The PROMOTION project is an international research initiative aimed to answer key questions about the added value of Patient-Reported Outcomes (PROs) in cancer research.
This initiative led to the development of the PROMOTION Registry, that is a large database, containing information regarding, for example, the PRO assessment methodology, the statistical design and the outcome reporting of published studies in oncology with a PRO component, which are identified through systematic literature searches. This database contains data on cancer randomized controlled trials (RCTs) and it is being enlarged to also include non-RCT studies.
This is an example of a recent analysis of data from this registry, that provides an overview on the use of PRO measures in cancer trials over time (Giesinger JM, Efficace F, Aaronson N, et al. Value in Health. 2021; online ahead of print).
Assessing PROs requires making a number of challenging decisions with regard to, for example, the selection of the most appropriate PRO measures to be used in the specific research setting, the timing of PRO assessment, and the most appropriate PRO statistical analysis plan.
Therefore, methodological rigor in the assessment and reporting of PROs in cancer research is of paramount importance.
Head, Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy; Adjunct Professor, Feinberg School of Medicine, Northwestern University, Chicago, USA.
Emeritus Senior Staff Scientist/Group Leader, Division of Psychosocial Research & Epidemiology, The Netherlands Cancer Institute and Emeritus Professor, Department of Clinical Psychology, The University of Amsterdam, The Netherlands.
Senior Researcher, University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria.
Assistant Professor, Multiple Myeloma and Amyloidosis Program, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, NY.
Statistician, Department of Statistics, Léon Bérard Cancer Center, Lyon, France.
Professor and Chair, Department of Medical Social Sciences. Director, Institute for Public Health and Medicine (IPHAM) – Center for Patient-Centered Outcomes. Feinberg School of Medicine, Northwestern University, Chicago, USA
Senior statistician, Health Outcomes Research Unit, GIMEMA
Statistical Advisor for the PROMOTION Registry
Francesco Cottone supports the PROMOTION team in the statistical analyses and preparation of statistical reports of data contained in the PROMOTION Registry database.
He also assists PROMOTION team members in making decisions about the most appropriate statistical methods to use to address a specific research question.
Data manager, Health Outcomes Research Unit, GIMEMA
Project manager for the PROMOTION Registry
Francesco Sparano supports the Principal Investigator in all aspects of the project to ensure compliance with standard operating procedures and to ensure accuracy, completeness and proper usage of the PROMOTION Database. He is also responsible for checking data quality, coordinating the overall activities and communication amongst all collaborators from participating Institutions.