Delta-8 tetrahydrocannabinol, delta-10 tetrahydrocannabinol, and tetrahydrocannabinol-O acetate exposures reported to America's Poison Centers.

INTRODUCTION: Since the passage of the Farm Bill in 2018, the availability of synthetic tetrahydrocannabinols has increased, including delta-8 tetrahydrocannabinol, delta-10 tetrahydrocannabinol, and tetrahydrocannabinol-O acetate. The objective of this study is to investigate the characteristics of delta-8 tetrahydrocannabinol, delta-10 tetrahydrocannabinol, and tetrahydrocannabinol-O acetate exposures reported to United States poison centers from 2021 to 2022. METHODS: National Poison Data System data were analyzed, including year, individual demographics, substance category and type, reason for exposure, highest level of health care received, and medical outcome. United States Census Bureau data were used to calculate population-based rates. RESULTS: There were 5,022 reported cases involving delta-8 tetrahydrocannabinol, delta-10 tetrahydrocannabinol, and tetrahydrocannabinol-O acetate as the primary substance reported to United States poison centers from 1 January 2021 to 31 December 2022. The rate of exposure per 100,000 United States population increased by 89.1 percent from 0.55 in 2021 to 1.04 in 2022. Children less than 6 years old accounted for 30.1 percent of cases, with a mode at age 2 years (representing 8.9 percent of cases). Most cases involved delta-8 tetrahydrocannabinol (98.1 percent), were single-substance exposures (94.3 percent), or occurred in a residence (95.9 percent). Ingestions accounted for 94.2 percent of cases, including 95.1 percent among children less than 6 years old. The leading reason for exposure was unintentional-general (40.2 percent), followed by abuse (33.1 percent). The most common related clinical effects were mild central nervous system depression (25.0 percent), tachycardia (23.0 percent), and agitation (15.6 percent). More than one-third (38.4 percent) of cases experienced a serious medical outcome, and 10.3 percent were admitted to a noncritical care unit and 5.3 percent to a critical care unit. DISCUSSION AND LIMITATIONS: The National Poison Data System is limited by its passive surveillance design. Delta-8 tetrahydrocannabinol, delta-10 tetrahydrocannabinol, and tetrahydrocannabinol-O acetate have toxic effects, and reports to United States poison centers increased from 2021 to 2022. Unintentional ingestions by young children are of particular concern. CONCLUSIONS: Opportunities exist to improve regulation, with accompanying enforcement, of these products and to educate the public about their potential toxicity.

Efficacy of a stannous fluoride dentifrice for relieving dentinal hypersensitivity in Chinese population: an 8-week randomized clinical trial.

OBJECTIVES: To compare the effectiveness of using a 0.454% stannous fluoride-containing dentifrice twice daily in relieving dentinal hypersensitivity (DH) in a Chinese population. MATERIALS AND METHODS: This was a single-centre, randomized, controlled, examiner-blind, three-treatment-arm, parallel-group study in participants with clinically diagnosed DH. Subjects who met inclusion criteria (n = 197) were randomly allocated into 3 groups: test group (n = 66)-using a 0.454% stannous fluoride-containing dentifrice twice daily; positive control group (n = 64)-using a 5.0% calcium sodium phosphosilicate-containing dentifrice twice daily; negative control group (n = 67)-using a 1150 ppm of NaF dentifrice twice daily. Status of DH was assessed at week 4 and week 8 by the same independent examiner. Changes from baseline in Schiff sensitivity score, tactile threshold and Dentine Hypersensitivity Experience Questionnaire (DHEQ) score were analysed using analysis of covariance models. The DHEQ evaluated subject-perceived oral health-related quality of life (OHRQoL). RESULTS: Statistically significant improvements in mean Schiff scores (p < 0.0001 for all products at Weeks 4 and 8), tactile threshold (p < 0.0001 for test and negative control at Weeks 4 and 8: Week 4 p = 0.0040 and Week 8 p < 0.0001 for positive control) and all DHEQ scores (p < 0.01 for all groups) were observed. No statistically significant differences were observed in the adjusted mean between all dentifrices at both timepoints, potentially driven by a placebo effect. Forty-two treatment-emergent adverse events (TEAEs) were reported (n = 32 subjects), with 2 serious AEs (n = 1) in the test group. TEAEs were not considered treatment-related. CONCLUSIONS: All groups demonstrated statistically significant improvements in Schiff score, tactile threshold and OHRQoL. However, due to a possible placebo effect in the negative control, there were no statistically significant differences between the dentifrices. CLINICAL RELEVANCE: This study adds to the growing research exploring why the placebo effect is a common phenomenon in DH studies. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04950465.

Glucagon-Like Peptide-1 Receptor Agonist Cases Reported to United States Poison Centers, 2017-2022.

INTRODUCTION: Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are a class of medications for management of diabetes and obesity. The objective of this study is to characterize the epidemiology of GLP-1RA cases reported to US poison centers. METHODS: We analyzed cases involving a GLP-1RA reported to the National Poison Data System during 2017-2022. RESULTS: There were 5,713 single-substance exposure cases reported to US poison centers involving a GLP-1RA. Most cases were among females (71.3%) and attributable to therapeutic errors (79.9%). More than one-fifth (22.4%) of cases were evaluated in a healthcare facility, including 0.9% admitted to a critical care unit and 4.1% admitted to a non-critical care unit. Serious medical outcomes were described in 6.2% of cases, including one fatality. The rate of cases per one million US population increased from 1.16 in 2017 to 3.49 in 2021, followed by a rapid increase of 80.9% to 6.32 in 2022. Trends for rates of serious medical outcomes and admissions to a healthcare facility showed similar patterns with 129.9% and 95.8% increases, respectively, from 2021 to 2022. CONCLUSIONS: Most GLP-1RA cases reported to US poison centers were associated with no or minimal effects and did not require referral for medical treatment; however, a notable minority of individuals experienced a serious medical outcome or healthcare facility admission. The rate of reported cases increased during the study period, including an 80.9% increase from 2021 to 2022. Opportunities exist to improve provider and patient awareness of the adverse effects of these medications.

Evaluation of the relationship of xylazine and fentanyl blood concentrations among fentanyl-associated fatalities.

INTRODUCTION: Illicit fentanyl and fentanyl-analogs have produced a devastating increase in opioid fatalities in the United States. Increasingly, xylazine has been found in the illicit fentanyl supply. The role of xylazine in fentanyl intoxication remains unclear. We reviewed coroner records to evaluate trends and effects associated with xylazine in fentanyl-related fatalities. METHODS: This is a retrospective cohort study of all deaths reported to the Franklin County Coroner's Office in Ohio from 1 January 2019 to 16 March 2023, in which fentanyl was determined causative or contributory to death. Cases identified as fentanyl-associated fatalities were separated into two groups based on whether or not xylazine was also detected. RESULTS: There were 3,052 fentanyl-related fatalities during the study period. 4.8 percent of these decedents also tested positive for xylazine. There was no meaningful demographic difference between fentanyl-related fatalities in which xylazine was detected versus those without xylazine detected. There was a mean of 726 fentanyl-associated fatalities per year, with a peak of 846 deaths in 2020 and a decline thereafter. The percentage of fentanyl-related fatalities with xylazine detected increased in linear fashion from 2.7 percent in 2019 to 6.6 percent in 2022. The median fentanyl concentration was 17.0 µg/L (inter-quartile range: 7.9, 27.0) in cases with xylazine detected and 10.0 µg/L (inter-quartile range: 5.6, 18.0) without xylazine. The odds of a fentanyl concentration greater than 40 µg/L in cases with xylazine detected was more than twice as great (odds ratio: 2.41; 95 percent confidence interval: 1.58-3.64) than that in cases without xylazine detected. CONCLUSIONS: Postmortem fentanyl concentrations were greater in cases with xylazine detected than those without xylazine detected. Though it is unclear why patients who were exposed to xylazine tolerated higher opioid doses prior to succumbing to death, we postulate that xylazine may act to competitively antagonize some degree of mu-opioid receptor binding by opioids.

Spectral analysis of non-contrast fluoroscopy for evaluation of pulmonary perfusion: Feasibility and sensitivity testing with a phantom.

BACKGROUND: Oscillating x-ray attenuation in the lungs provides an opportunity to evaluate pulmonary perfusion without contrast. Recent intensity-based methods have been compared to pulmonary scintigraphy and CT angiography but lack rigorous phantom studies. PURPOSE: A new method to quantify the periodic signal amplitude was employed using spectral analysis. Performance was characterized using a water phantom capable of creating an oscillating x-ray attenuation at physiologic amplitudes. Feasibility in detecting abnormal perfusion was performed on a volunteer with pulmonary vascular disease and compared to pulmonary angiography, the clinical gold standard. METHODS: For each fluoroscopic acquisition, the normalized temporal signal from each pixel was decomposed into its frequency components using Fourier transformation, and the spectral amplitude, defined as the x-ray pulsatility index (XPI), was determined at the desired frequency using a band-pass filter. XPI was displayed as a pixel-wise parametric colormap. Based on XPI maps generated using two human volunteers, a water bath phantom was constructed with a fluctuating fluid height and a 1 cm diameter pulsatility defect. Contrast-to-noise (CNR) of the defect was measured using fluoroscopy images acquired at variable fluid height fluctuation (0.1-1.9 mm) and oscillation frequency (30-60 bpm). Various sampling frame rates (3-30 fps) and acquisition durations (1.8-8 s) using truncated datasets were reconstructed from full datasets. Fluoroscopic images were obtained in a patient just prior to pulmonary angiography in the same projection. RESULTS: XPI maps in human subjects showed high signal to background contrast with high central XPI measuring up to 0.5. Phantom experiments revealed CNR was linearly correlated to fluid height change (r2  = 0.998). CNR is proportional to increasing sampling frame rate and increasing acquisition duration as expected with Fourier analysis. XPI map displayed multifocal perfusion defects in good agreement with pulmonary angiography. CONCLUSION: Spectral analysis is an accurate and sensitive method to detect small changes in periodic x-ray attenuation using a short fluoroscopic acquisition. This method demonstrated good agreement to pulmonary angiography and shows promise for clinical imaging of pulmonary perfusion using standard fluoroscopic methods.

Differences in Overuse Injuries in Gender-Comparable Sports: A Nationally Representative Sample of High School Athletes.

CONTEXT: Participation in high school sports has physical, physiological, and social development benefits, while increasing the risk of acute and overuse injuries. Risk of sports-related overuse injury differs between boys and girls. OBJECTIVE: To investigate differences in overuse injuries among United States high school athletes participating in the gender-comparable sports of soccer, basketball, and baseball/softball. DESIGN: Descriptive epidemiology study using a nationally representative sample from the High School Reporting Information Online (RIOTM) database. SETTING: High schools. PATIENTS OR OTHER PARTICIPANTS: Athletes with overuse injuries during the 2006-2007 through 2018-2019 academic years. MAIN OUTCOME MEASURES: National estimates and rates of overuse injuries were extrapolated from weighted observed numbers (with the independent variables: sport, gender, academic year, class year, event type, body site, diagnosis, recurrence, activity, and position). RESULTS: Among an estimated 908, 295 overuse injuries nationally, 43.9% (n=398,419) occurred in boys' soccer, basketball, and baseball, while 56.1% (n=509,876) occurred in girls' soccer, basketball, and softball. When comparing gender across sports, girls were more likely to sustain an overuse injury than boys (soccer: IRR: 1.37; 95% CI: 1.20-1.57; basketball: IRR: 1.82; 95% CI: 1.56-2.14; and baseball/softball: IRR: 1.21; 95% CI: 1.04-1.41). Most overuse injuries in soccer and basketball for both genders occurred to a lower extremity (soccer: 83.9% [175,369/209,071] for boys, 90.0% [243,879/271,092] for girls; basketball: 77.0% [59,239/76,884] for boys, 80.5% [81,826/101,709] for girls), while most overuse injuries in baseball and softball were to an upper extremity (72.5% [81,363/112,213] for boys, 53.7% [73,557/136,990] for girls). For boys' baseball, pitching (43.5% [47,007/107,984]) was the most common activity associated with an overuse injury, which differed from the most common activity of throwing (31.7% [39,921/126,104]) for girls' softball. CONCLUSIONS: Gender differences observed in this study can help guide future strategies that are more specific to gender and sport to reduce overuse injuries among high school athletes.

A comparison of licensed driver counts from the Federal Highway Administration and driver licensing agencies in 11 states.

Objective: Those who study motor vehicle crashes may rely on counts of licensed drivers to estimate crash, injury, or fatality rates. These counts may be obtained from the U.S. Department of Transportation Federal Highway Administration's (FHWA) annual Highway Statistics Series or directly from state driver licensing agencies. However, previous studies have questioned the accuracy of these counts provided by the FHWA.Methods: To investigate this issue, we compared counts of licensed drivers from the FHWA and state licensing agencies in 11 states, categorized by sex and age group, from 2013 through 2017. We then assessed the impact of any potential differences by fitting two sets of Poisson regression models to estimate age- and sex-based driver fatality rate ratios. One set of models used counts from the FHWA as the offset and the other used counts from state licensing agencies.Results: Our analysis found that the differences between FHWA and state counts varied markedly. Seven states had substantial differences for at least one age group that spanned the entire study period. In several cases, these differences in license counts were large enough to produce directly contradictory driver fatality rate ratio estimates when comparing age groups.Conclusions: These findings highlight the continued concern regarding the accuracy of licensed driver counts from the FHWA and extend previous studies by illustrating the impact of using FHWA counts on statistical inference. We recommend against using these data for traffic safety research or policy evaluation. Nevertheless, we acknowledge the need for a centralized, easily accessible database for licensed driver data.

Longitudinal trends in liquid laundry detergent packet exposures: 2014-2022.

BACKGROUND: Liquid laundry detergent packet exposures modestly declined in the mid-2010s among children less than 6 years of age due to public awareness and voluntary product safety standards. We aimed to assess longitudinal trends in the number and rate of liquid laundry detergent packet exposures in the United States by age. METHODS: Data from the National Poison Data System were analyzed to characterize liquid laundry detergent packet exposures between January 2014 and December 2022. RESULTS: From 2014-2022, there were 114,826 single and polysubstance exposures to liquid laundry detergent packets. Children less than 6 years of age (86.8 percent) were most commonly exposed. When evaluating multi-year trends, we found that the annual exposure rate per 1 million children less than 6 years old increased by 16.8 percent from 392.6 in 2018 to 458.7 in 2020. Subsequently, the annual exposure rate in children less than 6 years of age declined by 6.8 percent from 2020 to 2022 (427.4 exposures per 1 million). The annual rate of adolescent exposures increased by 85.4 percent from 2014 (4.1 exposures per 1 million) to 2017 (7.6 exposures per 1 million), with a subsequent increase of 155.3 percent from 2017 to 2018 (19.4 exposures per 1 million). Among adults, the annual exposure rate increased by 147.1 percent from 2014 (1.7 exposures per 1 million) to 2022 (4.2 exposures per 1 million). The number of more serious medical outcomes and hospital admissions among children less than 6 years of age declined by 44.3 percent and 68.6 percent, respectively, between 2014 and 2018. CONCLUSIONS: Despite declines in the number, rate, and severity of liquid laundry detergent packet exposures among children less than 6 years old, the exposure burden remains high. Additionally, exposures have increased among older children, adolescents, and adults. Renewed safety efforts are warranted to protect prior public health gains and further reduce exposures.

Child maltreatment among victims of violent death: an analysis of national violent death reporting system data, 2014-2018.

BACKGROUND: Limited information is known about the impact of childhood maltreatment on lifetime risk of violent death. This study aimed to compare manner of death, demographics, age at time of death, and the presence of a mental health or substance use disorder among decedents of violent deaths with a history of child maltreatment to those without. METHODS: This cross-sectional study compared characteristics of pediatric and adult violent deaths with and without a history of child maltreatment that were captured in the National Violent Death Reporting System from 2014 through 2018. RESULTS: Decedents who were male, multiracial, and had adulthood substance or mental health disorders were more likely to have a history of maltreatment. All-age decedents with a history of maltreatment were more likely to die by homicide. Adult decedents with a history of maltreatment were more likely to die by suicide. Maltreated decedents died significantly younger than non-maltreated decedents. CONCLUSIONS: Among victims of violent deaths, an identified history of child maltreatment was associated with increased risk of homicide across the lifespan, adult suicide, and earlier death. A history of child maltreatment was also associated with mental health and substance use disorders, which may reflect one of the pathways through which the child maltreatment-to-death association functions.

Loperamide cases reported to United States poison centers, 2010-2022.

BACKGROUND: Intentional use of high doses of loperamide has been linked to serious cardiac toxicity. The objective of this study is to investigate the characteristics and trends of loperamide cases reported to United States (US) poison centers and to evaluate the changes in reported loperamide cases following US Food and Drug Administration (FDA) warnings, labeling requirements, and packaging restrictions for loperamide starting in 2016, with an emphasis on intentional exposures. METHODS: Data from the National Poison Data System were analyzed. RESULTS: There were 12,987 cases reported to US poison centers from 2010 to 2022, for which, loperamide was the most likely substance responsible for observed clinical effects. Although 46.1% of these cases were associated with minor or no effect, 13.4% resulted in a serious medical outcome, including 59 deaths (0.5%). Eight percent (8.1%) of cases were admitted to a critical care unit and 5.0% were admitted to a non-critical care unit. Among cases with a serious medical outcome, most were associated with loperamide abuse (38.0%), intentional-misuse (15.7%), or suspected suicide (27.5%). The majority (60.0%; n = 33) of fatalities were related to abuse, followed by suspected suicide (20.0%; n = 11) and intentional-misuse (5.5%, n = 3). The rate of loperamide cases per 100,000 US population reported to US PCs decreased from 0.44 in 2010 to 0.36 in 2015 (p = 0.0290), followed by an increase to 0.46 in 2017 (p = 0.0013), and then a trend reversal with a decrease to 0.28 in 2022 (p < 0.0001). The rate of serious medical outcomes related to loperamide increased from 0.03 in 2010 to 0.05 in 2015 (p = 0.0109), which subsequently increased rapidly to 0.11 in 2017 (p < 0.0001), and then demonstrated a trend reversal and decreased to 0.04 in 2022 (p < 0.0001). CONCLUSIONS: FDA warnings, labeling requirements, and packaging restrictions may have contributed to the observed trend reversal and decrease in reports to US poison centers of loperamide cases related to intentional misuse, abuse, and suspected suicide. This demonstrates the potential positive effect that regulatory actions may have on public health. These findings contribute to the evidence supporting the application of similar prevention efforts to reduce poisoning from other medications associated with intentional misuse, abuse, and suicide.

Does the urinary microbiome profile change after treatment of bladder cancer?

INTRODUCTION: We sought to investigate the change in the urinary microbiome profile after transurethral resection of bladder tumor (TURBT). METHODS: Urine specimens were collected from consecutive patients with bladder cancer. Patients were divided into those with bladder tumors ("Tumor group": de novo tumors or recurrent/progressed after TURBT ± intravesical therapy) versus those without evidence of recurrence after treatment "No Recurrent Tumor group". Samples were analyzed using 16S rRNA sequencing. Alteration in the urinary microbiome was described in terms of alpha (diversity within a sample measured by Observed, Chao, Shannon, and Simpson indices), beta diversities (diversity among different samples measured by Brady Curtis Diversity index), and differential abundance of bacteria at the genus level. Analyses were adjusted for gender, method of preservation (frozen vs preservative), and method of collection (mid-stream vs. catheter). RESULTS: Sixty-eight samples were analyzed (42 in "Tumor" vs 26 in "No Recurrent Tumor" groups). The median age was 70 years (IQR 64-74) and 85% were males. All patients in the "No Recurrent Tumor" group had non-muscle invasive bladder cancer and 85% received BCG compared to 69% and 43% for the "Tumor" group, respectively. There was no significant difference in alpha diversity (p > 0.05). Beta diversity was significantly different (p = 0.04). Veillonella and Bifidobacterium were more abundant in the "Tumor" group (> 2FC, p = 0.0002), while Escherichia-Shigella (> 2FC, p = 0.0002) and Helococcus (> 2FC, p = 0.0008) were more abundant in the "No Recurrent Tumor" group. CONCLUSION: Bladder cancer patients with no recurrence and/or progression exhibited a different urinary microbiome profile compared to those with tumors.

Hydrocarbon ingestions among individuals younger than 20 years old reported to United States Poison Centers, 2000-2021.

BACKGROUND: Hydrocarbon-based products have many household and commercial uses and exposure to these substances is common. Severe clinical effects can occur if these products are ingested. This study investigated the characteristics and trends of hydrocarbon ingestions reported to United States Poison Centers. METHODS: Data from the National Poison Data System were analyzed for cases of hydrocarbon ingestion among individuals < 20 years old reported to United States Poison Centers from January 1, 2000 through December 31, 2021. RESULTS: There were 284,085 hydrocarbon ingestions reported during the 22-year study period in which a hydrocarbon was the first-ranked substance. Most of these cases occurred among children < 6 years old (83.2%), males (64.6%), at a residence (96.5%), were single-substance exposures (98.3%), and were managed on-site rather than in a health care facility (74.9%). However, 4.5% of cases were associated with a serious medical outcome, including 34 deaths. Thirty-two deaths were among children < 6 years old and most were associated with aspiration. Gasolines accounted for 24.6% of total cases, followed by lubricating oils and/or motor oils (19.9%), other types of hydrocarbons (14.9%), lamp oils (11.3%), and lighter fluids and/or naphtha (10.3%). The rate of hydrocarbon ingestions among United States youth < 20 years old decreased significantly (p < 0.0001) by 66.5% from 2000 to 2021. The greatest rate decrease was observed among lamp oils (- 78.4%, p < 0.0001), followed by gasolines (- 75.9%, p < 0.0001). CONCLUSIONS: Although the rate of hydrocarbon ingestions decreased during the study period and most reported cases resulted in non-serious outcomes, the number of cases remains high with a non-trivial minority (4.5%) of cases associated with a serious medical outcome, including death. Most deaths were among children < 6 years old. This underscores the need to increase primary prevention efforts, especially for young children.

Pediatric ADHD Medication Errors Reported to United States Poison Centers, 2000 to 2021.

OBJECTIVES: To investigate the characteristics and trends of out-of-hospital attention-deficit/hyperactivity disorder (ADHD) medication-related therapeutic errors among youth <20 years old reported to US poison centers. METHODS: National Poison Data System data from 2000 through 2021 were analyzed. Population-based rates were calculated using US census data. RESULTS: There were 124 383 ADHD medication-related therapeutic errors reported to US poison centers from 2000 through 2021, with the annual frequency increasing by 299.0% during that period. Two-thirds (66.6%) of the 87 691 first-ranked exposures involved children 6 to 12 years old, three-fourths (76.4%) were among males, and half (50.5%) involved amphetamines and related compounds. Most (79.7%) therapeutic errors were single-substance exposures. Although most (82.7%) individuals did not receive treatment in a health care facility (HCF), 2.3% were admitted to a HCF and 4.2% had a serious medical outcome. Children <6 years old were more likely to experience a serious medical outcome (odds ratio = 2.1; 95% confidence interval: 1.9-2.3) or be admitted to a HCF (odds ratio = 3.4; 95% confidence interval: 3.0-3.7) than 6 to 19-year-olds. The most common scenarios were "inadvertently taken or given medication twice" (53.9%), followed by "inadvertently taken or given someone else's medication" (13.4%), and "wrong medication taken or given" (12.9%). CONCLUSIONS: The frequency of cases reported to poison centers of pediatric out-of-hospital therapeutic errors related to ADHD medications increased by almost 300% during the 22-year study period and is likely attributable to increased prescribing of these medications. Because therapeutic errors are preventable, more attention should be given to patient and caregiver education and development of improved child-resistant medication dispensing and tracking systems.

Sponsor Perspectives on the Impact of the COVID-19 Pandemic on Interventional Cancer Clinical Trial Protocols and Data Quality.

PURPOSE: The onset of the COVID-19 pandemic created major disruptions in the conduct of cancer clinical trials. In response, regulators and sponsors allowed modifications to traditional trial processes to enable clinical research and care to continue. We systematically evaluated how these mitigation strategies affected data quality and overall trial conduct. METHODS: This study used surveys and live interviews. Forty-one major industry and National Cancer Institute Network groups (sponsors) overseeing anticancer treatment trials open in the United States from January 2015 to May 2022 were invited to participate. Descriptive statistics were used for survey data summaries. Key themes from interviews were identified. RESULTS: Twenty sponsors (48.8%; 15 industry and five Network groups) completed the survey; 11/20 (55.0%) participated in interviews. Sponsors predominantly (n = 12; 60.0%) reported large (≥11 trials) portfolios of phase II and/or phase III trials. The proportion of sponsors reporting a moderate (9) or substantial (8) increase in protocol deviations in the initial pandemic wave versus the pre-pandemic period was 89.5% (17/19); the proportion reporting a substantial increased dropped from 42.1% (n = 8/19) in the initial wave to 15.8% (n = 3/19) thereafter. The most commonly adopted mitigation strategies were remote distribution of oral anticancer therapies (70.0%), remote adverse event monitoring (65.0%), and remote consenting (65.0%). Most respondents (15/18; 83.3%) reported that the pandemic had minimal (n = 14) or no impact (n = 1) on overall data integrity. CONCLUSION: Despite nearly all sponsors observing a temporary increase in protocol deviations, most reported the pandemic had minimal/no impact on overall data integrity. The COVID-19 pandemic accelerated an emerging trend toward greater flexibility in trial conduct, with potential benefits of reduced burden on trial participants and sites and improved patient access to research.

Pediatric Dance-Related Injuries Treated in Emergency Departments in the United States, 2000-2020.

OBJECTIVE: This study investigated the characteristics and trends of children aged 3 to 19 years treated in US emergency departments for dance-related injuries. METHODS: Retrospective analysis of data from the National Electronic Injury Surveillance System from 2000 through 2020 was conducted. RESULTS: An estimated 489,119 children received emergency treatment for a dance-related injury, averaging 23,291 children annually, and the rate of injury increased 68.1% during the 21-year study period. Girls accounted for 80.3% and children aged 15 to 19 years accounted for 46.5% of cases. Sprains/strains were the most frequent diagnosis (44.4%), and lower extremities were the most commonly injured body region (56.4%). Compared with other body regions, patients aged 3 to 10 years were more likely to sustain head/neck injuries (odds ratio, 3.94, 95% confidence interval, 3.42-4.52) than 11- to 19-year-olds. Falls and noncontact mechanisms of injury accounted for 35.6% and 32.1% of injuries, respectively. Unstructured dance activity was associated with 30.8% of dance-related injuries overall and 67.0% among children aged 3 to 5 years. Ballet/pointe dancers frequently sustained lower extremity sprains/strains (39.2%). Compared with other dance types, break dancing was more commonly associated with injuries to an upper extremity than other body regions (odds ratio, 4.76, 95% confidence interval, 3.66-6.19). CONCLUSIONS: The rate of pediatric dance-related injuries treated in US emergency departments is increasing. Unstructured dance activity was an important source of dance-related injury, especially among children aged 3 to 5 years. The injury diagnosis and body region injured varied by child age and type of dance. Additional targeted prevention efforts should be implemented that address the injury characteristics of dancer subgroups.

Synthesis and crystal structure of bis-(2-phthal-imido-eth-yl)ammonium chloride dihydrate.

The title compound {systematic name: bis-[2-(1,3-dioxoisoindol-2-yl)eth-yl]aza-nium chloride dihydrate}, C20H18N3O4 +·Cl-·2H2O, is a phthalimide-protected polyamine that was synthesized by a previous method. It was characterized by ESI-MS, 1H NMR, and FT-IR. Crystals were grown from a solution of H2O and 0.1 M HCl. The central nitro-gen atom is protonated and forms hydrogen bonds with the chloride ion and a water mol-ecule. The two phthalimide units make a dihedral angle of 22.07 (3)°. The crystal packing features a hydrogen-bond network, two-coordinated chloride, and off-set π-π stacking.

An epidemiological study of unintentional pediatric firearm fatalities in the USA, 2009-2018.

BACKGROUND: Firearm injuries are the leading cause of mortality among children and adolescents 1-19 years old in the USA. Many prior studies on this topic lack detailed information about the circumstances of the firearm fatalities and include decedents and shooters of all ages. This study characterizes firearm fatalities in the USA in which children < 15 years old unintentionally killed themselves or another child. METHODS: Ten years of data from the National Violent Death Reporting System were analyzed. Unintentional firearm fatalities among children were reviewed to identify characteristics of decedents and the children who inflicted the deaths, their relationship, and circumstances of the deaths. There were 279 firearm fatalities during the study period involving children < 15 years old who unintentionally killed themselves or another child < 15 years old. RESULTS: Most victims were male (81.4%), and 40.9% were 2-4 years old. Most incidents (64.0%) occurred at the victim's residence, and in 80.9% of cases the firearm owner was a relative of the shooter. In the < 5-year age group, 80.3% of injuries were self-inflicted, and in the 10-14-year age group, 32.3% of shooters were a friend of the victim. CONCLUSION: This study highlights that children in the USA are shooting themselves and each other in their own homes, and often accessing firearms owned by family members. These findings can be used to guide prevention efforts, such as child access prevention laws, to reduce the number of pediatric firearm fatalities in the future.

Inhalant misuse reported to America's Poison Centers, 2001-2021.

CONTEXT/OBJECTIVE: This study investigated characteristics and trends of inhalant misuse reported to United States poison centers from 2001 through 2021. METHODS: Using data from the National Poison Data System and the United States Census Bureau, analyses were conducted of demographic and other characteristics, inhalant category, level of health care received, and medical outcome, and population-based rate trends were assessed. RESULTS: United States poison centers managed 26,446 inhalant misuse cases from 2001 through 2021, which equaled an annual average of 1,259 cases. Most inhalant misuse involved males (73.0%) or a single substance (91.0%). Teenagers accounted for 39.7% of cases. Among inhalant misuse cases, 41.4% were associated with a serious medical outcome and 27.7% were admitted to a healthcare facility. Overall, the rate of inhalant misuse per 1,000,000 United States population increased by 9.6% (P = 0.0031) from 5.33 in 2001 to 5.84 in 2010, followed by a decrease to 2.60 (-55.5%, P < 0.001) in 2021. "Freon and other propellants" showed the largest change in rate, increasing from 1.28 in 2001 to 3.55 in 2010 (P < 0.001), before decreasing to 1.36 in 2021 (P < 0.001). This trend was driven by the 13-19-year-old age group, and the trend reversal in 2010 among teenagers coinciding with an almost complete ban on FreonTM by the United States Environmental Protection Agency, which it implemented under the Clean Air Act. CONCLUSIONS: Although the annual rate of inhalant misuse reported to United States poison centers has been decreasing since 2010, it remains an important public health problem. The United States Environmental Protection Agency's 2010 regulation of FreonTM may have been an important contributor to the dramatic trend reversal and decrease in inhalant misuse rates starting in that year. This may exemplify the potential effect that regulatory efforts can have on public health.

Suspected suicides and suicide attempts involving antipsychotic or sedative-hypnotic medications reported to America's Poison Centers, 2000-2021.

OBJECTIVE: To investigate the patterns and trends of suspected suicides and suicide attempts involving antipsychotic or sedative-hypnotic medications reported to United States poison centers. METHODS: Data from the National Poison Data System for 2000 through 2021 were retrospectively analyzed. RESULTS: There were 972,975 suspected suicides and suicide attempts with antipsychotics or sedative-hypnotics ranked as the primary substance reported to poison centers from 2000-2021, averaging 44,226 cases annually. Most (85.6%) cases occurred among individuals >19 years old, females accounted for 63.5% of cases, and 51.8% were single-substance exposures. The rate of reported exposures per 100,000 United States population increased significantly from 27.2 in 2000 to 49.1 in 2008 (P < 0.0001), then plateaued to 49.6 in 2016 (P = 0.1497), followed by a significant decrease to 38.7 in 2021 (P < 0.0001). Individuals 13-19 years old demonstrated the greatest increase in rate from 28.4 in 2000 to 79.6 in 2021 (P < 0.0001). Approximately half (48.8%) of primary substance exposures were benzodiazepines, followed by antipsychotic medications (36.7%) and other types of sedative/hypnotic/anti-anxiety or antipsychotic medications (14.6%). Most primary substance exposures were admitted to a critical care or non-critical care unit (43.3%) or directly to a psychiatric facility (27.9%), and 36.1% were associated with in a serious medical outcome, including 1,330 deaths. Individuals >49 years old were more likely to experience a serious medical outcome (relative risk = 1.25, 95% CI: 1.24-1.26), including death (relative risk = 3.06, 95% CI: 2.74-3.41), or be admitted to a critical care or non-critical care unit (relative risk = 1.24, 95% CI: 1.23-1.24) than younger individuals. CONCLUSIONS: Suspected suicides and suicide attempts involving antipsychotic or sedative-hypnotic medications increased during the 22-year study period, especially among individuals 13-19 years old, and these cases often had severe clinical consequences. Based on the characteristics and trends identified in this study, increased prevention efforts are warranted to help prevent these suspected suicides and suicide attempts.