Objective: There is currently no reliable tool for providing a global measurement of the severity of dyspepsia in patients with a variety of upper gastrointestinal disorders. We have designed a questionnaire which records frequency of symptoms, effect on routine activities, time off work, frequency of medical consultations, clinical investigations and use of over-the-counter and prescribed medications. The objective of the paper was to assess this questionnaire with respect to reproducibility, validity, responsiveness and performance time.
Methods and results: For intra-observer variation, one author interviewed 50 subjects (25 males) including 20 healthy volunteers and 30 with a variety of upper gastrointestinal pathologies. The interview was repeated one week later by the same author who was blinded to the dyspepsia score for the first interview. The second author, who was blinded to the diagnoses and subject identity, scored all the questionnaires. The mean dyspepsia score was 6.78 on Day 1 and was similar at 6.80 on Day 2. The coefficient of variation between Days 1 and 2 was 2%. For inter-observer variation, 30 patients with non-ulcer dyspepsia (NUD) were interviewed by one author and the interview was repeated on a separate occasion within 24 h by a second author who was blinded to the score from the first interview. The mean dyspepsia score for the first author was 10.7 and for the second author 10.9 with a coefficient of variation between the two authors of 8%. Validity was assessed by comparing the dyspepsia scores in healthy volunteers and patients with upper gastrointestinal diseases. The mean score in 80 healthy volunteers was 1.16 (range: 0-7) and was significantly higher in 70 duodenal ulcer (DU) patients (mean score 11.1, range: 6-16) and 80 NUD patients (mean score 10.5, range: 6-17) (P < 0.001 for both vs. healthy volunteers). Responsiveness was assessed by comparing dyspepsia scores before and one year after eradication of Helicobacter pylori infection in 42 DU patients. The mean dyspepsia score before eradication was 11.4 (range: 6-16) and fell to 1.33 (range: 0-11) one year after eradication (P < 0.001). The mean time taken to complete 150 questionnaires was 4 min (range: 3-5.5 min).
Conclusion: This new questionnaire for assessing the severity of dyspepsia is highly reproducible and has high validity and responsiveness. In addition, it is simple and rapid to perform. It provides a valuable tool for assessing the response to treatment in patients with dyspepsia.