- Where did you get my name and address from?
- I thought my medical records were confidential, so how did you know I had been in hospital?
- What is the point of this study?
- What if I can’t remember anything about my time in ICU?
- Why don’t you want to know about my time in ICU?
- Can someone else fill in the forms for me?
- Are the forms available in any other format?
- I’ve had other health issues since I was in ICU, so do I answer the questions by imagining how I would feel if I hadn’t been ill again?
- Since I left ICU I have had bad news/been dealing with a traumatic situation which is having a negative effect on my mood and general well-being but has nothing to do with my ICU illness. What shall I do?
- Is there a time limit on returning the questionnaires?
- Can you help me with my medical care?
- What is intensive care?
- I’ve heard that patients taking part in clinical trials receive payment for their involvement. How much does ICON pay?
- If I want to make a complaint how do I go about it?
The intensive care unit (ICU) where you were treated is participating in this research study and passed us your name and address so that we could write to you about the ICON study. If you are worried about your confidential patient information being shared without your permission, please refer to the section on data protection here.
I thought my medical records were confidential, so how did you know I had been in hospital? I haven’t given you permission to contact me.
All research studies have to be approved by more than one external body before they can begin. The ICON study has been approved by the NRES Committee South Central—Berkshire ethics committee which is assured that what we are trying to do is legal, ethical and likely to be of benefit to patients in the future. The NRES Committee South Central—Berkshire gave the study the ethics reference number 11/SC/0172.
We also applied to the Research and Development Department (R&D) of the hospital where you were treated and were given their permission to carry out the research.
In addition, the study has class IV support under Section 251 of the NHS Act 2006 to hold identifiable patient data without consent for the purposes of research. This support is given by the Ethics and Confidentiality Committee (ECC) of the National Information Governance Board on the basis that the ECC have carefully considered our application and judge the benefits of the proposed research to be significant enough to set aside the common law duty of confidentiality in favour of public interest. Before reaching this decision, the ICON study had to reassure the ECC that its data security processes are secure and that patient data will be treated with the utmost confidentiality. For more information about Section 251 of the NHS Act 2006, please click on this link.
If you tell us that you do not want to take part in the ICON study, we will remove your data from our records.
Each year the study has to submit a report to the ethics committee, the hospital R&D Department and the ECC of the National Information Governance Board to prove that the study is operating correctly. We must also allow these bodies to audit the study and its processes at any time.
We really don’t know much about the long-term effects of critical illness. The ICON study results will be used to help plan future services, change the ways we look after patients after critical illness, and allow health economists to cost any changes we plan. More knowledge about longer-term recovery from critical illness allows us to better inform our patients about what to expect when they get home.
Many patients have no recall of their time in an ICU. It does not matter if you can’t remember being in ICU, you can still take part in the study because none of our questions ask you about your time in ICU. We are more interested in finding out how you feel today.
The purpose of the ICON study is to find out how people feel AFTER they have spent time in ICU. We hope to gather information that tells us whether being treated in ICU has any effect on a patient’s recovery, health and general well-being. Other studies and audit projects look at the period in the ICU.
If you have difficulty filling in the forms, a close relative or someone involved in your medical care can help you, providing the answers are your own. There is a question on the final questionnaire where this person can indicate that they helped you. Alternatively, the ICON study staff would be happy to help you fill in the questionnaires over the telephone. Our contact details are on the covering letter sent with the questionnaires, or you can email us by clicking this link. We will even call you back to fill in the questionnaires at a convenient time if you ask us to.
However, it is important that if you are unable to answer the questions yourself, for example due to loss of consciousness or a mental incapacity such as confusion or memory loss, someone else should not attempt to answer the questions for you.
Unfortunately we don’t have the resources to provide the questionnaires in any other format. If you need help to fill in the questionnaires or have any questions about the study, you can let the study office know and someone will help you. Our contact details can be found by following this link.
I’ve had other health issues since I was in ICU, so do I answer the questions by imagining how I would feel if I hadn’t been ill again?
No, you should still answer the questions according to how you feel today even if you have separate health issues that are not related to your stay in ICU. At the end of the study we will request information about the illness which resulted in your ICU admission, and also on any subsequent illnesses, to assist us in the analysis of the results of the study. This will also help us to identify participants such as yourself who went on to develop other illnesses.
Since I left ICU I have had bad news/been dealing with a traumatic situation which is having a negative effect on my mood and general well-being but has nothing to do with my ICU illness. What shall I do?
If you feel up to taking part in the study, we would still welcome your participation. You should answer the questions according to how you feel today and hopefully when you are asked to fill in your follow-up questionnaires, your situation will have improved.
No, there isn’t a time limit on returning the completed questionnaires to us, please feel free to return the questionnaires when you are ready to. However, we do send a reminder mailing three weeks after the first set was sent out, just in case the first set went astray, and we may also try to ring you to find out whether you received our mailings and ask you if have had a chance to read the literature. We will not put pressure on you to take part if you don’t want to, but we try to ensure that we have invited as many ICU patients to participate as possible.
Unfortunately we are not able to help you with this as we are a research team. We suggest you contact your GP or the ICU where you were a patient for advice.
The hospital unit where you or your relative is/were being treated may have given you an information leaflet about the intensive care unit, but if not, or if you or your relative need further information about intensive care and what to expect when you or your relative have been treated in intensive care unit, The Intensive Care Society has some very useful information. This link will take you to the Intensive Care Society website.
I’ve heard that patients taking part in clinical trials receive payment for their involvement. How much does ICON pay?
Clinical studies which require patients to attend in person or to undergo medical procedures may be able to reimburse participants their travel expenses or make other payments. As ICON is a questionnaire-based study and does not require you to attend in person, we are unable to offer any financial reimbursement if you decide to take part.
If you have a complaint about the ICON study, you should write to the Chief Investigator, Dr Duncan Young, c/o The Kadoorie Centre, Level 3, John Radcliffe Hospital, Headley Way, Oxford, OX3 9DU.
If you have a complaint about your hospital care, please write to the Patient Advice and Liaison Service (PALS at the hospital where you were a patient. You should be able to find out their address by contacting the hospital’s main switchboard, or you can look up the nearest Patient Advice & Liaison office at http://www.pals.nhs.uk/.