■尽管在比利时的临床实践中逐渐采用了立体定向放射治疗(SBRT),由于仍然存在临床和经济不确定性,2011年的报销申请未获得批准.SBRT的证据开发(CED)计划始于2013年,旨在评估比利时的临床和技术护理模式,并监测每个适应症的生存率。考虑到支持纳入报销制度。
■比利时国家健康和残疾保险研究所(NIHDI)启动了这项前瞻性观察注册。参与部门,在临床实践中使用SBRT,签署了“NIHDI约定”。符合条件的患者患有原发性肿瘤(PT)或寡转移疾病(OMD)。病人,肿瘤,和治疗特征是通过比利时癌症登记处的在线模块收集的,融资的前提。5年总生存率(5YOS)和30天和90天死亡率是主要结果,来自重要状态信息。
■在2013年10月至2019年12月之间,24个认可的放射治疗部门中有20个参加了,六是学术性的。每个部门的注册病例范围为21至867。在分析的5675个注册中,大多数患者表现良好,病变数量有限.随着时间的推移,PT的入学率保持稳定,OMD几乎翻了一番。与OMDs一样,PT中的周围性肺病变占主导地位。其他转移是(旁)脊柱,“非标准”和肝。30天和90天死亡率分别低于0.5%[95%CI0.3%-0.8%]2.1%[95%CI1.6%-2.7%]。5YOS随指示变化,原发性前列腺患者表现最好(85%,95%CI[76%,96%]),肝转移最严重的患者(19%,95%CI[15%,24%])。在学术部门观察到更好的操作系统,科室规模对生存率无显著影响.2018-19年OMD生存率较好。
■CED可用于定义创新放射治疗的护理模式和现实生活结果。由于观察到的不同适应症的生存率与新兴文献中的结果一致,截至2020年1月,SBRT已被纳入比利时的报销系统。
■NIHDI资助每个注册案例的参与部门。
UNASSIGNED: Although stereotactic body radiotherapy (SBRT) was progressively adopted in clinical practice in Belgium, a reimbursement request in 2011 was not granted because of remaining clinical and economic uncertainty. A coverage with evidence development (CED) program on SBRT started in 2013, with the aim to assess clinical and technical patterns-of-care in Belgium and monitor survival per indication, in view of supporting inclusion in the reimbursement system.
UNASSIGNED: The Belgian National Institute for Health and Disability Insurance (NIHDI) initiated this prospective observational registry. Participating departments, using SBRT in clinical practice, signed the \'NIHDI convention\'. Eligible patients had a primary tumour (PT) or oligometastatic disease (OMD). Patient, tumour, and treatment characteristics were collected through an online module of the Belgian Cancer Registry, prerequisite for financing. Five-year overall survival (5YOS) and 30- and 90-days mortality were primary outcomes, derived from vital status information.
UNASSIGNED: Between 10/2013 and 12/2019, 20 of the 24 accredited radiotherapy departments participated, 6 were academic. Registered cases per department ranged from 21 to 867. Of 5675 registrations analysed, the majority had good performance status and limited number of lesions. Enrolment of PTs remained stable over time, OMDs almost doubled. Peripheral lung lesions dominated in PTs as in OMDs. Other metastases were (para)spinal, \'non-standard\' and hepatic. Thirty- and 90-days mortalities remained below 0.5% [95% CI 0.3%-0.8%] respectively 2.1% [95% CI 1.6%-2.7%]. 5YOS varied by indication, primary prostate patients performing best (85%, 95% CI [76%, 96%]), those with liver metastases worst (19%, 95% CI [15%, 24%]). Better OS was observed in academic departments, department size did not significantly impact survival. OMD survival was better in 2018-19.
UNASSIGNED: CED can be used to define patterns-of-care and real-life outcome of innovative radiotherapy. As the observed survival for different indications was in line with outcome in emerging literature, SBRT was included in the Belgian reimbursement system as of January 2020.
UNASSIGNED: NIHDI financed participating departments per registered case.