Journal
HAEMATOLOGICA
Volume 99, Issue 5, Pages 908-915Publisher
FERRATA STORTI FOUNDATION
DOI: 10.3324/haematol.2013.096461
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Funding
- European Group for Blood and Marrow Transplantation (EBMT)
- European Leukemia Net (ELN)
- Amgen Europe
- ViroPharma Europe
- Celegene International SARL
- Genzyme Europe B.V.
- Gilead Sciences Europe Ltd.
- Miltenyl Biotec GmbH
- Schering-Plough International Inc.
- Bristol Myers Squibb
- CaridiaBCT Europe NV
- Cephalon Europe
- F. Hoffmann-La Roche Ltd
- Fresenius Biotech GmbH
- Therakos Inc.
- Alexion Europe
- Chugai Sanofi - Aventis
- Merck Sharp and Dohme
- Novartis
- Pfizer
- Pierre Fabre Medicament
- Bangerter Foundation on outcome research
- National Institute for Health Research [NF-SI-0611-10275] Funding Source: researchfish
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Competent authorities, healthcare payers and hospitals devote increasing resources to quality management systems but scientific analyses searching for an impact of these systems on clinical outcome remain scarce. Earlier data indicated a stepwise improvement in outcome after allogeneic hematopoietic stem cell transplantation with each phase of the accreditation process for the quality management system JACIE. We therefore tested the hypothesis that working towards and achieving JACIE accreditation would accelerate improvement in outcome over calendar time. Overall mortality of the entire cohort of 107,904 patients who had a transplant (41,623 allogeneic, 39%; 66,281 autologous, 61%) between 1999 and 2006 decreased over the 14-year observation period by a factor of 0.63 per 10 years (hazard ratio: 0.63; 0.58-0.69). Considering JACIE-accredited centers as those with programs having achieved accreditation by November 2012, at the latest, this improvement was significantly faster in JACIE-accredited centers than in non-accredited centers (approximately 5.3% per year for 49,459 patients versus approximately 3.5% per year for 58,445 patients, respectively; hazard ratio: 0.83; 0.71-0.97). As a result, relapse-free survival (hazard ratio 0.85; 0.75-0.95) and overall survival (hazard ratio 0.86; 0.76-0.98) were significantly higher at 72 months for those patients transplanted in the 162 JACIE-accredited centers. No significant effects were observed after autologous transplants (hazard ratio 1.06; 0.99-1.13). Hence, working towards implementation of a quality management system triggers a dynamic process associated with a steeper reduction in mortality over the years and a significantly improved survival after allogeneic stem cell transplantation. Our data support the use of a quality management system for complex medical procedures.
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