Wherry Kael, Stromberg Kurt, Hinnenthal Jennifer A, Wallenfelsz Lisa A, El-Chami Mikhael F, Bockstedt Lindsay
Medtronic, Plc, Mounds View, MN, USA.
Division of Cardiology, Section of Electrophysiology, Emory University, Atlanta, GA, USA.
Pragmat Obs Res. 2020 Feb 28;11:19-26. doi: 10.2147/POR.S240913. eCollection 2020.
There is heightened interest in how real-world data (RWD) can be used to supplement or replace traditional mechanisms for collecting clinical information. A critical component in evaluating utility of RWD is assessing the validity and reliability of event measurement. Only two studies have validated Medicare claims with physician-adjudicated data collected in a clinical study and none in the pacemaker patient population. This study compares events identified in physician-adjudicated clinical registry data collected in the Micra Post-Approval Registry (PAR) with events identified via Medicare administrative claims in the Micra Coverage with Evidence (CED) Study.
Patients who were dually enrolled in the Micra CED and the Micra PAR between March 9, 2017 and December 1, 2017 were included in the validation analysis. All patients intended to be implanted with a Micra device were eligible for participation in the Micra PAR. All Medicare fee-for-service beneficiaries implanted with a Micra device who met the 12-month continuous enrollment criteria were included in the Micra CED. We compared the count of acute (30-day) complications identified in the Medicare claims and the physician-adjudicated PAR data to assess agreement between data sources.
There were 230 patients dually enrolled in the Micra CED and Micra PAR studies during the study period. Overall, there were 17 acute events reported in either the Micra CED or the Micra PAR, with 95% agreement in the identification of events and absence of events between studies. Study disagreement between events reported in either study varied: arteriovenous fistula (50%), pulmonary embolism (67%), hemorrhage/hematoma (75%), and deep vein thrombosis (100%). Among physician-adjudicated events, there was no disagreement between the Micra CED and Micra PAR studies in any event type.
Findings from this study demonstrate high agreement in event identification between Medicare claims data and registries for patients implanted with Micra leadless pacemakers.
人们对如何利用真实世界数据（RWD）补充或取代收集临床信息的传统机制的兴趣日益浓厚。评估RWD效用的一个关键组成部分是评估事件测量的有效性和可靠性。只有两项研究使用临床研究中收集的医生判定数据对医疗保险索赔进行了验证，而在起搏器患者群体中尚未有此类研究。本研究比较了在Micra批准后注册研究（PAR）中收集的医生判定临床注册数据中识别出的事件与通过Micra有证据覆盖（CED）研究中的医疗保险行政索赔识别出的事件。
2017年3月9日至2017年12月1日期间同时参加Micra CED和Micra PAR的患者纳入验证分析。所有打算植入Micra设备的患者均有资格参与Micra PAR。所有植入Micra设备且符合12个月连续参保标准的医疗保险按服务收费受益人纳入Micra CED。我们比较了医疗保险索赔和医生判定的PAR数据中识别出的急性（30天）并发症数量，以评估数据源之间的一致性。
在研究期间，有230名患者同时参加了Micra CED和Micra PAR研究。总体而言，Micra CED或Micra PAR中报告了17起急性事件，两项研究在事件识别和无事件识别方面的一致性为95%。两项研究中报告的事件之间的差异各不相同：动静脉瘘（50%）、肺栓塞（67%）、出血/血肿（75%）和深静脉血栓形成（100%）。在医生判定的事件中，Micra CED和Micra PAR研究在任何事件类型上均无差异。
本研究结果表明，对于植入Micra无导线起搏器的患者，医疗保险索赔数据与注册登记之间在事件识别方面具有高度一致性。
