Title: Medicines for Neonates: using routinely collected, standardised clinical data for clinical research
Funder: Department of Health (England)

Abstract: 1) AIMS The aim of this programme is to improve health outcomes in relation to medicines and other therapies for babies admitted to neonatal units, using routinely collected NHS electronic data to facilitate applied research processes. The term Medicines for Neonates (MfN) is adopted for brevity. 2) BACKGROUND Recent developments in the organisation of NHS neonatal services make this an opportune time to improve the poor representation of neonates in health research and bring about closer integration with clinical care. Following a Department of Health review in 2003 (1), neonatal services were organised into clinical networks with shared management and co-ordinated services. This led to the development of electronic neonatal records held on an NHS server, neonatal.net. Data are based on standardised definitions with the NHS number as principal identifier. Core electronic data are of high quality as they are used to support network management, commissioning, day-to-day clinical care, generation of discharge summaries, and to provide instant access to a full clinical record by the receiving hospital when a baby is transferred. These electronic data offer potential to facilitate applied research in neonatal medicine. 3) RESEARCH PLANS We will undertake a series of integrated studies that address parent engagement in research and priority areas of newborn care (pharmacovigilance; clinical trials to assess the health impact of human donor milk and reduce hospital acquired infection). These involve data held in full or in part in the electronic neonatal records. We will test the use of electronic clinical data to conduct specific research processes (data collection, measurement of health outcomes, economic evaluations, linkage with other NHS records) and concurrently employ systematic methods for data quality improvement and assurance. MfN builds on the research team’s previous and current work and the infrastructure of new NHS electronic technology. 4) RESEARCH TEAM The research team have essential prerequisites for a programme of this scope. They have senior multidisciplinary expertise, support from professional associations and users, and a track record of achievement evidenced by previous and ongoing collaborative research, peer reviewed grants and publications, professional leadership and contributions to health services policy development. 5) RESEARCH ENVIRONMENT The research environment bridges the clinical-academic interface. It will involve NHS clinicians, parents and managers in neonatal units and networks throughout England and BLISS, the leading UK charity for sick babies. Nine of the applicants hold academic appointments and 6 are clinicians. The lead NHS organisation, Chelsea & Westminster NHS Foundation Trust, is a Network Perinatal Centre providing a full range of neonatal and maternal services. The academic institutions are Imperial College London (Divisions of Medicine and Epidemiology, Public Health & Primary Care), University of Oxford (National Perinatal Epidemiology Unit), University of London (Queen Mary, Centre for Paediatric Pharmacy Research, Academic Unit of Paediatrics), University of Manchester (School of Nursing, Midwifery and Social Work) and University of Leicester (Department of Neonatal Medicine). 6) OUTCOMES & IMPACT MfN will improve outcomes, health and safety for newborn babies within the programme lifetime and enhance the evidence base for neonatal care. MfN builds on and will add to a continuum of research endeavour. Research capacity will be increased through training researchers, engaging the enthusiasm and involvement of NHS staff and establishing a cadre of experienced parent-users able to provide expert input into newborn research. By using routinely collected clinical data the complexity and cost of applied research and post discharge follow-up, and the time to achieve improved outcomes will be reduced. Added value will result from improved quality of routine NHS clinical data. Data linkage using the NHS number will lay the foundation for cradle-to-grave research. Outputs will be relevant to pharmaceutical and commercial research and generalisable nationally and internationally. 7) PUBLIC INVOLVEMENT Parents have been involved in a consultative capacity during planning stages. MfN is concerned with understanding parent perspectives in relation to clinical uncertainty, confidentiality and use of personal data, communicating the relevance of research, and achieving sustained user engagement. MfN involves the establishment of parent forums that will contribute through the life of the programme and be retained as an ongoing national resource able to provide expertise in training researchers recruiting in sensitive clinical situations, designing information and consent materials for parents from diverse educational and cultural backgrounds, advising on user-related research issues and highlighting areas considered important to them.


Research activity codes: 8.3 POLICY, ETHICS AND RESEARCH GOVERNANCE;7.4 RESOURCES AND INFRASTRUCTURE (DISEASE MANAGEMENT)
Health categories: GENERIC HEALTH RELEVANCE