SODA (severity of dyspepsia assessment): A new effective outcome measure for dyspepsia-related health

Linda Rabeneck, Karon F. Cook, Kimberly Wristers, Julianne Souchek, Terri Menke, Nelda Wray

Research output: Contribution to journalArticlepeer-review

61 Scopus citations

Abstract

The aim of this research was to develop and evaluate an instrument for measuring dyspepsia-related health to serve as the primary outcome measure for randomized clinical trials. Building on our previous work we developed SODA (Severity of Dyspepsia Assessment), a multidimensional dyspepsia measure. We evaluated SODA by administering it at enrollment and seven follow-up visits to 98 patients with dyspepsia who were randomized to a 6-week course of omeprazole versus placebo and followed over 1 year. The mean age was 53 years, and six patients (6%) were women. Median Cronbach's alpha reliability estimates over the eight visits for the SODA Pain Intensity, Non-Pain Symptoms, and Satisfaction scales were 0.97, 0.90, and 0.92, respectively. The mean change scores for all three scales discriminated between patients who reported they were improved versus those who were unchanged, providing evidence of validity. The effect sizes for the Pain Intensity (.98) and Satisfaction (.87) scales were large, providing evidence for responsiveness. The effect size for the Non-Pain Symptoms scale was small (.24), indicating lower responsiveness in this study sample. SODA is a new, effective instrument for measuring dyspepsia-related health. SODA is multidimensional and responsive to clinically meaningful change with demonstrated reliability and validity.

Original languageEnglish (US)
Pages (from-to)755-765
Number of pages11
JournalJournal of Clinical Epidemiology
Volume54
Issue number8
DOIs
StatePublished - Aug 18 2001

Keywords

  • Dyspepsia
  • Health status
  • Outcome measure
  • Quality of life

ASJC Scopus subject areas

  • Medicine(all)
  • Public Health, Environmental and Occupational Health
  • Epidemiology

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