Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 201B, Ottawa, ON, K1H 8L6, Canada.
School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
Trials. 2021 Apr 21;22(1):298. doi: 10.1186/s13063-021-05257-x.
Clinical trial recruitment is a continuing challenge for medical researchers. Previous efforts to improve study recruitment have rarely been informed by theories of human decision making and behavior change. We investigate the trial recruitment strategies reported by study recruiters, guided by two influential theoretical frameworks: shared decision-making (SDM) and the Theoretical Domains Framework (TDF) in order to explore the utility of these frameworks in trial recruitment.
We interviewed all nine active study recruiters from a multi-site, open-label pilot trial assessing the feasibility of a large-scale randomized trial. Recruiters were primarily nurses or master's-level research assistants with a range of 3 to 30 years of experience. The semi-structured interviews included questions about the typical recruitment encounter, questions concerning the main components of SDM (e.g. verifying understanding, directive vs. non-directive style), and questions investigating the barriers to and drivers of their recruitment activities, based on the TDF. We used directed content analysis to code quotations into TDF domains, followed by inductive thematic analysis to code quotations into sub-themes within domains and overarching themes across TDF domains. Responses to questions related to SDM were aggregated according to level of endorsement and informed the thematic analysis.
The analysis helped to identify 28 sub-themes across 11 domains. The sub-themes were organized into six overarching themes: coordinating between people, providing guidance to recruiters about challenges, providing resources to recruiters, optimizing study flow, guiding the recruitment decision, and emphasizing the benefits to participation. The SDM analysis revealed recruiters were able to view recruitment interactions as successful even when enrollment did not proceed, and most recruiters took a non-directive (i.e. providing patients with balanced information on available options) or mixed approach over a directive approach (i.e. focus on enrolling patient in study). Most of the core SDM constructs were frequently endorsed.
Identified sub-themes can be linked to TDF domains for which effective behavior change interventions are known, yielding interventions that can be evaluated as to whether they improve recruitment. Despite having no formal training in shared decision-making, study recruiters reported practices consistent with many elements of SDM. The development of SDM training materials specific to trial recruitment could improve the informed decision-making process for patients.
临床试验招募对于医学研究人员来说是一个持续存在的挑战。以前提高研究招募效果的努力很少受到人类决策和行为改变理论的指导。我们根据两个有影响力的理论框架：共享决策（SDM）和理论领域框架（TDF），调查研究招募者报告的试验招募策略，以探索这些框架在试验招募中的效用。
我们采访了来自一项多地点、开放标签试点试验的九位活跃研究招募者，该试验评估了一项大规模随机试验的可行性。招募者主要是护士或硕士级别的研究助理，经验从 3 年到 30 年不等。半结构化访谈包括有关典型招募遭遇的问题、有关 SDM 的主要组成部分的问题（例如，验证理解、指导与非指导风格），以及根据 TDF 调查招募活动的障碍和驱动因素的问题。我们使用有针对性的内容分析将引语编码到 TDF 领域中，然后进行归纳主题分析，将引语编码到领域内的子主题和 TDF 领域的总体主题中。与 SDM 相关的问题的回答根据认可程度进行汇总，并为主题分析提供信息。
分析有助于确定 11 个领域中的 28 个子主题。子主题被组织成六个总体主题：协调人员、为招募者提供关于挑战的指导、为招募者提供资源、优化研究流程、指导招募决策以及强调参与的好处。SDM 分析表明，即使没有进行入组，招募者也能够将招募互动视为成功，并且大多数招募者采取非指导性（即向患者提供关于可用选项的平衡信息）或混合方法（即关注招募患者入组研究）而不是指导性方法（即专注于将患者入组研究）。大多数核心 SDM 结构都得到了广泛认可。
确定的子主题可以与 TDF 领域相关联，这些领域已经有有效的行为改变干预措施，从而可以评估这些干预措施是否能提高招募效果。尽管没有共享决策方面的正式培训，但研究招募者报告的实践与 SDM 的许多要素一致。制定专门针对试验招募的 SDM 培训材料可以改善患者的知情决策过程。
