Efficiencies for Outcome Ascertainment throughout the Total Product Life Cycle

整个产品生命周期中结果确定的效率

• 批准号: 9143564
• 负责人: J Matthew Brennan
• 金额: $ 2.92万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-30 至 2017-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9143564
• 关键词: Efficiencies; Outcome; Ascertainment; throughout; Total

PROJECT SUMMARY Accurate and efficient assessment of outcomes is central to medical device innovation, evaluation and surveillance. Administrative claims could facilitate prospective device evaluations in older individuals if health outcomes of interest (HOIs) are reliable. Various HOI ascertainment tools, including site-based reporting and patient-reporting are commonly used without rigorous evaluation. Each increases resource utilization vs. claims-based HOI assessment without a clear demonstration of added value, particularly in older cohorts. Existing predicates using procedure-oriented national registries for evaluation of coronary stents, defibrillators and prosthetic heart valves already demonstrate efficiencies with high impact potential for device innovation over the total product life cycle. Extension of these efforts to long-term outcomes databases such as claims data, if reliable, would integrate these efficiencies for a far broader scope of device applications. Recently, both the Observational Medical Outcomes Partnership (OMOP) and the Mini-Sentinel groups have highlighted limitations of existing claims-based HOI ascertainment algorithms. Previous HOI validation efforts for myocardial infarction, stroke, heart failure, and bleeding have had limited ability to distinguish between incident and prevalent disease, to establish accuracy estimates within subgroups, or to assess adverse events absent re-hospitalization. In addition, existing claims-based HOI ascertainment algorithms rely solely on diagnostic codes, and the extent to which procedural billing codes would enhance their precision and accuracy is unknown. Enhanced efficiency cannot serve device evaluation without validated accuracy. This proposal applies a novel linkage of existing in-house clinical and claims data to provide a cost- and time-efficient evaluation of claims-based HOI ascertainment versus 'gold standard' CEC adjudicated outcomes. This study proposal is structured in 3 phases to progressively leverage deliverables through 3 potential years of funding. In PHASE 1 of this study (year 1), we will refine and validate administrative claims-based HOI coding algorithms using a novel linkage between Medicare claims data and existing clinical trial and registry records. In PHASES 2 and 3 (years 2 and 3, respectively), we will apply these refined mechanisms of HOI ascertainment to the conduct of both 1) the longitudinal surveillance of transcatheter aortic valve replacement (TAVR) prostheses using available unique device identifiers (UDI), and 2) a pragmatic registry-based clinical trial that builds on the successful piloting of the National Cardiovascular Research Infrastructure (NCRI) by the SAFE-PCI for Women Trial. This proposal expands and strengthens existing research collaborations and infrastructure for the performance of medical device surveillance and registry-based randomized clinical trials.

项目总结 准确和高效的结果评估是医疗设备创新、评估和 监视系统。如果老年人的健康状况良好，行政索赔可以促进对未来设备的评估 感兴趣结果(HOIS)是可靠的。各种HOI确定工具，包括基于现场的报告和 患者报告通常在没有严格评估的情况下使用。每一项都提高了资源利用率 基于索赔的HOI评估，没有明确显示附加值，特别是在较老的队列中。 使用面向程序的国家注册来评估冠状动脉支架的现有判定， 除颤器和人工心脏瓣膜已经显示出对设备的高冲击潜力的效率 在整个产品生命周期中进行创新。将这些努力扩展到长期成果数据库，如 正如声称的那样，如果数据可靠，将把这些效率整合到更广泛的设备应用中。 最近，观察性医疗结果伙伴关系(OMOP)和迷你哨兵小组 强调了现有基于声明的HOI确定算法的局限性。之前的HOI验证 对心肌梗死、中风、心力衰竭和出血的努力，其区分能力有限。 事件和流行疾病之间的关系，在分组内建立准确的估计，或评估 不良事件无再入院。此外，现有的基于声明的HOI确定算法依赖于 仅取决于诊断代码，以及程序性记帐代码将在多大程度上提高其精度和 精确度还不得而知。 如果没有经过验证的准确性，提高的效率将无法为设备评估提供服务。这项建议 应用现有内部临床和索赔数据的新链接，提供经济实惠的 评估基于索赔的HOI确定与“黄金标准”CEC裁决的结果。本研究 计划分3个阶段进行，通过3年的潜在资金逐步利用可交付成果。 在本研究的第一阶段(第一年)，我们将改进和验证基于管理声明的HOI编码 使用医疗保险索赔数据与现有临床试验和注册记录之间的新联系的算法。 在第二阶段和第三阶段(分别是第二年和第三年)，我们将应用这些改进的HOI机制 1)经导管主动脉瓣置换术的纵向监测 (TAVR)使用可用的唯一设备识别符(UDI)的假体，以及2)实用的基于注册的临床 这项试验建立在国家心血管研究基础设施(NCRI)的成功试点基础上 SAFE-妇女经皮冠状动脉介入治疗试验。 这项建议扩展和加强了现有的研究合作和基础设施 医疗器械监测和基于注册的随机临床试验的绩效。

项目成果

Use of left atrial appendage occlusion among older cardiac surgery patients with preoperative atrial fibrillation: a national cohort study.

在患有术前房颤的老年心脏手术患者中使用左心耳封堵术：一项全国队列研究。

• DOI: 10.1007/s10840-019-00519-w
• 发表时间: 2020
• 期刊: Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing
• 作者: Friedman,DanielJ;Gaca,JeffreyG;Wang,Tongrong;Malaisrie,SChris;Holmes,DavidR;Piccini,JonathanP;Suri,RakeshM;Mack,MichaelJ;Badhwar,Vinay;Jacobs,JeffreyP;Peterson,EricD;Chow,Shein-Chung;MatthewBrennan,J
• 通讯作者: MatthewBrennan,J