First Real-World Experience With Bigfoot Unity: A 6-Month Retrospective Analysis.

The Bigfoot Unity Diabetes Management System, a smart pen cap system cleared by the U.S. Food and Drug Administration in May 2021, incorporates continuous glucose monitoring data, real-time glycemic alerts, and clinician-directed dose recommendations. This study analyzed real-world clinical outcomes data for an initial cohort (n = 58, from 13 clinics) managing multiple daily injection insulin therapy using the pen cap system for 6 months. We examined glycemic control, including hypoglycemia events and interaction with and use of the pen cap system. In a cohort mainly consisting of adults with type 2 diabetes and an average age of 62 years, the results demonstrate close adherence to established glycemic targets, including a relatively short amount of time spent in the hypoglycemic range.

The associations of objective and perceived neighborhood disadvantage with stress among pregnant black women.

BACKGROUND: Neighborhood disadvantage may impact risk of preterm birth through stress. Few studies have examined how neighborhood disadvantage relates to stress during pregnancy, especially for Black women. METHODS: Secondary data analysis of 572 women in a prospective cohort in Detroit, MI and Columbus, OH. Participants completed questionnaires including the ROSS Neighborhood Disorder Scale, the crime subscale of the Perceived Neighborhood Scale (PNS), and the Perceived Stress Scale. An objective neighborhood disadvantage index (NDI) was created using principal components analysis after geocoding residential addresses and linking to Census data. RESULTS: All models used logistic regression. Adjusted for maternal age and annual household income, perceived stress was positively associated with perceived neighborhood disorder (p < .01). In a separate model, perceived neighborhood crime was positively associated with perceived neighborhood disorder (p = .005). In a joint model adjusted for age and income, the association of disorder with stress was similar in magnitude (p < .01) but the association between crime and stress weakened. The NDI was not associated with perceived stress before or after adjustment for confounders. CONCLUSIONS: Perceived neighborhood disadvantage may capture a different dimension than objective neighborhood disadvantage. Future studies should test stress as a pathway by which neighborhood environment increases risk of preterm birth.

Impaired NLRP3 inflammasome function in elderly mice during influenza infection is rescued by treatment with nigericin.

The NLRP3 inflammasome is activated in the lung during influenza viral infection; however, the impact of aging on inflammasome function during influenza infection has not been examined. In this study, we show that elderly mice infected with a mouse-adapted strain of influenza produced lower levels of IL-1ß during in vitro and in vivo infection. Dendritic cells from elderly mice exhibited decreased expression of ASC, NLRP3, and capase-1 but increased expression of pro-IL-1ß, pro-IL-18, and pro-IL-33 compared with dendritic cells from young infected mice. Treatment with nigericin during influenza infection augmented IL-1ß production, increased caspase-1 activity, and decreased morbidity and mortality in elderly mice. Our study demonstrates for the first time, to our knowledge, that during influenza viral infection, elderly mice have impaired NLRP3 inflammasome activity and that treatment with nigericin rescues NLRP3 activation in elderly hosts.

Residue dynamics of a contact and a systemic fungicide in pollen, nectar, and other plant matrices of courgette (Cucurbita pepo L.).

Pollen and nectar can be contaminated with a range of pesticides, including insecticides, fungicides, and herbicides. Since these matrices are important food sources for pollinators and other beneficial insects, their contamination can represent a key route of exposure. However, limited knowledge exists with respect to pesticide residue levels and their dynamics in these matrices for many crops and active ingredients (AIs). We used controlled glasshouse studies to investigate the residue dynamics of a systemic (cyprodinil) and a contact (fludioxonil) fungicide in the floral matrices and other plant parts of courgette/zucchini (Cucurbita pepo L.). We aimed to better understand the processes behind residue accumulation and decline in pollen and nectar. Each AI was applied to plants, either by spraying whole plants or by targeted spraying onto leaves only. Samples of pollen, nectar, anthers, flowers, and leaves were taken on the day of application and each subsequent morning for up to 13 days and analysed for residues using LC-MS/MS. Significant differences in residue levels and dynamics were found between AIs and floral matrices. The present study allowed for the identification of potential routes by which residues translocate between tissues and to link those to the physicochemical properties of each AI, which may facilitate the prediction of residue levels in pollen and nectar. Residues of the contact AI declined more quickly than those of the systemic AI in pollen and nectar. Our results further suggest that the risk of oral exposure for pollinators may be considerably reduced by using contact AIs during the green bud stage of plants, but application of systemic compounds could still result in a low, but continuous long-term exposure for pollinators with limited decline.

The Association of Avoidance Coping with Gestational Weight Gain among Pregnant Black Women.

Gestational weight gain (GWG) outside recommended parameters can lead to pregnancy or birth complications. Avoidance coping may influence GWG. We examined the association of avoidance coping with GWG among a sample of 112 pregnant Black women in the Midwest. Participants completed avoidance coping questionnaires at three time points throughout pregnancy. Data were abstracted from medical records for BMI and GWG. Overall, 23.2% gained inadequate weight, 30.4% adequate weight, and 46.4% excess weight. Multinomial logistic regression models indicated associations between avoidance coping and GWG adjusted for covariates. Participants with higher avoidance coping scores at 22-29 weeks' gestation were more likely to experience excess weight gain (odds ratio [OR] = 1.19, 95% CI [1.02, 1.37]). Participants with higher avoidance coping scores at 30-36 weeks' gestation were less likely to experience excess weight gain, (OR = 0.82, 95% CI [0.72, 0.93]). The impact of higher avoidance coping on excess weight gain depends on the time period in pregnancy.

Fathers Matter: Black Fathers' Relationships with their Partners during Pregnancy and Postpartum.

PURPOSE: To describe the characteristics of participants in the Fathers Matter study for a better understanding of fathers of the baby who engage in pregnancy research involving primarily Black couples and their relationships with their partners. STUDY DESIGN AND METHODS: The Fathers Matter Study uses a prospective design, identifying father-mother dyads during pregnancy and following them until birth as part of the Biosocial Impacts on Black Births Study. Participants completed prenatal and postpartum questionnaires. RESULTS: Our analyses are based on 111 fathers. Nearly all ( n = 101, 91.1%) of fathers identified as Black and 51.4% ( n = 57) had a high school diploma, graduate equivalency diploma, or higher. About half ( n = 57, 51.4%) reported annual incomes of $10,000 or less. Most reported that relationships with the mother were very close both before ( n = 100, 89.9%) and during ( n = 85, 76.6%) pregnancy. However, substantial variability was found in relationship satisfaction, involvement in the pregnancy, financial support provided, and scales of conflict and support. CLINICAL IMPLICATIONS: We found homogeneity in sociodemographic and basic relationship measures. Complex measures of the father-mother relationships demonstrated considerable variability. Data from fathers may identify their contributions to successful birth outcomes. Understanding relationships between fathers and mothers could identify risk or protective characteristics to be addressed at the family or community levels.

Late-Stage Metastatic Melanoma Emerges through a Diversity of Evolutionary Pathways.

Understanding the evolutionary pathways to metastasis and resistance to immune-checkpoint inhibitors (ICI) in melanoma is critical for improving outcomes. Here, we present the most comprehensive intrapatient metastatic melanoma dataset assembled to date as part of the Posthumous Evaluation of Advanced Cancer Environment (PEACE) research autopsy program, including 222 exome sequencing, 493 panel-sequenced, 161 RNA sequencing, and 22 single-cell whole-genome sequencing samples from 14 ICI-treated patients. We observed frequent whole-genome doubling and widespread loss of heterozygosity, often involving antigen-presentation machinery. We found KIT extrachromosomal DNA may have contributed to the lack of response to KIT inhibitors of a KIT-driven melanoma. At the lesion-level, MYC amplifications were enriched in ICI nonresponders. Single-cell sequencing revealed polyclonal seeding of metastases originating from clones with different ploidy in one patient. Finally, we observed that brain metastases that diverged early in molecular evolution emerge late in disease. Overall, our study illustrates the diverse evolutionary landscape of advanced melanoma. SIGNIFICANCE: Despite treatment advances, melanoma remains a deadly disease at stage IV. Through research autopsy and dense sampling of metastases combined with extensive multiomic profiling, our study elucidates the many mechanisms that melanomas use to evade treatment and the immune system, whether through mutations, widespread copy-number alterations, or extrachromosomal DNA. See related commentary by Shain, p. 1294. This article is highlighted in the In This Issue feature, p. 1275.

Is there a risk to honeybees from use of thiamethoxam as a sugar beet seed treatment?

The ban imposed by the European Union on the use of neonicotinoids as sugar beet seed treatments was based on the exposure of bees to residues of neonicotinoids in pollen and nectar of succeeding crops. To address this concern, residues of thiamethoxam (TMX) and clothianidin (CTD) were analyzed in soil collected from fields planted in at least the previous year with thiamethoxam-treated sugar beet seed. This soil monitoring program was conducted at 94 sites across Germany in two separate years. In addition, a succeeding crop study assessed residues in soil, guttation fluid, pollen, and nectar sampled from untreated succeeding crops planted in the season after thiamethoxam seed-treated sugar beet at eight field sites across five countries. The overall mean residues observed in soil monitoring were 8.0 ± 0.5 µg TMX + CTD/kg in the season after the use of treated sugar beet seed. Residue values decreased with increasing time interval between the latest thiamethoxam or clothianidin application before sugar beet drilling and with lower application frequency. Residues were detected in guttation fluid (2.0-37.7 µg TMX/L); however, the risk to pollinators from this route of exposure is likely to be low, based on the reported levels of consumption. Residues of thiamethoxam and clothianidin in pollen and nectar sampled from the succeeding crops were detected at or below the limit of quantification (0.5-1 µg a.i./kg) in 86.7% of pollen and 98.6% of nectar samples and, unlike guttation fluid residues, were not correlated with measured soil residues. Residues in pollen and nectar are lower than reported sublethal adverse effect concentrations in studies with honeybee and bumble bee individuals and colonies fed only thiamethoxam-treated sucrose, and are lower than those reported to result in no effects in honeybees, bumble bees, and solitary bees foraging on seed-treated crops. Integr Environ Assess Manag 2022;18:709-721. © 2021 SYNGENTA. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

The Prediction of Survival after Surgical Management of Bone Metastases of the Extremities-A Comparison of Prognostic Models.

Individualized survival prognostic models for symptomatic patients with appendicular metastatic bone disease are key to guiding clinical decision-making for the orthopedic surgeon. Several prognostic models have been developed in recent years; however, most orthopedic surgeons have not incorporated these models into routine practice. This is possibly due to uncertainty concerning their accuracy and the lack of comparison publications and recommendations. Our aim was to conduct a review and quality assessment of these models. A computerized literature search in MEDLINE, EMBASE and PubMed up to February 2022 was done, using keywords: "Bone metastasis", "survival", "extremity" and "prognosis". We evaluated each model's performance, assessing the estimated discriminative power and calibration accuracy for the analyzed patients. We included 11 studies out of the 1779 citations initially retrieved. The 11 studies included seven different models for estimating survival. Among externally validated survival prediction scores, PATHFx 3.0, 2013-SPRING and potentially Optimodel were found to be the best models in terms of performance. Currently, it is still a challenge to recommend any of the models as the standard for predicting survival for these patients. However, some models show better performance status and other quality characteristics. We recommend future, large, multicenter, prospective studies to compare between PATHfx 3.0, SPRING 2013 and OptiModel using the same external validation dataset.

Tetraplegia is associated with increased hypoxic ventilatory response during nonrapid eye movement sleep.

People with cervical spinal cord injury (SCI) are likely to experience chronic intermittent hypoxia while sleeping. The physiological effects of intermittent hypoxia on the respiratory system during spontaneous sleep in individuals with chronic cervical SCI are unknown. We hypothesized that individuals with cervical SCI would demonstrate higher short- and long-term ventilatory responses to acute intermittent hypoxia (AIH) exposure than individuals with thoracic SCI during sleep. Twenty participants (10 with cervical SCI [9 male] and 10 with thoracic SCI [6 male]) underwent an AIH and sham protocol during sleep. During the AIH protocol, each participant experienced 15 episodes of isocapnic hypoxia using mixed gases of 100% nitrogen (N2 ) and 40% carbon dioxide (CO2 ) to achieve an oxygen saturation of less than 90%. This was followed by two breaths of 100% oxygen (O2 ). Measurements were collected before, during, and 40 min after the AIH protocol to obtain ventilatory data. During the sham protocol, participants breathed room air for the same amount of time that elapsed during the AIH protocol and at approximately the same time of night. Hypoxic ventilatory response (HVR) during the AIH protocol was significantly higher in participants with cervical SCI than those with thoracic SCI. There was no significant difference in minute ventilation (V.E. ), tidal volume (V.T. ), or respiratory frequency (f) during the recovery period after AIH in cervical SCI compared to thoracic SCI groups. Individuals with cervical SCI demonstrated a significant short-term increase in HVR compared to thoracic SCI. However, there was no evidence of ventilatory long-term facilitation following AIH in either group.

Successful Recruitment Strategies for Engaging Pregnant African American Women in Research.

Participation by people of color in research studies is important for generalizability and to mitigate health disparities. Barriers to recruitment are well documented, but less well known is how to succeed. This paper describes successful strategies for recruitment and retention of pregnant Black women for a multisite study of preterm birth. Recruiters provided input on strategies. Participant level strategies include: commitment to being respectful, friendly, and reliable; addressing concerns regarding confidentiality; acknowledging competing priorities; and when possible, matching recruiters by gender and race. Clinical level strategies include: the formation of a good working relationship with the clinical staff; prioritizing clinical care above research activities; and obtaining access to the electronic medical record systems. Protocol level strategies include: a wide enrollment window; coordinating biospecimen collection with the clinical laboratory tests; collecting survey data on an electronic tablet; text messaging; and providing compensation for the time needed to complete study activities.

Loneliness and Depressive Symptoms among Pregnant Black Women during the COVID-19 Pandemic.

We explored the associations among perceived stress, depressive symptoms, loneliness, and social support during the COVID-19 pandemic; and differences in perceived stress, depressive symptoms, and social support prior to the pandemic and during the pandemic among pregnant Black women. A sample of 33 pregnant Black women who participated in the Biosocial Impact on Black Births (BIBB) and were still pregnant in May-June 2020 were invited to complete an online survey about their experiences during the pandemic. Fifteen women responded very much or somewhat to experiencing stress and anxiety because of the COVID-19 pandemic. Eight women had CES-D scores ≥23, which have been correlated with depression diagnosis. Women who reported higher levels of loneliness during the COVID-19 pandemic also reported higher levels of perceived stress and depressive symptoms and lower levels of social support during the pandemic. Women who reported lower levels of social support during the pandemic also reported higher levels of perceived stress and depressive symptoms during the pandemic. There were no changes in perceived stress, depressive symptoms, or social support prior to the pandemic and during the pandemic. Clinicians should assess for signs of loneliness and depressive symptoms for pregnant women and offer recommendations for therapy and support groups.

Does selectively endorsing different approaches to treating mental illness affect lay beliefs about the cause and course of mental illness?

The current paper reports three experimental studies that investigate how selectively emphasising different treatment approaches (biological, psychological or social) for mental health difficulties affects lay beliefs about those illnesses. Online experimental vignettes exposed participants to different treatment narratives for a clinical case of Major Depressive Disorder (Study 1; n=164), Generalized Anxiety Disorder (Study 2; n=173) and Schizophrenia (Study 3, n=170). Measures of causal attributions and illness perceptions assessed effects on beliefs about the causes and course of the illness. Emphasising psychological treatment of Major Depressive Disorder promoted more causal attributions to personal weakness, while endorsing biological treatment weakened confidence in individual control over the course of the illness. For Generalized Anxiety Disorder, stressing social treatment encouraged more causal attributions to personal weakness and lifestyle factors. Causal attributions for Schizophrenia did not shift according to treatment modality, but highlighting biological treatment made the symptoms appear more treatable, while emphasising psychological treatment made the illness seem more personally controllable. As lay understandings of the causes and course of mental illness have implications for help-seeking, treatment engagement and stigma, effects on illness beliefs may be an important consideration when endorsing a particular treatment approach in public discourse or clinical communication.

Mirtazapine reduces susceptibility to hypocapnic central sleep apnea in males with sleep-disordered breathing: a pilot study.

Studies in humans and animal models with spinal cord injury (SCI) have demonstrated that medications targeting serotonin receptors may decrease the susceptibility to central sleep-disordered breathing (SDB). We hypothesized that mirtazapine would decrease the propensity to develop hypocapnic central sleep apnea (CSA) during sleep. We performed a single-blind pilot study on a total of 10 men with SDB (7 with chronic SCI and 3 noninjured) aged 52.0 ± 11.2 yr. Participants were randomly assigned to either mirtazapine (15 mg at bedtime) or a placebo for at least 1 wk, followed by a 7-day washout period before crossing over to the other intervention. Split-night studies included polysomnography and induction of hypocapnic CSA using a noninvasive ventilation (NIV) protocol. The primary outcome was CO2 reserve, defined as the difference between eupneic and end of NIV end-tidal CO2 ([Formula: see text]) preceding induced hypocapneic CSA. Secondary outcomes included controller gain (CG), other ventilatory parameters, and SDB severity. CG was defined as the ratio of change in minute ventilation (V̇e) between control and hypopnea to the change in CO2 during sleep. CO2 reserve was significantly widened on mirtazapine than placebo (-3.8 ± 1.2 vs. -2.0 ± 1.5 mmHg; P = 0.015). CG was significantly decreased on mirtazapine compared with placebo [2.2 ± 0.7 vs. 3.5 ± 1.9 L/(mmHg × min); P = 0.023]. There were no significant differences for other ventilatory parameters assessed or SDB severity between mirtazapine and placebo trials. These findings suggest that the administration of mirtazapine can decrease the susceptibility to central apnea by reducing chemosensitivity and increasing CO2 reserve; however, considering the lack of changes in apnea-hypopnea index (AHI), further research is required to understand the significance of this finding.NEW & NOTEWORTHY To our knowledge, this research study is novel as it is the first study in humans assessing the effect of mirtazapine on CO2 reserve and chemosensitivity in individuals with severe sleep-disordered breathing. This is also the first study to determine the potential therapeutic effects of mirtazapine on sleep parameters in individuals with a spinal cord injury.

A Quantitative Sensory Testing Approach to Pain in Autism Spectrum Disorders.

Sensory abnormalities in autism has been noted clinically, with pain insensitivity as a specified diagnostic criterion. However, there is limited research using psychophysically robust techniques. Thirteen adults with ASD and 13 matched controls completed an established quantitative sensory testing (QST) battery, supplemented with measures of pain tolerance and central modulation. The ASD group showed higher thresholds for light touch detection and mechanical pain. Notably, the ASD group had a greater range of extreme scores (the number of z-scores outside of the 95% CI > 2), dynamic mechanical allodynia and paradoxical heat sensation; phenomena not typically seen in neurotypical individuals. These data support the need for research examining central mechanisms for pain in ASD and greater consideration of individual difference.

Buspirone decreases susceptibility to hypocapnic central sleep apnea in chronic SCI patients.

Spinal cord injury (SCI) is a risk factor for central sleep apnea (CSA). Previous studies in animal models with SCI have demonstrated a promising recovery in respiratory and phrenic nerve activity post-injury induced by the systemic and local administration of serotonin receptor agonists such as Buspirone and Trazodone. Human trials must be performed to determine whether individuals with SCI respond similarly. We hypothesized that Buspirone and Trazodone would decrease the propensity to hypocapnic CSA during sleep. We studied eight males with chronic SCI and sleep-disordered breathing (SDB) [age: 48.8 ± 14.2 yr; apnea-hypopnea index (AHI): 44.9 ± 23.1] in a single-blind crossover design. For 13 days, participants were randomly assigned either Buspirone (7.5-15 mg twice daily), Trazodone (100 mg), or a placebo followed by a 14-day washout period before crossing over to the other interventions. Study nights included polysomnography and induction of CSA using a noninvasive ventilation protocol. We assessed indexes of SDB, CO2 reserve, apneic threshold (AT), controller gain (CG), plant gain (PG), and ventilatory parameters. CO2 reserve was significantly widened on Buspirone (-3.6 ± 0.9 mmHg) compared with both Trazodone (-2.5 ± 1.0 mmHg, P = 0.009) and placebo (-1.8 ± 1.5 mmHg, P < 0.001) but not on Trazodone vs. placebo (P = 0.061). CG was significantly decreased on Buspirone compared with placebo (1.8 ± 0.4 vs. 4.0 ± 2.0 L/(mmHg·min), P = 0.025) but not on Trazodone compared with placebo (2.5 ± 1.1 vs. 4.0 ± 2.0 L/(mmHg·min); P = 0.065). There were no significant differences for PG, AT, or any SDB indexes (AHI, obstructive apnea index, central apnea index, oxygen desaturation index). The administration of Buspirone decreased the susceptibility to induced hypocapnic central apnea by reducing chemosensitivity and increasing CO2 reserve in chronic SCI patients.NEW & NOTEWORTHY This research study is novel as it is the first study in a humans that we are aware of that demonstrates the ability of Buspirone to increase CO2 reserve and hence decrease susceptibility to hypocapnic central apnea in patients with spinal cord injury.

Sleep-Disordered Breathing and Spinal Cord Injury: A State-of-the-Art Review.

Individuals living with spinal cord injury or disease (SCI/D) are at increased risk for sleep-disordered breathing (SDB), with a prevalence that is three- to fourfold higher than the general population. The main features of SDB, including intermittent hypoxemia and sleep fragmentation, have been linked to adverse cardiovascular outcomes including nocturnal hypertension in patients with SCI/D. The relationship between SDB and SCI/D may be multifactorial in nature given that level and completeness of injury can affect central control of respiration and upper airway collapsibility differently, promoting central and/or obstructive types of SDB. Despite the strong association between SDB and SCI/D, access to diagnosis and management remains limited. This review explores the role of SCI/D in the pathogenesis of SDB, poor sleep quality, the barriers in diagnosing and managing SDB in SCI/D, and the alternative approaches and future directions in the treatment of SDB, such as novel pharmacologic and nonpharmacologic treatments.

A review of the factors that influence pesticide residues in pollen and nectar: Future research requirements for optimising the estimation of pollinator exposure.

In recent years, the impact of Plant Protection Products (PPPs) on insect pollinator decline has stimulated significant amounts of research, as well as political and public interest. PPP residues have been found in various bee-related matrices, resulting in governmental bodies worldwide releasing guidance documents on methods for the assessment of the overall risk of PPPs to different bee species. An essential part of these risk assessments are PPP residues found in pollen and nectar, as they represent a key route of exposure. However, PPP residue values in these matrices exhibit large variations and are not available for many PPPs and crop species combinations, which results in inaccurate estimations and uncertainties in risk evaluation. Additionally, residue studies on pollen and nectar are expensive and practically challenging. An extrapolation between different cropping scenarios and PPPs is not yet justified, as the behaviour of PPPs in pollen and nectar is poorly understood. Therefore, this review aims to contribute to a better knowledge and understanding of the fate of PPP residues in pollen and nectar and to outline knowledge gaps and future research needs. The literature suggests that four primary factors, the crop type, the application method, the physicochemical properties of a compound and the environmental conditions have the greatest influence on PPP residues in pollen and nectar. However, these factors consist of many sub-factors and initial effects may be disguised by different sampling methodologies, impeding their exact characterisation. Moreover, knowledge about these factors is ambiguous and restricted to a few compounds and plant species. We propose that future research should concentrate on identifying relationships and common features amongst various PPP applications and crops, as well as an overall quantification of the described parameters; in order to enable a reliable estimation of PPP residues in pollen, nectar and other bee matrices.

Thiamethoxam: Long-term effects following honey bee colony-level exposure and implications for risk assessment.

Neonicotinoid insecticides have been used in a wide range of crops through seed treatment, soil and foliar applications and a large database exists on both their lethal and sub-lethal effects on honey bees under controlled laboratory conditions. However, colony-level studies on the effects of neonicotinoids in field studies are limited, primarily due to their complexity and the resources required. This paper reports the combined results of two large-scale colony-feeding studies, each with 6 weeks of continuous dosing of 12 colonies per treatment (24 control) to 12.5, 25, 37.5, 50 or 100 ng thiamethoxam/g sucrose solution. Exposure continued beyond dosing with residues present in stored nectar and bee-bread. The studies were conducted in an area with limited alternative forage and colonies were required to forage for pollen and additional nectar The studies provide colony-level endpoints: significant effects (reductions in bees, brood) were observed after exposure to the two highest dose rates, colony loss occurred at the highest dose rate, but colonies were able to recover (2-3 brood cycles after the end of dosing) after dosing with 50 ng thiamethoxam/g sucrose. No significant colony-level effects were observed at lower dose rates. The data reported here support the conclusions of previous colony-level crop-based field studies with thiamethoxam, in which residues in pollen and nectar were an order of magnitude below the colony-level NOEC of 37.5 ng thiamethoxam/g sucrose. The feeding study data are also compared to the outcomes of regulatory Tier 1 risk assessments conducted using guidance provided by the USA, Canada, Brazil and the EU regulatory authorities. We propose an adaptation of the European chronic adult bee risk assessment that takes into account the full dataset generated in laboratory studies while still providing an order of magnitude of safety compared with the colony feeding study NOEC.

Nocturnal swallowing and arousal threshold in individuals with chronic spinal cord injury.

Respiratory complications are potential causes of death in patients with spinal cord injury (SCI). Nocturnal swallowing could be related to transient arousals and could lead to fragmented sleep in SCI patients. However, the impact of nocturnal swallowing on breathing and sleep physiology in SCI is unknown. The objectives of this study were 1) to determine whether nocturnal swallowing is more common in SCI than in able-bodied (AB) subjects, 2) to determine the role of nocturnal swallowing on arousal threshold (ArTh) in SCI individuals with sleep-disordered breathing (SDB), and 3) to determine the effect of continuous positive airway pressure (CPAP) treatment on nocturnal swallowing. A total of 16 SCI and 13 AB subjects with SDB completed in-laboratory polysomnography with a pharyngeal catheter. A swallowing event (SW) was defined as a positive spike in pharyngeal pressure and was used to calculate the swallow index (SI) defined as a number of SW/total sleep time. Each SW was assessed for a relationship to the sleep stages and respiratory cycle phases, and associated arousals and ArTh were calculated. SI was higher in the SCI group compared with AB subjects during wake and different sleep stages ( P < 0.05). SWs were found to be significantly higher in the late expiratory phase in the group with SCI compared with the other respiratory phases and were eliminated by CPAP ( P < 0.05). ArTh for the subjects with SCI was significantly lower ( P < 0.05) compared with the AB subjects. Nocturnal swallowing is more common in SCI than in AB individuals who have SDB, particularly during the expiratory phase. The ArTh is significantly lower in SCI (indicating increased arousal propensity), which may contribute to the mechanism of sleep disturbances in SCI. NEW & NOTEWORTHY Nocturnal swallowing is common in patients with chronic spinal cord injury (SCI) and is associated with frequent arousals from sleep. The lower arousal threshold during sleep in SCI may contribute to the mechanism of sleep disturbances that are commonly found in cervical and high thoracic SCI. Continuous positive airway pressure may play a therapeutic role in alleviating nocturnal swallowing, which may contribute to reduced risk of aspiration.