Conclusiones del análisis de los proyectos seleccionados

A new challenge in paediatric research is to better utilise evolving healthcare technologies to facilitate faster dissemination of population-level interventions into the public domain.170 This should certainly be possible in the UK which is considered to be at the forefront of research

34 involving secondary use of healthcare data, as the NHS provides a unique source of national data due to its universal coverage.189 In light of the current financial climate and widely anticipated cutbacks to funding for research, universities and the NHS, attention is turning towards the utilisation of existing data sources for health services and clinical research. Data from routinely collected electronic patient health records are increasingly being used to address the methodological difficulties of carrying out research in populations that are typically challenging to study, due to significant ethical concerns and vulnerability, such as patients with very rare diseases, pregnant women and children. Already secondary use of routinely collected data from children has significantly contributed to improvements in child health research in the UK.6;190-194

For example, real-time data has been used to alert trusts of safety issues such as higher than expected child mortality following cardiac surgery.195 The fundamental advantages of using such routine databases are the minimal costs involved and magnitude of information they can provide, often at a national level. These are factors which have previously severely limited evaluation of health outcomes over long periods of time, in large geographically defined populations.170 Where survival is reported in neonatal studies for example, data are often from specialised units and are therefore subject to inherent selection bias resulting from different criteria for admissions, treatment or referrals.95 Routine data permit

investigation of long-term outcomes which is so rarely feasible in RCTs, thereby providing invaluable information about real-world implementation in populations outside trial inclusion criteria.

3.2.1 Ethical considerations and consent for long-term follow-up

The inherent difficulties surrounding anonymity and obtaining consent when using secondary data are well established189;196 and it has been suggested that current UK research

regulations can impede follow-up in multicentre studies.197-199 Difficulties in acquiring data on long-term outcomes were highlighted by the Bristol Royal Infirmary inquiry in 2001.197 The requirement for an individual's consent to confirm they are alive and monitor survival often precludes effective long-term follow-up for prospective studies due to the ethical and

practical complications of tracing participants who change address or die.197 A series of BMJ editorials highlighted some important issues surrounding the use of identifiable personal data for medical research purposes.189;196;200 This series stressed the need for regulating bodies to accept that current UK laws permit the secondary use of data without consent or full anonymisation, provided the likely public benefit is demonstrably proportionate to the risks of identification and subsequent distress this may cause.189

35 The National Information Governance Body (NIGB) Ethics and Confidentiality Committee determines when obtaining individual consent may not be practicable, for example when undertaking large population studies of survival, such as among children with chronic

conditions.197 Hansson‟s BMJ article rightly argues the need for a wider view of autonomy in epidemiological research.201 Systematically obtaining individual signed consent for sharing patient identifiable information is difficult and can sometimes hamper research.201-204 though for particular research questions it may be wholly necessary to obtain individual/parental consent .198

3.2.2 Potential uses of child health records for research

Information on birth characteristics, such as gestational age and birth weight, is needed for many epidemiological and health services research studies examining short- and longer- term clinical outcomes.205 Detailed information on early birth exposures is routinely captured in hospitals throughout England and can provide a rich electronic source of clinical

information about the health status of individuals at birth, as well as for measuring the quality of maternity care. Secondary use of such data involves comparatively minimal costs in comparison to bespoke prospective observational studies. Large epidemiological datasets are particularly useful for infant health research where life-long assessment of outcomes is required, but all too often precluded by reason of cost, methodological difficulty and

practicability. Consequently, much infant research is selective, poorly generalisable and focused on short-term outcomes. The secondary uses of data from electronic health records cannot replace nor precisely replicate the value of data collected for prospective studies, but the potential benefits for clinical and health services research and impact on patient care are well established.206-209 These data can facilitate benchmarking and comparison of outcomes between different hospital sites or geographical areas. Cohorts based on these data,

particularly when combined with novel techniques such as Mendelian randomisation, can provide representative population-level information that is highly generalisable, has power to detect small effect sizes and relates directly to real clinical practice. Such cohorts have the potential to answer an extensive range of research questions that require longitudinal follow- up, from examining long-term health outcomes and healthcare utilisation following preterm birth, to identifying risk factors for childhood hospital admission with influenza or respiratory syncytial virus infection.