Why does AMALFI need my data?
The AMALFI study has been designed to see if using a new home ECG monitor called a Zio Patch, will increase the number of people detected early with atrial fibrillation and therefore to bring down their risk of having a stroke. To do this we hope to recruit around 2500 people, half of whom will be asked to wear a patch and half of whom won’t need to. The reason for this approach is because we need to compare different treatments to find out which one is best for patients, so we divide participants into groups and give each group a different treatment. The groups are then compared to see if one treatment is better.
To compare the two groups in AMALFI, we will count how many people are diagnosed with atrial fibrillation at 1, 2½ and 5 years after entering the study. We will then analyse if there was any difference in the number of events between those who had a patch and those who didn’t. To enable us to do this we need to collect data during the course of the study which will come from your GP or NHS Digital. This will be routinely collected data (i.e. information that is normally collected as standard practice) and will include individual, patient-level data about any deaths or significant new medical diagnoses and medication, as well as data about in-patient hospitalisations, including major events such as heart attacks and strokes.