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

Aliment Pharmacol Ther. 2006 Feb 15;23(4):531-41. doi: 10.1111/j.1365-2036.2006.02775.x.

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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

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

Substances

  • Antacids
  • Anti-Ulcer Agents
  • Esomeprazole