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Preferences for Attachment Devices for Individuals with Lower-Limb Loss: A Discrete-Choice Study to Inform Regulatory

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Patients with lower-limb loss prioritize osseointegration benefits like pain reduction over risks. They are willing to trade risks for benefits, guiding prosthetic decisions and reducing abandonment.

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Area of Science:

  • Biomedical Engineering
  • Rehabilitation Medicine
  • Prosthetics and Orthotics

Background:

  • Patient perspectives are increasingly vital in medical device regulatory decisions.
  • The Food and Drug Administration's Patient Preference Initiative incorporates patient input.
  • Osseointegration offers potential benefits for individuals with lower-limb loss.

Purpose of the Study:

  • To evaluate patient preferences for risks and benefits associated with osseointegration.
  • To inform regulatory decision-making for medical devices.
  • To improve shared decision-making processes for prosthetic use.

Main Methods:

  • Choice-based conjoint (CBC) procedures and discrete-choice experiments were employed.
  • A study involved 188 adults with lower-limb loss.
  • Analysis utilized random parameters logit and latent class analysis.

Main Results:

  • Patients prioritized avoiding complications such as infection and device failure.
  • Eliminating daily pain was a highly preferred benefit.
  • Individuals demonstrated a willingness to accept certain risks for osseointegration benefits.

Conclusions:

  • Patient preferences highlight the importance of minimizing risks and maximizing benefits in osseointegration.
  • Risk-benefit tradeoffs are acceptable to patients at current risk levels.
  • Findings can guide regulatory policies and shared decision-making to reduce prosthetic abandonment.