使用医疗保险索赔来识别无铅起搏器植入后的急性临床事件。

IF 2.3 Q2 MEDICINE, GENERAL & INTERNAL Pragmatic and Observational Research Pub Date : 2020-02-28 eCollection Date: 2020-01-01 DOI:10.2147/POR.S240913
Kael Wherry, Kurt Stromberg, Jennifer A Hinnenthal, Lisa A Wallenfelsz, Mikhael F El-Chami, Lindsay Bockstedt
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引用次数: 8

摘要

背景:如何使用真实世界数据(RWD)来补充或取代收集临床信息的传统机制,引起了人们的高度兴趣。评估RWD的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。只有两项研究通过临床研究中收集的医生裁决数据验证了医疗保险索赔,而没有一项研究是在起搏器患者群体中进行的。本研究比较了Micra批准后注册(PAR)中收集的医生裁定的临床注册数据中确定的事件与Micra覆盖证据(CED)研究中通过医疗保险行政索赔确定的事件。方法:纳入2017年3月9日至2017年12月1日期间Micra CED和Micra PAR双入组的患者进行验证分析。所有打算植入Micra设备的患者都有资格参加Micra PAR。所有符合12个月连续登记标准的植入Micra设备的医疗保险服务收费受益人都包括在Micra CED中。我们比较了医疗保险索赔中确定的急性(30天)并发症的数量和医生判定的PAR数据,以评估数据源之间的一致性。结果:在研究期间,有230名患者双入组Micra CED和Micra PAR研究。总体而言,在Micra CED或Micra PAR中报告了17个急性事件,研究之间在事件识别和事件缺失方面的一致性为95%。两项研究报告的事件之间的研究差异各不相同: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都没有差异。结论:本研究结果表明,对于植入Micra无铅起搏器的患者,医疗保险索赔数据和登记之间的事件识别高度一致。
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Using Medicare Claims to Identify Acute Clinical Events Following Implantation of Leadless Pacemakers.

Background: 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.

Methods: 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.

Results: 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.

Conclusion: Findings from this study demonstrate high agreement in event identification between Medicare claims data and registries for patients implanted with Micra leadless pacemakers.

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来源期刊
Pragmatic and Observational Research
Pragmatic and Observational Research MEDICINE, GENERAL & INTERNAL-
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发文量
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期刊介绍: Pragmatic and Observational Research is an international, peer-reviewed, open-access journal that publishes data from studies designed to closely reflect medical interventions in real-world clinical practice, providing insights beyond classical randomized controlled trials (RCTs). While RCTs maximize internal validity for cause-and-effect relationships, they often represent only specific patient groups. This journal aims to complement such studies by providing data that better mirrors real-world patients and the usage of medicines, thus informing guidelines and enhancing the applicability of research findings across diverse patient populations encountered in everyday clinical practice.
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