How is information collected about me in AMALFI?
Potential participants for AMALFI are identified by their GP Practice and sent an invitation pack including a brief questionnaire. Those who are interested in taking part, complete the questionnaire which contains personal details (such as NHS number), contact details and 8 medical questions (such as ‘Have you had a heart attack?’) with yes/no answers. This questionnaire is returned to the study coordinating centre in Oxford and contains the only data that the study team have about participants at the beginning of the study.
However, if you decide to take part, further information will be requested from your GP and the coordinating centre in Oxford will ask for information about your health from NHS Digital. The AMALFI team would send your name, date of birth, NHS number and postcode to NHS Digital, who can link this information to individual participants in the study. NHS Digital then provides information about any admissions to hospital (called Hospital Episode Statistics) as well as information from primary care records and medications, and information about people who may have passed away, in order that the study does not make contact and cause any distress to relatives. This information includes date and cause of death. You can contact the study team at any time to withdraw permission for the study to obtain this information from your GP or NHS Digital.
If you decide to take part in the study, we will also ask you to complete a questionnaire (EQ5D) which aims to collect information about quality of life. We will do this either over the post or online at two timepoints: when recruitment to the study is completed, and approximately 2.5 years after that.
If you do choose to take part in the AMALFI study you will be free to withdraw at any stage. If you decide you no longer wish to continue, you can contact the study team, let us know you have changed your mind and we will remove your details from our contact list. You do not have to tell us the reason for decision if you do not wish to do so.