Why have I been invited to take part in the Airways-2 study?
The ambulance service that treated your cardiac arrest is taking part in this study. You have already received treatment for your cardiac arrest, and as part of your treatment either the newer supraglottic airway device or the intubation method was used to manage your airway. We would now like your permission to collect some additional information from you and your hospital notes about your quality of life around the time you leave hospital, and at approximately 3 and 6 months after your cardiac arrest happened. We are aiming to recruit 9,000 patients in total, with 3 and 6 month data being collected in patients that have survived and consent to continue in the study.
What will happen to me if I take part?
As you have already taken part in the study at this point, we will ask you to complete a consent form to indicate whether or not you would like to continue to be involved in the follow up phase of this study. Continuing in the study will not involve any additional or different treatment but it will allow us to collect important information about your recovery, and help us to determine which airway management technique should be used by paramedics attending a cardiac arrest.
If you would like to take part in the study you can consent to either active follow up or passive follow up – See ’What will I have to do?’ for a description of the two follow up methods.
If you do not wish to take any further part in the study, we will ask you to select this option on the consent form.
By selecting this option – no further information will be collected about your cardiac arrest, but the information about your cardiac arrest and treatment up to this point will still be included in the analysis of the study. It will be anonymised, so you cannot be personally identified. If you wish to take this option we will not contact you again.
What will I have to do?
Active follow up
If you consent to the active follow up we will continue to collect information about you from your records, for example: outpatient appointments, GP visits, A&E attendances, and any inpatient treatments. In addition, we would like to invite you to complete some questionnaires 3 months and 6 months after your cardiac arrest. These questionnaires will ask about your ongoing health and wellbeing, and will take no more than one hour to complete.
They can be administered over the telephone, by e-mail or by post or completed online. If you wish, it can also be administered in person at your home, or during a visit to a hospital clinic. This will give us important extra information about your recovery and allow us to plan future research in this area.
Passive follow up
If you consent to passive follow up we will continue to collect information about you from your records, for example: outpatient appointments, GP visits, A&E attendances, and any inpatient treatments but you will not have to complete any questionnaires.
What are the possible risks and benefits of taking part?
You have already received treatment for your cardiac arrest. There are no anticipated disadvantages or risks to you from taking part. Continuing to take part in the study will not benefit you directly, but the information we get from this study will help improve the treatment of people who have an out of hospital cardiac arrest in the future.
When does the research study stop?
Once we have collected follow-up data from you at 3 and 6 months your participation in the study will be complete.
You will not incur any expenses as a result of being in the study, and you will not be paid for taking part.
Will my taking part in the study be kept confidential?
Your medical notes will need to be seen by authorised members of the hospital research team so they can collect information needed for this research study. With your consent, your GP will also be informed that you are taking part in the research study. Your GP may be asked to provide information from your records which is required for the research.
Occasionally, other members of NHS staff or research staff may need to check your medical records. This will be done by NHS staff or by researchers who are bound by the same rules of confidentiality as all NHS staff. Regulatory authorities and the hospital trust overseeing the research may also need to look at your notes but the confidentiality of your medical records will be respected at all times.
All information which is collected about you during the course of this research will be kept strictly confidential. The information that will be collected includes personal information such as your name, address and NHS number. This will allow us to keep in touch with you during your participation in this research, enabling us to collect information about your quality of life.
Electronic information collected by the hospital where you were treated may be securely transferred within the NHS to the University Hospitals Bristol NHS Foundation Trust. The information collected will be stored in a secure database held at the co-ordinating centre (CTEU, Bristol) and will only be accessed by authorised members of staff involved in the research. This includes the hospital research team and staff at the coordinating centre who are managing the research and will be responsible for aspects of your follow-up such as sending you questionnaires.
The findings from the study may be reported in medical journals or presented at meetings but your identity will not be disclosed. During the course of the study we will ask you if you would like to receive a summary of the results by post after the research has finished.
Under no circumstances will you be identified in any way in any report arising from the study.
What will happen if I don’t want to carry on with the study?
You are free to withdraw from the study at any time, without giving a reason. If you withdraw, we will use the information that we have already collected about you unless you specifically request us not to.
To withdraw from the study, please contact your local research nurse – their details will be on the Patient Information Leaflet that you have been given.
Alternatively, you can contact the Project Manager via email at airways-2@bristol.ac.uk or via telephone 0117 342 2987
Fair processing statement
Part of the AIRWAYS-2 study is looking to link data collected during the study (study data) to routinely collected NHS data (routine data). This will provide the AIRWAYS-2 study with more information on patients care and survival following their cardiac arrest. This process is managed by a Data Controller, who in this instance is the study Sponsor (South Western Ambulance Service NHS Foundation Trust).
Study data has been collected from hospital records and will be sent from the AIRWAYS-2 team at University Hospitals Bristol NHS Foundation Trust to NHS Digital, who are the holders of the routine data. In order to link the study data to the routine data, some identifying patient data will be sent to NHS Digital (date of birth, full name, NHS number, gender and postcode). The transfer of identifiable data will be secure and only necessary data will be shared with NHS Digital. NHS Digital will link the relevant routine data to the study data and return it to the AIRWAYS-2 study team at University Hospitals Bristol NHS Foundation Trust. This linked data will include identifying patient data (date of birth, full name, NHS number, gender and postcode). AIRWAYS-2 study team in Bristol will undertake some data cleaning and then pseudonymise the data (all identifying patient data will be removed but the unique study ID will be included). This pseudonymised data will be sent to the University of Oxford where the AIRWAYS-2 health economists will analyse the data. This team will look at the value for money of the two treatments being compared.
If you wish to opt-out of this data sharing, you can do so at any time, without giving a reason, by contacting the Project Manager via email at airways-2@bristol.ac.uk or via telephone 0117 342 2987.
Further information
You can obtain general advice on out of hospital cardiac arrest and its treatment from the British Heart Foundation website.
Tel: 0300 330 3311
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 of this booklet can be downloaded from the UKCRC website.
Printed copies can be requested by emailing: crncc.info@nihr.ac.uk
Or contacting:
UK Clinical Research Collaboration,
C/O Medical Research Council
One Kemble Street
London WC2B 4TS
Tel: 020 7395 2271
