• Sonal Singh, Hassan Fouayzi, Kathryn Anzuoni, Leah Goldman, Jea Young Min, Marie Griffin, Carlos G Grijalva, James A Morrow, Christine C Whitmore, Charles E Leonard, Mano Selvan, Vinit Nair, Yunping Zhou, Sengwee Toh, Andrew Petrone, James Williams, Elnara Fazio-Eynullayeva, Richard Swain, Tyler Coyle D D Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA., and Susan Andrade.
• Department of Family Medicine and Community Health and Meyers Primary Care Institute, University of Massachusetts Medical School, 55 Lake Ave N, Worcester, MA, USA. Sonal.Singh@umassmemorial.org.
• Drug Saf. 2019 Apr 1; 42 (4): 515-527.

IntroductionValid algorithms for identification of cardiovascular (CV) deaths allow researchers to reliably assess the CV safety of medications, which is of importance to regulatory science, patient safety, and public health.ObjectiveThe aim was to conduct a systematic review of algorithms to identify CV death in administrative health plan claims databases.MethodsWe searched MEDLINE, EMBASE, and Cochrane Library for English-language studies published between January 1, 2012 and October 17, 2017. We examined references in systematic reviews to identify earlier studies. Selection included any observational study using electronic health care data to evaluate the sensitivity, specificity, positive predictive value (PPV), or negative predictive value (NPV) of algorithms for CV death (sudden cardiac death [SCD], myocardial infarction [MI]-related death, or stroke-related death) among adults aged ≥ 18 years in the United States. Data were extracted by two independent reviewers, with disagreements resolved through further discussion and consensus. The Quality Assessment of Diagnostic Accuracy Studies-2 instrument was used to assess the risk of bias.ResultsFive studies (n = 4 on SCD, n = 1 on MI- and stroke-related death) were included after a review of 2053 citations. All studies reported algorithm PPVs, with incomplete reporting on other accuracy parameters. One study was at low risk of bias, three studies were at moderate risk of bias, and one study was at unclear risk of bias. Two studies identified community-occurring SCD: one identified events using International Classification of Disease, Ninth Revision (ICD-9) codes on death certificates and other criteria from medical claims (PPV = 86.8%) and the other identified events resulting in hospital presentation using first-listed ICD-9 codes on emergency department or inpatient medical claims (PPV = 92.3%). Two studies used death certificates alone to identify SCD (PPV = 27% and 32%, respectively). One study used medical claims to identify CV death (PPV = 36.4%), coronary heart disease mortality (PPV = 28.3%), and stroke mortality (PPV = 34.5%).ConclusionTwo existing algorithms based on medical claims diagnoses with or without death certificates can accurately identify SCD to support pharmacoepidemiologic studies. Developing valid algorithms identifying MI- and stroke-related death should be a research priority. PROSPERO 2017 CRD42017078745.

13 keywords...

hide…