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Development of a core outcome set for groin hernia trials: a study protocol
Anders Gram-Hanssen1, Jacob Rosenberg
1anders@gram-hanssen.dk.
Danish Medical Journal
|December 1, 2021
Summary
Developing a core outcome set for groin hernia trials is essential for standardizing reporting and improving meta-analyses. This consensus-driven approach will enhance the quality and comparability of research findings in this field.
Area of Science:
- Hernia Surgery Research
- Clinical Trial Methodology
Background:
- Inconsistent outcome reporting in groin hernia trials hinders high-quality meta-analyses.
- Standardization is needed to improve the reliability and comparability of research findings.
Purpose of the Study:
- To develop a core outcome set for effectiveness trials in clinical groin hernia research.
- Establish a minimum set of outcomes for consistent reporting in all groin hernia trials.
Main Methods:
- Phase 1: Update systematic review to identify relevant outcomes.
- Phase 2: Multiple Delphi rounds with patients, surgeons, and researchers for consensus.
- Phase 3: Consensus meeting with stakeholders to finalize the core outcome set.
Main Results:
- The study aims to identify and achieve consensus on critical outcomes for groin hernia repair.
- The process involves systematic review, multi-stakeholder Delphi rounds, and a final consensus meeting.
Conclusions:
- Developing a core outcome set for groin hernia trials is both necessary and feasible.
- This initiative will lead to more standardized and reliable outcome reporting in the field.
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