{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T03:06:15Z","timestamp":1792551975434,"version":"4.5.0"},"reference-count":65,"publisher":"American Medical Association (AMA)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"\n Importance<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To evaluate the diagnostic accuracy of a handheld 6-lead ECG device within resource-constrained clinics.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n Diagnostic accuracy, repeatability, and feasibility of a 6-lead ECG device.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n 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,\n R<\/jats:italic>\n 2<\/jats:sup>\n \u2009=\u20090.4;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). 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 (\u00b150.2 milliseconds [coefficient of variation, 6.0%]) relative to the 12-lead ECG device (\u00b122.0 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.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2024.15576","type":"journal-article","created":{"date-parts":[[2024,6,7]],"date-time":"2024-06-07T11:33:03Z","timestamp":1717759983000},"page":"e2415576","source":"Crossref","is-referenced-by-count":13,"title":["Validation of a Handheld 6-Lead Device for QT Interval Monitoring in Resource-Limited Settings"],"prefix":"10.1001","volume":"7","author":[{"given":"John Z.","family":"Metcalfe","sequence":"first","affiliation":[{"name":"Division of Pulmonary and Critical Care Medicine, Zuckerberg San Francisco General Hospital and Trauma Center, University of California, San Francisco"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tamsin","family":"Economou","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fahd","family":"Naufal","sequence":"additional","affiliation":[{"name":"Division of Pulmonary and Critical Care Medicine, Zuckerberg San Francisco General Hospital and Trauma Center, University of California, San Francisco"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Murat","family":"Kucukosmanoglu","sequence":"additional","affiliation":[{"name":"D-Prime LLC, McLean, Virginia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Kleiman","sequence":"additional","affiliation":[{"name":"Clario Inc, Philadelphia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick P. 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