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在一个参与国际多中心研究的中心,通过电子病历收集临床研究数据的方法学描述。

Methodological description of clinical research data collection through electronic medical records in a center participating in an international multicenter study.

作者信息

Queiroz Veronica Neves Fialho, Oliveira Andrea da Costa Moreira de, Chaves Renato Carneiro de Freitas, Moura Lucas Araújo de Borges, César Daniel Sousa, Takaoka Flávio, Serpa Neto Ary

机构信息

Hospital Israelita Albert Einstein, São Paulo, SP, Brazil.

Irmandade da Santa Casa de Misericórdia de Santos, Santos, SP, Brazil.

出版信息

Einstein (Sao Paulo). 2019 Sep 23;17(4):eAE4791. doi: 10.31744/einstein_journal/2019AE4791. eCollection 2019.

DOI:10.31744/einstein_journal/2019AE4791
PMID:31553359
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6748344/
Abstract

Data collection for clinical research can be difficult, and electronic health record systems can facilitate this process. The aim of this study was to describe and evaluate the secondary use of electronic health records in data collection for an observational clinical study. We used Cerner Millennium®, an electronic health record software, following these steps: (1) data crossing between the study's case report forms and the electronic health record; (2) development of a manual collection method for data not recorded in Cerner Millennium®; (3) development of a study interface for automatic data collection in the electronic health records; (4) employee training; (5) data quality assessment; and (6) filling out the electronic case report form at the end of the study. Three case report forms were consolidated into the electronic case report form at the end of the study. Researchers performed daily qualitative and quantitative analyses of the data. Data were collected from 94 patients. In the first case report form, 76.5% of variables were obtained electronically, in the second, 95.5%, and in the third, 100%. The daily quality assessment of the whole process showed complete and correct data, widespread employee compliance and minimal interference in their practice. The secondary use of electronic health records is safe and effective, reduces manual labor, and provides data reliability. Anesthetic care and data collection may be done by the same professional.

摘要

临床研究的数据收集可能具有挑战性,而电子健康记录系统有助于这一过程。本研究的目的是描述和评估电子健康记录在一项观察性临床研究的数据收集中的二次使用情况。我们使用了Cerner Millennium®电子健康记录软件,具体步骤如下:(1)研究病例报告表与电子健康记录之间的数据交叉;(2)开发一种针对未记录在Cerner Millennium®中的数据的手动收集方法;(3)开发一个用于在电子健康记录中自动收集数据的研究界面;(4)员工培训;(5)数据质量评估;以及(6)在研究结束时填写电子病例报告表。在研究结束时,三份病例报告表被整合到电子病例报告表中。研究人员对数据进行了每日定性和定量分析。数据来自94名患者。在第一份病例报告表中,76.5%的变量通过电子方式获取,在第二份中为95.5%,在第三份中为100%。对整个过程的每日质量评估显示数据完整且正确,员工普遍遵守规定,且对其工作的干扰最小。电子健康记录的二次使用是安全有效的,减少了体力劳动,并提供了数据可靠性。麻醉护理和数据收集可以由同一名专业人员完成。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a91/6748344/eb5e652e3a7a/2317-6385-eins-17-04-eAE4791-gf04-pt.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a91/6748344/0bf46a72b072/2317-6385-eins-17-04-eAE4791-gf02-pt.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a91/6748344/499b9de2cf62/2317-6385-eins-17-04-eAE4791-gf03-pt.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a91/6748344/eb5e652e3a7a/2317-6385-eins-17-04-eAE4791-gf04-pt.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a91/6748344/80d6e8b532f6/2317-6385-eins-17-04-eAE4791-gf01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a91/6748344/c81a98a747c5/2317-6385-eins-17-04-eAE4791-gf02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a91/6748344/4c22b5f2b5e8/2317-6385-eins-17-04-eAE4791-gf03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a91/6748344/c4f7391ca1b7/2317-6385-eins-17-04-eAE4791-gf04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a91/6748344/158713ea702d/2317-6385-eins-17-04-eAE4791-gf01-pt.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a91/6748344/0bf46a72b072/2317-6385-eins-17-04-eAE4791-gf02-pt.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a91/6748344/499b9de2cf62/2317-6385-eins-17-04-eAE4791-gf03-pt.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a91/6748344/eb5e652e3a7a/2317-6385-eins-17-04-eAE4791-gf04-pt.jpg

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