Research Department, Providence VA Medical Center, Providence, RI.
Health Services, Policy and Practice, Brown University, Health Services, Policy and Practice Brown University, Providence, RI.
PM R. 2019 Dec;11(12):1261-1271. doi: 10.1002/pmrj.12147. Epub 2019 May 29.
Osseointegrated (OI) prostheses have a unique benefit-risk profile among prosthetic alternatives and have been marketed in the United States under a Humanitarian Device Exemption since 2015. Information about upper limb prosthesis user perspectives on benefits and risks, prosthesis-user subpopulations for whom OI is most acceptable, and outcomes that matter most to patients could help inform clinical and regulatory decision-making. Recent 21st Century Cures legislation expanded the role of patient experience data in the decision-making process of the U.S. Food and Drug Administration, recognizing that patient perspectives may be informative to regulators.
To better understand prosthesis user perspectives about the benefits and risks associated with upper limb OI prostheses.
Patient perspective survey.
Telephone administration.
National sample of veterans with upper limb loss.
NA MAIN OUTCOME MEASURES: Benefit-risk survey developed for this study.
Twenty-eight percent of unilateral and 13% of bilateral amputees were willing to consider osseointegration surgery. Multivariate logistic regression models [OR; 95% CI] showed that transhumeral amputation level [OR 1.40; 1.01-1.98] was associated with greater willingness to consider surgery, whereas older age [OR 0.17; 0.09-0.32] and higher VR-12 Mental Component Summary [OR 0.53; 0.35-0.81] were associated with less willingness. Having a durable/reliable device, the ability to do more activities, and having a comfortable device were rated as very important or somewhat important by 98% or more for every risk condition.
Persons who were older, had transradial amputation (compared to transhumeral), and those who had better mental functioning were less willing to consider this surgery. Respondents who were willing to consider surgery indicated that the most important potential benefits were obtaining a durable/reliable device, the ability to do more activities, and having a comfortable device. Most were willing to accept one or more risks of surgery, with long-term risks including chronic pain, loss of nerve function, or device failure considered the most unacceptable.
III.
在假肢替代物中，骨整合（OI）假体具有独特的获益-风险特征，自 2015 年以来，根据《人道主义设备豁免》在美国上市。关于上肢假体使用者对获益和风险的看法、OI 最能被接受的假体使用者亚组，以及对患者最重要的结果的信息，可能有助于为临床和监管决策提供信息。最近的 21 世纪治愈法案扩大了患者体验数据在美国食品和药物管理局决策过程中的作用，认识到患者的观点可能对监管机构有帮助。
更好地了解上肢 OI 假体相关获益和风险的假体使用者观点。
患者观点调查。
电话管理。
上肢缺失的退伍军人的全国样本。
无
为本研究开发的获益-风险调查。
28%的单侧截肢者和 13%的双侧截肢者愿意考虑骨整合手术。多变量逻辑回归模型[OR；95%CI]显示，肱骨截肢水平[OR 1.40；1.01-1.98]与更大的手术意愿相关，而年龄较大[OR 0.17；0.09-0.32]和较高的 VR-12 心理成分综合评分[OR 0.53；0.35-0.81]与较小的手术意愿相关。98%或以上的受访者认为每一种风险情况都有耐用/可靠的设备、能够进行更多活动和拥有舒适的设备是非常重要或有些重要的。
年龄较大、接受桡骨截肢（而非肱骨截肢）和心理功能较好的人不太愿意考虑这种手术。愿意考虑手术的受访者表示，最有可能的潜在获益是获得耐用/可靠的设备、能够进行更多活动和拥有舒适的设备。大多数人愿意接受一种或多种手术风险，长期风险包括慢性疼痛、神经功能丧失或设备故障，被认为是最不可接受的。
III。
