VA Cooperative Studies Program Coordinating Center, Boston, Massachusetts.
Department of Radiation Oncology, School of Medicine, Case Western Reserve University, Cleveland, Ohio.
JAMA Netw Open. 2023 Sep 5;6(9):e2332049. doi: 10.1001/jamanetworkopen.2023.32049.
Participant diversity is important for reducing study bias and increasing generalizability of comparative effectiveness research.
Demonstrate the operational efficiency of a centralized electronic health record (EHR)-based model for recruiting difficult-to-reach participants in a pragmatic trial.
DESIGN, SETTING, AND PARTICIPANTS: This comparative effectiveness study was a secondary analysis of Diuretic Comparison Project, a randomized clinical trial conducted between 2016 and 2022 (mean [SD] follow-up, 2.4 [1.4] years) comparing 2 commonly prescribed antihypertensives, which used an EHR-based recruitment model. Electronic study workflows, in tandem with routine clinical practice, were adapted by 72 Veteran Affairs (VA) primary care networks. Data were analyzed from August to December 2022.
Measures reflecting recruitment capacity (monthly rate), operational efficiency (median time for completion of electronic procedures), and geographic reach (percentage of patients recruited from rural areas) were examined.
A total of 13 523 patients with hypertension (mean [SD] age, 72 [5.4] years; 13 092 male [96.8%]) were recruited from 537 outpatient clinics. Approximately 205 patients were randomized per month and a median of 35 days (Q1-Q3, 23-80 days) was needed to complete electronic recruitment. The annual income was below the national median for 69% of the cohort. Patients from all 50 states, Puerto Rico, and the District of Columbia were included and 45% resided in rural areas.
In this secondary analysis of a multicenter pragmatic trial, a centralized EHR-based recruitment model was associated with improved participation from underrepresented groups. These participants often are difficult to reach, with their exclusion potentially biasing trial results; eliminating in-person study visits and local site involvement can minimize barriers for the recruitment of patients from rural and lower socioeconomic areas.
The Diuretic Comparison Project (DCP) was registered on ClinicalTrials.gov Identifier: NCT02185417.
参与者多样性对于减少研究偏倚和提高比较有效性研究的普遍性非常重要。
展示一种集中式电子健康记录 (EHR) 为基础的模型在实用试验中招募难以接触的参与者的操作效率。
设计、地点和参与者：这项比较有效性研究是利尿剂比较项目 (Diuretic Comparison Project) 的二次分析，这是一项在 2016 年至 2022 年期间进行的随机临床试验 (平均 [标准差] 随访时间为 2.4 [1.4] 年)，比较了两种常用的抗高血压药物，该研究使用了基于 EHR 的招募模型。电子研究工作流程与常规临床实践相结合，被 72 个退伍军人事务部 (VA) 初级保健网络所采用。数据于 2022 年 8 月至 12 月进行分析。
评估了反映招募能力的指标（每月招募率）、操作效率（完成电子程序的中位数时间）和地理范围（从农村地区招募的患者比例）。
从 537 个门诊诊所招募了 13523 名高血压患者（平均 [标准差] 年龄为 72 [5.4] 岁；13092 名男性 [96.8%]）。每月约有 205 名患者被随机分配，完成电子招募需要中位数 35 天（四分位间距，23-80 天）。队列中 69%的人的年收入低于全国中位数。包括来自所有 50 个州、波多黎各和哥伦比亚特区的患者，45%的患者居住在农村地区。
在这项多中心实用试验的二次分析中，集中式基于 EHR 的招募模型与代表性不足的群体的参与度提高有关。这些参与者通常难以接触，他们的排除可能会使试验结果产生偏差；消除面对面的研究访问和当地机构的参与，可以最大限度地减少招募农村和低社会经济地区患者的障碍。
利尿剂比较项目 (DCP) 在 ClinicalTrials.gov 上注册，标识符为 NCT02185417。
