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Article ; Online: Biomarker-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection

Simon M. Schoenbuchner / Chao Huang / Cherry-Ann Waldron / Emma Thomas-Jones / Kerenza Hood / Enitan D. Carrol / Philip Pallmann

Trials, Vol 24, Iss 1, Pp 1-

statistical analysis plan for the BATCH trial and PRECISE sub-study

2023 Volume 11

Abstract: Abstract Introduction The BATCH trial is a multi-centre randomised controlled trial to compare procalcitonin-guided management of severe bacterial infection in children with current management. PRECISE is a mechanistic sub-study embedded into the BATCH ... ...

Abstract	Abstract Introduction The BATCH trial is a multi-centre randomised controlled trial to compare procalcitonin-guided management of severe bacterial infection in children with current management. PRECISE is a mechanistic sub-study embedded into the BATCH trial. This paper describes the statistical analysis plan for the BATCH trial and PRECISE sub-study. Methods The BATCH trial will assess the effectiveness of an additional procalcitonin test in children (aged 72 h to 18 years) hospitalised with suspected or confirmed bacterial infection to guide antimicrobial prescribing decisions. Participants will be enrolled in the trial from randomisation until day 28 follow-up. The co-primary outcomes are duration of intravenous antibiotic use and a composite safety outcome. Target sample size is 1942 patients, based on detecting a 1-day reduction in intravenous antibiotic use (90% power, two-sided) and on a non-inferiority margin of 5% risk difference in the composite safety outcome (90% power, one-sided), while allowing for up to 10% loss to follow-up. Results Baseline characteristics will be summarised overall, by trial arm, and by whether patients were recruited before or after the pause in recruitment due to the COVID-19 pandemic. In the primary analysis, duration of intravenous antibiotic use will be tested for superiority using Cox regression, and the composite safety outcome will be tested for non-inferiority using logistic regression. The intervention will be judged successful if it reduces the duration of intravenous antibiotic use without compromising safety. Secondary analyses will include sensitivity analyses, pre-specified subgroup analyses, and analysis of secondary outcomes. Two sub-studies, including PRECISE, involve additional pre-specified subgroup analyses. All analyses will be adjusted for the balancing factors used in the randomisation, namely centre and patient age. Conclusion We describe the statistical analysis plan for the BATCH trial and PRECISE sub-study, including definitions of clinical outcomes, ...
Keywords	Antimicrobial stewardship ; Procalcitonin ; Severe bacterial infection ; Hospitalised children ; Randomised controlled trial ; Statistical analysis plan ; Medicine (General) ; R5-920
Subject code	310
Language	English
Publishing date	2023-05-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Paediatric Outpatient Parenteral Antimicrobial Therapy (OPAT)

Bernie Carter / Debra Fisher-Smith / David Porter / Steven Lane / Matthew Peak / David Taylor-Robinson / Louise Bracken / Enitan D Carrol

PLoS ONE, Vol 16, Iss 4, p e

An e-survey of the experiences of parents and clinicians.

2021 Volume 0249514

Abstract: Background Little evidence exists about parental satisfaction and their influence on referral to paediatric Outpatient Parenteral Antimicrobial Therapy (OPAT). Aim This study aimed to examine the experiences of parents, children and clinicians of OPAT at ...

Abstract	Background Little evidence exists about parental satisfaction and their influence on referral to paediatric Outpatient Parenteral Antimicrobial Therapy (OPAT). Aim This study aimed to examine the experiences of parents, children and clinicians of OPAT at a large tertiary children's hospital. Method A prospective e-survey, using closed and open questions, of parents (n = 33) of 33 children who had received OPAT (3 children completed a survey), and clinicians (n = 31) involved in OPAT at a tertiary hospital. Data were collected September 2016 to July 2018. Results Data were analysed using simple descriptive statistics. The results show that OPAT offered benefits (less stress, re-establishment of family life) compared to hospital-based treatment for parents and children, although some were anxious. Clinicians' referral judgements were based on child, home, and clinical factors. Some clinicians found the process of referral complex. Conclusion Most parents and children were satisfied with the OPAT service and preferred the option of home-based treatment as it promoted the child's comfort and recovery and supported family routines.
Keywords	Medicine ; R ; Science ; Q
Subject code	360
Language	English
Publishing date	2021-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Using technology to reduce critical deterioration (the DETECT study)

Eduardo Costa / Céu Mateus / Bernie Carter / Holly Saron / Chin-Kien Eyton-Chong / Fulya Mehta / Steven Lane / Sarah Siner / Jason Dean / Michael Barnes / Chris McNally / Caroline Lambert / Bruce Hollingsworth / Enitan D. Carrol / Gerri Sefton

BMC Health Services Research, Vol 23, Iss 1, Pp 1-

a cost analysis of care costs at a tertiary children's hospital in the United Kingdom

2023 Volume 10

Abstract: Abstract Background Electronic early warning systems have been used in adults for many years to prevent critical deterioration events (CDEs). However, implementation of similar technologies for monitoring children across the entire hospital poses ... ...

Abstract	Abstract Background Electronic early warning systems have been used in adults for many years to prevent critical deterioration events (CDEs). However, implementation of similar technologies for monitoring children across the entire hospital poses additional challenges. While the concept of such technologies is promising, their cost-effectiveness is not established for use in children. In this study we investigate the potential for direct cost savings arising from the implementation of the DETECT surveillance system. Methods Data were collected at a tertiary children’s hospital in the United Kingdom. We rely on the comparison between patients in the baseline period (March 2018 to February 2019) and patients in the post-intervention period (March 2020 to July 2021). These provided a matched cohort of 19,562 hospital admissions for each group. From these admissions, 324 and 286 CDEs were observed in the baseline and post-intervention period, respectively. Hospital reported costs and Health Related Group (HRG) National Costs were used to estimate overall expenditure associated with CDEs for both groups of patients. Results Comparing post-intervention with baseline data we found a reduction in the total number of critical care days, driven by an overall reduction in the number of CDEs, however without statistical significance. Using hospital reported costs adjusted for the Covid-19 impact, we estimate a non-significant reduction of total expenditure from £16.0 million to £14.3 million (corresponding to £1.7 million of savings – 11%). Additionally, using HRG average costs, we estimated a non-significant reduction of total expenditure from £8.2 million to £ 7.2 million (corresponding to £1.1 million of savings – 13%). Discussion and conclusion Unplanned critical care admissions for children not only impose a substantial burden on patients and families but are also costly for hospitals. Interventions aimed at reducing emergency critical care admissions can be crucial to contribute to the reduction of these episodes’ ...
Keywords	Children’s critical care ; Cost analysis ; Critical deterioration events ; Paediatric ; Paediatric early warning system score ; Paediatric early warning system ; Public aspects of medicine ; RA1-1270
Subject code	360
Language	English
Publishing date	2023-07-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Navigating uncertain illness trajectories for young children with serious infectious illness

Sarah Neill / Lucy Bray / Bernie Carter / Damian Roland / Enitan D. Carrol / Natasha Bayes / Lucie Riches / Joanne Hughes / Poornima Pandey / Jennifer O’Donnell / Sue Palmer-Hill

BMC Health Services Research, Vol 22, Iss 1, Pp 1-

a modified grounded theory study

2022 Volume 19

Abstract: Abstract Background Infectious illness is the biggest cause of death in children due to a physical illness, particularly in children under five years. If mortality is to be reduced for this group of children, it is important to understand factors ... ...

Abstract	Abstract Background Infectious illness is the biggest cause of death in children due to a physical illness, particularly in children under five years. If mortality is to be reduced for this group of children, it is important to understand factors affecting their pathways to hospital. The aim of this study was to retrospectively identify organisational and environmental factors, and individual child, family, and professional factors affecting timing of admission to hospital for children under five years of age with a serious infectious illness (SII). Methods An explanatory modified grounded theory design was used in collaboration with parents. Two stages of data collection were conducted: Stage 1, interviews with 22 parents whose child had recently been hospitalised with a SII and 14 health professionals (HPs) involved in their pre-admission trajectories; Stage 2, focus groups with 18 parents and 16 HPs with past experience of SII in young children. Constant comparative analysis generated the explanatory theory. Results The core category was ‘navigating uncertain illness trajectories for young children with serious infectious illness’. Uncertainty was prevalent throughout the parents’ and HPs’ stories about their experiences of navigating social rules and overburdened health services for these children. The complexity of and lack of continuity within services, family lives, social expectations and hierarchies provided the context and conditions for children’s, often complex, illness trajectories. Parents reported powerlessness and perceived criticism leading to delayed help-seeking. Importantly, parents and professionals missed symptoms of serious illness. Risk averse services were found to refer more children to emergency departments. Conclusions Parents and professionals have difficulties recognising signs of SII in young children and can feel socially constrained from seeking help. The increased burden on services has made it more difficult for professionals to spot the seriously ill child.
Keywords	Serious infectious illness ; Illness trajectories ; Parents ; Children under 5 years ; Health professionals ; Uncertainty ; Public aspects of medicine ; RA1-1270
Subject code	360
Language	English
Publishing date	2022-08-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A systematic review of the organizational, environmental, professional and child and family factors influencing the timing of admission to hospital for children with serious infectious illness.

Bernie Carter / Damian Roland / Lucy Bray / Jane Harris / Poornima Pandey / Jo Fox / Enitan D Carrol / Sarah Neill

PLoS ONE, Vol 15, Iss 7, p e

2020 Volume 0236013

Abstract: Background Infection, particularly in the first 5 years of life, is a major cause of childhood deaths globally, many deaths from infections such as pneumonia and meningococcal disease are avoidable, if treated in time. Some factors that contribute to ... ...

Abstract	Background Infection, particularly in the first 5 years of life, is a major cause of childhood deaths globally, many deaths from infections such as pneumonia and meningococcal disease are avoidable, if treated in time. Some factors that contribute to morbidity and mortality can be modified. These include organisational and environmental factors as well as those related to the child, family or professional. Objective Examine what organizational and environmental factors and individual child, family and professional factors affect timing of admission to hospital for children with a serious infectious illness. Design Systematic review. Data sources Key search terms were identified and used to search CINAHL Plus, Medline, ASSIA, Web of Science, The Cochrane Library, Joanna Briggs Institute Database of Systematic Review. Study appraisal methods Primary research (e.g. quantitative, qualitative and mixed methods studies) and literature reviews (e.g., systematic, scoping and narrative) were included if participants included or were restricted to children under 5 years of age with serious infectious illnesses, included parents and/or first contact health care professionals in primary care, urgent and emergency care and where the research had been conducted in OECD high income countries. The Mixed Methods Appraisal Tool was used to review the methodological quality of the studies. Main findings Thirty-six papers were selected for full text review; 12 studies fitted the inclusion criteria. Factors influencing the timing of admission to hospital included the variability in children's illness trajectories and pathways to hospital, parental recognition of symptoms and clinicians non-recognition of illness severity, parental help-seeking behaviour and clinician responses, access to services, use and non-use of 'gut feeling' by clinicians, and sub-optimal management within primary, secondary and tertiary services. Conclusions The pathways taken by children with a serious infectious illness to hospital are complex and influenced ...
Keywords	Medicine ; R ; Science ; Q
Subject code	360
Language	English
Publishing date	2020-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Proteomic profiling to identify markers of bacterial meningitis

Enitan D. Carrol / L Gómez-Baena / G Laing / R Beynon

European Journal of Molecular and Clinical Medicine, Vol 2, Iss

2015 Volume 2

Abstract: Bacterial meningitis is usually fatal without treatment and prompt and accurate diagnosis coupled with the timely administration of parenteral antibiotics are necessary in order to save lives. Despite the availability of highly effective antibiotics, the ...

Abstract	Bacterial meningitis is usually fatal without treatment and prompt and accurate diagnosis coupled with the timely administration of parenteral antibiotics are necessary in order to save lives. Despite the availability of highly effective antibiotics, the complications from bacterial meningitis (such as deafness, hydrocephalus, seizures and cerebral palsy) remain high. In areas with a high incidence of human immunodeficiency virus infection, Streptococcus pneumoniae is the commonest cause of bacterial meningitis. The diagnosis of bacterial meningitis can sometimes be delayed whilst samples are analysed in a laboratory using traditional methods of microscopy and antigen testing. We used cutting-edge high definition and quantitative mass spectrometry to identify specific protein signatures in cerebrospinal fluid associated with Streptococcus pneumoniae infection which could lead to the development of assays or point-of-care devices to improve the speed and accuracy of diagnosis, and consequently to enhance the prognosis of adults and children with bacterial meningitis. A range of samples (cases and controls, n=12) from Malawian children has been analysed. Our data indicate some clear trends, and confirm that quantitative proteomics analysis will be successful in generating a comprehensive protein list from which markers might be nominated. We identified a total of 519 proteins in data dependent discovery proteomics and obtained quantitative data for 161 proteins using data independent Hi3 quantification. Using Progenesis LCMS we obtained a list of 202 potential candidates using data dependent acquisition approach and 109 using data independent acquisition, 82 proteins being common to both workflows. The protein profiles clearly differentiated cases and controls and have the potential to inform diagnosis and management of bacterial meningitis, especially in the developing world where the disease burden and mortality is greatest.
Keywords	Medicine ; R
Subject code	572
Language	English
Publishing date	2015-02-01T00:00:00Z
Publisher	Ubiquity Press
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection (BATCH)

Matthew Peak / Enitan D Carrol / Chao Huang / Kerenza Hood / Emma Thomas-Jones / Colin Powell / Céu Mateus / Saul N Faust / Jennifer Preston / Sanjay Patel / Cherry-Ann Waldron / Lucy Brookes-Howell / Debbie Harris / Philip Pallmann / Jolanta Bernatoniene / Stephane Paulus / Lucy Hinds

BMJ Open, Vol 12, Iss

protocol for a randomised controlled trial

2022 Volume 1

Keywords	Medicine ; R
Language	English
Publishing date	2022-01-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Impact of Digital Educational Interventions to Support Parents Caring for Acutely Ill Children at Home and Factors That Affect Their Use

Madison Milne-Ives / Sarah Neill / Natasha Bayes / Mitch Blair / Jane Blewitt / Lucy Bray / Enitan D Carrol / Bernie Carter / Rob Dawson / Paul Dimitri / Monica Lakhanpaul / Damian Roland / Alison Tavare / Edward Meinert

JMIR Research Protocols, Vol 10, Iss 6, p e

Protocol for a Systematic Review

2021 Volume 27504

Abstract: BackgroundUrgent and emergency care health services are overburdened, and the use of these services by acutely ill infants and children is increasing. A large proportion of these visits could be sufficiently addressed by other health care professionals. ... ...

Abstract	BackgroundUrgent and emergency care health services are overburdened, and the use of these services by acutely ill infants and children is increasing. A large proportion of these visits could be sufficiently addressed by other health care professionals. Uncertainty about the severity of a child’s symptoms is one of many factors that play a role in parents’ decisions to take their children to emergency services, demonstrating the need for improved support for health literacy. Digital interventions are a potential tool to improve parents’ knowledge, confidence, and self-efficacy at managing acute childhood illness. However, existing systematic reviews related to this topic need to be updated and expanded to provide a contemporary review of the impact, usability, and limitations of these solutions. ObjectiveThe purpose of this systematic review protocol is to present the method for an evaluation of the impact, usability, and limitations of different types of digital educational interventions to support parents caring for acutely ill children at home. MethodsThe review will be structured using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) and Population, Intervention, Comparator, and Outcome (PICO) frameworks. Five databases will be systematically searched for studies published in English during and after 2014: Medline, EMBASE, CINAHL, APA PsycNet, and Web of Science. Two reviewers will independently screen references’ titles and abstracts, select studies for inclusion based on the eligibility criteria, and extract the data into a standardized form. Any disagreements will be discussed and resolved by a third reviewer if necessary. Risk of bias of all studies will be assessed using the Mixed-Methods Appraisal Tool (MMAT), and a descriptive analysis will be used to evaluate the outcomes reported. ResultsThe systematic review will commence during 2021. ConclusionsThis systematic review will summarize the impact, usability, and limitations of digital interventions for parents with acutely ill children. It will provide an overview of the field; identify reported impacts on health and behavioral outcomes as well as parental knowledge, satisfaction, and decision making; and identify the factors that affect use to help inform the development of more effective and sustainable interventions. International Registered Report Identifier (IRRID)PRR1-10.2196/27504
Keywords	Medicine ; R ; Computer applications to medicine. Medical informatics ; R858-859.7
Subject code	306
Language	English
Publishing date	2021-06-01T00:00:00Z
Publisher	JMIR Publications
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Procalcitonin, C-reactive protein, neutrophil gelatinase-associated lipocalin, resistin and the APTT waveform for the early diagnosis of serious bacterial infection and prediction of outcome in critically ill children.

Maryke J Nielsen / Paul Baines / Rebecca Jennings / Sarah Siner / Ruwanthi Kolamunnage-Dona / Paul Newland / Matthew Peak / Christine Chesters / Graham Jeffers / Colin Downey / Caroline Broughton / Lynsey McColl / Jennifer Preston / Anthony McKeever / Stephane Paulus / Nigel Cunliffe / Enitan D Carrol

PLoS ONE, Vol 16, Iss 2, p e

2021 Volume 0246027

Abstract: Objective Bacterial Infections remains a leading cause of death in the Paediatric Intensive Care Unit (PICU). In this era of rising antimicrobial resistance, new tools are needed to guide antimicrobial use. The aim of this study was to investigate the ... ...

Abstract	Objective Bacterial Infections remains a leading cause of death in the Paediatric Intensive Care Unit (PICU). In this era of rising antimicrobial resistance, new tools are needed to guide antimicrobial use. The aim of this study was to investigate the accuracy of procalcitonin (PCT), neutrophil gelatinase-associated lipocalin (NGAL), resistin, activated partial thromboplastin time (aPTT) waveform and C-reactive protein (CRP) for the diagnosis of serious bacterial infection (SBI) in children on admission to PICU and their use as prognostic indicators. Setting A regional PICU in the United Kingdom. Patients Consecutive PICU admissions between October 2010 and June 2012. Measurements Blood samples were collected daily for biomarker measurement. The primary outcome measure was performance of study biomarkers for diagnosis of SBI on admission to PICU based on clinical, radiological and microbiological criteria. Secondary outcomes included durations of PICU stay and invasive ventilation and 28-day mortality. Patients were followed up to day 28 post-admission. Main results A total of 657 patients were included in the study. 92 patients (14%) fulfilled criteria for SBI. 28-day mortality was 2.6% (17/657), but 8.7% (8/92) for patients with SBI. The combination of PCT, resistin, plasma NGAL and CRP resulted in the greatest net reclassification improvement compared to CRP alone (0.69, p<0.005) with 10.5% reduction in correct classification of patients with SBI (p 0.52) but a 78% improvement in correct classification of patients without events (p <0.005). A statistical model of prolonged duration of PICU stay found log-transformed maximum values of biomarkers performed better than first recorded biomarkers. The final model included maximum values of CRP, plasma NGAL, lymphocyte and platelet count (AUC 79%, 95% CI 73.7% to 84.2%). Longitudinal profiles of biomarkers showed PCT levels to decrease most rapidly following admission SBI. Conclusion Combinations of biomarkers, including PCT, may improve accurate and timely ...
Keywords	Medicine ; R ; Science ; Q
Subject code	610 ; 310
Language	English
Publishing date	2021-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Sex differences in febrile children with respiratory symptoms attending European emergency departments

Chantal D. Tan / Soufiane el Ouasghiri / Ulrich von Both / Enitan D. Carrol / Marieke Emonts / Michiel van der Flier / Ronald de Groot / Jethro Herberg / Benno Kohlmaier / Michael Levin / Emma Lim / Ian K. Maconochie / Federico Martinon-Torres / Ruud G. Nijman / Marko Pokorn / Irene Rivero-Calle / Maria Tsolia / Clementien L. Vermont / Werner Zenz /

Dace Zavadska / Henriette A. Moll / Joany M. Zachariasse / On behalf of PERFORM consortium (Personalised Risk assessment in febrile children to optimise Real-life Management across the European Union)

PLoS ONE, Vol 17, Iss

An observational multicenter study

2022 Volume 8

Abstract: Objective To assess sex differences in presentation and management of febrile children with respiratory symptoms attending European Emergency Departments. Design and setting An observational study in twelve Emergency Departments in eight European ... ...

Abstract	Objective To assess sex differences in presentation and management of febrile children with respiratory symptoms attending European Emergency Departments. Design and setting An observational study in twelve Emergency Departments in eight European countries. Patients Previously healthy children aged 0–<18 years with fever (≥ 38°C) at the Emergency Department or in the consecutive three days before Emergency Department visit and respiratory symptoms were included. Main outcome measures The main outcomes were patient characteristics and management defined as diagnostic tests, treatment and admission. Descriptive statistics were used for patient characteristics and management stratified by sex. Multivariable logistic regression analyses were performed for the association between sex and management with adjustment for age, disease severity and Emergency Department. Additionally, subgroup analyses were performed in children with upper and lower respiratory tract infections and in children below five years. Results We included 19,781 febrile children with respiratory symptoms. The majority were boys (54%), aged 1–5 years (58%) and triaged as low urgent (67%). Girls presented less frequently with tachypnea (15% vs 16%, p = 0.002) and increased work of breathing (8% vs 12%, p<0.001) compared with boys. Girls received less inhalation medication than boys (aOR 0.82, 95% CI 0.74–0.90), but received antibiotic treatment more frequently than boys (aOR 1.09, 95% CI 1.02–1.15), which is associated with a higher prevalence of urinary tract infections. Amongst children with a lower respiratory tract infection and children below five years girls received less inhalation medication than boys (aOR 0.77, 95% CI 0.66–0.89; aOR 0.80, 95% CI 0.72–0.90). Conclusions Sex differences concerning presentation and management are present in previously healthy febrile children with respiratory symptoms presenting to the Emergency Department. Future research should focus on whether these differences are related to clinicians’ attitudes, ...
Keywords	Medicine ; R ; Science ; Q
Subject code	150
Language	English
Publishing date	2022-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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