PMID: 15382762Sep 24, 2004Paper

Methodology for quality-of-life assessment: a critical appraisal

Thoracic Surgery Clinics
Benny Zee, Tony S K Mok

Abstract

The methodology for QOL assessment covers a wide range of topics. It involves a proper choice of instruments with appropriate psychometric properties, the administration of these instruments, frequency of measurements, missing data problems, and the method of analysis. There are currently debates on the meaning and interpretation of the HRQOL domains taking the form of arguing how to define minimal clinically meaningful difference and whether this can be used in regulatory approval for drug development. From a practical point of view, the authors proposed that a disease-specific checklist or symptom domains incorporated within a HRQOL questionnaire may be a middle ground to gain general agreements among academic institutions, manufacturers, and regulatory agencies to use a specific symptom checklist or domain as the primary end point for clinical trials together with other HRQOL domains as ancillary data for the study. Antiemetic trial with HRQOL assessments is an example. Most would agree, however, that no matter what HRQOL domains or symptoms are being studied, it should be based on a patient self-administered questionnaire as shown by the lack of sensitivity in the example in this article. Missing data are a problem in the d...Continue Reading

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