Adverse event recording failed to reflect potential harms: A review of trial protocols of behavioural, lifestyle and psychological therapy interventions.

Non-pharmacological interventions can cause harm or unintended effects, yet within public health and psychological therapy fields, clinical trials have not adequately considered these outcomes [1 –7]. This is of concern since intervention assessment in clinical trials requires risk-benefit analysis. Beneficial effects must be considered alongside harmful effects. This could leave harms, typically termed Adverse Events (AEs), unidentified.
Source: Journal of Clinical Epidemiology - Category: Epidemiology Authors: Source Type: research