PDF(Pubmed)
Abstract：
UNASSIGNED: Rifampin-resistant tuberculosis treatment regimens require electrocardiographic (ECG) monitoring due to the use of multiple QTc-prolonging agents. Formal 12-lead ECG devices represent a significant burden in resource-constrained clinics worldwide and a potential barrier to treatment scale-up in some settings.
UNASSIGNED: To evaluate the diagnostic accuracy of a handheld 6-lead ECG device within resource-constrained clinics.
UNASSIGNED: This diagnostic study was performed within a multicenter, pragmatic (broad eligibility criteria with no exclusions for randomized participants), phase 3 rifampin-resistant tuberculosis treatment trial (BEAT Tuberculosis [Building Evidence for Advancing New Treatment for Tuberculosis]) in South Africa. A total of 192 consecutive trial participants were assessed, and 191 were recruited for this substudy between January 21, 2021, and March 27, 2023. A low proportion (3 of 432 [0.7%]) of all screened trial participants were excluded due to a QTc interval greater than 450 milliseconds. Triplicate reference standard 12-lead ECG results were human calibrated with readers blinded to 6-lead ECG results.
UNASSIGNED: Diagnostic accuracy, repeatability, and feasibility of a 6-lead ECG device.
UNASSIGNED: A total of 191 participants (median age, 36 years [IQR, 28-45 years]; 81 female participants [42.4%]; 91 participants [47.6%] living with HIV) with a median of 4 clinic visits (IQR, 3-4 visits) contributed 2070 and 2015 12-lead and 6-lead ECG assessments, respectively. Across 170 participants attending 489 total clinic visits where valid triplicate QTc measurements were available for both devices, the mean 12-lead QTc measurement was 418 milliseconds (range, 321-519 milliseconds), and the mean 6-lead QTc measurement was 422 milliseconds (range, 288-574 milliseconds; proportion of variation explained, R2 = 0.4; P < .001). At a QTc interval threshold of 500 milliseconds, the 6-lead ECG device had a negative predictive value of 99.8% (95% CI, 98.8%-99.9%) and a positive predictive value of 16.7% (95% CI, 0.4%-64.1%). The normal expected range of within-individual variability of the 6-lead ECG device was high (±50.2 milliseconds [coefficient of variation, 6.0%]) relative to the 12-lead ECG device (±22.0 milliseconds [coefficient of variation, 2.7%]). The mean (SD) increase in the 12-lead QTc measurement during treatment was 10.1 (25.8) milliseconds, with 0.8% of clinic visits (4 of 489) having a QTc interval of 500 milliseconds or more.
UNASSIGNED: This study suggests that simplified, handheld 6-lead ECG devices are effective triage tests that could reduce the need to perform 12-lead ECG monitoring in resource-constrained settings.
UNASSIGNED: To evaluate the diagnostic accuracy of a handheld 6-lead ECG device within resource-constrained clinics.
UNASSIGNED: This diagnostic study was performed within a multicenter, pragmatic (broad eligibility criteria with no exclusions for randomized participants), phase 3 rifampin-resistant tuberculosis treatment trial (BEAT Tuberculosis [Building Evidence for Advancing New Treatment for Tuberculosis]) in South Africa. A total of 192 consecutive trial participants were assessed, and 191 were recruited for this substudy between January 21, 2021, and March 27, 2023. A low proportion (3 of 432 [0.7%]) of all screened trial participants were excluded due to a QTc interval greater than 450 milliseconds. Triplicate reference standard 12-lead ECG results were human calibrated with readers blinded to 6-lead ECG results.
UNASSIGNED: Diagnostic accuracy, repeatability, and feasibility of a 6-lead ECG device.
UNASSIGNED: A total of 191 participants (median age, 36 years [IQR, 28-45 years]; 81 female participants [42.4%]; 91 participants [47.6%] living with HIV) with a median of 4 clinic visits (IQR, 3-4 visits) contributed 2070 and 2015 12-lead and 6-lead ECG assessments, respectively. Across 170 participants attending 489 total clinic visits where valid triplicate QTc measurements were available for both devices, the mean 12-lead QTc measurement was 418 milliseconds (range, 321-519 milliseconds), and the mean 6-lead QTc measurement was 422 milliseconds (range, 288-574 milliseconds; proportion of variation explained, R2 = 0.4; P < .001). At a QTc interval threshold of 500 milliseconds, the 6-lead ECG device had a negative predictive value of 99.8% (95% CI, 98.8%-99.9%) and a positive predictive value of 16.7% (95% CI, 0.4%-64.1%). The normal expected range of within-individual variability of the 6-lead ECG device was high (±50.2 milliseconds [coefficient of variation, 6.0%]) relative to the 12-lead ECG device (±22.0 milliseconds [coefficient of variation, 2.7%]). The mean (SD) increase in the 12-lead QTc measurement during treatment was 10.1 (25.8) milliseconds, with 0.8% of clinic visits (4 of 489) having a QTc interval of 500 milliseconds or more.
UNASSIGNED: This study suggests that simplified, handheld 6-lead ECG devices are effective triage tests that could reduce the need to perform 12-lead ECG monitoring in resource-constrained settings.
摘要：
■利福平耐药的结核病治疗方案由于使用了多种QTc延长剂，因此需要进行心电图（ECG）监测。正式的12导联ECG设备在全球资源有限的诊所中代表了巨大的负担，并且在某些情况下是治疗规模扩大的潜在障碍。
■在资源有限的诊所中评估手持式6导联ECG设备的诊断准确性。
■这项诊断研究是在多中心进行的，务实(广泛的资格标准，不排除随机参与者)，南非3期利福平耐药结核病治疗试验（BEAT结核病[为推进结核病新疗法建立证据]）。总共对192名连续试验参与者进行了评估，在2021年1月21日至2023年3月27日期间,招募了191人参与这项子研究.由于QTc间期大于450毫秒，所有筛选试验参与者中有较低比例(432人中的3人[0.7%])被排除。一式三份参考标准12导联ECG结果是用对6导联ECG结果不知情的读取器进行人类校准的。
■诊断准确性，重复性,6导联心电图装置的可行性。
■共有191名参与者(平均年龄，36年[IQR，28-45岁]；81名女性参与者[42.4%]；91名参与者[47.6%]感染艾滋病毒)，中位数为4次诊所就诊(IQR，3-4次访问)贡献了2070和2015年的12导联和6导联心电图评估，分别。在170名参与者中，总共有489次临床就诊，两种设备均可获得有效的三份QTc测量值，平均12导联QTc测量为418毫秒(范围，321-519毫秒），平均6导联QTc测量为422毫秒(范围，288-574毫秒；解释的变化比例，R2=0.4；P<.001）。在QTc间隔阈值为500毫秒时，6导联ECG装置的阴性预测值为99.8%(95%CI,98.8%-99.9%),阳性预测值为16.7%(95%CI,0.4%-64.1%).6导联ECG设备的个体内变异性的正常预期范围很高（±50.2毫秒[变异系数，6.0％]）相对于12导联ECG设备（±22.0毫秒[变异系数，2.7%]）。治疗期间12导联QTc测量值的平均（SD）增加为10.1（25.8）毫秒，0.8％的诊所就诊（489个中的4个）的QTc间期为500毫秒或以上。
■这项研究表明，手持式6导联ECG设备是有效的分诊测试，可以减少在资源受限的环境中执行12导联ECG监测的需要。
■在资源有限的诊所中评估手持式6导联ECG设备的诊断准确性。
■这项诊断研究是在多中心进行的，务实(广泛的资格标准，不排除随机参与者)，南非3期利福平耐药结核病治疗试验（BEAT结核病[为推进结核病新疗法建立证据]）。总共对192名连续试验参与者进行了评估，在2021年1月21日至2023年3月27日期间,招募了191人参与这项子研究.由于QTc间期大于450毫秒，所有筛选试验参与者中有较低比例(432人中的3人[0.7%])被排除。一式三份参考标准12导联ECG结果是用对6导联ECG结果不知情的读取器进行人类校准的。
■诊断准确性，重复性,6导联心电图装置的可行性。
■共有191名参与者(平均年龄，36年[IQR，28-45岁]；81名女性参与者[42.4%]；91名参与者[47.6%]感染艾滋病毒)，中位数为4次诊所就诊(IQR，3-4次访问)贡献了2070和2015年的12导联和6导联心电图评估，分别。在170名参与者中，总共有489次临床就诊，两种设备均可获得有效的三份QTc测量值，平均12导联QTc测量为418毫秒(范围，321-519毫秒），平均6导联QTc测量为422毫秒(范围，288-574毫秒；解释的变化比例，R2=0.4；P<.001）。在QTc间隔阈值为500毫秒时，6导联ECG装置的阴性预测值为99.8%(95%CI,98.8%-99.9%),阳性预测值为16.7%(95%CI,0.4%-64.1%).6导联ECG设备的个体内变异性的正常预期范围很高（±50.2毫秒[变异系数，6.0％]）相对于12导联ECG设备（±22.0毫秒[变异系数，2.7%]）。治疗期间12导联QTc测量值的平均（SD）增加为10.1（25.8）毫秒，0.8％的诊所就诊（489个中的4个）的QTc间期为500毫秒或以上。
■这项研究表明，手持式6导联ECG设备是有效的分诊测试，可以减少在资源受限的环境中执行12导联ECG监测的需要。
