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<jats:sec id="abs1-1"> <jats:title>Background</jats:title> <jats:p>Clinical data offer the potential to advance patient care. Neonatal specialised care is a high-cost NHS service received by approximately 80,000 newborn infants each year.</jats:p> </jats:sec> <jats:sec id="abs1-2"> <jats:title>Objectives</jats:title> <jats:p>(1) To develop the use of routinely recorded operational clinical data from electronic patient records (EPRs), secure national coverage, evaluate and improve the quality of clinical data, and develop their use as a national resource to improve neonatal health care and outcomes. To test the hypotheses that (2) clinical and research data are of comparable quality, (3) routine NHS clinical assessment at the age of 2 years reliably identifies children with neurodevelopmental impairment and (4) trial-based economic evaluations of neonatal interventions can be reliably conducted using clinical data. (5) To test methods to link NHS data sets and (6) to evaluate parent views of personal data in research.</jats:p> </jats:sec> <jats:sec id="abs1-3"> <jats:title>Design</jats:title> <jats:p>Six inter-related workstreams; quarterly extractions of predefined data from neonatal EPRs; and approvals from the National Research Ethics Service, Health Research Authority Confidentiality Advisory Group, Caldicott Guardians and lead neonatal clinicians of participating NHS trusts.</jats:p> </jats:sec> <jats:sec id="abs1-4"> <jats:title>Setting</jats:title> <jats:p>NHS neonatal units.</jats:p> </jats:sec> <jats:sec id="abs1-5"> <jats:title>Participants</jats:title> <jats:p>Neonatal clinical teams; parents of babies admitted to NHS neonatal units.</jats:p> </jats:sec> <jats:sec id="abs1-6"> <jats:title>Interventions</jats:title> <jats:p>In workstream 3, we employed the Bayley-III scales to evaluate neurodevelopmental status and the Quantitative Checklist of Autism in Toddlers (Q-CHAT) to evaluate social communication skills. In workstream 6, we recruited parents with previous experience of a child in neonatal care to assist in the design of a questionnaire directed at the parents of infants admitted to neonatal units.</jats:p> </jats:sec> <jats:sec id="abs1-7"> <jats:title>Data sources</jats:title> <jats:p>Data were extracted from the EPR of admissions to NHS neonatal units.</jats:p> </jats:sec> <jats:sec id="abs1-8"> <jats:title>Main outcome measures</jats:title> <jats:p>We created a National Neonatal Research Database (NNRD) containing a defined extract from real-time, point-of-care, clinician-entered EPRs from all NHS neonatal units in England, Wales and Scotland (<jats:italic>n</jats:italic> = 200), established a UK Neonatal Collaborative of all NHS trusts providing neonatal specialised care, and created a new NHS information standard: the Neonatal Data Set (ISB 1595) (see <jats:uri xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="http://webarchive.nationalarchives.gov.uk/±/http://www.isb.nhs.uk/documents/isb-1595/amd-32–2012/index_html" xlink:role="web">http://webarchive.nationalarchives.gov.uk/±/http://www.isb.nhs.uk/documents/isb-1595/amd-32–2012/index_html</jats:uri>; accessed 25 June 2018).</jats:p> </jats:sec> <jats:sec id="abs1-9"> <jats:title>Results</jats:title> <jats:p>We found low discordance between clinical (NNRD) and research data for most important infant and maternal characteristics, and higher prevalence of clinical outcomes. Compared with research assessments, NHS clinical assessment at the age of 2 years has lower sensitivity but higher specificity for identifying children with neurodevelopmental impairment. Completeness and quality are higher for clinical than for administrative NHS data; linkage is feasible and substantially enhances data quality and scope. The majority of hospital resource inputs for economic evaluations of neonatal interventions can be extracted reliably from the NNRD. In general, there is strong parent support for sharing routine clinical data for research purposes.</jats:p> </jats:sec> <jats:sec id="abs1-10"> <jats:title>Limitations</jats:title> <jats:p>We were only able to include data from all English neonatal units from 2012 onwards and conduct only limited cross validation of NNRD data directly against data in paper case notes. We were unable to conduct qualitative analyses of parent perspectives. We were also only able to assess the utility of trial-based economic evaluations of neonatal interventions using a single trial. We suggest that results should be validated against other trials.</jats:p> </jats:sec> <jats:sec id="abs1-11"> <jats:title>Conclusions</jats:title> <jats:p>We show that it is possible to obtain research-standard data from neonatal EPRs, and achieve complete population coverage, but we highlight the importance of implementing systematic examination of NHS data quality and completeness and testing methods to improve these measures. Currently available EPR data do not enable ascertainment of neurodevelopmental outcomes reliably in very preterm infants. Measures to maintain high quality and completeness of clinical and administrative data are important health service goals. As parent support for sharing clinical data for research is underpinned by strong altruistic motivation, improving wider public understanding of benefits may enhance informed decision-making.</jats:p> </jats:sec> <jats:sec id="abs1-12"> <jats:title>Future work</jats:title> <jats:p>We aim to implement a new paradigm for newborn health care in which continuous incremental improvement is achieved efficiently and cost-effectively by close integration of evidence generation with clinical care through the use of high-quality EPR data. In future work, we aim to automate completeness and quality checks and make recording processes more ‘user friendly’ and constructed in ways that minimise the likelihood of missing or erroneous entries. The development of criteria that provide assurance that data conform to prespecified completeness and quality criteria would be an important development. The benefits of EPR data might be extended by testing their use in large pragmatic clinical trials. It would also be of value to develop methods to quality assure EPR data including involving parents, and link the NNRD to other health, social care and educational data sets to facilitate the acquisition of lifelong outcomes across multiple domains.</jats:p> </jats:sec> <jats:sec id="abs1-13"> <jats:title>Study registration</jats:title> <jats:p>This study is registered as PROSPERO CRD42015017439 (workstream 1) and PROSPERO CRD42012002168 (workstream 3).</jats:p> </jats:sec> <jats:sec id="abs1-14"> <jats:title>Funding</jats:title> <jats:p>The National Institute for Health Research Programme Grants for Applied Research programme (£1,641,471). Unrestricted donations were supplied by Abbott Laboratories (Maidenhead, UK: £35,000), Nutricia Research Foundation (Schiphol, the Netherlands: £15,000), GE Healthcare (Amersham, UK: £1000). A grant to support the use of routinely collected, standardised, electronic clinical data for audit, management and multidisciplinary feedback in neonatal medicine was received from the Department of Health and Social Care (£135,494).</jats:p> </jats:sec>

Original publication

DOI

10.3310/pgfar07060

Type

Journal article

Journal

Programme Grants for Applied Research

Publisher

National Institute for Health Research

Publication Date

09/2019

Volume

7

Pages

1 - 396