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电子健康记录数据在关节植入物登记处的提取能力和准确性评估。

Assessment of Extractability and Accuracy of Electronic Health Record Data for Joint Implant Registries.

机构信息

Center for Innovation to Implementation, VA Palo Alto Health Care System, Palo Alto, California.

Department of Orthopedic Surgery, Stanford University, Stanford, California.

出版信息

JAMA Netw Open. 2021 Mar 1;4(3):e211728. doi: 10.1001/jamanetworkopen.2021.1728.

Abstract

IMPORTANCE

Implant registries provide valuable information on the performance of implants in a real-world setting, yet they have traditionally been expensive to establish and maintain. Electronic health records (EHRs) are widely used and may include the information needed to generate clinically meaningful reports similar to a formal implant registry.

OBJECTIVES

To quantify the extractability and accuracy of registry-relevant data from the EHR and to assess the ability of these data to track trends in implant use and the durability of implants (hereafter referred to as implant survivorship), using data stored since 2000 in the EHR of the largest integrated health care system in the United States.

DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of a large EHR of veterans who had 45 351 total hip arthroplasty procedures in Veterans Health Administration hospitals from 2000 to 2017. Data analysis was performed from January 1, 2000, to December 31, 2017.

EXPOSURES

Total hip arthroplasty.

MAIN OUTCOMES AND MEASURES

Number of total hip arthroplasty procedures extracted from the EHR, trends in implant use, and relative survivorship of implants.

RESULTS

A total of 45 351 total hip arthroplasty procedures were identified from 2000 to 2017 with 192 805 implant parts. Data completeness improved over the time. After 2014, 85% of prosthetic heads, 91% of shells, 81% of stems, and 85% of liners used in the Veterans Health Administration health care system were identified by part number. Revision burden and trends in metal vs ceramic prosthetic femoral head use were found to reflect data from the American Joint Replacement Registry. Recalled implants were obvious negative outliers in implant survivorship using Kaplan-Meier curves.

CONCLUSIONS AND RELEVANCE

Although loss to follow-up remains a challenge that requires additional attention to improve the quantitative nature of calculated implant survivorship, we conclude that data collected during routine clinical care and stored in the EHR of a large health system over 18 years were sufficient to provide clinically meaningful data on trends in implant use and to identify poor implants that were subsequently recalled. This automated approach was low cost and had no reporting burden. This low-cost, low-overhead method to assess implant use and performance within a large health care setting may be useful to internal quality assurance programs and, on a larger scale, to postmarket surveillance of implant performance.

摘要

重要性

植入物登记处提供了有关实际环境中植入物性能的宝贵信息,但传统上建立和维护这些登记处的成本很高。电子健康记录(EHR)被广泛使用,并且可能包含生成类似于正式植入物登记处的临床有意义报告所需的信息。

目的

从美国最大的综合医疗保健系统的 EHR 中提取与登记处相关的数据的可提取性和准确性,并评估这些数据跟踪植入物使用趋势和植入物耐用性(以下简称植入物存活率)的能力,使用自 2000 年以来存储在 EHR 中的数据。

设计、地点和参与者:对 2000 年至 2017 年期间在美国退伍军人事务部医院进行的 45351 例全髋关节置换术的大型 EHR 进行回顾性队列研究。数据分析于 2000 年 1 月 1 日至 2017 年 12 月 31 日进行。

暴露

全髋关节置换术。

主要结果和测量

从 EHR 中提取的全髋关节置换术数量、植入物使用趋势和植入物相对存活率。

结果

2000 年至 2017 年间共确定了 45351 例全髋关节置换术,涉及 192805 个植入物部件。数据的完整性随着时间的推移而提高。2014 年后,85%的美国退伍军人事务部医疗系统使用的假体头、91%的外壳、81%的柄和 85%的衬垫都可以通过零件号识别。翻修负担和金属对陶瓷假体股骨头使用的趋势与美国关节置换登记处的数据一致。使用 Kaplan-Meier 曲线,召回的植入物明显是植入物存活率的负异常值。

结论和相关性

尽管失访仍然是一个挑战,需要进一步关注以提高计算出的植入物存活率的定量性质,但我们得出的结论是,在 18 年的时间里,从大型健康系统的常规临床护理中收集并存储在 EHR 中的数据足以提供有关植入物使用趋势的有临床意义的数据,并确定随后被召回的不良植入物。这种自动方法成本低,没有报告负担。这种在大型医疗保健环境中评估植入物使用和性能的低成本、低开销方法可能对内部质量保证计划有用,并且在更大范围内对植入物性能的上市后监测有用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e78/7961313/1b8e46addd0f/jamanetwopen-e211728-g001.jpg

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