Abstract
OBJECTIVE: To critically evaluate the quality of health-related quality of life (HRQoL) instruments for use in clinical trials of non-small cell lung cancer (NSCLC). METHODS: A structured review of literature was conducted by searching MEDLINE (1975–2000) and PsycINFO (1977–2000) using the keywords “lung cancer”, “quality of life” and “questionnaire”, and manually. HRQoL instruments that had been used in or designed for lung cancer were selected for review. Each instrument was assessed for its general features, feasibility, scoring and interpretation, and psychometric properties. RESULTS: Ten instruments were selected for review: EORTC-QLQ30, EORTC-LC13, FACT-L, LCSS, FLIC, CARES, CARES-SF, RSCL, FLIC and MQOL. Most questionnaire items were appropriately generated through multiple cycles of input from patients and clinicians. The most studied psychometric properties were internal consistency and convergent/divergent validity, with most instruments having Cronbach's a> 0.7 and acceptable correlation coefficients for convergent/divergent validity. Responsiveness, interpretability of the scale score, and validity testing in cross-cultural settings were either inadequately evaluated or missing. All instruments have a good readability level, an administration time less than 20 minutes, a time horizon of one week or less, and are multilingual. All questionnaires have been used in clinical trials for non-small cell lung cancer except CARES, CARES-SF and MQOL. CONCLUSIONS: There are several reliable and validated HRQoL instruments that are appropriate for use in clinical trials of NCSLC. In particular, the EORTC-QLQ30 and its lung cancer supplement, the LC13, LCSS, RSCL, FACT-L, and CARES have greater evidence of good psychometric properties. Further research is required to evaluate the cross-cultural performance, score interpretability and correlation with clinical outcomes of these instruments.
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