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Do district general hospitals have a role?
The aim of this leading article is to explore the important topic of research in general paediatrics. The need for research in this field will be reviewed along with where and who should be carrying this out. The role of district general hospitals (DGHs) in research in general paediatrics is discussed.
WHY DO WE NEED RESEARCH IN GENERAL PAEDIATRICS?
Decision making within medicine has correctly shifted towards evidence based practice. It is important to ensure that in the most common conditions seen in general paediatrics children receive the best treatment. There are still many situations, for example, treatment of acute seizures and sedation for procedures, which have outstanding therapeutic and management questions that need answering through research. The need to encourage research has been acknowledged by the inclusion of a general paediatric section in the Royal College of Paediatrics and Child Health Annual Meeting in York over the past few years.
A review of randomised controlled trials (RCTs) published in Archives of Disease in Childhood from 1982 to 1996 found 249 RCTs, with only 28% being classified as being within the area of general paediatrics.1 This suggests that much of our research potential is concentrated on rare conditions and neglects the more common general paediatrics.
WHERE SHOULD RESEARCH IN GENERAL PAEDIATRICS BE PERFORMED?
Research is often thought of as non-clinical and clinical research. Non-clinical research, such as molecular and animal studies, is usually performed in academic laboratory based facilities and gives us the ideas and theories that are carried through into our clinical research. Clinical research, such as that into new drug therapies, is usually carried out initially in healthy adult volunteers and then tested in the paediatric patient population.2,3 Therefore wherever there is a paediatric population of patients there is the potential for research. General paediatricians in DGHs have participated in large multicentre trials, for example, the OSIRIS trial of surfactant in preterm babies with respiratory distress.4
Most research is carried out in teaching hospitals. Relatively little research is carried out in either DGHs or primary care. DGHs cover a large proportion of the paediatric population in the UK. They therefore have a larger exposure to common general paediatric conditions than specialist tertiary centres. This is already being utilised for our medical students and junior doctors in their training with placements in DGHs.5 The recruitment of children is a major issue in clinical trials6 and health professionals need to ensure that large groups of children—that is, those within DGHs and the community are not excluded from research.7 Patients in DGHs and the community are also more likely to be representative of a paediatric condition than patients in specialist tertiary centres, where there will be a disproportionate number of severe cases.
We carried out a review of original articles in Archives of Disease in Childhood for the year 2001 (excluding personal practice, current topics, review articles, and case reports). There were 145 papers, of which 52% were UK based. Sixty two per cent of the papers were considered to be of a general paediatric nature—that is, of use to a general paediatrician in their practice in a DGH. From the UK papers, over 90% of original research in this year originated from tertiary referral centres, with only seven papers (9.6%) having lead authors based at DGHs8–14 (table 1). All but one of these papers from DGHs involved areas of general paediatrics.
Many DGHs can also provide excellent facilities for children which are ideal for clinical research. Clinical trials in children need to be carried out in child friendly locations. Research into models for service development, such as attendance at outpatient clinics,15 and economic evaluation16 can also take place within the DGH setting. Research can also be performed at home. We are currently involved in studies of drug metabolism using breath tests and drug toxicity involving ECGs and interviews which have been carried out in the child’s home. This is more convenient for both child and family.
WHO SHOULD CARRY OUT RESEARCH IN GENERAL PAEDIATRICS?
A simple answer to this would be any health care professional who is involved in the care of children. Many specialist registrars spend time during their training in the DGH setting.
They should have protected time in their working week to dedicate to professional development and research. This should help facilitate and stimulate research. Both the RCPCH and the Department of Health recommend that all consultants should be able to critically appraise research evidence. This implies the need for research experience by specialist registrars and for their consultant supervisors to have the skills to supervise this activity. Promotion and participation within research raises the profile of research and evidence based medicine as a whole within these trusts.
Research is nowadays a multidisciplinary activity. Many research projects are run on a team basis in both primary and secondary care,17 with investigators coming from a nursing or pharmacy background.6,18,19 No matter what the project, it is important to make all the professional groups aware of its impact on their own practice and get their support before starting a project.
HOW CAN RESEARCH BE DONE?
Research in children differs from that in adults because of the necessity to make research appropriate for the different age groups and also to address the issue of potential individual benefit for each child.
Trials in children need to be discussed with a paediatrician, and in drug trials ideally a paediatric clinical pharmacologist or an experienced paediatric pharmacist.2,3 Study design needs to consider the intended target population and have clear inclusion and exclusion criteria. Ethical issues need to be addressed early. A clear study question and simplicity is important.
Statistical analysis of the data and the number of patients needed within the protocol (that is, power calculations) need to be considered at an early stage. A basic guide such as Medical statistics: a common sense approach20 is a useful starting point and discussion with a statistician should take place. Many hospitals now have access to a medical statistician. One needs to understand the statistical tests one uses.
For large studies, there is a need to establish a database to record all the data. This is best done early so that data can be inputted as the study is being carried out. Software programmes such as Excel and SPSS are useful for this task. Clear hypotheses and questions that the data need to answer are required before starting the study—not after collection of the data.
Many research and development departments or local charities have small amounts of funding that may be used for the purpose of research projects. Larger scale studies require specific grant funding from a central organisation or charitable fund. A useful website is www.rdinfo.org.uk, which is a digest of health related research funding and training opportunities. Small studies can be carried out without additional funding.21,22 The difficulties of obtaining funding for research in general paediatrics in DGHs or for professions allied to medicine needs to be recognised.19
This has been one of the reasons cited why more paediatric research is not taking place. Recruitment of children into clinical trials has been considered a difficult problem to overcome.6 During the design of a study, the acceptability and convenience to both the family and child must be paramount to combat this. Therefore measures such as minimising blood taking and consideration of home visits (as opposed to bringing the child to hospital) should be considered.
IS THIS RESEARCH GOOD FOR CHILDREN AND THEIR FAMILIES?
Any research that can help provide evidence behind clinical practice is very important for the care of children. A review of informed consent, parental awareness, and reasons for parents participating in RCTs showed that the most frequent reason for participation was contribution to clinical science (51%).23 Most families who take part in research are willing to participate in similar studies in the future.23
HOW CAN WE TAKE RESEARCH IN GENERAL PAEDIATRICS FORWARD?
For many doctors the time available for research is small. This may be one of the factors for the declining number of trials seen originating from DGHs. A possible answer to this is to try and foster more links between DGHs and academic units to allow more general paediatricians with dedicated time for research. Funding of research sessions alongside a reduction of excessive clinical duties need to be addressed24 to enable research to take place.
Traditionally some DGHs have a history of research and affiliation with universities. An example of this is the university departments in Derby6,10,17,18,22 and Penarth.11,12 Many other units such as Bath8 and Brighton9 have good links with their local universities and tertiary centres and a proven track record of research. Increasing medical student numbers may result in an increase of academic activity in DGHs. Creating a research network within general paediatrics and DGHs may be one way to promote research in this setting and field.
It is important that research in paediatrics addresses the common conditions as well as the rare. There is a large population of children with general paediatric conditions who are seen predominantly in the DGH setting. DGHs currently contribute only a small proportion to overall research in children. Both participation in multicentre trials and original research within this setting should be encouraged.
Do district general hospitals have a role?
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