Responsiveness and interpretation of a symptom severity index specific to upper gastrointestinal disorders

Dennis A. Revicki, Anne M. Rentz, Jan Tack, Vincenzo Stanghellini, Nicholas J. Talley, Peter Kahrilas, Christine De La Loge, Elyse Trudeau, Dominique Dubois

Research output: Contribution to journalArticlepeer-review

52 Scopus citations

Abstract

Background & Aims: Determining clinically meaningful change of patient-reported outcome measures is important for evaluating effectiveness of treatments for gastrointestinal (GI) diseases. This study evaluates responsiveness of the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) in gastroesophageal reflux disease (GERD) and dyspepsia. Methods: The PAGI-SYM was based on a review of the published literature and interviews with patients and clinicians. Items were developed to be linguistically and culturally appropriate for multicountry studies. The PAGI-SYM includes 6 subscales: heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain. Subjects with GERD (n = 810) or dyspepsia (n = 767) participated in this multicountry, observational study. All subjects completed the PAGI-SYM, a global symptom relief questionnaire, and a measure of patient-rated change in GI-related symptoms, the Overall Treatment Effect (OTE) scale. Responsiveness was evaluated at 8 weeks by comparing groups by disease, symptom relief, and OTE (improved, stable, and worsened). Results: Subjects reporting symptom relief reported significantly lower (better) PAGI-SYM scores than those reporting no symptom relief (P < 0.0001 to P < 0.0005). Subjects with improvements in overall GI symptoms exhibited significant decreases in PAGI-SYM subscale scores compared with those who remained the same or worsened (all P values < 0.0001). Effect sizes ranged from 0.21-1.28, and standard errors of measurement ranged from 0.29-0.63, depending on subscale and disease sample. Conclusions:The PAGI-SYM is a brief symptom severity instrument that measures common GI symptoms. Results suggest that the PAGI-SYM is responsive and sensitive to change in clinical status in subjects with GERD or dyspepsia.

Original languageEnglish (US)
Pages (from-to)769-777
Number of pages9
JournalClinical Gastroenterology and Hepatology
Volume2
Issue number9
DOIs
StatePublished - Sep 2004

Keywords

  • ANCOVA
  • GERD
  • GI
  • OTE
  • Overall Treatment Effect
  • PAGI-SYM
  • Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index
  • SEM
  • analysis of covariance
  • gastroesophageal reflux disease
  • gastrointestinal
  • standard error of measurement

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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