Download Start/End Dates - The Canadian Neonatal Network

EPIC Abstractor’s Manual
2004
REVISED OCTOBER 21ST 2002
COMPILED BY JENNIFER CLAYDON
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TABLE OF CONTENTS
INTRODUCTION
CHAPTER ONE: BACKGROUND…………………………………………………………..
CHAPTER TWO: INTRODUCTION………..……………………………………...…..….…
CHAPTER THREE: IMPROVING NICU CARE ……………………………..…………..…….
CHAPTER FOUR: RESEARCH METHODS……………………………………………….….
CHAPTER FIVE: DATA ELEMENTS……..………………….………………………..……
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SCREEN DEFINITIONS
NEW MATERNAL/OBSTETRIC INFORMATION ………………………………………...…..
INFECTION WORKUP…….…………………………………………………………...…...
NUTRITION…………...……………………………………………………………..…....
VASCULAR ACCESS…..………….……………………………………………....……....
CXR (CHEST X-RAY)…………………...…………………………………………....……
MEDICATIONS...…………………………………………………….…………………..
RESPIRATORY SUPPORT.……………………..……………...……………………....……
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APPENDIX
APPENDIX I: DEFINITIONS….…………………………………………………………… 17
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CHAPTER ONE: BACKGROUND
Since 1995, the Canadian Neonatal Network (CNN)1 has conducted a program of MRC-funded research
(Principal Investigator – Shoo Lee) aimed at using small area variations in outcomes to examine the
relative effectiveness of differing medical practices. It comprises 17 NICUs with 75% of the tertiary level
NICU beds in Canada. The CNN’s main objective being to use this information to improve NICU
outcomes and quality of care. To date, we have (only key findings are described here):
1. Created a standardized national NICU database for research, and described outcomes
Lee et al1 used the data to provide the first comprehensive description of Canadian NICU outcomes and
practices. Chan et al2 reported on outcomes of extremely preterm infants. Chien et al3 confirmed that
preterm infants had better outcomes if they were born at tertiary perinatal centres.
2. Evaluated important clinical practice guidelines
Lee et al’s4 findings that infants >1,200g birth weight did not require treatment for retinopathy of
prematurity led to review of national screening guidelines that will half the number of infants routinely
screened, and reduce costs by over $1 million annually. Zupancic et al5 reported on cost-effectiveness of
intraventricular hemorrhage screening strategies and types of infant transport systems.
3. Developed risk-adjustment instruments to permit valid comparison of NICU outcomes
Richardson et al6 developed and validated the Score for Neonatal Acute Physiology, Version II (SNAP-II)
to measure neonatal illness severity and predict mortality, and Chien et al7 showed that it was also
predictive of morbidity. Richardson et al8 showed how risk adjustment can be used to make valid
comparisons of NICU outcomes. Lee et al9 developed and validated the Transport Risk Index of
Physiologic Stability (TRIPS) to assess transport outcomes.
1
Lee SK, McMillan DD, Ohlsson A, Pendray M, Synnes A, Whyte R, Chien LY, Sale J and The Canadian Neonatal
Network. Variations in outcomes and practice in Canadian NICUs. Pediatrics 2000;106:1070-1079
2
Chan KJ, Ohlsson A, Synnes A, Lee DSC, Chien LY, Lee SK and the Canadian NICU Network. Survival,
morbidity and resource use of 25 weeks gestation infants. Am J Obstet Gynecol 2001;185:220-226
3
Chien LY, Whyte R, Thiessen P, Matthew D, Aziz K, Lee SK and the Canadian Neonatal Netowkr. Improved
outcome of preterm infants when delivered in tertiary care centers. Obstet & Gynecol 2001;98:247-252
4
Lee SK, Normand C, McMillan DD, Ohlsson A, Vincer M et al. Evidence for changing guidelines for routine
screening for retinopathy of prematurity. Arch Pediatr Adolescent Med 2001;155:387-395
5
Zupancic J, Stewart S, Synnes A, DSC Lee, Lee SK. Decision analysis and cost-effectiveness analysis of alternate
screening strategies for neonatal intraventricular hemorrhage. Pediatr Res 2001;49:365A
Richardson DK, Corcoran JD, Esobar G, Lee SK. The Canadian NICU Network et al. SNAP-II and SNAPPE-II –
newborn illness severity and mortality risk scores. J Pediatr 2001;138:92-100
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7
Chien LY, Whyte R, Thiessen P, Walker R, Brabyn D, Lee SK and the Canadian Neonatal Network.
SNAP-II predicts intraventricular hemorrhage and chronic lung disease. J Perinatol (in press)
8
Richardson D, Tarnow-Mordi WO, Lee SK. Risk adjustment for quality improvement. Pediatrics 1999;103(1):255265
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Lee SK, Zupancic JAF, Robin Whyte, Barbara Schmidt, Margaret Pendray, David Shorten, Shawn Stewart and the
Canadian Neionatal Network. Transport risk index of physiologic stability (TRIPS) – a practical system for
assessing transport outcomes. J Pediatr 2001;139:220-226
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4. Used these risk adjustment instruments to examine variations in NICU outcomes and practices
Sankaran et al10 reported that variations in mortality among Canadian NICUs persisted even after risk
adjustment. We have also reported risk adjusted variations and risk factors for intraventricular
hemorrhage, chronic lung disease, necrotizing enterocolitis, nosocomial infection, retinopathy of
prematurity, transport outcomes, ECMO outcomes, blood transfusions, narcotic and sedative use,
antibiotic use, and treatment intensity.
5. Identified practices associated with variations in outcomes for potential intervention
Synnes et al11 reported that differences in 4 key practices accounted for the variation in intraventricular
hemorrhage among Canadian NICUs and postulated that it may be possible to improve NICU outcomes
by targeting specific practices identified by such data-driven analysis. McMillan et al12,13 reported that
assisted ventilation, central lines and parental nutrition were significant risk factors for nosocomial
infection. Chien et al14 found that 42% of nosocomial infections were central line related and speculated
that targeted interventions to reduce central line infections can significantly reduce the incidence of
nosocomial infection.
Next Step: Proposal for Development of National System to Improve NICU Outcomes:
We now propose to use the information learned to design, implement and evaluate a national system for
implementing practice change in NICUs. We hypothesize that our Evidence-based Practice Identification
and Change (EPIC) system will reduce nosocomial infections in the NICU. Nosocomial infection with a
16% incidence rate is one of the most important problems in the NICU. It is our intention that such
improvements are on going, based on published evidence and actual data from Canadian NICUs and
potentially generalized for use in all NICUs. This will represent a significant advance over present
subjective CQI methods, which are mostly intra-institutional in nature, and their results cannot be easily
generalized to other institutions.
10
Sankaran K, Chien LY, Walker R, Seshia M, Ohlsson A, Lee SK and the Canadian Neonatal Network. Variations
in mortality rates among Canadian neonatal intensive care units. CMAJ 2001 (in press)
11
Synnes AR, Chien LY, Peliowski A, Baboolal R, Lee SK and the Canadian NICU Network. Variations in
intraventricular hemorrhage incidence rates among Canadian neonatal intensive care units. J Pediatr 2001;138:52531
12
McMillan DD, Klassen AF, Seshia MK, Matthew JD, Synnes AR, Lee SK and the Canadian Neonatal Network.
Benchmarks for nosocomial infection rates in neonatal intensive care units. Pediatr Res 1999;45:270A
13
McMillan DD, Chien LY, Pendray MR, Matthew JD, Andrews W, lee SK and the Canadian Neonatal Network.
Differing factors associated with nosocomial infection (NI) in babies 1500g and 1500g birth weight. Pediatr Res
2000;47:344A
14
Chien LY, MacNab Y, Aziz K, Andrews W, McMillan DD, Lee SK and the Canadian Neonatal Network.
Variations in Central Venous Catheter Related Infection Risks among Canadian Neonatal Intensive Care Units. Ped
Infect Dis J (in press)
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CHAPTER TWO: INTRODUCTION
Nosocomial Infection
Nosocomial infection is one of the most important causes of mortality, morbidity and resource use in the
neonatal intensive care unit (NICU)1. Since NICU care is very expensive (costing about US$2-3 billion
annually in the US)15 and is associated with significant mortality and morbidity1, reducing nosocomial
infection is critical to efforts to improve outcomes and reduce costs in the NICU. Although much has
been published about risk factors for infection in the NICU, efforts by individual NICUs to reduce the
incidence of nosocomial infection have met with limited success. Existing methods use continuous
quality improvement (CQI) techniques, but are often not evidence-based, do not use data from the
institutions concerned, and cannot be easily generalized for use in all NICUs. An on-going system for
reducing NICU nosocomial infection that is based on evidence and data, utilizes the collective expertise
of a network of clinicians and other experts, and permits NICUs to learn from each other, is urgently
needed.
Variations in Nosocomial Infection Rates
Lee et al1 reported significant variation in nosocomial infection rates among Canadian NICUs (range 640%). Variations in NICUs are important because they are “natural experiments” reflecting the practice
patterns of small groups of physicians. Wennberg et al16 previously showed that small area variations can
be used to study the relative effectiveness of differing medical practices and technologies. He also
reported that feedback of information concerning variations in practices could modify physician practices.
This is important because it offers a potential tool to effect practice change based on data and evidence. In
addition, studies of neonate infection risk factors12,13,14 have found results that suggest it may be possible
to significantly reduce nosocomial infection by focusing on specific practices associated with high
incidence of infection (e.g. tracheal care for infants needing assisted ventilation, central line insertion and
care, parental nutrition type and administration.)
Specific Aims
The specific aims of this study are to develop, implement and evaluate an Evidence-based Practice
Identification and Change (EPIC) system for reducing nosocomial infection in NICUs that:
1. Uses evidence in the published literature
2. Extends existing evidence-based methods by using risk-adjusted data to identify risk factors
and practices associated with good and poor outcomes for targeted intervention.
3. Capitalizes on the collective expertise of a network of experts (neonatology, infection control,
CQI) to establish an on-going national system for reducing nosocomial infection
15
U.S. Congress, Office of Technology Assessment. Neonatal intensive care for very low weight infants: costs and
effectiveness (Health Technology Case Study 38) OTA-HCS-38. Washington DC: US Congress Office of
Technology Assessment, December 1987
16
Wennberg JE, Blowers L, Parker R, Gittelsohn AM. Changes in tonsillectomy rates associated with feedback and
review. Pediatrics 1977;59:821-826
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CHAPTER THREE: IMPROVING NICU CARE
A unique opportunity exists to develop an Evidence-based Practice Identification and Change (EPIC)
system for improving care in the NICU that is objective, evidence-based, data-driven, and utilizes the
collective expertise of a network of providers. EPIC incorporates three features:
(a) Systematic review of evidence (including clinical trials) in the published literature.
(b) Quantitative analysis of multi-center outcomes and practice data to identify practices associated
with outcome variation that can be targeted for intervention.
(c) Utilize the collective expertise of a multi-disciplinary network of clinicians and experts in
infection control and quality improvement, in an on-going national effort to continuously reevaluate, change practices and improve care in the NICU.
Previous efforts
Previous efforts to improve NICU outcomes (including the Vermont-Oxford Trials Network NICQ
Study) used traditional CQI methods. These methods lacked risk-adjusted benchmarked data from the
institutions concerned to identify key practice differences for targeted intervention. In addition they did
not develop practice change systems that could be easily generalized for use in other NICUs.
EPIC is innovative and differs from previous efforts because it:
(a) establishes a national system for on-going efforts to change practice and improve outcomes in
NICU
(b) uses benchmarked data from the institutions concerned to identify key practices for targeted
intervention (instead of the “hit-or-miss” approach of traditional CQI methods)
(c) creates a Template for practice change that can be potentially generalized to other NICUs
EPIC adds scientific objectivity to traditional CQI methods, focuses efforts on interventions with
identified effect, maximizes impact, and is more meaningful for individual NICUs.
Significance
This project will demonstrate how a national network of clinicians and researchers can be engaged in a
collaborative system that utilizes their cumulative experience and expertise to mutually encourage
evidence-based practice change. EPIC is innovative because it establishes a national system for on-going
efforts that are evidence-based. In addition to using available published evidence, EPIC utilizes objective
local and national benchmarked data to identify practices associated with outcome differences for targeted
change. This maximizes impact and is more meaningful for individual NICUs. EPIC may be a model for
other areas of health care.
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CHAPTER FOUR: RESEARCH METHODS
Participating NICUs and Data Collection
The study will be conducted at 12 tertiary level NICUs across Canada. The 12 NICUs have a mix of
high, median and low incidence of nosocomial infection, as previously reported by Lee et al 1. We will
modify the existing CNN Database program (section E.3) to prospectively collect data for this study. The
Co-ordinating Center will review data weekly and contact sites with missing or erroneous data, or that fall
behind in data collection. Data abstractors will receive 2 days of training and use a handbook with
definitions and protocols. We will re-abstract a random 5% of charts to check reliability and to reinforce
standard procedure. This system worked well for the SNAP study.
Study Population and Design
The study cohort will include all infants 32 weeks gestation (n=6000) admitted to the 12 study NICUs
(Appendix B) during a 3 year period. The 12 NICUs will be centrally randomized into 2 equal groups –
Intervention and Control. In phase 1 (year 1) baseline data will be collected on patient demographics,
outcomes (nosocomial infection, death, necrotizing enterocolitis, intraventricular hemorrhage, and
chronic lung disease) and key processes affecting infection control. A multi-disciplinary group (Research
Committee) will systematically review the literature, revise checklists of key infection control processes,
and recommend practice guidelines. Hierarchical modeling will be used to examine outcome differences
between NICUs, and identify key process differences associated with outcome differences for particular
attention. Site visits to a NICU with low nosocomial infection incidence will reinforce the need for
change. In phase 2 (year 2), practice guidelines will be implemented at Intervention NICUs. Control
NICUs will be blinded to the changes. Quarterly feedback using Control Charts to show trends of
outcome and process indicators will inform participants about their progress and encourage further effort.
The Research Committee will review trends and recommend changes to practice guidelines. An external
Monitoring Committee will monitor outcomes and recommend changes if needed. At study conclusion,
the paired t-test and multivariate hierarchical modeling will be used to compare outcomes within NICUs
and between Intervention and Control groups, before and after guideline implementation.
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CHAPTER FIVE: DATA ELEMENTS
Basic NICU data
To be recorded by all NICUs throughout the 3 year study period to permit risk adjustment and
information for 1 year before and 2 years after EPIC. Baseline data includes:
Demographic: birth weight, gestation, sex, Apgar score, area code
Obstetric/perinatal risk factors: maternal age, race, education, smoking, drug use during pregnancy,
antenatal care/complications, hypertension, preterm labor/rupture of membranes, diabetes, group B
streptococcus carriage, chorioamnionitis, multiple gestation, antenatal steroids, delivery mode and
presentation, drug treatment, delivery complications and resuscitation
Admission illness severity: SNAP-II obtained during the first 12 hours of NICU admission
Outcomes data
(a) Primary: Nosocomial infection (Blood, lung, gastrointestinal, urinary tract, eye).
(b) Secondary (Clinical): Death, necrotizing enterocolitis, chronic lung disease, intraventricular
hemorrhage, and retinopathy of prematurity.
(c) Secondary (Resource Use): Antibiotic use, surgery, duration of assisted ventilation, oxygen
therapy, NICU stay.
Definition of Clinical Outcomes
Nosocomial infection: will be defined using the Center for Disease Control criteria106, based on the
following principles:
[i] combinations of clinical, laboratory and other diagnostic test information
[ii] clinical diagnosis is an accepted criteria
[iii] the infection was not incubating at the time of hospital admission (defined as development of
clinical signs of infection and positive blood cultures more than 48 hours after NICU admission)
[iv] infection is not acquired transplacentally (defined as infections known to be transmitted
primarily transplacentally, e.g. cytomegalovirus, toxoplasmosis, rubella, hepatitis B, and human
immunedeficiency virus)
[v] evidence of hospital acquisition is considered individually
Necrotizing enterocolitis: is defined using Bell’s criteria107
Chronic lung disease: is defined according to Shennan et al108
Intraventricular hemorrhage: will be classified using the Canadian Pediatric Society classification109,
from cranial ultrasound performed during the first 28 days of life.
Retinopathy of prematurity: will be staged according to the International Classification of retinopathy of
Prematurity110.
Key Process Indicators for Infection Control
General Unit Policies and Procedures: handwashing, gloves and gowns, cohorting of patients, isolation
policies, visitation policies, equipment cleaning and maintenance
Skin care: cleaning procedures/fluids, probes/sensors, humidification, temperature, bedding, procedures
for skin breakdown, edema and leakage of infusates into subcutaneous tissue
Care of the intubated patient: tracheal suctioning, aspirate, culture and treatment policies.
Intravenous access (peripheral and central): line type, skin preparation, line placement/securing,
infusates (type, volume and duration), procedure for changing infusates, blocked lines
Total parent nutrition: protocol for routine use, infusates (type, volume and duration) and additives,
procedure in presence of sepsis, type of intravenous lines used for infusion
Enteral feeding: feeding protocol, method (nasogastric tube, oral, bolus, continuous), quantity (amount,
frequency, rate of increase), and type (breast milk, formula, additives)
Antibiotic use: indications for use, protocol for prophylactic use and for suspected sepsis (type, dose,
duration, route of administration, dates of use), protocol for treatment of sepsis
Post-natal cortiocosteroid treatment: indications for use, protocol for use (type, dose, duration, route of
administration, dates of use)
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CNN MOTHER/OBSTETRIC SCREEN DEFINITIONS
NEW MATERNAL/OBSTETRICAL INFORMATION
Mother Education
Choose from the scroll down list the highest level of education completed by the mother at the time of birth.
Junior High refers to the completion of grade 10. If mother’s education is unknown or not recorded, score as
such.
Chorioamnionitis
Chorioamnionitis is defined as inflammation of the chorion and amnion. Answer yes, no or unknown to a
diagnosis of chorioamnionitis during pregnancy/labour or delivery.
Tocolysis
Tocolysis is defined as the delaying/halting of labour. Answer yes, no or unknown to medical tocolysis during
labour.
Diabetics
Answer yes, no or unknown regarding mother’s status as a diabetic. This includes both gestational diabetes as
well as previous maternal diabetes (ie. prior to conception).
Was systemic
antibiotics given to
mother?
Record whether systemic antibiotics were given to the mother in the 24 hours prior to delivery. This includes
antibiotics given only enterally or parentally, not topical antibiotics. If antibiotics were given to the mother,
choose yes from the scroll down list under ‘antibiotics given to mother?’ and complete the start/end dates as
well as the type of antibiotic administered. If the dates are unknown record the missing value. If the type of
antibiotic given is unknown score as such. If no antibiotics given or if this item is unknown, leave start/end
dates and antibiotic type blank and choose ‘no’ or ‘unknown’ respectively under ‘antibiotics given to
mother?’
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EPIC INFECTION WORKUP SCREEN DEFINITIONS
*Note EPIC data need only be collected for those infants less than or equal to 32 weeks gestational age at birth.
Also note that if a patient is included in the EPIC study, you NEED NOT COMPLETE the positive blood/CSF
cultures, central venous lines or clinical diagnosis of infection forms on the Cultures/CVL/Trans screen. They
are redundant with the EPIC Infection study; therefore, simply leave the appropriate CNN forms blank.
INFECTION WORKUP
Diagnosis Date
Record the date the infection was first diagnosed. Score as YY/MM/DD.
Type
Choose from the scroll down list the appropriate CDC diagnosis type. See appendix I for the CDC
definitions of different perinatal infections.
1. A diagnosis of meningitis can NOT be included here UNLESS a positive CSF culture is found; if no
positive CSF culture, simply a CNS infection.
2. A diagnosis of pneumonia requires a chest x-ray compatible with pneumonia.
Episode #
This field MUST BE COMPLETED, it links all the information with a specific episode. Include all
infection episodes. An ‘episode’ is defined as any event where infection is suspected, and as a result
begins with:
(a) bacteriological or viral samples are taken, or
(b) antibiotics are initiated, or
(c) a diagnosis of infection is made.
Enter the infection episode number (beginning with 1 for the first infection episode following admission).
An infection episode includes everything within 7 days of the beginning of an episode, where the first day
of the episode is considered day 1. After the 7th day another positive culture would be considered a
DIFFERENT episode. Unless otherwise specified by the Site Investigator.
Note that an infection episode need NOT necessarily be confirmed by a positive culture.
Culture / Sample
List all cultures taken during the infection episode regardless of culture outcome (positive or negative).
Date
Record the date the culture was drawn (YY/MM/DD).
Organism
If the culture is positive, choose from the scroll down list the appropriate organism found. If the culture is
negative leave this field blank.
Source
Choose from the scroll down list the source of the culture.
Result
Choose from the scroll down list indicating whether the culture is positive or negative.
Antibiotics given 24
hrs. prior to culture?
Answer yes or no to whether antibiotics were given 24 hours prior to the first culture listed for the given
episode.
Baby Isolation
Answer yes or no to whether the baby was placed in isolation as a result of this infection episode.
Comments
Enter any comments regarding unusual diagnosis of infection here.
Add New Episode
Record
Search by Episode
Number
Preview Episodes
Click here to begin a new episode of infection.
Use this list to scroll between episode #’s, where data has already been entered.
Allows you to preview data entered for all episodes of infection.
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EPIC NUTRITION SCREEN DEFINITIONS
TOTAL PARENTAL NUTRITION
Type
Choose from the scroll down list either ‘proteins’ or ‘lipids’ according to the type of total parental
nutrition (TPN) given throughout the infant’s hospital stay. Note it is not necessary to specify the name
of TPN, just whether it was proteins or lipids being given.
Date Start
Enter the date (YY/MM/DD) the appropriate TPN was started.
Stop Date
Enter the date (YY/MM/DD) TPN was stopped. Record an end date only when TPN is stopped for at least
48 hours. If TPN was stopped for less than 48 hours, it is not necessary to begin a new line as this does
not count as a new session of TPN administration.
FEEDING
Type
Choose from the scroll down list the type of enteral feeding used throughout the infant’s hospital stay.
whether just expressed breast milk, formula or a combination of both. Breast milk’s fortified with
additives such as HMF are scored as ‘Both’.
Start Date
Enter the date (YY/MM/DD) the appropriate enteral feeding was started.
Stop Date
Enter the date (YY/MM/DD) the appropriate enteral feeding was stopped. Begin a new line only when the
particular type of enteral feed was stopped for more than 48 hours. Such that an infant who becomes NPO
for eye surgery one afternoon, will not be captured assuming enteral feeds are begun again within 48
hours.
Date Full Feed
Achieved
Enter the date (YY/MM/DD) at which full feeds are first established. Full feeds are considered to be
established when the infant is taking his total intake of feeds by breast, bottle, nasogastric (NG), etc.
These feeds can be ad lib, q1h, q2h, q3, q4h or continuous. Note that for full feeds to be established the
infant should not be receiving any parental nutrition or fluids via IV, however they may be receiving
medications via IV.
BABY’S WEIGHT
Birth Weight
This field will be automatically entered if this data has already been entered on the patient log/admission
screen from CNN.
Date BW regained
Enter the date (YY/MM/DD) at which the infant first surpasses (or regains equally) his/her original birth
weight.
Weight Day 3, 7, 14
& Week 36
Enter present weight in grams on days: 3, 7, & 14 of life, and on corrected gestational age week 36. If any
of the weights on these days are unavailable enter the closest available weight up to 48 hours plus or
minus the original day. If 2 weights are given within 24 hours (ie. if no weight on day 3, but a weight is
given on days 2 and 4), use the weight given the day after, before the weight on the day before (ie. record
the weight on day 4). If no weight is given during the appropriate time period score the missing value.
Date Recorded
Enter the calendar date (YY/MM/DD) on which the weight for each day was scored. If no weight is given
during the appropriate time period score the missing value.
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EPIC VASCULAR ACCESS SCREEN DEFINITIONS
CENTRAL LINE
Type of Line Inserted
Include all central (umbilical, percutaneous and surgically implanted) lines placed throughout the hospital
stay. Choose from the scroll down list the type of line inserted.
Location of Line
Record the insertion location of the particular central line. Choose from the scroll down list.
# of Lumen
Score the number of lumen (or tubes within a tube - for example some tubes are really 2 or 3 tubes joined
side by side into one tube) in the central line.
Date In/Out
Enter the dates (YY/MM/DD) the central line was placed and removed.
Complication
Score any complications caused as a result of the particular central lines. Complications may include:
infection, thrombosis, bleeding, thrombocytopenia, embolism, leakage of IV fluid, perforation of heart, or
blockage of central line. If more than one complication, score the first to arise or that considered to be the
most severe. If there was no complication throughout the time this line was in place score as N/A.
Date of Complication
Enter the date (YY/MM/DD) at which the given complication was first noticed. If there was no
complication throughout the time this line was in place score N/A under complication and leave the date
field blank.
PERIPHERAL INTRAVENOUS ACCESS
IV Date Start
Record all Peripheral IV’s placed throughout the patient’s hospital stay. Enter the start date ( YY/MM/DD)
as the day the IV was first placed.
Finish Date
Record the finish date (YY/MM/DD) of a PIV. Do not record every time IV’s are changed or pulled and a
new started the same day. In other words, record finish date as the date PIV therapy was stopped for more
than 24 hours.
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EPIC CXR (CHEST X-RAY) SCREEN DEFINITIONS
Use the last chest x-ray done within +/- 7 days of 36 weeks corrected gestational age. If this chest x-ray is not
compatible with the course of chronic lung disease (CLD) then use any chest x-ray during the patient’s course
that is compatible with CLD.
CHEST TUBE
Date
Enter the date (YY/MM/DD) all chest tubes were first inserted.
Total # of Tubes
Record the number of chest tubes inserted on the date specified. If a chest tube was never inserted enter 0 here
and leave the date field blank.
AIR LEAK
Date
Enter the date (YY/MM/DD) the air leak syndrome was first diagnosed via chest x-ray.
Syndrome
Choose from the scroll down list the appropriate air leak syndrome. If an air leak was never confirmed by chest
x-ray score ‘none’ and leave the date field blank.
PULMONARY HAEMMORRHAGE
Date
Enter the date (YY/MM/DD) pulmonary haemorrhage was first diagnosed. Pulmonary hemorrhage is defined as
clinical deterioration with blood in secretions, regardless of chest x-ray diagnosis.
Haemmorrhage
If pulmonary haemorrhage was diagnosed choose ‘yes’ from the scroll down list. If pulmonary haemorrhage
was never diagnosed score ‘no’ and leave the date field blank.
13
EPIC MEDICATIONS SCREEN DEFINITIONS
Note that the end date for a particular medication need only be recorded when the medication has stopped being
administered for more than 48 hours. If the medication is discontinued and restarted again within 48 hours this
need NOT be recorded as a new line of start and end dates, but continues on from the original start date. Note if
a medication is only given for 1 day, then score that day as both the start and end dates.
Also note that if a patient is included in the EPIC study, you NEED NOT COMPLETE THE MEDICATIONS
SCREEN IN CNN, simply leave the CNN screen blank.
For a complete list of medications and the classifications they are given here, see appendix I of the CNN manual.
If you are unsure what category a medication is grouped in contact the NCC for advice.
ANTIBIOTICS
Start/End Dates
Record the start and end dates (YYMMDD) of all antibiotics given throughout this hospital stay. Record
regardless of method of administration (i.e. bolus or infusion).
Type
Select from the scroll down list the type of antibiotic administered (ie. acyclovir, amphotericin B, ampicillin,
gentamycin, cefotaxime, flagyl, cloxacillin, vancomycin, etc.) If a medication is not included in the list
simply add it.
BRONCHODILATORS
Start/End Dates
Record the start and end dates (YY/MM/DD) of all bronchodilators given throughout a patient’s hospital stay.
Type
Choose from the scroll down list the type of bronchodilator given (ie. isoproterenol, albuterol, etc.) If a
bronchodilator is not included in the list simply add it.
DIURETICS
Start/End Dates
Record the start and end dates (YY/MM/DD) of only those diuretics given continuously for 5 or more days.
Therefore, a diuretic given only for 4 days would not be recorded here.
Type
Choose from the scroll down list the type of diuretic administered (ie. aldactone, diuril, hydrocholorthiazide
(hctz), lasix, spironolactone, etc.)
NITRIC OXIDE
Start/End Dates
Record the start and end dates (YY/MM/DD) of when nitric oxide (NO/iNO) is given during a patient’s
hospital stay.
PARALYTICS
Start/End Dates
Record the start and end dates (YY/MM/DD) of all paralytics given during this hospital stay.
Type
Select from the scroll down list the type of paralytic administered (ie. lorazepam, pancuronium (pavulon),
phenobarbital, phenytoin, vecuronium, succynylcholine, etc.)
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RESPIRATORY STIMULI
Start/End Dates
Record the start and end dates (YY/MM/DD) of all respiratory stimuli given.
Type
Score all respiratory stimuli administered during the patient’s hospital stay. Choose from the scroll down list
the type of respiratory stimuli given (ie. caffeine or theophylline).
RSV IMMUNIZATION
Start/End Dates
Record when the infant was given a RSV immunization, including start and end dates (YY/MM/DD) of when
the immunization drug was administered. If a medication is only given for 1 day, then score that day as both
the start and end dates.
SEDATIVES / NARCOTICS
Start/End Dates
Record the start and end dates (YYMMDD) of all sedatives/narcotics given throughout this hospital stay.
Record regardless of method of administration (i.e. bolus or infusion).
Type
Select from the scroll down list the type of sedative/narcotic administered (ie. fentanyl, morphine, codeine,
methadone, opium, acetaminophen (tylenol), chloral hydrate, midazolam,etc.)
STERIODS
Start/End Dates
Record the start and end dates (YYMMDD) of all steriods given throughout the infant’s hospital stay. Do NOT
score steroids given to the mother prior to the infant’s birth.
Type
Select from the scroll down list the type of post-natal steroid administered (ie. dexamethasone, budesonide,
hydrocortisone, beclamethasone, etc)
Baby’s Weight
Record the infant’s weight in grams on the day steroids were started.
SURFACTANT
Type
Score all surfactants (ie. BLES, surfvanta, exosurf, etc.) administered during the patient’s hospital stay.
Age first dose (Hrs)
Record the approximate age in hours at which the first dose of this particular surfactant was given, where
the first hour after birth counts as age 0 hours.
# of doses
Record the total number of doses of the particular surfactant given.
VITAMIN A
Start/End Dates
Record the start and end dates (YYMMDD) only when 2000 units or more is given of vitamin A. This is
meant to account for when vitamin A is given for the purpose of chronic lung disease treatment, as opposed
to just dietary supplement.
15
EPIC RESPIRATORY SUPPORT SCREEN DEFINITIONS
Note that the end date for a particular type of respiratory support need only be recorded when the support has
been stopped for more than 48 hours. If for example, CPAP has been discontinued, but is restarted again within
48 hours this need NOT be recorded as a new period of CPAP, but will continue on from the original CPAP start
date. However, the time the infant was off CPAP and was on say high flow, should be recorded under oxygen
treatment.
INTUBATION
Date
Score all successful intubation episodes throughout the patient’s hospital stay. Record date ( YYMMDD)
endotrachial tube was successfully inserted.
# of Attempts
Record number of intubation attempts required to get a successful intubation. For example, if a patient had 2
unsuccessful attempts, preceeding a successful intubation attempt, score as 3 attempts.
Bleeding
Answer yes, no or unknown as to whether bleeding occured as a result of the intubation attempt(s).
MECHANICAL VENTILATION
Start/End Dates
Score all periods of ventilator use throughout the patient’s hospital stay. Record start and end dates ( YYMMDD)
for each continuous ventilation period.
Type
Record the type of ventilation used during each continuous period (eg. assist, conventional, high frequency jet,
high frequency oscillation, volume guarantee.)
CPAP
Start/End Dates
Score all periods of CPAP use throughout the patient’s hospital stay. Record start and end dates (YY/MM/DD) for
each continuous CPAP period.
OXYGEN TREATMENT
Start/End Dates
Score all periods during which the infant received oxygen treatment (high flow, low flow, ambient) but not
mechanical ventilation or CPAP. Record start and end dates (YYMMDD) for each period in which oxygen was
administered. Note DO score days on which oxygen was not given continously, ie. for feeds.
BLOOD GASES
Blood Gas
Use the first blood gas drawn after midnight on the day requested (ie. where day 2 is the second day of
admission). Record the pH, pCO2 of this blood gas as well as the mean airway pressure (MAWP) at the time the
blood gas was drawn. This information can come from either capillary or arterial blood gases, select the check
box to record appropriately which blood gas was used to gather the information provided. If there was no blood
gas on the day requested for days 2-7 check the N/A box. If there was no blood gas on the day requested for days
14-28 use the closest blood gas within 48 hours (before or after each day). If there was still no blood gas check
the N/A box.
16
APPENDIX I
DEFINITIONS
-When confirming a diagnosis for a given infection episode, look first for a positive culture, then for the
administration of appropriate antibiotic therapy and finally look for the clinical signs listed below to infer the
appropriate diagnosis type for a particular infection.
CENTRAL NERVOUS SYSTEM INFECTION: Includes
meningitis, ventriculitis, spinal abscess without meningitis and
brain abscess (ie. epidural abscess).
Meningitis or ventriculitis must meet the following criterion:
a)
A pathogen must be isolated from or detected in CSF.
EYE, EAR, NOSE, THROAT AND MOUTH INFECTION: Eye
infection includes conjunctivitis and other eye infections.
Ear infections include otitis externa, otitis media, otitis interna, and mastoiditis. Nose, throat and mouth
infections include oral cavity infections, upper respiratory infections, and sinusitis. Record only infections
where pathogens were isolated/detected (including viruses) from cultures.
Conjunctivitis must meet either of the following criteria:
1.
2.
Pathogen isolated from culture of purulent exudate obtained from conjunctiva or contiguous tissues, such as
eyelid, cornea, meibomian glands, or lacrimal glands.
Pain or redness of conjunctiva or around eye and any of the following:
a) White blood cells and organisms seen on Gram stain of exudate
b) Purulent exudate
c) Positive antigen test on exudate or conjunctival scraping
d) Multinucleated giant cells seen on microscopic examination of conjunctival exudate or scrapings
e) Positive viral culture on conjunctival exudate
f) Diagnostic single antibody titer (IgM) or fourfold increase in paired serum samples (IgG) for pathogen
-Conjunctivitis organisms include: Neisseria gonorrhoeae, Neisseria meningitidis, Chlamydia trachomatis,
Staphylococcus aureus, Moraxella catarrhalis, Haemophilus influenzae, Haemophilus species, Streptococcus
pneumoniae, Peptostreptococcus, Peptococcus, Streptococcus pyogenes, Pseudomonas aeruginosa, Adenovirus,
Herpes simplex, Enterococcus, Other Gram negative enteric bacteria (E. Coli, etc.)
Upper respiratory tract infection (pharyngitis, laryngitis, epiglottis and viral infections (including parainfluenza,
influenza, adenovirus, and respiratory syncytial virus(RSV) must meet the following criterion:
1.
Patient is less than or equal to 12 months of age and has two of the following: fever (>38 oC), hypothermia
(<37oC), apnea, bradycardia, nasal discharge, or purulent exudate in throat, and any of the following:
a) Organism isolated from culture of specific site
b) Organism isolated from blood culture
c) Positive antigen test on blood or respiratory secretions
d) Diagnostic single antibody titer (IgM) or fourfold increase in paired serum samples (IgG) for pathogen
e) Physician’s diagnosis
Lower respiratory tract (pneumonia) must meet the following criterion:
1.
Patient is less than or equal to 12 months of age and has chest x-ray changes consistent with ‘pneumonia’,
‘consolidation’ or ‘infiltrates’ and worsening respiratory signs (increased respiratory distress or oxygen or
ventilation requirements in the previous 24 hours (ie. temp. instability, apnea, bradycardia, etc.)
17
GASTROINTESTINAL SYSTEM INFECTION: Includes
gastroenteritis, hepatitis, necrotizing enterocolitis,
gastrointestinal tract infections, and intraabdominal infections not specified elsewhere.
Gastroenteritis must meet either of the following criteria:
1.
2.
Acute onset of diarrhea (liquid stools–2 or more in 12 hours) with or without vomiting or fever (>38 oC) and no
likely noninfectious cause (e.g. diagnostic tests, therapeutic regimen, acute exacerbation of a chronic condition,
psychological stress)
A positive enteric pathogen isolated on culture and two of the following with no other recognized cause:
nausea, vomiting, abdominal pain, or liquid stools.
Infant necrotizing enterocolitis (NEC) must meet the following criterion:
1.
According to Bell’s criteria, stage 2 or higher. If there is definite pneumatosis (air in the bowel wall) or
portal/hepatic air (air in the liver) diagnosed by x-ray, or if there is a surgical or autopsy diagnosis of NEC. If
surgical autopsy diagnosis conflicts with x-ray diagnosis, the surgical/autopsy diagnosis takes priority. X-rays
showing free air WITHOUT pneumatosis do NOT count as NEC diagnosis. Vomiting, abdominal distension
and bloody stools without pneumatosis may lead to a suspected diagnosis and treatment, but is not counted as
NEC diagnosis.
PRIMARY BLOODSTREAM INFECTION: Includes
laboratory-confirmed bloodstream infection and clinical sepsis.
Laboratory-confirmed bloodstream infection must meet one of the following criteria:
1.
2.
Recognized pathogen isolated from a blood culture where pathogen is not related to infection at another site.17
One of the following: fever (>38oC), chills, or hypotension and any of the following:
a) Common skin contaminant18 isolated from 2 blood cultures drawn on separate occasions and where the
organism is not related to infection at another site1
b) Common skin contaminant isolated from patient’s blood culture with intravascular access device and
physician institutes appropriate antimicrobial therapy
c) Positive antigen test on blood19 and organism is not related to infection at another site
3.
Patient is less than or equal to 12 months of age and has one of the following: fever (>38oC), hypothermia
(<37oC), apnea, or bradycardia and any of the following:
a) Common skin contaminant2 isolated from 2 blood cultures drawn on separate occasions and where
the organism is not related to infection at another site1
b) Common skin contaminant isolated from patient’s blood culture with intravascular access device
and physician institutes appropriate antimicrobial therapy
c) Positive antigen test on blood3 and organism is not related to infection at another site
Clinical sepsis must meet either of the following criterion:
1.
Patient is less than or equal to 12 months of age and has one of the following clinical signs or symptoms with no
other recognized cause: fever (>38oC), hypothermia (<37oC), apnea, or bradycardia and all of the following:
a) Blood culture not done or no organism or antigen detected in blood
b) No apparent infection at another site
c) Physician institutes appropriate antimicrobial therapy for sepsis
17
When an organism isolated from a blood culture is compatible with a related nosocomial infection at another site,
the bloodstream infection is classified as a secondary bloodstream infection. Exceptions to this are intravascular
device-associated bloodstream infections, all of which are classified as primary even if localized signs of infection
are present at the access site.
18
Organisms that are normal skin flora (eg. diphtheroids, Bacillus sp., Propionibacterium sp., coagulase-negative
staphylococci, or micrococci).
19
Detection of bacterial, fungal, or viral antigen (eg. Candida sp.,herpes simplex, varicella zoster, Haemophilus
influenzae, streptococcus pneumoniae, Neisseria meningitidis, group B strptococci) by rapid diagnostic test (eg.
counterimmunoelectrophoresis, coagulation, or latex agglutination)
18
RESPIRATORY SYNCYTIAL VIRUS (RSV): A viral
infection of the nose and throat and a major cause of bronchiolitis
and pneumonia in young children.
SKIN AND SOFT TISSUE INFECTION: Includes
skin infection (other than an incisional wound infection), soft tissue
infection, decubitus ulcer infection, burn infection, breast abscess or mastitis, omphalitis, infant pustulosis,
and newborn circumcision infection.
Skin infection must meet either of the following criteria:
1.
2.
Purulent drainage, pustules, vesicles, or boils.
Two of the following at affected site: localized pain or tenderness, swelling, redness, or heat and any of the
following:
a) Organism isolated from culture of aspirate or drainage from affected site; if organism is normal skin
flora, must be a pure culture of a single organism
b) Organism isolated from a blood culture
Soft tissue infection (necrotizing fasciitis, infectious gangrene, necrotizing cellulitis, infectious myositis,
lymphadenitis, or lymphangitis) must meet one of the following criteria:
1.
2.
3.
4.
Organism isolated from culture of tissue or drainage from affected site.
Purulent drainage from affected site.
Abscess or other evidence of infection seen during surgery or by histopathologic examination.
Two of the following at affected site: localized pain or tenderness, redness, swelling, or heat and organism
isolated from blood culture.
Pustulosis in infant (< 12 months of age) must meet either of the following criteria:
1.
2.
Infant has pustules and physician’s diagnosis.
Physician institutes appropriate antimicrobial therapy.
URINARY TRACT INFECTION: Includes
symptomatic urinary tract infection, asymptomatic bacteriua, as well as other
infections of the urinary tract.
Symptomatic urinary tract infection must meet either of the following criteria:
1.
Patient is less than or equal to 12 months of age and has one of the following: fever (>38oC), hypothermia
(<37oC), apnea, bradycardia, dysuria, lethargy, or vomiting and a urine culture of >102 colonies/ml of urine
with no more than 2 species of organisms in a catheter specimen or bladder tap.
19