Close
The main aim of this pilot implementation study is to assess the feasibility and acceptability of implementing cytomegalovirus (CMV) screening in the antenatal population at UCLH.
CMV is one of the most common congenital infections, with around 1 in 200 infants born in the UK estimated to be infected. For most babies with congenital CMV this does not cause any problems, but for around 1 in 5 it causes long term health problems such as hearing loss.
Pregnant women are not routinely offered CMV testing in the UK currently. One reason for this has been the lack of available interventions to prevent a CMV infection being passed from mother to unborn baby, and development of CMV-related problems in the baby. Recently, studies have shown that antiviral medication can reduce the risk of transmission of CMV from mother to unborn baby if the mother has a first-time (‘primary’) infection in early pregnancy and this has raised new questions around CMV screening, and whether this should be offered routinely in pregnancy. These include questions around the epidemiology of CMV among women seeking antenatal care in the UK, feasibility of incorporating CMV screening into existing antenatal NHS pathways, and the views of pregnant women on the screening process and subsequent options after receiving results.
In our study, we will explore how common a previous CMV infection is among women who had previously received antenatal care at UCLH or North Middlesex hospitals. We will conduct a prospective study in which CMV screening is offered to around 1,000 women booking for antenatal care at UCLH, and investigate feasibility, acceptability (including surveys/interviews of women and healthcare professionals) and gain preliminary data on cost. Women identified as having a recent primary CMV infection through screening will follow standard of care with respect to further testing, monitoring and offer of treatment where appropriate. Sub-studies will explore emerging predictive markers in amniotic fluid and novel diagnostics for CMV, and current policy and practice around antenatal CMV screening and use of antivirals in the UK and other European countries. The study findings will inform future research and screening policy.
- What is this Privacy Notice about?
This privacy policy outlines the purpose of the research and explains how we will collect and use the data for this study. It also describes how to get further information and what to do if you do not want to be part of the study.
- What is this study about?
The main aim of this project is to assess the feasibility and acceptability of offering screening for cytomegalovirus (CMV) to pregnant women. Around 1 in 200 children are thought to be born with CMV infection in England, with around 1 in 1000 likely to have lifelong disability caused by the infection. About 40-50% of pregnant women are thought never to have had a CMV infection before, and so could be infected for the first time in pregnancy (a “primary” infection). A primary infection is the type of infection more likely to be passed to the baby. Although CMV infection can pass from the mother to the baby at any point during pregnancy, it is more likely to cause problems for the baby’s health if this happens earlier on.
Recent studies have shown that a medicine (antiviral) given to pregnant women with a first-time CMV infection in early pregnancy can reduce the chance of the infection being passed to the baby. This has raised questions around whether CMV screening should be offered to pregnant women, and how this could best be done – questions that we want to address in this project.
In our project we will also investigate predictive markers in amniotic fluid and novel diagnostics for CMV, and current recommendations, policy and clinical practice in this rapidly evolving area across the UK and in Europe.
- What is the lawful basis for using this information?
The lawful basis for using information collected for this research project at UCL is ‘public task’, which falls under Article 6(1)(e) of the General Data Protection Regulation. It also falls under Article 9(2)(j), “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes”.
We are currently applying for ethics approval for all aspects of this project that involve collection or testing of samples, collection of clinical data on participants and completion of interviews or surveys by patients. These parts of the project will not start until ethics approval is in place, details will be added here once available.
We are also conducting surveys of healthcare professionals in the UK and other European countries as part of this study which meet the definition of service evaluation, and as such do not require ethics approval; no individual patient data will be collected in these surveys.
- What information will we collect about you (or your child) for the study?
As part of this project, some pregnant women receiving antenatal care at UCLH will be invited to take part in a screening study, which will involve collection of clinical data, completion of surveys and interviews, and the offer of CMV testing. The information collected includes socio-demographics (such as age, ethnicity, country of birth), details of previous pregnancies, clinical information about the current pregnancy (such as CMV and other test results, pregnancy outcome), and the baby including scan findings and test results and assessments once born. The surveys and interview will contain questions about yourself, your pregnancy and your views on CMV and screening. Survey responses will only be accessible to the research team at UCL (not anyone involved in your clinical care), who will link these with clinical information, but will not have access to personal information that could identify you or your child at any time.
In addition to the screening study, women with a diagnosis of CMV in a prior pregnancy, those who are having an amniocentesis in a current pregnancy (for any reason) and families of babies being tested for CMV will be invited to take part in sub-studies. In these sub-studies, samples will be collected from mother and baby (or stored samples used), along with clinical data.
As a separate part of this project, we will do CMV testing on leftover blood samples from women who previously received antenatal care at UCLH or North Middlesex University Hospital. These women will not be contacted individually about this testing, which will be done only after the samples have been fully anonymised, with no way of linking test results back to individuals. Minimal demographic information will be recorded with test results: ethnicity, age, country of birth and parity.
Only certain members of the research team based at the hospitals or partner labs will have access to medical records and identifying information (e.g. name, address, NHS number), they will hold this information securely and will not disclose any identifying information to researchers outside of the clinical teams.
If you are a healthcare professional you may be invited to take part:
- As an interviewee in the screening study. You will be asked about your views on CMV screening. Only your role (not your name) will be recorded with your responses.
- As a survey respondent. If you respond to a survey being conducted as part of this study, you will be asked to provide your name, job title, clinic site, country and contact details so that researchers at UCLH and UCL can contact you about the possibility of taking part in a future study.
- How will the information be used?
The data collected for this study will be used to describe:
- The characteristics of women accessing antenatal care in North London in terms of prior CMV infection
- Whether women who take part in the screening study at UCLH differ from those who do not (using aggregate data for those who do not take part)
- Views of women taking part in the screening study on CMV screening and management options, whether /how these relate to their sociodemographic and clinical characteristics, and the views of healthcare professionals on CMV screening
- Address questions around biological predictors of infection outcomes in pregnancy and the fetus, and CMV diagnostics.
Clinic survey data will be analysed to describe policy and practice around CMV testing in pregnancy, in the UK and in other European countries, aggregate data on the number of CMV infections identified in pregnant women using these policies, and availability of data and interest in participation in future research.
The findings of the different components of this study will be used to inform future research and screening policy around CMV testing for pregnant women. We will publish results in open access journals so that they can be read online and downloaded for free. It will not be possible to identify any individual patients in the study publications.
- Where will the data be stored?
All study data will be securely transferred and stored on UCL servers. All clinical data will be held in the UCL Data Safe Haven. The UCL Data Safe Haven, is a registered data processor under the terms of the Data Protection Act 2018.
The research team will seek permission to keep the data for 10 years after completion of the project, after which time its retention will be reviewed. It will not be used for marketing purposes, shared with or transferred to any third parties. The data provided to the team for research will not be transferred to other countries.
- Your rights
Data held about patients by the University research team will be pseudonymised (with a unique study number used in place of identifying information such as name, address etc), or fully anonymised. For pseudonymised data, only certain members of the research team based at the hospitals or partner labs will know which study number belongs to an individual. They will hold this information securely and will not disclose this to researchers outside of the clinical teams. The research team at UCL will therefore not be able to uphold requests for access or erasure, as they will have no way of knowing which data belong to you, and nor is automated decision (including profiling) applicable.
Surveys of healthcare professionals will collect identifiable information about these respondents (but not any patients).
- What if I do not want my data (or child’s data) to be used in this study?
You can decline an invitation to take part in this study or withdraw your consent to participate at any time, without giving a reason. This will not affect the care you receive from the NHS. Please see the Participant Information Sheet for more information and contact the research midwife to let them know. If you consent to take part and later withdraw, we will keep and continue to use all your previously collected data but will not collect any further data about you.
In one part of this study, we will test leftover blood samples anonymously, without contacting individuals for consent. You have the right to tell NHS Digital that you do not want the information you provide to the NHS to be used beyond the purpose of providing healthcare. This is known as a ‘patient objection’ and ‘opting out’. Opting out of your information being used for research cannot be applied to this study’s historic data. Please visit the NHS website for further details.
Your choice will not affect the health care you receive.
If you are a healthcare professional and would like your name and contact details to be removed from any survey response you submit for this study, please contact the research team at the contact details below.
- Access to your (or your child's) information in the study?
If you or your child are a patient, it will not be possible to access your study data from the University research team or for them to uphold requests for erasure because the study data will be pseudonymised or fully anonymised, with no way of University researchers knowing which data belong to you. However you can request access to your medical records from the NHS Trust where you are a patient. For more information on your rights, please contact the NHS Trust directly.
If you are a healthcare professional and want to access the information that we hold about you from your survey response (e.g. your job title and contact details) then please contact the study team at uclh.cmvsurveys@nhs.net
- How do I contact the Research team (or Data Controller)?
If you have questions or concerns about the study please contact:
Dr Heather Bailey:
Mortimer Market Centre
Off Capper Street
London WC1E 6JB
Email: heather.bailey@ucl.ac.ukProfessor Eleni Nastouli
Consultant Virologist and Director
University College London Hospitals NHS Trust
Advanced Pathogen Diagnostics Unit
60 Whitfield Street
London W1T 4EU
Email: eleni.nastouli@nhs.netYou may also contact the UCL Data Protection Officer:
Data Protection and Freedom of Information (FOI) Officer
University College London
Legal Services, 6th Floor
1-19 Torrington Place
London
WC1E 7HB
Email: data-protection@ucl.ac.ukOr the UCLH Data Protection Officer
2nd Floor
Maple House
Tottenham Court Road
London
W1T 7NF
Email: UCLH.IGQueries@nhs.netYou also have the right to complain directly to the Information Commissioner’s Office, which is an independent regulatory authority set up to uphold information rights.