In the field of rehabilitation following amputation, several guidelines, such as PI-COS[1] and COMPASS[2], have been published to evaluate functional outcomes. However, the importance of outcome measures may shift after the provision of a bone-anchored prosthesis (BAP), as this treatment might substantially influence function. With the increasing number of BAP treatment centers, standardizing care across institutions is becoming increasingly important for both quality control and facilitating comparisons and collaborations between centers (e.g., for multi-centered studies). Therefore, we seek to establish consensus within the BAP-treatment expert community to identify a streamlined yet meaningful core set of outcome measures for assessing functioning, disability, and health in lower-extremity BAP-users. The scope of this study does not include assessment of safety, such as adverse events, as this was recently explored[3]. This core set will formulate recommendations on relevant International Classification of Functioning (ICF) domains and the recommended outcome measures.
[1] Clarke, L., Ridgewell, E., & Dillon, M. P. (2024). Development of a Core Outcome Set for users and funders of lower-limb prosthetic interventions (PI-COS): a step to inform the benefits measured in prosthetic health economic evaluations. Disability and Rehabilitation, 46(19), 4407-4419.
[2] Tan, J. M., Halford, G. R., Lukin, M., & Kohler, F. (2023). Recommendations from the ISPO lower-limb COMPASS: Patient-reported and performance-based outcome measures. Prosthetics and Orthotics International, 47(1), 13-25.
[3] Ahmed, K., & Ortiz-Catalan, M. (2024). A Real Time Delphi Study on the Challenges and Adverse Events to Percutaneous Osseointegrated Implant Integration and Long-Term Fixation in Limb Amputation. Prosthesis, 6(5), 1262-1280.
Principal investigator: Ruud Leijendekkers and Vera Kooiman, Radboudumc Nijmegen the Netherlands.
Collaborators: Robin Atallah; Tim Crul; Niels Jonkergouw; Board of SIGBAL: Jan Paul Frölke, Jason Stoneback, Laurent Frossard, Mitch Grant; Mohamed Awad; Kirstin Ahmed.
Disease Category: Rehabilitation
Disease Name: Lower Limb Amputation
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Device, Rehabilitation, Surgery
- Clinical experts
- Consumers (patients)
- Device manufacturers
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Delphi process
- Literature review
We intend to conduct 3 rounds in this Delphi study. After each round, an analysis will determine whether consensus has been reached on the selected items. Items that do not reach consensus will be included in the subsequent round. In the second and third round, respondents will have access to their own score and the median score of the previous round. To inquire the level of importances of the different items, we will be using a 9-point Likert scale. The following criteria should be met to establish that consensus was met.
Consensus on inclusion in the core-set:
• 70% or more rates the item with a 7 or higher.
• 15% or less rates the item with a 3 or lower.
Additional criteria when establishing the consensus on inclusion of the outcome measures
• 50% or more should know or use the outcome measure.
Consensus on exclusion out of the core-set:
• 70% or more rates the item with a 3 or lower.
• 15% or less rates the item with a 7 or higher.
Initial criteria when establishing the consensus on exclusion of the outcome measures
• 70% or less does not know or use the outcome measure.
If this initial criteria is met on the assessment of outcome measures, consensus on exclusion is directly met for this item.
For adding domains or outcome measures proposed by the experts to the Delphi study, the following criteria should be met:
• 15% or more has to mention the proposed outcome measure.