Development and alpha testing of a patient shared decision aid for prosthesis design for new lower limb prosthesis users.

Background: After lower limb amputation, several prosthesis design options exist. However, prosthesis design decisions do not always reflect a prosthesis user's needs, values, and preferences.

Objective: To develop a patient decision aid (PDA) prototype for prosthetists and new prosthesis users facing prosthesis design decisions after lower limb amputation, and to assess its usability, accuracy, and comprehensibility.

Study design: Exploratory mixed methods.

Methods: PDA development was informed by a qualitative needs assessment and guided by the International Patient Decision Aid Standards. The PDA was evaluated by steering groups of experienced prosthesis users and prosthetic professionals (prosthetists and researchers) to test usability, accuracy, and comprehensibility through focus groups, individual interviews, and rating on a Likert scale ranging from 1 to 10.

Results: The resulting PDA included 6 sections: (1) Amputation and Early Recovery, (2) Communication, (3) Values, (4) Prosthesis Design, (5) Preferences, and (6) Prosthetic Journey. Usability, accuracy, and comprehensibility were rated as 9.2, 9.6, and 9.6, respectively, by prosthetic professionals, and 9.4, 9.6, and 9.6, respectively, by prosthesis users.

Discussion: The PDA incorporated guidance by relevant stakeholders and was rated favorably, emphasizing a need for shared decision-making support in prosthesis design. One challenge was determining the amount of information in the PDA, highlighting the diversity in end users' informational needs. Future iterations of the PDA should undergo beta testing in clinical settings.

Conclusions: A standardized, iterative method was used to develop a PDA for new lower limb prosthesis users and prosthetists when considering prosthesis design decisions. The PDA was considered useable, accurate, and comprehensible.