Published online by Cambridge University Press: 10 March 2009
We propose a method for selecting quality-of-life instruments for use in phase III trials using the convergent validity of patient responses collected in phase I and II clinical trials.Two generic and two disease-specific instruments were administered to patients with breast cancer undergoing peripheral blood progenitor cell mobilization and transplantation. They included the visual analog scale from the EuroQoL EQ5D instrument, the SF-36, the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30, and the Functional Assessment of Cancer Therapy instrument. No single instrument was found to have superior convergent validity in all domains, but the EORTC-QLQ-C30 seemed to perform better than the SF-36.