Validation of a symptom diary for patients with gastro-oesophageal reflux disease

M. A. Puhan, G. H. Guyatt, D. Armstrong, I. Wiklund, C. A. Fallone, D. Heels-Ansdell, A. Degl'Innocenti, S. J O Veldhuyzen Van Zanten, L. Tanser, A. N. Barkun, N. Chiba, P. Austin, S. El-Dika, H. J. Schünemann

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Symptom diaries are potentially attractive but, because of concerns about patient compliance, they have had limited use in clinical trials. We assessed the validity and responsiveness of a symptom diary for patients with gastro-oesophageal reflux disease. Methods: We included 215 patients with gastro-oesophageal reflux disease after starting treatment for 4 weeks with 40 mg esomeprazole once daily. Patients recorded whether they experienced night-time heartburn (yes/no), the severity of daytime heartburn on a scale from 1 (no heartburn) to 4 (severe heartburn) and their antacid use. Patients also completed a number of disease-specific and preference-based Health-related Quality of Life questionnaires at baseline and follow-up. Results: Consistent with a priori predictions, daytime heartburn showed moderate to strong correlations with the Quality of Life in Reflux and Dyspepsia questionnaire (0.36-0.67) and four scales of symptom severity (0.36-0.70) for baseline, follow-up and change scores, but low correlations with the Standard Gamble. Responsiveness of the daytime heartburn item was excellent with a mean change from baseline to follow-up of -1.3 (95% CI -1.4 to -1.1) and a standardized response mean of 1.33 while responsiveness of the daily antacid use item was moderate (mean change scores -1.8 tablets taken, 95% CI -2.3 to -1.3 and standardized response mean of 0.64). Conclusions: The excellent psychometric properties of this simple gastro-oesophageal reflux disease diary make it an attractive measure for future trials.

Original languageEnglish (US)
Pages (from-to)531-541
Number of pages11
JournalAlimentary Pharmacology and Therapeutics
Volume23
Issue number4
DOIs
StatePublished - Feb 2006
Externally publishedYes

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

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