When did the study start?
CAPS was initially set up as a pilot study in 2001 and ethical approval for the full study was given on 18th February 2003.
Why has your child been chosen?
We are asking all children who have recently been diagnosed with arthritis to take part in this study.
Do we have to take part?
Your child does not have to take part in this study. It is up to you to decide whether or not to take part. Your child's treatment will not be affected if you decide not to take part. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form.
What will happen to my child if they take part?
The study will begin as part of a normal visit to the Rheumatology Clinic. The Hospital Consultant will ask patients and parents whether they are happy to take part in the study. If you agree then the consultant will send your child's name, address and telephone number to the Research Nurse. The Consultant will also provide details of your child's illness and treatment as well as the results of any blood test or X-rays that have been done as part of the normal hospital visit.
The Nurse will contact you by telephone to arrange a visit at a mutually convenient time. The visit can either be at your home or at the hospital during your next routine visit. With your help she will complete a form about your child's medical history, present health and treatment history. You/your child will be asked to complete some questionnaires about how the arthritis affects your child’s daily activities, their moods and how it affects you. You will also be asked about any family history of arthritis and related conditions. You and your child together will be asked to complete a diagram showing which joints have been affected. Occasionally, these questions may be posed over the telephone or we may post the questionnaires to your home. Follow-up visits will be arranged approximately once per year, although these may become less frequent as the study progresses. At this stage we do not know how long in total we will want to collect this information from you/ your child but in the first instance we imagine this will be for at least 10 years.
Information regarding your child’s illness will also be obtained from the medical case notes.
What will happen to my child if they take part?
There is no risk associated with taking part in the study and the only inconvenience is the time given over to the Nurse's visit and to complete the questionnaires. As mentioned above, the research blood sample would be taken at the same time as blood was required for routine testing and so no additional risk would be involved.
What are the possible benefits of taking part?
The research may not have a direct benefit for your child or the family. However, many families find it helpful to talk about the illness and the impact that it is having on the life of the family with someone who is independent (e.g. a Research Nurse).
Will taking part in this study be kept confidential?
The patient's notes are kept confidential as usual at the hospital. Separate research records will be kept by the Research Nurse and only those involved in the study will have access to them. Since this study involves a number of Centres in the United Kingdom, information about your child will be sent to the Arthritis Research UK Epidemiology Unit at The University of Manchester. Each participant will be given a code number so that they cannot be identified. All data will be stored on a secure database that can only be looked at by authorised individuals. The individual results from any genetic studies will not be provided to the child, the family, the Consultant or any other organisation or individual. With your permission your child’s GP will be notified of their participation in the study.
Do I or my child need to complete the CAPS questionnaires if my child is well?
To understand why some children get better, we need to collect information on individuals in remission as well as those who remain unwell, so it is extremely important to follow-up all study participants.
Am I free to withdraw from the study?
What will happen to the results of the research study?
The results of the study will be presented at scientific meeting and published in medical journals but, again, no identifying information will be given in these publications
If you decide to take part you are still free to withdraw at any time and without giving a reason. It is possible for a you to withdraw from any aspect of the study, Medical Case Notes, Visit Forms and Questionnaires, independently or simultaneously.
What is the 'National Health Services Information Centre (NHS-IC)' and 'The National Health Services Central Register (NHSCR)'?
Both the Health & Social Care Information Centre (HSC-IC) & National Health Service Central Register (NHSCR) collect statistics on health outcomes across the United Kingdom in collaboration with the NHS. Examples of this data include information on any resident of the UK who dies and anybody who develops a cancer. Researchers can “flag” the names of participants involved in their research with the NHSIC or NHSCR such that in the rare event one of these health outcomes occurs, the researchers will be informed. This allows them to have almost 100% complete information on these rare outcomes. With your permission, your child’s name would be “flagged” with the NHS-IC. This will allow us to study very long-term outcomes, far into adulthood, in children who have or have had arthritis.