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应用卫生技术评估核心模型对转移性去势抵抗性前列腺癌患者镭-223治疗的有效性和质量进行综合评估。

Application of the HTA Core Model for complex evaluation of the effectiveness and quality of Radium-223 treatment in patients with metastatic castration resistant prostate cancer.

作者信息

Kiselova Bilekova Beata, Gavurova Beata, Rogalewicz Vladimír

机构信息

Institute of Nuclear and Molecular Medicine, Imaging Diagnostics Department, Rastislavova 785/43, 042 53, Košice, Slovakia.

Research and Innovation Centre Bioinformatics, TECHNICOM, Němcovej 5, Kosice, Slovakia.

出版信息

Health Econ Rev. 2018 Oct 22;8(1):27. doi: 10.1186/s13561-018-0211-9.

DOI:10.1186/s13561-018-0211-9
PMID:30349986
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6755544/
Abstract

BACKGROUND

Health technology assessment (HTA) is currently one of the major challenges in assessing medical innovations and healthcare systems. In Europe, the European Network for Health Technology Assessment (EUnetHTA) has been aspiring to develop and implement standards for international sharing of HTA results and studies. Slovakia and many other EU countries do not have an established HTA system yet. This paper is focused on an exact description of the EUnetHTA Core Model individual domains applied to the process of selecting patients in the terminal stage of prostate cancer for Radium-223 treatment under particular conditions of the Institute of Nuclear and Molecular Medicine (INMM) in Košice, Slovakia.

RESULTS

We produced the first pilot HTA report using the HTA Core Model in Slovakia. The main objective was to collect all relevant information on the particular technology, and provide its summary to the interested stakeholders on one spot. Rather than applying detailed individual items, i.e. assessment elements and assessment element cards, we concentrated on the content of individual domains and tried to fill them with the best country, facility and intervention related data. The dataset consisted of 52 patients that finished the treatment in the period 2015-2017. The patients were carefully selected according to the Radium-223 producer's criteria. Only 33 patients received the full therapy consisting of six applications; their average survival was 10.5 months from the application of the last dose.

CONCLUSIONS

Based on the results of our analyzes, we recommended several changes to the INMM processes and patient follow-up checks during the treatment process in order to make the therapy more effective. The greatest benefit is expected after the implementation of a Ge/Ga generator in 2018, as the selection of patients suitable for the Radium-223 treatment will improve. We showed that the HTA Core Model can be implemented in Slovakia, even under conditions of no formal HTA support or institutionalization.

摘要

背景

卫生技术评估(HTA)是当前评估医疗创新和医疗保健系统的主要挑战之一。在欧洲,欧洲卫生技术评估网络(EUnetHTA)一直致力于制定和实施卫生技术评估结果及研究国际共享的标准。斯洛伐克和许多其他欧盟国家尚未建立完善的卫生技术评估体系。本文着重精确描述EUnetHTA核心模型的各个领域,这些领域应用于斯洛伐克科希策核与分子医学研究所(INMM)特定条件下为晚期前列腺癌患者选择镭 - 223治疗的过程。

结果

我们在斯洛伐克使用HTA核心模型编制了首份试点卫生技术评估报告。主要目的是收集有关特定技术的所有相关信息,并将其摘要一次性提供给感兴趣的利益相关者。我们没有应用详细的单个项目,即评估要素和评估要素卡片,而是专注于各个领域的内容,并尝试用与国家、机构和干预措施相关的最佳数据来填充这些领域。数据集包括2015 - 2017年期间完成治疗的52名患者。这些患者是根据镭 - 223生产商的标准精心挑选的。只有33名患者接受了由六次应用组成的完整治疗;他们从最后一剂应用后的平均生存期为10.5个月。

结论

根据我们的分析结果,我们建议在治疗过程中对INMM的流程和患者随访检查进行若干更改以使治疗更有效。预计2018年实施锗/镓发生器后将带来最大益处,因为适合镭 - 223治疗的患者选择将得到改善。我们表明,即使在没有正式的卫生技术评估支持或制度化的情况下,HTA核心模型也可以在斯洛伐克实施。

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