title: 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.affiliation: Horten Centre, University of Zurich, Switzerland.
authors.forename: M A
authors.initials: MA
authors.lastname: Puhan
authors.forename: G H
authors.initials: GH
authors.lastname: Guyatt
authors.forename: D
authors.initials: D
authors.lastname: Armstrong
authors.forename: I
authors.initials: I
authors.lastname: Wiklund
authors.forename: C A
authors.initials: CA
authors.lastname: Fallone
authors.forename: D
authors.initials: D
authors.lastname: Heels-Ansdell
authors.forename: A
authors.initials: A
authors.lastname: Degl'Innocenti
authors.forename: S J O
authors.initials: SJ
authors.lastname: Veldhuyzen van Zanten
authors.forename: L
authors.initials: L
authors.lastname: Tanser
authors.forename: A N
authors.initials: AN
authors.lastname: Barkun
authors.forename: N
authors.initials: N
authors.lastname: Chiba
authors.forename: P
authors.initials: P
authors.lastname: Austin
authors.forename: S
authors.initials: S
authors.lastname: El-Dika
authors.forename: H J
authors.initials: HJ
authors.lastname: Schünemann
mesh_terms: D000863:Antacids / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D003430:Cross-Sectional Studies; D064098:Esomeprazole / Q000627:therapeutic use; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications* / Q000188:drug therapy; D006356:Heartburn / Q000188:drug therapy / Q000209:etiology; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000863:Antacids; D000897:Anti-Ulcer Agents; D064098:Esomeprazole