Appendix a patient information sheet
The EMPiRE trial:
AntiEpileptic drug Monitoring in PREgnancy study
Participant Information Sheet
You are invited to participate in the study
You are invited to take part in the EMPIRE study. Through this study we plan to find the AED monitoring method that is best and safe for seizure control in pregnancy. The study is entirely voluntary – you do not have to take part, nor do you have to give a reason if you decide not to participate. Before you decide whether or not to take part, it is important that you understand why the study is done and what it involves. Please take time to read this information sheet carefully and talk to others about the study if needed. If there is anything that is not clear, or if you would like more information, you can ask the doctor, midwife or nurse listed above for further advice.
How are mothers with epilepsy on antiepileptic drugs (AED) managed in pregnancy?
Most mothers require long-term treatment with drugs to manage epilepsy, called antiepileptic drugs (AED). These drugs levels in the blood usually fall in pregnancy. This may increase the risk of seizures. Currently, some doctors do regular blood tests to check the level of the drugs in the blood in pregnancy. They offer to increase the dose if the levels fall compared to the last level. This is called Therapeutic Drug Monitoring (TDM). Other doctors do not do regular blood tests in pregnancy. They only increase the dose if seizures worsen or if they occur for the first time in pregnancy. This is called Clinical Features Monitoring (CFM).
Why is this study needed?
We do not have enough evidence to strongly recommend one method of monitoring over the other in pregnancy.
Why have I been asked to take part?
You are a pregnant woman and known to have epilepsy. You are currently on one or more of the following drugs that we are studying: carbamazepine, lamotrigine, levetiracetam or phenytoin. In addition, we would also like to study your views and thoughts on your experiences during the study and the costs involved.
Do I have to take part?
It is entirely your decision to take part or not take part in the study. If you do not wish to participate, you do not have to give a reason and your decision will not affect the standard of care you will receive. Similarly, if you do decide to participate, you are entitled to withdraw from the study at any time, without having to give a reason, and this will not affect the standard of your medical care in any way.
If you do not wish to participate in the monitoring methods part of the study, then you will be approached to provide your views about your experiences of epilepsy and pregnancy for the qualitative part of the study. It is completely upto you to decide to participate in this discussion and your decision will not affect your care.
What will happen to me if I take part?
If you participate in the study, you will be seen as usual every 4-5 weeks up until 6 weeks after you give birth. You will have regular blood tests every 4-5 weeks to check your drug (AED) levels until labour or delivery. Your blood samples will be stored for the lifetime of the trial and for 3 years after the completion of the trial. After this period, the samples will be destroyed.
You will be asked to complete a seizure diary throughout your pregnancy and up to 6 weeks after birth to document the type and frequency of any seizures you may experience, including any side-effects. We will also ask about your mood and general well-being by asking you to fill out a questionnaire at your visits. When your baby is born, the umbilical cord will be cut and is usually disposed of. We will take a sample of blood from the umbilical cord after it has been cut. This will give us information on the level of AED in your baby’s blood at birth.
When your baby is 6 weeks old, at your routine 6 week postnatal appointment, we will assess clinical information about you and your baby. This will be recorded in the medical notes for later use if needed.
The research team may approach you in the future to invite you to participate in a possible long term follow up study about your child(ren)’s development. Funding, ethical approval and consent for specific investigations / examinations will be obtained nearer the time. You can choose whether or not to be contacted.
You may also be asked to complete a questionnaire about any out of pocket expenses (e.g. transport costs, time lost from work or child care costs) you may have incurred when attending the clinics. This will help us find out about the wider cost implications of the two monitoring methods on the health service.
If I take part will I undergo Therapeutic Drug Monitoring (TDM) or Clinical Features Monitoring?
If there is a significant fall in your blood levels of the drug (AED) you will be randomly allocated (like flipping a coin) to receive either Therapeutic Drug Monitoring (TDM) or Clinical Features Monitoring (CFM). We will allocate you randomly to one of these two groups because we do not know which monitoring method is best. If your blood levels of the drug do not fall, you will continue to have 4 weekly blood AED levels monitored. Your doctor or nurse will only inform you of your drug levels if you are allocated to the TDM group or if you specifically request this information. You may sometimes need frequent monitoring if there is a concern about your seizure control.
What will happen to me if I take part in the qualitative part of the study?
Whether or not you choose to take part in the monitoring part of the study, you will be asked to consider taking part in the qualitative study. We are doing this to obtain the views of mothers about the management of their epilepsy while they are pregnant.
If you decide to take part, your care team will pass your contact information to the research team. A member of the research team will contact you to arrange an interview which will last approximately 45 minutes and will take place at a time and place that is convenient for you. We will meet with you once in pregnancy and once after the birth of your baby. You will have one additional visit if you your seizures worsen in pregnancy.
With your permission we will tape record the interviews. All information that is collected during this study will be anonymous and treated with complete confidentiality. Although individual quotations may be used
no individuals will be identified in any publications resulting from this study. Data will be handled, stored and destroyed in accordance with the Data Protection Act (1998).
Are there any benefits for me from taking part in the study?
As we do not know the best method to monitor your drugs in pregnancy, we cannot say if there will be any direct benefit to you and your baby. However, your taking part in this study will help inform decisions about management of pregnant women with epilepsy in the future.
What are the side effects of treatment received when taking part?
You may have side effects related to the type and dose of AED. It is expected that you will remain on your usual AEDs, as it is less likely for these to be changed during pregnancy. If it is necessary to increase/decrease the dose of your AEDs or change them, then the reasons for this will be discussed with you by your epilepsy specialist in the usual way, giving you the opportunity to discuss concerns about the process. If you do feel ill in any way at all, you must tell your doctor.
LOCAL HOSPITAL EMPIRE TRIAL RESEARCH STAFF CONTACT DETAILS
NEUROLOGIST: Dr Jane Adcock, Tel: 01865 741166
OBSTETRIC PHYSICIAN: Dr Lucy Mackillop TEL: 01865 851165
RESEARCH NURSE/MIDWIFE: Nicola Higgins TEL: 01865 221107
What are the possible risks and disadvantages of taking part?
The majority of women with epilepsy have healthy pregnancies and give birth to healthy babies. In a small proportion of women with epilepsy there is a slightly higher chance of having a baby with a problem, which may be related to the drugs or the epilepsy itself. The risk of the drugs causing birth defects in an unborn child appears to be greatest during the first three months of pregnancy. If you need to increase the dose of the drug in the study it will only be done after this period. Your doctor or midwife will discuss the risks relating to the type and dose of your drug. Seizures may cause risks to you and your baby and affect your driving licence status. We do not know which method is best for the long term outcome of your baby.
What if new information becomes available?
Sometimes during the course of a research project, new information becomes available about the treatment that is being studied. If this happens, your doctor will tell you about it and discuss with you what to do next. If you decide to withdraw, you and your doctor will decide your future care. If you decide to continue in the study you will be asked to sign an updated consent form.
What will happen if I don’t want to continue with the study?
You are free to withdraw at any time without giving a reason. Your care will not be affected in any way. The data we have collected about you will be analysed, unless you specify otherwise.
Who has organised, reviewed and funded the research?
The trial is funded by NIHR and The Pragmatic Clinical Trials unit (PCTU) at the Queen Mary, University of London will collect and analyse the data and the The National Epilepsy Society for Therapeutic Drug Monitoring Unit, Buckinghamshire will store and analyse blood samples. Queen Mary, University of London are the trial sponsor.
The doctors involved are not being paid for recruiting women into the study. Patients are not paid to take part either, but their help in finding out more about how best to treat epilepsy during pregnancy is much appreciated.
All research in the NHS is looked at by independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by Coventry and Warwickshire Research Ethics Committee.
What if there is a problem?
Every care will be taken to avoid any known problems to you or your baby in the course of this study. Whether or not you take part in this trial, you would retain the same legal rights as any other patient treated in the National Health Service. However in the unlikely event that you or your baby is injured by taking part, compensation may be available. Queen Mary, University London holds a no fault indemnity.
If you are not satisfied with any aspect of the way you have been approached or treated during the course of this study, you should first speak to the research team (please see contact on page 1) who will do their best to answer your questions.
If you remain unhappy and wish to complain formally, the normal National Health Service complaints mechanisms are available to you: ask to speak to the complaints manager for the Hospital.
Please ask to speak to Patient Liaison and Advice Service (PALS) on 01865 741166 or contact on Research Governance Office on 01865 572224.
Will information about me be kept confidential?
Yes, all information collected in the study will be kept strictly confidential in the same way as your other medical records. If you agree to take part, doctors involved in your medical care will collect medical information about you, your baby and your condition and send it to the Trial Office in London on paper and electronically. Blood samples sent to the National Society for Epilepsy Therapeutic Drug Monitoring Unit, Buckinghamshire for analysis will also be kept confidential. Data will be securely stored under the provisions of the 1998 Data Protection Act and/ or applicable laws and regulations.
Information held by the NHS may be used to follow your progress. Your GP, and other doctors involved in your clinical care, will be kept informed, but otherwise all information about you, your baby and your treatment will be kept confidential.
If you take part in the trial, your relevant medical records may be inspected by authorised individuals. They may also be looked at by regulatory authorities. The purpose of this is to check the trial is being carried out correctly.
What will happen to the results of the research study?
When the results of the study are known they will be published in medical journals and the results circulated to medical staff and participants. No individuals will be identified.
Involvement of the General Practitioner/Family doctor
With your consent we will inform your GP of your participation in the trial.
Do you have any further questions?
Having read this leaflet, it is hoped that you will choose to take part in the study. Please keep this copy of the Participant Information Sheet. You will also be given a copy of your signed consent form to keep if you decide to participate in the trial.
If you have any questions about the study now or later feel free to ask your epilepsy specialist, obstetrician or a member of the research team.
You can also contact the Trial Co-ordinator on 020 7882 3446 or 07917736924. The address of the Trial Office is: Women’s Health Research Unit, Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Yvonne Carter Building, 58 Turner Street, London E1 2AB.
Thank you for taking the time to read this Participant Information Sheet about the Trial.
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