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Collecting Sleep, Circadian, Fatigue, and Performance Data in Complex Operational Environments
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Published on: August 8, 2019

Framework for planning and conducting pilot studies.

Lisa Janette Smith1, Margaret B Harrison

  • 1Hotel Dieu Hospital, Kingston, Ontario, Canada. smithl2@hdh.kari.net

Ostomy/Wound Management
|December 30, 2009
PubMed
Summary
This summary is machine-generated.

Researchers developed a new framework, the Pilot Research Process (PReP) Framework, to guide the planning of pilot studies for community-based health research. This framework aids in designing effective pilot trials for larger definitive studies.

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Area of Science:

  • Health Services Research
  • Clinical Trial Methodology
  • Community-Based Research

Background:

  • Planning pragmatic multicenter community-based trials requires robust pilot studies.
  • A lack of established frameworks for pilot study methodology was identified.
  • Previous pilot studies offered limited guidance for developing larger definitive trials.

Purpose of the Study:

  • To develop a framework for pilot study methodology to inform research planning.
  • To identify recognized pilot study aims, processes, and methodologies from existing literature.
  • To create a structured approach for designing effective pilot research.

Main Methods:

  • An integrative literature review was conducted using an explicit search strategy.
  • Inclusion criteria focused on pilot study aims, purposes, and definitions.
  • Methodologies from 11 eligible community pilot studies were reviewed.

Main Results:

  • Pilot research processes can be divided into early planning and pilot trial stages.
  • Key areas for pilot study planning include eligibility, recruitment, data collection, management, and analysis.
  • The review informed the development of the Pilot Research Process (PReP) Framework.

Conclusions:

  • The Pilot Research Process (PReP) Framework provides a structured approach for planning pilot studies.
  • This framework can assist researchers and clinical partners in designing effective pilot trials.
  • The PReP Framework may serve as a foundation for developing methodologies for large-scale studies.