Value of surgical pilot and feasibility study protocols.

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.