Download A “yellow card” reporting system for sight loss in giant cell arteritis

A “yellow card” reporting system for sight loss in giant cell arteritis
INFORMATION SHEET
Your health records are being used in a research study on giant cell arteritis. The purpose of this
leaflet is to explain why the research is being done and what steps are being taken to protect your
anonymity in the study.
Please talk to others about the study if you wish and ask us if there is anything that is not clear.
What is the purpose of the study?
Blindness can be a serious consequence of untreated giant cell arteritis. With proper, early
treatment, this can be prevented in the majority of patients. Early treatment requires early
recognition.
The purpose of this study is to firstly estimate how many people are affected by sight loss in giant cell
arteritis every year, and secondly to look at some characteristics of patients with giant cell arteritis to
see if any patients are at particular risk of sight loss.
We think this information would help target resources to allow us to recognise giant cell arteritis
earlier.
Why have I been registered in this study?
You have been registered because you have been diagnosed with giant cell arteritis. We are
interested in identifying all patients diagnosed with giant cell arteritis, with and without sight loss, in
order to be as accurate as possible.
Do I have to take part?
You can choose not to take part in the study. You are free to withdraw at any time, without giving a
reason. This will not affect the standard of care you receive, which will continue as it is normally
provided.
What will happen to me if I continue to take part?
This is an observational study – in other words no change to your standard treatment will occur.
Information relevant to this study, about yourself and your condition, will be recorded for later
analysis. This will be information that is already recorded as part of your standard assessment. The
information that is retained will be anonymised so that the researchers, who are based at a central
site and are not directly involved with your care, will not be able to identify you.
In detail, when you are first diagnosed, your doctor, or your local research team on your doctor’s
behalf, will email an electronic “yellow card” to the central research team notifying them of your
diagnosis. A request for further information about your case will then be made. The information
collected will include: age, when you were referred and first seen, how long you had symptoms for,
details about the symptoms you experienced, how you responded to treatment, what the findings of
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the eye department were (if applicable), results of any scans performed, the medications you were
taking, any risk factors you had for heart disease or stroke, a number approximately representing
your socioeconomic background based on your home address, and the result of any biopsy
performed.
Will my taking part in this study be kept confidential?
Yes. We will follow standard ethical and legal practice regarding confidentiality. All information which
is collected about you during the course of the research will be kept strictly confidential. Access to
your full record will be limited to your local clinical and research team. Anonymous information will
be passed to the central research team.
In order to preserve your anonymity your name, date of birth and address will be removed from the
information when it is passed to the central research team based at Southend University Hospital,
and the information collected will not be provided to anyone else. It will be stored securely and used
only for the purpose of this study.
Your normal clinical records will have an entry showing that you are being included in this study, but
will otherwise be unaffected.
What are the possible disadvantages and risks of taking part?
Information about you will be recorded securely on a centrally held database. The risk of identifying
you from this information will be minimised as much as possible, but it may be that people can
identify who you are from the information held if they are already familiar with your case.
This can include people who have already been involved in your medical care, or friends and relatives
who are aware of some of your medical details and are also part of the research team.
We do not foresee it to be possible to identify you based on information solely obtained from our
database.
What are the possible benefits of taking part?
No direct benefit is foreseen to yourself by taking part. Communication between the different
departments involved in your care would be encouraged by participation in this study, and it is
expected that this would form part of your standard clinical care.
What happens when the research study stops?
The study will take place over a year and we estimate we will need to retain your data for another
year after that in order to fully analyse it.
After this we may archive the data obtained for up to 15 years in total. However If any further
analysis not originally planned for this study is considered, it would only be after obtaining further
ethical approval for that research.
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What if relevant new information about my condition becomes available?
Sometimes, in the course of a study, we may get new information about how your condition should
be treated. If this happens, we may be able to identify if your own treatment should be changed
from the records held about you. In this case your doctors will be informed.
What will happen if I don’t want to carry on with the study?
If you wish to withdraw from the study, the investigators will be notified and all or part of your
record, depending on your wishes, will be deleted. This will not affect the information held in your
normal clinical records.
During the course of the study information about you will be analysed and shared among the group
of investigators and collaborators. Eventually information about you may form the basis for a
scientific publication accessible to the general public. It is very unlikely that it would be possible to
personally identify you from records such as these, but withdrawing your data from an analysis after
it has been performed and publicised would not be possible.
What if there is a problem?
If you have a concern about any aspect of this study, you can discuss it with the doctors looking after
you who have registered you for the study.
You can also contact the researchers at the following address:
Professor B Dasgupta
Research and Development
Southend University Hospital NHS Foundation Trust
Prittlewell Chase
Westcliff-on-Sea
Essex SS0 0RY.
The information held centrally about individuals will be limited, and to fully address your queries we
may need your permission to contact your doctor for further details.
If you remain unhappy and wish to complain formally, you can do this through the Patient Advice and
Liaison service, details of which are included at the end of this leaflet.
Harm
In the event that something does go wrong and you are harmed through this research, and this is due
to someone‘s negligence, then you may have grounds for a legal action for compensation against
Southend University Hospital NHS Trust, but you may have to pay your legal costs. The normal
National Health Service complaints mechanisms will still be available to you (if appropriate).
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What will happen to the results of the research study?
We expect that, once fully analysed, the results of this study will be submitted for presentation at
scientific meetings and publication in a scientific journal. The results will be publicly accessible,
although you will not be personally identifiable.
Who is organising and funding the research?
This research is being organised through the Research and Development Department at Southend
University Hospital NHS Trust.
Funding from the charity Fight for Sight will contribute to the running of this study.
No commercial organisations are providing financial support for this study.
12. Who has reviewed the study?
All research in the NHS is looked at by independent group of people, called a Research Ethics
Committee, to protect your interests. This study has been reviewed and given favourable opinion by
the London-Hampstead Research Ethics Committee.
13. Further information and contact details
Further information about this research project can be obtained from the local investigating team at
your hospital, led by:
[insert local details]
You can also discuss it with the doctors looking after your condition.
If you are unhappy with any aspect of the way you are treated as part of this study you can discuss
this with your hospital’s Patient advice and Liaison service, whose contact details are as follows:
[insert local details]
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