Welcome to the FOCUS trial website.

What is the FOCUS trial?

The FOCUS trial is a randomised controlled trial which aims to find out whether fluoxetine given to people for six months after a stroke improves long-term recovery, even if they do not have depression.

What does FOCUS stand for?

All trials need a 'snappy' name. We have selected 'FOCUS'. 'F' stands for Fluoxetine, 'O' for 'Or', and 'C' for 'Control'. 'US' stands for 'Under Supervision' to emphasise that we are monitoring patients' progress carefully throughout in the trial.


Recruitment has now closed! Thank you to all the participating centres and collaborators.


Privacy Notice

The University of Edinburgh is registered as a Data Controller under the Data Protection Act 1998 (the “1998 Act”). The University of Edinburgh upholds the relevant data protection principles and processes all personally identifiable information about you ("personal data") in accordance with the 1998 Act and other relevant legislation. The FOCUS trial abides by the University of Edinburgh privacy policy. To view this policy which describes the information we collect about you, our security agreement and your rights. https://www.ed.ac.uk/about/website/privacy

 

This notice describes how the FOCUS trial processes your data including NHS Scotland from the Public Benefit Privacy Panel and NHS Digital Hospital Episode Statistics (HES), England and Wales data for the purposes of the FOCUS trial in accordance with University Policy.

Background

The FOCUS trial aims to establish whether a six month course of fluoxetine, started within the first 15 days after an acute stroke, improves patients recovery over the first year. Also whether the treatment is cost effective (i.e. that any costs associated with the treatment are offset by health gains, and or reductions in healthcare and social care costs. This research aims to improve the care received by NHS patients and the use of NHS resources.

Recruitment to the trial closed on the 31st March 2017. 3127 participants were recruited to the trial. The final patient and GP follow-ups for the patients recruited on the 31st March 2017 are due on 31st March 2018. 

 

What legal basis do we have to process this information?

The FOCUS trial required ethically approved voluntary explicit written consent to participate. Information given to the participants, family member or carer in the FOCUS trial is included within the relevant participant information sheets, consent forms, and other project-specific documentation created and supplied by those running the FOCUS trial. Processing your information for the trial is necessary for the performance of a task carried out in the public interest (GDPR Article 6(1)(e)) and under Article 9(2)(j) necessary for archiving purposes in the public interest, scientific or historical research purposes in accordance with Article 89 (1).

 

Where is the data collected from?

The information we process may come from a variety of sources following consent from you or your closest relative or carer for us to do so. This may have been be provided by you, a family member, from your hospital medical records, from your GP records and other approved third parties. The information we collect is restricted to only what is necessary for the conduct of the study.

 

What we do with your information

The FOCUS trial team take our responsibility for looking after your information seriously. We take every step available to keep all data confidential in line with legal rules and guidelines.

As FOCUS is researching long-term recovery and outcomes for participants and the cost effectiveness of the treatment we are interested to find out what happens. For this reason participants all patients in the UK will be followed up with NHS Digital in England and Wales (https://digital.nhs.uk/) and the Public Benefit Privacy Panel for Healthy and Social Care (in Scotland) (http://www.isdscotland.org/index.asp) at the end of the follow-up period of the trial. This will allow us to find out your status and if you have been admitted to hospital or attended hospital as an outpatient (Hospital Episodes Statistics (HES)) within the period of the trial and how long you have spent in hospital. We provide identifiable information (NHS/CHI number, Name and Date of Birth) to NHS Digital or PBPP. Both NHS Digital and PBPP have HES dataset and which they can link to individual participants in the study. NHS Digital and PBPP are subject to strict regulatory standards to make sure care information is looked after in line with good practice and the law.

 

The data received from NHS Scotland and HES will be imported into a securely accessed folder within the Edinburgh University ‘Safe Haven’ and used solely for the purposes of this research by the FOCUS study team. We will augment our FOCUS database with any new information provided by HES/PBPP.

 

Whilst the information received is specific to each study 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 with the appropriate agreements/approvals.

 

 

If study participants decide they no longer want their study data to be linked in this way they can withdraw from this follow-up, without affecting their current medical care in any way, by contacting Professor Martin Dennis, FOCUS Chief Investigator, University of Edinburgh, Centre for Clinical Brain Sciences (CCBS), University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB. Email: www.focustrial.org.uk. Tel: 0131 242 7741.

 

Under Article 17 of the GDPR individuals have the right to have personal data erased. This is also known as the ‘right to be forgotten’. The right is not absolute and only applies in certain circumstances.

 

Individuals have the right to have their personal data erased if:

a)     the personal data are no longer necessary in relation to the purposes for which they were collected or otherwise processed;

b)     the data subject withdraws consent on which the processing is based according to point (a) of Article 6(1), or point (a) of Article 9(2), and where there is no other legal ground for the processing;

c)     the data subject objects to the processing pursuant to Article 21(1) and there are no overriding legitimate grounds for the processing, or the data subject objects to the processing pursuant to Article 21(2);

d)     the personal data have been unlawfully processed;

e)     the personal data have to be erased for compliance with a legal obligation in Union or Member State law to which the controller is subject;

f)      the personal data have been collected in relation to the offer of information society services referred to in Article 8(1).

 

2.    Where the controller has made the personal data public and is obliged pursuant to paragraph 1 to erase the personal data, the controller, taking account of available technology and the cost of implementation, shall take reasonable steps, including technical measures, to inform controllers which are processing the personal data that the data subject has requested the erasure by such controllers of any links to, or copy or replication of, those personal data.

 

3.    Paragraphs 1 and 2 shall not apply to the extent that processing is necessary:

a)    for exercising the right of freedom of expression and information;

b)    for compliance with a legal obligation which requires processing by Union or Member State law to which the controller is subject or for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

c)    for reasons of public interest in the area of public health in accordance with points (h) and (i) of Article 9(2) as well as Article 9(3);

d)    for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) in so far as the right referred to in paragraph 1 is likely to render impossible or seriously impair the achievement of the objectives of that processing; or

e)    for the establishment, exercise or defence of legal claims.

f)     As contractually required, HES data is not kept for longer than necessary and will then be securely destroyed in accordance with the contract. All trial data (research data) will be archived for 15 years after the end of the trial when your data will be disposed of securely in accordance with sponsor policy.

Data Protection Officer

If you have any questions, comments or complaints about how your information is handled in this study, or wish to obtain a copy of the Standard Data Protection Clauses, you should contact the Data Protection Officer (DPO) either via email at dpo@ed.ac.uk or via post to Data Protection Officer, Governance and Strategic Planning, University of Edinburgh, Old College, Edinburgh, EH8 9YL

 

Right to complain

You have the right to complain to the Information Commissioner’s Office, you can use this link https://ico.org.uk/global/contact-us

 

There are National Offices for Scotland, Northern Ireland and Wales (see ICO website).