Efficiencies for Outcome Ascertainment throughout the Total Product Life Cycle

项目摘要 准确有效的结果评估是医疗器械创新、评估和 监视如果健康状况良好，管理声明可以促进老年人的前瞻性器械评价 关注结果（HOI）是可靠的。各种HOI确定工具，包括基于站点的报告， 患者报告通常在没有严格评估的情况下使用。每种方法都能提高资源利用率， 基于索赔的HOI评估，没有明确的附加值证明，特别是在老年人群中。 使用以程序为导向的国家登记系统评价冠状动脉支架的现有等同器械， 人工心脏瓣膜和人工心脏瓣膜已经证明了对设备具有高影响潜力的效率 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， 如果可靠的话，作为索赔数据将整合这些效率，用于更广泛的设备应用范围。 最近，观察性医疗结果伙伴关系（OMOP）和微型哨兵小组 已经强调了现有的基于索赔的HOI确定算法的局限性。既往HOI确认 对于心肌梗死、中风、心力衰竭和出血的努力， 在发病和流行疾病之间，建立亚组内的准确性估计，或评估 无再次住院的不良事件。此外，现有的基于索赔的HOI确定算法依赖于 仅对诊断代码，以及在何种程度上，程序计费代码将提高其精度， 准确性是未知的。 如果没有经过验证的准确性，提高的效率无法用于设备评估。这项建议 应用现有内部临床和索赔数据的新型链接， 基于索赔的HOI确定与“金标准”CEC裁定结果的评价。本研究 提案分为3个阶段，以通过3个潜在供资年逐步利用可交付成果。 在本研究的第1阶段（第1年），我们将完善和验证基于行政索赔的HOI编码 算法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型联系。 在第2阶段和第3阶段（分别为第2年和第3年），我们将应用这些细化的HOI机制 确定1）经导管主动脉瓣置换术的纵向监测 使用可用的唯一器械标识符（UDI）的TAVR假体，以及2）基于注册的务实临床 该试验建立在美国国家心血管研究基础设施（NCRI）的成功试点基础上， 女性安全PCI试验。 该提案扩大和加强了现有的研究合作和基础设施， 医疗器械监督和基于注册的随机临床试验的性能。

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.