Alliance of Wound Care Stakeholders Wound Care Evidence Summit

伤口护理利益相关者联盟伤口护理证据峰会

基本信息

批准号：
10467648
负责人：
Marcia Nusgart
金额：
$ 5万
依托单位：
ALLIANCE OF WOUND CARE STAKEHOLDERS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-05-15 至 2023-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10467648
关键词：
Academy Address Advocacy Advocate Affect Age American American Nurses&apos Association American Physical Therapy Association Americas Amputation Amputees Ankle Area Blood Vessels Caring Chronic Clinic Clinical Clinical Practice Guideline Clinical Trials Clinical Trials Design Clinical effectiveness Code Collaborations Communities Consensus Data Diabetes Mellitus Diagnosis Dietetics Effectiveness Enterostomal Therapy Nurse Specialist Family Fostering Future Goals Government Agencies Guidelines Health Services Accessibility Health Status Healthcare Interest Group Knowledge Lymphatic Lymphedema Manufacturer Name Measures Medical Medical Societies Medicare Medicine Mission Nurse Practitioners Nursing Societies Operative Surgical Procedures Outcome Patient Care Patient Representative Patient advocacy Patient-Focused Outcomes Patients Persons Physician Executives Plastic Surgeon Play Podiatry Policies Policy Maker Policy Research Practice Guidelines Protocols documentation Public Policy Quality of Care Quality of life Research Research Personnel Risk Role Safety Services Societies Source Surgeon United States Agency for Healthcare Research and Quality United States National Institutes of Health Update Veins Venous Visiting Nurse Voice Work advocacy organizations base beneficiary care providers chronic wound clinical care clinical development college cost cost effectiveness decubitus ulcer economic impact foot health care delivery improved meetings member multidisciplinary non-healing wounds nutrition outreach pain reduction patient registry payment programs routine care social health determinants symposium wound wound care wound closure wound healing

项目摘要

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.

项目摘要/摘要慢性伤口的管理仍然是美国和全球的主要医疗挑战。一个最近的分析支持，慢性非修改奖金影响了几乎15％的医疗保险受益人，或大约820万人。慢性伤口的经济影响很大。保守派他们在美国对医疗保险受益人的年度费用的估计为280亿美元。开始至关重要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：1。）伤口护理研究基础的差距在哪里？ 2.）哪些临床问题和类型需要产生证据以提高伤口护理疗法的临床和成本效益吗？ 3.）什么临时临床结果或终点是否会为伤口护理临床试验设计中的利益相关者提供价值吗？ 4.）在研究和政策中应“现实世界数据”和“现实世界证据”发挥什么作用 - 研究可以接受监管机构，临床医生和付款人，并且可以推广到典型的慢性伤口护理患者吗？ 5.）未来的伤口护理研究方法的变化很可能会增加其所需价值？到探索并回答这些和其他关键问题，伤口护理利益相关者的联盟（“联盟”）是召集拟议的伤口护理证据峰会。联盟是一个非营利性的多学科临床协会和患者倡导组织的协会，其使命是促进质量照顾和使用慢性伤口患者的产品和服务。它使伤口护理临床社区，可以协作参与通用性问题，提升知名度和联合声音伤口护理提供者到监管机构和政策制定者。关键重点领域是：伤口护理研究，质量措施和报销（编码，承保范围和付款）。这次会议将为批判性提供付款人，相关政府机构的政策制定者需要多学科和独特的平台，著名的研究人员，患者和临床协会的代表，伤口护理诊所和制造商要解决与监管机构和医疗董事沟通的共同目标制定临床试验和覆盖政策，探索当前伤口护理和伤口护理的状态研究，并讨论如何使用临床实践指南和研究结果利益相关者。在所有利益相关者的所需研究方法中，我们正在寻求更好的一致性。很少研究人员，临床医生和制造商是否有机会亲自讨论和合作政策制定者在临床试验问题上。这些对话是理解每个人的观点的第一步查看，导致将来进一步合作。这次会议将为与会者提供可行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以及需要。这次会议将是制定“下一步”计划的论坛，包括知道的方法转移。