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Video Movement Analysis Using Smartphones ViMAS: A Pilot Study
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Value of surgical pilot and feasibility study protocols.

K Fairhurst1, J M Blazeby1, S Potter1

  • 1Centre for Surgical Research and Medical Research Council (MRC) ConDuCT-II Hub for Trials Methodology Research, Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.

The British Journal of Surgery
|May 11, 2019
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Summary

Pilot and feasibility studies (PFS) in surgery are crucial for improving randomized controlled trials (RCTs). However, current pretrial surgical research often fails to address key uncertainties, limiting their potential to optimize definitive study design and conduct.

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Area of Science:

  • Surgical research methodology
  • Clinical trial design
  • Pilot and feasibility studies

Background:

  • Randomized controlled trials (RCTs) in surgery face significant methodological challenges.
  • Pilot and feasibility studies (PFS) can mitigate these issues, enhancing the success of main surgical trials.
  • This study examines UK-funded surgical PFS to identify areas for improvement in trial design and conduct.

Purpose of the Study:

  • To analyze protocols of UK-funded surgical pilot and feasibility studies.
  • To explore the current utilization of PFS in surgical research.
  • To identify specific areas for enhancing the practice of pretrial surgical studies.

Main Methods:

  • Identification of surgical intervention PFS funded by UK National Institute for Health Research (2005-2015).
  • Extraction of data on study design, reasons for undertaking the study, and publication status from protocols and publications.
  • Analysis of methodological components and addressed uncertainties within the identified PFS.

Main Results:

  • Thirty-five surgical studies were analyzed, with 29 being randomized.
  • Over half of randomized PFS (15/29) incorporated additional methodological components, including qualitative research and participant surveys.
  • Most studies (32/35) focused on recruitment uncertainties, while fewer addressed surgical-specific issues like intervention stability or implementation (10/35).
  • Publication of results was limited, with only 19 of 35 studies making their findings publicly available.

Conclusions:

  • The full potential of pilot and feasibility studies in surgery is currently underutilized.
  • There is a need to better address surgical-specific uncertainties in pretrial research.
  • Improving the reporting and accessibility of PFS findings is essential for optimizing definitive surgical trials.