Lessons from studies of medication reduction in psychosis: giving participants accurate information about risk in psychiatric research trials.

Abstract

All research needs ethical regulation, which is institutionalized in research ethics committees. The patient information sheet, approved by a research ethics committee, sets out what patients need to know to make an informed choice about research participation. However, guidance from research ethics committees is much less explicit about risk communication. In this commentary, the balance of risk in the patient information sheets from protocols of 2 randomized controlled trials (RCTs) of medication reduction in psychosis was compared with numbers needed to treat and harm from the literature. The patient information sheet omitted risk of excess death and incomplete recovery following relapse, and overestimated the anticipated benefits. All of these risks were demonstrated in the published results of 1 of the 2 RCTs. Quantifying and tabulating risk might improve patient information sheets.