If you are invited back for further tests after your Lung Health Check, we would like to invite you to take part in a research study being led by the University of Oxford. This research study is called DART, which stands for ‘The Integration and Analysis of Data using Artificial Intelligence to Improve Patient Outcomes with Thoracic Diseases’.

The study aims to improve the diagnosis and treatment of lung cancer in the future using computer technology and data from patients who attend the Lung Health Checks. This data could include clinical data and CT scan images, which will be analysed by computers in a process known as intelligent medical imaging or artificial intelligence.

The study will use computer technology (also called artificial intelligence), medical imaging and data from people attending a Lung Health Check to:

• Develop new ways of finding and interpreting evidence of lung health problems, for example, lung cancer.
• Develop tools to screen patients with possible lung health problems more easily, which will mean problems are diagnosed earlier and patients will not need surgery as often.
• Identify more easily the best treatment options for patients.

We aim to develop ‘intelligent’ tools to support radiologists in their analysis, so that we can provide faster and more accurate results and better patient care.

The study will use data and samples from participants who have had a Lung Health Check to develop new ways of using of computer technology (artificial intelligence) to improve lung health care. The study uses computer programs (called ‘algorithms’) which can be trained to analyse medical images. Training these algorithms requires large amounts of data so that the algorithm can ‘learn’ to recognize a normal scan or detect different kinds of abnormalities. Once developed, these algorithms can be used to support doctors in analysing scans by increasing their speed and accuracy. The data that you contribute will be used to help design and train these algorithms, as well as contributing to other health research studies.

All research in the NHS is looked at by independent group, called a Research Ethics Committee, to protect your interests.

Medical imaging (or ‘scanning’) allows doctors to ‘look inside’ a patient’s body. It is an important tool in the diagnosis of injury and illness. It can also help us better understand the progression of disease and choose the most effective treatment. Medical images are assessed by highly trained doctors called radiologists.  

We aim to develop ‘intelligent’ tools to support radiologists in their analysis, so that we can provide faster and more accurate results and better patient care.

Intelligent Medical Imaging uses computer programs (called ‘algorithms’) which can be trained to analyse medical images. Training these algorithms requires large amounts of data, so that the algorithm can ‘learn’ to recognize a normal scan or detect different kinds of abnormalities. Once developed, these algorithms can be used to support doctors in analysing scans, to increase their speed and accuracy. The data that you contribute will be used to help design and train these algorithms, as well as contributing to other health research studies. 

In this project, artificial intelligence is the use of computer technology to create software (algorithms) which can be used to detect abnormalities more quickly, more effectively or with less discomfort to patients than is possible without computer involvement.

Computers are trained to read scans for information.  The greater the volume of data used in training computers, the more accurate their predictions can become.

You will be making a valuable contribution to the development of intelligent medical imaging in the NHS, which has the potential to improve diagnosis and treatment across a wide range of injuries and illnesses. It may not help you directly, but we believe that this will help to improve the quality of care for patients in the future.

By taking part you help promote the development of new technology, to better diagnose and treat patients, by providing researchers with controlled access to research data from large numbers of people.

Your lung health check and any follow-on appointments, if needed, will take place as normal.

The majority of individuals who agree to be part of the DART project will not have to do anything additional.

Participation is voluntary and you may change your mind at any time. Leaving this study will not change your health care. If you change your mind about taking part in the study at any time, all you need to do is contact your local Lung Health Check Service or ouh-tr.dart@nhs.net and ask for any of your data that has not already been used in reports to be removed from the study.

You can find details of your Lung Health Check on this page.

Not at all.

It is completely up to you to decide whether or not to take part; participation is entirely voluntary. If you do decide to take part, you will be asked to sign a consent form. You will remain free to withdraw at any time. You do not have to give a reason and this will not affect your clinical care or treatment (if you are undergoing treatment).

If you change your mind about taking part in the study at any time, all you need to do is contact the Lung Health Check Service and ask for your data to be removed from the study.  You can find details of your Lung Health Check on this page.

Data collected by DART will be stored in the NCIMI Research Database.

Over the past 30 years, medical imaging such as X-Ray, MRI and CT scans have transformed how medical professionals diagnose diseases and chronic conditions. Every year the NHS performs 40 million scans, but these are not stored or analysed in the same way throughout the NHS. Subject to patient consent, NCIMI’s aim is to collect this kind of information inside one secure central research database. By creating a source of high-quality data from a large number of patients across the UK, the NCIMI database will allow researchers to make the best use possible of patient data.

A small number of people will be called back for biospies or resections. Your hospital will run tests on them. Normally, the slides are then stored as part of your medical record. During the biopsy or resection, a tiny sample is put onto a microscope glass slide These slides are used by doctors to help decide on the treatment needed.

The hospital will send your slides securely to the DART study team. A study number will be added to your slides (so you cannot be identified) and they will be scanned onto a computer. Your slides will then be returned to your hospital and stored as part of your medical record as usual.

Computers will be trained to read your scanned slides. This will help develop artificial intelligence which can be used by the NHS in the future to diagnose lung disease more quickly and more easily in future.

SCOOT is the Sample Collection for the Integration and Analysis of Data using Artificial Intelligence to Improve Patient Outcomes with Thoracic Diseases.  It is tasked with collecting blood samples for DART researchers.

At the initial Lung Health Check you have the opportunity to donate data, including general information from the medical records gathered during your Lung Health Check, as well as a copy of your CT images and scanned copies of any biopsy or resection slides..  You do not have to do anything for this to happen, data is shared with DART by the Lung Health Check, but if you do not want to participate you can tell them at any time.

SCOOT requires the donation of a blood sample (up to 30mls or 2 tablespoons).  This is additional to your normal health care so you will be asked to give permission for this.

If your health team decide you would benefit from further examination, at that time you will be asked to provide an additional small sample of blood (30mls, equivalent to approximately 2 tablespoons), taken from the cannula you have already had inserted for the PET-CT scan or tissue biopsy which will be used for the project. You won’t have to come to the hospital for an additional appointment to give this blood sample.

If you are thinking about taking part in another study, or you are currently taking part in another study, they may need to know about the blood sample we take. Please inform them.

You will be asked to provide a small sample of blood (30mls, equivalent to approximately 2 tablespoons), taken from the cannula you have already had inserted for the PET-CT scan or tissue biopsy. You won’t have to come to the hospital for an additional appointment to give this blood sample.

Blood samples will be used to check the effectiveness of a test which has already been developed by a commercial company who are called Roche, before it can be used in the NHS.  Roche are a pharmaceutical company and a partner in the DART study. Half of your blood sample will be used by Roche and half will be used by University researchers and may be used soon after collection but it is more likely that it will be stored for many years. We will not contact you in future if we want to make use of the sample you have already provided.

The research may take place in hospitals, universities, non-profit institutions or commercial laboratories/ companies worldwide, and will have been approved by a recognised ethics committee. The research may be funded by research councils, research charities, government bodies, commercial companies or other organisations. All projects are reviewed and must meet regulatory conditions before being allowed to use your samples. We sometimes charge researchers for providing samples to cover our running costs but would never make a profit from your samples.

After you donate the blood sample, it will be labelled both with your NHS number as well as a unique study sample number and sent securely to a laboratory that is licensed to look after your samples.

This means that nobody outside of DART and the NHS will be able to identify you from your sample.

Samples you donate  as a gift will be transferred to laboratories for analysis and storage. These laboratories may be owned by universities, the NHS charitable organisations or companies in this country or abroad. As a gift, you understand that if this research leads to the development of a new treatment or medical test that you will not benefit financially. We would like to keep your samples for possible use in future studies or diagnostic test development that cannot yet be specified. We may share samples with scientists at other organisations including private companies located within the UK or abroad. The use of data or tissue samples in future studies will be only be carried out if further review and approval is given by an independent committee.

Data collected by DART/SCOOT will be stored in the NCIMI Research Database.

Over the past 30 years, medical imaging such as X-Ray, MRI and CT scans have transformed how medical professionals diagnose diseases and chronic conditions. Every year the NHS performs 40 million scans, but these are not stored or analysed in the same way throughout the NHS. Subject to patient consent, NCIMI’s aim is to collect this kind of information inside one secure central research database. By creating a source of high-quality data from a large number of patients across the UK, the NCIMI database will allow researchers to make the best use possible of patient data.

Any data which identifies you will be tightly controlled and only Data Managers working for DART will have access to it. Researchers, including third parties working with the University of Oxford on this study, will not have access to any data which identifies you. Any research which is published will also never identify individuals.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.  

We will keep all information about you safe and secure.  

We have strict measures in place to protect the security of your data, and ensure it is kept confidential.  

• We do not include any details which make you identifiable. 
• We keep any information that could identify you (e.g. your NHS number) separately from other information in the Research Database. 
• If your information is transferred using your NHS number – (this may be done in some sub-studies to ensure that the data about you is able to be linked and not mixed up) – this data will always only be transferred to the NHS Radiology Research Facility in the Churchill Hospital in Oxford, and only viewed by Oxford NHS staff. It will immediately be anonymised in Oxford and only anonymised data will ever leave the NHS facility in Oxford. 
• We use firewalls and other security measures to block unauthorized access to the computers which hold personal information. 
• All of our procedures comply with international standards, including the General Data Protection Regulations (GDPR). 

Data protection regulation provides you with control over your personal data and how it is used.  When you agree to your information 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: http://www.admin.ox.ac.uk/councilsec/compliance/gdpr/individualrights/ 

Your data will be transferred and stored carefully and in accordance with General Data Protection Regulation (GDPR). As above [link to will my data be kept confidential] your data will be kept confidential and researchers will not be able to identify you. Any research which is published will also never identify individuals. However, there is always a very small risk of a data breach when data is stored. The University of Oxford has procedures in place to address this, if it should happen.

The minimum possible identifiable information will be used when transferring your samples. Your samples will be labelled with your NHS number before they leave your hospital. Before they are shared with researchers, samples will be given a study code (and the NHS number will be removed) so that researchers/ scientists using the samples will not be able to identify you as the donor. This code will be stored on a secure computer network within the Oxford University Hospitals NHS Trust.  Data linked to samples by a code in this way is called pseudonymised.

Only the clinical lead of the study (Prof Fergus Gleeson), and personnel authorised by him, will have access to the study codes so they are able to link the various samples from the same donor.

Your information will be treated in the strictest confidence. Researchers will not have access to any information which can identify you. When research from this study is published no individual participants will be identified.

Further information about your rights with respect to your personal data is available at: http://www.admin.ox.ac.uk/councilsec/compliance/gdpr/individualrights/

Data protection regulation also requires that we state the legal basis for processing information about you.

The legal basis for the processing of data about you will be:

• GDPR Article 6(1)(e):
  • the Processing is necessary for the performance of a task – namely research – carried out in the public interest.

And in the case of Special Categories of Personal Data:

• GDPR Article 9(2)(j):
  • Processing is necessary for archiving purposes in the public interest, scientific or historical research purposes, or statistical purposes.

Your local trust will keep identifiable information about you, such as the consent form, in keeping with local policies for retention of medical records.

Some of your information may be accessed by approved researchers in countries outside the UK. They must follow all the same rules as UK-based researchers to keep your information safe.

Only approved researchers will have access to the data. This may include researchers at UK universities and research institutions, scientists working in countries outside the UK, and in commercial companies. The NCIMI data access committee, composed of expert researchers, ethicists, and representatives of the public, are responsible for approving data access. 

Some of your information will be accessed by approved researchers in countries outside the UK. They must follow all the same rules as UK-based researchers to keep your information safe.  

We will never pass your information to insurance companies, or employers. We will not allow relatives to access your information without your permission. Any access to your information by legal authorities (e.g., police) will be done in accordance with data protection regulations (i.e., GDPR).

Research results will be published in journals and may be shared at conferences. You will not be identified in these publications.   

Scientists and researchers who use the data from the NCIMI Research Database must make public the results of all research so that everyone can benefit from its findings. We have also developed agreements with commercial partners to ensure that the NHS receives ‘fair value’ for health data. For more information about our work ensuring fair value visit the NCIMI website.

In the first instance, you can talk to the nurse or doctor at your lung health check appointment who will explain the study to you.

If you still have questions or concerns, please contact:

Chief Investigator: Professor Fergus Gleeson 

Study Office: National Consortium of Intelligent Medical Imaging (NCIMI), The University of Oxford, Big Data Institute, Old Road Campus, Roosevelt Drive, Oxford, OX3 7LF 

Email: dart@oncology.ox.ac.uk 

Telephone number: 01865 618184 

Your best sources of information about lung cancer is your GP, oncology nurse or the Roy Castle Lung Cancer Foundation https://www.roycastle.org/help-and-support/

Roy Castle Lung Cancer Foundation offer a wide range of lung cancer information so everyone affected can understand the disease. They work with lung cancer experts and others affected by the disease so the information they provide is relevant, clear and accurate.

Their lung cancer information covers all aspects, from advice on living with lung cancer to treatments such as chemotherapy and understanding what lung cancer is. The information will help you from the time you are diagnosed, as well as supporting you through and after any treatment.

You will also find more information from the Lung Health Check websites