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PARTICIPANT INFORMATION SHEET
Study Title: Effective Treatments for Thoracic Aortic Aneurysms
(ETTAA study): A prospective observational study
You are being invited to take part in a research study. Before you decide whether to take
part, it is important for you to understand why the research is being done and what it will
involve. Feel free to discuss the study with others if you wish. Please take time to decide
whether or not you wish to take part.
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1. What is the purpose of this study?
The aim of this study is to collect information on patients such as yourself who have been
diagnosed with a chronic thoracic aortic aneurysm (CTAA) to determine the best
management strategy, timing and cost effectiveness of different interventions for the
treatment of CTAA.
The study will follow patients from a number of centres across the UK over a period of
time to see how well they do. The type of treatment patients receive will not be altered
by taking part in this study.
The results from this study will enable clinicians to make a more informed decision about
which treatment option will be best for individual patients.
We aim to analyse all the information collected in order to:
1. Understand the growth rate of Chronic Thoracic Aortic Aneurysms and identify which
factors influence the growth rate.
2. Understand how quality of life changes following surgical procedures.
3. Estimate the cost-effectiveness of the different treatment options by measuring
changes in survival and quality of life of patients compared to the cost of treatment and
post-operative patient care.
4. Create a risk score that will help specialists determine which intervention (stent grafting
or surgery) is best suited to a given patient and when this treatment should be offered.
ETTAA Participant Information Sheet and Consent Form
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2. Why have I been invited?
You have been invited to take part in this study because you have been diagnosed with a
CTAA and have been referred to one of the hospitals participating in the study. Your
doctor will have identified you as a patient who is eligible for the study, but this will not
have affected the choice of treatment pathways available to you.
3. Do I have to take part?
No. Your participation in this study is entirely voluntary. If you decide to take part you will
be asked to sign a consent form. You are under no pressure to take part and may
withdraw from the study if you wish at any time, without having to explain why. If you
decide not to take part, the quality of medical and nursing care you receive will not be
affected. With your permission we will keep the information we have already collected
about you. You will not be contacted again about the study.
4. What will happen to me if I take part?
If you agree to take part you will be observed from the time you agree to take part until
the study concludes at the end of December 2019. No additional tests will be undertaken
as part of the study, but you will be asked to complete some short questionnaires which
provide us with information on your quality of life and use of NHS and social care services
throughout the course of the study. You will also be asked to give permission for your
medical records to be examined in detail, in order to collect information about your
health status and any treatments that you have throughout the follow up period. This will
include both hospital and general practice (GP) records.
Your treatment options will not be altered in any way by taking part in this study. Your
doctor will decide on the best treatment for you. Participation in the study does not
restrict your ability to change from one treatment option to another.
There will be no additional visits as part of the study. The questionnaires will either be
completed at your routine hospital follow-up visits; over the telephone or by post.
However, your routine visits will be up to an hour longer to allow time to meet the
research team and complete the questionnaires.
A more detailed explanation of what will take place is given below:
Initial review: The first visit is a baseline visit and will take up to 1 hour. A member of the
research team will explain the study and you will be given the opportunity to ask any
questions you might have. If you are happy to take part then you will be asked to sign a
consent form. Following this you will be asked some information about your past medical
history and you will complete baseline questionnaires.
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If you are having a procedure you will be followed up at 1, 3, 6, 12, 18, 24 months postsurgery and annually thereafter. We will also collect data from your hospital records
about your procedure and stay in hospital.
If you are not having a procedure you will be followed up at 3, 6, 12, 18, 24 months after
entry to the study and annually thereafter.
With your agreement, we would like to follow your health status by using the information
collected on NHS Databases (e.g. Health and Social Care Information Centre). To obtain
this information we will need to disclose your date of birth and national health number;
these details will be treated in confidence in accordance with the data protection act.
5. What are the possible disadvantages and risks of taking part?
There are no anticipated disadvantages or risks involved in this study as it is an
observational study of NHS care for patients with CTAA.
6. What are the benefits of taking part?
There are no direct benefits to yourself from taking part in this study but the information
we get may help to improve the treatment of other people with CTAA in the future.
7. What if there is a problem?
Any complaint about the way you have been dealt with during the study or any possible
harm you might suffer will be fully addressed.
If you have a concern about any aspect of this study, you should ask to speak with the
researchers who will do their best to answer your questions. If you remain unhappy and
wish to complain formally, you can do this through the NHS Complaints Procedure.
Details can be obtained from your doctor.
8. Will my taking part in the study be kept confidential?
All information that is collected about you during the course of this study will be kept
strictly confidential. Paper records regarding your case and your study number will be
held securely. Electronic information will be kept on computers that are protected by
passwordsThe electronic data stored for this study will be kept on a database, but we will
not keep any identifiable information.
Anonymised copies of any CT scans you undertake as part of your routine care will be
reviewed by a central NHS laboratory in the UK.
When the study is reported it will not be possible to identify you personally.
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Representatives from regulatory authorities and the study sponsors may need to look at
your medical records and the data collected in the study to check that the study was
carried out correctly. Confidentiality will be maintained at all times.
9. Will my GP be informed of my participation in this study?
With your permission, we will inform your GP of your participation in this study.
10. What will happen to the results of the research study?
The results of the study will be published in scientific journals and presented at scientific
meetings. A summary will also be published on clinicalstrials.gov which is a publically
accessible website. You will not be identified in any report/publication.
11. Who is organising and funding the research?
The study is being organised and run by Papworth Hospital NHS Foundation Trust and
funded by the National Institute for Health Research Health Technology Assessment (HTA)
Programme.
The doctor and the research team conducting the research are not receiving additional
payments for including you in this study.
12. Who has reviewed the study?
This study was reviewed and approved by a group of independent experts from the
National Institute for Health Research.
All research carried out in the NHS is assessed by an independent committee who make
sure that studies are scientifically and ethically sound. This study has been reviewed and
given a favourable opinion by the South Birmingham Ethics Committee.
13. Contact details:
In the first instance please contact the (Name of participating hospital) Research Team
on (Tel no.) E-mail: [email protected]
Alternatively, you can speak to a member of the central ETTAA team:
Tel: 01480 364980; email: [email protected]
Thank you for taking time to read this sheet and for considering taking part in this study.
ETTAA Participant Information Sheet and Consent Form
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Version 4.0 19th May 2015
STUDY TITLE: Effective Treatments for Thoracic Aortic
Aneurysms (ETTAA study): A prospective observational
study.
Chief Investigator:
Mr Stephen Ralph Large
Principal Investigator: >Insert name<
Please initial each box & sign at bottom
1.
1. I confirm that I have read and understood the ‘Patient Information Sheet’
(version 4.0 dated 19th May 2015 ) for the above study. I have had the
opportunity to consider the information, 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 and without my medical care or legal
rights being affected.
3. I understand that relevant sections of any of my medical notes and data
collected during the study may be looked at by responsible individuals from
Name of participating Hospital, Papworth Hospital NHS Foundation Trust or
from regulatory authorities, where it is relevant to my taking part in the
research. I give permission for these individuals to have access to my records.
I agree that researchers can have access to information about me that is
registered on national databases (e.g. Health and Social Care Information
Centre).
4.
5.
2. I consent to my GP being informed of my participation in this study.
6.
3. I consent to my data being retained if I withdraw from the study
7.
4. I agree to take part in the above study.
5.
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Name of patient (please print)
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Researcher (please print)
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Date
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Date
ETTAA Participant Information Sheet and Consent Form
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Signature
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Signature
Version 4.0 19th May 2015