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The COVID-19 pandemic changed the clinical research landscape in America. The most urgent challenge has been to rapidly review protocols submitted by investigators that were designed to learn more about or intervene in COVID-19. International Review Board (IRB) offices developed plans to rapidly review protocols related to the COVID-19 pandemic. An online survey was conducted with the IRB Directors at Clinical and Translational Science Awards (CTSA) institutions as well as two focus groups. Across the CTSA institutions, 66% reviewed COVID-19 protocols across all their IRB committees, 22% assigned protocols to just one committee, and 10% created a new committee for COVID-19 protocols. Fifty-two percent reported COVID-19 protocols were reviewed much faster, 41% somewhat faster, and 7% at the same speed as other protocols. Three percent reported that the COVID-19 protocols were reviewed with much better quality, 32% reported slightly better quality, and 65% reported the reviews were of the same quality as similar protocols before the COVID-19 pandemic. IRBs were able to respond to the emergent demand for reviewing COVID-19 protocols. Most of the increased review capacity was due to extra effort by IRB staff and members and not changes that will be easily implemented across all research going forward.
Precise instrumental calibration is of crucial importance to 21-cm cosmology experiments. The Murchison Widefield Array’s (MWA) Phase II compact configuration offers us opportunities for both redundant calibration and sky-based calibration algorithms; using the two in tandem is a potential approach to mitigate calibration errors caused by inaccurate sky models. The MWA Epoch of Reionization (EoR) experiment targets three patches of the sky (dubbed EoR0, EoR1, and EoR2) with deep observations. Previous work in Li et al. (2018) and (2019) studied the effect of tandem calibration on the EoR0 field and found that it yielded no significant improvement in the power spectrum (PS) over sky-based calibration alone. In this work, we apply similar techniques to the EoR1 field and find a distinct result: the improvements in the PS from tandem calibration are significant. To understand this result, we analyse both the calibration solutions themselves and the effects on the PS over three nights of EoR1 observations. We conclude that the presence of the bright radio galaxy Fornax A in EoR1 degrades the performance of sky-based calibration, which in turn enables redundant calibration to have a larger impact. These results suggest that redundant calibration can indeed mitigate some level of model incompleteness error.
Recent commercialization of auxin herbicide–based weed control systems has led to increased off-target exposure of susceptible cotton cultivars to auxin herbicides. Off-target deposition of dilute concentrations of auxin herbicides can occur on cotton at any stage of growth. Field experiments were conducted at two locations in Mississippi from 2014 to 2016 to assess the response of cotton at various growth stages after exposure to a sublethal 2,4-D concentration of 8.3 g ae ha−1. Herbicide applications occurred weekly from 0 to 14 weeks after emergence (WAE). Cotton exposure to 2,4-D at 2 to 9 WAE resulted in up to 64% visible injury, whereas 2,4-D exposure 5 to 6 WAE resulted in machine-harvested yield reductions of 18% to 21%. Cotton maturity was delayed after exposure 2 to 10 WAE, and height was increased from exposure 6 to 9 WAE due to decreased fruit set after exposure. Total hand-harvested yield was reduced from 2,4-D exposure 3, 5 to 8, and 13 WAE. Growth stage at time of exposure influenced the distribution of yield by node and position. Yield on lower and inner fruiting sites generally decreased from exposure, and yield partitioned to vegetative or aborted positions and upper fruiting sites increased. Reductions in gin turnout, micronaire, fiber length, fiber-length uniformity, and fiber elongation were observed after exposure at certain growth stages, but the overall effects on fiber properties were small. These results indicate that cotton is most sensitive to low concentrations of 2,4-D during late vegetative and squaring growth stages.
The use of pharmacogenomics (PGx) testing has the potential to accelerate response to psychopharmacologic therapy (Rx) and improve outcomes; accordingly PGx use to select appropriate Rx is increasing. One such commercially available test is the Genecept Assay (the Assay [Genomind]) which measures variants of 18 genes (12 pharmacodynamic and 6 CYP450) for which response, tolerability or exposure to various Rx has been reported. Recent interest in genetics has led patients (pts) to be stewards of their own genetic data. In 2017 we launched a Patient Gateway to allow pts to retrieve their genetic results, have access to mental health information, and record outcomes following use of the Assay.
To assess the effectiveness of Rx recommendations following use of the Assay, as reported on a purpose-built patient portal.
Pts receiving the Assay were invited to visit an online, interactive portal. Pts providing informed consent (IC) were asked to record their baseline overall health using a 4- point modified patient global index (m-PGI) of severity. Pts also recorded their conditions, medications, and supplements, and various symptoms. Pts were invited to visit the portal ad libitum and re-rate their overall health using the m-PGI. These data were then combined with the pts’ genetic results using custom scripts in Python (v 3.6.4) and R (v 3.5.1). All identifying data were removed. Pts included in this analysis responded (at least) twice to the health questionnaire. New medications were subsequently scored as concordant, discordant, or indeterminate with the Assay’s recommendations, using predetermined criteria. We report the initial results for this subgroup herein.
Since launch 9,401 unique patient profiles were created on the Gateway; 5,207 (55%) of these provided IC. Of these, 410 provided at least 2 m-PGI scores. Seventy-three (73) of these pts reported scores at least 4weeks apart and started 222 medications in the interim. 69.4% of pts identified as female; 70.8% had a diagnosis of generalized anxiety disorder, while 50.0% and 31.9% had diagnoses of major depressive disorder and post-traumatic stress disorder, respectively. 60.2% of pts reported improvement on the m-PGI of ≥1 unit; 20% had a ≥2-unit improvement. Pts reporting improvement were more likely (77% vs 66%); to have been placed on medication that were concordant with the assay than those who were not improved, although this difference did not reach statistical significance.
In this naturalistic, virtual trial of a PGx assay to guide pharmacotherapy in individuals with mental health illness, most users reported improvement in overall health. More pts whose medication was reported as concordant with the Assay reported improvement than those with discordant medications. Data collection is ongoing and updated data will be provided.
The introduction of auxin herbicide weed control systems has led to increased occurrence of crop injury in susceptible soybeans and cotton. Off-target exposure to sublethal concentrations of dicamba can occur at varying growth stages, which may affect crop response. Field experiments were conducted in Mississippi in 2014, 2015, and 2016 to characterize cotton response to a sublethal concentration of dicamba equivalent to 1/16X the labeled rate. Weekly applications of dicamba at 35 g ae ha−1 were made to separate sets of replicated plots immediately following planting until 14 wk after emergence (WAE). Exposure to dicamba from 1 to 9 WAE resulted in up to 32% visible injury, and exposure from 7 to 10 WAE delayed crop maturity. Exposure from 8 to 10 and 13 WAE led to increased cotton height, while an 18% reduction in machine-harvested yield resulted from exposure at 6 WAE. Cotton exposure at 3 to 9 WAE reduced the seed cotton weight partitioned to position 1 fruiting sites, while exposure at 3 to 6 WAE also reduced yield in position 2 fruiting sites. Exposure at 2, 3, and 5 to 7 WAE increased the percent of yield partitioned to vegetative branches. An increase in percent of yield partitioned to plants with aborted terminals occurred following exposure from 3 to 7 WAE and corresponded with reciprocal decreases in yield partitioned to positional fruiting sites. Minimal effects were observed on fiber quality, except for decreases in fiber length uniformity resulting from exposure at 9 and 10 WAE.
Social impact bonds are payment by results contracts that leverage private social investment to cover the up-front expenditure associated with welfare services. The introduction of private principles and actors through outcome-based commissioning has received a great deal of attention in social policy research. However, there has been much less attention given to the introduction of private capital and its relation to more established forms of quasi-marketisation. This paper examines what effect private social investment has on outcome-based commissioning and whether the alternative forms of performance measurement and management, that social impact bonds bring to bear on service operations, demonstrate the capacity to engender: innovation in service delivery; improved social outcomes; future cost savings; and additionality. This paper draws on an in-depth study of four social impact bonds in the UK context, as the welfare regime at the vanguard of this policy development. The findings suggest that the introduction of private capital in outcome-based commissioning has had a number of unique and unintended effects on service providers, operations and outcomes. The paper concludes by considering whether social impact bonds represent a risk or an opportunity for public service reform both in the UK and further afield.
The relative contribution of demographic, lifestyle and medication factors to the association between affective disorders and cardiometabolic diseases is poorly understood.
To assess the relationship between cardiometabolic disease and features of depresion and bipolar disorder within a large population sample.
Cross-sectional study of 145 991 UK Biobank participants: multivariate analyses of associations between features of depression or bipolar disorder and five cardiometabolic outcomes, adjusting for confounding factors.
There were significant associations between mood disorder features and ‘any cardiovascular disease’ (depression odds ratio (OR) = 1.15, 95% CI 1.12–1.19; bipolar OR = 1.28, 95% CI 1.14–1.43) and with hypertension (depression OR = 1.15, 95% CI 1.13–1.18; bipolar OR = 1.26, 95% CI 1.12–1.42). Individuals with features of mood disorder taking psychotropic medication were significantly more likely than controls not on psychotropics to report myocardial infarction (depression OR = 1.47, 95% CI 1.24–1.73; bipolar OR = 2.23, 95% CI 1.53–3.57) and stroke (depression OR = 2.46, 95% CI 2.10–2.80; bipolar OR = 2.31, 95% CI 1.39–3.85).
Associations between features of depression or bipolar disorder and cardiovascular disease outcomes were statistically independent of demographic, lifestyle and medication confounders. Psychotropic medication may also be a risk factor for cardiometabolic disease in individuals without a clear history of mood disorder.
To examine the use of vitamin D supplements during infancy among the participants in an international infant feeding trial.
Information about vitamin D supplementation was collected through a validated FFQ at the age of 2 weeks and monthly between the ages of 1 month and 6 months.
Infants (n 2159) with a biological family member affected by type 1 diabetes and with increased human leucocyte antigen-conferred susceptibility to type 1 diabetes from twelve European countries, the USA, Canada and Australia.
Daily use of vitamin D supplements was common during the first 6 months of life in Northern and Central Europe (>80 % of the infants), with somewhat lower rates observed in Southern Europe (>60 %). In Canada, vitamin D supplementation was more common among exclusively breast-fed than other infants (e.g. 71 % v. 44 % at 6 months of age). Less than 2 % of infants in the USA and Australia received any vitamin D supplementation. Higher gestational age, older maternal age and longer maternal education were study-wide associated with greater use of vitamin D supplements.
Most of the infants received vitamin D supplements during the first 6 months of life in the European countries, whereas in Canada only half and in the USA and Australia very few were given supplementation.
The diameter of the pupil is affected by changes in ambient illumination, color, spatial structure, movement, and mental effort. It has now been found that pupil diameter can be affected by cognitive processes. That is, it can be entrained by alternations between broadly spread and narrowly focused attention that are cued exogenously (attention is “summoned” by the cue) or endogenously (attention changes under the perceiver’s intentional control). Pupil diameter also is affected by post-eye-blink constrictions that occur most often when attention is narrowed, and possibly by changes evoked by the near reflex, although changes in attention state parsimoniously account for the entirety of the results. Changes in pupil diameter produce differences in spherical aberration that alternately blur (when the pupil dilates) and sharpen the retinal image (when the pupil constricts), affecting the relative sensitivity of large receptive fields that mediate broadly spread attention compared with smaller receptive fields that mediate more narrowly focused attention. Results for endogenously cued, intentional changes in attentional spread provide definitive behavioral evidence for cortical feedback to subcortical nuclei that control pupil diameter, either directly or through pupil-constricting eye blinks. Analyses of convergent and divergent changes in eye position indicate that the near reflex was activated long after the initiation of relatively gradual attentionally cued changes in pupil diameter, and further, that when it occurs, the near reflex facilitates ongoing changes in pupil diameter.
We investigate the possibility of using Luminous Red Galaxies (LRGs) as “Cosmic chronometers” to measure the expansion rate of the universe to 3% over a redshift range 0.1 < z < 1.0. In this method, H(z) is directly measured by using the ages of passively evolving galaxies to determine dz/dt. We first present results from our study of LRGs in simulations Crawford et al. where we explore the impact of extended star formation histories on the measurements of the Hubble parameter. We then extract a carefully selected sample of LRGs taken from Sloan Digital Sky Survey (SDSS) Data Released Seven (DR7), stack spectra in redshift bins to increase the signal-to-noise, and use the Lick index modelling presented in Thomas et al. to age-date the sample. We discuss the implications for expansion rate measurements and outline a proposal to observe LRGs with the Southern African Large Telescope (SALT).
The National Academy of Sciences — National Research Council (NAS-NRC) twin panel, created nearly 50 years ago, had twin zygosity determined primarily via a similarity questionnaire that has been estimated to correctly classify at least 95% of twins. In the course of a study on the genetics of healthy ageing in the NAS-NRC twins, DNA was collected for genome-wide scanning and zygosity confirmation was examined in 343 participating pairs. The sample was supplemented from two other studies using NAS-NRC twins where one or both co-twins were suspected to have Alzheimer disease or another dementia, or Parkinson's disease. Overall 578 twin pairs with DNA were analyzed. Zygosity assignment for 96.8% (519/536) was confirmed via questionnaire. Among 42 pairs whose questionnaire responses were inconclusive for assigning zygosity, 50% were found to be monozygous (MZ) and 50% were dizygous (DZ). There was some evidence for greater misclassification of presumed DZ pairs in the healthy ageing study where participation favored pairs who were similar in having a favorable health history and willingness to volunteer without any element of perceived risk for a specific disease influencing participation.
The spectra of the Sloan Digital Sky Survey (SDSS) are being used to construct a catalogue of QSO absorption lines, for use in studies of abundances, relevant radiation fields, number counts as a function of redshift, and other matters, including the evolution of these parameters. The catalogue includes intervening, associated, and BAL absorbers, in order to allow a clearer definition of the relationships between these three classes. We describe the motivation for and the data products of the project to build the SDSS QSO absorption line catalogue.