The Methodological Quality Assessment Tools for Preclinical and Clinical Studies, Systematic Review and Meta-Analysis, and Clinical Practice Guideline: A Systematic Review
Abstract
OBJECTIVE: To systematically review the methodological assessment tools for pre-clinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline. METHODS: We searched PubMed, the Cochrane Handbook for Systematic Reviews of Interventions, Joanna Briggs Institute (JBI) Reviewers Manual, Centre for Reviews and Dissemination, Critical Appraisal Skills Programme (CASP), Scottish Intercollegiate Guidelines Network (SIGN), and the National Institute for Clinical Excellence (NICE) up to May 20th, 2014. Two authors selected studies and extracted data; quantitative analysis was performed to summarize the characteristics of included tools. RESULTS: We included a total of 21 assessment tools for analysis. A number of tools were developed by academic organizations, and some were developed by only a small group of researchers. The JBI developed the highest number of methodological assessment tools, with CASP coming second. Tools for assessing the methodological quality of randomized controlled studies were most abundant. The Cochrane Collaboration's tool for assessing risk of bias is the best available tool for assessing RCTs. For cohort and case-control studies, we recommend the use of the Newcastle-Ottawa Scale. The Methodological Index for Non-Randomized Studies (MINORS) is an excellent tool for assessing non-randomized interventional studies, and the Agency for Healthcare Research and Quality (ARHQ) methodology checklist is applicable for cross-sectional studies. For diagnostic accuracy test studies, the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool is recommended; the SYstematic Review Centre for Laboratory animal Experimentation (SYRCLE) risk of bias tool is available for assessing animal studies; Assessment of Multiple Systematic Reviews (AMSTAR) is a measurement tool for systematic reviews/meta-analyses; an 18-item tool has been developed for appraising case series studies, and the Appraisal of Guidelines, Research and Evaluation (AGREE)-II instrument is widely used to evaluate clinical practice guidelines. CONCLUSIONS: We have successfully identified a variety of methodological assessment tools for different types of study design. However, further efforts in the development of critical appraisal tools are warranted since there is currently a lack of such tools for other fields, e.g. genetic studies, and some existing tools (nested case-control studies and case reports, for example) are in need of updating to be in line with current research practice and rigor. In addition, it is very important that all critical appraisal tools remain subjective and performance bias is effectively avoided.
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Study quality was examined using the Agency for Health Research and Quality (AHRQ) Methodology Checklist.
“Two researchers (JS-R and JMM-S) examined the quality of the studies using the Agency for Health Research and Quality (AHRQ) Methodology Checklist [15].”
From Body Composition of Male Professional Soccer Players Using Different Measurement Methods: A Systematic Review and Meta-Analysis (2023) · cites this paper as [15]
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Self-citation
- Authors
- Zeng, X., Zhang, Y., Kwong, J. S. W., Zhang, C., Li, S., Sun, F., Niu, Y., & Du, L.
- Affiliations
- Center for Evidence‐Based and Translational Medicine Zhongnan Hospital Wuhan University Wuhan China
- Sichuan University (CN)
- Hubei University of Medicine (CN)
- Wuhan University (CN)
- Peking University (CN)
- Center for Evidence‐based Medicine and Clinical Research Taihe Hospital Hubei University of Medicine Shiyan China
- Corresponding author
- Du, Liang
- Venue
- Journal of Evidence-Based Medicine
- Publisher
- Wiley
- Published
- 2015-02
- Volume
- 8
- Issue
- 1
- Pages
- 2-10
- ISSN
- 1756-5383 (ISSN-L)
- 1756-5391
- OpenAlex
- W1709885097
- Cited by
- 2,082
- References
- 96
- Citations by year
- 2026: 141 · 2025: 212 · 2024: 278 · 2023: 226 · 2022: 204 · 2021: 253 · 2020: 237 · 2019: 145 · 2018: 156 · 2017: 121 · 2016: 67 · 2015: 40
- FWCI
- 21.07
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Evidence-Based Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Scientific Fund and project (81302508, 81403276)
- China Medical Board Collaboration Program in Health Policy Evidence
- Foundation of Education and Science Planning Project of Hubei Province (2012A050)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Keywords
- methodological quality assessment, preclinical research, meta-analysis, risk of bias, randomized controlled trials, observational studies, diagnostic accuracy studies, animal studies, Joanna Briggs Institute, CASP, Newcastle-Ottawa Scale, QUADAS-2, AMSTAR, AGREE II, performance bias
- MeSH terms
- Clinical Studies as Topic, Data Accuracy, Animals, Humans, Research Design, Review Literature as Topic, Meta-Analysis as Topic, Practice Guidelines as Topic, Evidence-Based Medicine, Biomedical Research
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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