We would like to invite you to take part in a research study exploring Swallowing, Feeding and Eating in children born with oesophageal atresia/trache-oesophageal fistula, called the SaFE study for short.

Before you decide whether you would like your child to take part, it is important that you understand why the research is being done and what it would involve. Please take time to read this information carefully. Discuss it with family and friends if you wish.

You are free to decide whether or not to take part. The care you receive from the hospital or at home will not be affected if you choose not to take part. Please ask if there is anything that is not clear or if you would like more information.  If you, or a family member would like an interpreter or someone to read the questions to help you take part, please contact us (alex.stewart@gosh.nhs.uk or 020 7813 8110) and we would be happy to arrange this. 

SaFE is a PhD project being carried out by Alex Stewart, a speech and language therapist, alongside a team of researchers at Great Ormond Street Hospital and University College London. It is supported by "TOFS", the support group for those born with oesophageal atresia and trache-oeosphageal fistula and their families.

You may know that in November/December 2020 we carried out an online forum on Facebook. Many thanks if you took part. We have looked at everything that what said and now want to understand some parts in more detail using a questionnaire.  The questionnaire focuses on how OA/TOF feeding difficulties affects parents. Research has already shown that caring for a child with OA/TOF can be anxiety-provoking. We would like to understand how much of a part feeding difficulties play in this. We hope that understanding the full extent of what families are dealing with will help health professionals provide the best possible care.

What does taking part in the study involve?
This part of the SaFE study involves completing a questionnaire. You can complete it online, or there is a paper version if you prefer. We will ask you to provide some details about you and your child, including: your age, where in the UK you live, your ethnicity, the type of OA/TOF your child has and some basic medical information. 

The questionnaire will take about 20 minutes to complete.

Why have I been invited to take part?
You have been invited because you are the parent of a child born with OA/TOF. We would very much like all parents of children over 6 months old and under 12 years old to take part in the study. We would really like mothers and fathers to take part, but please complete separate questionnaires.

What are the possible benefits of taking part?
We don't think there will be any immediate benefits to you if you take part. However, you will be helping health professionals to understand the whole impact of OA/TOF feeding difficulties. This will mean that we can improve care for families who have a child born with OA/TOF in the future.

What are the possible disadvantages of taking part?
You may find thinking about the effects of your child's feeding difficulties upsetting. If you do, please speak to someone about how it has made you feel. This may be a family member, friend or one of the TOFS TLC members. But if you are still worried, please speak to a health professional about your concerns. There are many places to get support and help.

Do I have to take part?
No. It is totally up to you whether to take part or not. Your decision won't effect the care your child is given.

What if I decide I no longer want to take part?
You may choose not the complete the questionnaire.  However, as we do not know who has completed each questionnaire, once it is submitted we will not be able to withdraw your responses. 

What will happen to the results of this study?
The project will be presented at national and/or international medical conferences. Results will be shared with the OA/TOF community, with the support of the TOFS charity and the international EAT federation (a group of international OA/TOF support groups which includes the UK TOFS charity). They will be published in a medical journal and included in a publicly available PhD thesis.
All information will be shared anonymously. Neither you nor your child will ever be able to be identified.

Who is organising and funding this study?
The lead researcher on this project is Alex Stewart, an experienced Speech and Language Therapist working at Great Ormond Street Hospital. The research team includes Professor De Coppi (Consultant Paediatric Surgeon at Great Ormond Street Hospital), Professor Jo Wray (a Psychologist) and Dr Christina Smith (a Speech and Language Therapist).
The project has been funded by the National Institute of Health Research.

How have patients and the public been involved in this study?
10 parents of children born with OA/TOF were involved in designing the project. 4 parents are closely involved in delivering the project. They have been involved in thinking about the risks/benefits, how best to ask families to be involved and how best to carry out the project. Please ask if you would like to talk to one of these parents about the project. They would be very happy to answer questions from a parent's perspective.

Who has reviewed this study?
All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee. This study has been reviewed and given a favourable ethical opinion for conduct in the NHS by the London-Central Research Ethics Committee. It has also been approved by the Research Department at Great Ormond Street Hospital.

I'm interested in taking part, what should I do?
Please continue to complete the questionnaire. You can save it and finish it later if you need to. If you would like to be sent a paper copy with a stamped addressed envelope to return it in, please contact Alex Stewart by phone or email.

If you have any further questions please contact Alex Stewart on:
020 7813 8110 or alex.stewart@gosh.nhs.uk.