What matters most: difficult caesarean births

What is the aim of this project?

• Impacted fetal head during caesarean birth occurs when the baby's head is wedged low in the pelvis, causing difficulties in the birth of the baby. This happens in 1 in 10 caesarean births. When this happens, doctors and midwives may use different techniques to assist the birth of the baby.
• All caesarean births carry some risks. These risks are higher when the baby's head is stuck, and extra help is needed to deliver the baby. This can potentially lead to serious outcomes for the mother or baby.
• Improving outcomes for women and babies when an impacted fetal head occurs is a priority. But for healthcare professionals and researchers seeking to improve care, there is currently no agreement on which outcomes should be measured in research and in hospitals. Without this agreement, it is hard to build knowledge and improve care. ‍
• The aim of this project is to find out which outcomes matter most when the baby's head is stuck during a caesarean birth. This applies to outcomes for both the mother and the baby. Your answers will help create a standard set of outcomes that all research in this area will measure.

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Who is invited to take part?

• A woman or person who has had an emergency caesarean birth.
• The partner of a woman or person who has had an emergency caesarean birth.

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Do I have to take part?

• Taking part in the project is completely voluntary. We hope you will take part as this will provide helpful insights into the most important outcomes for women and babies who experience an intervention during caesarean birth.
• If you change your mind about taking part, you can withdraw at any time without giving a reason. However, it may not be possible to remove data that you have already submitted to the project through Thiscovery. To withdraw from the project please email help@thiscovery.org.  

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Who is running this project?

• This project is being led by a research team at the University of Bristol, comprising clinicians and researchers.
• The project will be hosted on Thiscovery, a secure online platform that enables the health and care system to improve and innovate through collaboration. Thiscovery is developed and run by THIS Labs, an independent organisation formed as a strategic collaboration between THIS Institute and The Health Foundation. THIS Labs administers this project for the University of Bristol.

How do I take part?

This project consists of one survey in which you will be:  

• Presented with groups of outcomes relating to interventions for impacted fetal head during caesarean birth. For each group, you will identify which outcome is most important to measure and which is least important to measure.
• There are no correct or incorrect responses. Please answer based on what you think matters most.
• Your responses will inform the development of a core outcome set for research and clinical practice in this area.

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Do I have to answer all the questions?

• You do not have to answer all of the questions. However, we hope you will answer as many questions as possible, as this will provide the best possible information about your views.

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How much time will it take?

• Each online survey is expected to take approximately 20 minutes, however you can take as much time filling in the survey as you require.

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Can I take a break part way through answering questions?

• Yes of course. You do not have to answer all the questions in one go.
• If you would like to take a break, use the 'Next' button to save your answers. When you return use the same browser and device.
• Once you have completed each page, please do press the 'next' or 'submit' button so we receive your responses to that point.

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Can I ask for help to complete the questions?

• Please do feel free to ask someone to help you navigate Thiscovery or answer the questions, if you would like. This could be a family member or friend, for example.
• If you ask for help, please do answer the questions from your own point of view, rather than the views of the person helping.

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Is there a deadline for completing the questions?

• The deadline for completing questions is shown on the project webpage. Please do answer all the questions you wish to by this date.

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What if I want to stop taking part?

• If you change your mind about taking part in this project you can withdraw at any time without giving a reason. However, it may not be possible to remove data that have already been submitted. To withdraw from the project please email help@thiscovery.org.  

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What are the possible benefits of taking part?

• By taking part in this study, you will have an opportunity to share your views on what needs to be measured for women and babies who experience an intervention during caesarean birth. This is a key step in developing a standardised approach to outcome measurement in this important area.

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Are there any disadvantages or risks of taking part?

• Talking about caesarean birth can be difficult. We won’t ask you to answer any questions about previous experiences you might have had; we are just interested in knowing your views on important outcomes. You do not have to answer any questions you do not want to and can stop at any time. If you find taking part in this project distressing in any way, please get in touch directly with us via help@thiscovery.org.

What happens to my answers?

• Your answers will be analysed along with the answers from all other participants and will be used in the next stage in this project to build an agreed set of outcomes.
• Findings from the project may also be published in online reports or journals and publicised on social media. Nobody will be able to identify you in any findings that are published: any quotations used in reporting will be anonymised.

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How can I learn about the findings of the project?

• Thiscovery will email you with a summary of findings once these have been produced by the project team, if you have given permission to be contacted in this way.
• The project team may also email you about the project’s findings if you wish to be kept informed by them. You can let us know if you are happy to be contacted in this way by the University of Bristol team at the end of the survey, should you choose to take part.

Data security   

• Your right to privacy is important to Thiscovery and to the project team. 
• Thiscovery takes the security of your information seriously and has policies and processes in place to ensure that your data is safe.
• Thiscovery’s privacy policy describes the way we collect information, how we use it and how we protect it. 
• For specific information about how information will be used in this project, please see below.

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Who is responsible for collecting my information?  

• We are collecting information about you on behalf of the University of Bristol.
• Under data protection legislation, the University of Bristol is the Controller responsible for the processing of your personal information to conduct the project. This means that they are responsible for making sure your personal information is kept secure, confidential and used only in the way you have been told it will be used.
• They are supported in this by us (Thiscovery), who are known as data processors for this project. 

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What information will you collect about me?   

• To take part in this project the project team will need to collect information that could identify you, called “personal identifiable information”. We will need to use the following information from you for this project:
  
  • Your answers to questions; some of the information that you provide whilst answering questions might be considered as health data or other data that would be classed as Special Category data under the UK General Data Protection Regulation (UK GDPR).
  • Your name and email address if you would like to be invited to the next stage of the project or receive a summary of the results.

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What is your lawful basis for processing my personal information?

• We are collecting and storing this personal identifiable information in accordance with UK data protection laws which protect your rights. These state that we must have a lawful basis (specific reason) for collecting your data. The lawful basis for processing your personal information is decided by the University of Bristol as Controllers for the data.
• For this University of Bristol project, the collection of the personal identifiable information is done on the basis of “a legitimate interest” and/or “a process necessary for research purposes” .

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How will my personal information be looked after?   

Your data will be looked after in the following way: 

• If you opt to provide your name and email address, only THIS Labs will have access to this. We will only contact you with your permission to provide a summary of results and invite you to the next part of this project.
• The only circumstances in which the University of Bristol will have access to your name and email address is if you have given permission for them to contact you directly. In these circumstances, your name and email address are not linked to the information you have provided by answering questions in the project.
• We separate your name and email address (if provided) from any answers you provide as part of this project and store these securely in separate datasets, one containing contact details and one containing your project responses.
• This means that in the project dataset, instead of using your name and email to identify your responses, an ID number will be used instead. This is called pseudonymisation.
• The pseudonymised dataset is what the project team at the University of Bristol will use for analysis. This dataset may contain other personal information as part of the answers you give to questions in the project, such as information about your role.
• Unfortunately, if you opt out of providing your name or email, you will not be able to withdraw from the project if you decide later you no longer wish to be involved, as we will be unable to identify your response.
• We take appropriate technical and organisational measures to ensure that we keep your information secure, accurate and up to date, and that we only keep it as long as is reasonable and necessary.
• Although we use appropriate security measures once we have received your personal information, the transmission of information when you submit it over the internet is never completely secure. We do our best to protect personal information, but we cannot guarantee the security of information transmitted to our website, so any transmission is at the user’s own risk.
• Information on how THIS Labs will process your personal information, and how to manage your Thiscovery account, is available on Thiscovery's privacy policy.

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Will my personal information ever be shared?   

• We will never share personal information in any way not described in this participation information or in Thiscovery's privacy policy.
• However, occasionally information provided within a project may be useful to better understand how to conduct online research or to develop new approaches to analysing data.
• If you agree to take part in this project, we may use some of the information we gather from you to improve the methods we use on Thiscovery. If, to do so, we need to share information with external researchers or analysts, all information will be fully anonymised.
• By anonymised, we mean that we will remove the ID number used to link your answers to your name, locate and remove any other identifying information (for example, names of NHS Trusts, place names), and any other indirect identifying information (such as specific details about health or experiences).

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How long will my personal information and identifiable responses be held?

• Thiscovery and the University of Bristol will not keep personal data longer than is necessary for the purpose or purposes for which they were collected. For this project, this means that once the project team have finished all analyses and produced all the outputs needed for the project, we will take all reasonable steps to destroy, or erase from our systems, all data that is no longer required.

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What if I have a complaint or concern?   

• For questions or concerns about anything to do with the project or for technical problems or questions about the platform, please contact the Thiscovery team at help@thiscovery.org.
• If you have any concerns and would like to contact someone who is independent of the study, please contact the University of Bristol Governance Team by email: research-governance@bristol.ac.uk.‍

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How can I find out more about how my personal data is used?   

• University of Bristol’s privacy notice describes how they use personal data and explains how you can contact them. The University of Bristol will protect your information in line with the requirements of the UK Data Protection Act 2018.
• Thiscovery's privacy notice describes how we use personal data and protect your information.