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 需要为设备设计、临床决策和研究提供信息。该字段缺少有效的和 响应性患者报告结果测量(PROMS)解决假体满意度、能力 为了在日常生活中使用假体，使关节窝合适性和残肢健康。广泛使用，现有 为截肢者制定的措施是为男性制定的，从未在女性身上进行过审查，和/或没有 为上肢假肢使用者验证。未经验证，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衡量标准，以及 女性退伍军人上肢截肢不能仔细评估。总的目标是 这项建议是为上肢截肢者开发和验证PROMS， 如果需要，使用基于Rasch的评分根据性别进行调整，提高了测量精度。 具体地说，我们的目标是：1)完善三位一体截肢和假肢体验量表(磁带) 满意度子量表和矫形假体用户调查(OPUS)患者对 设备(CSD)量表，以纳入女性关心的问题，然后评估可靠性、有效性、 和基于性别的评分；2)开发和评估 OPUS上肢功能量表的修订版，P-UEFS，它测量 使用上肢假体时感觉到的活动表现困难；3)评估 假体评估问卷(PEQ)的信度、效度和基于性别的评分 和残肢健康子量表；以及4)使用新的量度来比较假体满意度， 男性和女性的自述活动能力、假体效用和残肢健康 按截肢级别和器械类型分类的退伍军人。这项混合方法研究将使用定性的 项目生成、认知访谈和先导测试的方法，然后是量化 按性别进行测量评估和比较的方法。样本将由参与者组成 世卫组织完成了我们正在进行的关于退伍军人和军人的国家研究的基线调查 接受上肢截肢(由国防部和退伍军人管理局资助)的人，他们同意在未来联系 活动。认知访谈样本将由10人(5男5女)组成；飞行员 测试样本将由10人(一男一女)组成，分别来自以下小组- 类别：经桡骨截肢、经胸截肢、肩关节脱位/前臂截肢 截肢、双侧截肢、非假肢使用者。随机挑选的50名参与者将 参加可靠性测试，其他350人将完成电话面试。全部400个数据 完成电话调查的参与者将被用于校准分析。我们将完善 基于认知测试和试点测试的措施。然后，我们将评估重测的可靠性 细化措施，检查每个措施的维度和层次，检查项目 潜在的性别差异项目功能。我们将考察并发群、发散群和已知群 每项措施的有效性。最后，我们将使用这些衡量标准来描述和比较 按截肢水平划分的男性和女性退伍军人在假肢护理方面产生的可推广数据 弗吉尼亚州这项工作将推动上肢截肢结果测量领域的发展，导致 改进了对假体的评估，并更好地护理了患有严重上肢截肢的妇女。

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.