SISAQOL is an international Consortium of experts convened with the aim to develop recommendations the analysis of patient reported outcomes (PRO) data in cancer randomized trials.
With patient-centered care gaining a more central role in oncology, patient-reported outcomes, such as health-related quality of life and symptoms, are increasingly being captured in cancer randomized controlled trials (RCTs) to provide valuable information on treatment risks, benefits and tolerability.
Diverse ways of analyzing, interpreting and reporting PRO data hinders comparability and credibility of results across trials. Subsequent inconsistencies in the results cause inefficient resource use, fragmented reporting, and interpretational barriers.
The goal of the SISAQOL initiative is to create international recommendations on how to analyze PRO data in clinical trials. In order to be successful, these recommendations need to be supported by a broad consensus, balancing different needs and requirements. It is hoped that these guidelines and tools would facilitate the analysis of PRO outcomes and would result in more reliable findings, improved interpretability and faster dissemination of data that stem from a higher quality use of statistical methods.