一项混合方法案例研究，旨在调查随机对照试验（RCT）在实践中是如何报告、理解和解释的。

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

机构信息

Centre for Surgical Research, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Clifton, Bristol, BS8 2PS, UK.

Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.

出版信息

BMC Med Res Methodol. 2020 May 12;20(1):112. doi: 10.1186/s12874-020-01009-8.

DOI:10.1186/s12874-020-01009-8

PMID:32398100

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7216481/

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

We employed a case-study approach, comprising mixed methods to examine the case of interest: the primary outcome paper of a surgical RCT (the TIME trial). Letters and editorials citing the TIME trial's primary report underwent qualitative thematic analysis, and the RCT was critically appraised using validated tools. These analyses were compared to provide insight into how the TIME trial findings were interpreted and appraised by the clinical community.

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 the trial without consistent justification. Authors discussed aspects of internal and external validity covered by appraisal tools but 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 limited issues with trial design. Responses did not provide coherent rationales for accepting (or not) trial results. Findings may suggest that authors lacked skills in appraisal of RCT design and conduct. Multiple case studies with cross-case analysis of other trials are needed.

摘要

背景

虽然随机对照试验（RCT）提供了高质量的证据来指导实践，但许多常规护理并非基于现有 RCT。证据与实践之间的这种脱节尚未得到充分理解。本案例研究采用新方法探讨了这种关系。更好地理解可能会改善试验设计、实施、报告，帮助患者从最佳现有证据中受益。

方法

我们采用案例研究方法，结合混合方法来研究感兴趣的案例：一项外科 RCT（TIME 试验）的主要结局论文。引用 TIME 试验主要报告的信件和社论进行了定性主题分析，并使用经过验证的工具对 RCT 进行了批判性评估。这些分析进行了比较，以深入了解临床社区如何解释和评估 TIME 试验的结果。

结果

研究了 23 封信件和社论。大多数作者至少包括一名学术人员（20/23）和一名外科医生（21/23）。作者确定了广泛的问题，包括混杂变量或结局选择。缺乏对偏倚或普遍性的明确描述。结构评估确定了偏倚风险。非 RCT 证据的批判性评估较少。作者在没有一致理由的情况下对试验得出了不同的结论。作者讨论了评估工具涵盖的试验内部和外部有效性的各个方面，但没有在文章中使用这些方法学术语。