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Journal articleModi N, 2020,
Improving the Efficiency and Impact of Clinical Research: A Game Changer for 21st Century Neonatology
, NEONATOLOGY, Vol: 117, Pages: 207-210, ISSN: 1661-7800 -
Journal articleDuffy JMN, Cairns AE, Magee LA, et al., 2020,
Standardising definitions for the pre-eclampsia core outcome set: A consensus development study
, Pregnancy Hypertension, Vol: 21, Pages: 208-217, ISSN: 2210-7789OBJECTIVES: To develop consensus definitions for the core outcome set for pre-eclampsia. STUDY DESIGN: Potential definitions for individual core outcomes were identified across four formal definition development initiatives, nine national and international guidelines, 12 Cochrane systematic reviews, and 79 randomised trials. Eighty-six definitions were entered into the consensus development meeting. Ten healthcare professionals and three researchers, including six participants who had experience of conducting research in low- and middle-income countries, participated in the consensus development process. The final core outcome set was approved by an international steering group. RESULTS: Consensus definitions were developed for all core outcomes. When considering stroke, pulmonary oedema, acute kidney injury, raised liver enzymes, low platelets, birth weight, and neonatal seizures, consensus definitions were developed specifically for low- and middle-income countries because of the limited availability of diagnostic interventions including computerised tomography, chest x-ray, laboratory tests, equipment, and electroencephalogram monitoring. CONCLUSIONS: Consensus on measurements for the pre-eclampsia core outcome set will help to ensure consistency across future randomised trials and systematic reviews. Such standardization should make research evidence more accessible and facilitate the translation of research into clinical practice. Video abstract can be available at: www.dropbox.com/s/ftrgvrfu0u9glqd/6.%20Standardising%20definitions%20in%20teh%20pre-eclampsia%20core%20outcome%20set%3A%20a%20consensus%20development%20study.mp4?dl=0.
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Journal articleDuffy JMN, Cairns AE, Richards-Doran D, et al., 2020,
A core outcome set for pre-eclampsia research: An international consensus development study
, BJOG: an International Journal of Obstetrics and Gynaecology, Vol: 127, Pages: 1516-1526, ISSN: 1470-0328OBJECTIVE: To develop a core outcome set for pre-eclampsia. DESIGN: Consensus development study. SETTING: International. POPULATION: Two hundred and eight one healthcare professionals, 41 researchers, and 110 patients, representing 56 countries, participated METHODS: Modified Delphi method and Modified Nominal Group Technique. RESULTS: A longlist of 116 potential core outcomes was developed, by combining the outcomes reported in 79 pre-eclampsia trials with those derived from thematic analysis of 30 in-depth interviews of women with lived experience of pre-eclampsia. Forty-seven consensus outcomes were identified from the Delphi process following which 14 maternal and eight offspring core outcomes were agreed at the consensus development meeting. Maternal core outcomes: death, eclampsia, stroke, cortical blindness, retinal detachment, pulmonary oedema, acute kidney injury, liver haematoma or rupture, abruption, postpartum haemorrhage, raised liver enzymes, low platelets, admission to intensive care required, and intubation and ventilation. Offspring core outcomes: stillbirth, gestational age at delivery, birth weight, small-for-gestational-age, neonatal mortality, seizures, admission to neonatal unit required, and respiratory support. CONCLUSIONS: The core outcome set for pre-eclampsia should underpin future randomised trials and systematic reviews. Such implementation should ensure future research holds the necessary reach and relevance to inform clinical practice, enhance women's care, and improve the outcomes of pregnant women and their babies.
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Journal articleGale C, Knight M, Ladhani S, et al., 2020,
National active surveillance to understand and inform neonatal care in COVID-19
, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 105, Pages: 346-347, ISSN: 1359-2998 -
Journal articleWebbe J, Duffy JMN, Afonso E, et al., 2020,
Core outcomes in neonatology: Development of a core outcome set for neonatal research
, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 105, Pages: 425-431, ISSN: 1359-2998BackgroundNeonatal research evaluates many different outcomes using multiple measures. This canprevent synthesis of trial results in meta-analyses and selected outcomes may not berelevant to former patients, parents and health professionals.ObjectiveTo define a core outcome set (COS) for research involving infants receiving neonatal care ina high income setting.DesignOutcomes reported in neonatal trials and qualitative studies were systematically reviewed.Stakeholders were recruited for a three-round international Delphi survey. A consensusmeeting was held to confirm the final COS, based upon the survey results.ParticipantsFour hundred and fourteen former patients, parents, healthcare professionals andresearchers took part in the eDelphi survey; 173 completed all 3 rounds. Sixteenstakeholders participated in the consensus meeting.ResultsThe literature reviews identified 104 outcomes; these were included in round one.Participants proposed ten additional outcomes; 114 outcomes were scored in round two andthree. Round one scores showed different stakeholder groups prioritised contrastingoutcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotisingenterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability,quality of life, adverse events, visual impairment/blindness, hearing impairment /deafness,retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia.6Conclusions and relevanceA COS for clinical trials and other research studies involving infants receiving neonatal carein a high-income setting has been identified. This COS for neonatology will help standardiseoutcome selection in clinical trials and ensure these are relevant to those most affected byneonatal care.
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Journal articleKnight M, Bunch K, Vousden N, et al., 2020,
Characteristics and outcomes of pregnant women admitted to hospital with confirmed SARS-CoV-2 infection in UK: national population based cohort study.
, BMJ, Vol: 369, Pages: 1-7, ISSN: 1759-2151OBJECTIVES: To describe a national cohort of pregnant women admitted to hospital with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the UK, identify factors associated with infection, and describe outcomes, including transmission of infection, for mothers and infants. DESIGN: Prospective national population based cohort study using the UK Obstetric Surveillance System (UKOSS). SETTING: All 194 obstetric units in the UK. PARTICIPANTS: 427 pregnant women admitted to hospital with confirmed SARS-CoV-2 infection between 1 March 2020 and 14 April 2020. MAIN OUTCOME MEASURES: Incidence of maternal hospital admission and infant infection. Rates of maternal death, level 3 critical care unit admission, fetal loss, caesarean birth, preterm birth, stillbirth, early neonatal death, and neonatal unit admission. RESULTS: The estimated incidence of admission to hospital with confirmed SARS-CoV-2 infection in pregnancy was 4.9 (95% confidence interval 4.5 to 5.4) per 1000 maternities. 233 (56%) pregnant women admitted to hospital with SARS-CoV-2 infection in pregnancy were from black or other ethnic minority groups, 281 (69%) were overweight or obese, 175 (41%) were aged 35 or over, and 145 (34%) had pre-existing comorbidities. 266 (62%) women gave birth or had a pregnancy loss; 196 (73%) gave birth at term. Forty one (10%) women admitted to hospital needed respiratory support, and five (1%) women died. Twelve (5%) of 265 infants tested positive for SARS-CoV-2 RNA, six of them within the first 12 hours after birth. CONCLUSIONS: Most pregnant women admitted to hospital with SARS-CoV-2 infection were in the late second or third trimester, supporting guidance for continued social distancing measures in later pregnancy. Most had good outcomes, and transmission of SARS-CoV-2 to infants was uncommon. The high proportion of women from black or minority ethnic groups admitted with infection needs urgent investigation and explanation. STUDY REGISTRATION: ISRCTN 4
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Journal articleModi N, 2020,
Children first, or last?
, EBIOMEDICINE, Vol: 56, ISSN: 2352-3964 -
Journal articleTume LN, Woolfall K, Arch B, et al., 2020,
Routine gastric residual volume measurement to guide enteral feeding in mechanically ventilated infants and children: the GASTRIC feasibility study
, Health Technology Assessment, Vol: 24, Pages: 1-122, ISSN: 1366-5278BackgroundThe routine measurement of gastric residual volume to guide the initiation and delivery of enteral feeding is widespread in paediatric intensive care and neonatal units, but has little underlying evidence to support it.ObjectiveTo answer the question: is a trial of no gastric residual volume measurement feasible in UK paediatric intensive care units and neonatal units?DesignA mixed-methods study involving five linked work packages in two parallel arms: neonatal units and paediatric intensive care units. Work package 1: a survey of units to establish current UK practice. Work package 2: qualitative interviews with health-care professionals and caregivers of children admitted to either setting. Work package 3: a modified two-round e-Delphi survey to investigate health-care professionals’ opinions on trial design issues and to obtain consensus on outcomes. Work package 4: examination of national databases to determine the potential eligible populations. Work package 5: two consensus meetings of health-care professionals and parents to review the data and agree consensus on outcomes that had not reached consensus in the e-Delphi study.Participants and settingParents of children with experience of ventilation and tube feeding in both neonatal units and paediatric intensive care units, and health-care professionals working in neonatal units and paediatric intensive care units.ResultsBaseline surveys showed that the practice of gastric residual volume measurement was very common (96% in paediatric intensive care units and 65% in neonatal units). Ninety per cent of parents from both neonatal units and paediatric intensive care units supported a future trial, while highlighting concerns around possible delays in detecting complications. Health-care professionals also indicated that a trial was feasible, with 84% of staff willing to participate in a trial. Concerns expressed by junior nurses about the intervention arm of not measuring gastric residual volumes
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Journal articleGale C, McGuire W, Juszczak E, 2020,
Randomised controlled trials for informing perinatal care
, Neonatology, Vol: 117, Pages: 8-14, ISSN: 1661-7800BACKGROUND: Randomised controlled trials provide the best evidence for the effects of interventions and are a key tool in the effort to improve the care and outcomes for newborn infants. METHODS: We discuss the role of randomisation for minimising selection bias in clinical trials and describe examples of seminal trials that have shaped the development of modern perinatal care. We consider the challenges inherent in designing and delivering large, simple, and pragmatic trials, and the need for the development and adoption of core outcome sets to ensure that trials provide high-quality evidence of sufficient validity and applicability to guide policy and practice. RESULTS: Since the earliest days of modern neonatology, the randomised controlled trial has been recognised as the best method for assessing treatments and practices. While many strategies that reduce mortality and morbidity have been introduced following randomised trials, there are, however, important examples of ineffective or potentially harmful practices that have been adopted in the absence of trial-based evidence. Typically, randomised controlled trials in perinatal care need to recruit several thousand participants to be able to detect modest but potentially important effects of new interventions on the most important but rare outcomes. Given the concerns about the financial burden and regulatory complexity of standard trial designs, innovative "efficient" trial designs are being evaluated to streamline processes while safeguarding participants. CONCLUSIONS: Well-conducted randomised controlled trials provide the most robust evaluation of interventions aimed at improving outcomes for newborn infants and their families. Increasingly, these trials will need to be large and multicentre (often international) and use a simple and pragmatic protocol, incorporating meticulous follow-up procedures and assessment of long-term outcomes.
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Journal articleMedvedev MM, Brotherton H, Gai A, et al., 2020,
Development and validation of a simplified score to predict neonatal mortality risk among neonates weighing 2000 g or less (NMR-2000): an analysis using data from the UK and The Gambia.
, Lancet Child and Adolescent Health, Vol: 4, Pages: 299-311, ISSN: 2352-4642BACKGROUND: 78% of neonatal deaths occur in sub-Saharan Africa and southern Asia, among which, more than 80% are in low birthweight babies. Existing neonatal mortality risk scores have primarily been developed for high-resource settings. The aim of this study was to develop and validate a score that is practicable for low-income and middle-income countries to predict in-hospital mortality among neonates born weighing 2000 g or less using datasets from the UK and The Gambia. METHODS: This analysis used retrospective data held in the UK National Neonatal Research Database from 187 neonatal units, and data from the Edward Francis Small Teaching Hospital (EFSTH), Banjul, The Gambia. In the UK dataset, neonates were excluded if birthweight was more than 2000 g; if the neonate was admitted aged more than 6 h or following discharge; if the neonate was stillborn; if the neonate died in delivery room; or if they were moribund on admission. The Gambian dataset included all neonates weighing less than 2000 g who were admitted between May 1, 2018, and Sept 30, 2019, who were screened for but not enrolled in the Early Kangaroo Mother Care Trial. 18 studies were reviewed to generate a list of 84 potential parameters. We derived a model to score in-hospital neonatal mortality risk using data from 55 029 admissions to a random sample of neonatal units in England and Wales from Jan 1, 2010, to Dec 31, 2016. All candidate variables were included in a complete multivariable model, which was progressively simplified using reverse stepwise selection. We validated the new score (NMR-2000) on 40 329 admissions to the remaining units between the same dates and 14 818 admissions to all units from Jan 1, to Dec 31, 2017. We also validated the score on 550 neonates admitted to the EFSTH in The Gambia. FINDINGS: 18 candidate variables were selected for inclusion in the modelling process. The final model included three parameters: birthweight, admission oxygen saturation, and highest level of r
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