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Science as a Profession, Art as
Individual Physicians
Horner Lecture
University of Tennessee
October 17, 2003
James L. Reinertsen, M.D.
www.reinertsengroup.com
“Every system is perfectly designed
to achieve the results it gets.”
Donald Berwick, M.D.
The American health care system is perfectly
designed to produce dazzling technologies,
large numbers of exceptionally well-trained
doctors, very high costs, serious safety risks,
underuse, overuse, and misuse of resources,
mind-boggling administrative waste, lack of
access for a significant number of Americans,
and distrust and dissatisfaction for virtually
everyone—including the key professionals
who are needed to deliver quality care.
Perhaps the most troublesome piece
of data from the past 3 years…
More than 40% of nurses surveyed
would not feel comfortable
having a family member or loved
one cared for in the facility
where they worked.
American Nurses Association, 2001
It’s not just the nurses:
Sources of MD unrest
• Hassles of daily practice
– Documentation
– Billing and coding
• Not enough time for each patient
– 28 minutes per office hour?
• Loss of autonomy
– Everyone, it seems, is looking over our shoulders
A glimpse of a solution
Jody the medical office assistant asks:
“Why can’t you guys do this the
same way?”
The IOM’s Questions
• Can you use all the science you
know?
• Can you think and act as a system?
• Could you center the design and
delivery of care on the patient?
Crossing the Quality Chasm
We aren’t using all the science we know
• Ten-year time lag between new
knowledge and widespread application
• Geographic variation: isn’t science
constant across geography?
• Creating versus applying clinical practice
guidelines
Barriers to using the science we know
• Professional culture
– High Science and Low Science
– Autonomy—individual and professional
• Daily workflow
– Time
– Hassles and barriers
• Business Case
– Can doctors do well by doing good?
Barriers to using the science we know
• Professional culture
– High Science and Low Science
– Autonomy—individual and professional
• Daily workflow
– Time
– Hassles and barriers
• Business Case
– Can doctors do well by doing good?
Professional culture
We were taught to revere pure
science and descriptive
statistical evidence, and to
disdain applied science and
operational (analytic)
statistics
Two types of statistics
• Descriptive:
– Key question: “Is population A different from population
B?” (comparison)
– Variables are controlled in order to focus on a single
variable of interest
– High science, RCTs, publications…
• Analytic
– Key question: “How will this process perform the next time
a patient experiences it?” (prediction)
– Complex variables are inherent in the system
– Low science, quality improvement “run charts,” ….
High Science and Low Science:
Two Pathways to Improved Care
Clinical Sciences
Better Results
Process Improvement
Basic Sciences
Change Leadership
Theory of systems
Theory of variation
Current Results
Theory of human psychology
Theory of knowledge
System Design
Tacrolimus: A “Low Science” Project
• Useful, dangerous transplant drug
• Therapeutic blood levels have a narrow window
• Typical process: each physician measures blood
level and uses individual “best judgment” to adjust
dosage
• Despite best efforts, renal toxicity is 30%
• A transplant physician asks: “Could we improve this
process?”
Tacrolimus
levels before intervention
>12 months after transplantation, 15 patients
50
100.00%
Target range
40
75.00%
30
#
50.00%
20
25.00%
10
0
.00%
2
4
6
8
10
12
14
16
tacrolimus level
18
20
22
date
8/
12
/0
2
7/
15
/0
2
7/
29
/0
2
7/
1/
02
6/
17
/0
2
6/
3/
02
5/
20
/0
2
5/
6/
02
0.0
4/
22
/0
2
4/
8/
02
3/
25
/0
2
tacrolimus level
Tacrolimus Levels in an individual patient
30.0
25.0
20.0
15.0
10.0
5.0
Target range
This system of tacrolimus administration
perfectly designed to achieve…
• Wildly variable, often toxic blood levels
• 40% of the time, blood levels will be out
of therapeutic range
• 30% incidence of renal toxicity, and a
high frequency of other drug-related
complications
Low science: Statistical Process Control applied
to tacrolimus administration
• Depict the most recent 20 tacrolimus blood levels from each
patient on a run chart.
• Team meets daily to adjust drug levels.
• If the mean value for the baseline is within specifications, continue
the present dose. Dose will not be adjusted based on common
cause variation unless the level exceeds 20ng/ml.
• If tacrolimus blood levels are out of control then special cause
variation will be considered. Contact the family and proceed with
a structured interview to identify potential cause.
• If no special cause variation is identified to account for the out of
control process, then the drug dose will be adjusted by 25% or
more to achieve the target range.
Process Definitions
• Out of control process
– 2 of 3 drug levels beyond 1 standard
deviation
– 6 consecutive levels above or below the mean
– 5 consecutive ascending or descending blood
levels
– Any drug level beyond 2 standard deviations
Tacrolimus levels in 15 patients without “tampering”
8
7
1
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
Target range
frequency
6
5
4
3
2
1
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
tacrolimus level
cumulative %
>12 months after transplantation
Tacrolimus blood levels in an individual patient
without “tampering”
Stopped
Tampering
25.0
20.0
intervention
15.0
10.0
5.0
Target range
date
10
/8
/2
00
2
9/
8/
20
02
8/
8/
20
02
7/
8/
20
02
6/
8/
20
02
5/
8/
20
02
0.0
4/
8/
20
02
tacrolimus level
30.0
The new system is perfectly designed
to produce….
• No episodes of allograft rejection
• No opportunistic infections
• No episodes of increased serum
creatinine
• 5 more hours per week of nurse’s
time!
Questions about this “Low Science”Project”
• Is this improvement?
• Is it research?
• Is the knowledge generated from this project
potentially useful to others in the profession?
• Could this “experiment” be published?
• Could the lessons from this work be applied to
drugs other than tacrolimus?
• Where did the doctor and nurse who did this
project learn about SPC and tampering?
If evidence-based medicine is to be
reliably implemented….
• Physicians need to use both descriptive and
analytical statistics
• Physicians need to know both pathways for
improvement
• Knowledge gained by “Low Science” needs to be
valued more highly, and shared more widely
• We must lead this change in our own profession
Barriers to using all the science we
know
• Professional culture
– High Science and Low Science
– Autonomy—individual and
professional
• Daily workflow
– Time
– Hassles and barriers
• Business Case
How did medicine earn its autonomy?
• Dedication to welfare of the patient??
• Skilful building of political power?
• Modern science, and its miracles?
“Having a craft worth knowing, and
applying it for the benefit of our
patients”
Why have physicians lost autonomy?
• Failure of the many to clean up the
messes of the few
• Fading political power, as more
physicians put self-interest above patient
interest
• Not practicing the art of medicine
• Not practicing the science?
We are losing our clinical autonomy
in part because the public has
learned that the basis for it, the full
power of our scientific knowledge,
is not being consistently applied for
their benefit.
Example: Ventilator “Bundle”
•
By the evidence, virtually every patient on
mechanical ventilation should receive
1.
2.
3.
4.
5.
•
HOB 30 degrees elevation
PUD prophylaxis
DVT prophylaxis
Sedation vacation daily
Intensive insulin therapy
Mortality, morbidity, LOS…potentially
reduced up to 20-30% if all 5 of these are
done for every patient
Another example: Surgical Wound
Infection “Bundle”
1.
2.
3.
4.
5.
6.
Use prophylactic antibiotics appropriately
Maintain normothermia peri-operatively
Maintain glucose control
Optimize oxygen tension
Avoid shaving surgical site
Use basic prevention strategies
Surgical Wound Site Infection Prevention Collaborative, www.ihi.org
Grand Rounds:
Individual Autonomy meets Evidence
• If this were Grand Rounds, and I
had just reviewed the evidence for
these evidence-based bundles…
• What would happen next?
PHYSICIAN CULTURE
We regularly engage in vigorous conversations
about clinical evidence with our colleagues.
But we seldom enter into those conversations
with the clear understanding that any
conclusions we reach will be translated into
a system of standing orders, reminders,
measurements, feedback loops, and other
steps to implement any consensus that
emerges from the dialogue.
A paradox: more individual autonomy
means less professional autonomy
•
•
•
•
•
We talk about evidence in groups
We implement it as individuals
The resulting variation looks like the Tower of
Babel, to our nurses and pharmacists.
Our results fall short of what we and our patients
want
Society acts to reduce our professional autonomy
Questions for the Medical Staff
• Beyond sterile technique in the OR, could you
agree on evidence-based practices that should be
done for a particular diagnosis or procedure for
every patient, even if a doctor doesn’t order them?
• If you reached agreement on a list of these
“operating systems,” how would you make sure
that they are done, reliably?
• How would incorporate new evidence into these
operating systems?
Good changes being made by our profession
• Hospital-wide order sets based on evidence
• Automatic substitution of orders based on
evidence
• Closed units based on evidence
• “Operating systems” based on evidence
• Computer order entry where the default orders
and options are based on evidence
Does practicing clinical
science as a team make
a difference for
patients?
Oct 99-Oct 01
ct
O
Au
g
Ju
n
Ap
r
Fe
b
De
c
ct
O
Au
g
Ju
n
Ap
r
Fe
b
16 Evidence-based
Processes Standardized
Jan-Apr 01
De
c
ct
9
8
7
6
5
4
3
2
1
0
O
% Mortality
Practicing science as a team:
CABG mortality at BIDMC
Note:
Our professional challenge is not
just about standardizing to the
science. It’s also about
standardizing within the science.
Yes, buts…
• We can’t agree on all the science
• Specialties will make self-serving judgments
about the science
• Guidelines expose us to legal risks
• It’s cookbook medicine
• Protocols stifle innovation
• Guidelines are unprofessional
• …..?
Does practicing clinical
science as a team make
life better for
physicians?
Standardization, simplification, and time
• Evidence-based medicine, practiced as a
team, usually also involves
standardization and/or simplification, and
this frees up “touch time.”
– “Start Methotrexate”
– Acute MI admission orders…
– Preventive care system
Putting it all together:
Science, Art, Autonomy, and Time
Practice the science of medicine as a team,
so that society will continue to give us
the privilege of practicing the art of
medicine as individuals. By sharing
individual autonomy in the science, we
can regain professional autonomy, and
rediscover precious touch time.
“Now, isn’t that better?”
Jody, my medical office assistant
Ventilator Bundle References
• Kress JP, Pohlman AS, O’Connor MF, Hall JB. Daily interruption of sedative
infusions in critically ill patients undergoing mechanical ventilation. The New
England Journal of Medicine. 2000; 342: 1471-1477.
• Drakulovic MB, Torres A, Bauer TT, Nicolas JM, Nogue S, Rerrer M. Supine body
position as a risk factor for nosocomial pneumonia in mechanically ventilated
patients: a randomized trial. The Lancet. 1999; 354: 1851-1858.
• Cook DJ, Fuller HD et al. Risk factors for gastrointestinal bleeding in critically ill
patients. Canadian Critical Care Trials Group. N Engl J Med 1994;330(6):377-81
• Attia J, Ray JG, Cook DJ, et al: Deep vein thrombosis in critically ill adults. Arch
Intern Med 161(10):1268-79, 2001.
• Van den Berghe G, Wouters P, Weekers F, et al. Intensive insulin therapy in the
critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67
• Torres A, Serra-Batlles J, Ros E, Piera C, Puig de la Bellacasa J, Cobos A, Lomena
F, Rodrigues-Roisin R. Pulmonary aspiration of gastric contents in patients
receiving mechanical ventilation: the effect of body position. Annals of Internal
Medicine. 1992;116:540-543.
Surgical Wound Infection References
• www.qualityhealthcare.org/QHC/Topics/PatientSafety/Surgica
lSiteInfections/Literature
• Balthazar ER, Colt JD, Nichols RL. Preoperative hair removal:
A random prospective study of shaving versus clipping.
Southern Medical Journal. 1982;75(7):799–801.
• Kurz A, Sessler DI, Lenhardt R.: Perioperative normothermia
to reduce the incidence of surgical-wound infection and
shorten hospitalization. Study of Wound Infection and
Temperature Group. New England Journal of Medicine.
1996;334(19):1209–1215
• Silver A, Eichorn A, Kral J, et al. Timeliness and use of
antibiotic prophylaxis in selected inpatient surgical procedures.
The Antibiotic Prophylaxis Study Group. American Journal of
Surgery. 1996;171(6):548–552.
Surgical wound infection references
contd.
• Rivers EP, Ander DS, Powell D. Central venous oxygen saturation
monitoring in the critically ill patient. Critical Care. 2001;7(3):204-211.
• Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC
definitions of nosocomial surgical site infections, 1992: A modification of
CDC definitions of surgical wound infections. American Journal of
Infection Control. 1992;20(5):271–274.
• Burke JP. Maximizing appropriate antibiotic prophylaxis for surgical
patients: An update from LDS Hospital, Salt Lake City. Clinical Infectious
Diseases. 2001;33(Suppl 2):S78–83
• Pomposelli JJ, Baxter JK 3rd, Babineau TJ, Pomfret EA, Driscoll DF, Forse
RA, Bistrian BR. Early postoperative glucose control predicts nosocomial
infection rate in diabetic patients. Journal of Parenteral and Enteral
Nutrition. 1998;22(2):77–81.
• Greif R, Akca O, Horn EP, Kurz A, Sessler DI. Supplemental perioperative
oxygen to reduce the incidence of surgical-wound infection. Outcomes
Research Group. New England Journal of Medicine. 2000;342(3):161–167.
Other Resources
• Gosfield, A, and J Reinertsen. Doing Well By
Doing Good: Improving the Business for
Quality (White paper available at www.ufta.com)
• Reinertsen, JL. Zen and the art of physician
autonomy maintenance. Ann Intern Med
2003;138:992-5