Alliance of Wound Care Stakeholders Wound Care Evidence Summit

项目摘要/摘要 慢性伤口的管理在美国和世界范围内仍然是一项重大的医疗挑战。一个 最近的分析支持，慢性无法愈合的伤口影响到近15%的医疗保险受益人，或 大约820万人。慢性创伤的经济影响是巨大的。保守派 据估计，在美国，联邦医疗保险受益人每年的成本为280亿美元。关键是要开始 付款人和监管机构与伤口护理社区之间的对话，以解决这些关键问题 问题：1.)伤口护理研究基地的差距在哪里？)什么临床问题和什么样的 是否需要证据来提高伤口护理治疗的临床和成本效益？什么 在伤口护理临床试验设计中，临时临床结果或终点是否会为利益相关者提供价值？ 4.)“真实世界数据”和“真实世界证据”应该在研究和政策中发挥什么作用-研究 监管机构、临床医生和付款人是否可以接受，并可推广到典型的慢性伤口护理患者？ 未来伤口护理研究方法的哪些变化最有可能增加其所需的价值？至 探索并回答这些和其他关键问题，伤口护理利益相关者联盟(“联盟”)是 召开拟议的伤口护理证据峰会。联盟是一个非营利性的多学科组织 以提高质量为使命的临床协会和患者倡导组织协会 为慢性创伤者提供护理和获得产品和服务的机会。它使伤口护理成为可能 临床社区协作参与共性问题，提高知名度和团结声音 向监管机构和政策制定者介绍伤口护理提供者的情况。重点关注的领域是：伤口护理研究， 质量措施和补偿(编码、覆盖和付款)。这次会议将提供一个批判性的 需要为付款人、相关政府机构的政策制定者、 知名研究人员，来自患者和临床协会、伤口护理诊所和 制造商应解决与监管机构和医疗主管就 开发临床试验和覆盖政策，探索伤口护理和伤口护理的现状 研究，并讨论临床实践指南和研究结果是如何被 利益相关者。我们正在寻求在所有利益相关者之间更好地协调所需的研究方法。少之又少 研究人员、临床医生和制造商是否有机会与 临床试验问题的政策制定者。这些对话是理解每个人观点的第一步 视图，从而在未来实现进一步的合作。本次会议将为与会者提供可操作的知识 并帮助他们准备科学证据，以最好地满足临床医生、监管机构和付款人的要求 需要。这次会议将是制定“下一步”计划的论坛，包括获取知识的途径。 调职。

Project Summary/Abstract Management of chronic wounds continues to be major a healthcare challenge in the U.S. and worldwide. A recent analysis supports that chronic nonhealing wounds affect nearly 15% of Medicare beneficiaries, or approximately 8.2 million people. The economic impact of chronic wounds is substantial. A conservative estimate of their annual cost in the U.S. for Medicare beneficiaries is $28 billion. It is critical to begin the dialogue between the payers and regulators with the wound care community to address these critical problems: 1.) Where are the gaps in the wound care research base? 2.) What clinical questions and kind of evidence needs to be produced to improve the clinical and cost effectiveness of wound care therapy? 3.) What interim clinical outcomes or endpoints would provide value to stakeholders in wound care clinical trial design? 4.) What role should “real world data” and “real world evidence” play in research and policy---research that is acceptable to regulators, clinicians and payers and is generalizable to typical chronic wound care patients? 5.) What changes in future approaches to wound care research will most likely add to its needed value? To explore and answer these and other key questions, the Alliance of Wound Care Stakeholders (“Alliance”) is convening the proposed Wound Care Evidence Summit. The Alliance is a nonprofit multidisciplinary association of clinical associations and patient advocacy organizations whose mission is to promote quality care and access to products and services for people with chronic wounds. It has enabled the wound care clinical community to collaboratively engage on issues of commonality, elevating the visibility and united voice of wound care providers to regulators and policy makers. The key focus areas are: wound care research, quality measures and reimbursement (coding, coverage and payment). This conference will provide a critically needed multi-disciplinary and unique platform for payers, policymakers from relevant government agencies, prominent researchers, representatives from patient and clinical associations, wound care clinics and manufacturers to address the shared goals of communicating with regulators and medical directors on the development of clinical trials and coverage policies, exploring the current state of wound care and wound care research, and discussing how clinical practice guidelines and research findings are being used by stakeholders. We are seeking better alignment in needed research approaches across all stakeholders. Rarely do researchers, clinicians and manufacturers have an opportunity to discuss and collaborate in person with policy makers on clinical trial issues. These dialogues are the first step in understanding each person’s point of view, leading to further collaboration in the future. This meeting will provide actionable knowledge for attendees and help them to prepare scientific evidence to best meet clinicians, regulators and payers’ requirements and needs. This meeting will be the forum for creating a “next steps” plan, including approaches to knowledge transfer.