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

PurposeLittle is known about the outcomes that are most important to prosthesis users and funders. A Prosthetic Interventions Core Outcome Set (PI-COS) will help researchers and practitioners measure outcomes that are the most important to prosthesis users and funders.Materials and methodsProsthesis users and funders rated the importance of 121 International Classification of Functioning, Disability, and Health (ICF) second-level categories using a two-round Delphi survey. A Consensus Meeting using the nominal group technique resolved rating differences between groups. The ICF second-level categories were ranked according to importance and a K-Means Cluster Analysis helped establish the PI-COS.Results65 users and 8 funders completed the Delphi surveys, followed by a Consensus Meeting. 26 ICF second-level categories were considered important to prosthesis users and funders and a PI-COS of 14 ICF second-level categories drawn predominantly from five ICF chapters was established: Sensory Functions and Pain (b2), Neuromusculoskeletal and Movement-related Functions (b7), General Tasks and Demands (d2), Mobility (d4), and Products and Technology (e1).ConclusionsThe PI-COS describes the outcomes that are most important to prosthesis users and funders. The PI-COS can help focus on the most important outcome measures in clinical practice and research, including future prosthetic health economic evaluations.