NHS Digital Data Release Register - reformatted
University of Sheffield
Opt outs honoured: Y
Basis: Section 251 approval is in place for the flow of identifiable data
Format: Identifiable Sensitive
How often: Ongoing
When: unknown — 11/2016
HSCIC Id: DARS-NIC-315175-P8X6Z-v1.4
Data: MRIS - Flagging Current Status Report
Data: Hospital Episode Statistics Admitted Patient Care
Data: Hospital Episode Statistics Accident and Emergency
Data: Hospital Episode Statistics Admitted Patient Care
Data: Hospital Episode Statistics Critical Care
Data: Office for National Statistics Mortality Data (linkable to HES)
Data: MRIS - Cause of Death Report
Data: Hospital Episode Statistics Accident and Emergency
Data: Hospital Episode Statistics Admitted Patient Care
Data: Hospital Episode Statistics Critical Care
Data: Office for National Statistics Mortality Data
Data: Hospital Episode Statistics Accident and Emergency
Data: Hospital Episode Statistics Admitted Patient Care
Data: MRIS - Flagging Current Status Report
Output: The study findings will be published in journals and presented at research conferences. Findings will be made available through the study website. The UoS will also use the information to design better information leaflet to parents. Outputs will be available to clinicians, academics and the public. Outputs are expected from August 2017. The final Health Technology Assessment (HTA) report will be due December 2017.
Multidisciplinary and general medical journals, such as The Lancet will be the target of the outputs as the results of the study will be 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 will be targeted for dissemination of the research findings.
Activities: Once the research team at the UoS has received the data from the NHS Digital, it will be stored on the University secure network drive in a restricted access folder. The data will also be imported in to the study propsect database. The database is username and password protected. The information will be 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 have consented to be approached about further research are 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 will be sent by the UoS research team to NHS Digital, including the unique study participant identifier
(3) Data provided to be linked by NHS Digital to the Mortality Data Patient Tracking system
(4) Information returned to the research team at the UoS, using the unique study identifier, regarding fact of death where applicable (other identifiable information will be removed)
(5) Once received by the UoS the MERIDIAN database will be updated accordingly. No contact will be made with any families whose child is identified as no longer being alive
The data will be stored and processed within Clinical Trials Unit, School of Health and Related Research at the UoS. The pseudonymised data will also be accessible by the study chief investigator and appropriate members of the research team in the Academic Unit of Radiology, UoS.
There will be 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 is not contacted to participate in the study as part of the screening process.
The fact of death will be entered directly onto a secure area of the MERIDIAN database which will have restricted access.
Objective: The objective for receiving this data is to determine whether or not to approach the current 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 wish to identify whether the child is still alive before making contact with the family, to avoid any emotional distress or upset. Section 251 approval has been given for this purpose. If the data shows that the child is no longer alive, no contact will be made with the family.
The study already has consent from the cohort to be approached about future research regarding their child’s development.
The cohort are 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 will incorporate 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 will recruit participants from the MERIDIAN cohort when the children are aged 2-3 years old. The study will update and refine 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 will explore the functional development of the children which will be used to assess the prognostic capabilities of iuMR and ultrasound (US).
Benefits: The initial outputs from NHS Digital will allow the University to approach the families from the MERIDIAN study and obtain renewed consent to complete the follow up study. The outputs are important to ensure that there is 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 will provide an updated diagnostic accuracy assessment based on longer term follow up and additional prognostic information which will help clinicians when counselling women and their families during pregnancy. The results will allow 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 will therefore allow 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 will also be made available on the study website which is easily accessible to ensure that wide range of audiences are reached.
This information is expected to be available to health professionals and the public from August 2017.
Source: NHS Digital.