Identifying and prioritizing concerns associated with prosthetic devices for use in a benefit-risk assessment

a mixed-methods approach

Ellen M. Janssen, Heather L. Benz, Jui Hua Tsai, John F.P. Bridges

Research output: Contribution to journalArticle

Abstract

Objective: We identified and prioritized concerns reported by stakeholders associated with novel upper-limb prostheses. Methods: An evidence review and key-informant engagement, identified 62 concerns with upper-limb prostheses with implantable components. We selected 16 concerns for inclusion in a best-worst scaling (BWS) prioritization survey. Focus groups and BWS were used to engage stakeholders at a public meeting on prostheses. In 16 BWS choice tasks, attendees selected the most and least influential concern when choosing an upper-limb prosthesis. Aggregate data were analyzed using choice frequencies and conditional logit analysis. Latent class analysis examined heterogeneity in priorities. Estimates were adjusted to importance ratios which indicate how influential each concern is in the decision making process. Results: Forty-seven (47) stakeholders from diverse backgrounds completed the BWS survey (response rate 51%). On aggregate, the most influential concern was reliability of the device (importance ratio: 13%), and least influential was the concern of an outdated device (importance ratio: 1%). Latent class analysis identified two classes with approximately 50% of participants each. The first class was most influenced by effectiveness of the device. The second class was most influenced by minimizing risks. Conclusion: In this pilot, we identified heterogeneity in how participants prioritize concerns for upper-limb prostheses.

Original languageEnglish (US)
Pages (from-to)385-398
Number of pages14
JournalExpert Review of Medical Devices
Volume15
Issue number5
DOIs
StatePublished - May 4 2018

Fingerprint

Artificial Limbs
Prosthetics
Upper Extremity
Risk assessment
Equipment and Supplies
Focus Groups
Prostheses and Implants
Decision Making
Decision making

Keywords

  • best-worst scaling
  • prioritization
  • Stated-preference methods
  • survey development
  • upper-limb prostheses

ASJC Scopus subject areas

  • Surgery
  • Biomedical Engineering

Cite this

Identifying and prioritizing concerns associated with prosthetic devices for use in a benefit-risk assessment : a mixed-methods approach. / Janssen, Ellen M.; Benz, Heather L.; Tsai, Jui Hua; Bridges, John F.P.

In: Expert Review of Medical Devices, Vol. 15, No. 5, 04.05.2018, p. 385-398.

Research output: Contribution to journalArticle

Janssen, Ellen M. ; Benz, Heather L. ; Tsai, Jui Hua ; Bridges, John F.P. / Identifying and prioritizing concerns associated with prosthetic devices for use in a benefit-risk assessment : a mixed-methods approach. In: Expert Review of Medical Devices. 2018 ; Vol. 15, No. 5. pp. 385-398.
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