The Pediatric Cancer Quality of Life Inventory: A modular approach to measuring health-related quality of life in children with cancer

Measurement of pediatric cancer patients' health-related quality of life (H RQL) in phase III randomized, controlled clinical trials is being recognize d increasingly as an essential component in evaluating the comprehensive he alth outcomes of modern anti-neoplastic treatment protocols. Use of a brief core measure of HRQL plus disease-specific symptom modules is a way to ass ess specific HRQL outcomes with a minimum of subject burden. Demonstrating a measure's feasibility, reliability and validity also represents children' s ability to provide reliable and valid responses to HRQL questions. The Pe diatric Cancer Quality of Life Inventory (PCQL) Modular Approach consists o f a 15-item core measure of HRQL and 2 specific symptom modules: pain and n ausea. To validate a patient-report form and a parent-report form, the PCQL was administered to 291 pediatric cancer patients and to their parents. Fe asibility and range of measurement, as well as patient-parent concordance, were assessed. Internal consistency reliability was assessed via Cronbach's alpha. Validity was determined by the known-groups approach and by correla ting PCQL scores with days missed from school. Patients had minimal missing data, and the range of measurement for the items was good, Patient-parent concordance was large but not perfect. For both patient and parent forms, i nternal consistency reliability of the PCQL core scale (0.83 and 0.86, resp ectively) was strong. The internal consistency reliabilities of the 2 sympt om modules for both patient and parent forms were in the acceptable range f or group comparisons, Regarding clinical validity, the core scale and the 2 symptom modules distinguished between patients on and off treatment for bo th patient and parent reports. Further, both patient and parent reports cor related with days of missed school in the past 6 and 12 months, The PCQL Mo dular Approach has demonstrated acceptable internal consistency reliability and clinical validity for both patient-report and parent-report forms. By implication, children are capable of providing reliable and valid responses to these HRQL questions. Int. J. Cancer Suppl. 12:71-76, 1999, (C) 1999 Wi ley-Liss, Inc.