Wound Healing Society

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Results Of The ‘Opinion Survey From People With Wounds'
Lisa Gould1, Vickie Driver2, Jing Liu3, Peggy Dotson4.
1South Shore Health Center for Wound Healing, Weymouth, MA, USA, 2Novartis Institute for Biomedical Research, Cambridge, MA, USA, 3Northwestern University Feinberg School of Medicine, Chicago, IL, USA, 4Health Care Reimbursement Strategy, Wilmington, NC, USA.

BACKGROUND The 2006 FDA ‘Guidance for Industry Chronic Cutaneous Wounds and Burns - Developing Products for Treatment’ emphasizes wound closure as the primary outcome for clinical trials. Wound-care professionals understand that complete wound healing is not always appropriate or achievable when evaluating new, innovative treatments. AAWC and WHS are working collaboratively with FDA to identify scientifically achievable, clinically relevant, patient-centered endpoints with sufficient support to serve as primary outcomes for clinical trials. The recently published survey of 628 wound-care professionals identified and content-validated 15 potential primary endpoints. The ‘Opinion Survey from People with Wounds’ addresses an important gap: the correlation between clinicians’ perception and the patient perspective regarding clinically meaningful endpoints for wound care.METHODS The survey, adapted from the clinician survey with adjustment for health literacy, was pilot tested and revised based on a limited number of patients in a single clinic. After central IRB approval, the on-line survey was administered in English and Spanish and submitted anonymously to a secure server with cooperation of multiple wound clinics and societies.RESULTS 451 patients and caregivers from across the US responded over a 10-month period. The most valuable clinical endpoints were reduced infection, recurrence, and amputation. The most valuable quality of life outcomes were increased independence, reduced social isolation and pain. The top five endpoints in terms of usefulness for measuring clinical trial success were faster healing, reduced size, infection, recurrence and pain. Free-text responses emphasized inability to perform activities of daily living and pain as major factors that impact the daily lives of patients with wounds.CONCLUSIONS Engagement of patients in clinical trials and evaluating future treatments is critical to the success of wound care. This survey provides insight into the needs of wound-care patients and how to structure future clinical trials to better meet those needs and improve patient care.


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