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NICE publishes draft guidance evaluation for smartphone-linked ECG device

NICE has published its first draft guidance from its early value assessment pilot project on a smartphone-linked ECG device for measuring cardiac QT interval in people having antipsychotic medication.

The draft guidance, now subject to a consultation phase, focuses on the KardiaMobile application, a portable ECG device to provide readings on a smartphone.

This topic is the first to use the new early value assessment approach from NICE, which aims to provide quicker conditional recommendations from the organisation on promising medical technologies. For the evaluation of the KardiaMobile tech, a consultation phase is now open to support the process, and a final recommendation published from NICE is expected in October 2022.

Commenting on the pilot project, NICE noted that there is “unmet clinical need for a more easily accessible and available ways to measure heart rhythm disturbance such as QT interval in the psychiatric service setting.” The body added that “a portable ECG recording device that is a less intrusive way of measuring heart changes may affect the choice of medication taken for psychiatric disorders.”

In the draft recommendation, NICE says that “using the KardiaMobile device should be offered as an option in psychiatric services to measure heart rhythm disturbances”, such as a QT interval, in “people taking or about to take antipsychotic medication while further real-world evidence is generated”.

The consultation process for this device has started, with comments requested to be submitted by Thursday 25 August 2022.

The advisory committee reviewing the consultation are looking for comments on whether all the relevant evidence has been considered; whether the summaries of clinical effectiveness, costs and resource use reasonable interpretations of the evidence; and whether the recommendations are sound, and a suitable basis for early value guidance to the NHS.

To find out more, please visit the NICE website here.