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Original Investigation
March 4, 2020

Agreement and Accuracy of Medication Persistence Identified by Patient Self-report vs Pharmacy Fill: A Secondary Analysis of the Cluster Randomized ARTEMIS Trial

Author Affiliations
  • 1Leonard Davis Institute of Health Economics, Penn Cardiovascular Outcomes, Quality and Evaluative Research Center, Cardiovascular Medicine Division, University of Pennsylvania, Philadelphia
  • 2Department of Medicine, Duke University, Durham, North Carolina
  • 3Duke Clinical Research Institute, Duke University, Durham, North Carolina
  • 4Cardiovascular Division, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  • 5Center for Healthcare Delivery Sciences, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  • 6The Carl and Edyth Lindner Center for Research and Education, The Christ Hospital, Cincinnati, Ohio
  • 7University of Missouri–Kansas City School of Medicine, Kansas City
  • 8AstraZeneca, Wilmington, Delaware
  • 9Division of Cardiology, Ronald Reagan UCLA Medical Center, Los Angeles, California
  • 10Associate Editor for Health Care Quality and Guidelines, JAMA Cardiology
JAMA Cardiol. Published online March 4, 2020. doi:10.1001/jamacardio.2020.0125
Key Points

Question  Pharmacy fill data are increasingly accessible to evaluate medication-taking behavior, yet how often do patient-reported and pharmacy fill–based medication persistence agree?

Findings  Of 8373 patients included in this post hoc hypothesis-driven secondary analysis of the cluster randomized ARTEMIS trial, 50.0% were concordantly persistent by both self-report and pharmacy fills, 36.5% were discordantly persistent, and 13.5% were concordantly nonpersistent. Observed rates of death, myocardial infarction, or stroke were highest for patients who were concordantly nonpersistent.

Meaning  Patient-reported and pharmacy fill–based persistence measures are frequently discordant, but patients who are nonpersistent by both methods have the worst clinical outcomes and should be prioritized for interventions to improve medication-taking behavior.

Abstract

Importance  Pharmacy fill data are increasingly accessible to clinicians and researchers to evaluate longitudinal medication persistence beyond patient self-report.

Objective  To assess the agreement and accuracy of patient-reported and pharmacy fill–based medication persistence.

Design, Setting, and Participants  This post hoc analysis of the cluster randomized clinical trial ARTEMIS (Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) enrolled patients at 287 US hospitals (131 randomized to intervention and 156 to usual care) from June 5, 2015, to September 30, 2016, with 1-year follow-up and blinded adjudication of major adverse cardiovascular events. In total, 8373 patients with myocardial infarction and measurement of P2Y12 inhibitor persistence by both patient self-report and pharmacy data were included. Serum P2Y12 inhibitor drug levels were measured for 944 randomly selected patients. Data were analyzed from May 2018 to November 2019.

Interventions  Patients treated at intervention-arm hospitals received study vouchers to offset copayments at each P2Y12 inhibitor fill for 1 year after myocardial infarction.

Main Outcomes and Measures  Nonpersistence was defined as a gap of 30 days or more in P2Y12 inhibitor use (patient report) or supply (pharmacy fill) and as serum P2Y12 inhibitor levels below the lower limit of quantification (drug level). Among patients in the intervention arm, a “criterion standard” definition of nonpersistence was a gap of 30 days or more in P2Y12 inhibitor use by both voucher use and pharmacy fill. Major adverse cardiovascular events were defined as adjudicated death, recurrent myocardial infarction, or stroke.

Results  Of 8373 patients included in this analysis, the median age was 62 years (interquartile range, 54-70 years), 5664 were men (67.7%), and 990 (11.8%) self-reported as nonwhite race/ethnicity. One-year estimates of medication nonpersistence rates were higher using pharmacy fills (4042 patients [48.3%]) compared with patient self-report (1277 patients [15.3%]). Overall, 4185 patients (50.0%) were persistent by both pharmacy fill data and patient report, 1131 patients (13.5%) were nonpersistent by both, and 3057 patients (36.5%) were discordant. By application of the criterion standard definition, the 1-year nonpersistence rate was 1184 of 3703 patients (32.0%); 892 of 3318 patients (26.9%) in the intervention arm who self-reported persistence were found to be nonpersistent, and 303 of 1487 patients (20.4%) classified as nonpersistent by pharmacy fill data were actually persistent. Agreement between serum P2Y12 inhibitor drug levels and either patient-reported (κ = 0.11-0.23) or fill-based (κ = 0.00-0.19) persistence was poor. Patients who were nonpersistent by both pharmacy fill data and self-report had the highest 1-year major adverse cardiac event rate (18.3%; 95% CI, 16.0%-20.6%) compared with that for discordant patients (9.7%; 8.7%-10.8%) or concordantly persistent patients (8.2%; 95% CI, 7.4%-9.0%).

Conclusions and Relevance  Patient report overestimated medication persistence rates, and pharmacy fill data underestimated medication persistence rates. Patients who are nonpersistent by both methods have the worst clinical outcomes and should be prioritized for interventions that improve medication-taking behavior.

Trial Registration  ClinicalTrials.gov Identifier: NCT02406677

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