PROMOTION Registry | Gimema Health Outcomes Research Unit
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The Unit

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.

Quality of Life in Hematology

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.

Some Leading Publications

Patient-Reported Outcomes as Independent Prognostic Factors for Survival in Oncology: Systematic Review and Meta-Analysis.

Efficace F, Collins GS, Cottone F, Giesinger JM, Sommer K, Anota A, Schlussel MM, Fazi P, Vignetti M.

Value Health. 2021 Feb;24(2):250-267.

Quality of patient-reported outcome reporting in randomised controlled trials of haematological malignancies according to international quality standards: a systematic review

Chakraborty R, Cannella L, Cottone F, Efficace F.

Lancet Haematol. 2020, Dec;7(12):e892-e901.

The IPSS-R more accurately captures fatigue severity of newly diagnosed patients with myelodysplastic syndromes compared with the IPSS index.

Efficace F, Cottone F, Oswald LB, Cella D, Patriarca A, Niscola P, Breccia M, Platzbecker U, Palumbo GA, Caocci G, Stauder R, Ricco A, Petranovic D, Caers J, Luppi M, Fianchi L, Frairia C, Capodanno I, Follini E, Sarlo C, Fazi P, Vignetti M.

Leukemia. 2020 Sep;34(9):2451-2459.

Validation of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Summary Score in Patients With Hematologic Malignancies.

Efficace F, Cottone F, Sommer K, Kieffer J, Aaronson N, Fayers P, Groenvold M, Caocci G, Lo Coco F, Gaidano G, Niscola P, Baccarani M, Rosti G, Venditti A, Angelucci E, Fazi P, Vignetti M, Giesinger J.

Value in Health. 2019 Nov;22(11):1303-1310. 

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 Nov;16(15):1506-1514.

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.

Personnel
KEY RESEARCH PROJECTS
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