Many Systematic Reviews Do Not Fully Report Adverse Events
Of 146 protocols analyzed, 65 percent fully reported adverse events as intended by the protocol
TUESDAY, Feb. 12, 2019 (Pharmacist's Briefing) -- Many systematic review protocols in the International Prospective Register of Systematic Reviews (PROSPERO) do not include adverse event reporting, according to a study published in the April issue of the Journal of Clinical Epidemiology.
Rachael Parsons, M.P.H., from the University of York in the United Kingdom, and colleagues conducted a retrospective cohort study to examine the risk for adverse events-reporting bias in systematic reviews of health care interventions registered to PROSPERO. They determined the completeness of reporting for adverse event outcomes.
A total of 1,376 protocols for systematic reviews were screened, and 38 percent of them listed adverse events outcomes. A total of 186 protocols were published in 2017 and 2018, and 146 were included in the analysis. The researchers found that 65 percent of the included systematic reviews fully reported the adverse event outcomes as intended by the protocol. Eight percent of protocols excluded adverse event outcomes entirely, while adverse event outcomes were partially reported or changed in the remaining 27 percent of protocols.
"It appears that although few protocols specify an adverse events outcome, those that do are quite likely to at least partially, if not fully, report the adverse outcomes in their published review," the authors write.