Pilot and feasibility studies: extending the conceptual framework

Area of Science:

• Clinical Trials Methodology
• Research Design
• Health Services Research

Background:

• A prior framework for pilot and feasibility studies was established in 2016.
• Subsequent developments include the CONSORT extension for pilot and feasibility trials.
• The pilot study landscape has evolved, necessitating an updated framework.

Purpose of the Study:

• To revisit and extend the 2016 conceptual framework for pilot and feasibility studies.
• To incorporate diverse feasibility pathways, including internal pilot studies.
• To provide guidance on effective and efficient approaches, ethical considerations, and funder perspectives.

Main Methods:

• Revisiting and extending a previous conceptual framework.
• Incorporating recent developments like the CONSORT extension for pilot trials.
• Using examples to illustrate effective and efficient feasibility study approaches.

Main Results:

• The updated framework accommodates various feasibility pathways, such as internal pilot studies.
• Guidance is provided on selecting appropriate feasibility and pilot study designs.
• Considerations for ethical issues, funder decisions, and policy implications are discussed.

Conclusions:

• An updated framework enhances the planning and execution of pilot and feasibility studies.
• The framework supports pragmatic decision-making for researchers navigating uncertainties.
• Effective feasibility work is crucial for efficient research progress and resource allocation.