Department of Pediatrics, Division of Pediatric Endocrinology, Stanford University, Stanford, California, USA
Department of Pediatrics, Stanford Diabetes Research Center, Stanford, California, USA.
BMJ Open. 2023 Aug 30;13(8):e072546. doi: 10.1136/bmjopen-2023-072546.
Individuals under-recruited in diabetes research studies include those not seen at endocrinology centres and those from rural, low socioeconomic and/or under-represented racial/ethnic groups. The purpose of this descriptive analysis is to detail recruitment and retention efforts of Project ECHO Diabetes clinical sites affiliated with Stanford University and University of Florida.
Prospective collection of participant engagement and qualitative analysis of barriers and facilitators of research engagement within Project ECHO Diabetes, a virtual tele-education programme for healthcare providers in the management of individuals with insulin-requiring diabetes.
Data were collected at the patient level, provider level and clinic level between 1 May 2021 and 31 July 2022.
Participants and study personnel were recruited from 33 Project ECHO Diabetes sites in California and Florida.
We report study completion rates for participants recruited into 33 Project ECHO Diabetes sites. Using barrier analysis, a methodology designed for the real-time assessment of interventions and system processes to identify barriers and facilitators, study personnel identified significant barriers to recruitment and retention and mapped them to actionable solutions.
In total, 872 participants (California n=495, Florida n=377) were recruited with differing recruitment rates by site (California=52.7%, Florida=21.5%). Barrier analysis identified lack of trust, unreliable contact information, communication issues and institutional review board (IRB) requirements as key recruitment barriers. Culturally congruent staff, community health centre (CHC) support, adequate funding and consent process flexibility were solutions to address recruitment challenges. Barriers to retention were inconsistent postal access, haemoglobin A1c kit collection challenges, COVID-19 pandemic and broadband/connectivity issues. Additional funding supporting research staff and analogue communication methods were identified as solutions address barriers to retention.
Funded partnerships with CHCs, trusted by their local communities, were key in our recruitment and retention strategies. IRB consent process flexibility reduced barriers to recruitment. Recruiting historically under-represented populations is feasible with funding aimed to address structural barriers to research participation.
在糖尿病研究中招募不足的人群包括未在内分泌中心就诊的人群以及来自农村、社会经济水平较低和/或代表性不足的种族/民族群体的人群。本描述性分析的目的是详细介绍斯坦福大学和佛罗里达大学附属 ECHO 糖尿病项目临床站点的招募和保留工作。
前瞻性收集参与情况，并对 ECHO 糖尿病项目（针对需要胰岛素治疗的糖尿病患者管理的医疗保健提供者的虚拟远程教育计划）中研究参与的障碍和促进因素进行定性分析。
数据于 2021 年 5 月 1 日至 2022 年 7 月 31 日在患者、提供者和诊所层面收集。
参与者和研究人员来自加利福尼亚州和佛罗里达州的 33 个 ECHO 糖尿病项目。
我们报告了 33 个 ECHO 糖尿病项目中招募的参与者的研究完成率。使用障碍分析（一种旨在实时评估干预措施和系统流程以识别障碍和促进因素的方法），研究人员确定了招募和保留的重大障碍，并将其映射到可操作的解决方案上。
共有 872 名参与者（加利福尼亚州 495 名，佛罗里达州 377 名）被招募，各站点的招募率不同（加利福尼亚州 52.7%，佛罗里达州 21.5%）。障碍分析确定缺乏信任、不可靠的联系信息、沟通问题和机构审查委员会（IRB）要求是招募的主要障碍。具有文化一致性的员工、社区健康中心（CHC）支持、充足的资金和同意书流程灵活性是解决招募挑战的方法。保留的障碍是不一致的邮政访问、糖化血红蛋白试剂盒收集挑战、COVID-19 大流行和宽带/连接问题。确定额外的资金支持研究人员和模拟通信方法是解决保留障碍的方法。
与 CHC 建立资金合作伙伴关系，这些 CHC 受到当地社区的信任，是我们招募和保留策略的关键。IRB 同意书流程的灵活性降低了招募的障碍。通过为解决研究参与的结构性障碍提供资金，招募历史上代表性不足的人群是可行的。
