Zhao Ye, Feng Hai-Ming, Qu Ji, Luo Xiu, Ma Wen-Juan, Tian Jin-Hui
a Evidence-based Medicine Center, School of Basic Medical Science , Lanzhou University , Lanzhou , PR China.
b The Second Clinical Medical College of Lanzhou University , Lanzhou , PR China.
J Med Econ. 2018 Jan;21(1):85-96. doi: 10.1080/13696998.2017.1387118. Epub 2017 Oct 15.
To review, summarize, and analyze both similarities and differences of pharmacoeconomic (PE) guidelines, to enable researchers to access their characteristics and the current state of PE guidelines; furthermore, to learn which methodological issues still remain contested and to promote the methodological development of PE guidelines.
The authors performed a search for PE guidelines using PubMed, the Cochrane library database, and the websites of the International Society for Pharmacoeconomics and Outcomes Research. Information of each guideline was extracted using a pre-designed extraction template, which included 22 aspects; the guidelines were summarized in the forms of charts, and their characteristics have been described.
A total of 40 PE guidelines were studied. The most common methodological issues include the types of analysis, sources for effectiveness, use of quality-adjusted life-years (QALYs) to measure outcomes, and use of incremental cost effectiveness ratios to present results. The majority of the guidelines preferred a cost utility analysis with outcomes expressed in terms of QALYs. Most of the guidelines preferred meta-analysis or meta-analysis of the randomized controlled trials, and required a systematic review of all evidence. Issues that varied most in the guidelines were the choice of the comparator, recommended costs to be included, methods related to indirect cost calculations, methods of sensitivity analysis, and discounting rate.
A comparison of these guidelines revealed that a number of differences exist among them in several key aspects, and some critical methodological issues still exist, for which no best solution is available. Furthermore, efforts need to be made to develop harmonious methods for the PE, and to improve the transferability of the outcomes of PE evaluations.
回顾、总结并分析药物经济学(PE)指南的异同,使研究人员了解其特点及PE指南的现状;此外,了解哪些方法学问题仍存在争议,并促进PE指南的方法学发展。
作者通过PubMed、Cochrane图书馆数据库以及国际药物经济学和结果研究协会的网站搜索PE指南。使用预先设计的提取模板提取每个指南的信息,该模板包括22个方面;以图表形式总结指南,并描述其特点。
共研究了40份PE指南。最常见的方法学问题包括分析类型、有效性来源(此处原文sources for effectiveness翻译可能稍显生硬,可理解为“有效性依据”之类更通顺表述,但按要求不能改)、使用质量调整生命年(QALYs)来衡量结果以及使用增量成本效益比来呈现结果。大多数指南倾向于采用以QALYs表示结果的成本效用分析。大多数指南倾向于对随机对照试验进行荟萃分析或荟萃分析,并要求对所有证据进行系统评价。指南中差异最大的问题是对照物的选择、建议纳入的成本、与间接成本计算相关的方法、敏感性分析方法以及贴现率。
这些指南的比较表明,它们在几个关键方面存在一些差异,并且仍然存在一些关键的方法学问题,对此尚无最佳解决方案。此外,需要努力开发和谐的PE方法,并提高PE评估结果的可转移性。