Transcript STS-CHSS Linkage - Congenital Heart Surgeons' Society Data

CHSS
Chicago
October 20, 2013
STS – CHSS Link
Marshall L. Jacobs, M.D.
Jeffrey P. Jacobs, M.D.
Johns Hopkins University
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Investigative
Team
Jeffrey P. Jacobs, MD
Sara K. Pasquali, MD, MHS
Erle Austin, MD
J. William Gaynor, MD
Carl Backer, MD
Jennifer C. Hirsch-Romano, MD
William G. Williams, MD
Chris Caldarone, MD
Brian W. McCrindle, MD
Karen E. Graham, RN
Rachel S. Dokholyan, MPH
Gregory J. Shook, BS
Jennifer Poteat, MA
Maulik V. Baxi, MD, MPH
0Tara Karamlou, MD, MSc
Eugene H. Blackstone, MD
Constantine Mavroudis, MD
John E. Mayer, Jr, MD
Richard A. Jonas, MD
Marshall L. Jacobs, MD
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Investigative
Team
Jeffrey P. Jacobs, MD
Sara K. Pasquali, MD, MHS
Erle Austin, MD
J. William Gaynor, MD
Carl Backer, MD
Jennifer C. Hirsch-Romano, MD
William G. Williams, MD
Chris Caldarone, MD
Brian W. McCrindle, MD
Karen E. Graham, RN
Rachel S. Dokholyan, MPH
Gregory J. Shook, BS
Jennifer Poteat, MA
Maulik V. Baxi, MD, MPH
Tara Karamlou, MD, MSc
Eugene H. Blackstone, MD
Constantine Mavroudis, MD
John E. Mayer, Jr, MD
Richard A. Jonas, MD
Marshall L. Jacobs, MD
$200,000 over 2 years:
“Linking the Congenital Heart Surgery
Database of the Society of Thoracic
Surgeons (STS) with the Congenital
Heart Surgeons’ Society (CHSS)
Database”
Background
In January 2012, when this study began:
– 100 centers participated in the STS-CHSD
– 74 centers participated in the CHSS
– Only 4 CHSS centers do not participate in STS-CHSD
– 70 centers participated in both STS-CHSD and CHSS
• 40 of these 70 agreed to participate in this linkage project.
Methods
• Five matrices, based on CHSS inclusionary
criteria and STS-CHSD codes, were created to
facilitate the automated identification of
patients in the STS-CHSD who meet eligibility
criteria for the five active CHSS studies.
Five active CHSS studies
1. Tricuspid Atresia (TA) Study
2. Pulmonary Conduit (PC) Study
3. Critical Left Ventricular Outflow Tract (LVOTO)
Study
4. Anomalous Aortic Origin of a Coronary Artery
(AAOCA) Study
5. Unbalanced atrioventricular septal defect (uAVSD)
Study
Methods
• The matrices were evaluated with a manual
adjudication process and were iteratively
refined. The sensitivity and specificity of the
original matrices and the refined matrices
were assessed.
Four centers were selected as “alpha test
centers” in order to assure a range of center
surgical case volume and geography:
1. Children’s Hospital of Philadelphia, Philadelphia,
Pennsylvania
2. Kosair Children’s Hospital, University of Louisville,
Louisville, Kentucky;
3. Northwestern University Feinberg School of Medicine,
Ann & Robert H. Lurie Children’s Hospital of Chicago,
Chicago, Illinois
4. University of Michigan, Ann Arbor, Michigan
The matrices were applied the 40
participating sites to:
1. estimate the denominator of patients that are
potentially eligible for CHSS studies,
2. estimate the completeness of enrollment of patients
eligible for CHSS studies among all CHSS sites,
3. estimate the completeness of enrollment of patients
eligible for CHSS studies among those CHSS institutions
participating in each CHSS cohort study, and
4. compare “eligible and enrolled patients” to “eligible and
not enrolled patients” to assess the generalizability of
CHSS studies.
Results
• The manual adjudication process and the
refinement of the matrices resulted in an
increase in the sensitivity of the matrices
from 93% to 100% and an increase in the
specificity of the matrices from 94% to
98%.
Initial Matrices
Matrix Says CHSS Eligible
Matrix Says CHSS Not Eligible
True CHSS Eligible
218
16
True CHSS Not Eligible
Total
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233
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Total
234
Sensitivity = 218/234 = 93.2%
Specificity = 218/233 = 93.6%
Revised Matrices after Manual Adjudication
Matrix Says CHSS Eligible
Matrix Says CHSS Not Eligible
True CHSS Eligible
234
0
True CHSS Not Eligible
Total
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239
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Sensitivity = 234/234 = 100%
Specificity = 234/239 = 97.9%
Total
234
Two types of completeness are
estimated:
1. Completeness at centers actively enrolling
patients in a given study (Completeness at
actively participating centers)
2. Completeness of enrollment amongst the
entire cohort of 40 centers participating in
this project (Completeness at all potential
centers).
• For the Tricuspid Atresia (TA) Study, for
Modified Blalock-Taussig Shunt,
completeness at actively participating centers
was 30%, and completeness at all potential
centers was 12%.
• For the Pulmonary Conduit (PC) Study, for
Truncus arteriosus repair, completeness at
actively participating centers was 29%, and
completeness at all potential centers was 10%.
• For the Critical Left Ventricular Outflow Tract
Study (LVOTO) Study, for Norwood procedure,
completeness at actively participating centers
was 34%, and completeness at all potential
centers was 11%.
• For the Anomalous Aortic Origin of a Coronary
Artery (AAOCA) Study, for Anomalous aortic
origin of coronary artery from aorta (AAOCA)
repair, completeness at actively participating
centers was 40%, and completeness at all
potential centers was 12%.
For the most common operations
performed on patients who are
enrolled in CHSS cohorts:
• approximately one third of eligible patients
are actually enrolled at those CHSS member
institutions who are actively enrolling patients
in a given study, and
• approximately 10% to 15% of potentially
eligible patients are enrolled across the entire
CHSS.
Representativeness
As a representative example of these data,
for the Norwood Operation,
Discharge mortality:
- 15% among 227 enrolled patients
- 16% among 1768 non-enrolled potentially
eligible patients from the 40 participating
centers.
Representativeness
As a representative example of these data,
for the Norwood Operation,
Median postoperative Length of Stay :
- 31 days among 227 enrolled patients
- 26 days among 1768 non-enrolled potentially
eligible patients from the 40 participating
centers.
Conclusions (1)
The CHSS Database (CHSS-D) has been
successfully linked to the STS Congenital Heart
Surgery Database (STS-CHSD).
Conclusions (2)
Algorithms have been developed for all
five active CHSS protocols to identify patients in
STS-CHSD who are eligible for CHSS studies.
Conclusions (3)
Determination of the denominator of
patients eligible for CHSS studies and
comparison of “eligible and enrolled patients” to
“eligible and not enrolled patients” provides an
estimate of the extent to which patients in CHSS
studies are representative of the overall
population of eligible patients; however,
opportunities exist to improve enrollment.