Objective: To provide an overview of comparative effectiveness research (CER) methodology and discuss the challenges of health economics and outcomes research (HEOR) in wound care. Approach: Narrative description of HEOR methodology with supporting references. Results: With the increasing costs of clinical trials, the use of observational studies in a real-world setting will be essential. Wound care clinicians should understand the importance of proper methods for conducting CER studies. Propensity score methods and marginal structural modeling can create a "quasi-randomized" environment for measuring wound closure and can help drive informed decision-making. In wound care, a paucity of HEOR information is available with great reluctance to use this information by payers, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, and other agencies. Furthermore, a limited amount of high-quality retrospective data to measure wound care outcomes exist. The U.S. Wound Registry is one of few data sources that accurately reports on outcomes for all wound types and is a Qualified Clinical Data Registry. Innovation and Conclusions: Several CER approaches in observational studies provide sufficiently detailed information to help decision-makers make informed choices about wound care products regarding efficacy in the real-world setting. Using CER and cost-effectiveness studies succinctly needs to be incorporated if progress is to be made in improving wound care outcomes and reducing cost.

译文

:目的:提供比较有效性研究(CER)方法的概述,并讨论健康经济学和结局研究(HEOR)在伤口护理方面的挑战。方法:对HEOR方法论的叙述性描述,并带有辅助性参考文献。结果:随着临床试验成本的增加,在现实环境中使用观察性研究将至关重要。伤口护理临床医生应了解进行CER研究的正确方法的重要性。倾向评分方法和边缘结构建模可以创建用于测量伤口闭合的“准随机”环境,并有助于推动明智的决策。在伤口护理中,可用的HEOR信息很少,付款人,食品和药物管理局,医疗保险和医疗补助服务中心以及其他机构极不愿意使用此信息。此外,还存在数量有限的高质量回顾性数据来衡量伤口护理的效果。美国伤口登记处是准确报告所有伤口类型结局的少数数据来源之一,并且是合格的临床数据登记处。创新与结论:观察研究中的几种CER方法可提供足够详细的信息,以帮助决策者就现实世界中的功效对伤口护理产品做出明智的选择。如果要在改善伤口护理效果和降低成本方面取得进展,则必须简洁地使用CER和成本效益研究。

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