Lessons Learned From the Design and Implementation of Myocardial Infarction Adjudication Tailored for HIV Clinical Cohorts

Abstract

We developed, implemented, and evaluated a myocardial infarction (MI) adjudication protocol for cohort research of human immunodeficiency virus. Potential events were identified through the centralized Centers for AIDS Research Network of Integrated Clinical Systems data repository using MI diagnoses and/or cardiac enzyme laboratory results (1995-2012). Sites assembled de-identified packets, including physician notes and results from electrocardiograms, procedures, and laboratory tests. Information pertaining to the specific antiretroviral medications used was redacted for blinded review. Two experts reviewed each packet, and a third review was conducted if discrepancies occurred. Reviewers categorized probable/definite MIs as primary or secondary and identified secondary causes of MIs. The positive predictive value and sensitivity for each identification/ascertainment method were calculated. Of the 1,119 potential events that were adjudicated, 294 (26%) were definite/probable MIs. Almost as many secondary (48%) as primary (52%) MIs occurred, often as the result of sepsis or cocaine use. Of the patients with adjudicated definite/probable MIs, 78% had elevated troponin concentrations (positive predictive value = 57%, 95% confidence interval: 52, 62); however, only 44% had clinical diagnoses of MI (positive predictive value = 45%, 95% confidence interval: 39, 51). We found that central adjudication is crucial and that clinical diagnoses alone are insufficient for ascertainment of MI. Over half of the events ultimately determined to be MIs were not identified by clinical diagnoses. Adjudication protocols used in traditional cardiovascular disease cohorts facilitate cross-cohort comparisons but do not address issues such as identifying secondary MIs that may be common in persons with human immunodeficiency virus.

Types of Myocardial Infarction Among Human Immunodeficiency Virus–Infected Individuals in the United States

“…Central adjudication is preferable to local adjudication with or without secondary central review 20 . Clinical MI definitions have changed over time 36 .…”

“…Potential MIs were identified retrospectively in the CNICS data repository by the presence of a clinical MI diagnosis or coronary intervention such as coronary artery bypass graft (CABG) or elevated troponin or CK-MB values 20 . For each potential MI, the site assembled de-identified packets that included available physician notes, ECGs, results from imaging studies, and laboratory results.…”

Increased Risk of Myocardial Infarction in HIV-Infected Individuals in North America Compared With the General Population

“…Potential MI events were centrally ascertained within the NA-ACCORD data repository using a standard protocol based on the presence of an MI diagnosis or elevated cardiac biomarkers. We have shown among HIV-infected adults that screening based on cardiac biomarkers in addition to diagnoses increases the sensitivity of identifying confirmed T1MIs compared with relying on diagnosis codes alone 36 . Comprehensive medical records pertaining to each potential event including clinician progress notes, electrocardiograms, laboratory measures, echocardiography results, and coronary catheterization and operative reports were abstracted from EMRs at the contributing site, de-identified and uploaded to the NA-ACCORD data repository.…”

“…The protocol for ascertainment, validation and classification of MIs within NA-ACCORD has been previously published 36 . Potential MI events were centrally ascertained within the NA-ACCORD data repository using a standard protocol based on the presence of an MI diagnosis or elevated cardiac biomarkers.…”

Assessing and Refining Myocardial Infarction Risk Estimation Among Patients With Human Immunodeficiency Virus

“…27 CNICS is a multi-center clinical cohort comprised of HIV+ adults 18 years of age or older receiving HIV care at one of eight CFAR clinics in the U.S.; initial enrollment was 1995 or later depending on the site, enrollment and follow-up are continuous (most recent adjudicated MIs: July 2015), and rigorous central adjudication for MI within CNICS has been described in detail. 27 …”