Use of the quality management system "JACIE" and outcome after hematopoietic stem cell transplantation

Abstract

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.

Figure 1.

The figure depicts the diversity of the population of patients and the heterogeneity in outcome as illustrated by the Kaplan-Meier estimates of overall survival for 107,904 patients who underwent allogeneic (n=41,623) or autologous (n=66,281) HSCT in Europe between 1999 and 2006. (A) Allogeneic HSCT and (B) autologous HSCT showing overall survival by main disease category (acute leukemia, blue; chronic leukemia, orange; lymphoma, red; plasma cell disorders, purple; myelodysplastic disorders/myeloproliferative neoplasms, yellow; and bone marrow failure syndromes, allogeneic only, pink). No P values are given. The figure simply illustrates the heterogeneity; the study was not meant to assess differences between main disease categories. (C) Allogeneic HSCT and (D) autologous HSCT showing overall survival depending on EBMT risk score. Allogeneic HSCT: score 0+I (n=7,217; blue), score II+III (n=18,524; yellow), score IV+V (n=13,781; red), and score VI+VII (n=2,101; lilac). Autologous HSCT: score 0+I (n=3,889; blue), score II+III (n=36,290; yellow), and score IV+V (n=39,883; red). The hazard ratios for increasing risk with increasing score are depicted in Table 2. (E) Overall survival (OS) of 15,618 patients with an allogeneic HSCT in 1999 (4,742 patients; OS at 3 years 47.3%; blue), in 2002 (5,043 patients; OS at 3 years 50.5%; green) and in 2005 (5,833 patients; OS at 3 years 53.8%; yellow), illustrating the improvement over calendar time.

Figure 2.

“JACIE” accreditation status of the transplant team by November 2012 and outcome of patients transplanted between 1999 and 2006. (A) Kaplan-Meier estimates of overall survival of 17,655 patients with an allogeneic HSCT, transplanted in the years 2004–2006 in a center accredited (green line; n=8,983) or not (blue line; n=8,672) by 2012. The respective hazard ratios are presented in Table 2A. (B) Overall survival (OS) and non-relapse mortality (NRM) at 72 months by EBMT risk score for 17,243 patients transplanted with an allogeneic HSCT in a large center accredited by November 2012 (blue line) or not (red line). (C) Overall survival and non-relapse mortality at 72 months by EBMT risk score for 28,052 patients transplanted with an autologous HSCT in a large center accredited by November 2012 (blue line) or not (red line).