Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Berlin, Germany.
Center for Musculoskeletal Surgery, Charité-University Medicine Berlin, Berlin, Germany.
J Am Geriatr Soc. 2020 Dec;68(12):2955-2963. doi: 10.1111/jgs.16875. Epub 2020 Oct 19.
To identify barriers and solutions for the recruitment and retention of older (aged ≥65 years) people in clinical trials.
Systematic literature review.
Three databases (Medline, Embase, and CENTRAL) were searched for articles reporting on barriers or solutions regarding the recruitment or retention of older people. Only original research articles were included.
Fifty eligible articles were identified. Exclusion criteria were the most common cause of poor recruitment of older adults (mainly age and comorbidities). Patients' families or physicians often advised against participation (22% of included studies). Lack of interest (18%) and problems with transportation (18%) were also commonly cited as challenges. Fourteen trials (28%) reported that monitoring and adapting their recruitment methods helped, along with a flexible research team (26%) and provision of transportation (24%). Retention was impaired by death (12%), illness (8%), and loss of interest (6%). Methods with a positive effect on retention included financial incentives and regular information about the progress of the study (12%), a low staff turnover (12%), flexibility in appointment making (10%), and expression of appreciation by the staff through letters, gifts, and cards to the participants (10%).
We identified several barriers and have listed potential solutions that may improve recruitment and lead to fewer dropouts in trials involving older populations. Implementation of our findings may help mitigate the manifold challenges that come with running a trial with older people.
确定招募和保留老年(年龄≥65 岁)人群参与临床试验的障碍和解决方案。
系统文献回顾。
在 Medline、Embase 和 CENTRAL 三个数据库中搜索报告有关招募或保留老年人的障碍或解决方案的文章。仅纳入原始研究文章。
确定了 50 篇符合条件的文章。排除标准是导致招募老年人效果不佳的最常见原因(主要是年龄和合并症)。患者家属或医生经常建议他们不要参与(22%的纳入研究)。缺乏兴趣(18%)和交通问题(18%)也是常见的挑战。14 项试验(28%)报告说,监测和调整他们的招募方法有帮助,同时还有灵活的研究团队(26%)和提供交通(24%)。死亡(12%)、疾病(8%)和失去兴趣(6%)会导致保留率受损。对保留率有积极影响的方法包括经济奖励和定期提供研究进展信息(12%)、低员工流动率(12%)、灵活安排预约(10%)以及通过信件、礼物和卡片向参与者表达感谢(10%)。
我们确定了一些障碍,并列出了可能改善招募并减少老年人群体参与试验的脱落率的潜在解决方案。实施我们的发现可能有助于减轻与开展老年人试验相关的多种挑战。