BEST-VIVA Registry (vCLI)

项目摘要/摘要 严重肢体缺血(CLI)，以休息时腿部疼痛或组织丢失为特征的腿部血流不足， 影响到大约200万美国人，其特点是心血管和肢体发病率增加 并发症。随着微创技术的出现，CLI的管理正在迅速发展 恢复血液流动和伤口护理的进步。然而，对于最优方案，人们几乎没有达成共识。 治疗。正在进行的NIH资助的BEST-CLI旨在评估 然而，CLI中微创与完全手术恢复血流的对比研究对电流知之甚少。 CLI中的全国性实践模式、结果、生活质量和医疗资源利用。另外， BEST-CLI试验将招募可能不能完全代表“真实世界”的选定患者群体 CLI患者。因此，结合BEST-CLI调查人员和BEST-CLI试验，我们 建议配套的BEST-VIVA注册中心(VCLI)调查以下目标：1)描述 被排除在外的连续患者的基线人口统计学、合并症和治疗策略 BEST-CLI试验，并包含在vCLI注册中，重点介绍护理变化2)描述临床 结果--特别是主要不良肢体事件(男性)无存活率、伤口愈合和主要不良反应 心血管事件(MACE)-CLI患者的治疗策略，重点是结果的原因 治疗策略中的差异3)描述与医疗保健相关的生活质量和医疗成本，通过 在vCLI注册表中的治疗策略，重点是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私合作伙伴关系提供资金，并由双方共同管理 VCLI主要调查员和BEST-CLI主要调查员。对于目标1，多水平多变量回归 将用于确定患者、医生/医院和与变化相关的地理因素 治疗策略。对于目标2，Kaplan Meier和肢体和心血管的累积发病率估计 结果将根据治疗策略和其他感兴趣的亚组进行分层。糖尿病的影响和 CKD将通过多变量建模进行量化，临床风险预测评分将单独制定 对于每种治疗策略。对于目标3，将描述每个目标的生活质量、成本和成本效益 将通过多变量确定治疗策略和每个治疗策略内的差异来源 回归。影响：赠款的结果将有助于阐明目前的护理做法和结果 CLI。生成的数据涉及患者的人口统计数据、临床结果的变化以及成本的变化 /成本效益将用于1)确定未来医疗系统干预措施改进的目标 遵守指南建议的护理和2)为以下结论提供背景和概括性 BEST-CLI试验和3)确定特定的医疗系统目标，以帮助加快采用BEST-CLI试验 将这些发现转化为临床实践。

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.