Participant Information

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 The bladder health checks are being offered to the following people in Yorkshire;

• 2000 men and women in Leeds, that are taking part in the Leeds Lung Health Check, and have agreed to be contacted about other research studies

• 3000 men aged 65-79 years old across Sheffield, Doncaster, Rotherham, and Barnsley registered at selected GP Practices

• 1000 men and women aged 65-79 years old who have been referred for an urgent hospital appointment for the investigation of bladder symptoms.

The bladder health checks will only be offered to select eligible people from the groups stated above. If you receive a self-testing kit in the post, then you will be able to take part in the study.

People invited to take part in YORKSURe will receive a self-testing kit in the post.

The self-testing kit includes 6 urine test strips which you dip into a urine sample. Urine test strips are routinely used for picking up things like urinary tract infections.

We ask that you test your urine once a day for up to 6 days in a row. Self-testing is simple to do and should take you no longer than 10 minutes each day. We will ask you to record your test strip results either via our study mobile App or freephone service. Full instructions are included in the self-testing kit.

There are 2 methods by which you can record your results: either the YORKSURe mobile App or the YORKSURe freephone service.

If you decide to use the App you will need to:

• Download the YORKSURe mobile App. Either scan the QR code in your information booklet or go to the Apple App store or Android Play store on your smartphone and search for ‘YORKSURe’. We would recommend using the QR code reader built into your device camera instead of using a QR reader app.

• Please note that the App is only suitable for smartphones that have a camera with a flash. Tablet devices are not suitable. If your smartphone does not have a camera with a flash, please use the freephone service to record your results.

• If you agree to receive notifications on your smartphone you will receive a daily reminder for the 5 days following your first completed test strip

• Refer to the instructions in your self-testing kit. The App will guide you through the steps.

Please note, the following smartphone models are not suitable for use with the app: POCO, Realme and Samsung A22. Please use the freephone service to record your results if you only have access to one of these phone models.

The scan can be sensitive to light conditions. Try the following tips to help:

• Ensure you have allowed the app permission to access your phone camera. This should appear as a pop-up when you first download the app.

• Scan in good light

• Avoid having a strong light source behind the test strip

• Lay the test strip on a flat surface and hold your mobile phone steady when scanning

• Avoid any shadows on the test strip

• Ensure your test strip is lined up with the blue box displayed on the App screen

Do not worry if you miss a day of testing due to not being able to scan your test strip, this will not affect you taking part in the study. We will only send a replacement kit if you have not been able to complete a minimum of 4 tests.

If you are still having problems, please email us at sth.yorksure@nhs.net and explain the issue as best you can, or consider using the freephone service to record your results. 

There are 2 methods by which you can record your results: either the YORKSURe mobile App or the YORKSURe freephone service.

If you don’t have a smartphone, or you don’t want to use the App, you can call our freephone number on 0800 030 9251. Please note, that this is an automated service for collecting your urine test strip results and is not a helpline.

• If you decide to use the freephone, call the freephone number and follow the prompts to register your Study ID (your Study ID is on your invitation letter)

• On the first call to the freephone service you will be asked some questions about you and your health. The questions you will be asked are listed on page 22-24 of your information booklet, along with the numbers for the answers which indicate the number on the keypad you should press

• After you have dipped your test strip you will need to use your keypad to report the colour of each square on your test strip in order from top to bottom, using the numbers 1 to 5 as indicated on the colour chart on page 26 of your information booklet. Please see the diagram below, ensuring your test strip is positioned so that the QR code is at the top of the test strip, and listen to the freephone prompts to help.

• Please contact the study team if you feel you have incorrectly pressed the wrong number when answering the questions or recording your results.

• Diagram

If your test strips are unusable, you can request a replacement kit. Do not worry if miss 1 or 2 days of testing, this will not affect you taking part in the study. We will only send a replacement kit if you have not been able to complete a minimum of 4 tests.

Please contact us at sth.yorksure@nhs.net if you require a replacement kit. We can only provide you with a replacement kit in the 4 weeks after your original kit was sent out.

Your urine self-test results will be reviewed by one of the study research nurses who will check the information that you recorded either in the App or by freephone. Depending on the results, you will receive either a letter, or a phone call followed by a letter within 14 days of your final test.

If your urine self-test results detect anything abnormal, we will let you and your GP know. You may be invited for further tests in a local GP practice or your local hospital.

The bladder health check is completely free and can be performed in your own home.

For most people, the check will provide reassurance that your bladder is in good health.

For some people, the bladder health check may detect a problem even if you have no symptoms. Finding out about a problem early, before you have symptoms, can mean that treatment is more effective. If your self-test results detect anything abnormal, we will let you and your GP know and you may be invited for further tests.

• If you decide to take part, you will be contributing to important research that may benefit people in the future.

• There are no risks associated with taking part in the study.

• We don’t know whether urine screening may be beneficial or not which is why we are running the study. 

• No screening test is 100% accurate and it could lead to further tests or treatment.

• A disadvantage is the time you will need to complete self-testing; however, this should only take around 10 minutes each day (the first day will take slightly longer).

• We will collect information from you about any bladder symptoms, but we will not review this information until the end of the study. Therefore, it is important that you see your GP if you currently have or develop any symptoms such as pain around your bladder, pain on passing urine, blood in the urine, or frequent urine infections. 

It will take about 3 years before we can get the main results of the study and share them publicly. Results will be shared with the public in science journals, press releases, articles from national charities supporting the study, and on the study website.  

Please find contact information on the contact us page.

As part of the process to join YORKSURe, your Participant Information Booklet explained that some of the trial researchers and the Cancer Prevention Trials Unit team (who help organise YORKSURe) were based at King’s College London. In late 2023, Professor Peter Sasieni and the team organising YORKSURe have moved from King’s College London to Queen Mary University of London. Therefore, some responsibilities previously given to King’s College London have now passed to Queen Mary University of London. There have been no other changes to the groups that may use/access/store your data.

What does this mean for your data?

Currently, your data is still being held in secure King’s College London databases. Queen Mary University of London will now be involved as a research team partner. Therefore, your data may now also be viewed by relevant research team members employed by Queen Mary University of London. Accessing and storing your data will remain subject to the same security principles. 

At some point in the future, your data will be transferred from King’s College London to Queen Mary University of London, using secure transfer methods. King’s College London and Queen Mary University of London have a responsibility to keep information collected about you safe and secure. They also have responsibility for ensuring the highest integrity of research data. Specialist teams within King’s College London and Queen Mary University of London continually assess and ensure that data is held in the most appropriate and secure way. 

There have been no further changes to the information you were provided with at the start of your participation. This includes:

• The type of data collected about you (e.g. NHS number, date of birth) 

• How this data is collected, stored or shared

• How long this data will be stored for

Further information:

• Queen Mary University of London has established a new, globally leading Centre for Cancer Screening, Prevention and Early Diagnosis. This brings together existing expertise in prevention research, as part of Queen Mary’s Wolfson Institute of Population Health (WIPH). The centre will deliver internationally recognised research and training. Professor Peter Sasieni, together with his research group and the Cancer Prevention Trials Unit team at King’s College London, have moved to jointly establish the new Centre for Cancer Screening, Prevention and Early Diagnosis.

• Health Research Authority: Patient Data and Research leaflet

Full information on how we use your data can be found in the study information booklet.

Your data will be processed in accordance with the UK General Data Protection Regulation (GDPR) and the Data Protection Act 2018. 

You can find out more about how we use your information at;

• www.hra.nhs.uk/information-about-patients/ 

• https://www.sheffield.ac.uk/govern/data-protection 

• www.hra.nhs.uk/patientdataandresearch 

Your personal details

• Personal details such as your name, address, telephone number, date of birth, and NHS number will be stored in a secure database managed at King’s College London. Access to your personal details will be restricted to only study team members that need to access this information and have been trained in information security. This includes access by the YORKSURe Research Nurse team, based at Sheffield Teaching Hospitals NHS Foundation Trust, so that they can contact you about your urine testing results.

• King’s College London has a responsibility to keep information collected about you safe and secure, and to ensure the integrity of research data. Specialist teams within King’s College London continually assess and ensure that data is held in the most appropriate and secure way. This may include storage of personal data with a contracted GDPR compliant third party storage provider within the UK, where they are assessed as the best data storage option. Employees of the third parties will have access to your data to fulfil their role as a third-party service providers, but your records and information will be kept strictly confidential.

• To invite you to take part in the study, your name and address will be sent to a third-party mailing company who will send out the urine self-testing kits. The mailing company will only keep your details for a maximum of 7 days and will securely delete them after this.

• Your contact details (name, address, telephone number) will be kept by King’s College London until they are longer needed i.e., once you have completed all parts of the study

• If you take part in the study, we will keep some of your details (NHS number and date of birth) for up to 3 years after the end of the study. This is so that we can collect information about you from a national health registry (the National Cancer Registration and Analysis Service).  Please see https://www.ndrs.nhs.uk/patients/ for more information about the National Cancer Registration and Analysis Service. We will delete your NHS number and date of birth from our records once we have received the information from the registry.

• If you do not respond to the study invitation all your details will be deleted from our system at end of active recruitment to the study which we anticipate will be September 2023.