MERIDIAN 2-3 year follow-on Study (MR1402)

This is an application to retain data by the University of Sheffield in relation to the research previously undertaken, It is being retained to meet the appropriate research standards, and to permit further analysis or research in the event of queries or new initiatives. Such further work would be subject to an amendment to this application. The data may therefore only be processed for the purposes of back-up and storage under this agreement. No new outputs will therefore be created, and the rest of the application has been provided for information only.

The objective for receiving this data was to determine whether or not to approach the study cohort (with the intention to re-consent for the follow-up study) and to refine the estimates of diagnostic accuracy made in the original MERIDIAN study.

In order to re-consent the cohort for the follow-up study, the University of Sheffield (UoS) first identified whether the child was still alive before making contact with the family, to avoid any emotional distress or upset. Section 251 approval was given for this purpose. If the data showed that the child was no longer alive, no contact was made with the family.

The study already had consent from the cohort to be approached about future research regarding their child’s development.

The cohort were part of the MERIDIAN study (HTA 09-06-01) which is the largest iuMR study to date and assessed the diagnostic accuracy of in utero magnetic resonance (iuMR) imaging and ultrasound for the detection of fetal brain abnormalities. The MERIDIAN 2-3 year follow up study incorporated additional follow-up of its participants, specifically: i) to incorporate longer term outcomes observed over the first 2-3 years of life, and ii) to undertake a detailed neurodevelopmental assessment of infants. It recruited participants from the MERIDIAN cohort when the children were aged 2-3 years old. The study updated and refined the estimates of diagnostic accuracy from the original study using clinical data which is available when the children are aged 2-3 years. In addition the study explored the functional development of the children which was used to assess the prognostic capabilities of iuMR and ultrasound (US).

Once the research team at the UoS received the data from the NHS Digital, it was stored on the University secure network drive in a restricted access folder. The data was also imported in to the study propsect database. The database was username and password protected. The information was linked with the study information (mother's name, child's name, date of birth) already held (with consent) for this participant using the unique study identifier.

See below an overview of the data flow:

(1) Eligible participants from MERIDIAN who consented to be approached about further research were identified through the MERIDIAN database and through a consent form audit

(2) The date of birth and NHS number of the child/children born during the MERIDIAN study were sent by the UoS research team to NHS Digital, including the unique study participant identifier.

(3) Data provided was linked by NHS Digital to the Mortality Data Patient Tracking system

(4) Information was returned to the research team at the UoS, using the unique study identifier, regarding fact of death where applicable (other identifiable information was removed)

(5) Once received by the UoS the MERIDIAN database was updated accordingly. No contact was made with any families whose child was identified as no longer being alive

The data was stored and processed within Clinical Trials Unit, School of Health and Related Research at the UoS. The pseudonymised data was also accessible by the study chief investigator and appropriate members of the research team in the Academic Unit of Radiology, UoS.

There was a requirement for the collaborating consultant neonatologist at the Newcastle upon Tyne NHS Foundation Trust to access the fact of death information to ensure that the child's family was not contacted to participate in the study as part of the screening process.

The fact of death was entered directly onto a secure area of the MERIDIAN database which has restricted access.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).

The study findings were published in journals and presented at research conferences. Findings were made available through the study website. The UoS also used the information to design better information leaflet to parents. Outputs were made available to clinicians, academics and the public. Outputs were published from August 2017. The final Health Technology Assessment (HTA) report was published in December 2017.

Multidisciplinary and general medical journals, such as The Lancet were the target of the outputs as the results of the study were of interest to a wide range of clinicians (foetal medicine, radiology, neonatology, paediatrics, pathology, clinical genetics and health service providers). Foetal medicine and neonatology conferences were targeted for dissemination of the research findings.

All outputs will only contain results in highly aggregated format and as statistical summaries and measures of association. Small numbers will be suppressed in line with the HES Analysis Guide. Record level information will not be released to any third party.

This data will be retained to comply with guidance and policy on good clinical practice and regulations.

The initial outputs from NHS Digital allowed the University to approach the families from the MERIDIAN study and obtain renewed consent to complete the follow up study. The outputs were important to ensure that there was no contact with the family of a deceased child which may cause emotional upset and distress to the family.

The results and associated outputs of the overall study provided an updated diagnostic accuracy assessment based on longer term follow up and additional prognostic information which helped clinicians when counselling women and their families during pregnancy. The results allowed the University to have a better understanding of brain abnormalities detected antenatally and how they may affect a child’s long term development, which is extremely important to clinicians and families.

The study will benefit pregnant women in the future who have been told that their baby might have a problem with their brain development. It is anticipated that this study will improve understanding for both parents and health professionals. The results allowed the production of improved information leaflets aimed at pregnant women and their families to help them understand the screening process and the impact of the potential brain abnormality on the child’s development and the prognosis for the child. The findings were also made available on the study website which is easily accessible to ensure that wide range of audiences are reached.

This information was made available to health professionals and the public from August 2017.