The reporting of outcomes in randomised controlled trials

Ghert, Michelle

doi:10.1302/2046-3758.610.bjr-2017-0296

Cited by 7 publications

(3 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…If an experiment or study can be independently verified, its conclusions can be considered more reliable. 2 Our results strengthen the current consensus in meta-research literature that both observational 10,19,20 and experimental 21,22 studies in many surgical fields are generally deficient in transparency and reproducibility, though previous research has not applied our sampling techniques to enable generalizability. In this section, we discuss several findings with particularly poor results.…”

Section: Discussionsupporting

confidence: 75%

Transparent and Reproducible Research Practices in the Surgical Literature

Hughes

Niemann

Tritz

et al. 2022

Journal of Surgical Research

View full text Add to dashboard Cite

Section: Discussionsupporting

confidence: 75%

Transparent and Reproducible Research Practices in the Surgical Literature

Hughes

Niemann

Tritz

et al. 2022

Journal of Surgical Research

View full text Add to dashboard Cite

“…Second, we restricted the ASI studies to RCT design, which means the estimand should be carefully selected and pre-defined, and information on these outcomes (including missing data handling) should be more precise. 39 , 40 Finally, this review followed the preferred reporting items for systematic reviews and meta-analyses statement. 41 The limitations of our review were, firstly, we only searched PubMed and Embase and excluded non-English studies and unpublished studies.…”

Section: Discussionmentioning

confidence: 99%

A systematic review investigating the use of microbiology outcome measures in randomized controlled trials evaluating antimicrobial stewardship interventions published between 2011 and 2021

Lau

Daniel

Hughes

et al. 2022

JAC-Antimicrobial Resistance

View full text Add to dashboard Cite

Introduction Antimicrobial stewardship interventions (ASIs) aim to reduce the emergence of antimicrobial resistance. We sought to systematically evaluate how microbiological outcomes have been handled and analysed in randomized controlled trials (RCTs) evaluating ASIs. Methods We searched PubMed and Embase from 2011–21. Studies were selected if they were RCTs evaluating ASIs. A narrative synthesis approach was taken, identifying whether the study reported any microbiological data (bacterial genus/species; bacterial colony counts; prevalence of bacterial, microbiologically defined infections; and antibiotic susceptibility, measured pre-randomization or post-randomization in one arm only) or outcomes (post-randomization data compared between arms). Studies with or without microbiological data/outcomes were summarized in terms of study characteristics, methods of reporting and analysis of these outcomes. Results We identified 117 studies, with 34 (29.1%) collecting microbiological data and 18 (15.4%) reporting microbiological outcomes. Most studies with microbiological outcomes were conducted in secondary care (12/18, 66.7%) and targeted adult populations (14/18, 77.8%), and the intervention involved biomarker-guided rapid diagnostic testing (7/18, 38.9%). The overall quality of reporting and analysing microbiological outcomes was low and inconsistent. The selected study population in analyses and methods of handling missing data were unclear. Conclusions This review demonstrates that the quality of handling and reporting microbiological outcomes in RCTs of ASIs was low. The lack of consistency and clarity made it difficult to compare the findings across studies, limiting policy- and clinical decision-making. Therefore, there is a clear need for the development of guidance for handling microbiological outcomes in RCTs and adopting appropriate methods to evaluate these data carefully.

show abstract

“…High-quality clinical research in surgery is characterized by randomized controlled trials (RCTs) 1 , 2 and large registry-based investigations. 3 - 5 Trial design is a nuanced technique and requires careful thought.…”

mentioning

confidence: 99%