2 Evidence gaps
This section describes the evidence gaps, why they need to be addressed and their relative importance for future committee decision making.
The committee will not be able to make a positive recommendation without the essential evidence gaps (see section 2.1) being addressed. The company can strengthen their evidence base by also addressing as many other evidence gaps (see section 2.2) as possible. Addressing these will help the committee to make a recommendation by better understanding the patient or healthcare system benefits of the technology.
2.1 Essential evidence for future committee decision making
Testing and interpretation
Addressing these evidence gaps is necessary to understand the resource use impact:
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how long it takes to do the test and get the QT interval result using KardiaMobile 6L and a 12-lead electrocardiogram (ECG) device
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how often ECGs are interpreted by different healthcare professionals, and by different services, when using KardiaMobile 6L and a 12-lead ECG device
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how often QT interval measurement is repeated using a 12-lead ECG device after using KardiaMobile 6L and why.
Diagnostic accuracy
This evidence is needed to ensure that KardiaMobile 6L is effective in measuring QT interval in adults having or about to have antipsychotic medication.
Time to antipsychotic medication and impact of ECG result
Evidence is needed on 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. Differences in how long it takes to do the test, who interprets the ECG, and the number of repeat tests (see the section on testing and interpretation) may also affect the time to antipsychotic medication.
In addition to diagnostic accuracy (see the section on diagnostic accuracy), evidence is needed on whether QTc measurements from a 12-lead ECG device and from KardiaMobile 6L lead to different treatment decisions.