Category: Liability

By Sharona Hoffman

Patient-reported outcome measures (PROMs) are questionnaires that patients fill out on tablets or other computers or devices. They ask patients to check boxes in answer to questions about their symptoms, treatment effects, and ability to function physically, emotionally, and socially. They thus may solicit very sensitive information about matters such as anxiety, depression, and sexual satisfaction. To illustrate, a query might be “in the past month, how often did you have a lot of trouble falling asleep,” and the patient is asked to check “never,” “rarely,” “sometimes,” “often,” or “always.”

PROM responses can be used for purposes of clinical care, research, quality improvement, Food and Drug Administration (FDA) approval of drugs and devices, and even insurance reimbursement. For example, insurers hypothetically could decide to decline coverage of particular treatments based on PROM responses indicating that many patients find them to be unhelpful.

I first became interested in patient-reported outcome measures because of an experience my husband had. Andy has Parkinson’s disease, and one of the neurologists he saw asked him to fill out a long questionnaire on a tablet computer before each appointment. This task was difficult for Andy because he had a hand tremor, and it was stressful because Andy worried that he would not have time to complete the survey before his appointment began. Moreover, Andy’s physician never referred to his responses and appeared never to look at them. Upon investigation, I found little to no analysis of PROMs in the legal literature, so Andy and I recently published a law review article about them.

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