Clinical and psychometric validation of a questionnaire module, the EORTC QLQ-OG25, to assess health-related quality of life in patients with cancer of the oesophagus, the oesophago–gastric junction and the stomach
Introduction
The epidemiology of oesophageal and gastric tumours has shown marked changes over the past two decades.1 There are increasing numbers of distal oesophageal adenocarcinomas and cancers of the proximal stomach. Treatment for oesophago–gastric junctional tumours is difficult, and five year survival may only be achieved in 40%.2 Important outcomes for patients with upper gastrointestinal cancers, therefore, include survival, treatment-related morbidity and toxicity, and health-related quality of life (HRQL). Accurate and valid assessment of HRQL may be performed using generic cancer measures such as the FACT-G or EORTC QLQ-C30, and both have supplementary site specific modules for oesophageal and gastric cancers.3, 4, 5, 6, 7, 8 It is unclear, however, which questionnaire module is most appropriate for patients with oesophago–gastric junctional tumours. The aim of this study, therefore, was to improve assessment of HRQL in patients with upper gastrointestinal cancer by producing a single EORTC questionnaire module to measure HRQL in patients with oesophageal or gastric cancer, including tumours of the oesophago–gastric junction.
Section snippets
Patients
Prospectively recruited patients were entered into this study between August 2005 and August 2006. Patients were eligible if they had a histological diagnosis of oesophageal or gastric cancer, including tumours of the oesophago–gastric junction. The definition of oesophageal cancer was adenocarcinoma or squamous cell carcinoma of the oesophagus. Tumours of the oesophago–gastric junction included Siewert I–III.9 The definition of gastric cancer was adenocarcinoma of the stomach, and included all
Patient characteristics
A total of 303 patients were recruited from seven institutions in four different countries. Of these, two were excluded because of previous cancer and one was excluded due to incomplete data resulting in 300 patients for the final analyses. In Table 2, socio-demographic data and clinical details are presented. Most of the patients had started treatment (63%) including patients who had already finished their treatment, and had local or locally advanced disease (72%).
Defining scales and items
Both the multi-trait scaling
Discussion
This international study indicates that the new module, the EORTC QLQ-OG25, is a reliable and valid questionnaire to supplement the EORTC QLQ-C30 to assess HRQL among patients with cancer of the oesophagus, oesophago–gastric junction or the stomach.
Measurement of HRQL in patients with oesophageal or gastric cancer, including junctional tumours, has become an important outcome in clinical trials, clinical practice and in longitudinal studies. Using the core instrument remains important because
Conflicts of interest statement
None declared.
Acknowledgement
P.L. was supported by the Karolinska Institutet (Center for Health Care Sciences), the Swedish Society for Medical Research and the Swedish Cancer Society. O.S. was supported by a research grant from Deutsche Krebshilfe, Bonn, Germany. J.M.B. was supported by the UK Medical Research Council Clinician Scientist Award. We thank the Upper GI multi-disciplinary team at United Bristol Healthcare Trust, Bristol UK for allowing us to study patients under their care. We thank Joanna Nicklin and Linda
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