Title: KardiaMobile 6L for measuring QT interval in people having antipsychotic medication [DAP62]
Funder: Department of Health and Social Care

Abstract: Some medicines used for people with certain mental health problems can increase the risk of developing serious heart conditions. Although these heart conditions are rare it is generally recommended that people have an electrocardiogram (ECG) examination before starting to take these medicines. People who need to continue on these medications over a period of time may need additional ECGs every so often, to check for any heart problems that have developed recently._x000D_ _x000D_ An ECG is a test to check whether there are any problems with the heartbeat. This can include a heartbeat that is irregular or too fast. ECGs are usually carried out in hospitals or GP surgeries. The machine that is most often used is called a 12-lead ECG. A nurse or doctor will ask the patient to remove their upper clothing and it is possible that the patient’s skin might need to be cleaned or shaved. The nurse or doctor will then place several small electrodes onto different parts of the patient’s body including the chest, wrists and ankles. A special gel is applied underneath the electrodes to help them pick up the heartbeat. This gel usually feels cold on the skin. The patient is asked to keep still for a few minutes while the ECG test is being done. The ECG records a tracing of the heartbeat from different angles which can help to show which part of the heart has a problem. The ECG tracing can be viewed on a screen or saved as an electronic file or printed on paper. Having an ECG is not painful and does not involve delivering an electric shock to the patient. However, some people may find the procedure upsetting because having to undress and be washed or shaved or having a cold gel applied may be distressing or unacceptably intrusive. In addition, some patients may have difficulty in travelling to a hospital or GP surgery to have the ECG carried out._x000D_ _x000D_ KardiaMobile 6L is a portable (or 6-lead) ECG may offer a less intrusive way to take ECG measurements. This is because less undressing is not needed since the electrodes are only applied to the wrists and ankles and the cold gel is not needed. Testing using the KardiaMobile 6L device can be carried out at the patient’s home. These features might mean that the KardiaMobile 6L device could be more acceptable than the 12-lead ECG to some patients._x000D_ This assessment will consider whether the KardiaMobile 6L device has the potential to provide an effective and safe alternative to 12-lead ECG for initial assessment and monitoring of the risk of cardiac problems in people taking antipsychotic medications.

Lay abstract: This assessment aims to provide a comprehensive summary of all available evidence that may be relevant to the potential implementation of KardiaMobile 6L, in the context of QT-interval assessment for service users who require antipsychotic medication. It is anticipated that currently available evidence will not be sufficient to inform assessment of the efficacy and safety of KardiaMobile 6L, in people taking antipsychotic medications, and to support full cost effectiveness modelling. The assessment will, therefore, focus on whether the KardiaMobile 6L device has the potential to offer advantages over the use of 12-lead ECG for initial assessment and monitoring of the risk of cardiac problems in people taking antipsychotic medications, such that further research to establish clinical efficacy and safety is warranted. The assessment will include a detailed description of evidence gaps where further research is required. This assessment will not include cost effectiveness modelling, but may inform exploratory modelling to be undertaken by the NICE Decision Support Unit (DSU).

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: CARDIOVASCULAR;MENTAL HEALTH