Department of Health Planning and Economics, National School of Public Health, Institute of Health Carlos III, Madrid, Spain
Department of Medicine, University of Valencia/INCLIVA Health Research Institute and CIBERSAM, Valencia, Spain.
BMJ Open. 2020 Feb 13;10(2):e034463. doi: 10.1136/bmjopen-2019-034463.
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.
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.
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.
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能够重现研究结果。健康经济评估是对替代干预措施的成本和结果进行比较分析，被认为是为决策提供信息的重要工具。本研究旨在调查 2012 年（n=200）、2019 年（n=200）和 2022 年（n=200）期间在 MEDLINE 中索引的医疗保健干预措施的经济评估文章纳入了多少促进透明度、开放性和可重复性的研究实践。
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）中注册了研究方案。我们将评估随机抽取的 600 篇成本效益分析出版物，这是健康经济评估的一种特定形式，这些出版物在 2012 年（n=200）、2019 年（n=200）和 2022 年（n=200）期间在 MEDLINE 中索引。我们将纳入用每获得的生命年成本、质量调整生命年和/或残疾调整生命年表示增量成本效益比的英文出版论文。文章的筛选和选择将由至少两名研究人员进行。使用标准化的数据提取表格，由多名研究人员提取每篇文章的可重复性研究实践、开放性和透明度，其中 33%的随机样本（n=200）进行重复提取。将按年份、引用综合健康经济评估报告标准（CHEERS）声明和期刊报告一般、方法和可重复性项目的信息。将计算 95%置信区间的风险比来表示 2012-2019 年和 2019-2022 年报告之间的变化。
由于拟议研究的性质，不需要伦理批准。所有数据将存储在跨学科公共存储库中。预计研究结果可能对各种受众相关。研究结果将在科学会议上进行传播，并发表在同行评议的期刊上。
