Measures of health-related quality of life (HRQoL) and other patient-reported outcomes (PRO) generate important data in cancer randomized controlled trials (RCTs) to assist in evaluating the risks and benefits of cancer therapies, and fostering patient-centered cancer care.
However, the various ways these measures are analyzed and interpreted make it difficult to compare results across trials. This hinders the application of research findings to inform publications, product labelling, clinical guidelines and health policy.
To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative was established.
This international multidisciplinary consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations to standardize the analysis of HRQoL and other PRO data in cancer RCTs.