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国内外卫生技术评估方法指南的系统评价

Methodological guidelines for health technology assessment:a systematic review

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目的 系统评价国内外已发表的卫生技术评估(health technology assessment,HTA)方法指南.方法 全面检索国内外常用数据库、指南数据库、国际HTA机构/组织网络、代表性国家HTA网络或政府卫生部门官方网站,搜集HTA实施或报告规范类文献,检索时限均为建库至2023年4月24日.采用系统评价方法,对纳入指南的基础信息、HTA实施步骤、评估指标、报告清单等信息进行提取,最后综合分析与描述.结果 本研究共纳入指南41篇,发表时间为2002年1月至2023年1月;发表机构涉及23个国家/国际组织;发表文献涉及6种语言;评估对象主要是所有卫生技术(n=23)、药品(n=4)、诊断/检测技术(n=4)、非药品卫生技术(n=3)、医疗器械/设备(n=3)、医院卫生技术(n=2)、医疗和外科手术的干预措施(n=1)、筛查技术(n=1);评估视角主要是卫生体系视角(n=16)、全社会视角(n=12)、医院视角(n=3),其余未提供评估视角信息;有28篇指南描述了详细HTA评估流程,涉及HTA评估步骤11个;有39篇指南详细介绍了评估领域与相关评估指标,涵盖评估领域2~9个不等,涉及一级评估指标10个;有10篇指南列出了 HTA报告清单,涉及报告条目18个;报告了利益冲突的指南为17篇,大多为不存在利益冲突(n=10),剩余7篇文献中有3篇未说明具体利益冲突,4篇文献中表明了可能的利益冲突来源.结论 HTA发展至今国际上已经形成了相对完善的评估体系,但目前需要统一卫生技术分类标准和报告规范,完善不同类型卫生技术评估的特异性指标,明确评估视角.同时结合我国HTA发展现状,制订本土化的HTA实施与报告指南,为合理配置卫生资源的决策,提供科学信息和方法基础.
Objective To systematically review published methodological guidelines for health technology assessment(HTA)at home and abroad.Methods Common electronic databases,guideline databases,international networks of HTA agencies/organizations,representative national HTA networks and official websites of governmental health departments were extensively searched and screened to identify guidelines for conducting or reporting HTA from inception to April 24,2023.Basic information on guidelines,HTA processes,assessment indicators,reporting checklists and other information was extracted,analyzed and described using a systematic review methodology.Results A total of 41 guidelines were included in this study,published from January 2002 to January 2023;the publishing institutions involved 23 countries/international organizations,and 6 languages;the assessments were mainly for all health technologies(n=23),pharmaceuticals(n=4),diagnostic/testing technologies(n=4),non-pharmaceutical health technologies(n=3),medical devices/equipment(n=3),hospital health technologies(n=2),medical and surgical interventions(n=1),and screening technologies(n=1);the assessment perspectives were mainly health system perspectives(n=16),societal perspectives(n=12),and hospital perspectives(n=3),while the rest did not provide information on the perspectives;28 guidelines described the detailed HTA assessment process,involving 11 steps;there were 39 guidelines described the assessment domains and related assessment indicators in detail,ranging from 2 to 9 assessment domains and involving 10 first-level assessment indicators;a checklist for HTA reports listed in 10 guidelines,involving 18 report entries;17 guidelines reported conflicts of interest,mostly no conflicts of interest(n=10),and 3 of the remaining 7 guidelines did not indicate a specific conflict of interest,while 4 guidelines in which possible sources of conflict of interest were indicated.Conclusion The development of HTA has formed a relatively perfect assessment system,but there is a need to unify the criteria for classification of health technologies and reporting checklist,improve the specificity indicators for different types of health technologies,and clarify the assessment perspectives.Combined with the current situation of HTA development in China,contextualized guidelines for HTA implementation and reporting should be formulated to provide scientific information and methodological basis for decision-making on rational allocation of health resources.

Health technology assessmentGuidelinesProcessesIndicatorsReport checklistSystematic review

吴雪、景城阳、施兰君、廖星

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中国中医科学院中医临床基础医学研究所循证医学基础研究室(北京 100700)

卫生技术评估 实施步骤 评估指标 报告清单 指南 系统评价

国家自然科学基金项目中国中医科学院科技创新工程项目中国中医科学院科技创新工程项目中国中医药循证医学中心"业务研究室主任专项"中国中医科学院基本科研业务费优秀青年科技人才(创新类)培养专项

82174239CI2021A00701-3CI2021A055032020YJSZX-2ZZ13-YQ-075

2024

中国循证医学杂志
四川大学

中国循证医学杂志

CSTPCD北大核心
影响因子:1.761
ISSN:1672-2531
年,卷(期):2024.24(9)
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