Original article
Alimentary tract
Evaluation of the Patient-Reported Outcomes Measurement Information System in a Large Cohort of Patients With Inflammatory Bowel Diseases

https://doi.org/10.1016/j.cgh.2013.10.019Get rights and content

Background & Aims

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).

Methods

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.

Results

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).

Conclusions

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.

Section snippets

Overall Study Design

Within a large internet cohort of adult patients with IBD, we performed a series of cross-sectional and longitudinal analyses to evaluate associations between PROMIS measures and disease activity indices, a disease-specific health-related quality-of-life (HRQOL) instrument, prednisone use, and ileal pouch-anal anastomosis (IPAA) status.

Study Population

The Crohn’s and Colitis Foundation of America (CCFA) Partners study is a longitudinal internet-based cohort of patients with IBD. The development of the cohort

Study Population

A total of 10,634 individuals with self-reported IBD joined CCFA Partners through October 22, 2012, and completed PRO testing. Of these, 6689 reported having CD, and 3945 reported UC or IC. Seventy-one percent of the study participants were women. The mean age of the study population was 44 years, and the mean time from diagnosis to PRO testing was 14.9 years. Additional demographic details are provided in Table 1.

Patient-Reported Outcomes Measurement Information System Testing

The mean PROMIS scores for depression, anxiety, fatigue, sleep disturbance,

Discussion

PROs are an essential component of patient-centered research, including clinical trials and comparative effectiveness research. The PROMIS provides measures that are efficient (minimizes item number without compromising reliability), flexible (enables optional use of interchangeable items), and precise (has minimal errors in estimate).5, 6 PROMIS measures have been evaluated extensively in the general population and in individuals with chronic illness.8 Here, we report a wide-scale,

References (19)

There are more references available in the full text version of this article.

Cited by (0)

Conflicts of interest The authors disclose no conflicts.

Funding This research was supported, in part, by a grant from the Crohn’s and Colitis Foundation of America, and by a grant from the National Institute for Diabetes and Digestive and Kidney Diseases (P30 DK034987 to R.S.S.).

View full text