More than a third of systematic health care reviews do not fully report adverse events outcomes, new research suggests.
As part of a new study, researchers examined the reporting of adverse events in 146 systematic review protocols registered to the International Prospective Register of Systematic Reviews (PROSPERO) and the respective reviews published between 2017 and 2018.
They found 65 per cent of reviews fully reported adverse event outcomes as intended by the protocol. However, 8 per cent entirely excluded the adverse event outcome. Twenty-seven per cent either partially reported or in some way changed the adverse event outcomes as specified in their respective PROSPERO-registered protocols. This included both positive changes such as adding new specific named adverse events and negative changes such as excluding certain specific named adverse events or by moving the outcome from a primary to a secondary outcome level. Others changed the reporting from the protocol in ways regarding the presentation of the adverse events, such as presenting the outcome as 'tolerability' instead of 'safety'.
The authors said researchers should be encouraged to include adverse events outcomes in their protocol before beginning a systematic review and follow harms reporting set out in guidelines.
The research is published in the Journal of Clinical Epidemiology.