Table A-1Recommendations for elements of assessing quality of the evidence when collecting and reporting harms, by study design

Study designQuality considerations
RCTsOn study conduct:
  • Are definitions of reported adverse effects given?
  • Were the methods used for monitoring adverse effects reported, such as use of prospective or routine monitoring; spontaneous reporting; patient checklist, questionnaire or diary; systematic survey of patients?
    What was the source to assess harms (self-report vs. medical exam vs. PI opinion)?
    Who decided seriousness, severity, and causal relation with the treatments?
On reporting:
  • Were any patients excluded from the adverse effects analysis?
  • Does the report provide numerical data by intervention group?
  • Which categories of adverse effects were reported by the investigators?
Case series
  • Do the reports have good predictive value?
  • How was causality determined?
  • Is there a plausible biological mechanism linking the intervention to the adverse event?
  • Do the reports provide enough information to allow detailed appraisal of the evidence?
Case control
  • Consider typical biases for this nonrandomized study design.

From Loke et al., 201123

From: Assessing the Risk of Bias of Individual Studies in Systematic Reviews of Health Care Interventions

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