4 Evidence generation recommendations

4.1 Further evidence generation is recommended on:

  • the effectiveness (diagnostic accuracy) of using KardiaMobile 6L to measure QT interval in adults having or about to have antipsychotic medications and the effect of the corrected QT interval (QTc) result on clinical decision making

  • how many adults having antipsychotic medication choose to have their QT interval measured using KardiaMobile 6L when it is offered as an alternative to 12-lead electrocardiogram (ECG)

  • how long it takes to do the test and get the QT interval result using KardiaMobile 6L and a 12‑lead device (including set up, ECG recording, QT measurement and correction calculation, reporting time)

  • how often are ECGs interpreted by different healthcare professionals (for example, a psychiatrist or a cardiologist), and by different services (for example, locally by the healthcare professional recording the ECG or making the treatment decision, or by a centralised service) when using KardiaMobile 6L and a 12‑lead device

  • how often is QT interval measurement repeated using a 12‑lead device after using KardiaMobile 6L and why (for example, because of an abnormal QTc result on KardiaMobile 6L, QT interval not measurable from KardiaMobile 6L ECG, or technical failure)

  • how long it takes before antipsychotic medication is started, whether having an ECG delays this and whether any treatment changes are made after the ECG result

  • how many adults who need an ECG to measure QT interval for having antipsychotic medication have one

  • how common prolonged QT is in adults having antipsychotics.

The evidence generation plan gives further information on the prioritised evidence gaps and outcomes, ongoing studies and potential real-world data sources. It includes how the evidence gaps could be resolved through real-world evidence studies.

  • National Institute for Health and Care Excellence (NICE)