Outcomes and perspectives on treatment for critical limb ischemia in patients with end-stage renal disease

终末期肾病患者严重肢体缺血治疗的结果和前景

• 批准号: 10673924
• 负责人: Samir Kaushik Shah
• 金额: $ 14.4万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10673924
• 关键词: Affect; Aftercare; American; Amputation; Biology; Blood Vessels; Bypass; Cardiology; Cardiovascular system; Caring; Catheters; Clinical Research; Complement 3; Conflict (Psychology); Data; Decision Aid; Decision Making; Development; Diagnosis; Dialysis procedure; Disease; End stage renal failure; Environment; Fee-for-Service Plans; Florida; Foundations; Gangrene; Geography; Goals; Grant; Guidelines; Health Personnel; Health Services Research; Hemodialysis; Hospital Referrals; Incidence; Intervention; Kidney Failure; Knowledge; Leadership; Learning; Length of Stay; Life; Limb structure; Literature; Managed Care; Medicare; Medicare claim; Medicine; Mentors; Mentorship; Methods; Morbidity - disease rate; Nephrology; Operative Surgical Procedures; Outcome; Outcomes Research; Pain; Pain management; Patient-Centered Care; Patient-Focused Outcomes; Patients; Peripheral arterial disease; Persons; Physicians; Population; Population Heterogeneity; Positioning Attribute; Procedures; Process; Provider; Recommendation; Research; Research Personnel; Research Priority; Resources; Rest; Risk Factors; Sample Size; Selection for Treatments; Societies; Stents; Symptoms; Techniques; Training; Treatment Factor; Treatment outcome; Universities; Vascular Diseases; Writing; accountable care organization; beneficiary; care outcomes; career; career development; clinical care; college; comorbidity; critical limb Ischemia; experience; follow-up; improved; large datasets; limb loss; mortality; multidisciplinary; non-healing wounds; preference; programs; risk sharing; satisfaction; shared decision making; skill acquisition; skills; treatment as usual; treatment choice; wound care

Project Summary/Abstract Amputation and mortality rates are extraordinarily high for patients living with both advanced peripheral arterial disease, or critical limb ischemia (CLI), and end-stage renal disease (ESRD). Treatment choices for patients with CLI include catheter-based procedures (e.g. vascular stenting), surgery (e.g. bypass), primary amputation, or symptom control alone (e.g. pain management and wound care). Overall, CLI has dismal outcomes with a 25% mortality and a 30% major amputation rate at one year from diagnosis. Limited data suggest even worse outcomes for patients with ESRD – for example, approximately 50% mortality at 18 months. The existing literature on outcomes is limited by small sample sizes, short follow-up, and a focus on only two of the treatment options, catheter-based interventions and surgery. Patients with ESRD and CLI are often faced with difficult treatment decisions that are complicated by a lack of 1) robust real-world evidence on outcomes and 2) clinical care guidelines. Shared decision-making often relies on these types of information. ESRD is a life-limiting disease and treatment of CLI is resource-intensive. Nevertheless, there are no existing cardiovascular or nephrology society guidelines regarding CLI treatment in patients with ESRD. Knowledge of outcomes of CLI treatment in patients with ESRD, factors affecting CLI treatment selection, and guidelines to direct care would unequivocally improve care by helping to align patient values and preferences with treatment decisions. Owing to these gaps in knowledge, I propose a mixed methods approach using the national Medicare data 2017-2019 to understand 1) factors affecting treatment selection, and 2) traditional and patient-centered outcomes after treatment of CLI in patients with ESRD, complemented by 3) a Delphi panel of expert health care providers and patients to help inform the establishment of care guidelines and identification of research priorities. In addition to helping develop critical data on patients with ESRD and CLI, this proposal will be an essential step in my development as an independent investigator. My long-term career goals are to develop a research program focusing on outcomes of treatment and decision-making surrounding peripheral arterial disease. I hope to advance the field of vascular surgery health services research to improve patient outcomes and aid physicians and patients in aligning decision-making with patient goals and values. This proposal will immediately contribute to my short-term career objectives: increasing expertise with use of Medicare fee-for- service claims data, understanding the practice of nephrology as it applies to ESRD and comorbid conditions such as CLI, learning relevant advanced quantitative and qualitative techniques, and improving grant writing, leadership, and other career development skills. This proposal will take place in the resource-rich environment of the University of Florida College of Medicine under the guidance of an expert mentoring team.

项目总结/摘要 截肢率和死亡率是非常高的患者生活与先进的外周 动脉疾病或严重肢体缺血（CLI）和终末期肾病（ESRD）。治疗选择 CLI患者包括基于导管的手术（例如血管支架植入术）、外科手术（例如搭桥术）、原发性 截肢，或单独的症状控制（例如疼痛管理和伤口护理）。总体而言，CLI令人沮丧 诊断后一年内死亡率为25%，大截肢率为30%。有限数据 这表明ESRD患者的结局甚至更差--例如，18岁时死亡率约为50% 个月现有的关于结果的文献受到样本量小、随访时间短以及关注 只有两种治疗选择，基于导管的干预和手术。ESRD和CLI患者 经常面临困难的治疗决定，这些决定由于缺乏1）关于以下方面的强有力的真实世界证据而变得复杂： 结果和2）临床护理指南。共同决策往往依赖于这些类型的信息。 ESRD是一种限制生命的疾病，CLI的治疗是资源密集型的。然而，没有 关于ESRD患者CLI治疗的现有心血管或肾病学会指南。 了解ESRD患者CLI治疗的结局、影响CLI治疗选择的因素，以及 指导护理的指南将通过帮助调整患者的价值观和偏好来明确改善护理 治疗决定。由于这些知识的差距，我提出了一个混合方法的方法，使用 2017-2019年国家医疗保险数据，以了解1）影响治疗选择的因素，以及2）传统和 ESRD患者CLI治疗后以患者为中心的结局，由3）一个德尔菲小组补充， 专家医疗保健提供者和患者帮助制定护理指南和识别 研究的优先事项。 除了帮助开发ESRD和CLI患者的关键数据外，该提案还将成为 这是我成为独立调查员的重要一步我的长期职业目标是发展一个 研究计划，重点关注外周动脉周围的治疗和决策结果 疾病我希望推进血管外科健康服务研究领域，以改善患者的治疗效果。 并帮助医生和患者将决策制定与患者目标和价值观相一致。这项建议会 立即有助于我短期职业目标：通过使用Medicare付费 服务索赔数据，了解适用于ESRD和合并症的肾脏病学实践 例如CLI，学习相关的先进定量和定性技术，以及改进赠款的撰写， 领导力和其他职业发展技能。这一提议将发生在资源丰富的环境中 佛罗里达大学医学院的专家指导团队的指导下。

项目成果

National Institutes of Health funding among vascular surgeons is rare.

美国国立卫生研究院对血管外科医生的资助很少。

• DOI: 10.1016/j.jvs.2023.05.052
• 发表时间: 2023
• 期刊: Journal of vascular surgery
• 影响因子: 4.3
• 作者: Mirzaie,AminA;Cooper,MicholA;Weaver,MLibby;Jacobs,ChristopherR;Cox,MorganL;Berceli,ScottA;Scali,SalvatoreT;Back,MartinR;Huber,ThomasS;Upchurch,GilbertR;Shah,SamirK
• 通讯作者: Shah,SamirK