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Pilot and feasibility studies: extending the conceptual framework.

Christine Bond1, Gillian A Lancaster2, Mike Campbell3

  • 1Primary Care, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK. c.m.bond@abdn.ac.uk.

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Summary
This summary is machine-generated.

This study updates a framework for pilot and feasibility studies, incorporating new guidelines and internal pilot study designs. It guides researchers and funders on effective, efficient, and ethical approaches to early-stage research planning.

Keywords:
ConceptsDefinitionsExternal pilotFeasibilityFrameworkInternal pilotRandomised controlled trial (RCT)ReportingUncertainties

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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.