A 'quality of life questionnaire' adapted to duodenal ulcer therapeutic trials.

In order to compare subpopulations of duodenal ulcer (DU) patients a quality of life (QoL) questionnaire (self-administered) was developed with the objective of investigating: (i) general parameters of health and well-being, and (ii) dimensions specifically adapted to patients with DU. For the former, Ware's MOS SF-36 was selected as a central core, with 36 items investigating 9 dimensions, and for the latter the anxiety scale (5 items) of the Psychological General Well-being Index (PGWBI) questionnaire and a further 5 dimensions (13 items) resulting from a preliminary survey of ulcer patients were selected. Validation of the proposed questionnaire was obtained for: linguistic aspects, content (i.e. ability to cover problems of patients suffering from DU), internal consistency, reliability, and sensitivity (i.e. analysis of discrimination between three groups of patients (acute DU episode, remission and control). The final version of the Quality of Life in Duodenal Ulcer Patients (QLDUP) questionnaire, which includes 54 items investigating 15 dimensions, appears to be a sensitive and reproducible tool, the simplicity of which makes it suitable for monitoring long-term treatments in DU.