Information for Patients
Why is the study being done?
Pneumonia is an inflammation of one or both lungs, usually caused by infection. Most people recover completely but some have complications. Two of the most significant complications are heart attack and stroke. Around 5 in 100 patients who are admitted to hospital with pneumonia have a heart attack or stroke within three months. These events are thought to occur because the infection affects blood vessels and causes clots, reducing the blood reaching the heart or brain.
Aspirin has been used for decades to reduce the chance of having a heart attack or stroke in patients at high risk of either event. It works quickly with limited side effects in the vast majority of patients. Some studies have shown that patients who develop pneumonia and take aspirin have a lower chance of these events.
The ASPECT trial aims to test whether aspirin reduces the risk of a heart attack or stroke in patients who are admitted to hospital with pneumonia. Those who agree to take part will be split into two groups. One group will be asked to take a course of low dose aspirin for 3 months, the other group will not. In all other respects, both groups will have the same treatment.
We will look at whether participants have had a heart attack or stroke, or any other serious events 3 months after joining the study. We will do this by reviewing the ‘usual care’ health records of participants held by NHS hospitals. This means that participants will not have to do anything. The first 2,000 participants will be asked to complete a questionnaire at 3 months. The questionnaire will ask about side effects and whether the aspirin was taken as prescribed.
Why have I been invited to take part in the ASPECT Study?
You have been invited because you are currently unwell with pneumonia in hospital.
We are hoping to recruit 22,600 pneumonia patients in England to the ASPECT study.
Who can take part?
Adults aged 50 years and over admitted to hospital with pneumonia will be invited to take part.
Who can NOT take part?
We will not include people who:
- are already taking “aspirin-like” medication (anti-platelet medication)
- have a known allergy to aspirin
What will I have to do if I take part?
Click link for more information.
What alternatives are there to taking part?
If you decide not to take part in the study, you will receive the usual care provided in your hospital.
What are the possible benefits of taking part?
There is a possibility that participants who receive aspirin will have a lower chance of suffering from a stroke or heart attack after pneumonia infection, but we cannot be certain, and this is what the study will help us find out.
What are the possible disadvantages and risks of taking part?
The possible risks of taking part in the study are the side effects from aspirin (see below), but the dosage in this study is very low, so the chances of side effects are also very low.
What is there is a problem?
If you have any concerns or questions about this study, please contact the research team (aspect-trial@bristol.ac.uk or 0117 455 1233)
If you have concerns about the way you have been treated during the study or wish to make a formal complaint, you may wish to contact your local Patient Advice and Liaison Service (PALS).
We have no reason to believe that you will be placed at any greater risk to your health by taking part in this study. However, if something goes wrong and you are harmed during the study there are no special compensation arrangements. If anything goes wrong because of taking part in the study due to negligence, the NHS trust responsible will compensate you. Negligence includes, for example, if injury was caused by a deviation from the study protocol by a researcher. The normal NHS complaints mechanisms will still be available to you.
Will my taking part in the study be kept confidential?
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What will happen if I don’t want to carry on with the study?
You are free to stop taking part in the study at any time without giving a reason and without this decision affecting your rights. You may just want to stop taking the aspirin and continue being part of the study by allowing the study team to access your health records.
If you are asked to complete the questionnaire, you can tell the team that you do not wish to do this as well, without having to give a reason. This will be discussed with you at the time of leaving the study.
Expenses
You will not have to attend any additional hospital visits for this study and therefore we will not refund any travel expenses.
What if relevant new information becomes available?
If we get new information about the treatment being studied, we will let you know and discuss whether you want to continue in the study.
Further information
It is unlikely that any life or medical insurance would be affected by taking part in this study, but you should consider this before consenting and seek advice if necessary.
You can obtain general information on clinical research from the UK Clinical Research Collaboration (UKCRC) who produce a booklet called “Understanding Clinical Trials”. This provides in-depth information on the design and conduct of clinical trials and aims to answer the questions of those considering taking part.
Electronic copies can be downloaded from the UKCRC website: https://www.ukcrc.org/public-awareness-of-clinical-research/information-resources-on-clinical-research/
Or contacting:
UK Clinical Research Collaboration,
C/O Medical Research Council
One Kemble Street
London
WC2B 4TS
Tel: 020 7395 2271
Email: crncc.info@nihr.ac.uk