BEST-VIVA Registry (vCLI)

项目总结/摘要 严重肢体缺血（CLI），腿部血流不足，特征为休息时腿部疼痛或组织损失， 影响大约200万美国人，其特征是心血管和肢体疾病的发生率增加， 并发症CLI的管理正在迅速发展，随着微创技术的出现， 恢复血液流动和伤口护理的进步。然而，关于最佳的 治疗正在进行的NIH资助的BEST-CLI旨在评估以下方法的比较有效性： 微创与完全手术恢复CLI的血流，然而，目前对 全国范围内的实践模式，结果，生活质量和CLI的医疗资源利用。此外，本发明还 BEST-CLI试验将招募可能不能完全代表“真实的世界”的选定患者群体 CLI患者。因此，我们与BEST-CLI研究者和BEST-CLI试验一起， 提出配套BEST-VIVA登记研究（vCLI），以研究以下目标：1）描述 基线人口统计学资料、合并症和治疗策略， BEST-CLI试验并纳入vCLI登记研究，重点关注护理变化2）描述临床 结局-特别是无严重不良肢体事件（男性）生存率、伤口愈合和严重不良 心血管事件（MACE）-按CLI患者的治疗策略列出，重点关注结局原因 治疗策略内的变化3）描述医疗保健相关的生活质量和医疗保健费用， vCLI登记研究中的治疗策略，重点关注生活质量和费用变化的原因。 方法：vCLI注册中心将由独特的公共/私营合作伙伴关系提供资金，由双方进行管理 vCLI主要研究者和BEST-CLI主要研究者。对于目标1，多水平多变量回归 将用于识别与以下变化相关的患者、医生/医院和地理因素： 治疗策略。对于目标2，肢体和心血管疾病的Kaplan Meier和累积发生率估计值 将根据治疗策略和其他关注的亚组对结局进行分层。糖尿病的影响， 将通过多变量建模量化CKD，并单独开发临床风险预测评分 每一种治疗策略。对于目标3，将分别描述生活质量、成本和成本效益 治疗策略和每种治疗策略中的变异来源将通过多变量 回归分析影响：补助金的结果将有助于阐明目前的做法和结果的照顾 的CLI。生成的关于患者人口统计学、临床结局变化和成本变化的数据 /成本效益将有助于1）确定未来医疗保健系统干预的目标，以改善 遵守指南推荐的护理和2）提供背景和概括性的结果， BEST-CLI试验和3）确定特定的医疗保健系统目标，以帮助加快BEST-CLI试验的采用 临床实践中的发现。

Project Summary / Abstract Critical limb ischemia (CLI), a lack of blood flow to the leg characterized by leg pain at rest or by tissue loss, affects approximately 2 million Americans and is characterized by increased rates of cardiovascular and limb complications. Management of CLI is rapidly evolving, with the advent of minimally invasive techniques to restore blood flow and advances in wound care. However, there is little consensus regarding optimal treatment. The ongoing NIH funded BEST-CLI is designed to assess the comparative effectiveness of minimally invasive versus full surgical restoration of blood flow in CLI, however, little is known about current nationwide practice patterns, outcomes, quality of life, and healthcare resource utilization in CLI. Additionally, the BEST-CLI trial will enroll a selected patient population that may not be fully representative of “real world” CLI patients. As a result, in conjunction with the BEST-CLI investigators and BEST-CLI Trial, we propose the companion BEST-VIVA registry (vCLI) to investigate the following aims: 1) Describe the baseline demographics, comorbidities, and treatment strategies of consecutive patients excluded from the BEST-CLI Trial and included in the vCLI registry, with a focus on variations in care 2) Describe the clinical outcomes – specifically major adverse limb events (MALE) free survival, wound healing, and major adverse cardiovascular events (MACE) - by treatment strategy in CLI patients, with a focus on causes of outcome variation within treatment strategy 3) Describe healthcare related quality of life and healthcare costs, by treatment strategy in the vCLI registry, with a focus on causes of variation in quality of life and costs. Methods: The vCLI registry will be funded by a unique public / private partnership with governance from both vCLI primary investigators and BEST-CLI primary investigators. For Aim 1, Multilevel multivariate regression will be used to identify patient, physician/hospital, and geographic factors associated with variations in treatment strategies. For Aim 2, Kaplan Meier and cumulative incidence estimates of limb and cardiovascular outcomes will be stratified by treatment strategy and other subgroups of interest. The impact of diabetes and CKD will be quantified by multivariable modeling and clinical risk prediction scores will be developed separately for each treatment strategy. For Aim 3, quality of life, costs, and cost effectiveness will be described for each treatment strategy and sources of variation within each treatment strategy will be identified via multivariable regression. Impact: The results of the grant will help to illuminate current practices and outcomes in the care of CLI. Data generated regarding patient demographics, variations in clinical outcomes, and variations in costs / cost effectiveness will serve to 1) identify targets for future healthcare systems interventions to improve adherence to guideline recommended care and 2) provide context and generalizability for the findings of the BEST-CLI Trial and 3) identify specific healthcare systems targets to help speed the adoption of BEST-CLI trial findings into clinical practice.