Practicalities of using a modified version of the Cochrane Collaboration risk of bias tool for randomised and non‐randomised study designs applied in a health technology assessment setting
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We describe our experience of using a modified version of the Cochrane risk of bias (RoB) tool for randomised and non‐randomised comparative studies. Objectives: To assess time to complete RoB assessment To assess inter‐rater agreement To explore the association between RoB and treatment effect size Methods: Cochrane risk of bias assessment was performed on a sample of full text primary reports included in a systematic review comparing operative techniques for radical prostatectomy. Inter‐rater agreement was assessed using the kappa statistic. Results: Twenty‐four studies were judged as high overall RoB, 13 were judged as low RoB and 11 were unclear. The weighted Kappa value was 0.35 indicating fair agreement. The median (range) time taken to rate each study was 30 min (10–49). The effect estimate for all studies was 0.61 (95% credible interval (CrI) 0.46–0.83) and 0.73 (95% CrI 0.29–1.75) for low risk studies. Conclusions: Although the process was time consuming, using a modified version of the RoB tool proved useful for demonstrating conservative effect estimates. That we only achieved a fair agreement between reviewers demonstrates the urgent need for further validation to improve inter‐rater agreement. We suggest additional RoB levels could improve inter‐rater reliability. © 2013 Crown copyright.
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RoB assessment has long been recognized as labor intensive, variably reproducible, and prone to misapplication in specific domains such as selective reporting.
“However, RoB assessment has long been recognized as labor intensive, variably reproducible, and prone to misapplication in specific domains such as selective reporting [14-16].”
From Retrieve-Then-Verify for Evaluating Evidence Support and Hallucination in Large Language Model–Generated Medical Information: Empirical Study (2026) · cites this paper as [14]
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- Authors
- Robertson, C., Ramsay, C., Gurung, T., Mowatt, G., Pickard, R., Sharma, P., & The UK Robotic Laparoscopic Prostatectomy HTA Study Group
- Affiliations
- University of Aberdeen (GB)
- Newcastle University (GB)
- Corresponding author
- Robertson, Clare
- Venue
- Research Synthesis Methods
- Publisher
- Wiley
- Published
- 2013-11-14
- Volume
- 5
- Issue
- 3
- Pages
- 200-211
- ISSN
- 1759-2879 (ISSN-L)
- 1759-2887
- OpenAlex
- W2009327399
- Cited by
- 38
- References
- 15
- Citations by year
- 2026: 5 · 2025: 1 · 2024: 5 · 2023: 2 · 2022: 5 · 2021: 6 · 2020: 2 · 2019: 6 · 2018: 4 · 2017: 2
- FWCI
- 0.00
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Locations
- Research Synthesis Methods (publishedVersion)
- PubMed (publishedVersion)
- Aberdeen University Research Archive (Aberdeen University) (submittedVersion)
- Newcastle University ePrints (Newcastle Univesity)
- Funders
- NIHR Health Services and Delivery Research (HS&DR) programme (09/14/02)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Keywords
- risk of bias assessment, Cochrane risk of bias tool, interobserver agreement, health technology assessment, radical prostatectomy, non-randomized studies, tool validation
- MeSH terms
- Research Design, Review Literature as Topic, Sensitivity and Specificity, Software, Technology Assessment, Biomedical, Reproducibility of Results, Observer Variation, Bias, Randomized Controlled Trials as Topic, Outcome Assessment, Health Care, Risk Assessment
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