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Radiocarbon dating and Bayesian chronological modelling have provided precise new dating for the henge monument of Mount Pleasant in Dorset, excavated in 1970–1. A total of 59 radiocarbon dates are now available for the site and modelling of these has provided a revised sequence for the henge enclosure and its various constituent parts: the timber palisaded enclosure, the Conquer Barrow, and the ditch surrounding Site IV, a concentric timber and stone monument. This suggests that the henge was probably built in the 26th century cal bc, shortly followed by the timber palisade and Site IV ditch. These major construction events took place in the late Neolithic over a relatively short timespan, probably lasting 35–125 years. The principal results are discussed for each element of the site, including comparison with similar monument types elsewhere in Britain and Ireland, and wider implications for late Neolithic connections and later activity at the site associated with Beaker pottery are explored.
Understanding differences in social-emotional behavior can help identify atypical development. This study examined the differences in social-emotional development in children at increased risk of an autism spectrum disorder (ASD) diagnosis (infant siblings of children diagnosed with the disorder). Parents completed the Brief Infant-Toddler Social-Emotional Assessment (BITSEA) to determine its ability to flag children with later-diagnosed ASD in a high-risk (HR) sibling population. Parents of HR (n = 311) and low-risk (LR; no family history of ASD; n = 127) children completed the BITSEA when their children were 18 months old and all children underwent a diagnostic assessment for ASD at age 3 years. All six subscales of the BITSEA (Problems, Competence, ASD Problems, ASD Competence, Total ASD Score, and Red Flags) distinguished between those in the HR group who were diagnosed with ASD (n = 84) compared to non-ASD-diagnosed children (both HR-N and LR). One subscale (BITSEA Competence) differentiated between the HR children not diagnosed with ASD and the LR group. The results suggest that tracking early social-emotional development may have implications for all HR children, as they are at increased risk of ASD but also other developmental or mental health conditions.
The semi-slug, Parmarion martensi, is an intermediate host of the zoonotic nematode, Angiostrongylus cantonensis, the aetiological agent of neuroangiostrongyliasis or rat lungworm disease in humans. Rearing methods were developed for P. martensi to facilitate studies on nematode transmission and control. Parmarion martensi exhibited high survivorship when reared on a diet of dog food and fresh fruits and vegetables in temperature-controlled cabinets at 21.4°C, 98% relative humidity and 12:12 L:D cycle. Rearing containers were lined with moist paper towels for substrate and plastic pots were provided for hiding/resting and egg-laying. Under these conditions, time to first reproduction was 165.3 ± 12.3 days, fecundity was approximately 34.5 ± 7.8 eggs per adult, and hatch rate was 52.7 ± 3.2%. Survivorship post egg hatch was 86.2 ± 2.9% at 30 days (neonates had a mortality rate of about 14%) and 99% thereafter for up to a year. The demographics of laboratory-reared and wild-caught P. martensi were similar except for the weight of reproductive adults, which was significantly higher in laboratory-reared adults (4.0 ± 0.2 g) than in field-collected adults (1.5 ± 0.1 g).
Spinal muscular atrophy (SMA) is a devastating rare disease that affects individuals regardless of ethnicity, gender, and age. The first-approved disease-modifying therapy for SMA, nusinursen, was approved by Health Canada, as well as by American and European regulatory agencies following positive clinical trial outcomes. The trials were conducted in a narrow pediatric population defined by age, severity, and genotype. Broad approval of therapy necessitates close follow-up of potential rare adverse events and effectiveness in the larger real-world population.
The Canadian Neuromuscular Disease Registry (CNDR) undertook an iterative multi-stakeholder process to expand the existing SMA dataset to capture items relevant to patient outcomes in a post-marketing environment. The CNDR SMA expanded registry is a longitudinal, prospective, observational study of patients with SMA in Canada designed to evaluate the safety and effectiveness of novel therapies and provide practical information unattainable in trials.
The consensus expanded dataset includes items that address therapy effectiveness and safety and is collected in a multicenter, prospective, observational study, including SMA patients regardless of therapeutic status. The expanded dataset is aligned with global datasets to facilitate collaboration. Additionally, consensus dataset development aimed to standardize appropriate outcome measures across the network and broader Canadian community. Prospective outcome studies, data use, and analyses are independent of the funding partner.
Prospective outcome data collected will provide results on safety and effectiveness in a post-therapy approval era. These data are essential to inform improvements in care and access to therapy for all SMA patients.
OBJECTIVES/GOALS: Older patients with HL have worse outcomes than younger patients, which may reflect treatment selection, including fewer chemotherapy cycles. Immortal time bias exists when patients must survival to initiation, and even completion, of treatment. We described treatment length and death to evaluate the extent of immortal time bias. METHODS/STUDY POPULATION: This retrospective cohort study utilized SEER-Medicare data from 1999-2014. Patients diagnosed with incident advanced stage HL at age ≥65 years and enrolled in Medicare Part A and B fee for service were included. Chemotherapy or radiotherapy treatment initiated within 4 months of diagnosis was determined from inpatient, outpatient, and physician/supplier claims. No treatment was defined by lack of treatment claims. Dates from claims were used to define length of treatment; ≥4 months of treatment indicated complete chemotherapy cycles. Date of death was obtained from Medicare data. Analyses were limited to 1 year post-diagnosis. Summary statistics were used to describe treatment length and subsequent death. RESULTS/ANTICIPATED RESULTS: We included 1492 advanced stage HL patients with a mean age of 76 years (SD = 7). 428 (29%) patients had no documented treatment; 397 (27%) were treated <4 months indicating fewer chemotherapy cycles; and 667 (45%) were treated for ≥4 months indicating complete chemotherapy cycles. Among those with no documented treatment, 15% died within 1 month of diagnosis with 78% dying by 1 year post-diagnosis. Among those treated <4 months, 36% died within 1 month of their last treatment claim with 64% dying by 1 year post-diagnosis. Among those treated ≥4 months, 7% died within 1 month of their last treatment claim with 14% dying by 1 year post-diagnosis. DISCUSSION/SIGNIFICANCE OF IMPACT: Few untreated patients died within 1 month of diagnosis. One-third of patients treated <4 months died soon after completion of treatment, while patients treated longer survived longer, suggesting some patients did not survive to complete treatment. To account for this immortal time bias, landmark analysis will be used to assess the relationship between treatment and survival.
Person-centred care is recognized as best practice in dementia care. The purpose of this study was to evaluate the effectiveness of a stakeholder engagement practice change initiative aimed at increasing the provision of person-centred mealtimes in a residential care home (RCH). A single-group, time series design was used to assess the impact of the practice change initiative on mealtime environment across four time periods (pre-intervention, 1-month, 3-month, and 6-month follow-up). Statistically significant improvements were noted in all mealtime environment scales by 6 months, including the physical environment (z = -3.06, p = 0.013), social environment (z = -3.69, p = 0.001), relationship and person-centred scale (z = -3.51, p = 0.003), and overall environment scale (z = -3.60, p = 0.002). This practice change initiative, which focused on enhancing stakeholder engagement, provided a feasible method for increasing the practice of person-centred care during mealtimes in an RCH through the application of supportive leadership, collaborative decision making, and staff engagement.
This research communication addresses the hypothesis that Southeast dairy producers' self-reported bulk tank somatic cell count (BTSCC) was associated with producers' response to three statements (1) ‘a troublesome thing about mastitis is the worries it causes me,’ (2) ‘a troublesome thing about mastitis is that cows suffer,’ and (3) ‘my broad goals include taking good care of my cows and heifers.’ Surveys were mailed to producers in Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee, and Virginia (29% response rate, N = 596; final analysis N = 574), as part of a larger survey to assess Southeastern dairy producers' opinions related to BTSCC. Surveys contained 34 binomial (n = 9), Likert scale (n = 7), and descriptive (n = 18) statements targeted at producer self-assessment of herd records, management practices, and BTSCC. Statements 1 and 2 were assessed on a 5-point Likert scale from ‘strongly disagree’ to ‘strongly agree.’ Statement 3 was assessed on a 5-point Likert scale from ‘very unimportant’ to ‘very important.’ Reported mean BTSCC for all participants was 254 500 cells/ml. Separate univariable logistic regressions using generalized linear mixed models (SAS 9.4, Cary, NC, USA) with a random effect of farm, were performed to determine if BTSCC was associated with probability for a producer's response to statements. If BTSCC was significant, forward manual addition was performed until no additional variables were significant (P ≤ 0.05), but included BTSCC, regardless of significance. Bulk tank somatic cell count was associated with ‘a troublesome thing about mastitis is the worries it causes me,’ but not with Statements 2 or 3. This demonstrates that >75% of Southeastern dairy producers are concerned with animal care and cow suffering, regardless of BTSCC. Understanding Southeast producers' emphasis on cow care is necessary to create targeted management tools for herds with elevated BTSCC.
Women are more likely to be admitted to nursing home after stroke than men. Differences in patient characteristics and outcomes by sex after institutionalization are less understood. We examined sex differences in the characteristics and care needs of patients admitted to nursing home following stroke and their subsequent survival.
We identified patients with stroke newly admitted to nursing home between April 2011 and March 2016 in Ontario, Canada, with follow-up until March 2018 using linked administrative data. We calculated prevalence ratios and 95% confidence intervals (CIs) for the primary outcomes of dependence for activities of daily living, cognitive impairment, frailty, health instability, and symptoms of depression or pain, comparing women to men. The secondary outcome was all-cause mortality.
Among 4831 patients, 60.9% were women. Compared to men, women were older (median age [interquartile range, IQR]: 84 [78, 89] vs. 80 [71, 86]), more likely to be frail (prevalence ratio 1.14, 95% CI [1.08, 1.19]), have unstable health (1.45 [1.28, 1.66]), and experience symptoms of depression (1.25 [1.11, 1.40]) or pain (1.21 [1.13, 1.30]), and less likely to have aggressive behaviors (0.87 [0.80, 0.94]). Overall median survival was 2.9 years. In a propensity-score-matched cohort, women had lower mortality than men (hazard ratio 0.85, 95% CI [0.77, 0.94]), but in the age-stratified survival analysis, the survival advantage in women was limited to those aged 75 years and older.
Despite lower subsequent mortality, women admitted to nursing home after stroke required more care than men. Pain and depression are two treatable symptoms that disproportionately affect women.
The diet of most adults is low in fish and, therefore, provides limited quantities of the long-chain, omega-3 fatty acids (LCn-3FAs), eicosapentaenoic and docosahexaenoic acids (EPA, DHA). Since these compounds serve important roles in the brain, we sought to determine if healthy adults with low-LCn-3FA consumption would exhibit improvements in neuropsychological performance and parallel changes in brain morphology following repletion through fish oil supplementation.
In a randomized, controlled trial, 271 mid-life adults (30–54 years of age, 118 men, 153 women) consuming ⩽300 mg/day of LCn-3FAs received 18 weeks of supplementation with fish oil capsules (1400 mg/day of EPA and DHA) or matching placebo. All participants completed a neuropsychological test battery examining four cognitive domains: psychomotor speed, executive function, learning/episodic memory, and fluid intelligence. A subset of 122 underwent neuroimaging before and after supplementation to measure whole-brain and subcortical tissue volumes.
Capsule adherence was over 95%, participant blinding was verified, and red blood cell EPA and DHA levels increased as expected. Supplementation did not affect performance in any of the four cognitive domains. Exploratory analyses revealed that, compared to placebo, fish oil supplementation improved executive function in participants with low-baseline DHA levels. No changes were observed in any indicator of brain morphology.
In healthy mid-life adults reporting low-dietary intake, supplementation with LCn-3FAs in moderate dose for moderate duration did not affect neuropsychological performance or brain morphology. Whether salutary effects occur in individuals with particularly low-DHA exposure requires further study.
Nonhuman primate (NHP) studies are crucial to biomedical research. NHPs are the species most similar to humans in lifespan, body size, and hormonal profiles. Planning research requires statistical power evaluation, which is difficult to perform when lacking directly relevant preliminary data. This is especially true for NHP developmental programming studies, which are scarce. We review the sample sizes reported, challenges, areas needing further work, and goals of NHP maternal nutritional programming studies. The literature search included 27 keywords, for example, maternal obesity, intrauterine growth restriction, maternal high-fat diet, and maternal nutrient reduction. Only fetal and postnatal offspring studies involving tissue collection or imaging were included. Twenty-eight studies investigated maternal over-nutrition and 33 under-nutrition; 23 involved macaques and 38 baboons. Analysis by sex was performed in 19; minimum group size ranged from 1 to 8 (mean 4.7 ± 0.52, median 4, mode 3) and maximum group size from 3 to 16 (8.3 ± 0.93, 8, 8). Sexes were pooled in 42 studies; minimum group size ranged from 2 to 16 (mean 5.3 ± 0.35, median 6, mode 6) and maximum group size from 4 to 26 (10.2 ± 0.92, 8, 8). A typical study with sex-based analyses had group size minimum 4 and maximum 8 per sex. Among studies with sexes pooled, minimum group size averaged 6 and maximum 8. All studies reported some significant differences between groups. Therefore, studies with group sizes 3–8 can detect significance between groups. To address deficiencies in the literature, goals include increasing age range, more frequently considering sex as a biological variable, expanding topics, replicating studies, exploring intergenerational effects, and examining interventions.
For over 120 years, the shell middens of western Scotland and the series of open-air sites on Oronsay have been the focus of debate in European Mesolithic studies. This paper challenges the significance of Oronsay in light of results from the geophysical survey and test-excavation of a new limpet and periwinkle shell midden dated to the late 5th or start of the 4th millennium cal bc at Port Lobh, Colonsay that offers fresh evidence to re-evaluate critically the role of Oronsay and coastal resources in island settlement models ahead of the Mesolithic–Neolithic transition. Test excavations recovered a marine molluscan assemblage dominated by limpet and periwinkle shells together with crab, sea urchin, a fishbone assemblage composed mainly of Gadidae, some identifiable bird and mammal bone, carbonised macroplant remains, and pumice as well as a bipolar lithic assemblage and coarse stone implements. Novel seasonality studies of saithe otolith thin-sections suggest wintertime tidal fishing practices. At least two activity events may be discerned, dating from the late 5th millennium cal bc. The midden could represent a small number of rapidly deposited assemblages or maybe the result of stocastic events within a more extended timeframe. We argue that alternative research questions are needed to advance long-standing debates about seasonal inter-island mobility versus island sedentism that look beyond Oronsay to better understand later Mesolithic occupation patterns and the formation and date of Oronsay middens. We propose alternative methodological strategies to aid identification of contemporaneous sites using geophysical techniques and lithic technological signatures.
The 11th revision to the WHO International Classification of Diseases (ICD-11) identified complex post-traumatic stress disorder (CPTSD) as a new condition. There is a pressing need to identify effective CPTSD interventions.
We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) of psychological interventions for post-traumatic stress disorder (PTSD), where participants were likely to have clinically significant baseline levels of one or more CPTSD symptom clusters (affect dysregulation, negative self-concept and/or disturbed relationships). We searched MEDLINE, PsycINFO, EMBASE and PILOTS databases (January 2018), and examined study and outcome quality.
Fifty-one RCTs met inclusion criteria. Cognitive behavioural therapy (CBT), exposure alone (EA) and eye movement desensitisation and reprocessing (EMDR) were superior to usual care for PTSD symptoms, with effects ranging from g = −0.90 (CBT; k = 27, 95% CI −1.11 to −0.68; moderate quality) to g = −1.26 (EMDR; k = 4, 95% CI −2.01 to −0.51; low quality). CBT and EA each had moderate–large or large effects on negative self-concept, but only one trial of EMDR provided useable data. CBT, EA and EMDR each had moderate or moderate–large effects on disturbed relationships. Few RCTs reported affect dysregulation data. The benefits of all interventions were smaller when compared with non-specific interventions (e.g. befriending). Multivariate meta-regression suggested childhood-onset trauma was associated with a poorer outcome.
The development of effective interventions for CPTSD can build upon the success of PTSD interventions. Further research should assess the benefits of flexibility in intervention selection, sequencing and delivery, based on clinical need and patient preferences.
OBJECTIVES/SPECIFIC AIMS: The development of new anti-cancer agents for children requires an inherently longer timeline than in adults. The 3+3 study design for Phase 1 dose escalation trials is commonly used to estimate the maximum tolerated dose and assess safety. The Rolling 6 study design was developed to shorten the study conduct timeline. METHODS/STUDY POPULATION: This study compares twenty Phase 1 COG Pilot and Phase 1 Consortium trials that employed the Rolling 6 design with hypothetical results under the assumption that a 3+3 design had been executed. The number of evaluable patients required to complete the study, number of DLTs, number of inevaluable patients, overall study duration, time suspended to enrollment (i.e., waiting for DLT evaluation), and DLT risk are compared between study designs using Wilcoxon’s signed rank test. RESULTS/ANTICIPATED RESULTS: The Rolling 6 study design required less time to complete the studies compared with 3+3 design (median 273 vs. 297 days, P = 0.01). In general, the Rolling 6 study design required more patients, had more inevaluable patients, and there were more dose limiting toxicity (DLT) events. However, there was no significant difference in DLT risk (median 0.15 vs. 0.17, P = 0.72). DISCUSSION/SIGNIFICANCE OF IMPACT: The Rolling 6 study design effectively shortens the study conduct timeline compared with the traditional 3+3 design for Phase 1 COG Pilot and Phase 1 Consortium trials without increasing the risk of toxicity.
OBJECTIVES/SPECIFIC AIMS: (1) To define and describe a cohort of patients aged ≥65 years with incident HL from SEER-Medicare data. (2) To identify patient, disease, and system-level factors associated with initial treatment for HL. METHODS/STUDY POPULATION: This retrospective cohort study utilized SEER-Medicare data from 1999-2014. Patients with incident classical HL were identified using SEER registry histology groupings. The cohort was restricted to those with Medicare Part A and B fee-for-service for 3 months prior to and 1 year after diagnosis (or until date of death) in order to fully capture claims for outpatient chemotherapy. Patients were excluded for the following reasons: missing month of HL diagnosis; unknown diagnostic confirmation; reporting from autopsy or death certificate; or another cancer diagnosis +/− 2 years of the HL diagnosis. Demographic and disease characteristics were defined based on SEER registry data. Broad treatment categories were defined using SEER data, while detailed treatment categories will be defined based on Medicare claims. Length of follow-up was defined as the number of months until the earliest of the following: death; end of continuous Medicare Part A and B fee-for-service enrollment; or the end of the available data (12/31/2014). Demographic, disease, and preliminary treatment characteristics were described for the cohort. Future analyses will explore patient and disease factors, including comorbidities and an estimate of frailty, as well as system-level factors associated with initial treatment of HL. RESULTS/ANTICIPATED RESULTS: We identified 2909 patients meeting eligibility for the cohort. The median length of follow-up was 22 months (Q1=5, Q3=62). Median age was 75.9 years (Q1=70, Q3=81), 49.6% were female, and 82.6% were non-Hispanic/White. Only 11.5% of patients were in rural or non-urban areas. 13.8% of patients were dual eligible for both Medicare and Medicaid. Nodular sclerosis was the most common histology (35.2%), followed by mixed cellularity (21.1%); 36.5% had histology that was not otherwise specified. Patients were evenly distributed across Ann Arbor Stage (21.8% with I; 22.3% with II; 25.8% with III; 24.2% with IV; 6% unknown). B symptoms were present in 35.2% of patients, absent in 39.6%, and unknown in 25.2%. Neither tumor bulk nor international prognostic score were available via SEER registry data. According to SEER registry data, most patients received some treatment for their HL (81.9%) and 75% of those patients initiated treatment within one month of diagnosis. 72% of patients died with median time to death of 9 months (Q1=3, Q3=43). DISCUSSION/SIGNIFICANCE OF IMPACT: We successfully identified and described a cohort of 2909 older patients with incident HL from the SEER-Medicare data. This provides a unique opportunity to study this cohort in a large, representative dataset with nearly 15 years of follow up. Future analysis will help us to better understand treatment patterns of HL in older patients and factors associated with treatment. These results can then be used to help improve care decisions and clinical outcomes.
We built an app to help clients of food pantries. The app offers vegetable-based recipes, food tips and no-cost strategies for making mealtimes healthier and for bargain-conscious grocery shopping, among other themes. Users customize materials to meet their own preferences. The app, available in English and Spanish, has been tested in a randomized field trial.
A randomized controlled trial with repeated measures across 10 weeks.
Clients of fifteen community food pantry distributions in Los Angeles County, USA.
Distributions were randomized to control and experimental conditions, and 289 household cooks and one of their 9–14-year-old children were enrolled as participants. Experimental dyads were given a smartphone with our app and a phone use-plan, then trained to use the app. ‘Test vegetables’ were added to the foods that both control and experimental participants received at their pantries.
After 3–4 weeks of additional ‘test vegetables’, cooks at experimental pantries had made 38 % more preparations with these items than control cooks (P = 0·03). Ten weeks following baseline, experimental pantries also scored greater gains in using a wider assortment of vegetables than control pantries (P = 0·003). Use of the app increased between mid-experiment and final measurement (P = 0·0001).
The app appears to encourage household cooks to try new preparation methods and widen their incorporation of vegetables into family diets. Further research is needed to identify specific app features that contributed most to outcomes and to test ways in which to disseminate the app widely.
Individuals with a borderline personality disorder (BPD) suffer from a constellation of rapidly shifting emotional, interpersonal, and behavioral symptoms. The menstrual cycle may contribute to symptom instability among females with this disorder.
Fifteen healthy, unmedicated females with BPD and without dysmenorrhea reported daily symptoms across 35 days. Urine luteinizing hormone and salivary progesterone (P4) were used to confirm ovulation and cycle phase. Cyclical worsening of symptoms was evaluated using (1) phase contrasts in multilevel models and (2) the Carolina Premenstrual Assessment Scoring System (C-PASS), a protocol for evaluating clinically significant cycle effects on symptoms.
Most symptoms demonstrated midluteal worsening, a perimenstrual peak, and resolution of symptoms in the follicular or ovulatory phase. Post-hoc correlations with person-centered progesterone revealed negative correlations with most symptoms. Depressive symptoms showed an unexpected delayed pattern in which baseline levels of symptoms were observed in the ovulatory and midluteal phases, and exacerbations were observed during both the perimenstrual and follicular phases. The majority of participants met C-PASS criteria for clinically significant (⩾30%) symptom exacerbation. All participants met the emotional instability criterion of BPD, and no participant met DSM-5 criteria for premenstrual dysphoric disorder (PMDD).
Females with BPD may be at elevated risk for perimenstrual worsening of emotional symptoms. Longitudinal studies with fine-grained hormonal measurement as well as hormonal experiments are needed to determine the pathophysiology of perimenstrual exacerbation in BPD.
Underlying mechanisms responsible for the cholesterol-lowering effect of β-glucan have been proposed, yet have not been fully demonstrated. The primary aim of this study was to determine whether the consumption of barley β-glucan lowers cholesterol by affecting the cholesterol absorption, cholesterol synthesis or bile acid synthesis. In addition, this study was aimed to assess whether the underlying mechanisms are related to cholesterol 7α hydroxylase (CYP7A1) SNP rs3808607 as proposed by us earlier. In a controlled, randomised, cross-over study, participants with mild hypercholesterolaemia (n 30) were randomly assigned to receive breakfast containing 3 g high-molecular weight (HMW), 5 g low-molecular weight (LMW), 3 g LMW barley β-glucan or a control diet, each for 5 weeks. Cholesterol absorption was determined by assessing the enrichment of circulating 13C-cholesterol over 96 h following oral administration; fractional rate of synthesis for cholesterol was assessed by measuring the incorporation rate of 2H derived from deuterium oxide within the body water pool into the erythrocyte cholesterol pool over 24 h; bile acid synthesis was determined by measuring serum 7α-hydroxy-4-cholesten-3-one concentrations. Consumption of 3 g HMW β-glucan decreased total cholesterol (TC) levels (P=0·029), but did not affect cholesterol absorption (P=0·25) or cholesterol synthesis (P=0·14). Increased bile acid synthesis after consumption of 3 g HMW β-glucan was observed in all participants (P=0·049), and more pronounced in individuals carrying homozygous G of rs3808607 (P=0·033). In addition, a linear relationship between log (viscosity) of β-glucan and serum 7α-HC concentration was observed in homozygous G allele carriers. Results indicate that increased bile acid synthesis rather than inhibition of cholesterol absorption or synthesis may be responsible for the cholesterol-lowering effect of barley β-glucan. The pronounced TC reduction in G allele carriers of rs3808607 observed in the previous study may be due to enhanced bile acid synthesis in response to high-viscosity β-glucan consumption in those individuals.