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Bleeding affects up to 40% of all trauma patients, up to 30% of all surgery patients and is one of the commonest causes of death for women giving birth. The presentation and features of bleeding are different between patients – in some cases bleeding is very obvious to recognise, but in other cases bleeding is more “hidden”, for example in the stomach. Bleeding must be stopped promptly to prevent severe illness or death. 

Many studies have shown differences in how patients who bleed are treated. There is also variation in how individual patients respond to the same treatment, with some patients doing better than others. Understanding how variation in practice and patient characteristics affect outcomes will help us design and test improvements in care.

Patients in hospital have regular tests that measure levels of the different types of cells in their blood and its ability to clot. For example, a drop in red blood cells can indicate that patients have suffered bleeding. More advanced blood tests are available that can provide more detailed information on why patients are bleeding and what treatments might be most effective.

This study aims to develop a real-time, hospital-wide digital system to identify patients in hospital who have suffered from bleeding and test whether this system could be used in the future to potentially identify patients to recruit into trials of new treatments or blood tests.

To do this, we will:

  • Assemble a panel of experts to identify criteria (for example, specific blood test results and drug prescriptions) that could indicate a patient has suffered from bleeding
  • Use historical electronic patient records to test how well these criteria identify patients who have received treatments for bleeding (blood transfusion)
  • Develop and refine a web-based digital system where the most useful criteria can be applied in “real-time” to identify bleeding patients
  • Test how well the digital platform identifies bleeding patients
  • Test whether a significant number of patients identified by the digital platform are willing to allow their routine blood samples tested for blood clotting and endothelial factors.

RE-BLEED:   A digital platform for identifying bleeding patients – a feasibility study

Who is responsible for your data?

The data controller for this study is the Sponsoring organisation, University of Oxford.

How will the study collect and process data?

This study does not change or affect patient care.  This study has been reviewed and approved by South Central, Hampshire A Research Ethics Committee  (21/SC/0290).

Data protection regulation requires that we state the legal basis for processing information about you.  Research is a task that we perform in the public interest. The University of Oxford, is the sponsor for this study, is based in the United Kingdom and is the data controller. This means that we, as University of Oxford researchers, are responsible for looking after your information and using it properly. We will use the minimum personally-identifiable information possible.

The study relies on accessing a large number of patient records. The first phase (retrospective cohort) of the study uses already anonymised data, whilst the second phase (prospective cohort) of the study requires access to health records gathered without individual patient consent. This is justified on the basis that in order to advance our understanding of bleeding, we need to detect as many early signs of bleeding as possible and this can happen at any time of the day or night.  It would therefore not be feasible to ask all patients in the hospital for their consent to be screened for possible bleeding, as this could occur at any point during their stay in hospital.

The study will use data, collected as part of patients’ routine care, to construct a research database of patients who have likely experienced bleeding. Data for those who are screened but who are not identified as having experienced bleeding during their hospital admission will be deleted. 

The legal basis for the processing and storage of personal data for The RE-BLEED Study is that it is ‘a task in the public interest’ (article 6(1)(e)) and, that sensitive personal data is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes (article 9 (2) (j), based on Article 89(1)).

The data provider (Oxford University Hospitals NHS Foundation Trust) will anonymise all participants’ data before transferring it securely to the study office at the University of Oxford. The Oxford University Hospitals NHS Foundation Trust will extract participants’ personal information (date of birth, NHS number, postcode and gender – known as direct identifiers) and create a unique (pseudonymous) study ID.  No direct identifiers (e.g., name, date of birth, NHS number) will be communicated to the study office / sponsor at any time and will not be retained in the study database. The study office will only hold the pseudonymous study ID.  The pseudo-anonymised record will contain other data from the time you were in hospital (such as lab records, treatments and drugs etc.). 

Importantly, whilst the information received is specific to each study participant, no individual person will be identifiable in any publication arising from this work. Your personal data will not be shared with any 3rd parties and will not be used for any automated decision making or profiling.

Under Section 251 of the NHS Act 2006, we have permission to conduct this study without consent.

We have special permission to conduct the RE-BLEED Study without study-specific consent (i.e. link, transfer, process and analyse the data) from the Confidential Advisory Group. This permission is required for the second phase of the study where the This permission is given under Section 251 of the National Health Service Act 2006 and its current regulations, the Health Service (Control of Patient Information Regulations 2002) (CAG reference number: 21/CAG/0123). 

How we use your personal data

Research is a task that we perform in the public interest. The University of Oxford, as sponsor, is the data controller. This means that we, as University of Oxford researchers, are responsible for looking after your information and using it properly. We will use the minimum personally-identifiable information possible.

The legal basis for the processing and storage of personal data for the REBLEED study is that it is ‘a task in the public interest’ (article 6(1)(e)) and, that sensitive personal data is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes (article 9 (2) (j), based on Article 89(1)).

How long we keep your data

The Sponsor will keep a record of your direct identifiers (e.g. data of birth, NHS number) until the end of the study. Your other (anonymised) personal data will be retained for at least five years, in line with the MRC Retention Framework for Research Data and Records and relevant legislation.

Further information on how long research information is retained by the University can be found in the University’s Policy on the Management of Research Data and Records, available via http://researchdata.ox.ac.uk/university-of-oxford-policy-on-the-management-of-data-supporting-research-outputs/.

How we protect your data

The Sponsor has security policies in place to protect your personal data against unauthorised access, unlawful use, accidental loss, corruption or destruction. These policies are reviewed regularly to ensure best practice.

The study will use secure computer systems, secure networking, NHS standard encryption and electronic records, secure disposal of confidential waste and computer storage media, and staff with a contracted obligation to ensure data protection.

Sharing data

The anonymised personal data collected and managed by the Sponsor will only be used for research purposes. The anonymised data will not be combined with any data sources that could identify you.  

Your rights

Under the UK General Data Protection Regulation (UK GDPR), you have the following rights over your personal information/data that we hold:

•            The right to request access to your data

•            The right to request correction of your data

•            The right to request your data is deleted

•            The right to object to processing or restrict processing of your data

For more information, please see: https://compliance.admin.ox.ac.uk/individual-rights. If you wish to exercise any of these rights, please contact the study at ccrg.research@ndcn.ox.ac.uk.

Dissent and withdrawing from the study

If you decide you do not want your data to be linked in this way you can withdraw from the study at any time, without affecting your current medical care, by contacting the study team (details below).

If you have previously completed the National NHS Opt-Out, we will have automatically excluded your data from all phases of the study.  Please feel free to contact us if you have any questions.

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 .

Further information

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 ctrg@admin.ox.ac.uk.  You have the right to lodge a complaint with the Information Commmissioner’s Office (0303 123 1113 or www.ico.org.uk.

Study team

Professor Peter Watkinson

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

peter.watkinson@ndcn.ox.ac.uk

ccrg.research@ndcn.ox.ac.uk

+44 (0)1865 223101    

RE-BLEED:   A digital platform for identifying bleeding patients – a feasibility study

Why is this study being done?

Bleeding affects up to 40% of all trauma patients, up to 30% of all surgery patients and is one of the commonest causes of death for women giving birth. The presentation and features of bleeding are different between patients – in some cases bleeding is very obvious to recognise, but in other cases bleeding is more “hidden”, for example in the stomach. Bleeding must be stopped promptly to prevent severe illness or death. 

Many studies have shown differences in how patients who bleed are treated. There is also variation in how individual patients respond to the same treatment, with some patients doing better than others. Understanding how variation in practice and patient characteristics affect outcomes will help us design and test improvements in care.

Patients in hospital have regular tests that measure levels of the different types of cells in their blood and its ability to clot. For example, a drop in red blood cells can indicate that patients have suffered bleeding. More advanced blood tests are available that can provide more detailed information on why patients are bleeding and what treatments might be most effective.

What is the purpose of this study?

This study aims to develop a real-time, hospital-wide digital system to identify patients in hospital who have suffered from bleeding and test whether this system could be used in the future to potentially identify patients to recruit into trials of new treatments or blood tests.

Study objectives:

·        Assemble a panel of experts to identify criteria (for example, specific blood test results and drug prescriptions) that could indicate a patient has suffered from bleeding

·        Use historical electronic patient records to test how well these criteria identify patients who have received treatments for bleeding (blood transfusion)

·        Develop and refine a web-based digital system where the most useful criteria can be applied in “real-time” to identify bleeding patients

·        Test how well the digital platform identifies bleeding patients

·       Test whether a significant number of patients identified by the digital platform are willing to allow their routine blood samples tested for blood clotting and endothelial factors.

Who is doing this study?

The study is being conducted by researchers at the University of Oxford, which acts as the sponsor for the research.

Who is included in this study?

All patients admitted to the Oxford University Hospitals NHS Trust will be digitally screened for signs that they have acquired bleeding of any severity.  We will only screen adults (16 years of age or over). We will exclude patients who either:

  1. inform us directly that they do not wish their records used in the study, or
  2. do not consent to having their blood samples being used in the study, or
  3. have completed the NHS-Opt out https://digital.nhs.uk/services/national-data-opt-out

How will the study collect and process data?

This study is assessing the feasibility of using a digital system to detect when someone is bleeding during their stay in hospital, using their electronic health care records. The study will collect data in two different stages. Firstly, we will analyse historical data (i.e., from patients previously admitted to hospital) to establish an “algorithm” that can identify patients who are bleeding. Secondly, we will apply this “algorithm” in real-time to screen all patients in the hospital for signs of bleeding.

Stage 1

The Oxford University Hospitals NHS Foundation Trust will extract 10 years of historic patient records including laboratory results, demographics, vital signs, prescriptions and administration of blood products and link them together using name, date of birth, NHS number, postcode and gender.  After they are linked the records will be allocation a unique (pseudonymous) study ID and then all the identifiable data will be removed (known as pseudonymisation).  This occurs before transferring it securely to the study office at the University of Oxford’.  The study office will only hold the pseudonymous study ID.  The pseudo-anonymised record.

Importantly, whilst 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 3rd parties and will not be used for any automated decision making or profiling.

Stage 2

Stage 1 will generate a mathematical set of rules (algorithm) that is designed to identify people who are bleeding using real time hospital data.  Stage 2 is designed to test its ability to work in a live hospital environment.  The algorithm will run on the IT systems of the Oxford University Hospitals NHS Foundation Trust.  It will receive data (similar in type to that used in stage 1) in real-time from all patients admitted to the hospital during the study period.  We will store a copy of all this data in identifiable form during each hospital admission.  If the patient shows signs of bleeding we will retain a copy of these records, if they do not we will delete all the data for this admission at the point they leave the hospital.  

A proportion of patients identified as having experiencing bleeding will be approached in person to provide written consent for us to analyse their left over blood samples.  If any patient removes their consent or contacts the study team to ask not to take part, their records will be deleted.  The data of those who consent and those that have bled but not removed their consent, will be pseudo-anonymised in the same manner as used for stage 1 before the records are securely transferred to the University of Oxford.  At the end of the study period the ability to link the identifiable records held in the OUH with the pseudo-anonymous records held by the University of Oxford will also be deleted.

Can I request 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:

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.

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 .

Further information

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 ctrg@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

Professor Peter Watkinson

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

peter.watkinson@ndcn.ox.ac.uk

ccrg.research@ndcn.ox.ac.uk

+44 (0)1865 223101