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Randomised point-of-care trials (POCT)1 or registry trials2 offer a potentially efficient, convenient and cost-effective alternative to conventional randomised controlled trials. By using information present in an existing database, registry or electronic patient record (EPR), POCT eliminate the need for duplicative data collection.1 Neonatal medicine is well placed to use this methodology; an existing national resource, the National Neonatal Research Database (NNRD), holds detailed data extracted from the neonatal EPR of all National Health Service neonatal units in England, Wales and Scotland; contributing units are known as the UK Neonatal Collaborative (UKNC).
We assessed the acceptability of neonatal POCT using the NNRD in two surveys. In the first (March–June 2014), we emailed all English UKNC leads, proposed a neonatal POCT and asked whether their unit would be willing to participate. In the second, we examined attitudes towards the neonatal EPR. We emailed neonatal trainees (n=108) and lead nurses, and asked them to cascade the survey on their unit. Using validated3 questions, we asked respondents about their current satisfaction with the EPR; POCT methodology was then described, and respondents rated their predicted satisfaction with using EPR data in this way using a Likert scale.
A total of 111/163 (68%) UKNC neonatal unit contacts responded to the first survey; 97/111 (87%) respondents expressed willingness for their neonatal unit to take part in the proposed POCT. A total of 162 neonatal health professionals responded to the second survey. Respondents were generally satisfied with the neonatal EPR (table 1). Approximately one in three indicated that using EPR data for POCT would lead them to view it as more worthwhile (table 2). A total of 139/157 (88%) respondents agreed with the statement, ‘if parents’ consent, I support using the EPR system to gather data for randomised trials’. The theme that emerged from narrative responses concerned EPR data quality.
We show that neonatal practitioners in England are willing to participate in POCT using EPR. Using neonatal data in this way is acceptable, and associated with greater satisfaction with the EPR in approximately one-third of the respondents. There is currently a high level of satisfaction with the UK neonatal EPR. Those surveyed have identified the need to improve EPR data quality; the neonatal EPR is used clinically and to generate discharge summaries, so enhancing data quality could also benefit patient care. Strengths include the national distribution and high response rates, although the voluntary nature may mean individuals with enthusiasm for the EPR are over-represented.
Neonatal practice is insufficiently evidence-based; 58% of neonatal Cochrane reviews published between 2006 and 2010 were inconclusive.4 Using existing EPR for randomised POCT would represent an important innovation, potentially improving neonatal care rapidly, and at lower cost than is presently the case. The results of our study are encouraging, and suggest that this approach would be well received, and increase the perceived utility of the EPR. We are currently undertaking work to understand parent views and determine research types suitable for this methodology. In conclusion, POCT using EPR and the NNRD are feasible and acceptable to health professionals.
Collaborators WHEAT trial development group members: C Gale, NIHR clinical lecturer, Imperial College London; N Modi, Professor of Neonatal Medicine, Imperial College London; H Robberts, mother of preterm twins; Z Chivers, Head of Services, Bliss; A Forster, neonatal nurse, James Cook Hospital, Middlesbrough; M Turner, Senior Lecturer in Neonatal Medicine, University of Liverpool; J Dorling, Clinical Associate Professor of Neonatal Medicine, University of Nottingham; TP van Staa, Professor of eHealth Research, University of Manchester and Utrecht Institute for Pharmaceutical Sciences, Utrecht University.
Contributors CG and NM conceived the study; CG designed the survey and collected study data; CG, NM and all members of the WHEAT trial development group contributed to writing the paper.
Funding This study was funded by an Academy of Medical Sciences Starter Grant for Clinical Lecturers, supported by the Medical Research Council, Wellcome Trust, British Heart Foundation, Arthritis Research UK, Prostate Cancer UK and The Royal College of Physicians.
Competing interests None declared.
Provenance and peer review Not commissioned; internally peer reviewed.
Data sharing statement Unpublished data are available on request from the corresponding author.