More than one-third of systematic reviews did not fully report the adverse events outcome

Ref ID 377
First Author R. Parsons
Journal JOURNAL OF CLINICAL EPIDEMIOLOGY
Year Of Publishing 2019
URL https://www.jclinepi.com/article/S0895-4356(18)30816-3/pdf
Keywords • Harms
• Protocols
Problem(s) • Selective reporting of harms / safety / adverse events / side effects
Article Type Empirical
Article Subtype Cross-sectional survey/Methodological systematic review
First Author Country United Kingdom
Aim To assess adverse events reporting bias in both protocol registration and published systematic reviews of health care interventions registered in PROSPERO published in 2017 or 2018.
Level of Investigation Descriptive
Summary of Findings Of the included review protocols of health care interventions in PROSPERO, only 38% listed adverse events as an outcome of interest. In a final cohort 146 published reviews 65% fully reported the adverse events outcome exactly as intended from the protocol. 8% of the reviews excluded the adverse effect outcome entirely. The remaining 27% at least partially reported adverse events or in some way changed the reporting of the outcomes.
Number of systematic reviews included 1376
Number of eligible systematic reviews assessed 2032
Treatment impacted No
Treatment impacted description
Interpretation impacted Not Applicable
Interpretation impacted description