Consolidated guidance for behavioral intervention pilot and feasibility studies

Area of Science:

• Behavioral Sciences
• Health Services Research
• Clinical Trials

Background:

• Pilot and/or feasibility studies (PFS) are crucial for informing larger trials in behavioral science.
• Existing guidance on PFS is fragmented across over 160 publications, making comprehensive understanding difficult for researchers.
• A need exists for a consolidated resource to guide the multifaceted aspects of PFS.

Purpose of the Study:

• To develop a unified set of considerations for the design, conduct, implementation, and reporting of PFS in behavioral science.
• To synthesize existing guidance and expert consensus into a practical resource for researchers.

Main Methods:

• A systematic review identified 161 relevant PFS guidelines, checklists, frameworks, and recommendations.
• A three-round Delphi study was conducted with authors of PFS guidance to achieve expert consensus.
• The review and Delphi process informed the generation of a consolidated list of considerations.

Main Results:

• Twenty key considerations for PFS were developed, categorized into six themes: intervention design, study design, trial conduct, intervention implementation, statistical analysis, and reporting.
• A comprehensive list of 161 publications was cross-referenced with each consideration.
• The findings provide a structured approach to PFS planning and execution.

Conclusions:

• Expert consensus distilled extensive literature into a universal resource for PFS in behavioral science.
• This consolidated guidance aims to improve the quality and impact of PFS.
• Researchers can utilize these considerations to enhance the design and reporting of interventions, ultimately increasing public health impact.