Background:

Research participant engagement, which we define as recruitment and retention in clinical trials, is a costly and challenging issue in clinical research. Research teams have leveraged a variety of strategies to increase research participant engagement in clinical trials, although a framework and evidence for effective participant engagement strategies are lacking. We (1) developed a novel conceptual framework for strategies used to recruit and retain participants in clinical trials based on their underlying behavioral principles and (2) categorized empirically tested recruitment and retention strategies in this novel framework.

Methods:

We conducted a synthetic analysis of interventions tested in studies from two Cochrane reviews on clinical trial recruitment and retention, which included studies from 1986 to 2015. We developed a conceptual framework of behavioral strategies for increasing research participant engagement using deductive and inductive approaches with the studies included in the Cochrane reviews. Reviewed interventions were then categorized using this framework. We examined the results of reviewed interventions and categorized the effects on clinical trial recruitment and retention as significantly positive, null, or significantly negative; summary statistics are presented for the frequency and effects of each behavioral strategy type.

Results:

We analyzed 141 unique interventions across 96 studies: 91 interventions targeted clinical trial research participant recruitment and 50 targeted retention. Our framework included 14 behavioral strategies to improve research participant engagement grouped into four general approaches: changing attitudes by appealing to social motivators, changing attitudes by targeting individual psychology, reducing barriers and cognitive burdens, and providing incentives. The majority of interventions (54%) aimed to reduce barriers or cognitive burdens, with improving comprehension (27%) as the most common specific strategy identified. For recruitment, the most common behavioral strategies tested were building legitimacy or trust (38%) and framing risks and benefits (32%), while financial or material incentives (32%) and reducing financial, time, and social barriers (32%) were most common for retention interventions. Among interventions tested in randomized controlled trials, 51% had a null effect on research participant engagement, and 30% had a statistically significant positive effect.

Discussion:

Clinical researchers have tested a wide range of interventions that leverage distinct behavioral strategies to achieve improved research participant recruitment and retention. Common behavioral strategies include building legitimacy or trust between research teams and participants, as well as improving participant comprehension of trial objectives and procedures. The high frequency of null effects among tested interventions suggests challenges in selecting the optimal interventions for increasing research participant engagement, although the proposed behavioral strategy categories can serve as a conceptual framework for developing and testing future interventions.

中文翻译：

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研究参与者参与的策略：综合审查和概念框架

背景：

研究参与者参与，我们将其定义为临床试验中的招募和保留，是临床研究中一个代价高昂且具有挑战性的问题。尽管缺乏有效的参与者参与策略的框架和证据，但研究团队已经利用各种策略来增加研究参与者对临床试验的参与。我们 (1) 开发了一个新的概念框架，用于根据他们的基本行为原则在临床试验中招募和留住参与者的策略，以及 (2) 在这个新框架中对经过经验测试的招募和留住策略进行分类。

方法：

我们对两项关于临床试验招募和保留的 Cochrane 综述的研究中测试的干预措施进行了综合分析，其中包括 1986 年至 2015 年的研究。纳入 Cochrane 评价。然后使用该框架对审查的干预措施进行分类。我们检查了审查干预措施的结果，并将对临床试验招募和保留的影响分类为显着阳性、无效或显着阴性；提供了每种行为策略类型的频率和效果的汇总统计数据。

结果：

我们分析了 96 项研究中的 141 项独特干预措施：91 项干预措施针对临床试验研究参与者招募，50 项干预措施有针对性地保留。我们的框架包括14个行为策略，以提高研究的参与者参与分为四大途径：通过吸引社会激励改变态度，通过针对个人心理改变态度，减少障碍和认知负担，并提供奖励. 大多数干预措施 (54%) 旨在减少障碍或认知负担，提高理解能力 (27%) 是最常见的具体策略。对于招聘，测试的最常见的行为策略是建立合法性或信任 (38%) 和制定风险和收益 (32%)，而财务或物质激励 (32%) 以及减少财务、时间和社会障碍 (32%)最常见于保留干预措施。在随机对照试验中测试的干预措施中，51% 的干预对研究参与者的参与没有影响，30% 有统计学上显着的积极影响。

讨论：

临床研究人员已经测试了广泛的干预措施，这些干预措施利用不同的行为策略来改善研究参与者的招募和保留。常见的行为策略包括在研究团队和参与者之间建立合法性或信任，以及提高参与者对试验目标和程序的理解。尽管提议的行为策略类别可以作为开发和测试未来干预措施的概念框架，但测试干预措施中无效效应的高频率表明在选择最佳干预措施以增加研究参与者参与方面存在挑战。