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卫生技术评估报告对卫生政策的影响:一项系统综述。

The impact of HTA reports on health policy: a systematic review.

作者信息

Gerhardus Ansgar, Dintsios Charalabos-Markos

机构信息

Institut für Gesundheits- und Medizinrecht, Universität Bremen, Bremen, Deutschland.

出版信息

GMS Health Technol Assess. 2005 Nov 2;1:Doc02.

Abstract

RESEARCH QUESTION

The objective of health technology assessment (HTA) is to support decision-making in the health sector by assessing health technologies systematically under medical, economic, social, and ethical aspects. The present study aims at identifying ways of enabling the impact of HTA on decision-making processes in the German health sector. The authors formulate three research questions: (1) Can methods be identified that allow a valid assessment of the impact of HTA reports on the decision-making processes? (2) Has been shown an impact of HTA reports on decision-making processes in the health sector? (3) Which are the factors responsible for a high or a low impact of HTA?

METHODS

The authors include studies that present a methodology to assess the impact of HTA, that investigate the impact of HTA on decision-making processes, or study the factors that might enhance or hinder the impact of HTA. Medical and social science electronic databases, lists of publications and projects of the European, North American, Canadian, and Australian HTA agencies, as well as the bibliography of the identified articles and documents are looked through. The writers do a handsearch of the International Journal of Technology Assessment in Health Care and contact 64 HTA agencies by a letter, requesting information on investigations that might not have been published.

RESULTS

Abstracts from about 5,000 articles are read. 57 articles are ordered as full-text, 43 are finally included and 14 excluded. (1) In eight studies interviews with decision-makers are used to elicit the information, in three studies document analysis is employed, and in six surveys the results rely only on the observations and interpretations of the authors. One study analyses service data and in nine examinations more than one of the methods listed above are employed. Only in two studies pre-defined indicators were used and only in one clinical trial a prospective design is chosen. (2) In nine studies the impact of a population of HTA reports is analysed: Among these, seven find that more than 70% of the reports have an impact on the decision-making process, in one study 50% of the reports have none or only a minimal impact. In one study on the impact of 50 short HTA reports, it is found that they contribute valuable information but do not influence decisions. However, because of methodological flaws the evidence base for these results is rather limited. Most of the conclusions presented in the publications are based on the appraisal of the authors who are often related to the program of which the impact has been "evaluated". (3) The writers divide the factors that are identified as modifying the degree of impact of the HTA reports in two groups: context factors and factors that are connected to the developing process, the subject, the format, the content, or the quality of the reports. However, the relevance of these factors has to be assessed with caution: none of the publications has the relevance for a primary research question and in none of the studies is the relevance of the factors investigated in a prospective and systematic manner.

CONCLUSION

There is little experience with study designs or methods that allow a valid assessment of the impact of HTA reports on the decision-making process in the health sector. However, some approaches, such as the use of pre-defined indicators, were identified that should be pursued and elaborated in further studies. Due to the lack of a developed methodology only limited conclusions related to the impact of HTA reports can be drawn. Among the studies that show a relevant impact, most are methodological. However, results from qualitative studies caution against assuming a causal relationship where a mere coincidence between the recommendations of an HTA report and health policy is identified. In order to produce evidence-based conclusions regarding the impact of HTA reports, validated indicators should be used. Study design should also aim at controlling for other influencing factors. None of the studies explicitly aim at examining the role of the factors that might be responsible for a low or high impact of the HTA reports. The non-systematic retrospective analyses do not allow reliable conclusions regarding the relevance of these factors. Therefore the factors identified here should only serve for hypothesis formation. On the basis of these studies it is not possible to give evidence-based recommendations on the way how to increase the impact of HTA on decision-making in Germany. Instead a concept for evaluation should be developed that combines quantitative and qualitative methods and considers the following questions:(1) What kind of impact should be measured? (2) Which are the target groups and at which level of the health system are they located? (3) Which are the outcome parameters and how can they be measured? (4) Which are the potential impact enhancing or limiting factors?

摘要

研究问题

卫生技术评估(HTA)的目标是通过在医学、经济、社会和伦理方面系统评估卫生技术,为卫生部门的决策提供支持。本研究旨在确定使HTA对德国卫生部门决策过程产生影响的方法。作者提出了三个研究问题:(1)能否确定允许对HTA报告对决策过程的影响进行有效评估的方法?(2)是否已证明HTA报告对卫生部门的决策过程有影响?(3)导致HTA产生高影响或低影响的因素有哪些?

方法

作者纳入了提出评估HTA影响的方法、研究HTA对决策过程的影响或研究可能增强或阻碍HTA影响的因素的研究。查阅了医学和社会科学电子数据库以及欧洲、北美、加拿大和澳大利亚HTA机构的出版物和项目清单,以及已识别文章和文件的参考文献。作者对《卫生保健技术评估国际杂志》进行了手工检索,并通过信件联系了64个HTA机构,询问可能未发表的调查信息。

结果

阅读了约5000篇文章的摘要。订购了57篇文章的全文,最终纳入43篇,排除14篇。(1)在八项研究中,通过与决策者访谈获取信息,三项研究采用文件分析,六项调查的结果仅依赖作者的观察和解读。一项研究分析服务数据,九项研究采用了上述多种方法。仅两项研究使用了预定义指标,仅一项临床试验采用了前瞻性设计。(2)九项研究分析了一批HTA报告的影响:其中七项发现超过70%的报告对决策过程有影响,一项研究中50%的报告没有影响或只有极小影响。一项关于50份简短HTA报告影响的研究发现,它们提供了有价值的信息,但不影响决策。然而由于方法缺陷,这些结果的证据基础相当有限。出版物中呈现的大多数结论是基于作者的评估,而作者往往与被“评估”影响的项目有关。(3)作者将被确定为改变HTA报告影响程度的因素分为两组:背景因素和与报告的制定过程、主题、格式、内容或质量相关的因素。然而,这些因素的相关性必须谨慎评估:没有一篇出版物与主要研究问题相关,也没有一项研究以前瞻性和系统性方式研究这些因素的相关性。

结论

对于能够有效评估HTA报告对卫生部门决策过程影响的研究设计或方法,经验很少。然而,确定了一些方法,如使用预定义指标,应在进一步研究中加以探讨和完善。由于缺乏完善的方法,只能得出与HTA报告影响相关的有限结论。在显示有相关影响的研究中,大多数存在方法问题。然而,定性研究的结果提醒我们,在仅确定HTA报告建议与卫生政策之间存在巧合时,不要假定存在因果关系。为了得出关于HTA报告影响的循证结论,应使用经过验证的指标。研究设计还应旨在控制其他影响因素。没有一项研究明确旨在研究可能导致HTA报告产生低影响或高影响的因素的作用。非系统性的回顾性分析无法就这些因素的相关性得出可靠结论。因此,这里确定的因素仅应用于形成假设。基于这些研究,无法就如何提高HTA对德国决策的影响给出循证建议。相反,应制定一个评估概念,将定量和定性方法结合起来,并考虑以下问题:(1)应衡量哪种影响?(2)目标群体有哪些,他们处于卫生系统的哪个层面?(3)结果参数有哪些,如何进行衡量?(4)潜在的增强或限制影响的因素有哪些?

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