HEALTH OUTCOMES RESEARCH UNIT

BACKGROUND 

In 2007 the Italian Group for Adult Hematologic Diseases (GIMEMA) created the Health Outcomes Research Unit with the main goal of implementing and coordinating a number of research projects aimed at enhancing understanding of how the life of patients with haematological diseases is affected by the disease and treatment and to provide evidence-based data to further improve clinical decision-making in this area. Health-related quality of life (HRQOL), symptoms and other types of patient-reported outcomes (PROs) have become critical to fully evaluate overall treatment effectiveness in medicine. Although research in this area has historically paid less attention to patients with haematological diseases, more emphasis is now being given to these patients so as it is pointed out by a number of international guidelines which strongly advocate the need of more research in this area.

Italian version

 Il GIMEMA ha creato nel 2007 la Health Outcomes Research Unit, con lo scopo di sviluppare e gestire programmi di ricerca clinica tesi a migliorare la qualità di vita dei pazienti con patologie ematologiche e, in generale, a contribuire a migliorare sempre più la qualità dell’assistenza sanitaria. Lo scopo di uno studio che abbia tra i suoi obiettivi anche la valutazione della qualità di vita del paziente è quello di fornire dati scientifici, basati sull’evidenza, utili ai medici e ai pazienti stessi per compiere scelte terapeutiche sempre più consapevoli. Questa Unità sta portando avanti una serie di importanti programmi di ricerca a livello nazionale ed internazionale in diverse patologie ematologiche quali leucemie acute, croniche e mielodisplasie. Molti degli studi attualmente in corso sono condotti in collaborazione con l’Associazione Italiana contro le Leucemie-linfomi e mieloma - AIL-  http://www.ail.it/ e con importanti Enti di ricerca in Europa e negli USA.

MISSION STATEMENT  

The main goal of the Unit is to conduct cutting edge research on a number of key health outcomes including HRQOL, symptoms, adherence to therapy, satisfaction with care, health state evaluations, and other health outcomes that can be relevant to further facilitate clinical decision-making. A number of national and international research projects are being carried out by the Unit in collaborations with key European and US Institutions as well as with main haematological centers in Italy. In addition, the Unit collaborates with all the GIMEMA Working Parties providing the necessary support when designing, analyzing and reporting studies which also include a PRO evaluation. 

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CORE RESEARCH TEAM

Fabio Efficace, PhD

Head of the Unit

Tel. +39 06 441639 831

Fax. + 39 06 4402516

E-mail: f.efficace@gimema.it

Francesco Cottone, PhD

Statistician

Tel. +39 06441639 830

E-mail: f.cottone@gimema.it

Mariagrazia Mecoli, PhD

Research Fellow

Tel. +39 441 639 838

E-mail: m.mecoli@gimema.it

Francesca Sperduti, MSc

Research Assistant

Tel. +39 441 639 833

E-mail: f.sperduti@gimema.it

SELECTED ONGOING PROJECTS:

-GIMEMA Study QoL-CML0208
Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia Patients with Complete Cytogenetic Response Treated with Imatinib as First Line Therapy: Health-Related Quality of Life, Symptom Burden and Adherence to Therapy Issues.  Study website: www.cliniconline.it/clinicaltrials/GIMEMA

-GIMEMA-EORTC Quality of Life Group Study QoL-MDS0108
Prognostic significance and longitudinal assessment of patient-reported quality of life and symptoms in high-risk myelodysplastic syndromes.  A large-scale international, observational study. Study website: www.cliniconline.it/clinicaltrials/GIMEMA 

-GIMEMA - ROMAIL Project, home-care Quality of Life and Symptom evaluation.
Quality of Life and symptom burden evaluation in chronic and pallaitive care hematological patients admitted to home care service.  

-GIMEMA Study QoL MDS0306
Quality of Life and symptom burden evaluation in patients with myelodysplastic syndromes (MDS) with IPSS low-risk and Intermediate-1. A national based multicenter prospective study.

-GIMEMA Study APL0406
Quality of Life and symptoms evaluation as secondary endpoint in Acute Promyelocytic Leukemia patients: a randomized study. 

-GIMEMA Study  ITP0207
Quality of Life evaluation as secondary endpoint in patients with Immune Thrombocytopenic Purpura (ITP). Comparison of standard dose prednisone versus high-dose Dexamethasone: a randomized study. 

-GIMEMA-EORTC Quality of Life Group Study on Chronic Myeloid Leukemia
Development of an international Quality of Life and Symptom burden measure to be used in patients with Chronic Myeloid leukemia. This porject involves several Europen countries and will provide the hematology community with a methodologically sound questionnaire to be used in these patients.  

RECENT NEWS  ! 

èInvited Talk, Education Session at the next "European Hematology Association" (EHA) Conference in Berlin. 

The Health Outcome Research Unit of the GIMEMA has been invited to give a Lecture entitled Designing and interpreting quality-of-life and other patient-reported outcomes in clinical trials at the next EHA Conference in Berlin (June, 2009). This talk will be part of the Education Session entitled: Clinical Trial Design. This is the first time that EHA organizes such education session and the GIMEMA is proud of being selceted for giving this talk.  Check the website:  http://eha.eurocongres.com/14th/program/friday0.asp

èUpdate Investigator's Meeting GIMEMA Study QoL-CML0208

Il 16 dicembre scorso si è svolta a Roma la riunione di presentazione del protocollo GIMEMA QoL-CML 0208, dedicato alla rilevazione della qualità di vita in pazienti affetti da Leucemia Mieloide Cronica ed in terapia con imatinib da almeno 3 anni.

Poichè tale studio è in collaboraione con l'AIL, alla riunione hanno anche partecipato molti rappresentanti delle diverse Sezioni AIL del territorio nazionale. Dapprima è stata illustrata l'importanza degli studi di rilevazione della Qualità di Vita, che stanno assumendo anche in ematologia un ruolo di primo piano nella sfida continua per migliorare le cure.

Nella seconda parte è stato illustrato il processo di registrazione di un paziente nello studio ed è stata discussa con i presenti la modalità di raccolta dei questionari.Di seguito è presente un file .zip disponibile per il download. Tale file  contiene la documentazione presentata nel corso della riunione.