Leonard Davis Institute of Health Economics, Penn Cardiovascular Outcomes, Quality and Evaluative Research Center, Cardiovascular Medicine Division, University of Pennsylvania, Philadelphia.
Department of Medicine, Duke University, Durham, North Carolina.
JAMA Cardiol. 2020 May 1;5(5):532-539. doi: 10.1001/jamacardio.2020.0125.
Pharmacy fill data are increasingly accessible to clinicians and researchers to evaluate longitudinal medication persistence beyond patient self-report.
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.
Patients treated at intervention-arm hospitals received study vouchers to offset copayments at each P2Y12 inhibitor fill for 1 year after myocardial infarction.
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.
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%).
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.
ClinicalTrials.gov Identifier: NCT02406677.
药剂师配药数据越来越容易被临床医生和研究人员获取，用于评估超出患者自我报告范围的长期药物持续使用情况。
评估患者报告和药剂师配药数据的药物持续使用的一致性和准确性。
设计、地点和参与者：这项对随机临床试验 ARTEMIS（心肌梗死后的负担能力和真实世界抗血小板治疗效果研究）的事后分析纳入了 287 家美国医院的 8373 名患者（131 名随机分配到干预组，156 名分配到常规护理组），从 2015 年 6 月 5 日至 2016 年 9 月 30 日进行为期 1 年的随访，并对主要不良心血管事件进行盲法裁决。共有 8373 名心肌梗死患者通过患者报告和药房数据测量了 P2Y12 抑制剂的持续使用情况。对 944 名随机患者进行了血清 P2Y12 抑制剂药物水平检测。数据分析于 2018 年 5 月至 2019 年 11 月进行。
在干预组医院接受治疗的患者在心肌梗死后的 1 年内，每次使用 P2Y12 抑制剂时都会获得研究优惠券，以抵消共付额。
非持续使用定义为 P2Y12 抑制剂使用（患者报告）或供应（药房配药）中断 30 天或以上，以及血清 P2Y12 抑制剂水平低于定量下限（药物水平）。在干预组的患者中，非持续使用的“标准”定义是使用优惠券和药房配药的 P2Y12 抑制剂使用中断 30 天或以上。主要不良心血管事件定义为经裁决的死亡、复发性心肌梗死或中风。
在这项分析中，8373 名患者的中位年龄为 62 岁（四分位距，54-70 岁），5664 名男性（67.7%），990 名（11.8%）自我报告为非白种人/族裔。使用药房配药数据估计的药物非持续使用率（4042 名患者[48.3%]）高于患者报告（1277 名患者[15.3%]）。总体而言，4185 名患者（50.0%）通过药房配药数据和患者报告均为持续使用，1131 名患者（13.5%）在两种方法中均为非持续使用，3057 名患者（36.5%）为不一致。根据标准定义的应用，1 年非持续使用率为 3703 名患者中的 1184 名（32.0%）；在报告持续使用的 3318 名患者中，有 269 名（26.9%）在干预组中被发现是非持续使用的，在被归类为非持续使用的 1487 名患者中，有 303 名（20.4%）实际上是持续使用的。血清 P2Y12 抑制剂药物水平与患者报告（κ=0.11-0.23）或基于配药数据的（κ=0.00-0.19）持续使用之间的一致性较差。在两种方法中均为非持续使用的患者在 1 年内的主要不良心脏事件发生率最高（18.3%；95%CI，16.0%-20.6%），与不一致的患者（9.7%；8.7%-10.8%）或一致持续使用的患者（8.2%；95%CI，7.4%-9.0%）相比。
患者报告高估了药物持续使用的比率，而药剂师配药数据低估了药物持续使用的比率。在两种方法中均为非持续使用的患者的临床结局最差，应优先采取干预措施，以改善用药行为。
ClinicalTrials.gov 标识符：NCT02406677。
