The DOI matches its Crossref record; 37 of the 37 references it cites were found in a registry or an index.
GRADE guidelines: 4. Rating the quality of evidence—study limitations (risk of 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 most of the relevant evidence comes from studies that suffer from a high risk of bias. Well-established limitations of randomized trials include failure to conceal allocation, failure to blind, loss to follow-up, and failure to appropriately consider the intention-to-treat principle. More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results. Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance. Risk of bias may vary across outcomes (e.g., loss to follow-up may be far less for all-cause mortality than for quality of life), a consideration that many systematic reviews ignore. In deciding whether to rate down for risk of bias--whether for randomized trials or observational studies--authors should not take an approach that averages across studies. Rather, for any individual outcome, when there are some studies with a high risk, and some with a low risk of bias, they should consider including only the studies with a lower risk of bias.
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In the citing paper
“Certainty of evidence was assessed with use of GRADE tools for RCTs (Guyatt et al., 2011; Ryan & Hill, 2016).”
From Effectiveness of Mental Health and Wellbeing Interventions for Children and Young People in Foster, Kinship, and Residential Care: Systematic Review and Meta-Analysis (2024) · cites this paper as Guyatt et al., 2011
In the citing paper
“Additionally, the researchers (JL and WS) will assess the evidence profiles for each of the identified outcomes based on the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to reviewing evidence [86–88].”
From Acceptance and commitment therapy for chronic pain: Protocol of a systematic review and individual participant data meta-Analysis (2019) · cites this paper as [88]
In the citing paper
“Relevant criteria from the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) handbook were used to assess bias in all other study designs [37].”
From Computerized cognitive behavior therapy for anxiety and depression in rural areas:a systematic review (2015) · cites this paper as [37]
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
“We also assessed each study for risk of potential bias following the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach and recorded the information in the extraction template469.”
From Health effects associated with exposure to secondhand smoke: a Burden of Proof study (2024) · cites this paper as [469]
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 [20]
In the citing paper
“applied the key criteria of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines for observational studies to assess the methodological quality of nonrandomised studies.31”
In the citing paper
“we assessed the risk of selection bias, performance bias, selective reporting bias, detection bias, attrition bias, and potential confounding [32].”
In the citing paper
“The overall quality of research evidence for mental health indicators was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework [32].”
In the citing paper
“The overall quality of evidence was rated as “very low” according to the GRADE framework [32].”
In the citing paper
“Second, the review used a rigorous methodology following the PRISMA statement for reporting systematic reviews and meta-analyses [26] and GRADE framework [32].”
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.”
In the citing paper
“To determine the quality of evidence, the GRADE approach was used [29–36].”
In the citing paper
“Risk of bias was assessed using the Cochrane risk‐of‐bias tool for RCTs, and certainty of the evidence was assessed using the GRADE approach.”
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“16,17 All authors discussed those assessments to form a consensus opinion.”
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Rodríguez, M. Á., Quintana‐Cepedal, M., Cheval, B., Thøgersen‐Ntoumani, C., Crespo, I., & Olmedillas, H. (2025) · British Journal of Sports Medicine · doi:10.1136/bjsports-2025-110027 · Cited by 38
“Quality was downgraded to moderate, low or very low when one of the following factors was rated as serious or very serious: risk of bias, 25 inconsistency, 26 indirectness, 27 imprecision 28 or publication bias.”
Li, Y.-K., Li, W., Ren, H., Xiao, C., Guo, Z., & Luo, J. (2025) · Inflammopharmacology · doi:10.1007/s10787-025-02044-x · Cited by 32
“We applied the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group approach to evaluate the certainty of evidence (Guyatt et al. 2011; Puhan et al. 2014).”
Musculoskeletal Injuries in Dance: A Systematic Review
WJ, A. N. R. (2014) · International Journal of Physical Medicine & Rehabilitation · doi:10.4172/2329-9096.1000252 · Cited by 32
Khouri, C., Jouvé, T., Blaise, S., Carpentier, P., Cracowski, J., & Roustit, M. (2016) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.12980 · Cited by 32
Alsubheen, S., Nazari, G., Bobos, P., MacDermid, J. C., Overend, T. J., & Faber, K. J. (2018) · Archives of Physical Medicine and Rehabilitation · doi:10.1016/j.apmr.2018.08.181 · Cited by 32
Breastfeeding in the time of Zika: a systematic literature review
Sampieri, C. L., & Montero, H. (2019) · PeerJ · doi:10.7717/peerj.6452 · Cited by 37
Oweini, D. A., Jawad, M., & Akl, E. A. (2019) · Tobacco Control · doi:10.1136/tobaccocontrol-2018-054870 · Cited by 29
Self-citationA Theoretical Framework and Competency-Based Approach to Training in Guideline Development
Sultan, S., Morgan, R. L., Murad, M. H., Falck-Ytter, Y. T., Dahm, P., Schünemann, H. J., & Mustafa, R. A. (2019) · Journal of General Internal Medicine · doi:10.1007/s11606-019-05502-9 · Cited by 35
Self-citationDufour, S., Wellemans, V., Roy, J., Lacasse, P., Ordonez-Iturriaga, A., & Francoz, D. (2019) · Animal Health Research Reviews · doi:10.1017/s1466252319000070 · Cited by 32
Mental Health and Cognition in Older Cannabis Users: a Review
Vacaflor, B., Beauchet, O., Jarvis, G. E., Schiavetto, A., & Rej, S. (2020) · Canadian Geriatrics Journal · doi:10.5770/cgj.23.399 · Cited by 33
Efficacy and Safety of Antibiotics for Treatment of Scrub Typhus
Yang, J., Luo, L., Chen, T., Li, L., Xu, X., Zhang, Y., Cao, W., Yue, P., Bao, F., & Liu, A. (2020) · JAMA Network Open · doi:10.1001/jamanetworkopen.2020.14487 · Cited by 32
Yang, C., Mauer, L., Vӧllm, B., & Khalifa, N. R. (2020) · Neuropsychology Review · doi:10.1007/s11065-020-09456-2 · Cited by 33
Kaddoura, R., Omar, A. S., Ibrahim, M. I. M., Alkhulaifi, A. M., Lorusso, R., Elsherbini, H., Soliman, O. I. I., & Çalişkan, K. (2021) · Journal of Cardiothoracic and Vascular Anesthesia · doi:10.1053/j.jvca.2021.01.019 · Cited by 31
Hesam‐Shariati, N., Chang, W., Wewege, M. A., McAuley, J. H., Booth, A., Trost, Z., Lin, C., Newton-John, T. R. O., & Gustin, S. M. (2021) · European Journal of Neurology · doi:10.1111/ene.15189 · Cited by 32
“To assign one of the four levels of certainty to the outcomes, we considered five factors including (i) risk of bias: when there was a high risk of bias for >25% and <50% of the included studies participants, we downgraded two levels, and when >50% of participants were from high risk of bias studies, we downgraded one…”
BackgroundGagelmann, N., Ayuk, F. A., Klyuchnikov, E., Wolschke, C., Berger, S. C., & Kröger, N. M. (2023) · Haematologica · doi:10.3324/haematol.2022.282510 · Cited by 32
“was documented according to the GRADE system, using the following levels of evidence: high, moderate, low and very low.(12) Because all undergone trials to date are nonrandomized single-arm trials, risk of bias was judged a priori to be serious.”
MethodBaltzell, P., Newton, H. P., & O'Connor, A. M. C. (2013) · Journal of Veterinary Internal Medicine · doi:10.1111/jvim.12112 · Cited by 32
Diagnosis and treatment of severely malnourished children with diarrhoea
Iannotti, L. L., Trehan, I., Clitheroe, K. L., & MANARY, M. J. (2014) · Journal of Paediatrics and Child Health · doi:10.1111/jpc.12711 · Cited by 30
Rezek, I., Mousan, G., Wang, Z., Murad, M. H., & Kallmes, D. F. (2013) · American Journal of Neuroradiology · doi:10.3174/ajnr.a3598 · Cited by 32
Patterson, B. A., & Ameringen, M. V. (2016) · Depression and Anxiety · doi:10.1002/da.22525 · Cited by 33
Marked variation in malignant transformation rates of oral leukoplakia
Anderson, A., & Ishak, N. (2015) · Evidence-Based Dentistry · doi:10.1038/sj.ebd.6401128 · Cited by 32
Hunter, J., Leach, M., Braun, L. A., & Bensoussan, A. (2017) · BMC Complementary and Alternative Medicine · doi:10.1186/s12906-017-1613-7 · Cited by 32
Isserlin, L., Spettigue, W. J., Norris, M. L., & Couturier, J. L. (2020) · Journal of Eating Disorders · doi:10.1186/s40337-020-00307-2 · Cited by 32
Pennitz, A., Kinberger, M., VALLE, G. L. A., Passeron, T., Nast, A., & Werner, R. N. (2022) · British Journal of Dermatology · doi:10.1111/bjd.21244 · Cited by 31
Prat-Luri, A., Ríos-Calonge, J. D. L., Moreno-Navarro, P., Manresa‐Rocamora, A., Vera-García, F. J., & Barbado, D. (2023) · Journal of Orthopaedic and Sports Physical Therapy · doi:10.2519/jospt.2023.11091 · Cited by 36
Shen, H., Jin, Z., Chen, Q., Zhang, L., You, J., Zhang, S., & Zhang, B. (2024) · La radiologia medica · doi:10.1007/s11547-024-01796-w · Cited by 30
“Fourth, a majority of the studies displayed a high or unclear risk of bias during patient selection and index tests, which further limited the conclusions that could be derived from the meta-analysis since the studies showing a high risk of bias overestimated the model performance [66].”
Norman‐Nott, N., Hesam‐Shariati, N., Wewege, M. A., Rizzo, R. R. N., Cashin, A. G., Wilks, C. R., Quidé, Y., McAuley, J. H., & Gustin, S. M. (2024) · European Journal of Pain · doi:10.1002/ejp.2268 · Cited by 36
Metadata
- Authors
- Guyatt, G. H., Oxman, A. D., Vist, G., Kunz, R., Brozek, J., Alonso-Coello, P., Montori, V., Akl, E. A., Djulbegovic, B., & Falck-Ytter, Y.
- Affiliations
- McMaster University (CA)
- Nasjonalt Kunnskapssenter for Helsetjenesten (NO)
- University of Basel (CH)
- University at Buffalo, State University of New York (US)
- Case Western Reserve University (US)
- Corresponding author
- Guyatt, Gordon H.
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2011-04
- Volume
- 64
- Issue
- 4
- Pages
- 407-415
- ISSN
- 0895-4356 (ISSN-L)
- OpenAlex
- W1981680557
- Cited by
- 2,798
- References
- 37
- Citations by year
- 2026: 130 · 2025: 182 · 2024: 238 · 2023: 199 · 2022: 264 · 2021: 280 · 2020: 284 · 2019: 198 · 2018: 184 · 2017: 180 · 2016: 176 · 2015: 179 · 2014: 120 · 2013: 95 · 2012: 65
- FWCI
- 100.89
- 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
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
- Keywords
- GRADE, risk of bias, quality of evidence, observational studies, allocation concealment, blinding, loss to follow-up, intention-to-treat analysis, early stopping, selective reporting
- MeSH terms
- Female, Humans, Male, Quality Assurance, Health Care, Randomized Controlled Trials as Topic, Practice Guidelines as Topic, Publication Bias, Risk Assessment, Evidence-Based Practice
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