Update of the EORTC questionnaire for assessing quality of life in lung cancer patients (EORTC QLQ-LC13).

Background: The EORTC QLQ-LC13 was the first module developed to be used in conjunction with the core questionnaire C30. Major advances have been made with regard to diagnostic and therapeutic options in lung cancer. Therefore, research objective was to develop a revised lung cancer module supported by the EORTC. Methods: EORTC employs a four phase methodology of modules development and Phases I to III have been completed. Phase I generates quality of life issues using a mix of sources. Phase II converts issues into questionnaire items. The Phase III study pre-tests a provisional module to evaluate the importance and acceptability of the items. Biometrical methods primarily included descriptive statistics and basic psychometric analyses. The 48 lung cancer items that emerged from Phases I to III were assessed against a set of pre-specified criteria comprised of patient ratings and distribution properties of the items. Results: 12 international centers participated in the Phase III study. 200 patients were enrolled. Mean age 64 years. 59% were male, 82% had NSCLC, 56% were treated with a palliative approach. Patients had to fill in the EORTC QLQ-C30 and a 48-item provisional lung cancer module and rated the lung cancer items. 29 lung cancer items met the pre-specified cut-off levels. Psychometric analyses suggested a five multi-item scale structure. Conclusions: The updated module retained 12 of the 13 original LC13 items. Further items were identified assessing side effects of targeted therapy, radiochemotherapy, and thoracic surgery. Phase IV will be a field study analyzing the proposed scale structure and assessing the psychometric properties of the module.