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

> **NIH VA I01** · PROVIDENCE VA  MEDICAL CENTER · 2021 · —

## Abstract

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-...

## Key facts

- **NIH application ID:** 10326332
- **Project number:** 5I01RX002936-04
- **Recipient organization:** PROVIDENCE VA  MEDICAL CENTER
- **Principal Investigator:** LINDA J. RESNIK
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2021
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2018-10-01 → 2023-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10326332

## Citation

> US National Institutes of Health, RePORTER application 10326332, Validation of patient reported outcomes for female Veterans with upper limb amputation (5I01RX002936-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10326332. Licensed CC0.

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