Patient Identification of the most important outcomes in a gastrointestinal behavioral health program

Brain-gut behavior therapies (BGBTs) are evidence-based treatments for patients with disorders of gut-brain interaction (DGBI) and inflammatory bowel disease (IBD). While BGBT clinical trials prioritize decreasing symptom severity and improving anxiety, depression, and quality of life, these outcomes are not designed based on patients' priorities. We aimed to determine the optimal patient-centered outcome measures to assess change following BGBT using a stakeholder-engaged qualitative process.

We interviewed patients 1:1 with DGBI and IBD with and without BGBT experience. Interview data were analyzed using rapid qualitative analysis. Subsequent focus groups reviewed the qualitative findings to verify accuracy, identify high-priority and missing constructs, and create clinical use recommendations. Measure recommendations were developed based on patients' perspectives and the extant literature.

Qualitative interviews (N = 20) yielded five domains: lived experience of disease, how to cope with illness, perceived value of behavioral intervention, outcomes and measurement, and behavioral intervention effects. Focus group participants (N = 14) broadly confirmed that the qualitative themes represented their experience with BGBTs and prioritized confidence in symptom management, social connectedness, lived experience with disease, and mental/behavioral health symptoms. They highlighted the importance of brevity, semi-regular re-evaluation, and access to results. Resultant measures included: Brief Illness Perception Questionnaire, PROMIS Self-Efficacy for Managing Chronic Conditions-Symptoms, UCLA Loneliness Scale, IBD DISK (adapted), and PHQ-2/GAD-2.

The identified treatment targets differed from those prioritized in clinical trials. However, DGBI and IBD literature suggests that many of the identified constructs supersede traditional outcomes such as anxiety and depression. These results can guide integration of patient-reported outcome measures into gastropsychology programs and highlight the value of involving patients in program development.