Evaluation of the patient-reported outcomes measurement information system in a large cohort of patients with inflammatory bowel diseases.

Patient-reported outcomes (PROs) convey important aspects of health status, complementing physician-reported measures. The PRO Measurement Information System (PROMIS) provides valid, widely available measures applicable to patients with chronic illness and the general population. We sought to evaluate these measures in a large cohort of patients with inflammatory bowel disease (IBD). By using data from the Crohn's and Colitis Foundation Association Partners internet cohort, we performed cross-sectional and longitudinal analyses to evaluate associations between PROMIS measures and validated disease activity indices (Short Crohn's Disease Activity Index and Simple Clinical Colitis Activity Index) and the Short IBD Questionnaire quality-of-life instrument. A total of 10,634 individuals (6689 with Crohn's disease and 3945 with ulcerative colitis or indeterminate colitis) completed PRO testing. Compared with the general population (mean PROMIS score, 50), IBD patients in this cohort reported more depression (mean, 54), anxiety (mean, 52), fatigue (mean, 56), sleep disturbance (mean, 52), and pain interference (mean, 53); and they had less social satisfaction (mean, 48). In each PROMIS domain, there was worse functioning with increasing levels of disease activity and worsening Short IBD Questionnaire scores (P < .001 for all). Longitudinal analyses showed improved PROMIS scores with improved disease activity and worsening PROMIS scores with worsening disease (P < .001 for all comparisons). In a cross-sectional and longitudinal study, we observed differences between patients with IBD and the general population in several important aspects of health. The improvement in diverse health outcome measures with improved disease control provides strong support for the construct validity of PROMIS measures in the IBD population. Their use should advance patient-centered outcomes research in IBD.

Kappelman MD ，Long MD ，Martin C ，DeWalt DA ，Kinneer PM ，Chen W ，Lewis JD ，Sandler RS ... -  《-》

Evaluation of Gastrointestinal Patient Reported Outcomes Measurement Information System (GI-PROMIS) Symptom Scales in Subjects With Inflammatory Bowel Diseases.

Kochar B ，Martin CF ，Kappelman MD ，Spiegel BM ，Chen W ，Sandler RS ，Long MD ... -  《-》

Patient-Reported Outcomes of Quality of Life, Functioning, and GI/Psychiatric Symptom Severity in Patients with Inflammatory Bowel Disease (IBD).

IsHak WW ，Pan D ，Steiner AJ ，Feldman E ，Mann A ，Mirocha J ，Danovitch I ，Melmed GY ... -  《-》

Qualitative and Psychometric Evaluation of 29-Item Patient-Reported Outcomes Measurement Information System® to Assess General Health-Related Quality of Life in Patients With Moderately to Severely Active Inflammatory Bowel Disease.

To evaluate content validity and psychometric properties of the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29) to determine its suitability in inflammatory bowel disease (IBD) clinical trials. Content validity of PROMIS-29 was evaluated using qualitative interviews, including concept elicitation and cognitive debriefing, among patients living with Crohn's disease (Crohn's disease n = 20) or ulcerative colitis (UC, n = 19). PROMIS-29 validity, reliability, and responsiveness were assessed using data from phase II clinical trials of Crohn's disease (N = 360) and UC (N = 518). Common (≥74%) symptoms reported in qualitative interviews were increased stool frequency, fatigue, abdominal pain/cramping, blood/mucus in stool, bowel urgency, and diarrhea. Disease impact aligned with PROMIS-29 content (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles/activities). Cognitive debriefing indicated that PROMIS-29 instructions were easily understood, items were relevant, and the recall period was appropriate. Psychometric evaluations demonstrated that PROMIS-29 scores indicating worse symptoms/functioning were associated with lower health-related quality of life and greater disease activity and severity. PROMIS-29 domain scores correlated (rs ≥ 0.40) with IBD Questionnaire domains and EuroQol-5-Dimension-5-Level dimensions measuring similar concepts. Test-retest reliability among patients with stable disease was moderate-to-excellent (0.64-0.94) for nearly all domains in all studies. PROMIS-29 was responsive to change in disease status from baseline to week 12. Thresholds for clinically meaningful improvement ranged from ≥3 to ≥8, depending on domain. PROMIS-29 is valid, reliable, and responsive for assessing general health-related quality of life and treatment response in IBD clinical trials.

Sands BE ，Panés J ，Feagan BG ，Zhang H ，Vetter ML ，Mathias SD ，Huang KG ，Johanns J ，Germinaro M ，Sahoo A ，Terry NA ，Han C ... -  《-》

mHealth Physical Activity and Patient-Reported Outcomes in Patients With Inflammatory Bowel Diseases: Cluster Analysis.

Griffin AC ，Mentch L ，Lin FC ，Chung AE ... -  《JOURNAL OF MEDICAL INTERNET RESEARCH》