BEST-VIVA Registry (vCLI)

BEST-VIVA 注册表 (vCLI)

• 批准号: 9913570
• 负责人: Manesh R Patel
• 金额: $ 77.04万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-15 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9913570
• 关键词: Adherence; Adoption; Affect; American; American Heart Association; Anatomy; Ankle; Blood Vessels; Blood flow; Cardiac; Cardiovascular Diseases; Cardiovascular system; Caring; Chronic Kidney Failure; Clinical; Companions; Comparative Effectiveness Research; Consensus; Critical Care; Data; Devices; Diabetes Mellitus; Diabetic Microangiopathies; Disease; Disease-Free Survival; Enrollment; Event; Funding; Future; Gender; Geographic Factor; Geography; Grant; Guidelines; Health Care Costs; Health Status; Healthcare; Healthcare Systems; Heart; Hospitals; Hyperlipidemia; Hypertension; Image; Incidence; Institute of Medicine (U.S.); Intervention; Kidney; Knee; Leg; Lesion; Limb structure; Location; Lower Extremity; Lung; Medicine; Methods; Modeling; National Heart, Lung, and Blood Institute; Necrosis; Observational Study; Operative Surgical Procedures; Outcome; Pain in lower limb; Patient Care; Patient Outcomes Assessments; Patients; Pattern; Peripheral arterial disease; Pharmaceutical Preparations; Physicians; Prevalence; Procedures; Quality of life; Registries; Reporting; Research Personnel; Resources; Rest; Risk; Site; Source; Specialist; Speed; Subgroup; Surgeon; Survival Rate; Techniques; Tissues; Treatment Cost; Treatment outcome; Ulcer; United States; United States National Institutes of Health; Variant; Woman; Work; base; clinical practice; clinical risk; comorbidity; comparative effectiveness; cost; cost effectiveness; critical limb Ischemia; demographics; design; foot; health care quality; improved; interest; limb amputation; minimally invasive; mortality; optimal treatments; patient population; patient subsets; population based; public-private partnership; radiologist; restoration; treatment strategy; working group; wound care; wound healing

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.

项目摘要 /摘要 临界肢体缺血（CLI），缺乏血液流向腿部的血液流动，其特征是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的率提高 并发症。 CLI的管理正在迅速发展，随着微创技术的冒险 恢复血流和伤口护理的进展。但是，关于最佳的共识几乎没有 治疗。正在进行的NIH资助的最佳CLI旨在评估比较有效性 然而，CLI中血流的最小侵入性与完全手术恢复，对电流知之甚少 CLI中的全国实践模式，成果，生活质量和医疗资源利用。此外， 最佳CLI试验将招募可能无法完全代表“现实世界”的选定患者人群 CLI患者。结果，与最佳CLI研究者和最佳CLI试验结合在一起，我们 提案伴侣最佳视觉注册表（VCLI）调查以下目的：1）描述 连续患者的基线人口统计，合并症和治疗策略排除在外 最佳CLI试验并包括在VCLI注册表中，重点是护理的变化2）描述临床 结果 - 特别是主要的不良肢体事件（男性）自由生存，伤口愈合和主要广告 心血管事件（MACE） - 通过CLI患者的治疗策略，重点是结果 治疗策略内的变化3）描述与医疗保健相关的生活质量和医疗保健成本， VCLI注册表中的治疗策略，重点是导致生活质量和成本差异的原因。 方法：VCLI注册表将由独特的公共 /私人合作伙伴关系以及两者的治理资助 VCLI主要研究人员和最佳CLI主要研究人员。对于AIM 1，多级多元回归 将用于识别患者，身体/医院以及与变化相关的地理因素 治疗策略。对于AIM 2，Kaplan Meier和肢体和心血管的累积事件估计值 结果将按照治疗策略和其他感兴趣的亚组进行分层。糖尿病和 CKD将通过多变量建模来量化，临床风险预测分数将分别开发 对于每个治疗策略。对于AIM 3，将描述每个人的生活质量，成本和成本效益 治疗策略和每个治疗策略内的变异来源将通过多变量确定 回归。影响：赠款的结果将有助于阐明当前的做法和护理的结果 CLI。生成有关患者人口统计学，临床结果差异和成本变化的数据 /成本有效性将有助于1）确定未来医疗保健系统干预措施的目标 遵守指南建议的护理和2）为调查结果提供背景和普遍性 最佳CLI试验和3）确定特定的医疗保健系统目标，以帮助加速最佳CLI试验 发现临床实践。