Department of Public Health & Preventive Medicine, SUNY Upstate Medical University, Syracuse, NY, United States.
Southern California Clinical and Translational Science Institute, Keck School of Medicine of USC, University of Southern California, Los Angeles, CA, United States.
J Med Internet Res. 2021 Oct 13;23(10):e28923. doi: 10.2196/28923.
Participant recruitment remains a barrier to conducting clinical research. The disabling nature of a stroke, which often includes functional and cognitive impairments, and the acute stage of illness at which patients are appropriate for many trials make recruiting patients particularly complex and challenging. In addition, people aged 65 years and older, which includes most stroke survivors, have been identified as a group that is difficult to reach and is commonly underrepresented in health research, particularly clinical trials. Digital media may provide effective tools to support enrollment efforts of stroke survivors in clinical trials.
The objective of this study was to compare the effectiveness of general practice (traditional) and digital (online) methods of recruiting stroke survivors to a clinical mobility study.
Recruitment for a clinical mobility study began in July 2018. Eligible study participants included individuals 18 years and older who had a single stroke and were currently ambulatory in the community. General recruiting practice included calling individuals listed in a stroke registry, contacting local physical therapists, and placing study flyers throughout a university campus. Between May 21, 2019, and June 26, 2019, the study was also promoted digitally using the social network Facebook and the search engine marketing tool Google AdWords. The recruitment advertisements (ads) included a link to the study page to which users who clicked were referred. Primary outcomes of interest for both general practice and digital methods included recruitment speed (enrollment rate) and sample characteristics. The data were analyzed using the Lilliefors test, the Welch two-sample t test, and the Mann-Whitney test. Significance was set at P=.05. All statistical analyses were performed in MATLAB 2019b.
Our results indicate that digital recruitment methods can address recruitment challenges regarding stroke survivors. Digital recruitment methods allowed us to enroll study participants at a faster rate (1.8 participants/week) compared to using general practice methods (0.57 participants/week). Our findings also demonstrate that digital and general recruitment practices can achieve an equivalent level of sample representativeness. The characteristics of the enrolled stroke survivors did not differ significantly by age (P=.95) or clinical scores (P=.22; P=.82). Comparing the cost-effectiveness of Facebook and Google, we found that the use of Facebook resulted in a lower cost per click and cost per enrollee per ad.
Digital recruitment can be used to expedite participant recruitment of stroke survivors compared to more traditional recruitment practices, while also achieving equivalent sample representativeness. Both general practice and digital recruitment methods will be important to the successful recruitment of stroke survivors. Future studies could focus on testing the effectiveness of additional general practice and digital media approaches and include robust cost-effectiveness analyses. Examining the effectiveness of different messaging and visual approaches tailored to culturally diverse and underrepresented target subgroups could provide further data to move toward evidence-based recruitment strategies.
参与者招募仍然是开展临床研究的一个障碍。中风的致残性质，包括功能和认知障碍，以及患者适合许多试验的急性阶段，使得招募患者变得特别复杂和具有挑战性。此外，年龄在 65 岁及以上的人群（包括大多数中风幸存者）被确定为一个难以接触到的群体，并且在健康研究中，特别是临床试验中普遍代表性不足。数字媒体可能提供有效的工具来支持中风幸存者参与临床试验。
本研究的目的是比较传统的一般实践（传统）和数字（在线）方法招募中风幸存者参加一项移动性临床研究的效果。
一项移动性临床研究的招募工作于 2018 年 7 月开始。合格的研究参与者包括年龄在 18 岁及以上、单次中风且目前在社区中能走动的个体。一般招募实践包括致电中风登记处列出的个人、联系当地物理治疗师，并在大学校园各处张贴研究传单。2019 年 5 月 21 日至 2019 年 6 月 26 日，还使用社交网络 Facebook 和搜索引擎营销工具 Google AdWords 进行了数字推广。招募广告（ads）包括指向研究页面的链接，点击该链接的用户将被引导至该页面。一般实践和数字方法的主要研究结果包括招募速度（入组率）和样本特征。使用 Lilliefors 检验、Welch 两样本 t 检验和 Mann-Whitney 检验分析数据。设 P=.05 为显著性水平。所有统计分析均在 MATLAB 2019b 中进行。
我们的研究结果表明，数字招募方法可以解决与中风幸存者有关的招募挑战。与使用一般实践方法（0.57 名/周）相比，数字招募方法允许我们以更快的速度招募研究参与者（1.8 名/周）。我们的研究结果还表明，数字和一般招募实践可以实现等效的样本代表性。入组中风幸存者的特征在年龄（P=.95）或临床评分（P=.22；P=.82）方面无显著差异。比较 Facebook 和 Google 的成本效益，我们发现 Facebook 的每次点击成本和每位参与者的每次招募成本更低。
与更传统的招募实践相比，数字招募可以加快中风幸存者的参与者招募速度，同时也能达到等效的样本代表性。一般实践和数字招募方法对于成功招募中风幸存者都很重要。未来的研究可以集中测试其他一般实践和数字媒体方法的有效性，并包括稳健的成本效益分析。研究不同的信息传递和视觉方法的有效性，针对文化多样和代表性不足的目标亚组进行定制，可能会提供更多数据，以推动基于证据的招募策略。
