Wolters Regine, Wöckel Achim, Wischnewsky Manfred, Kreienberg Rolf
Universität Bremen, Fachbereich Mathematik und Informatik.
Z Evid Fortbild Qual Gesundhwes. 2011;105(6):468-75. doi: 10.1016/j.zefq.2011.03.007. Epub 2011 Apr 7.
The development and implementation of the "Interdisciplinary S3 Guideline for the Diagnosis, Treatment and Follow-up Care of Breast Cancer" (3) is intended to optimise national health services. This guideline already serves both as a basis for the certification of German breast centres and for the external comparative quality assurance based on guideline based quality indicators. Nevertheless, the effects of the implementation on relevant outcomes have not been examined so far.
The retrospective cohort study analyses data of 3,976 female patients with primary breast cancer which were collected at the University of Ulm and co-operating certified breast centres between 2001 and 2005. Based on the S3 guideline, an analysis model was developed to allow for the examination of guideline-adherent therapy on the basis of the guideline recommendations, and the effects of guideline-adherent compared to not guideline-adherent therapy on overall (OAS) and recurrence-free survival (RFS) were examined subsequently.
In total, 2,063 (51.9%) of the 3,976 patients were treated in adherence the guideline. In 1,913 (48.1%) patients deviations from the guideline recommendations in at least one of the therapeutic options were found. The variable "guideline-adherent treatment" had significant influence on RFS [p < 0.001; HR=2.20; 95% CI (1.74 to 2.79)] and OAS (p < 0.001; HR=2.57; 95% CI (1.96 to 3.37)], each adjusted for age, tumour size, nodal status and grading. RFS decreases with the number of deviations from guideline recommendations [1 to 2 deviations: p < 0.001; HR=2.04; 95% CI (1.60 to 2.60); ≥ 3 deviations: p < 0.001; HR=3.64; 95% CI (2.43 to 5.45), also adjusted for age, tumour size, nodal status and grading]. Similar results were found for the OAS.
Patients with breast cancer should be treated in adherence to guideline recommendations. Deviations and barrier factors will have to be evaluated in the future in order to further optimise both the guideline and guideline-adherent therapy.
制定并实施《乳腺癌诊断、治疗及随访的跨学科S3指南》（3）旨在优化国家医疗服务。该指南已成为德国乳腺癌中心认证以及基于指南质量指标的外部比较质量保证的基础。然而，到目前为止，尚未对其实施对相关结果的影响进行研究。
这项回顾性队列研究分析了2001年至2005年间在乌尔姆大学及合作认证乳腺癌中心收集的3976例原发性乳腺癌女性患者的数据。基于S3指南，开发了一个分析模型，以便根据指南建议对遵循指南的治疗进行检查，并随后检查遵循指南治疗与不遵循指南治疗对总生存期（OAS）和无复发生存期（RFS）的影响。
在3976例患者中，共有2063例（51.9%）接受了遵循指南的治疗。在1913例（48.1%）患者中，发现至少有一种治疗选择偏离了指南建议。变量“遵循指南的治疗方案”对RFS有显著影响[p < 0.001；HR = 2.20；95% CI（1.74至2.79）]和OAS（p < 0.001；HR = 2.57；95% CI（1.96至3.37）），均对年龄、肿瘤大小、淋巴结状态和分级进行了调整。RFS随着偏离指南建议的数量增加而降低[1至2次偏离：p < 0.001；HR = 2.04；95% CI（1.60至2.60）；≥3次偏离：p < 0.001；HR = 3.64；95% CI（2.43至5.45），同样对年龄、肿瘤大小、淋巴结状态和分级进行了调整]。OAS也得到了类似结果。
乳腺癌患者应遵循指南建议进行治疗。未来必须评估偏差和障碍因素，以便进一步优化指南和遵循指南的治疗方案。
