Appendix 11: Information Sheet (main questionnaire study)

Study Title: Factors implicated in women’s decision-making regarding the uptake of prenatal diagnostic tests

We would like to invite you to take part in a research study. Before you decide we would like you to understand why the research is being done and what it would involve for you, so please take the time to read the following information carefully. You may also wish to talk to others about the study, and please feel free to ask us if there is anything that is not clear to you or if you would like more information.

What is the purpose of the study?

The purpose of this study is to explore the different factors which may impact on a woman’s decision to have a prenatal diagnostic test or not. Diagnostic tests include the option of amnio / CVS or Harmony. Amniocentesis and CVS are tests that may have been offered to you if you were found to have an increased risk following your first trimester ultrasound scan (if not already, your doctor will give you more information about these procedures if considered relevant). Harmony is a blood test and you may have been offered this choice if you were found to be at moderate – high risk. Past research has shown that when faced with such a decision a woman may be influenced by her own feelings and thoughts, and possibly by those of people she is close to. However, previous studies have not looked at a combination of these factors which will be the focus of this study. We understand that this is a very sensitive issue, and we are hoping that with your help we will be able to help women in the future decide whether or not they want to have a prenatal diagnostic test and support them in making the right choice for them.

Why have I been invited to take part?

You have been invited to take part because you are above 18 years of age and have been offered the option of one of the above tests, therefore meeting the criteria for the population

under study. We are contacting all women in this stage of their pregnancy, who are under the care of King’s College Hospital.

Do I have to take part?

No, it is up to you to decide to join the study. If you agree to take part, you will be asked to sign a consent form. You are free to withdraw at any time, without giving a reason and this would not affect the standard of care you receive. If, at any point after handing in your questionnaire you decide that you do not wish to be included in the analysis of the study please contact the Chief Investigator at [email protected] who will immediately remove and manually destroy your data.

What will happen to me if I take part and what will I have to do?

If you decide to take part in the study, you will be asked to fill out a questionnaire, which should take up to 20 minutes to complete. You will then be asked to return the completed questionnaire to the researcher, together with your signed consent form, using the enclosed pre-stamped envelope.

What are the possible disadvantages and risks of taking part?

This study addresses sensitive issues relating to pregnancy, and therefore carries the risk of causing feelings of distress. Information about relevant help-lines is provided on the debrief form so that you can access appropriate 24-hour support, but it is still very important for you to consider whether this is a sensitive topic for you, before deciding whether to participate or not.

What are the possible benefits of taking part?

We cannot promise that the study will help you, but we hope that the results of this study will contribute to a better understanding of the factors that mostly influence women in their decision to have a prenatal diagnostic test or not. This information may then be used by health professionals in order to support women in their decision.

What happens when the research study stops?

When the study is finished and we have analysed all the information, we aim to publish what we have found in relevant academic journals. We also hope to present the findings of the study at conferences but we will ensure that no individual participants in the study can be identified. You may also leave a contact e-mail address, if you wish to be informed of the results personally, although this will be a summary of the total results and not your individual score.

What if there is a problem?

University complaints mechanisms will be available to you. Please direct concerns to Dr Esther Murray, who will be supervising this project, at [email protected]

Will my taking part in this study be kept confidential?

Yes. We will follow ethical and legal practice and all information about you will be handled in confidence. All questionnaires will remain anonymous, and will be kept separately from the consent forms so as not to be linked to individuals. All files will be safely stored in a place where no one outside the research team will have access, and will be destroyed after the end of the study.

Who is organising and funding the research?

The research is being carried out at King’s College Hospital by Marilena Tzafettas, Dr Esther Murray, Dr Elizabeth Charman and Dr David Hardman of London Metropolitan University, and Professor Kypros Nicolaides of King’s College. They have the responsibility for ensuring that this research study is conducted safely, ethically, and according to best practice has no financial interest.

Who has reviewed the study?

All research in the NHS is looked at by independent groups of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given a favourable opinion by the London – Stanmore National Research Ethics Service Committee.

Contact for Further Information

If you are interested in taking part in the study please complete the consent form attached to this information sheet, and return it to the researcher together with the completed questionnaire using the enclosed pre-stamped envelope. If you have any questions please feel free to contact the chief investigator, Marilena Tzafettas at [email protected] . Alternatively you can contact the local principal investigator, Professor Kypros Nicolaides at [email protected].

Thank you for taking the time to read this information sheet. Please find enclosed a box of

“Pregnacare” vitamin and folic acid supplements which are yours to keep regardless of whether you decide to participate in the study or not.