Communication Science, University of Amsterdam, 1001 NH Amsterdam, The Netherlands.
Institute of Medical Sociology, Health Services Research and Rehabilitation Science, University of Cologne, 50933 Köln, Germany.
Int J Environ Res Public Health. 2020 Mar 14;17(6):1886. doi: 10.3390/ijerph17061886.
Randomized controlled trials (RCTs) are regarded as the most internally valid means of estimating the effectiveness of complex public health interventions, but the recruitment of participants can be difficult. The aim of this study was to explore factors that may have affected the recruitment of employees with musculoskeletal disorders (MSDs) to a multicenter worksite health promotion program from the perspective of recruiting case managers.
Factors in recruitment to the RCT were explored using three focus group discussions with case managers. Data were processed using MAXQDA and analyzed with a combination of content and sequence analysis.
Findings showed that randomization is a major challenge for recruitment. Case managers adapted their communication with, and approaches to possible participants because of the randomization design and employed coping strategies to compensate for allocation into the control arm of the study. Perceptions of the superiority of the intervention group over the control group, perceptions of the (mis)match of participants to one of the groups, as well as the understanding of the necessity of randomization for effectiveness evaluations, further affected recruitment. Perceived expectations of possible participants and their (emotional) reactions to the randomization allocation also complicated recruitment.
We were able to gain insight into the challenges of randomization for the recruitment of participants to a multicenter RCT. This study assisted the development of strategies to overcome barriers in the ongoing implementation process of the trial (i.e., the adaption of best practice information sheets and newsletters). There remains a need to develop effective interventions to help those recruiting to trials.
随机对照试验 (RCT) 被认为是估计复杂公共卫生干预措施有效性的最具内部有效性的方法，但参与者的招募可能很困难。本研究的目的是从招募案例经理的角度探讨影响肌肉骨骼疾病 (MSD) 员工参与多中心工作场所健康促进计划的因素。
使用与案例经理的三次焦点小组讨论来探讨 RCT 中的招募因素。使用 MAXQDA 对数据进行处理，并结合内容和序列分析进行分析。
研究结果表明，随机化是招募的主要挑战。由于随机设计，案例经理调整了他们与可能参与者的沟通方式和方法，并采用了应对策略来弥补研究对照组的分配。对干预组优于对照组的看法、对参与者与其中一组的（不）匹配的看法，以及对随机化对于效果评估的必要性的理解，进一步影响了招募。可能参与者的感知期望及其对随机分配的（情绪）反应也使招募复杂化。
我们能够深入了解随机化对多中心 RCT 参与者招募的挑战。本研究有助于制定策略来克服试验实施过程中的障碍（即最佳实践信息表和通讯的调整）。仍需要开发有效的干预措施来帮助那些参与试验的人。
