Harms in Systematic Reviews Paper 2: Methods used to assess harms are neglected in systematic reviews of gabapentin
- PMID: 34742789
- PMCID: PMC9875742
- DOI: 10.1016/j.jclinepi.2021.10.024
Harms in Systematic Reviews Paper 2: Methods used to assess harms are neglected in systematic reviews of gabapentin
Abstract
Objective: We compared methods used with current recommendations for synthesizing harms in systematic reviews and meta-analyses (SRMAs) of gabapentin.
Study design & setting: We followed recommended systematic review practices. We selected reliable SRMAs of gabapentin (i.e., met a pre-defined list of methodological criteria) that assessed at least one harm. We extracted and compared methods in four areas: pre-specification, searching, analysis, and reporting. Whereas our focus in this paper is on the methods used, Part 2 examines the results for harms across reviews.
Results: We screened 4320 records and identified 157 SRMAs of gabapentin, 70 of which were reliable. Most reliable reviews (51/70; 73%) reported following a general guideline for SRMA conduct or reporting, but none reported following recommendations specifically for synthesizing harms. Across all domains assessed, review methods were designed to address questions of benefit and rarely included the additional methods that are recommended for evaluating harms.
Conclusion: Approaches to assessing harms in SRMAs we examined are tokenistic and unlikely to produce valid summaries of harms to guide decisions. A paradigm shift is needed. At a minimal, reviewers should describe any limitations to their assessment of harms and provide clearer descriptions of methods for synthesizing harms.
Keywords: Clinical Trials; Harms; Meta-analysis; Synthesis; Systematic Reviews.
Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Conflict of interest: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
References
-
- Thomas J, Kneale D, Mckenzie JE, Brennan SE, Bhaumik S. Chapter 2: Determining the scope of the review and the questions it will address. Cochrane Handbook for Systematic Reviews of Interventions. 6.0; 2019.
-
- Peryer G, Golder S, Junqueira D, Vohra S, Kong Loke Y, et al. Chapter 19: Adverse effects Cochrane Handbook for Systematic Reviews of Interventions. Version 6. Cochrane Higgins J, Thomas J, Chandler J, et al., editors; 2019. https://training.cochrane.org/handbook/version-6/chapter-19-draftv2.
-
- Etminan M, Carleton B, Rochon PA. Quantifying adverse drug events: Are systematic reviews the answer? Drug Saf 2004;27(11):757–61. - PubMed
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