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STS – CHSS Link Marshall L. Jacobs, M.D. Jeffrey P. Jacobs, M.D. Johns Hopkins University Do This Immediately Do not Save this template. Use File…Save.

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Presentation on theme: "STS – CHSS Link Marshall L. Jacobs, M.D. Jeffrey P. Jacobs, M.D. Johns Hopkins University Do This Immediately Do not Save this template. Use File…Save."— Presentation transcript:

1 STS – CHSS Link Marshall L. Jacobs, M.D. Jeffrey P. Jacobs, M.D. Johns Hopkins University Do This Immediately Do not Save this template. Use File…Save As… and save as a PowerPoint 95 or 97 presentation, with a unique name, e.g. your own name, or subject of your presentation. If you modify any of the fonts you must also check the box labelled: Embed True Type Delete this box once you have followed these steps Tip Photos and images should not be scanned at high resolution for PowerPoint presentations. Set your scanning software for 120 dpi maximum. Delete this box once you have read it. CHSS Chicago October 20, 2013

2 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 0 Tara Karamlou, MD, MSc Eugene H. Blackstone, MD Constantine Mavroudis, MD John E. Mayer, Jr, MD Richard A. Jonas, MD Marshall L. Jacobs, MD Investigative Team

3 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 Investigative Team

4 $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”

5 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.

6 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.

7 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

8 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.

9 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

10 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.

11 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%.

12 Initial Matrices Matrix Says CHSS EligibleMatrix Says CHSS Not EligibleTotal True CHSS Eligible21816234 True CHSS Not Eligible15? Total233 Sensitivity = 218/234 = 93.2% Specificity = 218/233 = 93.6% Revised Matrices after Manual Adjudication Matrix Says CHSS EligibleMatrix Says CHSS Not EligibleTotal True CHSS Eligible2340 True CHSS Not Eligible5? Total239 Sensitivity = 234/234 = 100% Specificity = 234/239 = 97.9%

13 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).

14 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%.

15 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%.

16 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.

17 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.

18 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.

19 Conclusions (1) The CHSS Database (CHSS-D) has been successfully linked to the STS Congenital Heart Surgery Database (STS-CHSD).

20 Conclusions (2) Algorithms have been developed for all five active CHSS protocols to identify patients in STS-CHSD who are eligible for CHSS studies.

21 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.


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