Setting International Standards in Analysing
Patient-Reported Outcomes and Quality of Life Endpoints

The SISAQOL-IMI final recommendations are presented in key outputs and educational material to support and encourage the implementation. They include the following:

• Interactive table: a tool organised according to the study objective and PRO variable of interest, that provides researchers easy access to recommendations relevant for their specific study design;
• Guidebook: provides information about the background, development process, future plans, and guide the use by listing the recommendations according to the analytical framework;
• Glossary: terms and concepts, defined in scientific and plain language, available as a tool in the online guidebook and interactive table, and as independent source;
• Patient material: the recommendations adapted for a non-scientific audience, e.g. checklists for patient representatives and other stakeholder groups, and tutorial videos;
• Publications: SISAQOL-IMI scientific publications describe the process and results to support dissemination of the recommendations within the international scientific community;
• Educational material: documents and templates for clinical trials with PRO endpoints.

The mission of this four-year collaborative project is to develop standards for designing, analysing, presenting and interpreting health-related quality of life (HRQOL) and patient-reported outcome (PRO) data in cancer clinical trials. By improving standards for PRO- and HRQOL-based endpoints across trials, this will enable better use of these data to support regulatory and HTA decision-making, enhance patient-physician communication, and ultimately contribute to better patient outcomes.