Longitudinal assessment of patient-reported outcome measures in systemic sclerosis patients with gastroesophageal reflux disease - Scleroderma clinical trials consortium

Zsuzsanna McMahan, Tracy Frech, Veronica Berrocal, David Lim, Cosimo Bruni, Marco Matucci-Cerinic, Vanessa Smith, Karin Melsens, Susanna Proudman, Jinyu Zhang, Fabian Mendoza, Melanie Woods, Dinesh Khanna

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)78-84
Number of pages7
JournalJournal of Rheumatology
Volume46
Issue number1
DOIs
StatePublished - Jan 1 2019

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Systemic Scleroderma
Gastroesophageal Reflux
Clinical Trials
Los Angeles
Dyspepsia
Information Systems
Gastrointestinal Tract
Quality of Life
Surveys and Questionnaires
Patient Reported Outcome Measures

Keywords

  • Gastroesophageal reflux disease
  • Gastrointestinal tract
  • Outcome assessment
  • Scleroderma
  • Systemic sclerosis

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

Cite this

Longitudinal assessment of patient-reported outcome measures in systemic sclerosis patients with gastroesophageal reflux disease - Scleroderma clinical trials consortium. / McMahan, Zsuzsanna; Frech, Tracy; Berrocal, Veronica; Lim, David; Bruni, Cosimo; Matucci-Cerinic, Marco; Smith, Vanessa; Melsens, Karin; Proudman, Susanna; Zhang, Jinyu; Mendoza, Fabian; Woods, Melanie; Khanna, Dinesh.

In: Journal of Rheumatology, Vol. 46, No. 1, 01.01.2019, p. 78-84.

Research output: Contribution to journalArticle

McMahan, Z, Frech, T, Berrocal, V, Lim, D, Bruni, C, Matucci-Cerinic, M, Smith, V, Melsens, K, Proudman, S, Zhang, J, Mendoza, F, Woods, M & Khanna, D 2019, 'Longitudinal assessment of patient-reported outcome measures in systemic sclerosis patients with gastroesophageal reflux disease - Scleroderma clinical trials consortium', Journal of Rheumatology, vol. 46, no. 1, pp. 78-84. https://doi.org/10.3899/jrheum.180004
McMahan, Zsuzsanna ; Frech, Tracy ; Berrocal, Veronica ; Lim, David ; Bruni, Cosimo ; Matucci-Cerinic, Marco ; Smith, Vanessa ; Melsens, Karin ; Proudman, Susanna ; Zhang, Jinyu ; Mendoza, Fabian ; Woods, Melanie ; Khanna, Dinesh. / Longitudinal assessment of patient-reported outcome measures in systemic sclerosis patients with gastroesophageal reflux disease - Scleroderma clinical trials consortium. In: Journal of Rheumatology. 2019 ; Vol. 46, No. 1. pp. 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.",
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AU - McMahan, Zsuzsanna

AU - Frech, Tracy

AU - Berrocal, Veronica

AU - Lim, David

AU - Bruni, Cosimo

AU - Matucci-Cerinic, Marco

AU - Smith, Vanessa

AU - Melsens, Karin

AU - Proudman, Susanna

AU - Zhang, Jinyu

AU - Mendoza, Fabian

AU - Woods, Melanie

AU - Khanna, Dinesh

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N2 - 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.

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KW - Gastrointestinal tract

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KW - Scleroderma

KW - Systemic sclerosis

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