RT Journal Article
SR Electronic
T1 Longitudinal Assessment of Patient-reported Outcome Measures in Systemic Sclerosis Patients with Gastroesophageal Reflux Disease — Scleroderma Clinical Trials Consortium
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP jrheum.180004
DO 10.3899/jrheum.180004
A1 Zsuzsanna H.  McMahan
A1 Tracy Frech
A1 Veronica Berrocal
A1 David Lim
A1 Cosimo Bruni
A1 Marco Matucci-Cerinic
A1 Vanessa Smith
A1 Karin Melsens
A1 Susanna Proudman
A1 Jinyu Zhang
A1 Fabian Mendoza
A1 Melanie Woods
A1 Dinesh Khanna
YR 2018
UL http://www.jrheum.org/content/early/2018/11/12/jrheum.180004.abstract
AB Objective Validated gastrointestinal (GI) symptoms scales are used in clinical practice to assess patient-reported GI involvement. We sought to determine whether University of California, Los Angeles (UCLA) GI Tract Questionnaire (GIT) 2.0 Reflux scale, Patient-Reported Outcomes Measurement Information System (PROMIS) Reflux scale, and the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD) are sensitive to identifying changes in GI symptoms following therapeutic intervention in participants with systemic sclerosis (SSc) and gastroesophageal reflux disease (GERD). Methods Participants with active GERD were recruited during clinical visits at 6 international SSc centers. Patient-reported outcome surveys and the GI self-reported questionnaire were completed at baseline and again at 4 weeks following a single intervention, and patients were classified as “improved” or “not improved.” Effect size (ES) was calculated to assess the sensitivity to change. ES was interpreted as 0.50–0.79 as moderate effect and ≥ 0.80 as large effect. Results There were 116 participants with SSc and active GERD who enrolled. The average age was 53.8 years and mean disease duration was 12.0 years. The UCLA GIT 2.0 Reflux scale and PROMIS Reflux scale had a significant correlation at baseline (0.61, p < 0.0001), and both instruments correlated with the QOLRAD domains (–0.56 to –0.71). In participants who had the UCLA GIT 2.0, PROMIS Reflux scale, and QOLRAD administered over 2 timepoints (n = 57) and were classified as improved, the ES was large for the UCLA GIT 2.0 and PROMIS Reflux scale, and moderate to large across all QOLRAD domains. Conclusion The UCLA GIT 2.0 Reflux scale, PROMIS Reflux scale, and QOLRAD are sensitive to change and can be included in future clinical trials.