Reproducible research practices, openness and transparency in health economic evaluations: study protocol for a cross-sectional comparative analysis
Reproducible research practices, openness and transparency in health economic evaluations: study protocol for a cross-sectional comparative analysis
复制标题
DOI：
10.1136/bmjopen-2019-034463
复制
发表时间：
2020-02-01
期刊：
影响因子：
2.9
通讯作者：
Moher, David
中科院分区：
文献类型：
--
作者：
Catala-Lopez, Ferran;Caulley, Lisa;Moher, David
导言人们越来越意识到需要严格和透明地报告健康研究，以确保未来研究人员研究的可重复性。卫生经济评价，即对替代干预措施的成本和后果进行比较分析，已被作为决策的重要工具加以推广。这项研究的目的将是调查MEDLINE收录的医疗干预经济评估文章在多大程度上纳入了促进透明度、公开性和可重复性的研究实践。方法和分析这是一项横断面比较分析的研究方案。我们在开放科学框架(osf.io/gzaxr)中注册了该研究方案。我们将对随机抽样的600份成本效益分析出版物进行评估，这些出版物是卫生经济评估的一种具体形式，在2012年(n=200)、2019年(n=200)和2022年(n=200)期间在MEDLINE中被索引。我们将收录以英文发表的论文，报告每获得的生命年、质量调整的生命年和/或残疾调整的生命年的成本-效益增量比率。文章的筛选和选择将由至少两名研究人员进行。每篇文章的公开性和透明度将由多名研究人员使用标准化的数据提取表格提取，并抽取33%的随机样本(n=200)一式两份。将报告关于一般、方法和可重复性项目的信息，按年份分层，引用综合卫生经济评价报告标准(CHEERS)声明和期刊。具有95%CI的风险比率将被计算为代表2012-2019至2019-2020年间报告的变化。由于拟议研究的性质，将不需要伦理批准。所有数据都将存放在一个跨学科的公共存储库中。预计这项研究结果可能与各种受众相关。研究结果将在科学会议上传播，并在同行评议的期刊上发表。
Introduction There has been a growing awareness of the need for rigorously and transparent reported health research, to ensure the reproducibility of studies by future researchers. Health economic evaluations, the comparative analysis of alternative interventions in terms of their costs and consequences, have been promoted as an important tool to inform decision-making. The objective of this study will be to investigate the extent to which articles of economic evaluations of healthcare interventions indexed in MEDLINE incorporate research practices that promote transparency, openness and reproducibility.Methods and analysis This is the study protocol for a cross-sectional comparative analysis. We registered the study protocol within the Open Science Framework (osf.io/gzaxr). We will evaluate a random sample of 600 cost-effectiveness analysis publications, a specific form of health economic evaluations, indexed in MEDLINE during 2012 (n=200), 2019 (n=200) and 2022 (n=200). We will include published papers written in English reporting an incremental cost-effectiveness ratio in terms of costs per life years gained, quality-adjusted life years and/or disability-adjusted life years. Screening and selection of articles will be conducted by at least two researchers. Reproducible research practices, openness and transparency in each article will be extracted using a standardised data extraction form by multiple researchers, with a 33% random sample (n=200) extracted in duplicate. Information on general, methodological and reproducibility items will be reported, stratified by year, citation of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement and journal. Risk ratios with 95% CIs will be calculated to represent changes in reporting between 2012-2019 and 2019-2022.Ethics and dissemination Due to the nature of the proposed study, no ethical approval will be required. All data will be deposited in a cross-disciplinary public repository. It is anticipated the study findings could be relevant to a variety of audiences. Study findings will be disseminated at scientific conferences and published in peer-reviewed journals.