In the behavioral sciences, conducting pilot and/or feasibility studies (PFS) is a key step that provides essential information used to inform the design, conduct, and implementation of a larger-scale trial. There are more than 160 published guidelines, reporting checklists, frameworks, and recommendations related to PFS. All of these publications offer some form of guidance on PFS, but many focus on one or a few topics. This makes it difficult for researchers wanting to gain a broader understanding of all the relevant and important aspects of PFS and requires them to seek out multiple sources of information, which increases the risk of missing key considerations to incorporate into their PFS. The purpose of this study was to develop a consolidated set of considerations for the design, conduct, implementation, and reporting of PFS for interventions conducted in the behavioral sciences. To develop this consolidation, we undertook a review of the published guidance on PFS in combination with expert consensus (via a Delphi study) from the authors who wrote such guidance to inform the identified considerations. A total of 161 PFS-related guidelines, checklists, frameworks, and recommendations were identified via a review of recently published behavioral intervention PFS and backward/forward citation tracking of a well-known PFS literature (e.g., CONSORT Ext. for PFS). Authors of all 161 PFS publications were invited to complete a three-round Delphi survey, which was used to guide the creation of a consolidated list of considerations to guide the design, conduct, and reporting of PFS conducted by researchers in the behavioral sciences. A total of 496 authors were invited to take part in the three-round Delphi survey (round 1, N = 46; round 2, N = 24; round 3, N = 22). A set of twenty considerations, broadly categorized into six themes (intervention design, study design, conduct of trial, implementation of intervention, statistical analysis, and reporting) were generated from a review of the 161 PFS-related publications as well as a synthesis of feedback from the three-round Delphi process. These 20 considerations are presented alongside a supporting narrative for each consideration as well as a crosswalk of all 161 publications aligned with each consideration for further reading. We leveraged expert opinion from researchers who have published PFS-related guidelines, checklists, frameworks, and recommendations on a wide range of topics and distilled this knowledge into a valuable and universal resource for researchers conducting PFS. Researchers may use these considerations alongside the previously published literature to guide decisions about all aspects of PFS, with the hope of creating and disseminating interventions with broad public health impact.

中文翻译：

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行为干预试点和可行性研究综合指南

在行为科学中，进行试点和/或可行性研究 (PFS) 是一个关键步骤，它提供了用于指导更大规模试验的设计、进行和实施的基本信息。目前已发布 160 多个与 PFS 相关的指南、报告清单、框架和建议。所有这些出版物都提供了某种形式的 PFS 指导，但许多出版物只关注一个或几个主题。这使得研究人员很难更广泛地了解 PFS 的所有相关和重要方面，并要求他们寻找多种信息来源，这增加了错过纳入 PFS 的关键考虑因素的风险。本研究的目的是为行为科学干预措施的 PFS 的设计、实施、实施和报告制定一套综合考虑因素。为了进行整合，我们结合撰写此类指南的作者的专家共识（通过德尔菲研究）对已发布的 PFS 指南进行了审查，以告知已确定的注意事项。通过对最近发表的行为干预 PFS 的回顾以及对著名 PFS 文献（例如 CONSORT Ext. for PFS）的后向/前向引用跟踪，确定了总共 161 个 PFS 相关指南、清单、框架和建议。所有 161 份 PFS 出版物的作者均受邀完成一项三轮 Delphi 调查，该调查用于指导创建综合考虑因素清单，以指导行为科学研究人员进行 PFS 的设计、实施和报告。共有 496 名作者受邀参加三轮 Delphi 调查（第 1 轮，N = 46；第 2 轮，N = 24；第 3 轮，N = 22）。通过对 161 份 PFS 相关出版物的审查以及对三轮德尔菲流程的反馈。这 20 个考虑因素与每个考虑因素的支持性叙述一起呈现，并列出了与每个考虑因素一致的所有 161 种出版物，以供进一步阅读。我们利用了研究人员的专家意见，他们发布了与 PFS 相关的指南、检查表、框架和针对广泛主题的建议，并将这些知识提炼为研究人员进行 PFS 的宝贵且通用的资源。研究人员可以将这些考虑因素与之前发表的文献结合起来，指导有关 PFS 各个方面的决策，希望制定和传播具有广泛公共卫生影响的干预措施。