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

评估女性对上肢假肢的看法的心理测量学方法是 需要为器械设计、临床决策和研究提供信息。该字段缺少有效和 反应性患者报告结局指标（PROMS），解决假体满意度、能力 在日常生活中使用假肢、接受腔配合和残肢健康。广泛使用的，现有的 针对截肢者的措施是为男性制定的，从未在女性中进行过检查，和/或 为上肢假肢用户验证。如果没有验证，临床医生，监管机构，付款人和 研究人员无法选择或利用适当的结果指标， 上肢截肢的女性退伍军人不能仔细评估。的总体目标 该提案旨在为上肢截肢者开发和验证PROMS， 如果需要，使用针对性别调整的基于Rasch的评分来提高测量精度。 具体来说，我们的目标是：1）完善Trinity截肢和假体经验量表（TAPES） 满意度分量表和矫形假体使用者调查（OPUS） 器械（CSD）量表纳入女性关注的问题，然后评估可靠性、有效性， 和基于性别的评分; 2）制定并评估a的可靠性、有效性和基于性别的评分 OPUS上肢功能量表（P-UEFS）的修改版本，该量表测量 当使用上肢假肢时，活动表现的感知困难; 3）评估 假体评估问卷（PEQ）效用的信度、效度和基于性别的评分 和残肢健康分量表;和4）使用新的指标来比较假肢满意度， 男性和女性的自我报告活动能力、假肢效用和残肢健康 按截肢水平和器械类型划分的退伍军人。这种混合方法研究将使用定性 方法的项目生成，认知访谈和试点测试，然后定量 按性别进行措施评价和比较的方法。样本将由参与者组成 他们完成了我们正在进行的退伍军人和服务人员的国家研究的基线调查 上肢截肢（由国防部和退伍军人事务部资助），他们同意在未来联系 活动认知访谈样本将由10人组成（5男5女）; 测试样本将由以下小组各10人（一男一女）组成： 类别：经桡动脉截肢术、经肱骨截肢术、肩关节离断术/前半部分 截肢、双侧截肢、非假肢使用者。50名随机挑选的参与者将 参加可靠性测试，另外350人将完成电话采访。数据来自所有400 完成电话调查的参与者将用于校准分析。我们将完善 基于认知和试点测试的措施。然后，我们将估计重测信度的 细化度量，检查每个度量的维度和层次结构，并检查 按性别分类的潜在差异项目功能。我们将研究并发、发散和已知群 每项措施的有效性。最后，我们将使用这些指标来描述和比较 按截肢程度分列的男女退伍军人， 弗吉尼亚这项工作将推进上肢截肢的结果测量领域， 改善对假肢的评估，并为上肢大截肢的妇女提供更好的护理。

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.