FIT for Follow-Up Study
The FIT for Follow-Up study was started in 2012, recruiting almost 6,000 men and women. This study was funded by the Department of Health, through the National Institute for Health Research Health Technology Assessment (NIHR-HTA) programme.
Our Data Protection and Privacy Notice
This privacy notice explains your rights to your personal information, what you can expect us (the Cancer Screening and Prevention Research Group) to do with your personal data and our lawful basis for doing so. This notice also explains who you should contact if you have any queries or complaints about how we are processing your personal data.
Under the 2018 General Data Protection Regulation (GDPR) and accompanying Data Protection Act (2018) ‘personal data’ is any data that can be linked to an identifiable individual (for a full definition see: Information Commissioner’s Office (ICO) website: What is Personal Data?). Some types of personal data, such as health data, are additionally classified as ‘special category personal data’. The law considers special category personal data to be more sensitive and gives it more legal protection (for more information see: ICO website: Special Category Data). As the Cancer Screening and Prevention Research Group processes (processing is the term used to refer to collecting, analysing and storing data) health data, much of the personal data we hold is considered to be special category personal data.
Who is responsible for the lawful processing of your personal data?
The GDPR and Data Protection Act define roles and responsibilities for those involved in processing personal data.
The Cancer Screening and Prevention Research Group (hereafter; CSPRG) are a research group at Imperial College London. The CSPRG can be contacted via the ‘Contact Us’ page on this website. The data controller determines the purpose for which and the manner in which personal data is to be processed (see: ICO website: Controllers and Processors). For the personal data held by the CSPRG, the data controller is Imperial College London. The data controller’s representative for our data is the Director of Information Governance for Academic Health Sciences. All queries relating to the handling of personal data should be directed to the Imperial College London Data Protection Officer via email at firstname.lastname@example.org. Contact details can also be found at the end of this privacy notice.
Why are we processing personal data?
The research focus of the CSPRG is bowel cancer, also known as colorectal cancer. In the UK, every year over 41,000 people are diagnosed with bowel cancer and 16,000 people die from this disease. Through our research we hope to reduce the number of people being diagnosed with bowel cancer and dying from this disease. Much of our work focuses on how to help make bowel cancer screening and surveillance programmes more effective and acceptable for patients, and more efficient for the NHS, and other health services internationally. To understand the effectiveness of bowel cancer screening and surveillance programmes, we conduct large scale studies on procedures conducted and the benefits to patients. Identifiable patient data are usually necessary to track long-term health outcomes for participants enrolled in our studies. The CSPRG therefore needs to collect and hold personal data – often special category personal data. Our more specific purposes for processing data for each of our studies are detailed on the ‘Studies’ pages of our website.
What personal data do we have?
The personal data we hold is special category personal data relating to individual health. For example, for several of our studies we analyse procedure and treatment information, information about cancers occurring, whether they progress and the patients’ long-term health outcomes. In addition, we also often require some basic information about patients such as age and gender to inform our analysis. The full details of the personal data processed for each of our studies can be found on the ‘Studies’ pages of our website.
To fulfil our research aims we obtain personal data from a variety of sources. Much of our data is either obtained directly from NHS Trusts, or via third parties such as NHS Digital, the Office for National Statistics, the Bowel Cancer Screening Programme, National Cancer Registries (including the Welsh Cancer Intelligence and Surveillance Unit) and Information Services Division Scotland, part of NHS National Services Scotland. More detailed explanations of our sources of data can be found on the ‘Patient Data’ page and ‘Studies’ pages of our website.
Where data has been obtained from third party data providers under section 251 approval, national data opt-outs have been applied by the provider since 2016.
How do we process personal data?
All personal data we hold are processed in secure systems. For each active study we have completed a Data Protection Impact Assessment that has been approved by the Head of the CSPRG (as the Information Asset Owner) and the Imperial College London Data Protection Officer. No processing performed by the CSPRG involves automated decision-making or profiling. Unless stated otherwise on the ‘Studies’ pages of our website, all personal data are processed by the CSPRG and certain third parties (see ‘Third-party processing’ below). None of our studies process or transfer individual-level personal data outside the UK.
The Imperial College Data retention schedule mandates that data is retained for ten years after the end of a study (see the College Retention Schedule here). The expected end of these ten year retention periods for each of our studies are listed under the ‘Studies’ pages of our website under the ‘How long will we retain the data?’ sections.
For the purposes referred to in this privacy notice and relying on the bases for processing as set out above, we may share your personal data with certain third parties:
- Other College employees, agents, contractors and service providers (for example, suppliers of printing and mailing services, email communication services or web services, or suppliers who help us carry out any of the activities described above). Our third-party service providers are required to enter into data processing agreements with us. We only permit them to process your personal data for specified purposes and in accordance with our policies.
What is our lawful basis for processing personal data?
Processing personal data requires justification under two legal frameworks: the GDPR/Data Protection Act 2018 and under the common law duty of confidentiality.
Article 6 of the GDPR lays out six valid bases under which personal data can be processed lawfully. We process personal data under lawful basis 6(e) ‘Public task’ as: processing is necessary for the performance of a task carried out in the public interest. We are also required to have a separate lawful basis for processing the more sensitive special category personal data. Our legal basis for processing special category personal data is Article 9(j) ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes […]’
In addition, health data (such as that the CSPRG hold) require a separate lawful basis under the common law duty of confidentiality. In some of our studies, patients consented to be part of the study and for the CSPRG to process their data. In other studies, consent could not be sought due to practical considerations or the nature of the study. In these studies, we have obtained lawful permission to obtain and process personal data under section 251 of the National Health Act 2006. The common law legal bases for data processing in each study are explained in the ‘Studies’ pages of our website under the ‘What approvals has the study received?’ sections.
What are your rights concerning your personal data?
The GDPR grants individuals several rights concerning their personal data:
- The right to object (to processing of the data)
- The right to correct (inaccurate or incomplete data)
- The right to erasure (also known as “the right to be forgotten”)
- The right to restrict processing (e.g. while the accuracy of the data is contested)
- The right to portability (to have a copy of any data you have provided to us)
- The right to access (to have a copy of data we hold about you)
- The right to withdraw consent (if you have previously consented to take part)
If you think that we might be processing your data and you wish to exercise any of the rights listed above, please get in touch using the details on the Contact Us page or by contacting the Imperial College London Data Protection Officer via email at email@example.com. Though it may not always be possible for us to fulfil your request, we will respond to your query within one month. For more information on your GDPR rights, please see guidance provided by the Information Commissioner’s Office.
Where can you direct queries or complaints?
Please be aware that individuals also have a right to complain to a supervisory authority- in this case the Information Commissioner’s Office (ICO) – if they feel their data is being used unlawfully. The ICO does recommend that you seek to resolve matters with the data controller – for our data that is Imperial College London – before contacting the Commissioner’s Office. If you wish to raise a complaint on how we have handled your personal data or if you want to find out more about how we use your data, please contact Imperial College London’s Data Protection Officer via email at firstname.lastname@example.org, via telephone on 020 7594 3502 or via post at Data Protection Officer, Faculty Building Level 4, Imperial College London, London SW7 2AZ. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can raise your complaint with the Information Commissioner’s Office.
Privacy and data protection information relating specifically to the FIT for Follow-Up study
The Cancer Screening and Prevention Research Group (CSPRG) at Imperial College London processed special category personal data for the FIT for Follow-Up study. We used this information to investigate whether a Faecal Immunochemical Test (FIT), once a year, for people with one large or 3–4 small polyps found at colonoscopy (the ‘intermediate risk group’) is an effective and safe alternative to 3-yearly follow-up colonoscopy. The study also investigated how acceptable the FIT is to this intermediate-risk group as an alternative to follow-up colonoscopy, and whether it is a more effective use of health service resources. To fulfil these aims the CSPRG processed special category personal data to track the long-term health outcomes of our study participants. The special category personal data used in this study is crucial to the success of this project, and the public good generally.
Imperial College London (the data controller for data processed by the CSPRG, see above) are the recipient of data for the FIT for Follow-Up study. The special category personal data for the FIT for Follow-Up study was transferred to the CSPRG from four sources, given below.
NHS Digital collect and process data from across the health and social care system in England. NHS Digital provided data about the timings and outcome of colonoscopies and other surveillance to the CSPRG. NHS Digital obtained this colonoscopy data from the Bowel Cancer Screening Programme (BCSP).
The BCSP provided some data directly to the CSPRG. The data provided directly by the BCSP included: patient information (such as names and sex), the results of FIT tests and data about the incidence and progression of cancer. The cancer incidence and progression data were provided to the BCSP by National Cancer Registration and Analysis Service which is part of Public Health England.
Participating patients also provided some information directly to the CSPRG by returning questionnaires.
Pseudonymised questionnaire data was transferred out of the CSPRG to collaborators in the Department of Behavioural Science and Health at University College London (UCL). Pseudonymised data (see also GDPR Article 4.3) are personal data that can no longer be attributed to a specific individual without additional information. In our case, questionnaire data was transferred with easily-identifiable data (such as names and NHS numbers) removed. The data cannot be linked to specific individuals by our collaborators at UCL.
4. University of Southampton
In conjunction with the University of Southampton, the CSPRG developed a Patient Management System to securely store and organise patient data for the FIT for Follow-Up study. The Patient Management System was used to store patient information, organise the timely distribution of FIT kits and store the results of the FITs. The Patient Management System was accessible only to specific researchers in the CSPRG. The University of Southampton have now deleted the data from their system, specifically all data stored in the FIT for Follow-Up Patient Management System (hosted at https://fit.edge.nhs.uk/) or otherwise held by the Clinical Informatics Research Unit at the University of Southampton was deleted and they no longer hold data for the FIT for Follow-Up study. They have completed, signed and returned a CSPRG data destruction notice, confirming the date and method of destruction.
No other data was transferred out of the CSPRG.
What are the aims of the FIT for Follow-Up study?
In the English NHS Bowel Cancer Screening Programme, men and women aged 60–74 years old are invited to participate in screening for bowel cancer every two years. At the time this study was initiated, people in the eligible age range for screening were asked to complete a simple stool test (the guaiac Faecal Occult Blood test, gFOBt), which was sent to them in the post to be completed at home. People who have an abnormal stool test result (traces of blood are found in the stool) are invited for an examination of their large bowel to identify the source of the blood loss. Usually this examination is a colonoscopy, which is carried out by a specialist doctor or nurse in a hospital. One in every 5 people who have their colonoscopy, will have large (1cm across or larger) or multiple polyps found. It is known that people with large or multiple polyps are at higher risk of developing more polyps or bowel cancer in the future; for people with one large or 3–4 small polyps, this risk was classed as ‘intermediate’. At the time of the study, it was recommended that everyone in the intermediate risk group was offered another colonoscopy after 3 years to look for polyps or early cancers – this is called a follow-up colonoscopy.
Although follow-up colonoscopy is the most effective way to protect people in the intermediate risk group from developing cancer, it is not perfect. Colonoscopy is uncomfortable, carries a small risk of complications, and is also demanding on health service resources. More effective, and more acceptable, alternatives to the 3-yearly follow-up colonoscopy are being sought.
The FIT for Follow-Up study looked at whether offering a Faecal Immunochemical Test (FIT), a more sensitive stool-based test, once a year, to people in the intermediate risk group is an effective and safe alternative to 3-yearly follow-up colonoscopy. The study looked at how acceptable the FIT is to this group of people as an alternative to follow-up colonoscopy, and whether it is a more effective use of health service resources. The FIT test is described below.
What type of study is the FIT for Follow-Up study?
The study compared the accuracy of an annual Faecal Immunochemical Test (FIT) with the results of the year 3 follow-up colonoscopy.
People who agreed to take part in our research project and provided their consent were asked to complete a FIT once a year. If any of the annual FIT results were positive, the study participant was offered their planned 3-year follow-up colonoscopy immediately, rather than waiting until the third year. If a participant was negative at each FIT test, they were still offered their 3-year follow-up colonoscopy, as part of standard care within the NHS Bowel Cancer Screening Programme. Anyone who did not participate in the study were still offered a 3-year follow-up colonoscopy as part of standard care within the screening programme.
What is a FIT test (Faecal Immunochemical Test)?
FIT stands for Faecal Immunochemical Test. Like the guaiac Faecal Occult Blood Test (gFOBt), FIT is used to detect blood in the stool that is not visible to the eye (‘hidden blood’). Growths in the bowel, called ‘polyps’ or ‘adenomas’, can lead to small amounts of blood being lost in the stool as hidden blood. Bowel polyps are common and are not cancers, but they can develop into cancer over time, so they are removed if they are found. Bowel cancer can also cause blood to be lost in the stool. The FIT identifies any hidden blood in stool to determine whether an individual needs further examination, which can enable the removal of bowel polyps and identify bowel cancers at an early stage when they are much more likely to be successfully treated. The FIT can be sent in the post, is simple to do and can be completed at home.
When and where did the study take place?
The FIT for Follow-Up study took place in England. It began in February 2012, and recruitment was completed in December 2013. Data collection from participants was completed in 2016, and additional cancer registration data was obtained from Public Health England in 2017. Analysis of the dataset will continue until the end of December 2022.
Who was included in the study?
We invited people to participate in this study through the NHS Bowel Cancer Screening Programme. People were eligible to be invited if they were between 60 and 71 years of age, had taken part in the NHS Bowel Cancer Screening Programme, and tested positive for blood in their stool, and subsequently had a colonoscopy at which one large polyp or multiple small polyps were found (and so were considered at intermediate risk).
What type of information does the CSPRG hold for the purposes of the FIT for Follow-Up study?
We invited approximately 8,000 eligible people from across England to participate in this study between 2012 and 2014 and approximately 6,000 took part. If you received an invitation to participate in the study, your details were kept on a list of invited participants for the FIT for Follow-Up study that is held by the NHS Bowel Cancer Screening Programme. If you decided to participate and returned a consent form, your identifiable details will have been passed to the CSPRG and your data will have been used in the study.
We hold identifiable information (including name, address and date of birth) and clinical information relating to bowel tests during the time period of the study.
What approvals has this study received?
This study received:
- Ethics approval from the NHS Research Ethics Service (NRES) London – City and East committee.
- Section 251 approval from the National Information Governance Board (NIGB) Ethics and Confidentiality Committee (the predecessor of the Confidentiality Advisory Group).
- Research and Development Approval from the Royal Surrey County Hospital NHS Trust.
Why do we need to hold identifiable data for this study?
We needed to use identifiable information for this study to contact participants by mail throughout the study, and we needed to request data on follow-up colonoscopies from the local bowel cancer screening centres.
How long will we retain the data?
Collection of data from the study participants was completed in 2016. Additional cancer registration data was obtained from Public Health England in 2017. Analysis of the dataset will continue until the end of December 2022. It is a requirement of Imperial College London, which is the organisation responsible for this study, that we hold study data for 10 years after the end date. We therefore plan to hold the data for this study until December 2032.
What were the results of the study and what impact have they had?
The FIT for Follow-Up study aimed to find out whether annual Faecal Immunochemical Tests (FIT), which detect traces of blood in stool, are accurate enough to replace three-yearly colonoscopy (an examination of the inside of the bowel) in people who have previously had a large polyp, or a few small polyps, removed at colonoscopy. FITs are quicker, cheaper and easier than colonoscopy, which has risks of complications.
A total of 8,009 people were invited to participate in the study. Of those invited, 5,938 (74%) returned a signed consent form and completed a FIT at year one; these individuals were included in our study. Participation in the study was similar amongst men and women, and across age groups.
We found that FIT was well-accepted with 97% of participants returning FIT kits at years 2 and 3. Over the three years of the study, 786 (13%) participants tested FIT positive and, therefore, required a colonoscopy earlier than usually scheduled.
Unless they had a colonoscopy early as a result of a positive FIT, all participants were invited to have a colonoscopy at the end of the study (after 3 years). Of the 5,938 participants in the study, 5,225 had a colonoscopy at some time during the study. During the three years, bowel cancer was diagnosed in 29 participants and advanced adenomas were diagnosed in 446.
In total, 725 (12%) participants underwent a colonoscopy as a result of a positive FIT result. Amongst these individuals, cancer was found in 17 and advanced adenomas in 151. FIT therefore identified 17 of 29 (59%) participants with cancer and 151 of 446 (34%) participants with advanced adenomas.
Overall, the study demonstrated that annual FIT could identify 59 of every 100 cancers and 34 of every 100 patients with advanced adenomas if repeated over three years. To our knowledge, this study is the only one to have evaluated FIT for monitoring people who have previously had a large polyp, or a few small polyps, removed at colonoscopy.
The results of the FIT for Follow-Up study were published on the NHS National Institute for Health Research website and in the journal GUT in 2018. The results were also presented to an audience of clinicians, gastroenterologists and research scientists at the British Society of Gastroenterology Annual Meeting in Liverpool, UK, in June 2018.