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.

脚趾截肢往往被天真地视为一个无关紧要的外科手术， 冲击相反，脚趾截肢往往是一系列进行性功能丧失的诱因， 生活质量三分之一因慢性病接受脚趾截肢的人无法治愈截肢 需要额外的截肢手术，五分之一的人在第二年死亡。 愈合不充分可能与共病状况的次优管理有关（例如，糖尿病、 外周血管疾病、抑郁症和/或PTSD）。社会支持有限的退伍军人可能会进一步 自我管理疾病和参与治疗以促进治愈和预防的能力有限 额外截肢。经历过r的退伍军人 重复截肢失去功能寿命年， 住院、手术后恢复、再次住院和接受额外手术。 这项为期3年的研究有三个主要目的：1）描述截肢轨迹并评估 在初次脚趾截肢后的一年中，随后截肢和死亡的趋势， 人口统计学特征，选定的临床因素（例如，血管状态），和地理位置（例如， 退伍军人综合服务网络[VISN]），2）评估可改变的风险因素之间的关联 和随后截肢或死亡的1年风险，同时控制重要的风险因素， 3）获得与二级预防相关的知识、态度和行为 使用半结构化的访谈，在接受过脚趾截肢的患者和 护理这些患者，以制定未来的干预措施，改善这些患者的结局。我们将 通过使用新构建的VHA截肢者登记/存储库来实现这些目标， 相关的VA电子病历数据，并与供应商和患者进行深入访谈。我们提出的 研究-一项回顾性队列研究，包括所有VHA糖尿病患者（约16，000 - 19，000），首次 在2005年至2016年财政年度期间进行的脚趾截肢手术-将是迄今为止进行的最大规模的研究， 范围，并将补充结构化数据与非结构化数据，以确定关键信息，不仅 截肢以及其他相关的患者特征。对于目标1， 将获得以下临床结局：1个月、6个月和12个月内的后续截肢; 随后截肢; 12个月时截肢的最终水平;以及死亡。在评估原油价格后， 识别和检查异常值，我们将通过将年份作为预测因子来正式测试跨时间的趋势 逻辑回归模型中的变量，考虑使用分段回归以允许多个斜率 （非线性趋势）。将构建类似模型，以检验VISN之间的变异性。关键可变更风险 目标2的因素包括行为因素（例如，吸烟、酒精滥用）、血运重建手术和 类型（无、血管内和开放），以及治疗精神健康状况的充分性（例如，抑郁 和创伤后应激障碍）。对于目标3，我们将与提供者和患者进行深入访谈 已经和没有经历后续截肢的患者，以深入了解患者和系统水平 成功治愈的障碍，政策或其他活动，可以改善对接受治疗的患者的护理， 脚趾截肢，以及患者和提供者对他们认为会导致患者改善的因素的看法 结果。通过对时间和地理变化进行详细评估， 可修改的风险因素，并与患者和供应商进行访谈，我们将了解系统级和 结果的个体差异。 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 几十年来，截肢一直是退伍军人事务部成功的政策和计划。

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.