Patient-reported outcomes (PRO)—specific, standardized questionnaires that patients with chronic conditions can complete to give clinicians better understanding of how they feel—have added a new instrument to the clinician’s toolkit in diagnosing and treating patients. 

The National Institutes of Health has encouraged development of these person-centered measures for a range of chronic conditions, and they are being compiled in a growing database called PROMIS (Patient-Reported Outcomes Measurement Information System) that any clinician can use for free to evaluate patients. To date more than 300 conditions are included—many of them developed by Carole Tucker, associate professor in health and rehabilitation sciences in Temple’s College of Public Health. Under a new $250,000 grant, Tucker will add to the database by developing a measurement for fatigue among children with Crohn’s disease.

“For years in clinical practice, we've relied heavily on lab tests, things like blood tests, and on performance-based assessments, where the clinician says ‘move your arm’,” Tucker explains. PROs add depth by having the patients themselves report their conditions. “It’s not me as a clinician interviewing you, and then me writing down my interpretation, but you answering specific questions, about how well you can move in space, your physical function, how much pain interferes in your activities.”

In practice, patients providing this kind of feedback to clinicians may be handed an electronic tablet, where they complete a short survey about their condition.

“As a doctor you may think you understand what's interfering with my quality of life. But when you actually ask me, you may find it's not the pain from my hip, it may be that I can't sleep at night,” Tucker says.

Crohn's, an inflammatory bowel disease, often is treated with medication, and another expanding use of patient-reported outcomes is in trials of proposed new drugs and medical devices, Tucker says.

“Just within the last three to four years, the FDA has said it doesn’t want drug and device development trials to only have lab-based objective outcomes. Drug approval trials have to have patient-reported outcomes in them. Like what you’re seeing with COVID and the new vaccines,” she says. “At the end of this grant, we will have provided the FDA with all of the evidence they need, all the data they need, so that they can say: anybody doing a pediatric Crohn's disease trial, if you're going to measure fatigue, you should be using this measure.”