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一种用于评估、管理和监测精神科人群药物诱导的QTc间期延长的算法的内容效度

Content Validation of an Algorithm for the Assessment, Management and Monitoring of Drug-Induced QTc Prolongation in the Psychiatric Population.

作者信息

Zolezzi Monica, Elhakim Athar, Elamin Waad M, Homs Shorouk, Mahmoud Doaa E, Qubaiah Iman A

机构信息

College of Pharmacy, QU Health, Qatar University, Doha, Qatar.

School of Health Sciences, College of North Atlantic Qatar, Doha, Qatar.

出版信息

Neuropsychiatr Dis Treat. 2021 Nov 19;17:3395-3405. doi: 10.2147/NDT.S334350. eCollection 2021.

Abstract

BACKGROUND

QTc interval (QTcI) prolongation leads to serious complications, making it a concern for clinicians. Assessing the risk of QTcI prolongation in the psychiatric population is important because they are exposed to multiple medications known to increase the risk of life-threatening arrhythmias.

AIM

The study aims to validate the content of an algorithm for the assessment, management and monitoring of drug-induced QTc prolongation in the psychiatric population.

METHODOLOGY

Qualitative semi-structured interviews of cardiologists, to gather information regarding their approach in assessing the risk of drug-induced QTc prolongation at the time of prescribing. After the interview, an orientation to the algorithm was provided with a link to a cross-sectional, anonymous survey. The online survey included quantitative and qualitative components to gather feedback on the relevance and appropriateness of each step in the algorithm.

RESULTS

Interview responses were incorporated into 4 themes. Responses indicated a lack of a unified protocol when assessing QTcI prolongation, which supports the need of an algorithm that includes a verified risk scoring tool. Quantitative survey results showed a mean score ranging from 3.08 to 3.67 out of 4 for the appropriateness of the algorithm's steps, 3.08 to 3.58 for the safety and 3.17 to 3.75 for the reliability of references used. Additional analysis using the modified kappa and I-CVI statistical measures indicate high validity of contents and high degree of agreement between raters. As per the open-ended questions, cardiologists supported the implementation of the algorithm; however, they recommended simplification of the steps as they appear to be cumbersome.

CONCLUSION

The results demonstrate that the implementation of the algorithm after minor alterations can prove to be useful as a tool for the risk assessment of QTc prolongation. Further validation of the algorithm with mental health pharmacists and clinicians will be conducted as a separate phase of the study.

摘要

背景

QTc间期(QTcI)延长会导致严重并发症,这让临床医生深感担忧。评估精神科人群QTcI延长的风险十分重要,因为他们会使用多种已知会增加危及生命心律失常风险的药物。

目的

本研究旨在验证一种用于评估、管理和监测精神科人群药物性QTc延长的算法内容。

方法

对心脏病专家进行定性半结构式访谈,以收集他们在开药时评估药物性QTc延长风险的方法的相关信息。访谈结束后,提供了该算法的说明,并附上了横断面匿名调查的链接。在线调查包括定量和定性部分,以收集关于算法中每个步骤的相关性和适用性的反馈。

结果

访谈回复归纳为4个主题。回复表明在评估QTcI延长时缺乏统一方案,这支持了需要一种包含经过验证的风险评分工具的算法。定量调查结果显示,算法步骤的适用性平均得分在4分制中为3.08至3.67分,安全性为3.08至3.58分,所使用参考文献的可靠性为3.17至3.75分。使用修正的kappa和I-CVI统计量进行的进一步分析表明内容具有高度有效性,评分者之间的一致性程度较高。根据开放式问题,心脏病专家支持该算法的实施;然而,他们建议简化步骤,因为这些步骤似乎很繁琐。

结论

结果表明,稍作修改后实施该算法可作为QTc延长风险评估的有用工具。该算法将在研究的单独阶段与心理健康药剂师和临床医生进行进一步验证。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/802d/8612668/ca8f80a7a0aa/NDT-17-3395-g0001.jpg

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