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A mixed methods case study investigating how randomised controlled trials (RCTs) are reported, understood and
Ben E Byrne1, Leila Rooshenas2, Helen S Lambert3
1Centre for Surgical Research, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Clifton, Bristol, BS8 2PS, UK. benbyrne@doctors.org.uk.
BMC Medical Research Methodology
|May 14, 2020
Summary
Published responses to a surgical randomized controlled trial (RCT) identified few design issues and lacked consistent justification for conclusions. This suggests a need for improved critical appraisal skills in the clinical community regarding RCT evidence.
Area of Science:
- Clinical Research Methodology
- Evidence-Based Practice
- Medical Publication Analysis
Background:
- Randomized controlled trials (RCTs) represent high-quality evidence but are underutilized in routine clinical care.
- The gap between available RCT evidence and current practice is not well understood.
- This study investigates the interpretation and appraisal of RCT findings by the clinical community.
Purpose of the Study:
- To explore the disconnect between RCT evidence and clinical practice.
- To analyze how the findings of a specific surgical RCT (the TIME trial) were interpreted and appraised in published responses.
- To identify potential areas for improving trial design, conduct, reporting, and implementation.
Main Methods:
- A case study approach using mixed methods was employed, focusing on the primary outcome paper of the TIME surgical RCT.
- Qualitative thematic analysis was conducted on 23 letters and editorials citing the TIME trial's primary report.
- The RCT itself was critically appraised using validated tools, and these analyses were compared to understand community interpretation.
Main Results:
- Most published responses (23 letters/editorials) were authored by academics and surgeons.
- Authors raised various issues like confounding variables and outcome selection but often lacked clear descriptions of bias or generalizability.
- Structured appraisal revealed risks of bias, and non-RCT evidence was less critically appraised; conclusions on the trial varied without consistent justification.
Conclusions:
- Published responses to the TIME RCT identified limited design flaws and lacked coherent rationales for accepting or rejecting trial results.
- Findings suggest potential deficits in the skills required for appraising RCT design and conduct within the clinical community.
- Further case studies and cross-case analysis of other trials are recommended to validate these observations.
Keywords:
Evidence-based medicineHealth services researchMethodsRandomised controlled trialTranslational medical researchsurgeryMore Related Videos
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