Coffey Taylor, Young Naomi, Gillies Katie
Aberdeen Centre for Evaluation, University of Aberdeen, Foresterhill, UK.
Trials. 2025 Mar 25;26(1):104. doi: 10.1186/s13063-025-08808-8.
Clinical trials provide much of the evidence that guides decision making about treatment and care but are often complicated to deliver. Trials can be thought of as complex systems with interacting individuals, as such behavioural science is a useful lens to investigate how trial processes may be improved. To guide selection of an appropriate behavioural theory, model, or framework to further enhance trial processes, we sought to map their past application within the design, conduct, analysis and reporting of clinical trials.
A scoping review to investigate the breadth of trials methods research that has utilised a behavioural theory, model, or framework was conducted through a database search and citation analysis. Publications investigating any part of the trial lifecycle (from design to reporting) through a behavioural lens were included. Data were extracted from each study and organised thematically to summarise trends in behavioural approach application within different trial-related behaviours and contexts.
A total of 96 studies were included. A majority of these (n = 93, 97%) investigated trial conduct processes, such as recruitment and retention. A total of 23 unique theories, models or frameworks were identified. Three behavioural theories, models or frameworks, the Theory of Planned Behaviour (n = 23, 24%), Social Cognitive Theory (n = 12, 13%) and the Theoretical Domains Framework (n = 30, 31%), accounted for more than two-thirds of those utilised. When compared to key stages of the Knowledge to Action cycle, approaches reported in included studies were most often utilised to "Identify a problem" within trials (n = 40, 42%).
A wide variety of behavioural approaches to investigate trial conduct were identified. However, the trial processes studied were focused within trial recruitment and largely used a select number approaches. Future research should assess whether these approaches are fit for purpose, as well as prioritising other trial areas for methods research.
临床试验提供了许多指导治疗和护理决策的证据，但实施起来往往很复杂。试验可以被视为个体相互作用的复杂系统，因此行为科学是研究如何改进试验过程的有用视角。为了指导选择合适的行为理论、模型或框架以进一步优化试验过程，我们试图梳理它们过去在临床试验的设计、实施、分析和报告中的应用情况。
通过数据库搜索和引文分析，进行了一项范围综述，以调查利用行为理论、模型或框架的试验方法研究的广度。纳入了通过行为视角研究试验生命周期任何部分（从设计到报告）的出版物。从每项研究中提取数据，并按主题进行整理，以总结在不同试验相关行为和背景下行为方法应用的趋势。
共纳入96项研究。其中大多数（n = 93，97%）研究了试验实施过程，如招募和保留。总共确定了23种独特的理论、模型或框架。三种行为理论、模型或框架，即计划行为理论（n = 23，24%）、社会认知理论（n = 12，13%）和理论领域框架（n = 30，31%），占使用总数的三分之二以上。与知识转化为行动周期的关键阶段相比，纳入研究中报告的方法最常被用于在试验中“识别问题”（n = 40，42%）。
确定了多种用于研究试验实施的行为方法。然而，所研究的试验过程集中在试验招募方面，并且在很大程度上使用了少数几种方法。未来的研究应评估这些方法是否适用，以及优先考虑其他试验领域进行方法研究。
