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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High HIV, HPV, and STI Prevalence Among Young Western Cape, South African Women
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Baker, J. A., & Pereira, G. F. (2015) · Clinical Rehabilitation · doi:10.1177/0269215515593609 · Cited by 37
The Use of Bowel Protocols in Critically Ill Adult Patients: A Systematic Review and Meta-Analysis
Oczkowski, S. J. W., Duan, E. H., Groen, A., Warren, D., & Cook, D. J. (2017) · Critical Care Medicine · doi:10.1097/ccm.0000000000002315 · Cited by 37
Dib, R. E., Pereira, J. E. G., Agarwal, A., Gomaa, H. A., Ayala, A. P., Botan, A. G., Braz, L. G., de Oliveira, L. D., Lopes, L. C., & Mathew, P. J. (2017) · Journal of Clinical Anesthesia · doi:10.1016/j.jclinane.2017.05.010 · Cited by 37
Kannan, P., Winser, S. J., Ho, L., Hei, L. C., Kin, L. C., Agnieszka, G. E., & Jeffrey, L. H. (2019) · Clinical Rehabilitation · doi:10.1177/0269215519840392 · Cited by 37
Nazari, G., MacDermid, J. C., Bryant, D., Dewan, N., & Athwal, G. S. (2019) · PLoS ONE · doi:10.1371/journal.pone.0222953 · Cited by 37
Thrombolysis for acute ischemic stroke in the unwitnessed or extended therapeutic time window
Tsivgoulis, G. K., Katsanos, A. H., Malhotra, K., Sarraj, A., Barreto, A. D., Köhrmann, M., Krogias, C., Ahmed, N., Caso, V., Schellinger, P. D., et al. (2020) · Neurology · doi:10.1212/wnl.0000000000008904 · Cited by 37
Dijksma, I., Arslan, I. G., van Etten‐Jamaludin, F. S., Elbers, R. G., Lucas, C., & Stuiver, M. M. (2020) · PM&R · doi:10.1002/pmrj.12360 · Cited by 37
Neale, E. P., Guan, V. X., Tapsell, L. C., & Probst, Y. (2020) · British Journal Of Nutrition · doi:10.1017/s0007114520001415 · Cited by 35
Longo, U. G., Berton, A., Ambrogioni, L. R., Presti, D. L., Carnevale, A., Candela, V., Stelitano, G., Schena, E., Nazarian, A., & Denaro, V. (2020) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph17082852 · Cited by 37
Elfeky, A., Gillies, K., Gardner, H., Fraser, C. M., Ishaku, T., & Treweek, S. P. (2020) · Systematic Reviews · doi:10.1186/s13643-020-01471-x · Cited by 38
Mun, E., Li, X., Businelle, M. S., Hébert, E. T., Tan, Z., Barnett, N. P., & Walters, S. T. (2021) · Alcoholism Clinical and Experimental Research · doi:10.1111/acer.14571 · Cited by 37
Kuo, Y.-C., Lai, C., Wang, Y., Chen, C., & Wang, C. (2021) · Journal of Microbiology Immunology and Infection · doi:10.1016/j.jmii.2021.04.002 · Cited by 37
Licina, A., & Silvers, A. J. (2021) · Pain Medicine · doi:10.1093/pm/pnab210 · Cited by 40
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Li, H., Tan, C., Tan, L., & Xu, W. (2023) · Journal of Neurology Neurosurgery & Psychiatry · doi:10.1136/jnnp-2022-330246 · Cited by 45
Developing evidence-based immunization recommendations and GRADE
DUCLOS, P. J., Dürrheim, D. N., Reingold, A. L., Bhutta, Z. A., Vannice, K., & Rees, H. (2012) · Vaccine · doi:10.1016/j.vaccine.2012.02.041 · Cited by 37
Guo, X., Guo, S., Miao, Z., Li, Z., & Zhang, H. (2017) · Journal of Diabetes and its Complications · doi:10.1016/j.jdiacomp.2017.07.007 · Cited by 37
Imran, T. F., Ghazipura, M., Liu, S., Hossain, T., Ashtyani, H., Kim, B., Michael Gaziano, J., & Djoussé, L. (2016) · Heart Failure Reviews · doi:10.1007/s10741-016-9548-5 · Cited by 36
Predictors of response to acetylcholinesterase inhibitors in dementia: A systematic review
Pozzi, F. E., Conti, E., Appollonio, I., Ferrarese, C., & Tremolizzo, L. (2022) · Frontiers in Neuroscience · doi:10.3389/fnins.2022.998224 · Cited by 36
“These include failure to develop and apply appropriate eligibility criteria, flawed measurement of either predictors or response, failure to adequately control confounding factors, and incomplete follow-up (a drop-out rate of <20% was judged acceptable) (Guyatt et al., 2011).”
BackgroundLavikainen, L. I., Guyatt, G. H., Sallinen, V. J., Karanicolas, P. J., Couban, R., Singh, T., Lee, Y., Elberkennou, J., Aaltonen, R. L., Ahopelto, K., et al. (2023) · Annals of Surgery · doi:10.1097/sla.0000000000006059 · Cited by 36
“43 Through discussion and consensus building, and considering previous literature, 7 – 9, 44 – 46 we developed an instrument to categorize”
MethodSelf-citationPatient blood management guideline for adults with critical bleeding
Mitra, B., Jorgensen, M., Reade, M. C., Keegan, A., Holley, A., Farmer, S. L., Harvey, N., Winearls, J., Parr, M. J., & French, C. (2024) · The Medical Journal of Australia · doi:10.5694/mja2.52212 · Cited by 38
Implementing GRADE in systematic reviews that adhere to JBI methodological conduct
Stern, C., Munn, Z., Barker, T. H., Porritt, K. A., Stone, J., Pap, R., Khalil, H., & Aromataris, E. (2024) · JBI Evidence Synthesis · doi:10.11124/jbies-23-00543 · Cited by 41
“…GRADE approach can be applied to outcomes from randomized controlled trials and/or non-randomized studies (including observational studies) 20 – 26 (cid:129) GRADE approach can be applied to outcomes based on meta-analysis, network meta-analysis, 27 – 30 or those informed by narrative…”
MethodKubo, K., Sakuraya, M., Sugimoto, H., Takahashi, N., Kano, K., Yoshimura, J., Egi, M., & Kondo, Y. (2024) · Critical Care Medicine · doi:10.1097/ccm.0000000000006366 · Cited by 39
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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