Collaboration Encourages Innovation: Setting New Standards in Wound Care With the Wound Care Collaborative Community Expert Panel Consensus Recommendations

被引:0
|
作者
Driver, Vickie R. [1 ]
Walthall, Howard [2 ]
Oropallo, Alisha [3 ,4 ,5 ]
Carter, Marissa J. [6 ]
Tomic-Canic, Marjana [7 ]
Rolley, Joseph [8 ]
Henao, Maribel [9 ]
机构
[1] Washington State Univ, Elson S Floyd Coll Med, Spokane, WA 99163 USA
[2] ProgenaCare Global LLC, Marietta, GA USA
[3] Hofstra Northwell, Zucker Sch Med, Uniondale, NY USA
[4] Feinstein Inst Med Res, Manhasset, NY USA
[5] Northwell Comprehens Wound Healing Ctr & Hyperbar, North New Hyde Pk, NY USA
[6] Strateg Solut Inc, Cody, WY USA
[7] Univ Miami, Miller Sch Med, Wound Healing & Regenerat Med Res Program, Dr Phillip Frost Dept Dermatol & Cutaneous Surg, Miami, FL USA
[8] JTR Business Consulting LLC, Doylestown, PA USA
[9] Organogenesis Inc, Canton, MA USA
关键词
clinical trial design; real-world evidence; standard of care; wound; wound care; wound healing;
D O I
10.25270/wnds/24186
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Background. The Wound Care Collaborative Community (WCCC) assesses shortcomings and unmet needs in wound care by partnering with key stakeholders, such as the National Institutes of Health, the US Food and Drug Administration (FDA), industry leaders, and expert health care providers and researchers, to advance the study of wound healing. Through this work, the WCCC has identified a few key barriers to innovation in wound care. The WCCC aims to accelerate the development of science-based, patient-centered solutions and address public policy challenges related to ensuring patients receive early access to innovative treatment options. Objective. To develop consensus recommendations that would address current deficiencies in wound care and promote improved innovation and patient access with an expert panel discussion based on both the work conducted within the WCCC and the existing evidence. These recommendations include the voices of the at-large, US-based wound care community. Methods. In May 2024, a multi-panel summit with 65 leading voices in clinical practice, academia, industry, and the FDA convened in person in Orlando, Florida. Thirty-two participants with backgrounds in clinical practice, surgery, industry, academia, and research took part in panel discussions. Following the panel meeting, the group corresponded via email and a formal survey process to create consensus recommendations, with the ultimate goal of identifying and overcoming barriers to innovation in wound care. Results. A total of 32 experts convened during the 1-day summit, each representing key stakeholders. Five panel discussions took place to discuss the obstacles to innovation, including alternative primary and co-primary endpoints, generating and reporting evidence, real-world evidence in policy decision-making, and the appropriate standard of care in wound management. From these discussions, 12 consensus statements were generated. The statements, their proportion of agreement or disagreement, and summary comments are presented in the order they appeared at the presentation. Overall, greater than or equal to 85% agreement was received on all statements. Conclusion. The consensus recommendations promote and encourage a standardized path forward to established, consistent metrics that facilitate innovation and quality assessment, improving patient access to advancements in healing.
引用
收藏
页码:410 / 418
页数:9
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