi/health/3168608.stm.
3. Feifer M. Tourism in history. Briarcliff Manor (NY): Stein and
Day; 1986.
4. Peterson MJ. The medical profession in mid-Victorian London. Berkeley: University of California Press; 1978.
5. Wakely T. Preface. Lancet 1823 Oct 5;1(1):2.
6. Loudon J, Loudon I. Medicine, politics and the medical
periodical 1800-50. In: Bynum WF, Lock S, Porter R (editors).
Medical journals and medical knowledge. New York: Routledge; 1992. p 49-69.
7.Editors note. The influence of railway travel on public
health. Lancet 1861 Dec 14;1998:584.
8. Ellis R. Letter. The influence of railway travelling on public
health: The effects of railway travelling upon uterine disease. Lancet 1862 Feb 15;79(2007):184.
9. Solly S. Letter. The influence of railway travelling on public
health: congestion of the brain resulting from railway travelling. Lancet 1862 Feb 15;79(2007):184.
10. Acton W. Letter. The influence of railway travelling on
public health: personal experiences of an habitual traveller.
Lancet 1862 Feb 22;79(2008):210-1.
11. Small pox and vagrancy. Lancet 1904 Apr
30;163(4209):1215-6.
12.Editorial. The report on vagrancy. Lancet 1906 Mar
24;167(4308):841-3.
13.Titov N, Andrews G, Schwencke G, Drobny J, Einstein D.
Shyness 1: distance treatment of social phobia over the
Internet. Aust N Z J Psychiatry 2008 Jul;42(7):585-94.
An Intellectual Challenge
The history of medicine can teach students about the structure of
medical discovery and how it [affects] the way we think and the way
we behave. It explores the fundamental values underlying medical
practice and how they evolved. It examines both the experience of being
a physician and a patient and brings understanding to the dimensions
of suffering and healing. Finally, the history of medicine offers an
intellectual challenge for the student.
— Norman Gevitz, PhD, medical historian
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
91
Book review
La Clinica: A Doctor’s Journey Across Borders
by David P Sklar
Book review by Sara Nelson, MD, and Howard King, MD, MPH, FAAP
Albuquerque (NM):
University of New Mexico
Press, 2008
ISBN-10: 0826345247
ISBN-13: 978-0826345240
Hardbound: 234 pages
$26.95
The older a physician becomes, especially these
days, the harder it is to find time to read a good book.
If we are lucky, we find a Moby Dick with good plot,
development of character, and implications for our life
goals. Such a book is La Clinica: A Doctor’s Journey
Across Borders, an autobiographical work by David P
Sklar, MD, Associate Dean of Graduate Medical Education at the University of New Mexico (UNM) School of
Medicine in Albuquerque, NM.
Like many physicians, Dr Sklar chose medicine as a
career because he wanted to help people. His initiation
into medicine began six months prior to starting medical school. He had volunteered at La Clinica, a small,
free clinic in a Mexican village where, interestingly,
the patients’ needs had multiplied with modernization. The book juxtaposes Dr Sklar’s time at the clinic
in Mexico with his life, 24 years later, as Chairman of
the Emergency Medicine Department at UNM Health
Sciences Center. Implicitly, it questions how we train
physicians.
Physicians recognize that becoming a medical doctor is a long and demanding journey and entails many
sacrifices. Initially, the practice of medicine deprives
us of sleep and much of our youth, but most of us are
eager and proud to give these up in exchange for the
knowledge and opportunity that we anticipate will become more meaningful over time. But many of us will
discover that this medical education exacts a significant
cost upon our lives.
For many of us, irretrievable moments with spouses,
children, and friends increasingly slip out of our hands.
Others may give up on their idealism and turn to cynicism. And for some, the sacrifices are too great; they
turn to the material wealth and power that being a
physician can bring. Some make it through the journey
unscathed, but we haven’t met many.
Unlike many physicians who train and practice in the
US, Dr Sklar wasn’t seduced by the money and power
that being a physician can bring. He did what many
physicians only hope to do—he created a community
of caring where people helped and taught one another
at an academic medical center in the US. However, like
many physicians, Dr Sklar paid a steep price. The personal costs were significant, and included his decision
when he suspected that his idolized mentor might be
sexually abusing an adolescent child. Another occurred
when his spouse contemplated divorce in response
to the loneliness she experienced from his excessive
dedication to his work.
Physicians begin their medical careers learning to
elicit a description of symptoms from patients, learning to think in terms of differential diagnoses, and
developing the skill of prescribing medications. But
how do they learn to take care of their patients or, for
that matter, even of themselves?
In comparison to medical school, Dr Sklar describes
his volunteer stint in Mexico as the place where he
actually discovered how to be a physician. La Clinica
suggests that the traditional medical knowledge for
which one sacrifices so much may often be lacking
in certain insights and experiences. Like Dr Sklar and
many others, I (SN) became a physician to help people.
But, in many ways, my years of training in medical
school and residency did not prepare me to take care
of the true needs of my patients.
Most of my patients present with simple medical
problems but complex social issues. The medical problems are easy to fix and don’t require years of training
to memorize their solutions. It is the social issues that
motivate most of my patients to keep coming back to
my clinic. My colleagues and I sometimes feel that we
are just treading water to stay afloat. We seem to make
little progress on our patients’ biggest health issues—
obesity, teen pregnancy, and asthma to name a few.
Sara M Nelson, MD, is a Clinical Instructor in Pediatrics at the Harvard Medical School in Boston, MA, an Assistant in
Pediatrics at Massachusetts General Hospital, and a Pediatrician at the Massachusetts General Hospital-Chelsea HealthCare Center, Adolescent and Pediatric Unit in Chelsea, MA. E-mail: [email protected].
Howard King, MD, MPH, FAAP, is a Clinical Instructor in Pediatrics at Harvard Medical School, in Boston, MA; Founder of Children’s Emotional Healthlink (CEHL), Co-leader of Pediatrician-Parent Communication Training Program, and
the Continuing Education Committee, Harvard School of Public Health in Boston, MA. E-mail: [email protected].
92
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
La Clinica: A Doctor’s Journey Across Borders
Book Review
These are medical issues that are difficult to fix without Medicine is mystical to the uneducated and a powerful
identifying and improving the underlying issues; skills tool for those schooled in its ways, but human relationthat I was not taught in medical school.
ships are equally complex and influential.
For instance, a major study out of Kaiser PermaPerhaps as physicians we need to revisit the boundarnente (KP)1 discovered that 22% of KP patients have ies that we have collectively agreed to as a profession. been sexually abused as children. How does that Are we too focused on maintaining our distance from
affect such a person later in life? How does it show patients instead of finding ways to ask them difficult
up in the physician’s office? What does it mean that questions? Do our rules prevent us from finding the
such sexual abuse is usually never recognized or ac- time to genuinely care for our patients? If we modiknowledged? Have physicians limited themselves to fied the boundaries with our patients, would we more
the smallest part of the problem, that part where we likely be able to unearth the true illnesses that plague
are comfortable merely prescribing medication and our patients?
making diagnostic decisions?
We may need to approach our patients differently in
In medical training, we are taught specific rules that order to help them improve their lives and find ways
guide our interactions with patients. We are advised to to interrupt those cycles, which often lead to chronic
wear certain clothes. We learn to think in paternalistic poor health. Can we find another medical model, which
ways about our patients. These actions set us apart from might demand fewer personal sacrifices of a physician
our patients and serve to protect us from
but might also provide more appropritheir pain so we can seem to maintain
ate care for our patients?
Perhaps as
our objectivity when determining their
Reading Dr Sklar’s book forced me
physicians we
treatment. They also set us above our
(SN) to reconsider the experiences
need to revisit
patients and allow us the authority to
that had drawn me into medicine and
the boundaries
advise them how they should proceed
to reassess my own idealistic goals in
that we have
becoming a physician. I found myself
with their lives. collectively
compelled to evaluate the distance I
But setting these boundaries may
agreed to as a
had traveled in my career and where
have detrimental effects as well. The
profession. Are
I now find myself, twelve years later.
gap may become too wide between
we too focused
Reading La Clinica I was obliged to ask
us and our patients with the result
on maintaining
myself, “Where do I want to go now
that we may not ask uncomfortable
our distance from
and which path should I travel to get
questions. As a result, we may fail
patients instead
there?” Other physicians may find this
to acquire the necessary information
of finding ways to
question familiar.
to help them gain mastery over their
ask them difficult
Finally, the book left one of us (HK)
lives. These rules may also end up
questions?
pondering, how can my fellow educadistancing us emotionally from our
tors and I teach young physicians and
family and friends. One conclusion we might derive from La Clinica nurse practitioners to improve their ability to assess
is that we need to alter these boundaries by placing the emotional health of families without encouraging
physicians closer to their patients. In the course of them to consider their own personal and professional
describing the many relationships in his book, Dr Sklar history? Can we be successful only by teaching the use
challenges us to reconsider the traditional physician/ of psychotropic medications?
Isn’t it equally important to be willing to trust trainpatient boundaries and the usual ideas of what it means
to be a physician. He presents several typically taboo ees and ourselves to reflect upon the impact of our
relationships in such a way that one has to reconsider own historical and family experiences? As was asked
centuries ago, “If not now, when?” v
whether they are truly unacceptable.
These relationships remind us that no matter how
evidence-based the medical profession wishes to be, Reference
1.Felitti VJ. [The relationship of adverse childhood experiences
the practice of medicine is only as pure as the humanity
to adult health: Turning lead gold into lead.] [Article in Gerthat drives the mission. Even the free clinic in Mexico
man.] Z Psychosom Med Psychother 2002;48(4):359-69.
that Dr Sklar measures his life work against has a dark
dimension that runs counter to conventional altruism.
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
93
Book review
Medical Readers’ Theater: A Guide and Scripts
Todd L Savitt, Editor
Review by Vincent J Felitti, MD, FACP
The Permanente Journal is dedicated both to biomedicine and to humanism in medicine. Thus, Medical
Readers’ Theater is a singularly appropriate book to
review in these pages. Of the medical books that are
truly helpful, most have their value in their content;
Iowa City (IA): University
rarely does a book come along where equal value lies
of Iowa Press, 2002
in the concept. This is such a book.
ISBN 0-87745-798-0
This book consists of 14 medically oriented stories,
Paperback: 212 pages
many written by physicians with recognized literary
skills: William Carlos Williams, MD; Richard Selzer, MD;
$22.95
and Sir Arthur Conan Doyle, MD. The short stories are
divided into three categories: Physicians and Patients,
Being a Physician, and Ethical and Social Issues. An
imaginative faculty group at East Carolina University’s
School of Medicine adapted the stories into plays for
Vincent J Felitti, MD, FACP, informal enactment, the goal of which is to help the auis a retired Internist from the dience think and talk about those interpersonal aspects
Department of Preventive
of everyday medical practice that are critically important
Medicine at the Clairemont
to success, but sometimes carried out clumsily, thus
Mesa Medical Office in San
Diego, CA. He is a Clinical
not given consideration in our occasional analyses of
Professor of Medicine at the
why a case went well or poorly. A memorable story by
University of California, San
the surgeon Richard Selzer deals with the emotions of
Diego. E-mail: vjfmdsdca@
mac.com.
the widow of a man whose organs she agreed to have
transplanted into several other people. The stories are
adapted for a small cast, often with a narrator whose
role is somewhat like that of a Greek Chorus.
The stories by themselves are interesting to read.
Their adaptations for informal enactment by small
groups are imaginatively done. And the Questions for
Discussion at the end of each enactment are wonderfully probing, helpfully expanding our discussion and
our understanding of what is going on and why. Those
readers of this book who have seen any of the productions by Kaiser Permanente’s (KP’s) Educational Theater
Program will be struck by the recognition that theater
can have a major role in the education of physicians
as well as of Health Plan members, even children.
Advances often more readily occur at the interface of
different fields. This book, as well as an understanding
of the role of KP’s Educational Theater Program, will
provide meaningful benefit to those of us trying better
to understand the remarkably wide range of implications of our contacts with patients, and why sometimes
things go poorly when we did everything in a medically
appropriate manner. v
The Delivery Room
A library, to modify the famous metaphor of Socrates,
should be the delivery room for the birth of ideas
—a place where history comes to life.
— Norman Cousins, 1915-1990, political journalist, author, professor, and world peace advocate
94
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
This form is also available online: www.kp.org/permanentejournal
CME Evaluation Program
Physicians may earn up to 4 AMA PRA Category 1 creditsTM for reading and analyzing the four designated
articles. Other clinicians for whom CME is acceptable in meeting educational requirements may report up to
four hours of attendance.
You may earn CME credit for reading the four qualifying articles from this issue of The Permanente Journal
that are listed below and then taking the online quiz. To participate, go to www.kp.org/permanentejournal. Select the most appropriate answer to the questions and complete the online evaluation form. You must complete
all sections to receive credit.
Section A.
Article 1. (page 4)
Short- and Long-Term Antireflux and
Asthma Medication Use in Children After
Nissen Fundoplication
Article 2. (page 31)
An Exploratory Case Study: Effects of
a Physician Organizational Socialization
(Enculturation) Program
Regarding Pediatric Nissen fundoplication for GERD:
Which of the following is true?
a.neurologically healthy and impaired children
have similar outcomes
b.results in decreased use of asthma medications
c.results in decreased use of antireflux medications
d.is often performed for Barrett’s esophagus or
esophageal stricture
e.decreases hosptializations for pneumonia or
respiratory distress
Regarding an effective organizational socialization
(enculturation), which one of the following is
NOT true:
a.decreased salary requirements
b.increased job satisfaction
c.increased organizational commitment
d.decreased intention to leave
Which of the following is NOT true:
a.objective long-term data following Nissen
fundoplication in children are not available
b.Nissen fundoplication improves symptoms in
the majority of children
c.Nissen fundoplication may be safely performed
in infants weighing less than 3 kg
d.the complication rate following Nissen
fundoplication is similar in neurologically
impaired and healthy children
e.GERD and GERD-related complications may be
different based on age and associated neurologic
status
Regarding the Kaiser Permanente Orange County
enculturation program, which one is not true:
a.the participants improved communication skills
b.the participants’ intention to leave increased
c.the participants developed a sense of belonging
d.the participants learned skills to be more
effective at work and at home
Return
completed
form by
August 3, 2009
The Kaiser Permanente National Continuing Medical Education Program (KPNCMEP) is accredited by the Accreditation Council
for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The KPNCMEP designates this
educational activity for 4 AMA PRA Category 1 credits. Each physician should claim only those hours of credit that s/he actually spent
in the educational activity. All editors, reviewers, and authors have no conflicts of interest to disclose; where any possible conflict is
indicated, it has been reviewed and found not to have any impact on the article content.
The Permanente Journal has been reviewed and is acceptable for up to 8 Prescribed credits by the American Academy of
Family Physicians. AAFP accreditation begins 01/01/09. Term of approval is for one year from this date. This issue is approved for
2 Prescribed credits. Credit may be claimed for one year from the date of this issue.
The Permanente Journal/ Spring 2009/ Volume 13 No. 2
95
CME
CME Evaluation Program
Article 3. (page 50)
Incidental Gallstones
Article 4. (page 55)
An Unusual Presentation and Etiology of
Hypotension Seen in Nephrotic Syndrome
Which of the following differentiates
choledocholithiasis from cholecystitis?
a.biliary colic
b.laboratory abnormalities
c.a dilated common bile duct
d.the need for cholecystectomy
The most common type of amyloidosis is:
a.secondary amyloidosis (AA)
b.light chain amyloidosis (AA)
c.familial amyloidosis (AF)
d.heavy chain amyloidosis (AH)
Hypotension occurs in amyloidosis due
to all of the following etiologies EXCEPT:
a.anuric acute renal failure
b.vascular infiltration of amyloid
c.autonomic dysfunction
d.cardiomyopathy
Recent data has demonstrated that performing
concurrent cholecystectomy with which of
the following types of abdominal operations
has been shown to be safe:
a.colorectal
b.thoracic
c.vascular
d.all of the above
Objectives
1.to inculcate the use of evidence-based medicine as part of the science of medicine
2.to stress the art of medicine via enhanced patient-physician communication, improved care experience
for patients, and more satisfying caregiving experience for physicians and staff through better teamwork
3.to review appropriate updates on the diagnosis and treatment of clinical conditions
4.to describe infrastructure and systems improvements that lead to improvements in outcomes and patient care experiences
Section B. Referring to the CME articles and the stated objectives, please choose your level of agreement next to each
statement as appropriate.
Article 1Article 2Article 3Article 4
strongly
agree
The article covered the stated objectives.
I learned something new that was important.
I plan to use this information as appropriate.
I plan to seek more information on this topic.
I understood what the author was trying to say.
strongly
disagree
strongly
agree
strongly
disagree
strongly
agree
strongly
disagree
strongly
agree
strongly
disagree
96
Section C. What change(s) (if any) do you
plan to make in your practice as a result of
reading these articles?
Section D. (Please print)
____________________________________________
Title ___________________________________________
____________________________________________
NUID # ___________________________________________
____________________________________________
E-mail ___________________________________________
____________________________________________
Address ___________________________________________
____________________________________________
____________________________________________
Signature ___________________________________________
____________________________________________
Name ___________________________________________
___________________________________________
Date _________________________________________________
The Permanente Journal/ Spring 2009/ Volume 13 No. 2