Ikeda Andrea J, Fergason John R, Wilken Jason M
Center for the Intrepid, Department of Rehabilitation Medicine, Brooke Army Medical Center, 3551 Roger Brooke Drive, JBSA Fort Sam Houston, TX.
Extremity Trauma and Amputation Center of Excellence, 2748 Worth Road, Suite 29, JBSA Fort Sam Houston, TX.
Mil Med. 2019 Dec 1;184(11-12):601-605. doi: 10.1093/milmed/usz004.
Severe lower limb injuries have a negative impact on many aspects of an individual's life. One rehabilitative option for patients who have undergone limb salvage is the Intrepid Dynamic Exoskeletal Orthosis (IDEO). The IDEO is a custom-made dynamic response device which is used to restore function for patients with a wide variety of injuries. Clinical outcomes were routinely collected on patients fit with IDEOs at the Center for the Intrepid, Brooke Army Medical Center. The purpose of this retrospective study was to analyze the clinical outcomes collection process and the patient outcomes collected as part of routine clinical care.
The Brooke Army Medical Center IRB approved this study and granted waivers of informed consent and HIPAA authorization. Electronic medical records were reviewed over an 18-month period from July 2014 to January 2016. Records were examined to obtain the date of IDEO delivery, date of outcomes form completion, responses on the forms, and to verify diagnosis or injury. Data gathered included wear time, IDEO comfort, pain with and without the IDEO, Lower Extremity Functional Scale scores with and without the IDEO, and global rating of change questions for everyday activities and high impact activities. Wilcoxon signed-ranked tests were used to compare pain and function with vs. without the IDEO.
During the 18-month period, new IDEOs were delivered to 156 unique patients. Outcomes forms were collected as part of routine clinical care from 90 of these 156 patients (58%). An additional nine forms were collected from patients who received their IDEOs prior to July 2014. In all, 99 outcomes forms were collected. Mean follow-up time from IDEO delivery to outcomes form completion was 35 ± 31 days for the original 90 patients. The most common patient diagnoses were fracture, nerve injury, arthritis, and fusion. Responses on the forms indicated that patients were generally comfortable wearing their IDEOs (8.3 ± 1.3 on a 0-10 scale) and wore them most of the day (10.7 ± 3.4 hours per day). Improvement in pain (from 5.2 ± 2.9 to 1.7 ± 1.6 points on a 0-10 scale) and Lower Extremity Functional Scale scores (from 29.7 ± 16.6 to 59.5 ± 13.6 points) with the IDEO were both more than the minimal clinically important difference and were statistically significant (p < 0.001).
This descriptive retrospective study demonstrated that it was feasible to collect clinical outcomes data which were relevant for characterizing the effects of IDEO use and enabled quantification of improvements in self-reported function and walking pain with the IDEO. Due to the retrospective nature of this study, limitations include missing data and the lack of any performance measures to complement the self-reported data. Clinical outcomes collection continues as a routine part of clinical care and there remains an ongoing aim to collect information on all patients to obtain an accurate assessment of devices and services and ultimately better serve our patients.
严重的下肢损伤会对个人生活的许多方面产生负面影响。对于接受保肢手术的患者，一种康复选择是无畏动态外骨骼矫形器（IDEO）。IDEO是一种定制的动态响应装置，用于为各种损伤的患者恢复功能。布鲁克陆军医疗中心无畏中心会定期收集使用IDEO患者的临床结果。这项回顾性研究的目的是分析临床结果收集过程以及作为常规临床护理一部分收集的患者结果。
布鲁克陆军医疗中心机构审查委员会批准了本研究，并豁免了知情同意和《健康保险流通与责任法案》授权。回顾了2014年7月至2016年1月这18个月期间的电子病历。检查记录以获取IDEO交付日期、结果表单完成日期、表单上的回答，并核实诊断或损伤情况。收集的数据包括佩戴时间、IDEO舒适度、佩戴和不佩戴IDEO时的疼痛情况、佩戴和不佩戴IDEO时的下肢功能量表评分，以及日常活动和高强度活动的总体变化评分问题。使用Wilcoxon符号秩检验来比较佩戴和不佩戴IDEO时的疼痛和功能情况。
在这18个月期间，共向156名不同患者交付了新的IDEO。作为常规临床护理的一部分，从这156名患者中的90名（58%）收集了结果表单。另外从2014年7月之前接受IDEO的患者那里收集了9份表单。总共收集了99份结果表单。对于最初的90名患者，从IDEO交付到结果表单完成的平均随访时间为35±31天。最常见的患者诊断为骨折、神经损伤、关节炎和融合。表单上的回答表明患者佩戴IDEO时总体感觉舒适（0至10分制下为8.3±1.3分），并且一天中大部分时间都佩戴（每天10.7±3.4小时）。佩戴IDEO时疼痛改善（从0至10分制下的5.2±2.9分降至1.7±1.6分）和下肢功能量表评分改善（从29.7±16.6分升至59.5±13.6分）均超过最小临床重要差异，且具有统计学意义（p<0.001）。
这项描述性回顾性研究表明，收集与表征IDEO使用效果相关的临床结果数据是可行的，并且能够量化自我报告的功能改善以及佩戴IDEO时行走疼痛的改善情况。由于本研究的回顾性性质，局限性包括数据缺失以及缺乏补充自我报告数据的任何性能指标。临床结果收集作为临床护理的常规部分仍在继续，并且一直有一个目标，即收集所有患者的信息，以准确评估设备和服务，并最终更好地为我们的患者服务。
