Adverse event recording failed to reflect potential harms: review trial protocols psychosocial interventions, 2021, Papaioannou, Cooper et al

[JohnTheJack]

Full title:
Adverse event recording failed to reflect potential harms: a review of trial protocols of behavioral, lifestyle and psychological therapy interventions

https://www.sciencedirect.com/scien...fwLkGlDgt31WtgFVtDV4Adef6aYlZvD9dQo0PFehF2CJI

Conclusion
Monitoring and recording AEs in behavioral intervention trials was variable and frequently based on reporting guidelines for pharmacological trials. This may mean potential harms are being missed. Future trials should consider: 1) Potential harms posed by the intervention 2) How to define serious AEs 3) What are expected AEs. Further research to achieve consensus on AE recording is required, including identification of core adverse outcomes in clinical areas or caused by interventions.

 

[Creekside]

Good. It seems pretty obvious that there's a need for that.