Methodological quality (risk of bias) assessment tools for primary and secondary medical studies: what are they and which is better?
Open accessAbstract
Methodological quality (risk of bias) assessment is an important step before study initiation usage. Therefore, accurately judging study type is the first priority, and the choosing proper tool is also important. In this review, we introduced methodological quality assessment tools for randomized controlled trial (including individual and cluster), animal study, non-randomized interventional studies (including follow-up study, controlled before-and-after study, before-after/ pre-post study, uncontrolled longitudinal study, interrupted time series study), cohort study, case-control study, cross-sectional study (including analytical and descriptive), observational case series and case reports, comparative effectiveness research, diagnostic study, health economic evaluation, prediction study (including predictor finding study, prediction model impact study, prognostic prediction model study), qualitative study, outcome measurement instruments (including patient - reported outcome measure development, content validity, structural validity, internal consistency, cross-cultural validity/ measurement invariance, reliability, measurement error, criterion validity, hypotheses testing for construct validity, and responsiveness), systematic review and meta-analysis, and clinical practice guideline. The readers of our review can distinguish the types of medical studies and choose appropriate tools. In one word, comprehensively mastering relevant knowledge and implementing more practices are basic requirements for correctly assessing the methodological quality.
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Risk of bias was assessed by two independent authors using RoB 2.0, JBI Critical Appraisal Checklists, and the Newcastle-Ottawa Scale.
“Two independent authors used the following tools to assess risk of bias in the included studies: RoB 2.0 for randomized control trials, JBI Critical Appraisal Checklist for Case Series, JBI Critical Appraisal Checklist for Quasi-experimental Studies, and Newcastle–Ottawa Scale for case–control and cohort studies [14,15,16,17].”
From Reconstructive Procedures of the Auricular Concha after Cutaneous Oncologic Surgery: A Systematic Review (2023) · cites this paper as [15]
The sections on randomized trials, non-randomized studies, cohort studies, and case–control studies identify RoB 2.0, the JBI checklist for quasi-experimental studies, and the Newcastle–Ottawa Scale for the stated study designs. The section on case series and case reports does not identify a JBI checklist for case series; it identifies a JBI checklist for case reports instead. The statement that two independent authors performed the assessment describes the citing study’s own procedure, not a finding attributed to this source. (LLM, conf=0.84)
Experimental — accuracy not yet measuredStudy quality was assessed by two independent investigators using the NIH quality assessment tool, with disagreements adjudicated.
“Study quality was assessed using the National Institutes of Health (NIH) quality assessment tool for observational cohort and cross-sectional studies18,19. The quality of each study was evaluated by two independent investigators (MT and RR) and disagreements were resolved by adjudication by the same two reviewers.”
From Prevalence of Depression or Anxiety During Antepartum Hospitalizations for Obstetric Complications (2021) · cites this paper as [18]
The review followed PRISMA 2009 methodology and registered its protocol in PROSPERO.
“We followed PRISMA (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols) 2009 methodology17 for this review and registered the protocol in the PROSPERO International Prospective Register of Systematic Reviews (CRD42020172111).”
From Prevalence of Depression or Anxiety During Antepartum Hospitalizations for Obstetric Complications (2021) · cites this paper as [17]
The cited paper’s Background and Discussion discuss methodological quality and risk-of-bias assessment tools, not whether the citing authors followed PRISMA 2009 or registered their protocol. Searches of our copy for PRISMA, PROSPERO, and the stated registration number found no passage addressing those claims. (LLM, conf=0.76)
Experimental — accuracy not yet measuredWhere I-squared is greater than 50%, the DerSimonian-Laird random-effects model is recommended.
“Where I 2 is greater than 50%, the DerSimonian-Laird randomeffects model was recommended.40”
From Mindfulness-based interventions for psychological wellbeing and quality of life in men with prostate cancer: A systematic review and meta-analysis (2021) · cites this paper as [40]
The cited paper’s section on randomized controlled trials discusses risk-of-bias tools, not how to choose a meta-analysis model. Searches for DerSimonian–Laird, I-squared above 50%, and random-effects models found no passage in our copy addressing the recommendation. (LLM, conf=0.74)
Experimental — accuracy not yet measured
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- Authors
- Ma, L.-L., Wang, Y.-Y., Yang, Z.-H., Huang, D., Weng, H., & Zeng, X.-T.
- Affiliations
- Wuhan University (CN)
- Corresponding author
- Zeng, Xian-Tao
- Venue
- Military Medical Research
- Publisher
- Elsevier BV
- Published
- 2020-02-29
- Volume
- 7
- Issue
- 1
- Pages
- 7-7
- ISSN
- 2054-9369 (ISSN-L)
- PMC
- PMC7049186
- OpenAlex
- W3011962481
- Cited by
- 1,648
- References
- 115
- Citations by year
- 2026: 132 · 2025: 280 · 2024: 374 · 2023: 353 · 2022: 317 · 2021: 160 · 2020: 30 · 2019: 1 · 2012: 1
- FWCI
- 44.29
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Locations
- Military Medical Research (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Entrusted Project of National commission on health and health of China (No. [2019]099)
- National Key Research and Development Plan of China (2016YFC0106300)
- Nature Science Foundation of Hubei Province (2019FFB03902)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Health Sciences › Health Professions › Health Information Management › Methodologies in Health Research and Practice
- Keywords
- methodological quality assessment, risk of bias, quality assessment tools, randomized controlled trials, observational studies, cohort studies, case-control study, cross-sectional study, diagnostic studies, health economic evaluation, prediction model, patient-reported outcome measures, measurement validity, reliability statistics, systematic reviews, comparative effectiveness research, animal studies
- MeSH terms
- Animals, Humans, Psychometrics, Research, Research Design, Reproducibility of Results, Bias
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