The UCLA GI Tract (UCLA GIT) Questionnaire 2.0 Reflux scale, Patient-Reported Outcomes Measurement Information System (PROMIS) Reflux scale, and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire all proved sensitive to change and therefore, can be included in clinical trials. This according to a recent study that sought to determine whether these 3 patient-reported outcome measures are sensitive to identifying changes in gastrointestinal (GI) symptoms following therapeutic intervention in participants with systemic sclerosis (SSc) and gastroesophageal reflux disease (GERD). Participants (n=116) with active GERD were recruited during clinical visits at 6 international SSc centers. Researchers found:
- The UCLA GIT 2.0 Reflux scale and PROMIS Reflux scale had a significant correlation at baseline (0.61), and both instruments correlated with the QOLRAD domains (−0.56 to −0.71).
- For those who had the 3 measures administered over 2 time points (n=57) and were classified as improved, the effect size was large for the UCLA GIT 2.0 and PROMIS Reflux scale, and moderate to large across all QOLRAD domains.
McMahan ZH, Frech T, Berrocal V, et al. Longitudinal assessment of patient-reported outcome measures in systemic sclerosis patients with gastroesophageal reflux disease—Scleroderma Clinical Trials Consortium. J Rheumatol. 2019;46(1):78-84. doi:10.3899/jrheum.180004.