Analyzing Data [SISAQOL]

The use of standardized statistical methods is desirable in PRO research. SISAQOL (Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints Data) sets international standards for analyzing PRO and quality of life data from cancer clinical trials.

The guidance seeks to ensure consistent and methodologically appropriate analysis and provides a taxonomy of research objectives, outlines appropriate statistical methods, and advises on handling missing data.

This guidance is detailed in the paper International Standards for the Analysis of Quality-of-Life and Patient-Reported Outcome Endpoints in Cancer Randomised Controlled Trials: Recommendations of the SISAQOL Consortium.

The SISAQOL Consortium was formed by the European Organization for the Research and Treatment of Cancer (EORTC); work continues today via the SISAQOL-IMI Initiative.

In addition to the SISAQOL and SISAQOL-IMI recommendations,  guidance documents from the U.S. Food & Drug Administration (here) and European Medicines Agency (here and here) provide their perspectives on the use of PROMs for regulatory submissions.