Systematic reviews of adverse effects: framework for a structured approach
Open accessAbstract
Background: As every healthcare intervention carries some risk of harm, clinical decision making needs to be supported by a systematic assessment of the balance of benefit to harm. A systematic review that considers only the favourable outcomes of an intervention, without also assessing the adverse effects, can mislead by introducing a bias favouring the intervention. Much of the current guidance on systematic reviews is directed towards the evaluation of effectiveness; but this differs in important ways from the methods used in assessing the safety and tolerability of an intervention. A detailed discussion of why, how and when to include adverse effects in a systematic review, is required. Methods: This discussion paper, which presupposes a basic knowledge of systematic review methodology, was developed by consensus among experienced reviewers, members of the Adverse Effects Subgroup of The Cochrane Collaboration, and supplemented by a consultation of content experts in reviews methodology, as well as those working in drug safety. Results: A logical framework for making decisions in reviews that incorporate adverse effects is provided. We explore situations where a comprehensive investigation of adverse effects is warranted and suggest strategies to identify practicable and clinically useful outcomes. The advantages and disadvantages of including observational and experimental study designs are reviewed. The consequences of including separate studies for intended and unintended effects are explained. Detailed advice is given on designing electronic searches for studies with adverse effects data. Reviewers of adverse effects are given general guidance on the assessment of study bias, data collection, analysis, presentation and the interpretation of harms in a systematic review. Conclusion: Readers need to be able to recognize how strategic choices made in the review process determine what harms are found, and how the findings may affect clinical decisions. Researchers undertaking a systematic review that incorporates adverse effect data should understand the rationale for the suggested methods and be able to implement them in their review.
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The review used the 'broad sweep' approach recommended by the Cochrane Adverse Effects Methods Group.
“As this is the first systematic review of the literature involving meditation adverse events (MAEs), we utilized the 'broad sweep' approach recommended by the Cochrane Adverse Effects Methods Group (27) in order to gain a general view of the variety of adverse events, as well as attempting a preliminary estimate of their prevalence.”
From Adverse events in meditation practices and meditation‐based therapies: a systematic review (2020) · cites this paper as [27]
Twenty articles (22%) gave recommendations on the key item "research question", with publication dates between 1997 and 2015 (median year 2009).
“Twenty articles (22%) gave recommendations on the key item “research question” [29, 30, 35, 36, 38–43, 45–54], with publication dates between 1997 and 2015 (median year of publication 2009).”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [35]
Sixteen articles (17%) provided recommendations on the key item "protocol development", with publication dates between 1994 and 2015 (median year 2009).
“Sixteen articles (17%) provided recommendations on the key item “protocol development” (Table 3), [29–44] with publication dates between 1994 and 2015 (median year of publication 2009).”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [35]
There was some disagreement among the articles whether the research question should be specific (narrowly formulated) or general (broadly formulated).
“There was some disagreement (Table 4) whether the research question should be specific (narrowly formulated) [51, 53], or general (broadly formulated) [35, 47, 49].”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [35]
The articles recommended that the protocol should state the objectives, hypotheses to be tested and the rationale of the review, describe eligibility criteria, define the type of studies to be included, and give the reason when including observational studies in the review.
“The articles recommended that the protocol should state the objectives, hypotheses to be tested and the rationale of the review, [29] and that it should describe eligibility criteria [29, 33, 35, 36, 38, 39, 41], define the type of studies to be included [35, 37, 42, 44], and give the reason when including observational studies in the review [35, 37, 40].”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [35]
Thirty-three articles (35%) made recommendations about the key item "search strategy", with publication dates between 1995 and 2016 (median year 2007).
“Thirty-three articles (35%) made recommendations about the key item “search strategy” [12, 29, 30, 33–36, 38, 39, 43, 46–51, 53–69], with publication dates between 1995 and 2016 (median year of publication 2007).”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [35]
Nine articles (10%) made recommendations on how to perform data extraction, with publication dates between 1995 and 2016 (median year 2009).
“Nine articles (10%) made recommendations on how to perform data extraction [29, 33–35, 38, 43, 47, 48, 74], with publication dates between 1995 and 2016 (median year of publication 2009).”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [35]
The majority of articles discussed aspects general to systematic reviews including advantages and limitations of different literature sources and databases, search tools, the importance of identifying unpublished studies, literature searching techniques including how to build a search string and reporting.
“The majority of articles discussed aspects general to systematic reviews including advantages and limitations of different literature sources and databases, search tools, the importance of identifying unpublished studies, literature searching techniques including how to build a search string and reporting [12, 29, 33–36, 46, 48, 50, 51, 53, 54, 57, 59–62, 67, 68].”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [35]
Twenty-five (27%) articles gave recommendations on item "considering different study designs", with publication dates between 1995 and 2016 (median year 2007).
“Twenty-five (27%) articles gave recommendations on item “considering different study designs” [8, 29, 34, 35, 37–39, 42, 44, 49, 51, 56, 61, 65, 70, 73, 75, 76, 77–83], with publication dates between 1995 and 2016 (median year of publication 2007).”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [35]
Five articles discouraged combining different study designs in meta-analyses but saw the added value of including different designs in a systematic review.
“Five articles discouraged combining different study designs in meta-analyses but saw the added value of including different designs in a systematic review [35, 38, 56, 61, 75].”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [35]
Most articles considered the combination of RCTs and non-randomised designs.
“Most articles considered the combination of RCTs and non-randomised designs [29, 35, 38, 39, 49, 51, 56, 61, 75, 81].”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [35]
Authors agreed that combining different study designs in a meta-analysis can lead to misleading results if done without careful consideration.
“Authors agreed that combining different study designs in a meta-analysis can lead to misleading results if done without careful consideration [35, 38, 56, 70, 75, 76].”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [35]
The need for complete reporting of all relevant methodological aspects as a prerequisite to assessing the risk of bias of studies was highlighted in 10 articles, and was the focus of recommendations in a publication from the MOOSE group.
“The need for complete reporting of all relevant methodological aspects as a prerequisite to assessing the risk of bias of studies was highlighted in 10 articles, [16, 33, 35, 47, 50, 56, 86, 87, 90, 91] and was the focus of recommendations in a publication from the Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group [12].”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [35]
Thirty-nine articles (42%) made recommendations on the assessment of quality and risk of bias of individual studies, with publication dates between 1994 and 2016 (median year 2009).
“Thirty-nine articles (42%) made recommendations on the assessment of quality and risk of bias of individual studies, [12, 16, 29, 30, 32–35, 37, 38, 43, 47–50, 52–54, 56, 64–66, 70, 71, 73, 75, 77, 82, 84–94] with publication dates between 1994 and 2016 (median year of publication 2009).”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [35]
Fifty-two articles (56%) provided recommendations on the statistical analysis in the context of meta-analysis of observational studies, with publication dates between 1994 and 2016 (median year 2006).
“Fifty-two articles (56%), provided recommendations on the statistical analysis in the context of meta-analysis of observational studies [8, 12, 16, 29–31, 33–36, 38, 41–44, 47, 48, 52, 54–56, 61, 66, 70, 72, 73, 77, 79–83, 85, 87, 96, 100, 101, 103–105, 107–118], with publication dates between 1994 and 2016 (median year of publication 2006).”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [35]
Authors recommended not to pool if heterogeneity is too high, and use statistical measures of heterogeneity to choose between random-effects and fixed-effect models.
“Authors recommended not to pool if heterogeneity is too high [35, 38, 47, 85, 103], and use statistical measures of heterogeneity to choose between random-effects (in case of heterogeneity) and fixed-effect models [55, 66].”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [35]
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- Authors
- Loke, Y. K., Price, D., Herxheimer, A., & the Cochrane Adverse Effects Methods Group
- Affiliations
- University of East Anglia (GB)
- University of Oxford (GB)
- Cochrane (GB)
- Corresponding author
- Herxheimer, Andrew
- ORCID
- Loke, Yoon K
- Venue
- BMC Medical Research Methodology
- Published
- 2007-07-05
- Volume
- 7
- Issue
- 1
- Pages
- 32-32
- ISSN
- 1471-2288 (ISSN-L)
- PMC
- PMC1933432
- OpenAlex
- W2052762949
- Cited by
- 253
- References
- 26
- Citations by year
- 2026: 8 · 2025: 12 · 2024: 9 · 2023: 8 · 2022: 9 · 2021: 9 · 2020: 15 · 2019: 19 · 2018: 11 · 2017: 19 · 2016: 20 · 2015: 19 · 2014: 15 · 2013: 19 · 2012: 11
- FWCI
- 1.74
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Medical Research Methodology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- UEA Digital Repository (University of East Anglia) (submittedVersion)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- adverse effects, harm assessment, systematic review methodology, drug safety, benefit-harm balance
- MeSH terms
- Drug Evaluation, Humans, Research Design, Meta-Analysis as Topic, Randomized Controlled Trials as Topic, Databases, Bibliographic, Information Storage and Retrieval, Practice Guidelines as Topic, Risk Assessment, Decision Support Systems, Clinical, Consensus, Medical Subject Headings, Drug-Related Side Effects and Adverse Reactions
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