背景:在临床试验中保留参与者是一个既定的挑战。目前,该行业正在转向以技术为媒介的,运行试验的分散模型。这一转变为技术设计提供了一个机会,以帮助参与者体验并促进保留;然而,关于如何最好地支持这一点,还有许多悬而未决的问题。我们主张采用更强大的理论立场,以提高临床试验技术的设计决策质量,以促进参与者的参与。
目的:本研究旨在确定和分析已发表的临床试验中成功保留参与者的保留策略类型。
方法:对6个电子数据库进行了系统的范围审查,内容为1990年至2020年9月发表的文章,namelyCINAHL,科克伦图书馆,EBSCO,Embase,PsycINFO,和PubMed,使用“保留”概念,“\”战略,\“\”临床试验,“和”临床研究。“接下来是通过自决理论的视角对所包含的文章进行分析,基于证据的人类动机理论。
结果:本文共纳入26篇文献。在我们样本的临床试验中确定的动机策略分为8个主题:自主性;能力;相关性;受控动机;品牌,通信材料,和营销文献;联系人,跟踪,和调度方法和数据收集;便于数据收集;和组织能力。这些试验使用了广泛的动机策略。值得注意的是,这些试验通常依赖于控制动机干预和未充分利用的策略来支持内在动机.此外,传统的临床试验在很大程度上依赖于人的互动和“相关性”来支持动机和保留,这可能会在转向以技术为主导的分散试验中造成问题。我们发现数据报告方法不一致,基于动机理论的方法在策略设计中并不明显。
结论:本研究为指导未来分散临床试验的数字技术设计决策提供了方向和框架,以增强临床试验期间的参与者保留率。这项研究根据参与者的动机定义了以前的临床试验保留策略,确定激励策略,并提供了选择可以提高保留率的策略的理由。它强调使用理论框架来分析战略方法和辅助决策以提高技术设计决策质量的好处。
Retaining participants in clinical trials is an established challenge. Currently, the industry is moving to a technology-mediated, decentralized model for running trials. The shift presents an opportunity for technology design to aid the participant experience and promote retention; however, there are many open questions regarding how this can be best supported. We advocate the adoption of a stronger theoretical position to improve the quality of design decisions for clinical trial technology to promote participant engagement.
This study aimed to identify and analyze the types of retention strategies used in published clinical trials that successfully retain participants.
A systematic scoping
review was carried out on 6 electronic databases for articles published from 1990 to September 2020, namely CINAHL, The Cochrane Library, EBSCO, Embase, PsycINFO, and PubMed, using the concepts \"retention,\" \"strategy,\" \"clinal trial,\" and \"clinical research.\" This was followed by an analysis of the included articles through the lens of self-determination theory, an evidence-based theory of human motivation.
A total of 26 articles were included in this
review. The motivational strategies identified in the clinical trials in our sample were categorized into 8 themes: autonomy; competence; relatedness; controlled motivation; branding, communication material, and marketing literature; contact, tracking, and scheduling methods and data collection; convenience to contribute to data collection; and organizational competence. The trials used a wide range of motivational strategies. Notably, the trials often relied on controlled motivation interventions and underused strategies to support intrinsic motivation. Moreover, traditional clinical trials relied heavily on human interaction and \"relatedness\" to support motivation and retention, which may cause problems in the move to technology-led decentralized trials. We found inconsistency in the data-reporting methods and that motivational theory-based approaches were not evident in strategy design.
This study offers direction and a framework to guide digital technology design decisions for future decentralized clinical trials to enhance participant retention during clinical trials. This research defines previous clinical trial retention strategies in terms of participant motivation, identifies motivational strategies, and offers a rationale for selecting strategies that will improve retention. It emphasizes the benefits of using theoretical frameworks to analyze strategic approaches and aid decision-making to improve the quality of technology design decisions.