Abstract
The assessment of patient-reported outcomes (PROs) in clinical trials poses a number of potential problems. What happens when a patient reports a severe symptom and no one is monitoring that information; for example, when questionnaires are not reviewed until the end of a study? Do hospitals or researchers face liability if a patient reports suicidal thoughts on a questionnaire? Investigators and institutional review boards (IRBs) are increasingly concerned about the risks to patients, and the potential legal liability, when PRO information is not reviewed to detect concerning levels of psychological distress or physical symptoms that may require an immediate response.1 These so-called PRO alerts may present as extreme scores on questionnaires, in additional information provided by a patient, or in a discussion between a patient and research personnel. However, in all cases, the overarching priority must be to ensure the safety and well-being of patients participating in clinical trials.
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