Download Participant Information Sheet

THE UNIVERSITY OF SHEFFIELD
Infection and Immunity
L Floor, University of Sheffield Medical School,
Beech Hill Road,
Sheffield S10 2JF
Paul Collini MBChB PhD
Clinical Lecturer in Infectious Diseases
STH18690
Tel +44 (0)114-226 1113
Fax +44 (0)114-226 8898
[email protected]
Participant Information Sheet
RESEARCH INFORMATION SHEET
Study: Pulmonary MRI in Antiretroviral treated HIV
You are being asked to participate in a research study. Before you decide whether to consent to
take part 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 and ask us about it if you
wish. Ask us if there is anything that is not clear or if you would like more information. Take
time to decide whether or not you wish to take part.
What is the purpose of the study?
This study is a pilot study (small preliminary study) that aims to take a detailed look at the
airways and blood vessels in the lungs of healthy people with HIV who are taking combined
antiretroviral medication (cART) and healthy people without HIV. The objective is to
determine whether a new lung imaging technique is able to detect any early changes that are
associated with two lung conditions, chronic obstructive pulmonary disease (COPD or
chronic bronchitis / emphysema) and Pulmonary Hypertension (PH) which are more
common in HIV seropositive individuals. This technique is called hyperpolarized gas
magnetic resonance imaging.
To study the possible mechanisms that are driving damage to the airways it is likely to be
helpful to detect the damage at an early stage, particularly as this would enable the study of
any new medicines that could interrupt the process. Unfortunately, the tests that are
currently available are limited.
Imaging of the lung has traditionally relied on X-rays, which involves radiation exposure.
This limits the number of times people can have scans taken of their lungs and the amount
of information that can be obtained. A new technique, which involves breathing in gases
called Helium and Xenon, has made it possible to take pictures of the lungs using Magnetic
Resonance Imaging (MRI) and to use these pictures to measure how well the lungs work.
MRI is harmless, does not require X-rays, and is performed in many millions of people each
year. Further information about MRI is available on the accompanying sheet ‘MRI Scan’
from NHS Choices and on the NHS choices website http://www.nhs.uk/conditions/MRIscan/Pages/Introduction.aspx or this useful You Tube video
https://www.youtube.com/watch?v=AwXJNXNcLNs
Both Helium and Xenon are well known to us. Helium MRI studies have already been
carried out in hundreds of people. Xenon has been used a lot too to produce better pictures
in X-ray (CT) scanning. It acts as a sort of dye by dissolving into the blood. The gases are
scentless, so-called “inert” gases which means they don’t combine with things chemically.
THE UNIVERSITY OF SHEFFIELD
Infection and Immunity
L Floor, University of Sheffield Medical School,
Beech Hill Road,
Sheffield S10 2JF
Paul Collini MBChB PhD
Clinical Lecturer in Infectious Diseases
STH18690
Tel +44 (0)114-226 1113
Fax +44 (0)114-226 8898
[email protected]
Participant Information Sheet
This means they don’t produce poisonous things that could cause side effects, though
Xenon does have mild anaesthetic effects when inhaled in large quantities. Using this new
technique we are obtaining new, detailed information on how the lung functions. Crucially,
the technique appears to be able to pick up early signs of damage to the airways in those
who are developing COPD. It is particularly good at detecting changes that have only
occurred in small regions of the lung, which would otherwise be missed by traditional
breathing tests (spirometry) as these can only measure the function of the whole lung.
This imaging technique can also be used to measure blood vessels in the lung to detect high
pressures, which traditionally requires a complex test called right heart catheterisation (the
insertion of a wire into the heart through a neck vein) to make the diagnosis.
What will be involved if I agree to take part in the study?
If you agree (consent) to take part a doctor will ask you about your breathing and perform a
simple examination of you lungs.
This will also include tests of lung function; a test called spirometry which involves
blowing hard into a small tube to make measurements of how the air flows out of your
lungs; an indoor shuttle walk to determine how long it takes you to walk a set distance; a
test called Lung Diffusion Capacity Testing (DLCO) which measures how well oxygen
moves through the lung and into the bloodstream when you fully inhale and then exhale into
a gas analyser and measurement of your oxygen level using a technique called “pulse
oximetry”, that uses a small piece of equipment that fits over your finger and measures
oxygen using different types of light sensors. You will also be asked questions to check that
it is safe for you to have an MRI scan.
All this can be done at the time you enrol in the research study and take 1.5 hours. You will
be given a short questionnaire about respiratory symptoms you may sometimes get to take
home and an appointment will be made with you to return for the MRI lung scan.
The MRI will take place at the Academic Unit of Radiology (University MRI Unit), Royal
Hallamshire Hospital. We will ask you not to drink anything containing caffeine (such as
coffee, tea or cola) 8 hours prior to visit. The MRI scan will take 1.5 hours.
At the time of your visit you will be shown around the University MRI department and
shown the MRI scanner before your scan, and you will be given information about how to
breathe in the gases when necessary. This is done by breathing in from a tube coming from
a plastic bag containing the gas. You have to breathe in, hold your breath for a short while,
then breathe out again on a few occasions. This needs to be co-ordinated with taking
pictures but is an easy test to do. To look at the blood supply to your lungs we will give you
an injection of contrast agent (dye). A cannula (needle) will be placed in a vein on the inside
of your elbow or back of your hand to inject the dye. You will only be allowed to enter the
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THE UNIVERSITY OF SHEFFIELD
Infection and Immunity
L Floor, University of Sheffield Medical School,
Beech Hill Road,
Sheffield S10 2JF
Paul Collini MBChB PhD
Clinical Lecturer in Infectious Diseases
STH18690
Tel +44 (0)114-226 1113
Fax +44 (0)114-226 8898
[email protected]
Participant Information Sheet
MRI scanner room after filling in a standard questionnaire which is to double check that it is
safe for you to have an MRI scan.
During the time in the scanner, you will be asked to lie very still. We will check your health
using pulse oximetry to measure your heart rate and blood oxygen level. We will then ask
you to breathe in the gas as we have explained, and the scanner will take pictures. During
this process, you will hear some noise from the MR scanner – this is just the harmless sound
of the machine working. You will receive earplugs prior to the investigation to reduce the
noise. Some people may find the scanner claustrophobic and you may wish to have another
person present in the actual scanner room with you. This is usually a close relative or friend
and this is OK as long as they complete a visitor questionnaire and are deemed suitable to
enter the scanner room.
What if abnormalities are found?
As people who are HIV seropositive (HIV infected) are more likely to develop airways
disease or pulmonary hypertension, it is expected that early abnormalities may be
detectable in your lungs. We will contact you and your clinic doctor after the study to let
them know the findings, and with some advice. If you and they feel additional advice is
required, an appointment with a respiratory specialist can be arranged. One of the
investigators in this study, Dr Lawson, is a consultant respiratory physician and will be
available to give a respiratory opinion if needed. The significance of these early
abnormalities in asymptomatic people with HIV is not yet known, which is why this
research is being conducted.
What Are The Possible Discomforts & Risks Of Taking Part?
MRI scans
Having an MRI scan of the lungs requires lying down inside a relatively confined space.
Some people find this makes them anxious. The machine is also noisy so ear defenders are
provided.
Helium has been used extensively in MR imaging for many years. At ordinary room
pressure, no side effects have been reported in healthy volunteers and adult participants with
various lung diseases. However, a slight decrease in blood oxygen levels has been shown in
participants with very severe lung diseases or with a prolonged breath hold of more than 45
seconds. In the current study, we will only ask you to hold your breath for a short period of
time (less than 20 seconds). We will use a finger probe to check your oxygen levels
throughout the investigation.
Xenon gas has been used a lot to help CT scanning. In these cases the amount of gas used is
often much more than we will be using. It is very safe. However, a temporary slight
decrease in blood oxygen levels will occur, together with some light-headedness from the
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THE UNIVERSITY OF SHEFFIELD
Infection and Immunity
L Floor, University of Sheffield Medical School,
Beech Hill Road,
Sheffield S10 2JF
Paul Collini MBChB PhD
Clinical Lecturer in Infectious Diseases
STH18690
Tel +44 (0)114-226 1113
Fax +44 (0)114-226 8898
[email protected]
Participant Information Sheet
mild anaesthetic effect. If your blood oxygen saturation does not return to its usual level in a
short time or you experience any other side effects we will record the events with a written
letter to your GP or take any other action necessary. However, oxygen levels have always
gone back to their usual levels in all the participants that we’ve scanned so far.
Side effects of the contrast agent (dye) injection may include mild headache, a feeling of
sickness and local pain at the site of injection. Rarely (less than 1% of the time) low blood
pressure and light-headedness occurs which can be treated immediately with a drip
(intravenous fluid). Very rarely (less than one in one thousand), participants are allergic to
the contrast agent. These effects are most commonly hives and itchy eyes, but more severe
reactions have been seen which result in shortness of breath. If an allergic reaction occurs,
you will be promptly admitted to a ward and administered appropriate medications.
Spirometry/DLCO/ Shuttle walk
The breathing tests involve breathing in and out of tubes. They are the usual type of tests
carried out to check on people with lung diseases in hospitals. Blowing hard might make
you a bit light headed. However we wouldn’t expect them to cause side effects. The shuttle
walk will usually make people a little breathless.
Incidental findings
Very occasionally scans can reveal unexpected changes in the lung that may or may not be
important. If this happens will inform you and arrange for you to have an appointment with
a consultant respiratory physician to discuss the finding and any further tests if necessary.
In the unlikely event that you experience any other side effects that might be related to any
of the tests (scans or breathing tests) we will arrange extra check ups as necessary.
Do I have to take part?
No. You are free to refuse to participate. If you say no there will be no other consequences and
this will have no impact on your ongoing care.
Are there any reasons why I should not take part?
When we meet you we will ask you if you have any medical conditions and what regular
medicines you use and whether you have ever smoked. If so we may ask that you do not take
part.
What will we do with the measurements we take?
The images taken from the MRI scan will be stored on computers in the Academic Unit of
Radiology and will be looked at so that we can understand the changes in your lungs in terms of
passage of air and blood through the lungs. We will also measure other things, such as the size of
the air spaces within the lung. We will make comparisons between different areas of your lungs
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THE UNIVERSITY OF SHEFFIELD
Infection and Immunity
L Floor, University of Sheffield Medical School,
Beech Hill Road,
Sheffield S10 2JF
Paul Collini MBChB PhD
Clinical Lecturer in Infectious Diseases
STH18690
Tel +44 (0)114-226 1113
Fax +44 (0)114-226 8898
[email protected]
Participant Information Sheet
and compare your measurements to that obtained from other people. We will compare
information from the scan with information from breathing tests and symptom questionnaire.
How long will you keep information about me?
Any information about you collected during this study (images, medical history, questionnaire
answers and spirometry results) will be stored for a maximum period of 5 years after which time
it will be destroyed. The sample will be made anonymous so that the results obtained will not be
recognised as coming from your sample.
Will the information obtained in the study be confidential?
Anything you tell us and any information (data) relating to you that are generated during the
study will be treated in confidence. The only data with your details will be a paper record that is
kept in a locked cabinet in the research office in the department of infectious diseases on E floor
of the Royal Hallamshire Hospital. All the data will by pseudonymised; that means it won’t be
labelled with your name. We will use a code so people don’t know it’s yours. The answers to
screening questions about your health will be kept confidential and if they are deemed to result in
your exclusion from participating the results will not be kept. All the data used in the study will
be password protected and kept on a single computer belonging to Dr Collini. All recorded MRI
scan data will be held in a password protected university computer in a locked room in the Unit
of Academic Radiology at the University of Sheffield.
Will I benefit from the study?
There will be no direct benefits to participation. However, you will be helping us
understand a really important research question that we cannot tackle without studying the
lungs of human volunteers. Your contribution will help develop important insights into
mechanisms of lung diseases in HIV infected individuals and how these can be better
prevented in the future.
Who has assessed and funded this study?
This study has had independent scientific review and has been reviewed and given a
favourable opinion by the National Research Ethics (NRES) Committee Yorkshire & The
Humber. The work is funded by a grant from the National Institute for Health Research
(part of the NHS).
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THE UNIVERSITY OF SHEFFIELD
Infection and Immunity
L Floor, University of Sheffield Medical School,
Beech Hill Road,
Sheffield S10 2JF
Paul Collini MBChB PhD
Clinical Lecturer in Infectious Diseases
STH18690
Tel +44 (0)114-226 1113
Fax +44 (0)114-226 8898
[email protected]
Participant Information Sheet
What if I wish to complain about the way in which the study has been conducted?
If you have any cause to complain about any aspect of the way in which you have been
approached or treated during the course of this study, the normal National Health Service
complaints mechanisms are available to you. The research leads are Professor Jim Wild and
Dr Paul Collini. If you wish to discuss the study further please contact Dr Collini, by
telephoning him directly on 0114 226 1113 or by email [email protected].
Otherwise you can complain directly to the Medical Director who manages Dr Collini: Dr.
David Throssel, Medical Directorate, 8 Beech Hill Road, Sheffield S10 2SB, Tel 0114 271
2178
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