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GRADE guidelines: 5. Rating the quality of evidence—publication bias
Abstract
In the GRADE approach, randomized trials start as high-quality evidence and observational studies as low-quality evidence, but both can be rated down if a body of evidence is associated with a high risk of publication bias. Even when individual studies included in best-evidence summaries have a low risk of bias, publication bias can result in substantial overestimates of effect. Authors should suspect publication bias when available evidence comes from a number of small studies, most of which have been commercially funded. A number of approaches based on examination of the pattern of data are available to help assess publication bias. The most popular of these is the funnel plot; all, however, have substantial limitations. Publication bias is likely frequent, and caution in the face of early results, particularly with small sample size and number of events, is warranted.
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“Small-sample studies are generally more prone to bias, and the relatively large confidence intervals presented in these studies suggest high uncertainty around the point estimates [47, 48].”
From Depression, anxiety, PTSD, and OCD after stillbirth: a systematic review (2021) · cites this paper as [48]
In the citing paper
“To assess the certainty of the findings’ body of evidence, we will use the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology, which evaluates five pillars: risk of bias, imprecision, inconsistency, indirect assessment of outcomes, and publication bias [35].”
From Dialectical Behavior Therapy as an intervention for Treatment Resistant Depression in adults: A protocol for systematic review and meta-analysis (2024) · cites this paper as [35]
In the citing paper
“The overall quality of evidence was graded using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach, considering study limitations, inconsistency, indirectness, imprecision and publication bias [40–44].”
In the citing paper
“Quality of evidence in included systematic reviews was assessed by outcome using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) system criteria [17-27].”
From Effects of Home Telemonitoring Interventions on Patients With Chronic Heart Failure: An Overview of Systematic Reviews (2015) · cites this paper as [21]
In the citing paper
“To determine the quality of evidence, the GRADE approach was used [29–36].”
In the citing paper
“RCTs are first categorised as high-quality evidence in the GRADE system, while observational studies are classified as low-quality data supporting estimates of intervention effects.”
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Metadata
- Authors
- Guyatt, G. H., Oxman, A. D., Montori, V., Vist, G., Kunz, R., Brozek, J., Alonso-Coello, P., Djulbegovic, B., Atkins, D., Falck-Ytter, Y., Williams, J. W., Meerpohl, J., Norris, S. L., Akl, E. A., & Schünemann, H. J.
- Affiliations
- McMaster University (CA)
- Nasjonalt Kunnskapssenter for Helsetjenesten (NO)
- University Hospital of Basel (CH)
- VA Office of Research and Development (US)
- Case Western Reserve University (US)
- Duke Medical Center (US)
- University Medical Center Freiburg (DE)
- Oregon Health & Science University (US)
- University at Buffalo, State University of New York (US)
- ORCID
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2011-12
- Volume
- 64
- Issue
- 12
- Pages
- 1277-1282
- ISSN
- 0895-4356 (ISSN-L)
- OpenAlex
- W2109346853
- Cited by
- 1,819
- References
- 54
- Citations by year
- 2026: 75 · 2025: 142 · 2024: 153 · 2023: 144 · 2022: 172 · 2021: 180 · 2020: 196 · 2019: 120 · 2018: 122 · 2017: 123 · 2016: 109 · 2015: 109 · 2014: 77 · 2013: 51 · 2012: 40
- FWCI
- 57.89
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Epidemiology (publishedVersion)
- PubMed (publishedVersion)
- 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 › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
- Keywords
- publication bias, GRADE, quality of evidence, funnel plot, small-study effects, commercial funding, risk of bias
- MeSH terms
- Cross-Sectional Studies, Drug Industry, Review Literature as Topic, Statistics as Topic, Meta-Analysis as Topic, Randomized Controlled Trials as Topic, Practice Guidelines as Topic, Publication Bias, Evidence-Based Medicine
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.
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