The Gimema Data Center “Health Outcomes Research Unit” has the purpose of developing and managing high quality clinical research programs mainly aimed at improving the Health Related Quality of Life (HRQOL) of patients with haematological diseases, and of contributing to continued improvements in healthcare provision.
The mission of the Unit is to conduct studies collecting the patient’s perspective on treatments and thereby help clinicians manage side effects and also help patients understand both the short and long-term consequences of their disease and treatment.
Patient-Reported Outcomes (PROs) and HRQOL issues have been well studied in patients with solid tumors over the last twenty years; however our understanding of these issues in patients with haematologic cancers is lacking in comparison. There are now number of challenges that have to be faced by the clinical hematology community.
While clinical research in hematology is rapidly achieving a number of important goals, such as the outstanding progress in the treatment of chronic myeloid leukemia, the time is now mature for a more patient-centered approach in clinical research in hematology.
Prognostic value of self-reported fatigue on overall survival in patients with myelodysplastic syndromes: a multicentre, prospective, observational, cohort study.
Efficace F, Gaidano G, Breccia M, Voso MT, Cottone F, Angelucci E, Caocci G, Stauder R, Selleslag D, Sprangers M, Platzbecker U, Ricco A, Sanpaolo G, Beyne-Rauzy O, Buccisano F, Palumbo GA, Bowen D, Nguyen K, Niscola P, Vignetti M, Mandelli F.
Lancet Oncology, 2015 Sep 21. pii: S1470-2045(15)00206-5.
Randomized Phase III Trial of Retinoic Acid and Arsenic Trioxide versus Retinoic Acid and Chemotherapy in Patients with Acute Promyelocytic Leukemia: Health-Related Quality-of-Life Outcomes
Efficace F, Mandelli F, Avvisati G, Cottone F, Ferrara F, Di Bona E, Specchia G, Breccia M, Levis A, Sica S, Finizio O, Kropp MG, Fioritoni G, Cerqui E, Vignetti M, Amadori S, Schlenk R, Platzbecker U, Lo-Coco F
Journal of Clinical Oncology, 2014 Oct;32(30):3406-12.
Health-related quality of life in chronic myeloid leukemia patients receiving long-term therapy with imatinib compared with the general population.
Efficace F, Baccarani M, Breccia M, Alimena G, Rosti G, Cottone F, Deliliers GL, Baratè C, Rossi AR, Fioritoni G, Luciano L, Turri D, Martino B, Di Raimondo F, Dabusti M, Bergamaschi M, Leoni P, Simula MP, Levato L, Ulisciani S, Veneri D, Sica S, Rambaldi A, Vignetti M, Mandelli F; GIMEMA.
Blood. 2011 Oct 27;118(17):4554-60.
Chronic fatigue is the most important factor limiting health-related quality of life of chronic myeloid leukemia patients treated with imatinib.
Efficace F, Baccarani M, Breccia M, Cottone F, Alimena G, Deliliers GL, Baratè C, Specchia G, Di Lorenzo R, Luciano L, Turri D, Martino B, Stagno F, Dabusti M, Bergamaschi M, Leoni P, Simula MP, Levato L, Fava C, Veneri D, Sica S, Rambaldi A, Rosti G, Vignetti M, Mandelli F.
Leukemia. 2013 Jul;27(7):1511-9.
Preference for involvement in treatment decisions and request for prognostic information in newly diagnosed patients with higher-risk myelodysplastic syndromes.
Efficace F, Gaidano G, Sprangers M, Cottone F, Breccia M, Voso MT, Caocci G, Stauder R, Di Tucci AA, Sanpaolo G, Selleslag D, Angelucci E, Platzbecker U, Mandelli F.
Annals of Oncology. 2014 Feb;25(2):447-54.