KardiaMobile 6L for measuring cardiac QT interval in people having antipsychotic medication
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1 Recommendations
1.1 KardiaMobile 6L is conditionally recommended for use in psychiatric services, as an option to measure cardiac QT interval for people having or about to have antipsychotic medication only if:
a repeat QT interval measurement using a 12-lead electrocardiogram (ECG) device is offered to women who have corrected QT interval (QTc) longer than 470 milliseconds, men who have QTc longer than 440 milliseconds, and people who have an intersex condition or biological therapies relating to gender transition and QTc longer than 440 milliseconds,
training for healthcare professionals on recording an ECG, and measuring and interpreting QT interval is provided
further evidence is generated (see section 4), and
people are offered information about why this testing is done and why testing may be repeated using a 12-lead device after it has been measured using KardiaMobile 6L.
Why the committee made these recommendations
Detecting cardiac abnormalities such as prolonged QT interval in people having antipsychotic medication is important because some antipsychotics can prolong the QT interval and lead to severe cardiac events. There is an unmet clinical need for a more easily accessible and available QT interval measurement in the psychiatric service setting. KardiaMobile 6L has the potential to improve care for service users and to help NHS services to ensure timely ECG testing is available for all while creating more efficient care pathways. In particular, the absence of physical leads may make the test more tolerable for service users.
There is a lack of evidence around how well using KardiaMobile 6L works for measuring QT interval in the psychiatric service setting. There may be differences between a psychiatry population and other populations for example in the ability to sit still or having tremor, which could affect the readings given by the device. How accurate the ECG interpretation is (measuring QT length, calculating QTc, and deciding whether QT is prolonged) may also differ between professionals in different settings. Most evidence on KardiaMobile 6L is in cardiology services. Because of these differences in populations and in healthcare professionals' experience with ECGs, there is a need for a diagnostic accuracy study in the psychiatric service setting.
After reviewing the available evidence, the committee with its clinical experts noted that there may be some differences in the results obtained from measuring a QT interval from KardiaMobile 6L compared with a 12-lead ECG. To reduce the potential effect of false negatives, it decided that a QT interval longer than the relevant specified threshold in section 1.1. should be verified. It is expected that these people will have a 12-lead ECG in a timely manner, and that the number referred should not create an adverse effect on services.
Having early, conditional access to the technology could help people having antipsychotic medication get faster access to safe and effective antipsychotic treatment. Data should be collected so that a full assessment of the clinical and cost effectiveness of the technology can be done. Therefore, KardiaMobile 6L is conditionally recommended for use with evidence generation in psychiatric services as an option to measure QT interval in people having antipsychotic medication. It can only be used if people who need them have access to repeat 12 lead ECGs.
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