Paediatric critical care units are designed for children at a vulnerable stage of development, yet the evidence base for practice and policy in paediatric critical care remains scarce. In this Health Policy, we present a roadmap providing strategic guidance for international paediatric critical care trials. We convened a multidisciplinary group of 32 paediatric critical care experts from six continents representing paediatric critical care research networks and groups. The group identified key challenges to paediatric critical care research, including lower patient numbers than for adult critical care, heterogeneity related to cognitive development, comorbidities and illness or injury, consent challenges, disproportionately little research funding for paediatric critical care, and poor infrastructure in resource-limited settings. A seven-point roadmap was proposed: (1) formation of an international paediatric critical care research network; (2) development of a web-based toolkit library to support paediatric critical care trials; (3) establishment of a global paediatric critical care trial repository, including systematic prioritisation of topics and populations for interventional trials; (4) development of a harmonised trial minimum set of trial data elements and data dictionary; (5) building of infrastructure and capability to support platform trials; (6) funder advocacy; and (7) development of a collaborative implementation programme. Implementation of this roadmap will contribute to the successful design and conduct of trials that match the needs of globally diverse paediatric populations.
In a global landscape defined by polycrisis, children are being failed. To address this failure, we ask an ambitious yet fundamental question: how do we create child-inclusive societies where every child thrives and has the best start in life, where intergenerational disadvantage is redressed, and where child poverty is ended? Building on the power of the social determinants of health in advancing equity and human wellbeing, we argue that child inclusiveness requires three foundational actions linked to the political, commercial, and social determinants of health: (1) prioritising implementation of transformative collaboration between policy makers, public bodies, and communities to improve outcomes for children; (2) reclaiming the public good through child-centred regulatory frameworks that aim to deliver health care and improve wellbeing; and (3) valuing the time to care for children and to build meaningful and responsive relationships with them. With innovative thinking about our societies and their core values, we can design child-inclusive interventions and derive relevant metrics and indicators to track progress.
Background: Many children with mild traumatic brain injury (mTBI), defined by a Glasgow Coma Scale (GCS) score between 13 and 15, undergo hospitalisation or cranial CT (CCT) scans despite the absence of clinically important traumatic brain injury (ciTBI; ie, hospitalisation >2 days associated with intracranial lesions on CCT, neurosurgical intervention, intensive care admission, or death). Clinical algorithms have reduced CCT scans and hospitalisations by 10%. We aimed to established age-appropriate reference values for GFAP and UCH-L1 and evaluate their diagnostic test performance in identifying ciTBI in children.
Methods: This study was a diagnostic test accuracy substudy within the PROS100B stepped wedge cluster randomised trial that included children aged 16 years or younger, clinically managed within 3 h of mTBI, with a GCS score of 15 requiring hospitalisation or CCT scan according to French Pediatric Society guidelines (equivalent to the intermediate risk group of the PECARN algorithm). Enrolment for PROS100B occurred from Nov 1, 2016, to Oct 31, 2021, at 11 hospital emergency departments in France. Stored blood samples collected from March 1, 2015, to Oct 31, 2015, from children aged 16 years or younger who were outpatients for allergic conditions unrelated to mTBI and free of neurological disease were used as a control group to calculate reference values of GFAP and UCH-L1 across four age groups (<6 months, 6 months to <2 years, 2 years to <4 years, and 4 years to <16 years). The diagnostic test performance of GFAP and UCH-L1, both above the reference range to identify ciTBI, was evaluated in the children with mTBI. GFAP and UCH-L1 were measured with the Alinity analyser (Abbott, Chicago, IL, USA).
Findings: Reference values were calculated from GFAP and UCH-L1 measured in samples from 718 control children (378 [53%] boys and 340 [47%] girls). 531 children (334 [63%] boys and 197 [37%] girls) aged 0-16 years with mTBI were included. By applying our reference values for GFAP and UCH-L1 across four age groups the biomarker combination (both biomarkers above reference ranges) had a sensitivity of 100% (95% CI 69-100), a negative predictive value of 100% (99-100), a specificity of 67% (63-71), a positive likelihood ratio of 3·01 (2·67-3·40), a negative likelihood ratio of 0, and an area under the curve of 0·83 (0·81-0·85) in identifying ciTBI.
Interpretation: Serum GFAP and UCH-L1 identify ciTBI in children with 100% sensitivity and 67% specificity, which could potentially reduce unnecessary CCT scans and hospitalisations in children with mTBI if implemented.
Funding: French Ministry of Health.
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