Outcomes research in cancer symptom management trials: the Radiation Therapy Oncology Group (RTOG) conceptual model.

The Radiation Therapy Oncology Group (RTOG) Health Services Research and Outcomes (HSRO) Committee aims to guide the study of the interactions among clinical, humanistic, and economic variables that optimize patient outcomes on clinical trials. To guide this work, the RTOG Outcomes Model was developed. Within this framework, measurement focuses primarily on patient-reported outcomes (PROs). In the examples presented, these outcomes have served to better quantify the benefit of one therapy over alternative therapies, as in the example of multimodality therapy for lung cancer, and to add evidence to clinical outcomes when clinical outcomes alone have not been strong enough to change clinical practice, as in the example of palliative radiotherapy for painful bone metastasis. The unique contribution to the RTOG of the HSRO Committee is the selection and use of PRO measures that give "voice" to the patient in clinical trials as well as provide data to better manage symptoms.