Evaluation of clinical trajectories and identification of modifiable risk factors to improve secondary prevention of amputation in Veterans with diabetes following an initial toe amputation.

脚趾截肢通常被天真地认为是一种无关紧要的外科手术，几乎没有功能 冲击力。取而代之的是，脚趾截肢通常是渐进性功能丧失和 生活质量。每三个因慢性病接受脚趾截肢手术的人中就有一个无法治愈截肢 需要额外的截肢手术，每五个人中就有一个在下一年死亡。 愈合不充分可能与对并存疾病(例如，糖尿病， 外周血管疾病、抑郁和/或创伤后应激障碍)。社会支持有限的退伍军人可能会进一步 自我管理疾病和从事治疗以促进治愈和预防的能力有限 额外的截肢。经历战争的退伍军人 重复截肢失去了正常的生命年数 住院，从手术中恢复，再住院并接受额外的手术。 这项为期3年的研究有三个主要目标：1)描述截肢轨迹并评估 根据以下数据，初次截趾后一年内的后续截肢和死亡总体趋势 人口统计特征、选定的临床因素(例如，血管状况)和地理位置(例如， 退伍军人综合服务网络[VISN])，2)评估可更改的风险因素之间的关联 和1年后截肢或死亡的风险，同时控制令人困惑的重要风险因素 这些联系，以及3)获得与二级预防有关的知识、态度和行为 在接受了脚趾截肢手术的患者和提供脚趾截肢手术的患者之间使用半结构化访谈 护理这些患者，以制定未来的干预措施，改善这些患者的预后。我们会 通过使用新构建的VHA截肢者注册表/存储库实现这些目标，该注册表/存储库与 相关退伍军人事务部电子病历数据，以及对提供者和患者的深入访谈。我们的建议 研究-一项包括所有VHA患者(约16,000-19,000名)的回溯性队列研究 在2005财年至2016财年间进行的脚趾截肢--将是迄今为止进行的最大规模的研究，全国范围内 范围，并将用非结构化数据补充结构化数据，以确定不仅 截肢还有其他相关的患者特征。就目标1而言， 临床结果如下：在1个月、6个月和12个月内再次截肢； 随后的截肢；12个月时的最后一次截肢；以及死亡。在评估了原油价格后， 识别和检查离群值，我们将通过将年份作为预测值来正式测试时间趋势 Logistic回归模型中的变量，考虑使用分段回归以允许多个斜率 (非线性趋势)。将构建类似的模型来测试VISN之间的差异。关键的可修改风险 目标2的因素包括行为因素(如吸烟、酗酒)、血管重建术和 类型(无、血管内和开放)，以及治疗心理健康状况(例如，抑郁症)的充分性 和创伤后应激障碍)。对于目标3，我们将对提供者和患者进行深入访谈 有或没有接受过后续截肢手术，以深入了解患者和系统级别 成功治愈的障碍、政策或其他可以改善对经历了 脚趾截肢，以及患者和提供者对他们认为可以改善患者状况的因素的看法 结果。通过对时间和地理变化进行详细评估，确定 可修改的风险因素，以及与患者和提供者的访谈，我们将了解系统级别和 个体水平的结果差异。 我们的研究将为重新定位Pave计划以纳入脚趾/部分脚奠定基础 截肢是退伍军人事务部几十年来一直成功的政策和计划。

Toe amputations are often naively viewed as an inconsequential surgical procedure with little functional impact. Instead, a toe amputation is often the inciting event in a cascade of progressive loss of function and quality of life. One in three people undergoing toe amputations due to chronic illness fail to heal the amputation in a timely manner, requiring additional amputation surgery(ies) and one in five die in the following year. Inadequate healing may be related to suboptimal management of comorbid conditions (e.g., diabetes, peripheral vascular disease, depression and/or PTSD). Veterans with limited social support may be further limited in their ability to self-manage their illness and engage in treatment to facilitate healing and prevent additional amputation. Veterans who undergo r epeated amputations lose functional life years as they are hospitalized, recover from surgery, are re-hospitalized and undergo additional surgeries. This 3-year study has three primary aims: 1) to characterize amputation trajectories and evaluate trends in subsequent amputation and death in the year after initial toe amputation overall, based on demographic characteristics, selected clinical factors (e.g., vascular status), and geographic location (e.g., Veterans Integrated Service Networks [VISN]), 2) to evaluate the associations between modifiable risk factors and 1-year risk of subsequent amputation or death while controlling for important risk factors that confound these associations, and 3) to acquire knowledge, attitudes, and behaviors related to secondary prevention using semi-structured interviews among patients who have undergone a toe amputation and providers who care for these patients to develop future interventions that improve outcomes in these patients. We will accomplish these goals by using the newly constructed VHA Amputee Registry/Repository, merged with relevant VA electronic medical record data, and in-depth interviews with providers and patients. Our proposed research – a retrospective cohort study including all VHA patients (~16,000-19,000) with diabetes with a first ever toe amputation between FY 2005 and 2016 -- will be the largest study conducted to date, national in scope, and will supplement structured data with unstructured data to ascertain key information about not only the amputation but also other relevant patient characteristics. For Aim 1, frequencies and percentages of the following clinical outcomes will be obtained: subsequent amputation within 1-, 6-, and 12-months; counts of subsequent amputations; the final level of amputation at 12 months; and death. After evaluating crude rates, identifying and inspecting outliers, we will formally test for trends across time by including year as a predictor variable in logistic regression models, considering the use of piece-wise regression to allow for multiple slopes (non-linear trends). Similar models will be constructed to test for variation across VISN. Key modifiable risk factors for Aim 2 include behavioral factors (e.g., smoking, alcohol misuse), revascularization procedure and type (none, endovascular, and open), and adequacy of treatment mental health conditions (e.g., depression and post-traumatic stress disorder). For Aim 3, we will conduct in-depth interviews with providers and patients who have and have not undergone a subsequent amputation, to gain insight into patient and system-level barriers to successful healing, policies or other activities that could improve care for patients who undergo a toe amputation, and patient and provider perspectives on factors that they think would lead to improved patient outcomes. By conducting a detailed evaluation of temporal and geographic variation, identification of modifiable risk factors, and interviews with patients and providers, we will understand system-level and individual-level variation in outcomes. Our study will lay the groundwork to re-position the PAVE program to incorporate toe/partial foot amputations into what has been a successful policy and program in the VA for decades.