Validation of patient reported outcomes for female Veterans with upper limb amputation

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Psychometrically sound methods of evaluating women's perspectives on upper limb prostheses are needed to inform device design, clinical decision-making, and research. The field lacks valid and responsive patient reported outcome measures (PROMS) that address prosthetic satisfaction, ability to use a prosthesis in everyday life, socket fit and residual limb health. Widely used, existing measures for amputees were developed for men, have never been examined in women, and/or not validated for upper limb prosthesis users. Without validation, clinicians, regulators, payers and researchers cannot select or utilize appropriate outcome metrics, and the needs and function of female Veterans with upper limb amputation cannot be evaluated carefully. The overall objective of this proposal is to develop and validate PROMS for persons with upper limb amputation, with measurement precision enhanced using Rasch-based scoring adjusted for sex, if needed. Specifically, we aim to: 1) Refine the Trinity Amputation and Prosthetic Experience Scale (TAPES) Satisfaction subscale and the Orthotics Prosthetics Users Survey (OPUS) Client Satisfaction with Device (CSD) scales to incorporate issues of concern to women, and then evaluate reliability, validity, and gender-based scoring; 2) Develop and evaluate reliability, validity, and gender-based scoring of a modified version of the OPUS Upper Extremity Functional Scale, the P-UEFS, which measures perceived difficulty in activity performance when using an upper limb prosthesis; 3) Assess the reliability, validity and gender based scoring of the Prosthetics Evaluation Questionnaire (PEQ) utility and residual limb health subscales; and 4) Use the new metrics to compare prosthetic satisfaction, self-reported activity performance, prosthetic utility and residual limb health of male and female Veterans by amputation level, and device type. This mixed methods study will use a qualitative approach for item generation, cognitive interviewing and pilot testing, and then a quantitative approach for measure evaluation and comparisons by sex. The sample will consist of participants who completed the baseline survey of our ongoing national studies of Veterans and service members with upper limb amputation (funded by the DoD and VA) who have agreed to be contacted for future activities. The cognitive interviewing sample will consist of 10 persons (5 men and 5 women); the pilot testing sample will consist of 10 persons( a man and a woman) from each of the following sub- categories: transradial amputation, transhumeral amputation, shoulder disarticulation/forequarter amputation, bilateral amputation, non-prosthesis users. Fifty randomly selected participants will participate in reliability testing, and 350 others will complete telephone interviews. Data from all 400 participants who complete telephone surveys will be used for calibration analyses. We will refine the measures based on cognitive and pilot testing. We will then estimate test-retest reliability of the refined measures, examine dimensionality and hierarchy of each measure and inspect items for potential differential item functioning by sex. We will examine concurrent, divergent and known group validity of each measure. Finally, we will use the measures to describe and compare outcomes of men and women Veterans by amputation level producing generalizable data on prosthetic care in the VA. This work will advance the field of outcome measurement for upper limb amputation, leading to improved evaluation of prostheses and better care for women with major upper limb amputation.