Conservative versus liberal oxygenation targets in critically ill children (Oxy-PICU): a UK multicentre, open, parallel-group, randomised clinical trial.

BACKGROUND: The optimal target for systemic oxygenation in critically ill children is unknown. Liberal oxygenation is widely practiced, but has been associated with harm in paediatric patients. We aimed to evaluate whether conservative oxygenation would reduce duration of organ support or incidence of death compared to standard care. METHODS: Oxy-PICU was a pragmatic, multicentre, open-label, randomised controlled trial in 15 UK paediatric intensive care units (PICUs). Children admitted as an emergency, who were older than 38 weeks corrected gestational age and younger than 16 years receiving invasive ventilation and supplemental oxygen were randomly allocated in a 1:1 ratio via a concealed, central, web-based randomisation system to conservative peripheral oxygen saturations ([SpO2] 88-92%) or liberal (SpO2 >94%) targets. The primary outcome was the duration of organ support at 30 days following random allocation, a rank-based endpoint with death either on or before day 30 as the worst outcome (a score equating to 31 days of organ support), with survivors assigned a score between 1 and 30 depending on the number of calendar days of organ support received. The primary effect estimate was the probabilistic index, a value greater than 0·5 indicating more than 50% probability that conservative oxygenation is superior to liberal oxygenation for a randomly selected patient. All participants in whom consent was available were included in the intention-to-treat analysis. The completed study was registered with the ISRCTN registry (ISRCTN92103439). FINDINGS: Between Sept 1, 2020, and May 15, 2022, 2040 children were randomly allocated to conservative or liberal oxygenation groups. Consent was available for 1872 (92%) of 2040 children. The conservative oxygenation group comprised 939 children (528 [57%] of 927 were female and 399 [43%] of 927 were male) and the liberal oxygenation group included 933 children (511 [56%] of 920 were female and 409 [45%] of 920 were male). Duration of organ support or death in the first 30 days was significantly lower in the conservative oxygenation group (probabilistic index 0·53, 95% CI 0·50-0·55; p=0·04 Wilcoxon rank-sum test, adjusted odds ratio 0·84 [95% CI 0·72-0·99]). Prespecified adverse events were reported in 24 (3%) of 939 patients in the conservative oxygenation group and 36 (4%) of 933 patients in the liberal oxygenation group. INTERPRETATION: Among invasively ventilated children who were admitted as an emergency to a PICU receiving supplemental oxygen, a conservative oxygenation target resulted in a small, but significant, greater probability of a better outcome in terms of duration of organ support at 30 days or death when compared with a liberal oxygenation target. Widespread adoption of a conservative oxygenation saturation target (SpO2 88-92%) could help improve outcomes and reduce costs for the sickest children admitted to PICUs. FUNDING: UK National Institute for Health and Care Research Health Technology Assessment Programme.

Vital Signs: Drowning Death Rates, Self-Reported Swimming Skill, Swimming Lesson Participation, and Recreational Water Exposure - United States, 2019-2023.

Introduction: Drowning is the cause of approximately 4,000 U.S. deaths each year and disproportionately affects some age, racial, and ethnic groups. Infrastructure disruptions during the COVID-19 pandemic, including limited access to supervised swimming settings, might have affected drowning rates and risk. Data on factors that contribute to drowning risk are limited. To assess the potential impact of the pandemic on drowning death rates, pre- and post-COVID-19 pandemic rates were compared. Methods: National Vital Statistics System data were used to compare unintentional drowning death rates in 2019 (pre-COVID-19 pandemic onset) with those in 2020, 2021, and 2022 (post-pandemic onset) by age, sex, and race and ethnicity. National probability-based online panel survey (National Center for Health Statistics Rapid Surveys System) data from October-November 2023 were used to describe adults' self-reported swimming skill, swimming lesson participation, and exposure to recreational water. Results: Unintentional drowning death rates were significantly higher during 2020, 2021, and 2022 compared with those in 2019. In all years, rates were highest among children aged 1-4 years; significant increases occurred in most age groups. The highest drowning rates were among non-Hispanic American Indian or Alaska Native and non-Hispanic Black or African American persons. Approximately one half (54.7%) of U.S. adults reported never having taken a swimming lesson. Swimming skill and swimming lesson participation differed by age, sex, and race and ethnicity. Conclusions and Implications for Public Health Practice: Recent increases in drowning rates, including those among populations already at high risk, have increased the urgency of implementing prevention strategies. Basic swimming and water safety skills training can reduce the risk for drowning. Addressing social and structural barriers that limit access to this training might reduce drowning deaths and inequities. The U.S. National Water Safety Action Plan provides recommendations and tools for communities and organizations to enhance basic swimming and water safety skills training.

An aromatherapy massage intervention on sleep in the ICU: A randomized controlled feasibility study.

We conducted a feasibility randomized controlled trial exploring the effect of aromatherapy massage on sleep in critically ill patients. Patients were randomized to receive aromatherapy massage or usual care, and feasibility of recruitment and outcome data completion was captured. Sleep (depth) was assessed through Bispectral Index monitoring and self/nurse-reported Richards-Campbell Sleep Questionnaires, and the Sleep in the ICU Questionnaire. Thirty-four patients participated: 17 were randomized to aromatherapy massage and 17 to control. Five participants who received the intervention completed outcomes for analysis (alongside eight controls). A larger study was deemed unfeasible in this population, highlighting the value of testing feasibility of complex interventions, such as massage for sleep in ICU.

The effect of blood pressure on mortality following out-of-hospital cardiac arrest: a retrospective cohort study of the United Kingdom Intensive Care National Audit and Research Centre database.

BACKGROUND: Hypotension following out-of-hospital cardiac arrest (OHCA) may cause secondary brain injury and increase mortality rates. Current guidelines recommend avoiding hypotension. However, the optimal blood pressure following OHCA is unknown. We hypothesised that exposure to hypotension and hypertension in the first 24 h in ICU would be associated with mortality following OHCA. METHODS: We conducted a retrospective analysis of OHCA patients included in the Intensive Care National Audit and Research Centre Case Mix Programme from 1 January 2010 to 31 December 2019. Restricted cubic splines were created following adjustment for important prognostic variables. We report the adjusted odds ratio for associations between lowest and highest mean arterial pressure (MAP) and systolic blood pressure (SBP) in the first 24 h of ICU care and hospital mortality. RESULTS: A total of 32,349 patients were included in the analysis. Hospital mortality was 56.2%. The median lowest and highest MAP and SBP were similar in survivors and non-survivors. Both hypotension and hypertension were associated with increased mortality. Patients who had a lowest recorded MAP in the range 60-63 mmHg had the lowest associated mortality. Patients who had a highest recorded MAP in the range 95-104 mmHg had the lowest associated mortality. The association between SBP and mortality followed a similar pattern to MAP. CONCLUSIONS: We found an association between hypotension and hypertension in the first 24 h in ICU and mortality following OHCA. The inability to distinguish between the median blood pressure of survivors and non-survivors indicates the need for research into individualised blood pressure targets for survivors following OHCA.

Protocol for a Randomized Multiple Center Trial of Conservative Versus Liberal Oxygenation Targets in Critically Ill Children (Oxy-PICU): Oxygen in Pediatric Intensive Care.

OBJECTIVES: Oxygen administration is a fundamental part of pediatric critical care, with supplemental oxygen offered to nearly every acutely unwell child. However, optimal targets for systemic oxygenation are unknown. Oxy-PICU aims to evaluate the clinical effectiveness and cost-effectiveness of a conservative peripheral oxygen saturation (Sp o2 ) target of 88-92% compared with a liberal target of more than 94%. DESIGN: Pragmatic, open, multiple-center, parallel group randomized control trial with integrated economic evaluation. SETTING: Fifteen PICUs across England, Wales, and Scotland. PATIENTS: Infants and children age more than 38 week-corrected gestational age to 16 years who are accepted to a participating PICU as an unplanned admission and receiving invasive mechanical ventilation with supplemental oxygen for abnormal gas exchange. INTERVENTION: Adjustment of ventilation and inspired oxygen settings to achieve an Sp o2 target of 88-92% during invasive mechanical ventilation. MEASUREMENTS AND MAIN RESULTS: Randomization is 1:1 to a liberal Sp o2 target of more than 94% or a conservative Sp o2 target of 88-92% (inclusive), using minimization with a random component. Minimization will be performed on: age, site, primary reason for admission, and severity of abnormality of gas exchange. Due to the emergency nature of the treatment, approaching patients for written informed consent will be deferred to after randomization. The primary clinical outcome is a composite of death and days of organ support at 30 days. Baseline demographics and clinical status will be recorded as well as daily measures of oxygenation and organ support, and discharge outcomes. This trial received Health Research Authority approval on December 23, 2019 (reference: 272768), including a favorable ethical opinion from the East of England-Cambridge South Research Ethics Committee (reference number: 19/EE/0362). Trial findings will be disseminated in national and international conferences and peer-reviewed journals.

Trends in Intensive Care for Patients with COVID-19 in England, Wales, and Northern Ireland.

Rationale: By describing trends in intensive care for patients with coronavirus disease (COVID-19) we aim to support clinical learning, service planning, and hypothesis generation.Objectives: To describe variation in ICU admission rates over time and by geography during the first wave of the epidemic in England, Wales, and Northern Ireland; to describe trends in patient characteristics on admission to ICU, first-24-hours physiology in ICU, processes of care in ICU and patient outcomes; and to explore deviations in trends during the peak period.Methods: A cohort of 10,741 patients with COVID-19 in the Case Mix Program national clinical audit from February 1 to July 31, 2020, was used. Analyses were stratified by time period (prepeak, peak, and postpeak periods) and geographical region. Logistic regression was used to estimate adjusted differences in 28-day in-hospital mortality between periods.Measurements and Main Results: Admissions to ICUs peaked almost simultaneously across regions but varied 4.6-fold in magnitude. Compared with patients admitted in the prepeak period, patients admitted in the postpeak period were slightly younger but with higher degrees of dependency and comorbidity on admission to ICUs and more deranged first-24-hours physiology. Despite this, receipt of invasive ventilation and renal replacement therapy decreased, and adjusted 28-day in-hospital mortality was reduced by 11.8% (95% confidence interval, 8.7%-15.0%). Many variables exhibited u-shaped or n-shaped curves during the peak.Conclusions: The population of patients with COVID-19 admitted to ICUs, and the processes of care in ICUs, changed over the first wave of the epidemic. After adjustment for important risk factors, there was a substantial improvement in patient outcomes.

Effect of High-Flow Nasal Cannula Therapy vs Continuous Positive Airway Pressure Therapy on Liberation From Respiratory Support in Acutely Ill Children Admitted to Pediatric Critical Care Units: A Randomized Clinical Trial.

Importance: The optimal first-line mode of noninvasive respiratory support for acutely ill children is not known. Objective: To evaluate the noninferiority of high-flow nasal cannula therapy (HFNC) as the first-line mode of noninvasive respiratory support for acute illness, compared with continuous positive airway pressure (CPAP), for time to liberation from all forms of respiratory support. Design, Setting, and Participants: Pragmatic, multicenter, randomized noninferiority clinical trial conducted in 24 pediatric critical care units in the United Kingdom among 600 acutely ill children aged 0 to 15 years who were clinically assessed to require noninvasive respiratory support, recruited between August 2019 and November 2021, with last follow-up completed in March 2022. Interventions: Patients were randomized 1:1 to commence either HFNC at a flow rate based on patient weight (n = 301) or CPAP of 7 to 8 cm H2O (n = 299). Main Outcomes and Measures: The primary outcome was time from randomization to liberation from respiratory support, defined as the start of a 48-hour period during which a participant was free from all forms of respiratory support (invasive or noninvasive), assessed against a noninferiority margin of an adjusted hazard ratio of 0.75. Seven secondary outcomes were assessed, including mortality at critical care unit discharge, intubation within 48 hours, and use of sedation. Results: Of the 600 randomized children, consent was not obtained for 5 (HFNC: 1; CPAP: 4) and respiratory support was not started in 22 (HFNC: 5; CPAP: 17); 573 children (HFNC: 295; CPAP: 278) were included in the primary analysis (median age, 9 months; 226 girls [39%]). The median time to liberation in the HFNC group was 52.9 hours (95% CI, 46.0-60.9 hours) vs 47.9 hours (95% CI, 40.5-55.7 hours) in the CPAP group (absolute difference, 5.0 hours [95% CI -10.1 to 17.4 hours]; adjusted hazard ratio 1.03 [1-sided 97.5% CI, 0.86-∞]). This met the criterion for noninferiority. Of the 7 prespecified secondary outcomes, 3 were significantly lower in the HFNC group: use of sedation (27.7% vs 37%; adjusted odds ratio, 0.59 [95% CI, 0.39-0.88]); mean duration of critical care stay (5 days vs 7.4 days; adjusted mean difference, -3 days [95% CI, -5.1 to -1 days]); and mean duration of acute hospital stay (13.8 days vs 19.5 days; adjusted mean difference, -7.6 days [95% CI, -13.2 to -1.9 days]). The most common adverse event was nasal trauma (HFNC: 6/295 [2.0%]; CPAP: 18/278 [6.5%]). Conclusions and Relevance: Among acutely ill children clinically assessed to require noninvasive respiratory support in a pediatric critical care unit, HFNC compared with CPAP met the criterion for noninferiority for time to liberation from respiratory support. Trial Registration: ISRCTN.org Identifier: ISRCTN60048867.

Effect of High-Flow Nasal Cannula Therapy vs Continuous Positive Airway Pressure Following Extubation on Liberation From Respiratory Support in Critically Ill Children: A Randomized Clinical Trial.

Importance: The optimal first-line mode of noninvasive respiratory support following extubation of critically ill children is not known. Objective: To evaluate the noninferiority of high-flow nasal cannula (HFNC) therapy as the first-line mode of noninvasive respiratory support following extubation, compared with continuous positive airway pressure (CPAP), on time to liberation from respiratory support. Design, Setting, and Participants: This was a pragmatic, multicenter, randomized, noninferiority trial conducted at 22 pediatric intensive care units in the United Kingdom. Six hundred children aged 0 to 15 years clinically assessed to require noninvasive respiratory support within 72 hours of extubation were recruited between August 8, 2019, and May 18, 2020, with last follow-up completed on November 22, 2020. Interventions: Patients were randomized 1:1 to start either HFNC at a flow rate based on patient weight (n = 299) or CPAP of 7 to 8 cm H2O (n = 301). Main Outcomes and Measures: The primary outcome was time from randomization to liberation from respiratory support, defined as the start of a 48-hour period during which the child was free from all forms of respiratory support (invasive or noninvasive), assessed against a noninferiority margin of an adjusted hazard ratio (HR) of 0.75. There were 6 secondary outcomes, including mortality at day 180 and reintubation within 48 hours. Results: Of the 600 children who were randomized, 553 children (HFNC, 281; CPAP, 272) were included in the primary analysis (median age, 3 months; 241 girls [44%]). HFNC failed to meet noninferiority, with a median time to liberation of 50.5 hours (95% CI, 43.0-67.9) vs 42.9 hours (95% CI, 30.5-48.2) for CPAP (adjusted HR, 0.83; 1-sided 97.5% CI, 0.70-∞). Similar results were seen across prespecified subgroups. Of the 6 prespecified secondary outcomes, 5 showed no significant difference, including the rate of reintubation within 48 hours (13.3% for HFNC vs 11.5 % for CPAP). Mortality at day 180 was significantly higher for HFNC (5.6% vs 2.4% for CPAP; adjusted odds ratio, 3.07 [95% CI, 1.1-8.8]). The most common adverse events were abdominal distension (HFNC: 8/281 [2.8%] vs CPAP: 7/272 [2.6%]) and nasal/facial trauma (HFNC: 14/281 [5.0%] vs CPAP: 15/272 [5.5%]). Conclusions and Relevance: Among critically ill children requiring noninvasive respiratory support following extubation, HFNC compared with CPAP following extubation failed to meet the criterion for noninferiority for time to liberation from respiratory support. Trial Registration: isrctn.org Identifier: ISRCTN60048867.

Conflicts between parents and clinicians: Tracheotomy decisions and clinical bioethics consultation.

BACKGROUND: The parent of a child with profound cognitive disability will have complex decisions to consider throughout the life of their child. An especially complex decision is whether to place a tracheotomy to support the child's airway. The decision may involve the parent wanting a tracheotomy and the clinician advising against this intervention or the clinician recommending a tracheotomy while the parent is opposed to the intervention. This conflict over what is best for the child may lead to a bioethics consult. OBJECTIVE: The study explores the conflicts that may arise around tracheotomy placements. RESEARCH DESIGN: This study is a retrospective cohort study of pediatric patients for whom a tracheotomy decision required a bioethics consult. PARTICIPANTS AND RESEARCH CONTEXT: Pediatric patients aged birth to 18 years old with a bioethics consult for a tracheotomy decision conflict between April 2010 and December 2016. A standardized data collection tool was used to review notes entered by the palliative care team, social workers, primary clinical team interim summaries, and the bioethics consult service. ETHICAL CONSIDERATIONS: The study was reviewed and approved by the medical center's institutional review board. RESULTS: There were 248 clinical bioethics consults during the identified study period. There were 31 consults involving 21 children where the word tracheotomy was mentioned in the consult, and 13 of the 21 consults were for children with profound cognitive disability. DISCUSSION AND CONCLUSION: Clinicians need to be aware of their own biases when discussing a child's prognosis and treatment options while also understanding the parents' values and what the parent might consider to be burdensome in the care of their child and the acceptable burden for the child to experience.

Prognostic Factors for 30-Day Mortality in Critically Ill Patients With Coronavirus Disease 2019: An Observational Cohort Study.

OBJECTIVES: To identify characteristics that predict 30-day mortality among patients critically ill with coronavirus disease 2019 in England, Wales, and Northern Ireland. DESIGN: Observational cohort study. SETTING: A total of 258 adult critical care units. PATIENTS: A total of 10,362 patients with confirmed coronavirus disease 2019 with a start of critical care between March 1, 2020, and June 22, 2020, of whom 9,990 were eligible (excluding patients with a duration of critical care less than 24 hr or missing core variables). MEASUREMENTS AND MAIN RESULTS: The main outcome measure was time to death within 30 days of the start of critical care. Of 9,990 eligible patients (median age 60 yr, 70% male), 3,933 died within 30 days of the start of critical care. As of July 22, 2020, 189 patients were still receiving critical care and a further 446 were still in acute hospital. Data were missing for between 0.1% and 7.2% of patients across prognostic factors. We imputed missing data ten-fold, using fully conditional specification and continuous variables were modeled using restricted cubic splines. Associations between the candidate prognostic factors and time to death within 30 days of the start of critical care were determined after adjustment for multiple variables with Cox proportional hazards modeling. Significant associations were identified for age, ethnicity, deprivation, body mass index, prior dependency, immunocompromise, lowest systolic blood pressure, highest heart rate, highest respiratory rate, Pao2/Fio2 ratio (and interaction with mechanical ventilation), highest blood lactate concentration, highest serum urea, and lowest platelet count over the first 24 hours of critical care. Nonsignificant associations were found for sex, sedation, highest temperature, and lowest hemoglobin concentration. CONCLUSIONS: We identified patient characteristics that predict an increased likelihood of death within 30 days of the start of critical care for patients with coronavirus disease 2019. These findings may support development of a prediction model for benchmarking critical care providers.

Treatment of Coronavirus Disease 2019 (COVID-19) Patients with Convalescent Plasma.

Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2, has spread globally, and no proven treatments are available. Convalescent plasma therapy has been used with varying degrees of success to treat severe microbial infections for >100 years. Patients (n = 25) with severe and/or life-threatening COVID-19 disease were enrolled at the Houston Methodist hospitals from March 28, 2020, to April 14, 2020. Patients were transfused with convalescent plasma, obtained from donors with confirmed severe acute respiratory syndrome coronavirus 2 infection who had recovered. The primary study outcome was safety, and the secondary outcome was clinical status at day 14 after transfusion. Clinical improvement was assessed on the basis of a modified World Health Organization six-point ordinal scale and laboratory parameters. Viral genome sequencing was performed on donor and recipient strains. At day 7 after transfusion with convalescent plasma, nine patients had at least a one-point improvement in clinical scale, and seven of those were discharged. By day 14 after transfusion, 19 (76%) patients had at least a one-point improvement in clinical status, and 11 were discharged. No adverse events as a result of plasma transfusion were observed. Whole genome sequencing data did not identify a strain genotype-disease severity correlation. The data indicate that administration of convalescent plasma is a safe treatment option for those with severe COVID-19 disease.

Incidence of Nonfatal Traumatic Brain Injury-Related Hospitalizations - United States, 2018.

Traumatic brain injury (TBI), which can disrupt normal brain function and result in short- and long-term adverse clinical outcomes, including disability and death, is preventable. To describe the 2018 incidence of nonfatal TBI-related hospitalizations in the United States by sociodemographic characteristics, injury intent, and mechanism of injury, CDC analyzed data from the Healthcare Cost and Utilization Project (HCUP) National (Nationwide) Inpatient Sample. During 2018, there were 223,050 nonfatal TBI-related hospitalizations; rates among persons aged ≥75 years were approximately three times higher than those among persons aged 65-74 years, and the age-adjusted rate among males was approximately double that among females. Unintentional falls were the most common mechanism of injury leading to nonfatal TBI-related hospitalization, followed by motor vehicle crashes. Proper and consistent use of recommended restraints (i.e., seatbelts, car seats, and booster seats) and, particularly for persons aged ≥75 years, learning about individual fall risk from health care providers are two steps the public can take to prevent the most common injuries leading to nonfatal TBIs. The findings in this report could be used by public health officials and clinicians to identify priority areas for prevention programs.

The relation between falls risk and movement variability in Parkinson's disease.

Falls are a major health concern for older adults with Parkinson's disease (PD). This study was designed to examine differences in falls risk and its relation to changes in the average and variability (i.e. intra-individual variability) of reaction time (RT), finger tapping, standing balance and walking between healthy older adults and persons with PD. Thirty-nine adults with PD (70.0 ± 8.1 years) and 29 healthy older adults (66.8 ± 10.4 years) participated in this study. Falls risk (using the physiological profile assessment), gait, RT, balance and tapping responses were assessed for all persons. Results demonstrated that individuals with PD exhibited a greater risk of falling coupled with a general slowing of motor function covering declines in walking, RT and finger tapping. In addition, the movement responses of the PD group were more variable than the healthy older adults. Correlation results revealed group differences with regards to the neuromotor measures which were significantly correlated with falls risk. For the PD group, gait measures were highly correlated with their falls risk while, for the healthy older adults, falls risk was linked to balance measures even though PD persons had increased sway. Overall, persons with PD were at greater falls risk, moved slower and with increased variability compared to the healthy older adults. Further, while there are some similarities between the two groups in terms of those measures related to falls risk, there were also several differences which highlight that persons with PD can have different risk factors for falling compared to healthy adults of similar age.

Leiomyoma of digit of hand: Report of three cases with literature review.

Leiomyoma is a benign tumor of smooth muscle origin most common in areas of the body with abundant smooth muscle including the gynecologic, genitourinary, and gastrointestinal system. Leiomyoma outside of these locations is believed to arise from vascular smooth muscle and arrector pili muscles. Leiomyoma of an extremity is a rare diagnosis, especially when present in a digit of the hand due to the paucity of smooth muscle in this location. We report three cases of leiomyoma of a digit of the hand.

Tolerance to high temperature by arboreal mammals using nest boxes in southern Australia.

Nest boxes are used to manage populations of tree-cavity dependent birds and mammals. Concerns have been raised that due to their poor insulative properties nest boxes may cause heat stress and occasionally death during summers of extreme maximum temperatures. Our study investigated whether this nest box heat stress hypothesis applies to two small cavity-dependent mammals (brush-tailed phascogales and sugar gliders). Focusing on days when ambient temperature reached ≥40 °C, we recorded: i) temperatures within occupied nest boxes, ii) temperatures within nearby unoccupied tree cavities, iii) the duration of temperatures of ≥40 °C within nest boxes, iv) whether direct mortality was observed, and v) the relative abundance of these species in nest boxes before and after a very hot summer. When ambient temperature reached ≥40 °C, nest boxes were equivalent to ambient or 1-2 °C cooler, whereas tree cavities were 3-7 °C cooler than ambient. Exposure in nest boxes to temperatures of ≥40 °C lasted an average of 2-8 h. We observed no mortality over 65 records of phascogales and 31 records of gliders in nest boxes on days when ambient reached ≥40 °C. No decline in abundance was recorded after a summer with 11 days of temperatures ≥40 °C, with each species subsequently occupying >40 nest boxes. Our observations suggest these species are tolerant of the high temperatures that occurred. Nonetheless, provision of nest boxes designed to minimise summer heating is recommended.

Maintenance of clinical remission in early axial spondyloarthritis following certolizumab pegol dose reduction.

BACKGROUND: The best strategy for maintaining clinical remission in patients with axial spondyloarthritis (axSpA) has not been defined. C-OPTIMISE compared dose continuation, reduction and withdrawal of the tumour necrosis factor inhibitor certolizumab pegol (CZP) following achievement of sustained remission in patients with early axSpA. METHODS: C-OPTIMISE was a two-part, multicentre phase 3b study in adults with early active axSpA (radiographic or non-radiographic). During the 48-week open-label induction period, patients received CZP 200 mg every 2 weeks (Q2W). At Week 48, patients in sustained remission (Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3 at Weeks 32/36 and 48) were randomised to double-blind CZP 200 mg Q2W (full maintenance dose), CZP 200 mg every 4 weeks (Q4W; reduced maintenance dose) or placebo (withdrawal) for a further 48 weeks. The primary endpoint was remaining flare-free (flare: ASDAS ≥2.1 at two consecutive visits or ASDAS >3.5 at any time point) during the double-blind period. RESULTS: At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo. During Weeks 48 to 96, 83.7% (87/104), 79.0% (83/105) and 20.2% (21/104) of patients receiving the full maintenance dose, reduced maintenance dose or placebo, respectively, were flare-free (p<0.001 vs placebo in both CZP groups). Responses in radiographic and non-radiographic axSpA patients were comparable. CONCLUSIONS: Patients with early axSpA who achieve sustained remission at 48 weeks can reduce their CZP maintenance dose; however, treatment should not be completely discontinued due to the high risk of flare following CZP withdrawal. TRIAL REGISTRATION NUMBER: NCT02505542, ClinicalTrials.gov.

Trends in Emergency Department Visits for Contact Sports-Related Traumatic Brain Injuries Among Children - United States, 2001-2018.

During 2010-2016, there were an average of 283,000 U.S. emergency department (ED) visits each year among children for sports and recreation-related traumatic brain injuries (SRR-TBIs); approximately 45% of these SRR-TBIs were associated with contact sports (1). Although most children with an SRR-TBI are asymptomatic within 4 weeks, there is growing concern about potential long-term effects on a child's developing brain (2). This has led to calls to reduce the risk for traumatic brain injuries (TBIs) among child athletes, resulting in the introduction of state policies and the institution of safety rules (e.g., age and contact restrictions) for some sports programs. To assess changes in the incidence of ED-related SRR-TBI among children, CDC analyzed data from the National Electronic Injury Surveillance System-All Injury Program (NEISS-AIP) for the period 2001-2018. After more than a decade of increasing rates, the rate of contact sports-related TBI ED visits declined 32% from 2012 to 2018. This reduction was primarily the result of a decline in football-related SRR-TBI ED visits during 2013-2018. Decreased participation in tackle football (3) and implementation of contact limitations (4) were likely contributing factors to this decline. Public health professionals should continue to expand efforts to address SRR-TBIs in football, which is the sport with the highest incidence of TBI, and identify effective prevention strategies for all sports to reduce TBIs among children.

Impact of a nutrition education programme on preschool children's willingness to consume fruits and vegetables.

OBJECTIVE: To evaluate the impact of a preschool-based nutrition education programme consisting of twelve 'hands on' nutrition education lessons delivered during the school year on young children's willingness to consume fruits and vegetables. DESIGN: Quasi-experimental, pre-post design including the collection of plate waste evaluation data at the start and end of the 2015-2016 school year within two groups: (1) randomly selected classrooms receiving the intervention and (2) within conveniently sampled preschool classrooms not receiving the intervention serving as a comparison group. SETTING: Centre-based preschool programmes serving low-income families in the Denver metro area. PARTICIPANTS: Three- to five-year-old children in preschool classrooms participating in the intervention during the 2015-2016 school year (n 308) and children enrolled in comparison classrooms (n 215). RESULTS: Repeated-measures logit models assessed whether increases in the odds of consuming small samples of fruits and vegetables between Time 1 (pre-intervention) and Time 2 (post-intervention) were different for children within the intervention group compared with the comparison group. Analyses showed that the change over time in consumption of the three vegetable samples varied by intervention status with greater change occurring among children within the intervention group (edamame: P = 0·001; cauliflower: P ≤ 0·0001 and red pepper: P ≤ 0·0001). Unlike vegetables, the change over time in consumption of the two fruit samples was not different between children within the intervention and comparison groups. CONCLUSIONS: An experiential-learning nutrition education programme can positively influence eating behaviours of low-income preschoolers in a centre-based setting by increasing willingness to consume vegetables.

State-Level Numbers and Rates of Traumatic Brain Injury-Related Emergency Department Visits, Hospitalizations, and Deaths by Sex, 2014.

OBJECTIVE: To provide state-level traumatic brain injury (TBI)-related emergency department (ED) visit, hospitalization, and death estimates by sex for 2014. SETTING AND PARTICIPANTS: Centers for Disease Control and Prevention's Core Violence and Injury Prevention Program and State Injury Indicators-participating states. DESIGN: Cross-sectional. MAIN MEASURES: Number and rate of TBI-related ED visits, hospitalizations, and deaths (indicators) by sex in over 25 states. RESULTS: Across all states that supplied data, males had higher rates of TBI-related ED visits, hospitalizations, and deaths than females. However, for some indicators, high rates for both sexes and low rates for both sexes appeared clustered in a specific region of the United States. There was also within-state variability in TBI rates by indicator and sex. For example, within-state variability between sexes ranged from as low as 2.8% for ED visits and as high as 335% for deaths. CONCLUSION: TBI-related ED visits, hospitalizations, and deaths varied by state and by sex, and evidence was found for within-state variability in TBI rates by indicator and sex in 2014. Differences in TBI indicators by sex may have important implications for public health professionals implementing TBI prevention and care strategies at the state level.

State-Level Numbers and Rates of Traumatic Brain Injury-Related Emergency Department Visits, Hospitalizations, and Deaths in 2014.

OBJECTIVE: To provide state-level traumatic brain injury (TBI)-related emergency department (ED) visit, hospitalization, and death estimates for 2014. SETTING AND PARTICIPANTS: The Centers for Disease Control and Prevention's Core Violence and Injury Prevention Program and State Injury Indicators participating states. DESIGN: Cross-sectional. MAIN MEASURES: Number and incidence rates of TBI-related ED visits, hospitalizations, and deaths in more than 30 states. RESULTS: The rates of TBI-related ED visits in 2014 ranged from 381.1 per 100 000 (South Dakota) to 998.4 per 100 000 (Massachusetts). In 2014, Pennsylvania had the highest TBI-related hospitalization rate (98.9) and Ohio had the lowest (55.1). In 2014, the TBI-related death rate ranged from 9.1 per 100 000 (New Jersey) to 23.0 per 100 000 (Oklahoma). CONCLUSION: The variations in TBI burden among states support the need for tailoring prevention efforts to state needs. Results of this analysis can serve as a baseline for these efforts.