Kleijnen Systematic Reviews Ltd, York, UK.
Health Technol Assess. 2024 Mar;28(19):1-94. doi: 10.3310/TFHU0078.
The indication for this assessment is the use of the KardiaMobile six-lead electrocardiogram device for the assessment of QT interval-based cardiac risk in service users prior to the initiation of, or for the monitoring of, antipsychotic medications, which are associated with an established risk of QT interval prolongation.
To provide an early value assessment of whether KardiaMobile six-lead has the potential to provide an effective and safe alternative to 12-lead electrocardiogram for initial assessment and monitoring of QT interval-based cardiac risk in people taking antipsychotic medications.
Twenty-seven databases were searched to April/May 2022. Review methods followed published guidelines. Where appropriate, study quality was assessed using appropriate risk of bias tools. Results were summarised by research question; accuracy/technical performance; clinical effects (on cardiac and psychiatric outcomes); service user acceptability/satisfaction; costs of KardiaMobile six-lead.
We did not identify any studies which provided information about the diagnostic accuracy of KardiaMobile six-lead, for the detection of corrected QT-interval prolongation, in any population. All studies which reported information about agreement between QT interval measurements (corrected and/or uncorrected) with KardiaMobile six-lead versus 12-lead electrocardiogram were conducted in non-psychiatric populations, used cardiologists and/or multiple readers to interpret electrocardiograms. Where reported or calculable, the mean difference in corrected QT interval between devices (12-lead electrocardiogram vs. KardiaMobile six-lead) was generally small (≤ 10 ms) and corrected QT interval measured using KardiaMobile six-lead was consistently lower than that measured using 12-lead electrocardiogram. All information about the use of KardiaMobile six-lead, in the context of QT interval-based cardiac risk assessment for service users who require antipsychotic medication, was taken from retrospective surveys of staff and service users who had chosen to use KardiaMobile six-lead during pilots, described in two unpublished project reports. It is important to note that both these project reports relate to pilot studies which were not intended to be used in wider evaluations of KardiaMobile six-lead for use in the NHS. Both reports included survey results which indicated that the use of KardiaMobile six-lead may be associated with reductions in the time taken to complete an electrocardiogram and costs, relative to 12-lead electrocardiogram, and that KardiaMobile six-lead was preferred over 12-lead electrocardiogram by almost all responding staff and service users.
There was a lack of published evidence about the efficacy of KardiaMobile six-lead for initial assessment and monitoring of QT interval-based cardiac risk in people taking antipsychotic medications.
There is insufficient evidence to support a full diagnostic assessment evaluating the clinical and cost effectiveness of KardiaMobile six-lead, in the context of QT interval-based cardiac risk assessment for service users who require antipsychotic medication. The evidence to inform the aims of this early value assessment (i.e. to assess whether the device has the potential to be clinically effective and cost-effective) was also limited. This report includes a comprehensive list of research recommendations, both to reduce the uncertainty around this early value assessment and to provide the additional data needed to inform a full diagnostic assessment, including cost-effectiveness modelling.
This study is registered as PROSPERO CRD42022336695.
This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR135520) and is published in full in ; Vol. 28, No. 19. See the NIHR Funding and Awards website for further award information.
本评估的适应证是使用 KardiaMobile 六导联心电图仪，对接受抗精神病药物治疗前或治疗期间的服务使用者进行基于 QT 间期的心脏风险评估，因为这些药物会增加 QT 间期延长的风险。
早期评估 KardiaMobile 六导联是否有可能成为 12 导联心电图的有效和安全替代方法，用于初始评估和监测接受抗精神病药物治疗的患者的基于 QT 间期的心脏风险。
2022 年 4 月/5 月检索了 27 个数据库。综述方法遵循了已发表的指南。在适当的情况下，使用适当的偏倚风险工具评估研究质量。根据研究问题、准确性/技术性能、临床效果（心脏和精神科结局）、服务使用者接受度/满意度、KardiaMobile 六导联的成本，对结果进行总结。
我们没有发现任何研究提供了关于 KardiaMobile 六导联在任何人群中检测校正 QT 间期延长的诊断准确性的信息。所有报告 QT 间期（校正和/或未校正）测量与 KardiaMobile 六导联和 12 导联心电图之间一致性的研究都是在非精神科人群中进行的，使用心脏病专家和/或多位读者来解释心电图。如果有报告或可计算，设备之间校正 QT 间期的平均差异（12 导联心电图与 KardiaMobile 六导联）通常较小（≤10ms），并且使用 KardiaMobile 六导联测量的校正 QT 间期始终低于使用 12 导联心电图测量的校正 QT 间期。关于在需要抗精神病药物治疗的服务使用者中，使用 KardiaMobile 六导联进行基于 QT 间期的心脏风险评估的所有信息，都来自工作人员和服务使用者的回顾性调查，他们在两个未发表的项目报告中选择在试点期间使用 KardiaMobile 六导联。需要注意的是，这两个项目报告都涉及试点研究，这些研究不打算用于更广泛地评估 KardiaMobile 六导联在 NHS 中的使用。这两个报告都包括调查结果，表明与 12 导联心电图相比，使用 KardiaMobile 六导联可能会减少完成心电图的时间和成本，并且几乎所有接受调查的工作人员和服务使用者都更喜欢 KardiaMobile 六导联而不是 12 导联心电图。
关于 KardiaMobile 六导联在接受抗精神病药物治疗的患者中进行初始评估和监测基于 QT 间期的心脏风险的疗效，缺乏已发表的证据。
目前没有足够的证据支持对 KardiaMobile 六导联进行全面的诊断评估，以评估其在需要抗精神病药物治疗的服务使用者中进行基于 QT 间期的心脏风险评估时的临床和成本效益。为本次早期价值评估提供信息的证据（即评估该设备是否具有临床有效性和成本效益）也很有限。本报告包括一份全面的研究建议清单，既可以减少这一早期价值评估的不确定性，也可以提供进一步评估所需的额外数据，包括成本效益建模。
本研究在 PROSPERO 注册（CRD42022336695）。
本奖项由英国国家健康与保健卓越研究所（NIHR）证据综合计划（NIHR 拨款号：NIHR135520）资助，并在 ；第 28 卷，第 19 期。有关该奖项的更多信息，请访问 NIHR 资助和奖项网站。
