JAMA Study Shows a 6-Lead Device Could Reduce the Need to Perform a 12-Lead ECG In Resource Limited Settings
A new peer-reviewed study published in JAMA suggests that a 6-lead ECG device is an effective triage test and could reduce the need to perform standard 12-lead ECG monitoring in resource-limited settings.
At a QTc interval threshold of 500 milliseconds, the handheld 6-lead device had a high negative predictive value of 99.8%. The remote-friendly, easy-to-use, handheld device is pivotal in delivering high-quality trial data while alleviating long-standing cardiac monitoring challenges.
Traditional Challenges and Risks of 12L ECGs
While long trusted as the gold standard for cardiac monitoring, traditional standard 12-lead ECGs require a consistent power supply, specialized equipment, and trained personnel to accurately place leads, making them less practical and cost-effective¹, especially in resource-limited settings.
Additionally, the in-person office visits required for standard 12-lead ECGs can be invasive and burdensome for patients, leading to decreased adherence and the potential for decreased recruitment and study progress.¹
6-Lead Device Offers Clinical Trials Ground-Breaking Benefits
Accessible and Affordable
A 6-lead device can reduce study costs and resource usage by eliminating the need for expensive, time-consuming, and non-portable standard 12-lead ECG machines. In settings where remote monitoring is vital but traditionally burdensome, like patient homes or resource-limited sites, a 6-lead device offers efficient and non-invasive cardiac monitoring. This ease of use allows for broader demographic and geographic participation in clinical trials, ensuring diverse populations are included in research.
Empowering Patient-Centric Studies
The handheld, user-friendly design of a 6-lead device reduces the burden on patients while empowering them to take control of their care. Able to complete an ECG in 30 seconds without wiring or patches, patients can avoid the time-consuming procedures associated with standard 12-lead ECGs. This streamlined approach enables sponsors to better recruit and retain participants while ensuring high-quality data collection and compliance.
Efficiency for Clinics
In any clinical setting, the portable 6-lead device provides high-quality results faster and more easily, streamlining clinician workflow. The ability to transmit data in real time allows sponsors to receive ECG data from any location, speeding up the trial process and maximizing efficiency.
New Research Validates 99.8% Effectiveness
A recent study conducted in South Africa and published by JAMA ("Validation of a Handheld 6-Lead Device for QT Interval Monitoring in Resource-Limited Settings") compared a 6-lead device to traditional standard 12-lead ECGs in a resource-limited setting and delivered data with near-perfect accuracy.
"At a QTc interval threshold of 500 milliseconds, the handheld 6-lead device had a high negative predictive value of 99.8%²"
75% of nurses in the study recommended the 6-lead vs the conventional standard 12-lead device². 100% said they were confident in the results.² Citing the need for specialized supplies, consistent power, and trained personnel to accurately place leads, clinic professionals noted the standard 12-lead device was more difficult to use.
"Most nurses (75%) reported that the 6-lead device was easy to use and that patients were more satisfied with the testing relative to the standard 12-lead ECG, all were confident in the results provided and felt that the 6-lead device would improve clinic workflow, and most (75%) recommended the 6-lead over conventional standard 12-lead device.²"
Strategic Implications for Clinical Research
Proven remote cardiac monitoring technology signifies a shift towards innovative, efficient, and patient-friendly clinical trials. This breakthrough challenges the traditional standard 12-lead ECGs and paves the way for adaptable and scalable approaches in clinical trials and routine care.
Adopting digital health technologies is expected to enhance the speed and quality of clinical research by reducing logistical constraints and improving data accuracy. This supports the demand for decentralized and hybrid clinical trials, integrating real-world data seamlessly.
Moreover, embracing such technologies highlights the industry's commitment to innovation and patient-centricity, ensuring accessibility and inclusivity in medical research. The integration of these devices will drive further advancements in digital health, contributing to a more connected and responsive clinical research ecosystem.
Read the full article to discover how advanced ECG technologies can transform your clinical trials.
1 Chang, Ruey-Kang. "12-Lead ECG Systems in Clinical Trials." Clinical Trials Arena. 23 November 2018. clinicaltrialsarena.com.
2 Metcalfe JZ, Economou T, Naufal F, et al. Validation of a Handheld 6-Lead Device for QT Interval Monitoring in Resource-Limited Settings. JAMA Netw Open. 2024
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JAMA Study Shows a 6-Lead Device Could Reduce the Need to Perform a 12-Lead ECG In Resource Limited Settings
At a QTc interval threshold of 500 milliseconds, the 6-lead device had a high negative predictive value of 99.8% and was an effective triage test. This validation is pivotal for sponsors aiming to deliver quality data while alleviating common cardiac monitoring challenges.
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