title: Development of an EORTC module to improve quality of life assessment in patients with gastric cancer
abstract: AIMS: A valid measure of quality of life (QL) that is sensitive to clinically significant changes in health is important for the assessment of patients with gastric cancer. The aims of this study were to examine whether the EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 core questionnaire alone could distinguish between two clinically different groups of patients and to design a module, which included relevant patient-defined gastric cancer-specific variables. METHODS: The QLQ-C30 was completed by patients with potentially curable disease and those undergoing palliative treatment, and the results were compared between the two groups. A disease-specific module was then developed in four distinct phases according to EORTC guidelines. Relevant issues were identified from a literature search and structured interviews with patients and healthcare professionals, and worded into a provisional questionnaire which was pretested to determine any problems in its content, before formal validation. RESULTS: All of the subscales and single items within the QLQ-C30 were scored similarly by 144 patients, 86 with operable disease and 58 having palliative treatment, except constipation (P = 0.001). On the basis of interviews with 58 patients and 24 professionals, from the UK, France, Germany and Spain, 43 issues were reduced to produce a provisional questionnaire consisting of 24 items and pretested in 114 patients undergoing radical gastrectomy, palliative resection or other supportive measures. The resulting questionnaire, containing 22 items divided into five scales (dysphagia, pain, reflux, dietary restrictions and specific emotional problems related to gastric cancer and its treatment) and four single items, is undergoing validation. CONCLUSIONS: The EORTC QLQ-C30 is a valid generic instrument, but does not address all factors constituting QL in patients with gastric cancer. A specific module has been developed, which includes issues volunteered by patients to increase sensitivity and improve the evaluation of treatments for a disease where QL is important.
authors.affiliation: University Department of Surgery, Bristol and University Surgical Unit, Southampton, UK, and Centre Alexis Vautrin, Nancy, France.
authors.initials: CW
authors.lastname: Vickery
authors.initials: JM
authors.lastname: Blazeby
authors.initials: T
authors.lastname: Conroy
authors.initials: CD
authors.lastname: Johnson
authors.initials: D
authors.lastname: Alderson