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食品和药物管理局的 Mini-Sentinel 计划中急性心肌梗死的验证。

Validation of acute myocardial infarction in the Food and Drug Administration's Mini-Sentinel program.

机构信息

Meyers Primary Care Institute-Fallon Community Health Plan, Reliant Medical Group, and University of Massachusetts Medical School, Worcester, MA, USA.

出版信息

Pharmacoepidemiol Drug Saf. 2013 Jan;22(1):40-54. doi: 10.1002/pds.3310. Epub 2012 Jun 29.

DOI:10.1002/pds.3310
PMID:22745038
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3601831/
Abstract

PURPOSE

To validate an algorithm based upon International Classification of Diseases, 9(th) revision, Clinical Modification (ICD-9-CM) codes for acute myocardial infarction (AMI) documented within the Mini-Sentinel Distributed Database (MSDD).

METHODS

Using an ICD-9-CM-based algorithm (hospitalized patients with 410.x0 or 410.x1 in primary position), we identified a random sample of potential cases of AMI in 2009 from four Data Partners participating in the Mini-Sentinel Program. Cardiologist reviewers used information abstracted from hospital records to assess the likelihood of an AMI diagnosis based on criteria from the Joint European Society of Cardiology and American College of Cardiology Global Task Force. Positive predictive values (PPVs) of the ICD-9-based algorithm were calculated.

RESULTS

Of the 153 potential cases of AMI identified, hospital records for 143 (93%) were retrieved and abstracted. Overall, the PPV was 86.0% (95% confidence interval; 79.2%, 91.2%). PPVs ranged from 76.3% to 94.3% across the four Data Partners.

CONCLUSIONS

The overall PPV of potential AMI cases, as identified using an ICD-9-CM-based algorithm, may be acceptable for safety surveillance; however, PPVs do vary across Data Partners. This validation effort provides a contemporary estimate of the reliability of this algorithm for use in future surveillance efforts conducted using the Food and Drug Administration's MSDD.

摘要

目的

验证一种基于国际疾病分类第 9 版临床修订版(ICD-9-CM)编码的算法,用于在 Mini-Sentinel 分布式数据库(MSDD)中记录的急性心肌梗死(AMI)。

方法

使用基于 ICD-9-CM 的算法(主要位置为 410.x0 或 410.x1 的住院患者),我们从参与 Mini-Sentinel 计划的四个数据合作伙伴中随机选择了 2009 年的潜在 AMI 病例样本。心脏病专家审查员使用从医院记录中提取的信息,根据欧洲心脏病学会和美国心脏病学会全球工作组的标准评估 AMI 诊断的可能性。计算了基于 ICD-9 的算法的阳性预测值(PPV)。

结果

在确定的 153 例潜在 AMI 病例中,有 143 例(93%)的住院记录被检索并摘录。总体而言,PPV 为 86.0%(95%置信区间;79.2%,91.2%)。四个数据合作伙伴的 PPV 范围从 76.3%到 94.3%不等。

结论

使用基于 ICD-9-CM 的算法确定的潜在 AMI 病例的总体 PPV 可能可接受用于安全性监测;然而,PPV 在数据合作伙伴之间确实存在差异。这项验证工作提供了该算法在未来使用 FDA 的 MSDD 进行监测工作中的可靠性的当代估计。

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