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Longitudinal assessment of patient-reported outcome measures in systemic sclerosis patients with gastroesophageal reflux disease : Scleroderma Clinical Trials Consortium

(2019) JOURNAL OF RHEUMATOLOGY. 46(1). p.78-84
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Abstract
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.
Keywords
SYSTEMIC SCLEROSIS, SCLERODERMA, OUTCOME ASSESSMENT, GASTROESOPHAGEAL REFLUX DISEASE, GASTROINTESTINAL TRACT, MINIMALLY IMPORTANT DIFFERENCES, QUALITY-OF-LIFE, GASTROINTESTINAL-TRACT, BARRETTS-ESOPHAGUS, DIAGNOSIS, QUESTIONNAIRE, RESPONSIVENESS, GUIDELINES, MANAGEMENT, SYMPTOMS

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Chicago
McMahan, Zsuzsanna H, Tracy Frech, Veronica Berrocal, David Lim, Cosimo Bruni, Marco Matucci-Cerinic, Vanessa Smith, et al. 2019. “Longitudinal Assessment of Patient-reported Outcome Measures in Systemic Sclerosis Patients with Gastroesophageal Reflux Disease : Scleroderma Clinical Trials Consortium.” Journal of Rheumatology 46 (1): 78–84.
APA
McMahan, Z. H., Frech, T., Berrocal, V., Lim, D., Bruni, C., Matucci-Cerinic, M., Smith, V., et al. (2019). Longitudinal assessment of patient-reported outcome measures in systemic sclerosis patients with gastroesophageal reflux disease : Scleroderma Clinical Trials Consortium. JOURNAL OF RHEUMATOLOGY, 46(1), 78–84.
Vancouver
1.
McMahan ZH, Frech T, Berrocal V, Lim D, Bruni C, Matucci-Cerinic M, et al. Longitudinal assessment of patient-reported outcome measures in systemic sclerosis patients with gastroesophageal reflux disease : Scleroderma Clinical Trials Consortium. JOURNAL OF RHEUMATOLOGY. 2019;46(1):78–84.
MLA
McMahan, Zsuzsanna H, Tracy Frech, Veronica Berrocal, et al. “Longitudinal Assessment of Patient-reported Outcome Measures in Systemic Sclerosis Patients with Gastroesophageal Reflux Disease : Scleroderma Clinical Trials Consortium.” JOURNAL OF RHEUMATOLOGY 46.1 (2019): 78–84. Print.
@article{8581555,
  abstract     = {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 {\textacutedbl} improved{\textacutedbl} or {\textacutedbl} not improved.{\textacutedbl} 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 {\textlangle} 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.},
  author       = {McMahan, Zsuzsanna H and Frech, Tracy and Berrocal, Veronica and Lim, David and Bruni, Cosimo and Matucci-Cerinic, Marco and Smith, Vanessa and Melsens, Karin and Proudman, Susanna and Zhang, Jinyu and Mendoza, Fabian and Woods, Melanie and Khanna, Dinesh},
  issn         = {0315-162X},
  journal      = {JOURNAL OF RHEUMATOLOGY},
  language     = {eng},
  number       = {1},
  pages        = {78--84},
  title        = {Longitudinal assessment of patient-reported outcome measures in systemic sclerosis patients with gastroesophageal reflux disease : Scleroderma Clinical Trials Consortium},
  url          = {http://dx.doi.org/10.3899/jrheum.180004},
  volume       = {46},
  year         = {2019},
}

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