关键词:研究质量评价; 卫生经济学研究质量评价; QHES
一、QHES工具概述
卫生经济学评价是对卫生规划的制定、实施或产生的结果,从卫生资源的投入(卫生成本)和产出(效果、效益或效用)两个方面进行科学分析,对备选方案进行评价和选优,为政府或卫生部门从决策到实施提供评价和决策依据的方法。随着卫生经济学评价研究数量越来越多,行业内开始制定卫生经济学评价实施和报告指南,并逐渐发展为两个不同的方向。一类是以卫生经济学评价报告标准(Consolidated health economic evaluation reporting standards, CHEERS)为代表,旨在建立一套卫生经济学评价的报告标准,提高经济学评价报告的清晰度和透明度,使经济学评价报告的审稿人、编辑以及决策者可以更加清楚容易地读懂这些报告,CHEERS只针对报告本身开展质量评价。另一类以卫生经济研究质量评价(Quality of health economic studies, QHES)为代表,旨在通过卫生经济评价报告,评估该项经济学研究的质量,为读者区分不同循证级别的证据提供参考依据。
QHES由8名卫生经济学家制定评价框架和条目,经全球120名卫生经济学家赋予权重评估后所确定,于2003年发行。
二、QHES工具的使用
QHES共包含16个条目,每个条目分别用“是”和“否”来回答,最后对回答“是”的条目分数相加,获得该研究报告的总分。最高分为100分,一般认为分数>75分为研究质量较好。
需要注意的是,该工具兼顾定性和定量评价,运用过程中需要相关专家具有必备的专业知识,从而才能给特定条目进行判断打分,不同专业知识程度的专家评分结果可能会存在不小差异。其次,QHES工具每个条目的评分结果为二分类判断,缺乏具有连续尺度的中间度量值,这在实际应用中会损失一些重要的信息。另外,通过QHES工具评价,最后仅能获得一个分数,缺乏改进卫生经济研究质量的具体建议。最后,QHES要在国内加以应用,须经过规范的转换和验证研究。
三、QHES评价清单
Number 序号 | Items 评价条目 | Points 权重 | Yes/No 是/否 |
1. | Was the study objective presented in a clear, specific, and measurable manner? | 7 | |
1. | 译文:研究目标是否明确、具体和可测量? | 7 | |
2. | Were the perspective of the analysis (societal, third-party payer, etc) and reasons for its selection stated? | 4 | |
2. | 译文:是否说明了研究分析视角(社会视角、第三方付费视角,等)以及视角选择的原因? | 4 | |
3. | Were variable estimates used in the analysis from the best available source (i.e., randomized control trial-best, expert opinion-worst)? | 8 | |
3. | 译文:研究中使用的数据是否是现有条件下最好的[如随机对照试验(最好),专家意见(最差)]? | 8 | |
4. | If estimates came from a subgroup analysis, were the groups prespecified at the beginning of the study? | 1 | |
4. | 译文:如果分析数据来自于亚组人群,是否在研究分析前对该亚组人群有明确的界定和阐述? | 1 | |
5. | Was uncertainty handled by (1) statistical analysis to address random events; (2) sensitivity analysis to cover a range of assumptions? | 9 | |
5. | 译文:是否针对不确定性进行了一系列的处理,包括:(1) 应用统计分析方法处理随机效应;(2) 对一系列研究假设进行敏感性分析? | 9 | |
6. | Was incremental analysis performed between alternatives for resources and costs? | 6 | |
6. | 译文:是否采用了增量分析方法对研究组和对照组之间的资源消耗和成本进行了分析? | 6 | |
7. | Was the methodology for data abstraction (including the value of health states and other benefits) stated? | 5 | |
7. | 译文:是否详述了获取数据(包括健康状况和其他效益指标)的方法? | 5 | |
8. | Did the analytic horizon allow time for all relevant and important outcomes? Were benefits and costs that went beyond 1 year discounted (3% to 5%) and justification given for the discount rate? | 7 | |
8. | 译文:是否对研究时限进行了合理的设定,以包括所有重要的相关事件?一年以上的成本和产出是否进行了贴现处理(3%-5%)? | 7 | |
9. | Was the measurement of costs appropriate and the methodology for the estimation of quantities and unit costs clearly described? | 8 | |
9. | 译文:成本测算方法是否合理?资源消耗的数量和单位成本是否进行了合理的核算,并给予了清晰的说明? | 8 | |
10. | Were the primary outcome measure(s) for the economic evaluation clearly stated and did they include the major short-term was justification given for the measures/scales used? | 6 | |
10. | 译文:是否对健康产出变量进行了明确的界定和阐述,包括计算中所用到的短期疗效指标及其推算方法? | 6 | |
11. | Were the health outcomes measures/scales valid and reliable? If previously tested valid and reliable measures were not available, was justification given for the measures/scales used? | 7 | |
11. | 译文:健康产出变量的测量方法是否可信且经过校验?如果没有经过校验的工具,则是否清晰表述了本研究中的技术方法? | 7 | |
12. | Were the economic model (including structure), study methods and analysis, and the components of the numerator and denominator displayed in a clear transparent manner? | 8 | |
12. | 译文:是否明确透明的表述了本研究的模型、研究路线和分析方法、以及分子分母的界定? | 8 | |
13. | Were the choice of economic model, main assumptions, and limitations of the study stated and justified? | 7 | |
13. | 译文:是否明确阐述了本研究中模型的选择理由、研究中的主要假设及研究的局限性? | 7 | |
14. | Did the author(s) explicitly discuss direction and magnitude of potential biases? | 6 | |
14. | 译文:作者是否明确讨论了潜在偏倚的方向和大小? | 6 | |
15. | Were the conclusions/recommendations of the study justified and based on the study results? | 8 | |
15. | 译文:研究的结论/建议是否明确基于研究结果? | 8 | |
16. | Was there a statement disclosing the source of funding for the study? | 3 | |
16. | 译文:是否明确披露了研究资金资助来源? | 3 |
注:本文内容是参考相关文献后对卫生经济学研究质量评价(Quality of health economic studies, QHES)工具的概述,仅代表本网站观点。关于QHES的更多内容详见文章Examining the value and quality of health economic analyses: implications of utilizing the QHES。