RADIATION-THERAPY ONCOLOGY GROUP QUALITY-OF-LIFE ASSESSMENT - DESIGN,ANALYSIS, AND DATA MANAGEMENT ISSUES

The Radiation Therapy Oncology Group (RTOG) has embarked on seven phas e II or phase III multicentre clinical trials involving a quality of l ife component. Each quality of life trial used questionnaires or exami nations that have been tested for reliability and validity by independ ent investigators. Each trial includes questionnaires that examine the patient's physical, functional, social, and emotional status, and tha t measure a specific quality of life issue pertinent to the patient's diagnosis or treatment. Two trial designs have been implemented for st udies with quality of life endpoints. One design involves companion tr ials to the primary treatment study pertaining solely to the quality o f life endpoint. The second design integrates the quality of life comp onent into the primary trial design. The RTOG has found a need for edu cation of individuals and institutions expected to administer and obta in the quality of life data. Once the data have been collected several methods for the analysis of the quality of life data are available. H owever, there is no one best method for analysing quality of life data , thus more than one method should be used in order to provide insight into the data.