developments in the national neonatal research database · national neonatal research database...
Post on 27-Jun-2020
1 Views
Preview:
TRANSCRIPT
Developments in the National Neonatal Research Database
Neena ModiProfessor of Neonatal MedicineImperial College London
DirectorNeonatal Data Analysis Unit
Data management• Data flow• Quality assurance• Machine learning and artificial intelligence applications
Supporting newborn health services• National audits• Health services evaluations• Policy research
Reducing uncertainties in clinical care• Randomised controlled trials• Quasi‐randomised and observational studies• Long‐term outcomes ascertainment
Parent‐patient involvement• Data quality and parent satisfaction• Consent‐to‐contact• Long‐term retention
Commercial Electronic Patient Record
200 Neonatal Units
NHS Information Standard (Neonatal Data Set ISB1595)
Regulatory approvals: Caldicott Guardians
Lead CliniciansResearch Ethics
Confidentiality Advisory GroupGDPR complianceMultiple Outputs
Multi‐Professional Neonatal Data Analysis Unit Steering
Board with parent involvement
Password protected web‐portal for
cliniciandata feedback and validation checks
National Neonatal Research Database at the Neonatal Data Analysis Unit
Real‐time data entry by clinical
staff throughout patient stay
Hospital Episodes Statistics
Office for National Statistics
Linkage to create a cradle‐to‐grave
record
Extraction of Neonatal Data Set to create the NNRD, saving ~£600K pa
• Created from routine electronic patient records
• Used for multiple purposes including audit, evaluation, and research
• Data should be recorded once, and well
• Data should be quality assured
• Parents, healthcare professionals and policy‐makers should be involved in developing the wider secondary uses of healthcare data
The UK National Neonatal Research Database: “real-world” health data to improve newborn care
Gestational age specific survival for infants (24-29 weeks’ gestation, birth weight 1500 g) born between 2007 and 2013 and admitted to neonatal care in the iNeo networks
Helenius et al Pediatrics 2017;140:e20171264
©2017 by American Academy of Pediatrics
Standardised ratios for survival for infants (24‐29 weeks’ gestation, birth weight <1500g) born during the study period (2007‐2013) and admitted to neonatal care in each iNeonetwork comparing the survival in each network to all other networks combined.
Kjell Helenius et al Pediatrics 2017;140:e20171264
©2017 by American Academy of Pediatrics
NeoNet: Providing a national demand/capacity model for neonatal care in England
Confounding
Data may be unreliable
Costly and time consuming
Research protocol not the same as routine care
Findings may have limited generalisability
Data are recorded for specific trial purposes
Strong internal validity
Real world care
Findings more generalisable
Cheaper, faster
Slide courtesy of Dr Cheryl Battersby
• Power to detect a clinically relevant reduction in severe NEC (surgery and/or death), e.g. from 4% to 2.5% requires 2325 per group (90% power, α=0.05)
• The largest trial involving preterm infants, INIS, recruited 3493 participants, involved 113 hospitals in 9 countries,took 6 years and cost > £1m
• There are about 4200 <30w gestation babies born in the UK annually
• Together we could answer important questions about newborn care quickly and at lower cost
Reducing clinical uncertainties
Data linkage to ascertain long-term outcomes
National Pupil Database (Education)
Nationa
l Neo
natal R
esea
rch Datab
ase Primary and community care: General practice data
Secondary health: Hospital Episode Statistics, laboratory, imaging, prescribing data
Social care
Disease registries
Biobanks and ‘omic’ data Slide courtesy of Dr Cheryl Battersby
• Consent‐to‐contact• Ongoing consent to hold data• Two‐way information exchange• Patient involvement
Parents and young people are our partners
Parents are part of our steering boards; they have been involved in focus groups, social media surveys, one‐to‐one interviews, Delphi consensus groups, a genomics
study, and planning, designing, delivering and reporting studies Slide courtesy of Dr Susanna Sakonidou
top related