Imperial College London

Dr Chris Gale

Faculty of MedicineSchool of Public Health

Reader in Neonatal Medicine
 
 
 
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Contact

 

+44 (0)20 3315 3519christopher.gale Website

 
 
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Location

 

Academic Neonatal Medicine, H4.4,Chelsea and Westminster HospitalChelsea and Westminster Campus

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Summary

 

Overview

One in eight babies born in the United Kingdom require neonatal care (about 80,000 every year) and 40% of all childhood deaths occur in the neonatal period. In survivors, neonatal conditions can impair lifelong health and development. Despite its importance much neonatal care is inadequately evidence-based because research is lacking. As a result care is variable and unequal.

 

It is neither financially nor technically feasible to tackle the wide range of existing uncertainties using traditional clinical trials. An alternative methodology is to use electronic health records to make randomised clinical trials simpler and more efficient. This will improve patient care by resolving treatment uncertainties; such trials are called Point-of-Care trials. 

 

My research aims to demonstrate the feasibility and value of point-of-care trials using the National Neonatal Research Database.

Core outcomes for neonatal trials

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Point-of care trials are efficient largely because they use data that are simple to access from existing electronic health records. Multiple different outcomes can be extracted from these electronic health records, but the ones most important to parents, patients and other health professionals have not been defined. Other outcomes not currently collected by the National Neonatal Research Database but accessible at low cost, for example school attainment, may also be important. 

We plan to define a core outcome set for neonatal point-of-care trials, comprising outcomes that are can be efficiently collected from routine data sources.  Parent and patient involvement will be essential to this process.

How good are neonatal data?

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Point-of-care trials are efficient and cost-effective because they obviate the need for dedicated trial personnel and duplicative collection of data already held in the electronic health record. Their success thus hinges on the quality of this data. The quality and variation of data will influence the expected power and precision of any trial that utilises it. 

This work involves defining measures and metrics of quality for data held in the National Neonatal Research Database, to determine the influence of this on point-of-care trials.

Efficient research regulation

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It is estimated that 85% of all research is wasted. One cause is when the results of research are not useful to doctors; this often happens because the study was not big enough or it did not involve the type of patients seen in the National Health Service (NHS).  A way to make research more representative, more useful to doctors and hence less wasteful is to make it simpler and more efficient.

Several methods have been shown to make clinical trials more efficient, but these are not commonly used in the United Kingdom.  We wanted to know if this was because the way research is regulated prevents these approaches being used. We worked with the Health Research Authority to empirically test how research regulators deal with these clinical trial methods.

Involving parents in neonatal data

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Parent involvement in neonatal care is a powerful but underutilised resource.  We want to see whether involving parents more in their baby's electronic health data improves both their experience of neonatal care and the quality of data held in the electronic health record.

The WHEAT point-of-care trial

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Point-of-care trials using electronic health records have been shown to be practical and efficient in Scandinavia but the feasibility of these trials in NHS neonatal care has yet to be established. 

We will test whether a point-of-care trial is feasible using the National Neonatal Research Database.  This trial is called WHEAT (WithHolding Enteral feeds Around Transfusion). 

The purpose of WHEAT is to compare two practices that are widely used in neonatal units across the UK and around the world to see if one reduces the risk of necrotising enterocolitis in preterm babies.  Necrotising enterocolitis is a serious gut disease that affects about 1 in 20 very premature babies (approximately 500 each year).

Collaborators

Professor Jenny Kurinczuk, Policy Research Unit in Maternal and Neonatal Health and Care, National Perinatal Epidemiology Unit, University of Oxford, Policy research in maternal and neonatal health, 2019 - 2023

Professor Lucy Chappell, Kings College London, Patient involvementResearch priority settingPregnancy hypertension, 2018

Prof William Tarnow-Mordi, National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Development of an international perinatal clinical trial network to undertake very large, simple clinical trials, 2017

Massachusetts Veterans Epidemiology Research and Information Center, United States Department of Veterans Affairs, Clinical trials embedded within existing data systems such as electronic health record systems, 2017

Clinical Associate Professor Jon DorlingClinical Associate Professor Shalini Ojha, University of Nottingham, Neonatal nutritionNational Neonatal Research Database, 2017 - 2019

Professor Brett D. Thombs, PhD, Faculty of Medicine, McGill University, CONSORT Extension for Trials Conducted in Existing Data Structures, Including Researcher-generated Cohorts, Registries,Electronic Health Records, and Administrative Databases, 2017

Associate Professor Ed Jusczak, National Perinatal Epidemiology Unit Clinical Trials Unit, University of Oxford, Clinical trials using electronic patient record data, 2017

Associate Professor Lyvonne Tume, University of the West of England, Paediatric and neonatal nutrition, 2017

Dr Kjell HeleniusProf Liisa Lehtonen, University of Turku, Perinatal health services, 2015

Dr James Duffy, Nuffield Department of Primary Care Health Sciences, University of Oxford, Development of core outcome sets in women's health, 2015

Miss Zoe ChiversMiss Mehali Patel, Bliss: the charity for babies born premature or sick, Parent involvement in neonatal research, 2013

Guest Lectures

Neonatal complications of COVID-19, World Health Organisation: Departments of Maternal, Newborn, Child and Adolescent Health, Virtual lecture, 2020

Using routinely recorded neonatal electronic patient record data to realise a neonatal learning healthcare system., University of Aberdeen, Aberdeen, 2018

Neonatology and the Obstetrician., East of England Advanced Labour Ward Practice Course, Cambridge Postgraduate Medical Centre, Cambridge University Hospitals, 2018

Making paediatric and neonatal clinical trials more efficient – trials that use existing data structures., Academic Paediatrics Association Annual Meeting, UCL, Great Ormond Street Hospital Institute of Child Health, 2018

Getting started: Research for all, Great Ormond Street Hospital, Institute of Child Health, 2018

Making a difference together: public involvement in health informatics research, Understanding Patient Data, Wellcome Trust, Wellcome Trust, London, 2017

Routinely recorded neonatal electronic patient record (EPR) data to realise a neonatal learning healthcare system: the UK experience, Harvard University, Beth Israel Deaconess Medical Center, 2017

Big Data and Point of Care Trials, British Association of Perinatal Medicine, BAPM Annual Conference and Scientific Meeting, 2017

New ethical perspectives in clinical trials, Europaediatrics, The 8th Europaediatrics Congress 2017, Bucharest, Romania., 2017

Efficient trials in neonatal medicine., Europaediatrics, The 8th Europaediatrics Congress 2017, Bucharest, Romania, 2017

Core data items to facilitate large, simple and efficient clinical trials., European Workshop on Neonatology, Westerberg, Germany, 2017

Using routinely recorded neonatal electronic patient record (EPR) data to realise a neonatal learning healthcare system, University of Pennsylvania, Children's Hospital of Philadelphia, 2017

Making a difference together: How can public involvement improve the relevance, acceptability, quality and impact of health informatics research?, University of Manchester, Farr Health eResearch Centre, 2017

All paediatricians are researchers, London School of Paediatrics, London School of Pediatrics’ Conference: “Empowering Unheard Voices”, 2017

Improving neonatal care through simple, efficient randomised point-of-care trials, University of Glasgow, Queen Elizabeth University Hospital campus, 2016

Big data for our smallest patients: a model for harnessing clinical data for research., UCL, Farr Institute of Health Informatics Research, 2016

Research Staff

Jawad,S

Jeyakumaran,D

Research Student Supervision

Helenius,K, Effects of Birth Outside Tertiary Hospitals and Early Postnatal Transfers in Extremely Preterm Infants: a Population Based Study

Prior,E, The Epic Study: The Ex-Preterm Phenotype in Childhood Study

Sakonidou,S, Improving the parent experience of neonatal care through better use of data

Webbe,J, Core outcomes in neonatology

jawad,S, Should Electronic Patient Record data be used for neonatal clinical trials?