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Ganesan Baranidharan,1,2 Beatrice Bretherton,1,3 Richard G Feltbower,4 Jake Timothy,5 Almas Latif Khan,6,7 Ashok Subramanian,8 Mushtaq Ahmed,9 Tracey A Crowther,1,10 Helen Radford,10,11 Harun Gupta,12 Muthusamy Chandramohan,13 Douglas P Beall,14 Timothy R Deer,15 Thomas Hedman16 1Pain Management Department, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 2School of Medicine, University of Leeds, Leeds, UK; 3School of Biomedical Sciences, Faculty of Biological Sciences, University of Leeds, Leeds, UK; 4Leeds Institute for Data Analytics, School of Medicine, University of Leeds, Leeds, UK; 5Department of Neuroscience, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 6Department of Spine Surgery, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 7Institute of Medical and Biological Engineering, University of Leeds, Leeds, UK; 8Somerset Spinal Surgery Service, Musgrove Park Hospital, Taunton, UK; 9Department of Trauma and Orthopaedic Surgery, Dudley Group NHS Foundation Trust, Dudley, UK; 10Research & Innovation, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 11Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK; 12Department of Radiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 13Radiology Department, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK; 14Comprehensive Specialty Care, Edmond, OK, USA; 15The Spine and Nerve Center of the Virginias, Charleston, WV, USA; 16Department of Biomedical Engineering, University of Kentucky, Lexington, KY, USACorrespondence: Ganesan Baranidharan, Pain Management Department, Leeds Teaching Hospitals NHS Trust, Leeds, UK, Email g.baranidharan@nhs.netPurpose: An early-stage, multi-centre, prospective, randomised control trial with five-year follow-up was approved by Health Research Authority to compare the efficacy of a minimally invasive, laterally implanted interspinous fixation device (IFD) to open direct surgical decompression in treating lumbar spinal stenosis (LSS). Two-year results are presented.Patients and Methods: Forty-eight participants were randomly assigned to IFD or decompression. Primary study endpoints included changes from baseline at 8-weeks, 6, 12 and 24-months follow-ups for leg pain (visual analogue scale, VAS), back pain (VAS), disability (Oswestry Disability Index, ODI), LSS physical function (Zurich Claudication Questionnaire), distance walked in five minutes and number of repetitions of sitting-to-standing in one minute. Secondary study endpoints included patient and clinician global impression of change, adverse events, reoperations, operating parameters, and fusion rate.Results: Both treatment groups demonstrated statistically significant improvements in mean leg pain, back pain, ODI disability, LSS physical function, walking distance and sitting-to-standing repetitions compared to baseline over 24 months. Mean reduction of ODI from baseline levels was between 35% and 56% for IFD (p< 0.002), and 49% to 55% for decompression (p< 0.001) for all follow-up time points. Mean reduction of IFD group leg pain was between 57% and 78% for all time points (p< 0.001), with 72% to 94% of participants having at least 30% reduction of leg pain from 8-weeks through 24-months. Walking distance for the IFD group increased from 66% to 94% and sitting-to-standing repetitions increased from 44% to 64% for all follow-up time points. Blood loss was 88% less in the IFD group (p=0.024) and operating time parameters strongly favoured IFD compared to decompression (p< 0.001). An 89% fusion rate was assessed in a subset of IFD participants. There were no intraoperative device issues or re-operations in the IFD group, and only one healed and non-symptomatic spinous process fracture observed within 24 months.Conclusion: Despite a low number of participants in the IFD group, the study demonstrated successful two-year safety and clinical outcomes for the IFD with significant operation-related advantages compared to surgical decompression.Keywords: lumbar spinal stenosis, surgical decompression, posterior lateral arthrodesis, patient reported outcomes, minimally invasive spine, interspinous fixation device

Objectives: To describe end of life care in settings where, in the UK, most children die; to explore commonalities and differences within and between settings; and to test whether there are distinct, alternative models of end of life care., Methods: An online survey of UK neonatal units (NNUs), paediatric intensive care units (PICUs) and children/young people's cancer principal treatment centres (PTCs) collected data on aspects of service organisation, delivery and practice relevant to end of life outcomes or experiences (referred to as the core elements of end of life care) across three domains: care of the child, care of the parent and bereavement care., Results: 91 units/centres returned a survey (37% response rate). There was variation within and between settings in terms of whether and how core elements of end of life care were provided. PTCs were more likely than NNUs and PICUs to have palliative care expertise strongly embedded in the multidisciplinary team (MDT), and to have the widest range of clinical and non-clinical professions represented in the MDT. However, bereavement care was more limited. Many settings were limited in the practical and psychosocial-spiritual care and support available to parents., Conclusions: Children at end of life, and families, experience differences in care that evidence indicates matter to them and impact outcomes. Some differences appear to be related to the type of setting. Subsequent stages of this research (the ENHANCE study) will investigate the relative contribution of these core elements of end of life care to child/parent outcomes and experiences., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Competing Interests: No funding has been received to write this article. DS is funded by Strong-AYA, an academic research grant from Horizon Europe. DS has also received travel and accommodation reimbursement from the European Society of Medical Oncology Educational committee in 2022 and 2024 and has unpaid roles as the Chair for the European Network for Teenagers and Young Adults with Cancer, and is Chair for the Teenage and Young Adult Cancer research committee for teenage and young adult cancer and germ cell tumours. NH holds a National Institute for Health and Care Research academic clinical lectureship. RF declares no competing interests.

Objective: To explore the trends and changes in the transport of children to paediatric intensive care units (PICUs) between 2013 and 2022., Design: Retrospective analysis of routinely collected data., Patients: Children transported for care in a PICU in the UK and Ireland aged<16 years., Interventions: None., Measurements and Main Results: There were 43 058 transports to a PICU involving 36 438 children from 2013 to 2022 with the majority of children requiring only one transport. The number of transports increased from 4131 (2013) to 4792 (2022). Over the study period the percentage of children aged under 1 year who were transported decreased from 50.2% to 45.2% and similarly, the percentage who were invasively ventilated also decreased from 81.1% to 70.2%. Conversely, the use of non-invasive ventilation during transports increased slightly from 4.0% to 7.0%. The percentage of transports where a parent was able to accompany the child increased over time (2013: 66.2% to 2019: 74.9%), although there were reductions due to the COVID-19 pandemic and requirements for social distancing (2020: 52.4%)., Conclusions: We have demonstrated an increased use of specialist paediatric transport services and changes in the PICU population over time. Routine data collection from the transport services provide a means to measure improvements and changes over time in the service provided to critically ill children and young people who need transport to the PICU., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: Both phenotypic and genotypic variations now underpin glioma classification, thus helping to more accurately guide their clinical management. However, WHO Grade III anaplastic astrocytoma (AA) remains an unpredictable, heterogeneous entity; displaying a variable prognosis, clinical course and treatment response. This study aims to examine whether additional tumour characteristics influence either overall survival (OS) or 3-year survival in AA., Materials and Methods: Data were collected on all newly diagnosed cases of AA between 2003 and 2014, followed up for a minimum of 3 years. Molecular information was obtained from case records and if missing, was re-analysed. Histological slides were independently examined for Ki-67 proliferation index, cellularity and number of mitotic figures. Kaplan-Meier and Cox regression analyses were used to assess OS., Results: In total, 50 cases were included with a median OS of 14.5 months (range: 1-150 months). Cumulative 3-year survival was 31.5%. Median age was 50 years (range: 24 - 77). Age, IDH1 mutation status, lobar location, oncological therapy and surgical resection were significant independent prognostic indicators for OS. In cases demonstrating an OS   ≥   3 years ( n   =   15), Ki-67 index, number of mitotic figures and percentage areas of 'high cellularity' were significantly reduced, i.e. more characteristic of lower-grade/WHO Grade II glioma., Conclusions: IDH1 status, age, treatment and location remain the most significant prognostic indicators for patients with AA. However, Ki-67 index, mitotic figures and cellularity may help identify AA cases more likely to survive < 3 years, i.e. AA cases more similar to glioblastoma and those cases more likely to survive > 3 years, i.e. more similar to a low-grade glioma.

Background: Healthcare-associated infections are a major cause of morbidity and mortality in critically ill children. In adults, data suggest the use of selective decontamination of the digestive tract may reduce the incidence of healthcare-associated infections. Selective decontamination of the digestive tract has not been evaluated in the paediatric intensive care unit population., Objectives: To determine the feasibility of conducting a multicentre, cluster-randomised controlled trial in critically ill children comparing selective decontamination of the digestive tract with standard infection control., Design: Parallel-group pilot cluster-randomised controlled trial with an integrated mixed-methods study., Setting: Six paediatric intensive care units in England., Participants: Children (> 37 weeks corrected gestational age, up to 16 years) requiring mechanical ventilation expected to last for at least 48 hours were eligible for the PICnIC pilot cluster-randomised controlled trial. During the ecology periods, all children admitted to the paediatric intensive care units were eligible. Parents/legal guardians of recruited patients and healthcare professionals working in paediatric intensive care units were eligible for inclusion in the mixed-methods study., Interventions: The interventions in the PICnIC pilot cluster-randomised controlled trial included administration of selective decontamination of the digestive tract as oro-pharyngeal paste and as a suspension given by enteric tube during the period of mechanical ventilation., Main Outcome Measures: The decision as to whether a definitive cluster-randomised controlled trial is feasible is based on multiple outcomes, including (but not limited to): (1) willingness and ability to recruit eligible patients; (2) adherence to the selective decontamination of the digestive tract intervention; (3) acceptability of the definitive cluster-randomised controlled trial; (4) estimation of recruitment rate; and (5) understanding of potential clinical and ecological outcome measures., Results: A total of 368 children (85% of all those who were eligible) were enrolled in the PICnIC pilot cluster-randomised controlled trial across six paediatric intensive care units: 207 in the baseline phase (Period One) and 161 in the intervention period (Period Two). In sites delivering selective decontamination of the digestive tract, the majority (98%) of children received at least one dose of selective decontamination of the digestive tract, and of these, 68% commenced within the first 6 hours. Consent for the collection of additional swabs was low (44%), though data completeness for potential outcomes, including microbiology data from routine clinical swab testing, was excellent. Recruited children were representative of the wider paediatric intensive care unit population. Overall, 3.6 children/site/week were recruited compared with the potential recruitment rate for a definitive cluster-randomised controlled trial of 3 children/site/week, based on data from all UK paediatric intensive care units. The proposed trial, including consent and selective decontamination of the digestive tract, was acceptable to parents and staff with adaptations, including training to improve consent and communication, and adaptations to the administration protocol for the paste and ecology monitoring. Clinical outcomes that were considered important included duration of organ failure and hospital stay, healthcare-acquired infections and survival., Limitations: The delivery of the pilot cluster-randomised controlled trial was disrupted by the COVID-19 pandemic, which led to slow set-up of sites, and a lack of face-to face training., Conclusions: PICnIC's findings indicate that a definitive cluster-randomised controlled trial in selective decontamination of the digestive tract in paediatric intensive care units is feasible with the inclusion modifications, which would need to be included in a definitive cluster-randomised controlled trial to ensure that the efficiency of trial processes is maximised., Future Work: A definitive trial that incorporates the protocol adaptations and outcomes arising from this study is feasible and should be conducted., Trial Registration: This trial is registered as ISRCTN40310490., Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/152/01) and is published in full in Health Technology Assessment ; Vol. 28, No. 8. See the NIHR Funding and Awards website for further award information.