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Recommendations for optimising pilot and feasibility work in surgery.

K Fairhurst1, S Potter2, J M Blazeby2

  • 1Centre for Surgical Research, Medical Research Council ConDuCT-II Hub for Trials Methodology Research and Biomedical Research Centre, Department of Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Clifton, Bristol, BS8 2PS, UK. katherine.fairhurst@bristol.ac.uk.

Pilot and Feasibility Studies
|April 18, 2024
PubMed
Summary
This summary is machine-generated.

Optimizing pilot and feasibility studies (PAFS) in surgery requires addressing root causes like scope understanding and stakeholder appreciation. A new guidance tool aims to improve surgical research practice and future trial efficiency.

Keywords:
Feasibility studiesSurgeonsTrials

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Area of Science:

  • Surgical research methodology
  • Clinical trial design
  • Health services research

Background:

  • Surgical trials present unique challenges, impacting their design and execution.
  • Pilot and feasibility studies (PAFS) are crucial for optimizing surgical randomized trials but are underutilized.
  • A mixed-methods approach was employed to develop recommendations for enhancing surgical PAFS.

Purpose of the Study:

  • To identify root causes and challenges hindering the optimization of surgical pilot and feasibility studies (PAFS).
  • To develop practical recommendations and a guidance tool for improving the design, conduct, and reporting of surgical PAFS.
  • To foster a cultural shift towards appreciating the value of PAFS among all stakeholders in surgical research.

Main Methods:

  • Quantitative analysis of funded surgical PAFS over a decade.
  • In-depth qualitative interviews with surgeons, methodologists, and funders.
  • Triangulation and synthesis of findings with existing methodological guidance on PAFS.

Main Results:

  • An explanatory model identified four root causes for suboptimal surgical PAFS: scope understanding, design/conduct, reporting, and stakeholder appreciation.
  • Compounding challenges include cultural issues and difficulties in accessing/interpreting PAFS guidance.
  • A practical guidance tool was developed based on study findings and the explanatory model.

Conclusions:

  • Optimizing surgical PAFS necessitates a cultural shift among funders, institutions, regulators, journals, and surgeons.
  • The 'Top Tips' guidance tool provides an accessible framework for surgeons designing PAFS.
  • Adoption of these recommendations will enhance surgical PAFS, leading to more successful and efficient surgical trials.