Making a case for patient-reported outcomes in clinical inflammatory bowel disease practice
To that end, regulatory agencies, scientific bodies, and health care payors are shifting toward a more “patient-centered” approach with an emphasis on PROs. However, although the FDA is incorporating the patient perspective in its trials, measuring meaningful outcomes in day-to-day clinical care is challenging. In the absence of active inflammation, more than 30% of patients with IBD still suffer from gastrointestinal symptoms.9 Furthermore, physicians frequently underestimate the effect of depression, anxiety, fatigue, and sleep on patient health. Likewise, some patients with active small-bowel Crohn’s disease (CD) may experience few gastrointestinal symptoms but have profound fatigue, weight loss, and impaired quality of life. A focused assessment for disease activity may fail to identify aspects of health most relevant or important to individual patient well-being. There is a need for effective, efficient, and standardized strategies to better understand the concerns of the individual seeking help.
Although there are several PROs that measure disease activity primarily for clinical research trials,10 their prevalence in gastroenterology practices has not been assessed. Most likely, few clinical practices currently integrate standardized PROs in routine patient care. This may be because of several reasons, including lack of awareness of newly developed PROs, administrative burden including time and resources to collect PROs, potentially complex interpretation of results, and perhaps a reluctance among physicians to alter traditional patient interview methods of obtaining information about the health status of their patients. For effective use in clinical care, PROs require simple and relevant interpretation to add value to the clinician’s practice, and must minimally impact clinical flow and resources. The use of Internet-enabled tablets has been shown to be a feasible, efficient, and effective means of PRO assessment in gastroenterology practices, with good levels of patient satisfaction.11
Reaping potential benefits of patient-reported outcomes
The National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) is an initiative developed to investigate and promote implementation of PRO measures among patients with chronic diseases. The collection of PROMIS measures has been shown to be feasible at a tertiary care IBD center, enabling a biopsychosocial model of care.12 Likewise, implementation of PROs in other clinical areas including oncology, orthopedics, and rheumatology has been robust.
In an innovative orthopedic study, PROMIS measures collected and linked to the electronic medical record predicted the likelihood of a clinically meaningful benefit from foot and ankle surgery.13 This facilitated tailored patient-specific preoperative discussions about the expected benefit of surgery. In a study at a rheumatology clinic patients with rheumatoid arthritis were asked to identify their highest priority treatment targets using PROMIS domains (fatigue, pain, depression, social function). The highest priority domain was tracked over time as a patient-centered marker of health, essentially personalizing measures of success for the individual patient.14
PROs have the unique potential to affect multiple levels of health care. At the patient level, PRO data can identify specific concerns, manage expectations of recovery, and tailor treatment decisions to personal preference. At the population level, PRO data can be used to standardize aspects of care to understand comparative health and disease among all patients in a practice or relative to outside practices, identify outliers, and drive improvement.
