Alliance of Wound Care Stakeholders Wound Care Evidence Summit

项目总结/摘要 慢性伤口的管理仍然是美国和世界范围内的主要医疗挑战。一 最近的分析支持慢性不愈合伤口影响近15%的医疗保险受益人，或 约820万人。慢性创伤的经济影响是巨大的。一个保守 据估计，美国医疗保险受益人每年的费用为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缺口在哪里？2.）什么样的临床问题 需要提供证据来提高伤口护理治疗的临床和成本效益？3.）第三章什么 中期临床结局或终点是否会为伤口护理临床试验设计的利益相关者提供价值？ 4.）“真实的世界数据”和“真实的世界证据”在研究和政策中应该扮演什么角色？ 监管机构、临床医生和付款人可接受，并且可推广到典型的慢性伤口护理患者？5.） 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？到 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”） 召开拟议中的伤口护理证据峰会该联盟是一个非营利的多学科 临床协会和患者倡导组织的协会，其使命是促进质量 为慢性伤口患者提供护理和产品及服务。它使伤口护理 临床社区协作参与共同性问题，提高知名度和统一的声音 向监管机构和政策制定者提供伤口护理服务。主要关注领域是：伤口护理研究， 质量措施和报销（编码、覆盖面和支付）。本次会议将提供一个批判性的 需要多学科和独特的平台，供支付者、相关政府机构的决策者 杰出的研究人员，来自患者和临床协会，伤口护理诊所和 制造商，以解决与监管机构和医疗主任沟通的共同目标 制定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如何被使用， 持份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。很少 研究人员、临床医生和制造商是否有机会亲自与 临床试验问题的政策制定者。这些对话是理解每个人的观点的第一步， #21453;，以促进未来的进一步合作。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， 需求这次会议将是制定“下一步”计划的论坛，包括知识方法 转移

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.