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Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study.
Natalie S Blencowe1,2, Anni Skilton3, Daisy Gaunt4
1Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
BMJ Open
|March 4, 2019
Summary
This study outlines quality assurance measures for surgical randomized controlled trials (RCTs). It focuses on surgeon criteria, technique standardization, and intraoperative monitoring to improve surgical trial validity.
Area of Science:
- Surgical research methodology
- Clinical trial quality assurance
Background:
- Randomized controlled trials (RCTs) in surgery often face criticism for not accounting for surgeon expertise.
- Pragmatic surgical trials, conducted in real-world settings, are particularly susceptible to variations in surgical standards.
Purpose of the Study:
- To develop and test quality assurance (QA) measures for a pragmatic surgical RCT comparing minimally invasive and open esophagectomy.
- To build upon methods from the ROMIO pilot RCT to enhance surgical trial design and execution.
Main Methods:
- Implementing surgeon entry criteria via operative video assessment.
- Standardizing operative techniques by defining minimum key procedural phases.
- Monitoring surgeons through intraoperative photography and standardized pathological specimen assessment.
Main Results:
- Identified three distinct QA measure types: surgeon entry criteria, technique standardization, and intraoperative monitoring.
- QA measures adapted from a pilot study and tested iteratively.
- Video and photo assessment tools evaluated for reliability and validity.
Conclusions:
- Developed a robust QA framework for pragmatic surgical RCTs.
- The proposed QA measures aim to improve the standardization and reliability of surgical interventions in clinical trials.
- This protocol provides a model for enhancing the quality of surgical research.
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