Piloting Patient Reported Outcomes Measurement Information System for Pain Studies
Abstract: Pain is a therapeutic challenge as well as a public health problem that affects over 116 million American adults; reduces quality of life; and is estimated to cost up to $635 billion annually . There is a growing recognition that health care outcomes will be improved by matching proven effective treatments with knowledge of patients’ unique characteristics to optimize efficacy and safety. This project aims to assess the validity of the Patient Reported Outcomes Measurement Information System (PROMIS) for pain. PROMIS is a computerized system measuring patient-reported outcomes across a wide range of chronic conditions but has not yet been studied for acute pain. In this pilot study, PROMIS questionnaires will be given to healthy volunteers and, in a future study, the responses will be compared to those of patients with acute pain following the removal of wisdom teeth. We hypothesize that self-reported responses to PROMIS domains of physical, mental, and social health in patients with acute pain will differ from those of healthy volunteers. We predict that we can categorize patients into sub-groups based off PROMIS domains hypothesized to be related to acute pain. PROMIS item banks to be studied include pain intensity, pain interference, fatigue, anxiety, depression, the ability to participate in social roles and activities, physical function, and sleep disturbance. In this pilot study, a preliminary PROMIS study will be designed and tested for its ability to determine a healthy population and functionality in clinical research for pain. Validation of PROMIS for acute pain will allow for a more comprehensive phenotyping in future acute pain studies known as deep phenotyping. Combined with genomic data and quantitative sensory testing, PROMIS can help eliminate observer-based perceptions of patients’ pain and allow for more specific drug therapy.