Employing irritable bowel syndrome patient-reported outcomes in the clinical trenches

NIH PROMIS

Although there have been many efforts to implement PROs in routine clinical care, a recent confluence of scientific, regulatory, and political factors, coupled with technological advancements in PRO measurement techniques, have justified re-evaluation of the use of PROs in everyday practice. In response to the practical and technical challenges to employing PROs in the clinical trenches as described earlier, the NIH PROMIS (www.healthmeasures.net) was created in 2004 with the goal of developing and validating a toolbox of PROs that cover the breadth and depth of the human health and illness experience. The PROMIS initiative also was borne from the realization that patients are the ultimate consumers of health care and are the final judge on whether their health care needs are being addressed adequately.

By using modern psychometric techniques, such as item response theory and computerized adaptive testing, PROMIS offers state-of-the-art psychometrics, establishes common-language benchmarks for symptoms across conditions, and identifies clinical thresholds for action and meaningful clinical improvement or decline. PROMIS questionnaires, in light of accelerated EHR adoption in recent years, also are designed to be administered electronically and efficiently, allowing implementation in busy clinical settings. As of December 2017, these instruments can be administered and scored through EHRs such as Epic (Epic Systems, Verona, WI) and Cerner (Cerner Corporation, North Kansas City, MO), the PROMIS iPad (Apple Inc, Cupertino, CA) App, and online data collection tools such as the Assessment Center (www.assessmentcenter.net) and REDCap (Research Electronic Data Capture; Vanderbilt University, Nashville, TN).²⁵ An increasing number of health systems are making PROMIS measures available through their EHRs. For example, the University of Rochester Medical Center collects PROMIS scores for physical function, pain interference, and depression from more than 80% of their patients with in-clinic testing, and individual departments are able to further tailor their administered questionnaires.²⁶

Gastrointestinal PROs measurement information system scales

Because of the extraordinary burden of illness from digestive diseases, the PROMIS consortium added a GI item bank, which our research group developed.²³ By using the NIH PROMIS framework, we constructed and validated eight GI PROMIS symptom scales: abdominal pain, bloating/gas, constipation, diarrhea, bowel incontinence, dysphagia, heartburn/reflux, and nausea/vomiting.²³ GI PROMIS was designed from the outset to not be a disease-targeted item bank (e.g., IBS-, cirrhosis-, or inflammatory bowel disease specific), but rather symptom targeted, measuring the physical symptoms of the GI tract, because it is more useful across the population as a whole. In Supplementary Figure 1 (at https://doi.org/10.1016/j.cgh.2017.12.026), we include the abdominal pain, constipation, and diarrhea PROMIS scales because they form the cardinal symptoms of IBS.

GI PROMIS scales are readily accessible via the Assessment Center,²⁵ and we also have made them freely available via MyGiHealth — an iOS (Apple Inc) and online app (go.mygihealth.io) endorsed by the American Gastroenterological Association. The patient’s responses to the questionnaires are converted to percentile scores and compared with the general U.S. population, and then displayed in a symptom heat map. The app also allows users to track GI PROMIS scores longitudinally, empowering IBS patients (and any patient with GI symptoms for that matter) and their providers to see if they are objectively responding to prescribed therapies and potentially improving satisfaction and patient–provider communication.