IDENTIFYING THE BENEFITS AND RISKS OF EMERGING INTEGRATION METHODS FOR UPPER LIMB PROSTHETIC DEVICES- AN ENVIRONMENTAL SCAN

Author(s)

Kelley M1, Benz H2, Engdahl S3, Bridges JFP4
1Johns Hopkins Bloomberg School of Public Health, Santa Monica, CA, USA, 2US Food and Drug Administration, Silver Spring, MD, USA, 3University of Michigan, Ann Arbor, MI, USA, 4Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

Presentation Documents

OBJECTIVES: Upper limb loss greatly impacts one’s productivity and quality of life. Despite a wealth of prosthetic device options, high user dissatisfaction and rejection rates persist. Novel connective and control methods between a device and end-user have large potential rewards and risks, making economic evaluation difficult. We sought to identify the benefits and harms of emerging and existing integration technologies in upper limb prosthetic devices. Such information can inform future economic evaluation, including the development of a stated-preference instrument to understand why devices are acceptable to end users.

METHODS: An environmental scan was done to assess user perspectives on advancements in upper-limb prosthetic device integration. The environmental scan consisted of a PubMed keyword literature search, grey literature review, formation of a community advisory board (CAB), and key informant interviews with CAB members. The CAB guided this study and was comprised of adults with personal or professional experiences with upper limb prostheses. RESULTS: The environmental scan highlights 4 main types of integration in upper limb prosthetic devices: osseointegration, targeted muscle reinnervation, cortical integration, and peripheral nerve or muscle integration. The PubMed literature search resulted in the most matches for “targeted muscle reinnervation upper limb” (65 matches) and “upper limb osseointegration” (54 matches). The grey literature review found targeted muscle reinnervation and peripheral nerve integration to be most discussed amongst end-users and regulators. Of these four emerging methods, greater device control versus invasiveness of implant is a clear benefit-risk tradeoff.

CONCLUSIONS: This scan provides a cohesive summary of osseointegration, targeted muscle reinnervation, cortical integration, and peripheral nerve and muscle integration. It highlights the gap in user-centered research in upper limb prosthetic devices. Future directions include the development of a stated-preference instrument incorporating these methods of integration.

Conference/Value in Health Info

2019-05, ISPOR 2019, New Orleans, LA, USA

Value in Health, Volume 22, Issue S1 (2019 May)

Code

PMD42

Topic

Medical Technologies, Patient-Centered Research

Topic Subcategory

Medical Devices, Patient Engagement, Stated Preference & Patient Satisfaction

Disease

Injury and Trauma, Medical Devices

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