CODETECT

Contact details of Research Sites

Site 1 R&D

Site 2 R&D

Site 3 R&D

Why is this study being done?

Over two million people in the UK are unaware that they are living with a long-term (chronic) health condition, such as diabetes or a heart problem. These chronic conditions can lead to serious complications such as heart attacks, strokes, and kidney problems. By diagnosing these conditions earlier, effective treatments can be started sooner which will reduce the risk of harm. However, diagnosis relies on people having symptoms and contacting their doctor with symptoms or attending NHS Health Checks. 

There are over 16 million admissions to English hospitals each year. Hospitals collect a lot of information during a hospital stay including patients’ age, blood test results and blood pressure measurements. Research has shown that this information can be helpful in spotting people with chronic conditions. 

What is the purpose of this study?

This study aims to design and test a digital platform to find the patients in hospital who are most likely to have a chronic (long-term) disease or develop one in the near future.

To do this, we will:

• Use information from earlier research studies and experts to pinpoint which patient information (for example, certain blood tests) would be most useful to spot people with chronic (long-term) conditions.
• Collect relevant information from historical patient records, including who has these risk factors and which patients developed chronic conditions. We will use information from hospital and general practitioner records.
• Build tools to combine this information to predict which people have, or will develop, chronic conditions.
• Implement these tools into a “real-time” digital platform that could be used to find which people should undergo further testing for a chronic condition.
• Ask health care workers to try out the platform to see how easy it is to use.

Who is doing this study?

This study is being conducted by researchers lead by Chief Investigator Professor Peter Watkinson at the University of Oxford, which acts as the Sponsor for the study.

Whose data are included in this study?

The study will include pseudonymised data from all patients admitted to a participating hospital who are registered with a GP practice. Currently participating hospitals include:

-          [INSERT PARTICIPATING SITE NAME HERE]

If you have opted out of research via the NHS National Opt-out this will be respected. What data will be collected?

This study will use data from electronic patient records held by participating NHS hospitals. This includes routine clinical information recorded by healthcare staff.  Participating hospitals will extract participants’ personal information (name, address, date of birth, postcode, NHS number, local patient identifier, any unique client or booking reference—known as direct identifiers) from the dataset before making it available to the study team. The dataset will contain heath data from the time participants were in hospital such as laboratory records, treatments, and drugs. It should be noted that while direct identifiers will not be included in the study dataset, members of the research team may have access to directly identifiable patient data while creating the study data set and implementing the digital platform within the participating trusts IT system.

How will the study collect and process data?

The study will collect data in two distinct stages. Firstly, we will collect and analyse historical patient data from patients previously admitted to hospital, linking it to their GP data made available in hospital systems (we will not be collecting any data directly from GPs). We will collect all these data from participating hospitals electronic patient records. We will use these data to develop and test methods to predict potentially undiagnosed chronic health problems. Secondly, we will apply these prediction methods using "live data" to test the digital platform. The new prediction model will need testing to confirm that it can reliably spot people who have an undiagnosed chronic health condition or are likely to develop one. To do this we will use patients’ medical records to see if they are later diagnosed with a chronic health condition. As we do not yet know how well this will work (hence the need for the research), we will not contact patients to recommend further tests. If the digital platform is shown to reliably find patients with undiagnosed chronic health conditions, we will design a future study where clinicians discuss the predicted risk of an undiagnosed condition with patients and ask if they are willing to consent to further testing.

Access to pseudonymised data will be limited to authorised study team members within Oxford University NHS Trust Secure Data environment or the Data Safe Haven within the University of Oxford’s Critical Care Research Group. Pseudonymised data means all records have a unique study identifier and all directly identifiable data (e.g., names, dates of birth) are removed. If transferred between computers systems, all study data will be encrypted prior to transfer. The study office will then hold only the pseudonymised data securely.

Importantly, while the information received is specific to each participant, no individual person will be identifiable in any publication arising from this work. Your personal data will not be shared with any third parties and will not be used for any automated decision making or profiling.

This research activity is undertaken under “section 251 support” provided by the Health Research Authority, on advice from the Confidentiality Advisory Group (CAG). The study has been reviewed by a research ethics committee(REC). Both the REC and the CAG are groups of independent ethical reviewers who will assess the study to ensure it meets relevant ethical standards. This project also has the support of the Oxford Critical Care Research Public, Patient Involvement (PPI) group.

Future work including refinement and rollout of prediction models may require commercial links, however your data will not be shared with commercial enterprises. 

What will happen to my data?

Data protection regulation requires that we state the legal basis for processing information about you. In the case of research, this is ‘a task in the public interest.’ The University of Oxford is the sponsor for this study. It is the data controller, and is responsible for looking after your information and using it properly. Full details of how your data is processed are described in the study data privacy statement.

We will be using information from your medical records in order to undertake this study and will use the minimum personally-identifiable information possible by removing all direct identifiers before data is shared with the study team. We will store all study data (i.e. data collected from patient medical records) and study documents securely at the University of Oxford for 5 years after the end of the study, as part of the research record.

The local NHS Trust may use your direct personal identifiers (e.g. name, NHS number, date of birth) to link your medical records, including with GP data. All direct personal identifiers will be removed prior to analysis by the study team.

Can I ask that my medical records are not used in this study?

Yes. If you decide you do not want your data to be used for this study you can withdraw at any time, without affecting your medical care. There are several ways to do this:

1. You can register with the NHS Opt-out scheme to stop NHS England and other health and care organisations from sharing your data for research and planning. NHS Digital will inform us of anyone who has withdrawn consent in this scheme, allowing removal of your data.
2. You can withdraw consent for this study specifically by contacting your local hospital research and development department at <insert local Trust R&D department name and email>
3. You can also withdraw consent for this study specifically by visiting and following the process outlined on the study website at https://tinyurl.com/codetect-study under the “use of personal data” tab, OR contact the study team directly using the details below.

Your personal data is also protected by the General Data Protection Regulation and Data Protection Act 2018. Further details of these protections are given in the study Privacy Notice.

Further information and complaints 

Data protection regulation provides you with control over your personal data and how it is used. When your health care information is being used in research, however, some of those rights may be limited in order for the research to be reliable and accurate. Further information about your rights with respect to your personal data is available at https://compliance.admin.ox.ac.uk/individual-rights or by contacting the study team using the details below. The University’s data protection officer (DPO) can be reached at data.protection@admin.ox.ac.uk.

If you have further questions or are not happy with the way your data has been handled, please contact the study team using the contact details below. Alternatively, you can contact the study sponsor on 01865 616480 or rgea.complaints@admin.ox.ac.uk. You have the right to lodge a complaint with the Information Commissioner’s Office (0303 123 1113 or www.ico.org.uk).

Study team

Chief Investigator: Professor Peter Watkinson

Kadoorie Centre for Critical Care Research and Education, Level 3, John Radcliffe Hospital, Headley Way, Headington, Oxford OX3 9DU

Email: ccrg.research@ndcn.ox.ac.uk

Tel: +44 (0)1865 223101