A feasibility study evaluating the comparative effects of statins

REC Reference No. 10/H1102/30
A feasibility study evaluating the comparative effects of statins using your
GP’s medical records
Information Sheet


You are being invited to take part in a research study. Before you decide, it is important for you to
understand why the research is being done and what it will involve. Please take time to read the
following information carefully. Talk to others about the study if you wish.
What is the purpose of the study?
The purpose of this study is to evaluate whether a simple clinical trial that uses your GP’s medical
records is able to give us the information needed to improve patient care. ‘Clinical trials’ are widely
considered to be the best way of informing doctors about which treatments will be successful at
treating our symptoms and conditions. If your GP’s medical records can be used for clinical trials,
your GP can more easily conduct trials for questions they have about when to treat patients. Your
GP believes that you could benefit from a treatment called statins that lower the levels of cholesterol.
There are different types of statins your GP could prescribe you. Some GPs may give simvastatin
and others atorvastatin. Both these drugs are effective in lowering cholesterol, but your GP does not
know whether one type of statin is better than another. This study may help to find out whether one
type of statin is better than another.
Do I have to take part?
No, it is up to you to decide whether to take part or not. If you decide to take part, you will need to
sign the consent form. If you do choose to take part you are still free to withdraw from this study at
any time and without giving a reason. Whatever you decide at any time will not affect the standard
of care you receive from your GP or any other health professional.
What will happen to me if I take part?
Once you have agreed to take part in the study, you will be assigned randomly (like a flip of a coin)
to take either simvastatin or atorvastatin (two different types of statins). If your GP takes blood to
check the effects of the statin, you will be asked to give a small amount of additional blood to test
any changes in your cholesterol (this will be the equivalent of three teaspoons). If you agree, we
would like to take another blood sample for genetic testing. This will also be for a small amount of
blood equivalent to three teaspoons. The genetic tests will see whether any genetic factors determine
the response to a statin. If you do not wish to participate in the genetic testing, you can still take part
in the rest of the study.
What will happen if I don’t want to carry on with the study?
You are free to withdraw from this study at any time and without giving a reason. You do not have
to go to the pharmacy to get your statin. However, please tell your GP if you don’t want to take the
statin. A decision to withdraw at any time, or a decision not to take part in this study, will not affect
the standard of care you receive. If you decide to ‘opt-out’ of the study, your GP will decide on the
best further treatment for you, which may be the same as the one you receive in the study.
What are the possible benefits of taking part?
We cannot promise the study will help you but the information we get from this study will help
future people with high cholesterol levels. The study will hopefully provide GP’s with better
evidence to decide which type of statin to prescribe.
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REC Reference No. 10/H1102/30
What are the possible disadvantages and risks of taking part?
Your GP will manage your care as they would normally do. Please read the information leaflet
carefully when you collect the medicine from the pharmacist.
Will my taking part in this study be kept confidential?
Your GP and practice will remain responsible for your medical care. Your medical data will be kept
strictly confidential and will be protected. You will not be individually identified in any
report/publication. The researchers of this study will not know your name and address or where you
live within the UK. They will use anonymous medical records to follow you and other patients long-
term. The researchers plan to track all the medical events using a process called record-linkage. This
process will use the NHS electronic records of medical events that happen in the UK.
What will happen to the results of the research study?
The results of this study will be published once completed. We will also make the results available
on the study website (https://rct.gprd.com/retropro).
Who is organising and funding the research?
The research is funded by the Wellcome Trust (a charity that supports scientific research). This
study is being carried out by researchers from the General Practice Research Database
(y and London School of Hygiene & Tropical Medicine. The
researchers will pay your GP for including you into this study.
Who has reviewed the study?
All research in the NHS is looked at by an independent group of people, called a Research Ethics
Committee, in order to protect your interests. This study has been reviewed and given favourable
opinion by South East Research Ethics Committee.
What if something goes wrong?
If you have a concern about any aspect of this study, you should ask to speak to your GP who will
do their best to answer your questions. You may also contact the Principal Investigator (phone
number 020 3080 6383). If you remain unhappy and wish to complain formally, you can do this
through the NHS Complaints Procedure. Details can be obtained from your GP.
The London School of Hygiene & Tropical Medicine holds insurance policies which apply to this
study. If you experience harm or injury as a result of taking part in this study, you may be eligible to
claim compensation without having to prove that the School is at fault. This does not affect your
legal rights to seek compensation. If you are harmed due to someone’s negligence, then you may
have grounds for a legal action. Regardless of this, if you wish to complain, or have any concerns
about any aspect of the way you have been treated during the course of this study then you should
immediately inform your GP or the Principal Investigator (phone number 020 3080 6383). The
normal National Health Service complaint complaints mechanisms are also available to you.
Further information
You can ask your GP any further questions you may have about the study. Also, further information
related to this project is available on the study website (https://rct.gprd.com/retropro) or by
contacting the General Practice Research Database (by telephone 020 3080 6383 or by post
FREEPOST RSKH-TTAU-UKKX, GPRD, 151 Buckingham Palace Road, London, SW1W
9SZ).
.
The likely benefit to you from participating in this study is that you are prescribed a statin that
can help to lower your cholesterol levels. The results of this study may help that future patients
will start on the best statin.

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REC Reference No. 10/H1102/30
Consent Form
Study title: A feasibility study evaluating the comparative effects of statins

Protocol/Amendment date: 02/09/2011, version 1.5
1. I confirm that I have read and understand the information sheet dated 19/01/2011 for the
above study. I have had the opportunity to consider the information and ask questions, and have had these answered satisfactorily. 2. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected. If I withdraw I understand that the sponsor will retain the data collected. 3. I understand that relevant sections of any of my medical notes and data may be looked at by the study researchers. They will not know my name and address, where I live in the UK and they will never contact me directly. 4. I agree to take part in the above study.
Patient Identification Number:

COPY FOR YOU
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REC Reference No. 10/H1102/30
Consent Form
Study title: A feasibility study evaluating the comparative effects of statins

Protocol/Amendment date: 02/09/2011, version 1.5
1. I confirm that I have read and understand the information sheet dated 19/01/2011 for the above study. I have had the opportunity to consider the information and ask questions, and have had these answered satisfactorily. 2. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected. If I withdraw I understand that the sponsor will retain the data collected. 3. I understand that relevant sections of any of my medical notes and data may be looked at by the study researchers. They will not know your name and address, where you live in the UK and they will never contact you directly. 4. I agree to take part in the above study.
Patient Identification Number:

COPY FOR YOUR GP
19/01/2011
REC Reference No. 10/H1102/30
Consent Form
Study title: A feasibility study evaluating the comparative effects of statins

Protocol/Amendment date: 02/09/2011, version 1.5
1. I confirm that I have read and understand the information sheet dated 19/01/2011 for the above study. I have had the opportunity to consider the information and ask questions, and have had these answered satisfactorily. 2. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected. If I withdraw I understand that the sponsor will retain the data collected. 3. I understand that relevant sections of any of my medical notes and data may be looked at by the study researchers. They will not know your name and address, where you live in the UK and they will never contact you directly. 4. I agree to take part in the above study.
Patient Identification Number:

ANONYMOUS COPY FOR STUDY RESEARCHERS


XXXXXXXXXXXXX
_________________
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REC Reference No. 10/H1102/30
PARTICIPANT INFORMATION SHEET FOR BLOOD SAMPLE FOR
PHARMACOGENETIC RESEARCH
A feasibility study evaluating the comparative effects of statins - blood for future genetic
tests
You are being invited to take part in a research study. This is a voluntary project, and if,
when you have heard about the study, you would prefer not to take part, your decision will
be accepted without question and will not affect the standard of care you receive in any way.
If your GP takes blood to check the effects of the statin, you will be asked to give a small amount of
additional blood to test any changes in your cholesterol (this will be the equivalent of three
teaspoons). If you agree, we would like to take another blood sample for genetic testing. This will
also be for a small amount of blood equivalent to three teaspoons. The genetic tests will see whether
any genetic factors that predispose to better effects on cholesterol or to side-effects.
What are the possible disadvantages and risks of taking part?
For patients donating a blood sample, there may be some minor but short-lasting discomfort
from having a blood test. Taking part in the study will not affect your current treatment, nor
will it affect your ability to obtain insurance for health purposes.
What are the possible benefits of taking part?
We cannot promise the study will help you but the information we get from this study will help
future people with high cholesterol levels. The study will hopefully provide GP’s with better
evidence to decide to whom to prescribe a statin.
What will happen to my blood test?
The blood samples will be stored at the University of Liverpool. DNA will be extracted
from the samples at the University of Liverpool. It will be used to determine how your
genes interact with the statin treatments you have received. Your sample will be stored at
the University of Liverpool until it is used up.
It is important to note that all blood samples received by the University will be identified by
a code number only. All coded clinical details will be kept securely. Once the study has
been completed, we will irreversibly anonymise your clinical details and blood samples, and
therefore it will not be possible to trace the blood sample back to you. After anonymisation,
it will also not be possible for you to withdraw the blood sample. Once anonymised, the
DNA samples may be used for other research, but as this cannot be traced back to you, it
will have no direct bearing on your clinical care. Further approval will be sought from the
ethics committee for any future studies.
Your blood samples will be considered to be a gift to the University of Liverpool, which
will act as custodian of all the samples obtained as part of this project. In some cases, a
small amount of your sample will be provided to other researchers and may be sent to
countries outside Europe. Future tests on the samples will be confined to tests on the effects
of statins only. However, it is important to remember that the samples will only be identified
by a code.
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REC Reference No. 10/H1102/30

In the short-term, it is unlikely that the samples will be of any commercial value to the
University or the hospital. However, it is possible that there may be some commercial value
in the future, although it is important to note that any commercial value is likely to be due to
findings in a group of patients rather than from samples from a single patient. You will not
be paid for taking part in the study, nor will you derive financial benefit from future
discoveries.
Will my taking part in this study be kept confidential?
As stated above, your sample will be anonymised, and the genetic information obtained
from the DNA sample will be kept strictly confidential and not be disclosed to anyone. All
information collected about you during the course of the research will also be kept strictly
confidential. Any information about you, which leaves the research centres taking part, will
have your name and address removed so that you cannot be recognised from it. Your GP
will obviously be aware of you taking part as you will have been recruited from your
practice.
What will happen to the results of the research study?
Results from the project will be published in leading international medical journals.
Who is organising and funding the research?
This study has been designed as a collaborative project by The University of Liverpool, the
London School of Hygiene & Tropical Medicine, the General Practitioner Research
Database and The Royal Liverpool and Broadgreen University Hospital NHS Trust, and has
been funded by the Wellcome Trust.
Who has reviewed the study?
The study has been reviewed by South East Research Ethics Committee.
Contact for further information
If you need further information or are worried about any aspect of the study, please do not
hesitate to contact your GP or practice nurse at your practice.
You can also access a website designed by the research team offering further information
related to this project. The web address is https://rct.gprd.com/retropro. You can also contact the
General Practice Research Database (by telephone 020 3080 6383 or by post FREEPOST
RSKH-TTAU-UKKX, GPRD, 151 Buckingham Palace Road, London, SW1W 9SZ).
THANK YOU FOR READING THIS INFORMATION LEAFLET
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REC Reference No. 10/H1102/30
CONSENT FORM FOR BLOOD SAMPLE FOR PHARMACOGENETIC RESEARCH

Patient Identification Number:
Please initial each box before signing the form:

1
I confirm that I have read and understand the information sheet dated 19/01/2011 for the above study I have had the opportunity to discuss the research and ask questions I understand that my participation is voluntary and I may withdraw up until the time that my blood/urine samples can still be identified I understand that the results will not be added to my medical records I give permission to the researchers to have access to my medical records to extract information relevant to this study I agree to have blood samples taken for tests on genes and other factors that determine how people react to cholesterol lowering drugs (statins) I understand that my samples will be anonymised and will be stored, and it will not be possible to trace the samples back to me I understand that my samples may be used in the future for more genetic tests as there are more scientific advances …XXXXXXXXXXXX…………. ………………. ………………………………… Name …………………………………. ………………. …………………………………. Name of person taking consent 19/01/2011
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Ethnicity Questionnaire

Patient Identification Number:

Please tick/fill the following information about yourself and your family, if known:
Ethnic Origin
Grandmother
grandfather
grandmother
grandfather
(mother’s
(mother’s
(father’s side)
(father’s side)
(please specify)
Country
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Source: http://www.medicayr.co.uk/Documents/RETROPRO%20Study%20Information%20and%20Consent%20Form.pdf