title: Identification and content validation of wound therapy clinical endpoints relevant to clinical practice and patient values for FDA approval. Part 1. Survey of the wound care community.
abstract: Wounds that exhibit delayed healing add extraordinary clinical, economic, and personal burdens to patients, as well as to increasing financial costs to health systems. New interventions designed to ease such burdens for patients with cancer, renal, or ophthalmologic conditions are often cleared for approval by the U.S. Food and Drug Administration (FDA) using multiple endpoints but the requirement of complete healing as a primary endpoint for wound products impedes FDA clearance of interventions that can provide other clinical or patient-centered benefits for persons with wounds. A multidisciplinary group of wound experts undertook an initiative, in collaboration with the FDA, to identify and content validate supporting FDA criteria for qualifying wound endpoints relevant to clinical practice (CP) and patient-centered outcomes (PCO) as primary outcomes in clinical trials. As part of the initiative, a research study was conducted involving 628 multidisciplinary expert wound clinicians and researchers from 4 different groups: the interdisciplinary core advisory team; attendees of the Spring 2015 Symposium on Advanced Wound Care (SAWC); clinicians employed by a national network of specialty clinics focused on comprehensive wound care; and Association for the Advancement of Wound Care (AAWC) and Wound Healing Society (WHS) members who had not previously completed the survey. The online survey assessed 28 literature-based wound care endpoints for their relevance and importance to clinical practice and clinical research. Fifteen of the endpoints were evaluated for their relevance to improving quality of life. Twenty-two endpoints had content validity indexes (CVI) ≥ 0.75, and 15 were selected as meriting potential inclusion as additional endpoints for FDA approval of future wound care interventions. This study represents an important first step in identifying and validating new measurable wound care endpoints for clinical research and practice and for regulatory evaluation.
authors.affiliation: Brown University School of Medicine, Providence, Rhode Island.|New Indications Discovery Unit, Novartis Institutes for Biomedical Research, Cambridge, Massachusetts.
authors.forename: Vickie R
authors.initials: VR
authors.lastname: Driver
authors.affiliation: Wound Recovery Center, Kent Hospital, Warwick, Rhode Island.
authors.forename: Lisa J
authors.initials: LJ
authors.lastname: Gould
authors.affiliation: Healthcare Reimbursement Strategy Consulting, Bolivia, North Carolina.
authors.forename: Peggy
authors.initials: P
authors.lastname: Dotson
authors.affiliation: South Shore Hospital Center for Wound Healing, Weymouth, Massachusetts.
authors.forename: Gary W
authors.initials: GW
authors.lastname: Gibbons
authors.affiliation: The Angiogenesis Foundation, Cambridge, Massachusetts.
authors.forename: William W
authors.initials: WW
authors.lastname: Li
authors.affiliation: Department of Wound Care/Surgery, University of Illinois, Chicago, Illinois.
authors.forename: William J
authors.identifier: 0000-0003-4038-243X
authors.initials: WJ
authors.lastname: Ennis
authors.affiliation: Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, Florida.|Department of Epidemiology and Public Health, University of Miami Miller School of Medicine, Miami, Florida.
authors.forename: Robert S
authors.initials: RS
authors.lastname: Kirsner
authors.affiliation: Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, Florida.
authors.forename: William H
authors.initials: WH
authors.lastname: Eaglstein
authors.affiliation: Robert Wood Johnson University Medical School, New Brunswick, New Jersey.
authors.forename: Laura L
authors.initials: LL
authors.lastname: Bolton
authors.affiliation: Strategic Solutions, Inc, Cody, Wyoming.
authors.forename: Marissa J
authors.initials: MJ
authors.lastname: Carter
mesh_terms: D003695:Delivery of Health Care / Q000458:organization & administration*; D018795:Device Approval; D017277:Drug Approval; D023381:Endpoint Determination; D006801:Humans; D000071066:Patient Reported Outcome Measures; D000075082:Proof of Concept Study; D011785:Quality Assurance, Health Care / Q000458:organization & administration; D016032:Randomized Controlled Trials as Topic; D011795:Surveys and Questionnaires; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*; D058106:Wound Closure Techniques; D014945:Wound Healing; D014946:Wound Infection / Q000517:prevention & control*; D014947:Wounds and Injuries / Q000628:therapy*