Cherkaoui, Zineb, González, Cristians, Wakabayashi, Taiga, Delattre, Bastien, Léost, Elodie, Serra, Sébastien, Huppertz, Jerôme, Klein, Francine, Stéphan, Marie, Meyer, Jean-Michel, Schaff, Alain, Martinis, Elisa, Bangoura, Elena, Kieffer, Sophie, Blanès, Sophie, Haddad, Elham, De Guio, Gabrielle, Felli, Emanuele, Pernot, Sophie, and Marescaux, Jacques
Background: Global health systems are shifting toward value-based health care to improve patient outcomes in the face of rising health care costs. The challenge is to identify standardized outcome measurements that allow optimal quality-of-care monitoring and comparison to optimize medical practices and patient pathways. A common outcomes definition is required, including medical results (Clinical Reported Outcomes Measurements [CROMs]) and quality-of-life components that matter most to patients (Patient-Reported Outcomes Measurements [PROMs]), which are particularly important for severe pathologies with short life expectancy such as pancreatic cancer. This study aimed to create standardized metrics that could be used for outcomes analysis of pancreatic cancer care. Methods: A multidisciplinary working group (WG) was assembled. A systematic review was performed to collect the most used outcomes in clinical studies of pancreatic cancers. The study reviewed 570 studies published in the last 10 years. From these studies, 3370 outcomes, including CROMs, and PROMs, were listed and prioritized. The WG reached a consensus on key outcomes, proposed groupings for CROMs and PROMs, identified existing questionnaires that could be used for PROMs collection, and set the timeline for data collection. To refine and validate the final outcomes set, an international external committee completed a Delphi process (two rounds for both CROMS and PROMs). Results: After the systematic literature review, the WG selected 102 outcomes (92 CROMs and 10 PROMs) for submission to the international Delphi vote committee. The committee retrained 89 outcomes (78 CROMs and 11 PROMs). For the PROMs, the WG and the international external committee chose a validated questionnaire, the Functional Assessment of Cancer Therapy-Hepatobiliary, which covers all of the 11 selected PROMs. Conclusions: A standardized set of outcome measures that need to be validated through international health outcome comparisons and quality-of-care assessments was built. Pilot projects are underway to test and optimize the approach in real-life conditions. [ABSTRACT FROM AUTHOR]