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Journal articleKwakkenbos L, Juszczak E, Hemkens LG, et al., 2018,
Protocol for the development of a CONSORT extension for RCTs using cohort and routinely collected health data
, Research Integrity and Peer Review, Vol: 3, ISSN: 2058-8615BackgroundRandomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of their methodology in a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data.MethodsThe development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial “long list” of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the “long list” and generate a “short list” of key items. In phase 4, these i
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Journal articleBattersby C, Longford N, Patel M, et al., 2018,
Study Protocol: Optimising newborn nutrition during and after neonatal therapeutic hypothermia in the United Kingdom: Observational study of routinely collected data using propensity matching
, BMJ Open, Vol: 8, ISSN: 2044-6055ntroduction Therapeutic hypothermia is standard of care for infants born ≥36 weeks gestation with hypoxic ischaemic encephalopathy (HIE); consensus on optimum nutrition during therapeutic hypothermia is lacking. This results in variation in enteral feeding and parenteral nutrition (PN) for these infants. In this study, we aim to determine the optimum enteral nutrition and PN strategy for newborns with HIE during therapeutic hypothermia.Methods and analysis We will undertake a retrospective cohort study using routinely recorded electronic patient data held on the United Kingdom (UK) National Neonatal Research Database (NNRD). We will extract data from infants born ≥36 weeks gestational age between 1 January 2008 and 31 December 2016, who received therapeutic hypothermia for at least 72 hours or died during therapeutic hypothermia, in neonatal units in England, Wales and Scotland. We will form matched groups in order to perform two comparisons examining: (1) the risk of NEC between infants enterally fed and infants not enterally fed, during therapeutic hypothermia; (2) the risk of late-onset blood stream infections between infants who received intravenous dextrose without any PN and infants who received PN, during therapeutic hypothermia. The following secondary outcomes will also be examined: survival, length of stay, breast feeding at discharge, hypoglycaemia, time to full enteral feeds and growth. Comparison groups will be matched on demographic, maternal, infant and organisational factors using propensity score matching.Ethics and dissemination In this study, we will use deidentifed data held in the NNRD, an established national population database; parents can opt out of their baby’s data being held in the NNRD. This study holds study-specific Research Ethics Committee approval (East Midlands Leicester Central, 17/EM/0307). These results will help inform optimum nutritional management in infants with HIE receiving therapeutic hypothermia; resul
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Journal articleWebbe J, Brunton G, Ali S, et al., 2018,
Parent, patient and clinician perceptions of outcomes during and following neonatal care: a systematic review of qualitative research
, BMJ Paediatrics Open, Vol: 2, ISSN: 2399-9772Objective Multiple outcomes can be measured in infants that receive neonatal care. It is unknown whether outcomes of importance to parents and patients differ from those of health professionals. Our objective was to systematically map neonatal care outcomes discussed in qualitative research by patients, parents and healthcare professionals and test whether the frequency with which outcomes are discussed differs between groups.Design Systematic review of qualitative literature. The following databases were searched: Medline, CINAHL, EMBASE, PsycINFO and ASSIA from 1997 to 2017. Publications describing qualitative data relating to neonatal care outcomes, reported by former patients, parents or healthcare professionals, were included. Narrative text was analysed and outcomes grouped thematically by organ system. Permutation testing was applied to assess an association between the outcomes identified and stakeholder group.Results Sixty-two papers containing the views of over 4100 stakeholders were identified; 146 discrete outcomes were discussed; 58 outcomes related to organ systems and 88 to other more global domains. Permutation testing provides evidence that parents, former patients and health professionals reported outcomes with different frequencies (p=0.037).Conclusions Parents, patients and health professionals focus on different outcomes when discussing their experience of neonatal care. A wide range of neonatal care outcomes are reported in qualitative research; many are global outcomes relating to the overall status of the infant. The views of former patients and parents should be taken into consideration when designing research; the development of a core outcomes set for neonatal research will facilitate this.
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Journal articleVilleneuve E, Pitt M, Landa P, et al., 2018,
A framework to address key issues of neonatal service configuration in England: the NeoNet multimethods study
, Health Services and Delivery Research, Vol: 6, ISSN: 2050-4349BackgroundThere is an inherent tension in neonatal services between the efficiency and specialised care that comes with centralisation and the provision of local services with associated ease of access and community benefits. This study builds on previous work in South West England to address these issues at a national scale.Objectives(1) To develop an analytical framework to address key issues of neonatal service configuration in England, (2) to investigate visualisation tools to facilitate the communication of findings to stakeholder groups and (3) to assess parental preferences in relation to service configuration alternatives.Main outcome measuresThe ability to meet nurse staffing guidelines, volumes of units, costs, mortality, number and distance of transfers, travel distances and travel times for parents.DesignDescriptive statistics, location analysis, mathematical modelling, discrete event simulation and economic analysis were used. Qualitative methods were used to interview policy-makers and parents. A parent advisory group supported the study.SettingNHS neonatal services across England.DataNeonatal care data were sourced from the National Neonatal Research Database. Information on neonatal units was drawn from the National Neonatal Audit Programme. Geographic and demographic data were sourced from the Office for National Statistics. Travel time data were retrieved via a geographic information system. Birth data were sourced from Hospital Episode Statistics. Parental cost data were collected via a survey.ResultsLocation analysis shows that to achieve 100% of births in units with ≥ 6000 births per year, the number of birth centres would need to be reduced from 161 to approximately 72, with more parents travelling > 30 minutes. The maximum number of neonatal intensive care units (NICUs) needed to achieve 100% of very low-birthweight infants attending high-volume units is 36 with existing NICUs, or 48 if NICUs are located wherever there is c
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Journal articleModi N, Clarke J, McKee M, 2018,
Health systems should be publicly funded and publicly provided.
, BMJ, Vol: 362, ISSN: 0959-8138 -
Journal articleWong HS, Cowan FM, Modi N, et al., 2018,
Validity of neurodevelopmental outcomes of children born very preterm assessed during routine clinical follow-up in England
, Archives of Disease in Childhood. Fetal and Neonatal Edition, Vol: 103, Pages: F497-F484, ISSN: 1359-2998OBJECTIVE: To determine the validity of assessing and recording the neurodevelopmental outcome of very preterm infants during routine clinical follow-up in England. DESIGN: Children born <30 weeks gestation, attending routine clinical follow-up at post-term ages 20-28 months, were recruited. Data on neurodevelopmental outcomes were recorded by the reviewing clinician in a standardised format in the child's electronic patient record, based on a set of key questions designed to be used without formal training or developmental testing. Using a predefined algorithm, each participant was classified as having 'no', 'mild/moderate' or 'severe' impairment in cognitive, communication and motor domains. All participants also received a research assessment by a single assessor using the Bayley Scales of Infant Development, third edition (Bayley-III). The sensitivity and specificity of routine data in capturing impairment (any Bayley-III score <85) or severe impairment (any Bayley-III score <70) was calculated. RESULTS: 190 children participated. The validity of routine assessments in identifying children with no impairment and no severe impairment was high across all domains (specificities 83.9%-100.0% and 96.6%-100.0%, respectively). However, identification of impairments, particularly in the cognitive (sensitivity 69.7% (55.1%-84.3%)) and communication (sensitivity (53.2% (42.0%-64.5%)) domains, was poor. CONCLUSIONS: Neurodevelopmental status determined during routine clinical assessment lacks adequate sensitivity in cognitive and communication domains. It is uncertain whether this reflects the assessment or/and the recording of findings. As early intervention may improve education and social outcomes, this is an important area for healthcare quality improvement research.
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Journal articlePersson M, Shah PS, Rusconi F, et al., 2018,
Association of Maternal Diabetes With Neonatal Outcomes of Very Preterm and Very Low-Birth-Weight Infants An International Cohort Study
, JAMA PEDIATRICS, Vol: 172, Pages: 867-875, ISSN: 2168-6203 -
Journal articleMolloy EJ, Gale CRK, Marsh M, et al., 2018,
Developing core outcome set for women’s, newborn, and child health: the CROWN Initiative
, Pediatric Research, Vol: 84, Pages: 316-317, ISSN: 0031-3998 -
Journal articleGale CRK, 2018,
Time to move on from early cord clamping in preterm infants
, American Journal of Obstetrics and Gynecology, ISSN: 0002-9378 -
Journal articleBattersby C, Statnikov Y, Santhakumaran S, et al., 2018,
The United Kingdom National Neonatal Research Database: a validation study
, PLoS ONE, Vol: 13, ISSN: 1932-6203BackgroundThe National Neonatal Research Database (NNRD) is a rich repository of pre-defined clinical data extracted at regular intervals from point-of-care, clinician-entered electronic patient records on all admissions to National Health Service neonatal units in England, Wales, and Scotland. We describe population coverage for England and assess data completeness and accuracy.MethodsWe determined population coverage of the NNRD in 2008–2014 through comparison with data on live births in England from the Office for National Statistics. We determined the completeness of seven data items on the NNRD. We assessed the accuracy of 44 data items (16 patient characteristics, 17 processes, 11 clinical outcomes) for infants enrolled in the multi-centre randomised controlled trial, Probiotics in Preterm Study (PiPs). We compared NNRD to PiPs data, the gold standard, and calculated discordancy rates using predefined criteria, and sensitivity, specificity and positive predictive values (PPV) of binary outcomes.ResultsThe NNRD holds complete population data for England for infants born alive from 25+0 to 31+6 (completed weeks) of gestation; and 70% and 90% for those born at 23 and 24 weeks respectively. Completeness of patient characteristics was over 90%. Data were linked for 2257 episodes of care received by 1258 of the 1310 babies recruited to PiPs. Discordancy rates were <5% for 13/16 patient characteristics (exceptions: mode of delivery 8.7%; maternal ethnicity 10.2%, Lower layer Super Output Area 16.5%); <5% for 9/16 processes (exceptions: medical treatment for Patent ductus arteriosus 6.1%, high-dependency days 10.2%, central line days 11.2%, type of first milk 22.3%; and during first 14 days, summary of types of milk 13.8%; number of days of antibiotics 9.0%; whether antacid given 5.1%); and <5% for 10/11 clinical outcomes (exception: Bronchopulmonary dysplasia, defined as oxygen dependency at 36 weeks postmenstrual age 3.3%). The specificity of NNRD dat
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