Symptom diaries are potentially attractive but, because of concerns about patient compliance, they have had limited use in clinical trials.
Dr Puhan and colleagues assessed the validity and responsiveness of a symptom diary with gastro-esophageal reflux disease (GERD).
The research team included 215 patients with gastro-esophageal reflux disease after starting treatment for 4 weeks with 40 mg esomeprazole once daily.
Patients recorded whether they experienced night-time heartburn.
The severity of daytime heartburn on a scale from 1 or no heartburn to 4 with severe heartburn as well as antacid use was recorded.
| Daytime heartburn showed correlations with 4 scales of symptom severity for baseline scores|
|Alimentary Pharmacology & Therapeutics|
Patients also completed a number of disease-specific and preference-based health-related quality of life questionnaires at baseline and follow-up.
Daytime heartburn showed moderate to strong correlations with the Quality of Life in Reflux and Dyspepsia questionnaire.
The team noted that daytime heartburn also showed correlations with 4 scales of symptom severity for baseline, follow-up and change scores.
Daytime heartburn had low correlations with the Standard Gamble.
The researchers observed that responsiveness of the daytime heartburn item was excellent with a mean change from baseline to follow-up of about −1.
The standardized response mean was just over 1 while responsiveness of the daily antacid use item was moderate.
Dr Puhan's team concluded, “The excellent psychometric properties of this simple gastro-esophageal reflux disease diary make it an attractive measure for future trials.”