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Advance consent could allow individuals at high risk of stroke to provide consent before they might become eligible for enrollment in acute stroke trials. This survey explores the acceptability of this novel technique to Canadian Research Ethics Board (REB) chairs that review acute stroke trials. Responses from 15 REB chairs showed that majority of respondents expressed comfort approving studies that adopt advance consent. There was no clear preference for advance consent over deferral of consent, although respondents expressed significant concern with broad rather than trial-specific advance consent. These findings shed light on the acceptability of advance consent to Canadian ethics regulators.
We assess emerging relationships between production decisions and market channel selection among a small sample of hemp growers (22) in Colorado and Kentucky using qualitative interviews. We found producers differences by market channel, product and state. For instance, producers who relied on intermediated marketing strategies cultivated more acres on average and used fewer distinct market channels and strategies than those relying on direct markets. Product differences were found regarding processing, storage and perishability. Respondents identified four factors critical to their choice of market channels for their hemp products: research, profitability, trust and knowledge. The findings can help inform public and private decision-making regarding best hemp marketing practices and future needs of the hemp industry.
Advance consent presents a potential solution to the challenge of obtaining informed consent for participation in acute stroke trials. Clinicians in stroke prevention clinics are uniquely positioned to identify and seek consent from potential stroke trial participants. To assess the acceptability of advance consent to Canadian stroke clinic physicians, we performed an online survey. We obtained 58 respondents (response rate 35%): the vast majority (82%) expressed comfort with obtaining advance consent and 92% felt that doing so would not be a significant disruption to clinic workflow. These results support further study of advance consent for acute stroke trials.
Many triage algorithms exist for use in mass-casualty incidents (MCIs) involving pediatric patients. Most of these algorithms have not been validated for reliability across users.
Investigators sought to compare inter-rater reliability (IRR) and agreement among five MCI algorithms used in the pediatric population.
A dataset of 253 pediatric (<14 years of age) trauma activations from a Level I trauma center was used to obtain prehospital information and demographics. Three raters were trained on five MCI triage algorithms: Simple Triage and Rapid Treatment (START) and JumpSTART, as appropriate for age (combined as J-START); Sort Assess Life-Saving Intervention Treatment (SALT); Pediatric Triage Tape (PTT); CareFlight (CF); and Sacco Triage Method (STM). Patient outcomes were collected but not available to raters. Each rater triaged the full set of patients into Green, Yellow, Red, or Black categories with each of the five MCI algorithms. The IRR was reported as weighted kappa scores with 95% confidence intervals (CI). Descriptive statistics were used to describe inter-rater and inter-MCI algorithm agreement.
Of the 253 patients, 247 had complete triage assignments among the five algorithms and were included in the study. The IRR was excellent for a majority of the algorithms; however, J-START and CF had the highest reliability with a kappa 0.94 or higher (0.9-1.0, 95% CI for overall weighted kappa). The greatest variability was in SALT among Green and Yellow patients. Overall, J-START and CF had the highest inter-rater and inter-MCI algorithm agreements.
The IRR was excellent for a majority of the algorithms. The SALT algorithm, which contains subjective components, had the lowest IRR when applied to this dataset of pediatric trauma patients. Both J-START and CF demonstrated the best overall reliability and agreement.
Family members living with relatives with severe acquired brain injury (ABI) face many challenges. Although this is recognised, service provision in the UK is poor and needs development.
In order to support innovative service delivery for family members, we reflect on the research carried out by the first author using a new perspective – a lifeworld humanising approach in order to consider (a) the dehumanising existential challenges facing family members of people living with severe ABI and (b) what family members most value in service delivery presented in humanising terms.
Following ABI, family members may enter a parallel lifeworld (feeling separate from ‘usual’ life as it flows by) and face fundamental existential challenges of isolation, loss of agency, dislocation, loss of meaning and loss of personal journey. Family members have reported that service providers who are highly valued are those who act as ‘expert companions’. This role involves supporting families in some, if not all of the following (a) reaching across into the lifeworld of the family member and appreciating and validating what they are facing, (b) helping them make sense of their situation in terms which are meaningful to them and which they can explain to others, (c) through ABI expertise, supporting their relative through knowing their interests and needs and adapting the environment to suit these to help their relative to ‘settle’ and flourish, (d) supporting family members to share their life experiences – developing safe and trusting relationships, (e) having a humane, positive, creative and for some, a humorous approach, (f) being responsive to changing situations, (g) being available to call during times of worry or crisis and (h) help link with others and helpful networks.
It is suggested that the role and approach of companion may help family members regain some sense of their own life and their well-being.
Mass-casualty incident (MCI) algorithms are used to sort large numbers of patients rapidly into four basic categories based on severity. To date, there is no consensus on the best method to test the accuracy of an MCI algorithm in the pediatric population, nor on the agreement between different tools designed for this purpose.
This study is to compare agreement between the Criteria Outcomes Tool (COT) to previously published outcomes tools in assessing the triage category applied to a simulated set of pediatric MCI patients.
An MCI triage category (black, red, yellow, and green) was applied to patients from a pre-collected retrospective cohort of pediatric patients under 14 years of age brought in as a trauma activation to a Level I trauma center from July 2010 through November 2013 using each of the following outcome measures: COT, modified Baxt score, modified Baxt combined with mortality and/or length-of-stay (LOS), ambulatory status, mortality alone, and Injury Severity Score (ISS). Descriptive statistics were applied to determine agreement between tools.
A total of 247 patients were included, ranging from 25 days to 13 years of age. The outcome of mortality had 100% agreement with the COT black. The “modified Baxt positive and alive” outcome had the highest agreement with COT red (65%). All yellow outcomes had 47%-53% agreement with COT yellow. “Modified Baxt negative and <24 hours LOS” had the highest agreement with the COT green at 89%.
Assessment of algorithms for triaging pediatric MCI patients is complicated by the lack of a gold standard outcome tool and variability between existing measures.
Nonsuicidal self-injury (NSSI) is a common but poorly understood phenomenon in adolescents. This study examined the Sustained Threat domain in female adolescents with a continuum of NSSI severity (N = 142). Across NSSI lifetime frequency and NSSI severity groups (No + Mild NSSI, Moderate NSSI, Severe NSSI), we examined physiological, self-reported and observed stress during the Trier Social Stress Test; amygdala volume; amygdala responses to threat stimuli; and resting-state functional connectivity (RSFC) between amygdala and medial prefrontal cortex (mPFC). Severe NSSI showed a blunted pattern of cortisol response, despite elevated reported and observed stress during TSST. Severe NSSI showed lower amygdala–mPFC RSFC; follow-up analyses suggested that this was more pronounced in those with a history of suicide attempt for both moderate and severe NSSI. Moderate NSSI showed elevated right amygdala activation to threat; multiple regressions showed that, when considered together with low amygdala–mPFC RSFC, higher right but lower left amygdala activation predicted NSSI severity. Patterns of interrelationships among Sustained Threat measures varied substantially across NSSI severity groups, and further by suicide attempt history. Study limitations include the cross-sectional design, missing data, and sampling biases. Our findings highlight the value of multilevel approaches in understanding the complexity of neurobiological mechanisms in adolescent NSSI.
Substance use disorders are highly prevalent, affecting millions of Americans directly (social, occupational, and health problems) and indirectly (billions of dollars in health care costs and lost revenues due to disability). This section briefly introduces the chemical classification and neurobehavioral properties of the most commonly misused substances.
The most immediate response of the research community to COVID-19 has been a focus on understanding the effects, treatment and prevention of infection. Of equal and ongoing importance is elucidating the impact of mitigation measures, such as lockdown, on the well-being of societies. Research about mental health and lockdown in the UK has predominately involved large surveys that are likely to encounter self-selection bias. Further, self-reporting does not constitute a clinical judgement.
To (a) compare the age, gender and ethnicity of patients experiencing mental health emergencies prior compared with during lockdown, (b) determine whether the nature of mental health emergencies has changed during compared with before lockdown, (c) explore the utility of emergency medical service data for identifying vulnerability to mental health emergencies in real time during a pandemic.
A total of 32 401 clinical records of ambulance paramedics attending mental health emergencies in the East Midlands of the UK between 23 March and 31 July 2020 and the same period in 2019 were analysed using binary logistic regression.
People of younger age, male gender and South Asian and Black ethnicity are particularly vulnerable to acute mental health conditions during lockdown. Patients with acute cases of anxiety have increased during lockdown whereas suicide and intentional drug overdose have decreased.
Self-reported data may underrepresent the true impact of lockdown on male mental health and ethnic minority groups. Emergency medical data can be used to identify vulnerable communities in the context of the extraordinary circumstances surrounding the current pandemic, as well as under more ordinary circumstances.
As lidar becomes a regular part of surveying, ground-based platforms (handheld, mobile, and terrestrial lidar) and airborne platforms (piloted aircraft) are being joined by unpiloted aerial vehicle (UAV)–acquired lidar. We present a method for leveraging UAV-acquired lidar data with data collected using different lidar platforms (terrestrial and piloted aircraft), at a range of resolutions (1 to +1,000 points per m2) and geographic scales. We use these instruments to document a dry-masonry stone wall enclosing a religious precinct within the royal center at Kealakekua, Kona District, Hawai'i Island. Prior to European contact in AD 1779, Kealakekua was the center of the island-wide polity during the annual Makahiki festival. Results of this study suggest that when the wall was constructed around AD 1640, it was the largest structure ever built on the island of Hawai'i as well as a strong material expression of the power of state religion and the Makahiki rituals.
Registry-based trials have emerged as a potentially cost-saving study methodology. Early estimates of cost savings, however, conflated the benefits associated with registry utilisation and those associated with other aspects of pragmatic trial designs, which might not all be as broadly applicable. In this study, we sought to build a practical tool that investigators could use across disciplines to estimate the ranges of potential cost differences associated with implementing registry-based trials versus standard clinical trials.
We built simulation Markov models to compare unique costs associated with data acquisition, cleaning, and linkage under a registry-based trial design versus a standard clinical trial. We conducted one-way, two-way, and probabilistic sensitivity analyses, varying study characteristics over broad ranges, to determine thresholds at which investigators might optimally select each trial design.
Registry-based trials were more cost effective than standard clinical trials 98.6% of the time. Data-related cost savings ranged from $4300 to $600,000 with variation in study characteristics. Cost differences were most reactive to the number of patients in a study, the number of data elements per patient available in a registry, and the speed with which research coordinators could manually abstract data. Registry incorporation resulted in cost savings when as few as 3768 independent data elements were available and when manual data abstraction took as little as 3.4 seconds per data field.
Registries offer important resources for investigators. When available, their broad incorporation may help the scientific community reduce the costs of clinical investigation. We offer here a practical tool for investigators to assess potential costs savings.
The Sort, Access, Life-saving interventions, Treatment and/or Triage (SALT) mass-casualty incident (MCI) algorithm is unique in that it includes two subjective questions during the triage process: “Is the victim likely to survive given the resources?” and “Is the injury minor?”
Given this subjectivity, it was hypothesized that as casualties increase, the inter-rater reliability (IRR) of the tool would decline, due to an increase in the number of patients triaged as Minor and Expectant.
A pre-collected dataset of pediatric trauma patients age <14 years from a single Level 1 trauma center was used to generate “patients.” Three trained raters triaged each patient using SALT as if they were in each of the following scenarios: 10, 100, and 1,000 victim MCIs. Cohen’s kappa test was used to evaluate IRR between the raters in each of the scenarios.
A total of 247 patients were available for triage. The kappas were consistently “poor” to “fair:” 0.37 to 0.59 in the 10-victim scenario; 0.13 to 0.36 in the 100-victim scenario; and 0.05 to 0.36 in the 1,000-victim scenario. There was an increasing percentage of subjects triaged Minor as the number of estimated victims increased: 27.8% increase from 10- to 100-victim scenario and 7.0% increase from 100- to 1,000-victim scenario. Expectant triage categorization of patients remained stable as victim numbers increased.
Overall, SALT demonstrated poor IRR in this study of increasing casualty counts while triaging pediatric patients. Increased casualty counts in the scenarios did lead to increased Minor but not Expectant categorizations.
Major depressive disorder and neuroticism (Neu) share a large genetic basis. We sought to determine whether this shared basis could be decomposed to identify genetic factors that are specific to depression.
We analysed summary statistics from genome-wide association studies (GWAS) of depression (from the Psychiatric Genomics Consortium, 23andMe and UK Biobank) and compared them with GWAS of Neu (from UK Biobank). First, we used a pairwise GWAS analysis to classify variants as associated with only depression, with only Neu or with both. Second, we estimated partial genetic correlations to test whether the depression's genetic link with other phenotypes was explained by shared overlap with Neu.
We found evidence that most genomic regions (25/37) associated with depression are likely to be shared with Neu. The overlapping common genetic variance of depression and Neu was genetically correlated primarily with psychiatric disorders. We found that the genetic contributions to depression, that were not shared with Neu, were positively correlated with metabolic phenotypes and cardiovascular disease, and negatively correlated with the personality trait conscientiousness. After removing shared genetic overlap with Neu, depression still had a specific association with schizophrenia, bipolar disorder, coronary artery disease and age of first birth. Independent of depression, Neu had specific genetic correlates in ulcerative colitis, pubertal growth, anorexia and education.
Our findings demonstrate that, while genetic risk factors for depression are largely shared with Neu, there are also non-Neu-related features of depression that may be useful for further patient or phenotypic stratification.
While echocardiographic parameters are used to quantify ventricular function in infants with single ventricle physiology, there are few data comparing these to invasive measurements. This study correlates echocardiographic measures of diastolic function with ventricular end-diastolic pressure in infants with single ventricle physiology prior to superior cavopulmonary anastomosis.
Data from 173 patients enrolled in the Pediatric Heart Network Infant Single Ventricle enalapril trial were analysed. Those with mixed ventricular types (n = 17) and one outlier (end-diastolic pressure = 32 mmHg) were excluded from the analysis, leaving a total sample size of 155 patients. Echocardiographic measurements were correlated to end-diastolic pressure using Spearman’s test.
Median age at echocardiogram was 4.6 (range 2.5–7.4) months. Median ventricular end-diastolic pressure was 7 (range 3–19) mmHg. Median time difference between the echocardiogram and catheterisation was 0 days (range −35 to 59 days). Examining the entire cohort of 155 patients, no echocardiographic diastolic function variable correlated with ventricular end-diastolic pressure. When the analysis was limited to the 86 patients who had similar sedation for both studies, the systolic:diastolic duration ratio had a significant but weak negative correlation with end-diastolic pressure (r = −0.3, p = 0.004). The remaining echocardiographic variables did not correlate with ventricular end-diastolic pressure.
In this cohort of infants with single ventricle physiology prior to superior cavopulmonary anastomosis, most conventional echocardiographic measures of diastolic function did not correlate with ventricular end-diastolic pressure at cardiac catheterisation. These limitations should be factored into the interpretation of quantitative echo data in this patient population.
Analysis of human remains and a copper band found in the center of a Late Archaic (ca. 5000–3000 cal BP) shell ring demonstrate an exchange network between the Great Lakes and the coastal southeast United States. Similarities in mortuary practices suggest that the movement of objects between these two regions was more direct and unmediated than archaeologists previously assumed based on “down-the-line” models of exchange. These findings challenge prevalent notions that view preagricultural Native American communities as relatively isolated from one another and suggest instead that wide social networks spanned much of North America thousands of years before the advent of domestication.
The 2018 G20 Interfaith Forum took place 26–28 September 2018 in Buenos Aires, Argentina. This was the fifth annual event in a series of G20 interfaith fora held to coincide with the meetings of the international Group of Twenty Economic Summit. This year's G20 Summit will take place in Buenos Aires, from 30 November to 1 December. Previous interfaith fora have been held in Gold Coast, Australia (2014), Istanbul, Turkey (2015), Beijing, China (2016) and Potsdam, Germany (2017).
The International Consortium for Law and Religion Studies (ICLARS) chose Rio de Janeiro and the sun-kissed beaches of Ipanema and Copacabana for its fifth conference and, unsurprisingly, the event was heavily over-subscribed. ICLARS was founded in 2007 with the aim of providing a forum where information, data and opinions could be readily exchanged among members and made available to the broader scientific community. Its first conference was held in Milan in 2009, followed by meetings in Chile in 2011, the USA in 2013 and Oxford in 2016. The proceedings from all these conferences have been published, giving permanence and a wider readership to the innovative scholarship which these gatherings have consistently produced.
A debate between the virtue of self-interest and social conceptions of morality emerged in the seventeenth century. Aspects of the historical narrative of these ideas have been touched on by Franco Venturi (1971), Albert O. Hirschman (1977), Pierre Force (2003) and Eric MacGilvray (2011), among others, but broadly one can recognise two camps which ossified during the eighteenth century: those who saw public utility in self-interest emerge from the positive externalities of commerce, and those who had serious concerns over the political implications of entangling commerce and virtue. This chapter locates, primarily, Rousseau within this debate, and by looking at how his moral philosophy interacts with his political thought, argues that he is distinct from contemporary thinkers (in particular, Adam Smith), but in an often confused way: while some have been tempted to view Rousseau as a republican moralist, he is in fact a philosopher of the political and social good of self-interest.
To make this argument, this chapter opens with a brief exploration of Adam Smith's position and the ‘impartial spectator’, arguing that Smith is a moral sentimentalist and moral rationalist.
That is to say, first, moral ideas are born from moral sentiments, and these truths are discoverable through reason. The chapter then examines the source of morality and moral action in Rousseau's thought. It is argued that he is not a moral realist and instead agrees with Hobbes that morality comes to exist only with society (although he denies that this lack of morality is the equivalent to immorality – he is not a moral realist) (Second Discourse 1997a: 151/OC III: 153). Specifically, morality emerges due to perfectibility – the confluence of pity and reason result in moral concepts being developed. Thus, it is shown that Rousseau is a moral rationalist. However, this position is complicated by Rousseau's belief that moral rationalism is, by itself, incapable of ensuring moral actions. The chapter goes on to demonstrate that the source of this problem is, in fact, reason itself. He is, therefore, a moral rationalist in terms of source, but is sceptical of reason as a moral motivator.
How Rousseau solves this problem is the topic of the second part of this chapter.