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REporting quality of PilOt randomised controlled trials in surgery (REPORTS): a methodological survey protocol
Tyler McKechnie1,2, Tania Kazi3, Austine Wang3
1Department of Surgery, McMaster University, Hamilton, Ontario, Canada tyler.mckechnie@medportal.ca.
BMJ Open
|April 24, 2024
Summary
This review evaluates surgical pilot and feasibility randomized trials for CONSORT reporting completeness and spin. We assessed reporting quality and abstract-text consistency to improve trial reporting standards.
Area of Science:
- Methodological research in surgical trial reporting.
- Assessing adherence to reporting guidelines in clinical research.
Background:
- Pilot and feasibility randomized trials are crucial for surgical innovation.
- Incomplete reporting and "spin" can misrepresent trial outcomes.
Purpose of the Study:
- To evaluate the completeness of reporting for surgical pilot and feasibility randomized trials using the CONSORT extension checklist.
- To assess the prevalence of "spin" and abstract-main text reporting inconsistencies in these trials.
Main Methods:
- A systematic search of Medline, Embase, and CENTRAL databases.
- Inclusion of pilot or feasibility randomized trials of surgical interventions.
- Primary outcome: completeness of reporting based on the 40-item CONSORT extension checklist.
Main Results:
- Analysis of reporting completeness against the CONSORT extension checklist.
- Assessment of "spin" reporting strategies.
- Exploration of factors associated with reporting quality and spin.
Conclusions:
- Findings will inform best practices for reporting surgical pilot and feasibility trials.
- Improving reporting quality enhances the reliability of preliminary surgical research.
- Recommendations for adherence to CONSORT guidelines will be provided.
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