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Publication - Dr Leila Rooshenas

    A mixed methods case study investigating how randomised controlled trials (RCTs) are reported, understood and interpreted in practice.

    Citation

    Byrne, B, Rooshenas, L, Lambert, HS & Blazeby, JM, 2019, ‘A mixed methods case study investigating how randomised controlled trials (RCTs) are reported, understood and interpreted in practice.’. Implementation Science.

    Abstract

    Background: While randomised controlled trials (RCTs) provide high-quality evidence to guide practice, much routine care is not based upon available RCTs. This disconnect between evidence and practice is not sufficiently well understood. This case study explores this relationship using a novel approach. Better understanding may improve trial design, conduct, reporting and implementation, helping patients benefit from the best available evidence.

    Methods: This case study used mixed methods to examine a surgical RCT. Letters and editorials citing the index trial underwent descriptive and qualitative analysis using the constant comparison technique. In addition, the RCT was critically appraised using validated tools. These analyses were combined to provide a broad overview of the understanding and use of RCT evidence.

    Results: 23 letters and editorials were studied. Most authorship included at least one academic (20/23) and one surgeon (21/23). Authors identified wide-ranging issues including confounding variables or outcome selection. Clear descriptions of bias or generalisability were lacking. Structured appraisal identified risks of bias. Non-RCT evidence was less critically appraised. Authors reached varying conclusions about trial implementation without consistent justification. Considered together, internal and external validity emerged as key themes in discussing the index trial, although authors did not use these methodological terms in their articles.

    Conclusions: This novel method for examining interpretation of an RCT in the clinical community showed that published responses identified only limited issues with trial design. Responses did not provide coherent rationales for implementation (or not) of trial results. Findings may suggest that authors lacked skills in appraisal of RCT design and conduct. Future work to apply this method to other trials is needed.

    Full details in the University publications repository