Advancing the role of real-world evidence in comparative effectiveness research.

IF 1.9 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES Journal of comparative effectiveness research Pub Date : 2024-10-11 DOI:10.57264/cer-2024-0101
Monica Daigl, Seye Abogunrin, Felipe Castro, Sarah F McGough, Rachele Hendricks Sturrup, Cornelis Boersma, Keith R Abrams
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Abstract

Aim: Comparative effectiveness research (CER) is essential for making informed decisions about drug access. It provides insights into the effectiveness and safety of new drugs compared with existing treatments, thereby guiding better healthcare decisions and ensuring that new therapies meet the real-world needs of patients and healthcare systems. Objective: To provide a tool that assists analysts and decision-makers in identifying the most suitable analytical approach for answering a CER question, given specific data availability contexts. Methods: A systematic literature review of the scientific literature was performed and existing regulatory and health technology assessment (HTA) guidance were evaluated to identify and compare recommendations and best practices. Based on this review a methods flowchart that synthesizes current practices and requirements was proposed. Results: The review did not find any papers that clearly identified the most appropriate analytical approach for answering CER questions under various conditions. Therefore, a methods flowchart was designed to inform analyst and decision makers choices starting from a well-defined scientific question. Conclusion: The proposed methods flowchart offers clear guidance on CER methodologies across a range of settings and research needs. It begins with a well-defined research question and considers multiple feasibility aspects related to CER. This tool aims to standardize methods, ensure rigorous and consistent research quality and promote a culture of evidence-based decision-making in healthcare.

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促进真实世界证据在比较有效性研究中的作用。
目的:比较有效性研究(CER)对于做出有关药物使用的明智决策至关重要。通过比较新药与现有疗法的有效性和安全性,它可以为更好的医疗决策提供指导,并确保新疗法满足患者和医疗系统的实际需求。目标:提供一种工具,帮助分析人员和决策者在特定的数据可用性背景下,确定最适合回答 CER 问题的分析方法。方法:对科学文献进行系统的文献综述,并对现有的监管和卫生技术评估 (HTA) 指南进行评估,以确定并比较建议和最佳实践。在综述的基础上,提出了综合当前实践和要求的方法流程图。结果:审查没有发现任何论文明确指出在各种条件下回答 CER 问题的最合适分析方法。因此,我们设计了一个方法流程图,为分析师和决策者从明确的科学问题出发进行选择提供信息。结论:建议的方法流程图为各种环境和研究需求下的 CER 方法提供了明确的指导。它从明确界定的研究问题出发,考虑了与 CER 相关的多个可行性方面。该工具旨在实现方法标准化,确保严格一致的研究质量,并促进医疗保健领域的循证决策文化。
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来源期刊
Journal of comparative effectiveness research
Journal of comparative effectiveness research HEALTH CARE SCIENCES & SERVICES-
CiteScore
3.50
自引率
9.50%
发文量
121
期刊介绍: Journal of Comparative Effectiveness Research provides a rapid-publication platform for debate, and for the presentation of new findings and research methodologies. Through rigorous evaluation and comprehensive coverage, the Journal of Comparative Effectiveness Research provides stakeholders (including patients, clinicians, healthcare purchasers, and health policy makers) with the key data and opinions to make informed and specific decisions on clinical practice.
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