Kennedy Nan, Nelson Sarah, Jerome Rebecca N, Edwards Terri L, Stroud Mary, Wilkins Consuelo H, Harris Paul A
Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Pain Rep. 2022 Jun 21;7(4):e1007. doi: 10.1097/PR9.0000000000001007. eCollection 2022 Jul-Aug.
Opioid misuse is at a crisis level. In response to this epidemic, the National Institutes of Health has funded $945 million in research through the Helping to End Addiction Long-term (HEAL) Pain Management Initiative, including funding to the Vanderbilt Recruitment Innovation Center (RIC) to strategize methods to catalyze participant recruitment. The RIC, recognizing the challenges presented to clinical researchers in recruiting individuals experiencing pain, conducted a review of evidence in the literature on successful participant recruitment methods for chronic pain trials, in preparation for supporting the HEAL Pain trials. Study design as it affects recruitment was reviewed, with issues such as sufficient sample size, impact of placebo, pain symptom instability, and cohort characterization being identified as problems. Potential solutions found in the literature include targeted electronic health record phenotyping, use of alternative study designs, and greater clinician education and involvement. For retention, the literature reports successful strategies that include maintaining a supportive staff, allowing virtual study visits, and providing treatment flexibility within the trial. Community input on study design to identify potential obstacles to recruitment and retention was found to help investigators avoid pitfalls and enhance trust, especially when recruiting underrepresented minority populations. Our report concludes with a description of generalizable resources the RIC has developed or adapted to enhance recruitment and retention in the HEAL Pain studies. These resources include, among others, a Recruitment and Retention Plan Template, a Competing Trials Tool, and MyCap, a mobile research application that interfaces with Research Electronic Data Capture (REDCap).
阿片类药物滥用已达到危机程度。为应对这一流行病，美国国立卫生研究院通过“帮助终结长期成瘾（HEAL）疼痛管理倡议”提供了9.45亿美元的研究资金，其中包括向范德比尔特招募创新中心（RIC）提供资金，以制定促进参与者招募的策略。RIC认识到临床研究人员在招募疼痛患者时面临的挑战，对文献中关于慢性疼痛试验成功参与者招募方法的证据进行了审查，为支持HEAL疼痛试验做准备。审查了影响招募的研究设计，发现样本量不足、安慰剂影响、疼痛症状不稳定和队列特征等问题。文献中找到的潜在解决方案包括针对性的电子健康记录表型分析、使用替代研究设计以及加强临床医生教育和参与。关于保留率，文献报道了成功的策略，包括维持支持性的工作人员、允许虚拟研究访问以及在试验中提供治疗灵活性。发现社区对研究设计的意见有助于识别招募和保留的潜在障碍，这有助于研究人员避免陷阱并增强信任，尤其是在招募代表性不足的少数族裔人群时。我们的报告最后描述了RIC开发或调整的可推广资源，以加强HEAL疼痛研究中的招募和保留。这些资源包括招募和保留计划模板、竞争试验工具以及MyCap，MyCap是一款与研究电子数据采集（REDCap）接口的移动研究应用程序。
