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Cited by 1,581Meta-analysis and systematic reviewsStatistical Methods in EpidemiologyMethodologies in Health Research and Practice

Methodological quality of case series studies: an introduction to the JBI critical appraisal tool

Munn, Zachary, Barker, Timothy Hugh, Moola, Sandeep, Tufanaru, Catalin, Stern, Cindy, McArthur, Alexa, Stephenson, Matthew, Aromataris, Edoardo·2019·JBI Database of Systematic Reviews and Implementation Reports
DOI 10.11124/jbisrir-d-19-00099
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Abstract

INTRODUCTION: Systematic reviews provide a rigorous synthesis of the best available evidence regarding a certain question. Where high-quality evidence is lacking, systematic reviewers may choose to rely on case series studies to provide information in relation to their question. However, to date there has been limited guidance on how to incorporate case series studies within systematic reviews assessing the effectiveness of an intervention, particularly with reference to assessing the methodological quality or risk of bias of these studies. METHODS: An international working group was formed to review the methodological literature regarding case series as a form of evidence for inclusion in systematic reviews. The group then developed a critical appraisal tool based on the epidemiological literature relating to bias within these studies. This was then piloted, reviewed, and approved by JBI's international Scientific Committee. RESULTS: The JBI critical appraisal tool for case series studies includes 10 questions addressing the internal validity and risk of bias of case series designs, particularly confounding, selection, and information bias, in addition to the importance of clear reporting. CONCLUSION: In certain situations, case series designs may represent the best available evidence to inform clinical practice. The JBI critical appraisal tool for case series offers systematic reviewers an approved method to assess the methodological quality of these studies.

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  • Risk of bias was assessed using ROB II for RCTs, ROBINS-I for quasiexperimental and controlled cohort studies, a team-developed tool for uncontrolled cohort studies, and the Joanna Briggs Institute checklist for case series.

    “We consider to use the ROB II tool 22 for RCTs and the ROBINS-I tool 23 for quasiexperimental and controlled cohort studies. Uncontrolled cohort studies were assessed using a tool, developed by our team, to assess the risk of bias in series of subjects exposed to an intervention (see Supplementary Appendix 3). Case series were evaluated using the Joanna Briggs Institute checklist 24.”

    From Efectividad del tratamiento de la sífilis gestacional en el último trimestre sobre la incidencia de sífilis congénita: revisión sistemática y metanálisis (2025) · cites this paper as [24]

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Authors
Munn, Z., Barker, T. H., Moola, S., Tufanaru, C., Stern, C., McArthur, A., Stephenson, M., & Aromataris, E.
Affiliations
The University of Adelaide (AU)
Corresponding author
Barker, Timothy Hugh
ORCID
Venue
JBI Database of Systematic Reviews and Implementation Reports
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2019-09-23
Volume
Publish Ahead of Print
Issue
10
Pages
2127-2133
ISSN
2202-4433 (ISSN-L)
DOI
10.11124/jbisrir-d-19-00099
OpenAlex
W2974663997
Cited by
1,581
References
31
Citations by year
2026: 404 · 2025: 392 · 2024: 317 · 2023: 230 · 2022: 142 · 2021: 83 · 2020: 13
FWCI
39.81
Type
journal article
Language
en
Open access
closed
Locations
  • The JBI Database of Systematic Reviews and Implementation Reports (publishedVersion)
  • PubMed (publishedVersion)
  • Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion)
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 › Health Professions › Health Information Management › Methodologies in Health Research and Practice
Keywords
methodological quality, risk of bias, critical appraisal tools, internal validity, confounding, selection bias, information bias, reporting quality, evidence synthesis, systematic reviews
MeSH terms
Systematic Reviews as Topic, Research Design, Bias

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