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Issues relating to study design and risk of bias when including non‐randomized studies in systematic reviews on the effects of interventions
Abstract
Non‐randomized studies may provide valuable evidence on the effects of interventions. They are the main source of evidence on the intended effects of some types of interventions and often provide the only evidence about the effects of interventions on long‐term outcomes, rare events or adverse effects. Therefore, systematic reviews on the effects of interventions may include various types of non‐randomized studies. In this second paper in a series, we address how review authors might articulate the particular non‐randomized study designs they will include and how they might evaluate, in general terms, the extent to which a particular non‐randomized study is at risk of important biases. We offer guidance for describing and classifying different non‐randomized designs based on specific features of the studies in place of using non‐informative study design labels. We also suggest criteria to consider when deciding whether to include non‐randomized studies. We conclude that a taxonomy of study designs based on study design features is needed. Review authors need new tools specifically to assess the risk of bias for some non‐randomized designs that involve a different inferential logic compared with parallel group trials. Copyright © 2012 John Wiley & Sons, Ltd.
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“The non-randomised study was scored as high risk for 'random sequence generation' and 'allocation concealment' while grading for other items was similar to those of randomised trial.41”
From Mindfulness-based interventions for psychological wellbeing and quality of life in men with prostate cancer: A systematic review and meta-analysis (2021) · cites this paper as [41]
In the citing paper
“About one third of the articles acknowledged that searching for observational studies requires additional time and resources because of lack of specific search filters and poorly established or inconsistently used indexing terms [38, 39, 47, 49, 56, 58, 59, 64, 65].”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [65]
In the citing paper
“Many recommended that the eligibility criteria need to be pre-specified [30, 33, 38, 39, 47, 55, 65] and that the rationale for defining the eligibility criteria should be explicitly justified [38, 39, 65], unambiguous [65], and derived from the review question [47].”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [65]
In the citing paper
“Two recent articles advocated deciding on a case-by-case basis [37, 65].”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [65]
In the citing paper
“Recommendations were made mainly on 2 topics: whether different study designs should be included in a systematic review; [29, 34, 37–39, 49, 56, 65, 73, 75] and whether different study designs should be analysed together in a single meta-analysis [8, 34, 35, 37, 38, 42, 49, 51, 56, 61, 70, 75–78].”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [65]
In the citing paper
“Although many authoritative articles providing sound advice exist, such as those included in this review by Greenland [85], Egger et al. [29, 97], and a series in Research Synthesis Methods [37, 40, 65, 71, 75], the inexperienced reviewer may find them difficult to identify among the many other papers with contradictory advice.”
From Methods to systematically review and meta-analyse observational studies: a systematic scoping review of recommendations (2018) · cites this paper as [65]
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Programs and Practices Influencing Socio-Emotional Learning in Primary Schools: A Meta-Analysis
Hu, Y., Godor, B. P., Nederhand, M. L., Smeets, G., & der Hallen, R. V. (2026) · Journal of Applied School Psychology · doi:10.1080/15377903.2026.2701647
“The risk of bias for five domains was assessed to evaluate bias in non-randomized trials (Higgins, 2013): allocation concealment deviations from intended interventions, missing outcome data, measurement of outcome, and selection of reported result.”
Metadata
- Authors
- Higgins, J. P., Ramsay, C., Reeves, B. C., Deeks, J. J., Shea, B., Valentine, J. C., Tugwell, P., & Wells, G.
- Affiliations
- MRC Biostatistics Unit (GB)
- University of Aberdeen (GB)
- Bristol Royal Infirmary (GB)
- University of Birmingham (GB)
- University of Ottawa (CA)
- University of Louisville (US)
- Corresponding author
- Higgins, Julian PT
- ORCID
- Venue
- Research Synthesis Methods
- Publisher
- Wiley
- Published
- 2012-09-25
- Volume
- 4
- Issue
- 1
- Pages
- 12-25
- ISSN
- 1759-2879 (ISSN-L)
- 1759-2887
- OpenAlex
- W2062040186
- Cited by
- 183
- References
- 31
- Citations by year
- 2026: 3 · 2025: 7 · 2024: 17 · 2023: 23 · 2022: 8 · 2021: 17 · 2020: 18 · 2019: 21 · 2018: 10 · 2017: 16 · 2016: 11 · 2015: 11 · 2014: 11 · 2013: 9 · 2012: 1
- FWCI
- 2.82
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Research Synthesis Methods (publishedVersion)
- PubMed (publishedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion)
- Bristol Research (University of Bristol) (submittedVersion)
- Funders
- Scottish Government
- National Institute for Health and Care Research
- National Institutes of Health
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- non-randomized studies, risk of bias, study design classification, intervention effects, observational study design, causal inference
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