Accessing data from NHS Digital and the Office for National Statistics (ONS)

For this follow-up study, we will be requesting permission for subjects to access their electronic health records (held by NHS Digital) and the ONS mortality dataset, provided by NHS Digital on behalf of ONS, sourced from Civil Registration Data. We will obtain mortality data (date of death) held by NHS Digital.

In order to access the data, we will be providing some identifying information to NHS Digital, to include your name, date of birth and NHS number, as well as your FOURIER ID in order to link our FOURIER subjects to the NHS Digital database.

We will use this to additionally link participants to hospital NHS electronic health records for hospital admissions. This will allow us to compare rates of important health outcomes, including all cardiovascular events, experienced by participants in different randomised groups.

The data that we receive and analyse will be identified by an anonymised trial number only, and will not be identified by name, date of birth, NHS number or address. This information received from NHS Digital will be imported into a database held securely by Imperial College London (Data Controller), and used solely for academic research purposes. Before analysing this complete dataset (including information already provided by trial participants with information from NHS Digital) patient identifiers will be removed. Importantly, whilst the information received is specific to each trial participant, no individual person will be identifiable in any publication arising from this work. Anonymous results of the study may be made available to collaborators and relevant bone fide researchers according to the Imperial College London data sharing policy.

What if I wish to withdraw?

If participants decide they do not want their study data to be linked in this way they can withdraw from this follow-up, without affecting their current medical care, by contacting the NHS Digital for the national data opt-out, information available on the NHS Digital webapges

Can I take part in the study?

  • You must have completed a final (close-out) visit for FOURIER (whether you were still taking study medication or not).
  • You must have not been recruited into the FOURIER open-label extension study.
  • You are still eligible for the FOURIER Legacy study if you have joined other clinical trials, as the LEGACY study does not involve taking any medication and is only a questionnaire follow-up.     
  • The study is now closed to recruitment as of the 13th of January 2021