The United Kingdom National Neonatal Research Database: A validation study

BACKGROUND: The National Neonatal Research Database (NNRD) is a rich repository of pre-defined clinical data extracted at regular intervals from point-of-care, clinician-entered electronic patient records on all admissions to National Health Service neonatal units in England, Wales, and Scotland. We describe population coverage for England and assess data completeness and accuracy. METHODS: We determined population coverage of the NNRD in 2008–2014 through comparison with data on live births in England from the Office for National Statistics. We determined the completeness of seven data items on the NNRD. We assessed the accuracy of 44 data items (16 patient characteristics, 17 processes, 11 clinical outcomes) for infants enrolled in the multi-centre randomised controlled trial, Probiotics in Preterm Study (PiPs). We compared NNRD to PiPs data, the gold standard, and calculated discordancy rates using predefined criteria, and sensitivity, specificity and positive predictive values (PPV) of binary outcomes. RESULTS: The NNRD holds complete population data for England for infants born alive from 25(+0) to 31(+6) (completed weeks) of gestation; and 70% and 90% for those born at 23 and 24 weeks respectively. Completeness of patient characteristics was over 90%. Data were linked for 2257 episodes of care received by 1258 of the 1310 babies recruited to PiPs. Discordancy rates were <5% for 13/16 patient characteristics (exceptions: mode of delivery 8.7%; maternal ethnicity 10.2%, Lower layer Super Output Area 16.5%); <5% for 9/16 processes (exceptions: medical treatment for Patent ductus arteriosus 6.1%, high-dependency days 10.2%, central line days 11.2%, type of first milk 22.3%; and during first 14 days, summary of types of milk 13.8%; number of days of antibiotics 9.0%; whether antacid given 5.1%); and <5% for 10/11 clinical outcomes (exception: Bronchopulmonary dysplasia, defined as oxygen dependency at 36 weeks postmenstrual age 3.3%). The specificity of NNRD data was >85% for all outcomes; sensitivity ranged from 50–100%; PPV ranged from 58.8 (95% CI 40.8–75.4%) for porencephalic cyst to 99.7 (95% CI 99.2, 99.9%) for survival to discharge. CONCLUSIONS: The completeness and quality of data held in the NNRD is high, providing assurance in relation to use for multiple purposes, including national audit, health service evaluations, quality improvement, and research.