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Clinical Trials01:16

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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Developing a surgical trial intervention protocol: using qualitative methods in the operating theatre.

Maureen Twiddy1, Richard Jackson2, Kathryn Gordon3

  • 1Institute of Clinical and Applied Health Research, Hull York Medical School, University of Hull, Cottingham Road, Hull, HU6 7RX, England. hymt14@hyms.ac.uk.

Trials
|September 27, 2025
PubMed
Summary

Standardizing surgical procedures in randomized controlled trials (RCTs) is crucial. This study established key surgical steps for the near-infrared fluorescent imaging in thyroid surgery (NIFTy) RCT, ensuring consistent intervention delivery and clear results.

Keywords:
ConsensusIntervention standardizationQualitative research methodsRandomised controlled trialSurgery

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Area of Science:

  • Surgical standardization
  • Clinical trial methodology
  • Medical device evaluation

Background:

  • Standardizing surgical interventions in randomized controlled trials (RCTs) is essential for accurate interpretation of results.
  • Novel procedures require defined protocols to ensure consistent delivery.
  • This study aimed to define key surgical steps for the near-infrared fluorescent imaging in thyroid surgery (NIFTy) RCT.

Purpose of the Study:

  • To identify and agree upon the critical steps of a surgical intervention for the NIFTy RCT.
  • To inform the development of the surgical protocol and trial materials.
  • To ensure consistent application of surgical techniques in the trial.

Main Methods:

  • Qualitative case studies involving observation, video capture, and interviews with surgeons.
  • Development of a typology of operative steps.
  • Surveys to assess current practices and surgeon opinions on critical surgical steps.
  • An international expert panel meeting to review findings and agree on mandatory/optional surgical steps.

Main Results:

  • A typology of surgical steps was created, identifying potential applications for near-infrared fluorescence imaging.
  • Surgeons emphasized capsular dissection, parathyroid pedicle preservation, and clinical assessment for parathyroid preservation.
  • An expert panel reached consensus on key surgical components, influencing data collection for the NIFTy RCT.
  • Two surgical steps were strongly recommended, and three were mandated for the RCT.

Conclusions:

  • Pre-RCT qualitative research in the operating theatre successfully identified essential components of the surgical intervention.
  • Surveys and expert consensus confirmed the acceptability of the surgical protocol and determined core data for evidencing surgical decision-making.
  • This qualitative approach secured clinical buy-in, enhanced trial conduct, and facilitated a comprehensive explanation of trial outcomes.