Measuring satisfaction with orthotic and prosthetic devices.

PURPOSE: To develop a measure of satisfaction with orthoses and prostheses for the Limb Injury Measurement Battery for Quality of Life (LIMB-QOL). METHODS: Items were developed to assess an individual's satisfaction with, and emotional and physical assimilation of, an orthosis and/or prosthesis. Items covered topics of satisfaction with device performance and aesthetics as well as user adaptation to a device, including usage, fit, and comfort. A pool of 65 items was administered to 471 individuals in the LIMB-QOL field testing/calibration study. Item response theory was used to evaluate and calibrate the new items. Test-retest reliability after 1-2 weeks was evaluated in a subsample. RESULTS: From the original pool, 39 items were removed for content and 11 items were removed due to differential item functioning by type of injury/limb loss and device (orthosis vs. prosthesis). Following psychometric analysis, 15 items were calibrated as an item bank. These items exhibited acceptable internal consistency (α = 0.95) and fit to a unidimensional model. The final 15-item bank has strong psychometric properties (test-retest reliability α = 0.79), can be administered as a computerized adaptive test or 7-item short form, and is applicable to upper and lower injuries, limb loss and reconstruction, and orthotic and prosthetic device users. CONCLUSION: The LIMB-QOL Satisfaction with Orthosis/Prosthesis is a reliable measure, with evidence for validity in individuals with a variety of limb-affecting injuries and sudden-onset illnesses, and thus can be used broadly following major extremity trauma, and would be ideal for large-scale monitoring of QOL outcomes, although further evaluation of the validity for individuals with dysvascular or degenerative conditions is needed.