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

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.

• Authors: 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
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 23 Issue 4 Pg. 531-41 (Feb 15 2006) ISSN: 0269-2813 [Print] England
• PMID: 16441474 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Validation Study)

Chemical References

• Antacids
• Anti-Ulcer Agents
• Esomeprazole

Topics

• Antacids (therapeutic use)
• Anti-Ulcer Agents (therapeutic use)
• Cross-Sectional Studies
• Esomeprazole (therapeutic use)
• Female
• Gastroesophageal Reflux (complications, drug therapy)
• Heartburn (drug therapy, etiology)
• Humans
• Longitudinal Studies
• Male
• Medical Records
• Middle Aged
• Quality of Life
• Severity of Illness Index
• Treatment Outcome