Research output per year
Research output per year
Description
Thank you for taking the time to read this participant information sheet for the SIMPLE study.
If you would like an alternative format of this study information such as large print etc please let the researcher who gave you this sheet know.
If you have any further questions about the study please ask the research team member who gave you this information sheet or email [email protected].
We are inviting you to take part in a study
You are invited to take part in a research project. Before you decide whether or not you would like to participate it is important that you read the information provided below. This will help you to understand why and how the research is being carried out and what participation will involve. Please let the researcher who gave you this information know if anything is unclear or you have any questions.
Who is organising and funding this research?
This study is being sponsored by the University of Dundee. It is not receiving any specific funding. The study is being organised by Professor Jacob George (Chief Investigator) and Dr Damien Leith (Principle Investigator). Professor George and Dr Leith are employed by the University of Dundee.
Why are we conducting the study?
Fatty liver disease is becoming more common across the world, especially in people with what is called “metabolic syndrome” - which includes people with conditions such as high cholesterol, high blood pressure, type 2 diabetes and obesity. For most people with fatty liver disease (officially known as Metabolic Dysfunction-Associated Steatotic Liver Disease or MASLD for short) it causes no symptoms and no harm and people are often unaware they have it. However for a small number of people with the condition it can cause more serious liver damage. Currently there are few treatments for fatty liver disease. Some previous research studies have shown that a new type of cholesterol lowering medication, called PCSK9 inhibitors, may help lower fat in the liver as well as lower cholesterol levels. So these medicines may be a good treatment for fatty liver disease. We are undertaking a study in people who are starting PCSK9 inhibitor treatment for their cholesterol, to see if the treatment reduces fat in their liver as a positive side effect.
We are measuring the amount of fat in peoples’ liver using results of blood tests and using a special type of liver ultrasound (ultrasound is the type of scan used to look at babies in the womb in pregnancy). The special ultrasound machine is called a Fibroscan. We will also record information about peoples general health and other medications taken, and measure some features of peoples bodies (such as height, weight, hip and waist size), to see if certain people respond differently to the medications to others.
Why have I been invited to take part?
You have been invited to take part because you have been identified as someone who may be about to start a new PSCK9i medication to treat your high cholesterol level.
Do I have to take part?
No. Participation in the study is voluntary (you do not need to join the study). If you do decide to join the study now, you are free to change your mind and stop participating at any time in the future and do not need to give a reason for this. Importantly, whether you choose to join the study or not will not affect your usual healthcare in any way and will have no impact on any treatments you are offered or hospital appointments planned.
What will happen if I take part?
The SIMPLE study will not change any of your normal health care appointments or treatments.
The SIMPLE study will involve two study appointments over 9 months - we will aim for them to take place after your normal cholesterol clinic appointments (you should not need to make any extra visits to the hospital or GP for the SIMPLE study) in the same area of the hospital as the clinic visit. Each study appointment should last no more than 30 minutes after your normal clinic appointment, and will probably be less.
If you have time and are happy with the information in this Participant Information Sheet, the first study appointment can take place at the same time you attend the cholesterol clinic and agree with the doctor in the clinic that you will start PCSK9 inhibitor medication. If you would like more time to consider taking part in the SIMPLE study or would prefer another time for the first study appointment, you can arrange a later time for the first study appointment. This can be any time up until you start taking the new PCSK9 inhibitor medication. You can simply contact the study team on [email protected] to arrange an appointment slot (if you do not have access to email an alternative telephone number can be provided instead).
The second study appointment will take place when you are seen in the cholesterol clinic around 9 months after the first clinic appointment.
At the first study appointment you can ask any additional questions you have about the study and then you will complete a consent form, confirming you have read this information sheet and that you are happy to take part in the SIMPLE study.
At each study appointment you will be asked some questions about your health and lifestyle, including past medical history, medications you are taking, smoking and alcohol history; have some measurements taken (such as your height, weight, hip and waist measurements and hand grip strength) and then a Fibroscan test. Fibroscan is a non-invasive test (it does not cause any pain or discomfort to take) and is a type of scan that uses ultrasound (no x-rays or radiation), similar to the scan pregnant women have to look at their baby. Fibroscan gives us measurements on how hard or soft the liver is and how much fat is in the liver. We get the results from the Fibroscan instantly and can tell you at the study appointment about what the results tell us about your liver health. We get the best results from Fibroscan if you have not eaten or drank any drinks with sugar or milk for 3 or more hours before the test so we will ask when you last ate and if it is within 3 hours may delay the scan until 3 hours have passed. We will also use your medical records to obtain your previous blood test results and lists of medications you are taking etc.
Finally, you can choose to have some extra blood tests taken (these can be taken at the same time as your routine blood tests) to allow us to store some samples for future research use. If you do not wish to provide the additional blood samples you can still take part in the SIMPLE study without this.
IMPORTANTLY - if the first Fibroscan test shows you have no fat in your liver then you will not be asked to continue with the SIMPLE study as we are interested in looking at improvement in liver fat with PCSK9 inhibitors and will not be able to measure this in people with no fat to begin with. Similarly if the Fibroscan test shows there is scarring in your liver you will not be asked to continue in the SIMPLE study (see “Are there any risks in taking part?” below for more information about if we find scarring)
All information given for the study will be entirely confidential, held securely and will be held in an anonymised format (we will store your name and hospital number in separate files to the other information we obtain for the study). However, regulatory authorities/ University of Dundee Sponsor representatives may look at participant information for audit purposes
Are there any risks in taking part?
Apart from the time taken for you to take part in the study, there are no risks from the study itself as we will not change any of your treatments or routine medical care. The Fibroscan and measurements we take will not cause any pain or discomfort. If you choose to provide additional blood tests then there is a slight discomfort associated with having a blood test (although we will aim for these extra samples to be taken at the same time as your normal blood test that you will be having anyway).
It is possible that the Fibroscan test may find some underlying liver problems that were not previously known about. These may require further investigation and follow up in the liver clinic. If any new/ unexpected liver problems are discovered we will explain this to you at the time of the Fibroscan and, if you are happy for us to, we will let your GP know about what we have found. If necessary we will also offer an appointment in the liver clinic to follow these up.
What are the possible benefits of taking part?
There are no direct health benefits to you from taking part in the SIMPLE study, however you will gain some information and advice about your liver health that you normally wouldn’t have. Also, it is hoped that your involvement will help contribute to the development of liver health research and the care of people with fatty liver disease in the future. You will also have the option to opt-in to information about the results and publication of this research in the future.
Will my taking part in this project be kept confidential?
We will keep all information about you safe and secure. Electronic information collected as part of the SIMPLE study will be securely stored on NHS and University of Dundee computers. Access to the computers is password protected and access to files with the study information will have another password, only shared with the study team. Health and study information about you will not be stored alongside any of your personal information that would allow you to be identified (such as your name, date of birth or hospital number). Health and study information will be stored in an anonymous format, linked only to a study number. Identifiable information will be stored separately. Any information given in the study or results of any tests will not be shared with any other health care staff, such as your GP or hospital staff not involved in the SIMPLE study without your permission. There are no plans for any data to be shared outside the study team. The findings of the study will be published in medical journals when the study is finished, but no study results will include personal data of anyone that takes part in the study and no individual participant data will be published, only information about what we found in everyone together.
How will we use information about you?
We will need to use information provided by you, from tests we undertake (Fibroscan and body measurements) and from your hospital medical records for this research project.
This information will include your Community Health Index [CHI] number and postcode. People will use this information to do the research or to check your records to make sure that the research is being done properly.
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.
Once we have finished the study, we will keep some of the data for 5 years so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.
If you agree to take part in the study and later permanently lose capacity (become confused in such a way you can no longer understand information and give your permission) we will not bring you for any further study visits but would like to continue to collect additional information required from your medical records until the end of the study period. We will ask your next of kin to complete a Study Withdrawal form to let us know what to do with the information already collected and if they are happy for us to collect further relevant information. If we are unable to contact your next of kin, existing collected data will be used but no further information will be collected from your medical records.
What are your choices about how your information is used?
If you decide to join the study but change your mind later, you can withdraw from the study at any time. You can do this by letting the study team know.
Deciding to withdraw from the study will have no impact on any of your usual medical treatments or hospital follow-up.
We will keep information about you that we already have and, if you choose to stop taking part in the study, we would like to continue collecting relevant information about your health from your hospital records until the end of the study period. We will ask you to complete a Study Withdrawal form to let us know what to do with the information already collected and if you are happy for us to collect further relevant information.
Where can you find out more about how your information is used?
You can find out more about how we use your information at: www.hra.nhs.uk/information-about-patients/
or by asking one of the research team by sending an email to [email protected].
What if something goes wrong?
If you are concerned about your participation in the study you have the right to discuss your concern with a researcher involved in the study or a doctor involved in your care.
If you have a complaint about your participation first of all please talk to the researcher.
If you are not satisfied, you can make a formal complaint to a senior member of the research team or to the Complaints Officer for NHS Tayside.
Patient Experience Team
NHS Tayside
Ninewells Hospital
Dundee DD1 9SY
Freephone: 0800 027 5507
Email: [email protected]
If you think you have come to harm due to taking part in the study there are no automatic arrangements to get financial compensation.
Insurance
The University of Dundee is Sponsoring the study. The University of Dundee holds Clinical Trials indemnity cover which covers the University’s legal liability for harm caused to participants.
Who has reviewed this study?
This study has been reviewed and approved by the West of Scotland REC (Proportionate review subcommittee) who are responsible for reviewing research which is conducted in humans. The Research Ethics committee does not have any objections to this study going ahead.
Contact details for further information:
For further information please contact Dr Damien Leith (Principle Investigator) on email: [email protected]
Thank you for taking time to read this information and for considering taking part in the SIMPLE study.
If you would like an alternative format of this study information such as large print etc please let the researcher who gave you this sheet know.
If you have any further questions about the study please ask the research team member who gave you this information sheet or email [email protected].
We are inviting you to take part in a study
You are invited to take part in a research project. Before you decide whether or not you would like to participate it is important that you read the information provided below. This will help you to understand why and how the research is being carried out and what participation will involve. Please let the researcher who gave you this information know if anything is unclear or you have any questions.
Who is organising and funding this research?
This study is being sponsored by the University of Dundee. It is not receiving any specific funding. The study is being organised by Professor Jacob George (Chief Investigator) and Dr Damien Leith (Principle Investigator). Professor George and Dr Leith are employed by the University of Dundee.
Why are we conducting the study?
Fatty liver disease is becoming more common across the world, especially in people with what is called “metabolic syndrome” - which includes people with conditions such as high cholesterol, high blood pressure, type 2 diabetes and obesity. For most people with fatty liver disease (officially known as Metabolic Dysfunction-Associated Steatotic Liver Disease or MASLD for short) it causes no symptoms and no harm and people are often unaware they have it. However for a small number of people with the condition it can cause more serious liver damage. Currently there are few treatments for fatty liver disease. Some previous research studies have shown that a new type of cholesterol lowering medication, called PCSK9 inhibitors, may help lower fat in the liver as well as lower cholesterol levels. So these medicines may be a good treatment for fatty liver disease. We are undertaking a study in people who are starting PCSK9 inhibitor treatment for their cholesterol, to see if the treatment reduces fat in their liver as a positive side effect.
We are measuring the amount of fat in peoples’ liver using results of blood tests and using a special type of liver ultrasound (ultrasound is the type of scan used to look at babies in the womb in pregnancy). The special ultrasound machine is called a Fibroscan. We will also record information about peoples general health and other medications taken, and measure some features of peoples bodies (such as height, weight, hip and waist size), to see if certain people respond differently to the medications to others.
Why have I been invited to take part?
You have been invited to take part because you have been identified as someone who may be about to start a new PSCK9i medication to treat your high cholesterol level.
Do I have to take part?
No. Participation in the study is voluntary (you do not need to join the study). If you do decide to join the study now, you are free to change your mind and stop participating at any time in the future and do not need to give a reason for this. Importantly, whether you choose to join the study or not will not affect your usual healthcare in any way and will have no impact on any treatments you are offered or hospital appointments planned.
What will happen if I take part?
The SIMPLE study will not change any of your normal health care appointments or treatments.
The SIMPLE study will involve two study appointments over 9 months - we will aim for them to take place after your normal cholesterol clinic appointments (you should not need to make any extra visits to the hospital or GP for the SIMPLE study) in the same area of the hospital as the clinic visit. Each study appointment should last no more than 30 minutes after your normal clinic appointment, and will probably be less.
If you have time and are happy with the information in this Participant Information Sheet, the first study appointment can take place at the same time you attend the cholesterol clinic and agree with the doctor in the clinic that you will start PCSK9 inhibitor medication. If you would like more time to consider taking part in the SIMPLE study or would prefer another time for the first study appointment, you can arrange a later time for the first study appointment. This can be any time up until you start taking the new PCSK9 inhibitor medication. You can simply contact the study team on [email protected] to arrange an appointment slot (if you do not have access to email an alternative telephone number can be provided instead).
The second study appointment will take place when you are seen in the cholesterol clinic around 9 months after the first clinic appointment.
At the first study appointment you can ask any additional questions you have about the study and then you will complete a consent form, confirming you have read this information sheet and that you are happy to take part in the SIMPLE study.
At each study appointment you will be asked some questions about your health and lifestyle, including past medical history, medications you are taking, smoking and alcohol history; have some measurements taken (such as your height, weight, hip and waist measurements and hand grip strength) and then a Fibroscan test. Fibroscan is a non-invasive test (it does not cause any pain or discomfort to take) and is a type of scan that uses ultrasound (no x-rays or radiation), similar to the scan pregnant women have to look at their baby. Fibroscan gives us measurements on how hard or soft the liver is and how much fat is in the liver. We get the results from the Fibroscan instantly and can tell you at the study appointment about what the results tell us about your liver health. We get the best results from Fibroscan if you have not eaten or drank any drinks with sugar or milk for 3 or more hours before the test so we will ask when you last ate and if it is within 3 hours may delay the scan until 3 hours have passed. We will also use your medical records to obtain your previous blood test results and lists of medications you are taking etc.
Finally, you can choose to have some extra blood tests taken (these can be taken at the same time as your routine blood tests) to allow us to store some samples for future research use. If you do not wish to provide the additional blood samples you can still take part in the SIMPLE study without this.
IMPORTANTLY - if the first Fibroscan test shows you have no fat in your liver then you will not be asked to continue with the SIMPLE study as we are interested in looking at improvement in liver fat with PCSK9 inhibitors and will not be able to measure this in people with no fat to begin with. Similarly if the Fibroscan test shows there is scarring in your liver you will not be asked to continue in the SIMPLE study (see “Are there any risks in taking part?” below for more information about if we find scarring)
All information given for the study will be entirely confidential, held securely and will be held in an anonymised format (we will store your name and hospital number in separate files to the other information we obtain for the study). However, regulatory authorities/ University of Dundee Sponsor representatives may look at participant information for audit purposes
Are there any risks in taking part?
Apart from the time taken for you to take part in the study, there are no risks from the study itself as we will not change any of your treatments or routine medical care. The Fibroscan and measurements we take will not cause any pain or discomfort. If you choose to provide additional blood tests then there is a slight discomfort associated with having a blood test (although we will aim for these extra samples to be taken at the same time as your normal blood test that you will be having anyway).
It is possible that the Fibroscan test may find some underlying liver problems that were not previously known about. These may require further investigation and follow up in the liver clinic. If any new/ unexpected liver problems are discovered we will explain this to you at the time of the Fibroscan and, if you are happy for us to, we will let your GP know about what we have found. If necessary we will also offer an appointment in the liver clinic to follow these up.
What are the possible benefits of taking part?
There are no direct health benefits to you from taking part in the SIMPLE study, however you will gain some information and advice about your liver health that you normally wouldn’t have. Also, it is hoped that your involvement will help contribute to the development of liver health research and the care of people with fatty liver disease in the future. You will also have the option to opt-in to information about the results and publication of this research in the future.
Will my taking part in this project be kept confidential?
We will keep all information about you safe and secure. Electronic information collected as part of the SIMPLE study will be securely stored on NHS and University of Dundee computers. Access to the computers is password protected and access to files with the study information will have another password, only shared with the study team. Health and study information about you will not be stored alongside any of your personal information that would allow you to be identified (such as your name, date of birth or hospital number). Health and study information will be stored in an anonymous format, linked only to a study number. Identifiable information will be stored separately. Any information given in the study or results of any tests will not be shared with any other health care staff, such as your GP or hospital staff not involved in the SIMPLE study without your permission. There are no plans for any data to be shared outside the study team. The findings of the study will be published in medical journals when the study is finished, but no study results will include personal data of anyone that takes part in the study and no individual participant data will be published, only information about what we found in everyone together.
How will we use information about you?
We will need to use information provided by you, from tests we undertake (Fibroscan and body measurements) and from your hospital medical records for this research project.
This information will include your Community Health Index [CHI] number and postcode. People will use this information to do the research or to check your records to make sure that the research is being done properly.
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.
Once we have finished the study, we will keep some of the data for 5 years so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.
If you agree to take part in the study and later permanently lose capacity (become confused in such a way you can no longer understand information and give your permission) we will not bring you for any further study visits but would like to continue to collect additional information required from your medical records until the end of the study period. We will ask your next of kin to complete a Study Withdrawal form to let us know what to do with the information already collected and if they are happy for us to collect further relevant information. If we are unable to contact your next of kin, existing collected data will be used but no further information will be collected from your medical records.
What are your choices about how your information is used?
If you decide to join the study but change your mind later, you can withdraw from the study at any time. You can do this by letting the study team know.
Deciding to withdraw from the study will have no impact on any of your usual medical treatments or hospital follow-up.
We will keep information about you that we already have and, if you choose to stop taking part in the study, we would like to continue collecting relevant information about your health from your hospital records until the end of the study period. We will ask you to complete a Study Withdrawal form to let us know what to do with the information already collected and if you are happy for us to collect further relevant information.
Where can you find out more about how your information is used?
You can find out more about how we use your information at: www.hra.nhs.uk/information-about-patients/
or by asking one of the research team by sending an email to [email protected].
What if something goes wrong?
If you are concerned about your participation in the study you have the right to discuss your concern with a researcher involved in the study or a doctor involved in your care.
If you have a complaint about your participation first of all please talk to the researcher.
If you are not satisfied, you can make a formal complaint to a senior member of the research team or to the Complaints Officer for NHS Tayside.
Patient Experience Team
NHS Tayside
Ninewells Hospital
Dundee DD1 9SY
Freephone: 0800 027 5507
Email: [email protected]
If you think you have come to harm due to taking part in the study there are no automatic arrangements to get financial compensation.
Insurance
The University of Dundee is Sponsoring the study. The University of Dundee holds Clinical Trials indemnity cover which covers the University’s legal liability for harm caused to participants.
Who has reviewed this study?
This study has been reviewed and approved by the West of Scotland REC (Proportionate review subcommittee) who are responsible for reviewing research which is conducted in humans. The Research Ethics committee does not have any objections to this study going ahead.
Contact details for further information:
For further information please contact Dr Damien Leith (Principle Investigator) on email: [email protected]
Thank you for taking time to read this information and for considering taking part in the SIMPLE study.
| Date made available | 31 Oct 2024 |
|---|---|
| Publisher | University of Dundee |
| Date of data production | 8 Oct 2024 |
Research output
- 1 Other contribution
-
Assessing the impact of PCSK9 inhibitors in steatotic liver disease: a prospective observational cohort study (SIMPLE)
George, J., Leith, D., Dillon, J., Brennan, P., Handjiev, S. & Lynch, R., 29 Oct 2024, 23 p. University of Dundee.Research output: Other contribution
Open AccessFile