European Group for Blood and Marrow Transplantation Activity Survey Office, University Hospital, Basel, Switzerland.
J Clin Oncol. 2011 May 20;29(15):1980-6. doi: 10.1200/JCO.2010.30.4121. Epub 2011 Apr 11.
A comprehensive quality management system called JACIE (Joint Accreditation Committee International Society for Cellular Therapy and the European Group for Blood and Marrow Transplantation), was introduced to improve quality of care in hematopoietic stem-cell transplantation (HSCT). We therefore tested the hypothesis that the introduction of JACIE improved patient survival.
Data on 41,623 allogeneic (39%) and 66,281 autologous (61%) HSCTs for an acquired hematologic disorder performed between 1999 and 2007 by 421 teams in Europe were used to assess the outcomes of patients who received a transplantation at baseline (> 3 years before application or no application), during preparation (3 years before application), during application (time from application to accreditation), and after JACIE accreditation. The analysis was clustered by team and stratified for year of HSCT, donor type, disease, conditioning, and gross national income per capita of the respective country. Patient's risks were adjusted for by their European Group for Blood and Marrow Transplantation score.
Patient outcome was systematically better when the transplantation center was at a more advanced phase of JACIE accreditation, independent of year of transplantation and other risk factors. Improvement was robust as quantified for relapse-free survival after allogeneic HSCT compared with baseline by a hazard ratio (HR) of 0.96 (95% CI, 0.90 to 1.03; P = .22) for preparation, 0.95 (95% CI, 0.88 to 1.03; P = .20) for application, and 0.86 (95% CI, 0.78 to 0.95; P = .01) for the accreditation (test for trend P = .01). Improvement from baseline was similar after autologous HSCT (HR for accreditation, 0.83; 95% CI, 0.74 to 0.93; P < .01).
Even with all the limitations of an observational study, these findings support the hypothesis that introduction of a comprehensive clinical quality management system is associated with improved outcome of patients after HSCT.
引入了一个名为 JACIE（国际细胞治疗学会联合认证委员会和欧洲血液与骨髓移植学会）的全面质量管理体系，以提高造血干细胞移植（HSCT）的护理质量。因此，我们检验了这样一个假设，即 JACIE 的引入改善了患者的生存率。
我们使用了欧洲 421 个团队在 1999 年至 2007 年间进行的 41623 例异基因（39%）和 66281 例自体（61%）HSCT 的数据，以评估在基线（应用前> 3 年或未应用）、准备阶段（应用前 3 年）、应用阶段（从申请到认证）和 JACIE 认证后接受移植的患者的预后。分析按团队进行聚类，并按 HSCT 年份、供体类型、疾病、调理和各自国家的人均国民总收入进行分层。通过欧洲血液与骨髓移植学会评分调整患者的风险。
当移植中心处于 JACIE 认证的更高级阶段时，患者的预后得到了系统的改善，与移植年份和其他风险因素无关。这种改善是稳健的，正如异基因 HSCT 后无复发生存率相对于基线的危险比（HR）所量化的那样，准备阶段为 0.96（95%CI，0.90 至 1.03；P =.22），应用阶段为 0.95（95%CI，0.88 至 1.03；P =.20），认证阶段为 0.86（95%CI，0.78 至 0.95；P =.01）（趋势检验 P =.01）。自体 HSCT 后从基线的改善也相似（认证 HR，0.83；95%CI，0.74 至 0.93；P <.01）。
即使存在观察性研究的所有局限性，这些发现支持这样一个假设，即全面临床质量管理体系的引入与 HSCT 后患者预后的改善相关。
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