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In a Viewpoint appearing in the September 25 issue of JAMA, SPCR Doctoral student, Derek Kyte, (PRO Research Group, University of Birmingham), and colleagues Prof Heather Draper and Dr Melanie Calvert examine potential approaches to managing patient-reported outcomes (PRO) alerts (where a patient's self-reported data causes trial personnel to become concerned for their wellbeing or safety).

Patient reported outcome alerts ethical and logistical considerations in clinical trials

They issued the following press release: "There are strong ethical and scientific reasons to reach consensus about how PRO alerts should be dealt with by researchers. Ad hoc interventions may leave participants at risk of harm, place strain on individual researchers, risk cointervention bias, and compromise the integrity of the study. The optimal and most appropriate management strategy is unclear at this stage—the correct response may depend on the nature of the trial and its risk profile. Even if inter-trial consistency is not appropriate, consistency should exist at least across sites within trials. Researchers must, therefore, recognize that PRO alerts are a possibility that should be accommodated at the design stage of the study. Finally, arrangements set out in the protocol need to be reinforced by institutional review boards, with clear information for both participants and researchers."

Full article

PRO Research Group page