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Access to psychedelic drugs is liberalizing, yet responses are highly unpredictable. It is therefore imperative that we improve our ability to predict the nature of the acute psychedelic experience to improve safety and optimize potential therapeutic outcomes. This study sought to validate the ‘Imperial Psychedelic Predictor Scale’ (IPPS), a short, widely applicable, prospective measure intended to be predictive of salient dimensions of the psychedelic experience.
Methods
Using four independent datasets in which the IPPS was completed prospectively – two online surveys of ‘naturalistic’ use (N = 741, N = 836) and two controlled administration datasets (N = 30, N = 28) – we conducted factor analysis, regression, and correlation analyses to assess the construct, predictive, and convergent validity of the IPPS.
Results
Our approach produced a 9-item scale with good internal consistency (Cronbach's α = 0.8) containing three factors: set, rapport, and intention. The IPPS was significantly predictive of ‘mystical’, ‘challenging’, and ‘emotional breakthrough’ experiences. In a controlled administration dataset (N = 28), multiple regression found set and rapport explaining 40% of variance in mystical experience, and simple regression found set explained 16% of variance in challenging experience. In another (N = 30), rapport was related to emotional breakthrough explaining 9% of variance.
Conclusions
Together, these data suggest that the IPPS is predictive of relevant acute features of the psychedelic experience in a broad range of contexts. We hope that this brief 9-item scale will be widely adopted for improved knowledge of psychedelic preparedness in controlled settings and beyond.
Background: Nursing home (NH) residents are at high risk of COVID-19 from exposure to infected staff and other residents. Understanding SARS-CoV-2 viral RNA kinetics in residents and staff can guide testing, isolation, and return to work recommendations. We sought to determine the duration of antigen test and polymerase chain reaction (PCR) positivity in a cohort of NH residents and staff. Methods: We prospectively collected data on SARS-CoV-2 viral kinetics from April 2023 through November 2023. Staff and residents could enroll prospectively or upon a positive test (identified through routine clinical testing, screening, or outbreak response testing). Participating facilities performed routine clinical testing; asymptomatic testing of contacts was performed within 48 hours if an outbreak or known exposure occurred and upon (re-) admission. Enrolled participants who tested positive for SARS-CoV-2 were re-tested daily for 14 days with both nasal antigen and nasal PCR tests. All PCR tests were run by a central lab with the same assay. We conducted a Kaplan-Meier survival analysis on time to first negative test restricted to participants who initially tested positive (day zero) and had at least one test ≥10 days after initially testing positive with the same test type; a participant could contribute to both antigen and PCR survival curves. We compared survival curves for staff and residents using the log-rank test. Results: Twenty-four nursing homes in eight states participated; 587 participants (275 residents, 312 staff) enrolled in the evaluation, participants were only tested through routine clinical or outbreak response testing. Seventy-two participants tested positive for antigen; of these, 63 tested PCR-positive. Residents were antigen- and PCR-positive longer than staff (Figure 1), but this finding is only statistically significant (p=0.006) for duration of PCR positivity. Five days after the first positive test, 56% of 50 residents and 59% of 22 staff remained antigen-positive; 91% of 44 residents and 79% of 19 staff were PCR-positive. Ten days after the first positive test, 22% of 50 residents and 5% of 22 staff remained antigen-positive; 61% of 44 residents and 21% of 19 staff remained PCR-positive. Conclusions: Most NH residents and staff with SARS-CoV-2 remained antigen- or PCR-positive 5 days after the initial positive test; however, differences between staff and resident test positivity were noted at 10 days. These data can inform recommendations for testing, duration of NH resident isolation, and return to work guidance for staff. Additional viral culture data may strengthen these conclusions.
Disclosure: Stefan Gravenstein: Received consulting and speaker fees from most vaccine manufacturers (Sanofi, Seqirus, Moderna, Merck, Janssen, Pfizer, Novavax, GSK, and have or expect to receive grant funding from several (Sanofi, Seqirus, Moderna, Pfizer, GSK). Lona Mody: NIH, VA, CDC, Kahn Foundation; Honoraria: UpToDate; Contracted Research: Nano-Vibronix
To assess the impact of a diagnostic test stewardship intervention focused on tracheal aspirate cultures.
Design:
Quality improvement intervention.
Setting:
Tertiary care pediatric intensive care unit (PICU).
Patients:
Mechanically ventilated children admitted between 9/2018 and 8/2022.
Methods:
We developed and implemented a consensus guideline for obtaining tracheal aspirate cultures through a series of Plan-Do-Study-Act cycles. Change in culture rates and broad-spectrum antibiotic days of therapy (DOT) per 100 ventilator days were analyzed using statistical process control charts. A secondary analysis comparing the preintervention baseline (9/2018–8/2020) to the postintervention period (9/2020–8/2021) was performed using Poisson regression.
Results:
The monthly tracheal aspirate culture rate prior to the COVID-19 pandemic (9/2018–3/2020) was 4.6 per 100 ventilator days. A centerline shift to 3.1 cultures per 100 ventilator days occurred in 4/2020, followed by a second shift to 2.0 cultures per 100 ventilator days in 12/2020 after guideline implementation. In our secondary analysis, the monthly tracheal aspirate culture rate decreased from 4.3 cultures preintervention (9/2018–8/2020) to 2.3 cultures per 100 ventilator days postintervention (9/2020–8/2021) (IRR 0.52, 95% CI 0.47–0.59, P < 0.01). Decreases in tracheal aspirate culture use were driven by decreases in inappropriate cultures. Treatment of ventilator-associated infections decreased from 1.0 to 0.7 antibiotic courses per 100 ventilator days (P = 0.03). There was no increase in mortality, length of stay, readmissions, or ventilator-associated pneumonia postintervention.
Conclusion:
A diagnostic test stewardship intervention was both safe and effective in reducing the rate of tracheal aspirate cultures and treatment of ventilator-associated infections in a tertiary PICU.
How was trust created and reinforced between the inhabitants of medieval and early modern cities? And how did the social foundations of trusting relationships change over time? Current research highlights the role of kinship, neighbourhood, and associations, particularly guilds, in creating ‘relationships of trust’ and social capital in the face of high levels of migration, mortality, and economic volatility, but tells us little about their relative importance or how they developed. We uncover a profound shift in the contribution of family and guilds to trust networks among the middling and elite of one of Europe's major cities, London, over three centuries, from the 1330s to the 1680s. We examine almost 15,000 networks of sureties created to secure orphans’ inheritances to measure the presence of trusting relationships connected by guild membership, family, and place. We uncover a profound increase in the role of kinship – a re-embedding of trust within the family – and a decline of the importance of shared guild membership in connecting Londoners who secured orphans’ inheritances together. These developments indicate a profound transformation in the social fabric of urban society.
Chapter 11 focuses on ancient ‘contracts’, with specific reference to commerce, property and other economic activities for which there is relevant evidence. The chapter begins with urbanization in southern Mesopotamia in the fourth millennium bce, bringing together archaeological, material and written evidence in order to introduce a broad working idea of ‘contracts’. The next section moves on to a discussion of technical ancient terms and concepts, noting the ‘considerable terminological instability in the common English translations of the original terms’. The following section turns to ‘contracts’ between states, whilst the next develops a comparative analysis of ‘oaths in interpersonal agreements’. The following two sections analyse specific questions surrounding the use of writing and ’the contract of sale’, noting that there is surviving evidence for the use of (different forms of) contacts of sale across every ancient legal system. The chapter concludes by drawing together a set of generalized conceptions of ‘contract’ and briefly suggesting that long-distance trade - among other factors - may lie behind some of the similarities - for example the use of seals - evident across the extant ancient evidence.
Chapter 10 surveys the history, the concepts and the institutions of property in premodern India, China, the Near East, Egypt, Greece and Rome. Formal rules of ownership and inheritance formed the basis of all premodern legal regimes and undergirded economic performance (for instance, growth), as has been frequently stressed by New Institutional Economists. The enforcement of property rights reveals a good deal about the diverse economies, environments and cultures of premodern societies. The chapter summarizes the sources for property rights, which are rich and varied; and the control and use of resources occupy a considerable part of private legal documentation in all premodern systems that have yielded written material.
OBJECTIVES/GOALS: Empowering the Participant Voice (EPV) is a 6-CTSA Rockefeller-led collaboration to developcustom REDCap infrastructure to collect participant feedback using the validated Research Participant Perception Survey (RPPS), demonstrate its value in use cases, and disseminate it for broad adoption. METHODS/STUDY POPULATION: The EPV team developed data and survey implementation standards, and specifications for the dashboard and multi-lingual RPPS/REDCap project XML file. The VUMC built a custom At-a-Glance Dashboard external module that displays Top Box scores (percent best answer), with conditional formatting to aid analysis, and response/completion rates. Results populate site dashboards, and aggregate to a multi-site dashboard for benchmarking. Results can be filtered by participant/study characteristics. Sites developed individual use cases, leveraging local infrastructure, initiatives and stakeholder input. Infrastructure and guides were designed for dissemination through public websites. RESULTS/ANTICIPATED RESULTS: Five sites sent 23,797surveys via email, patient portal or SMS. 4,133 (19%) participants diverse in age, race, and ethnicity, returned responses. Sites analyzed their data and acted on selected findings, improving recruitment, communication and feeling valued. Aggregate scores for feeling listened to and respected were hight (>90%%); scores for feeling prepared by the consent process were lower (57-77%) and require action. Some groups experiences were better than others. Sites differed significantly in some scores. Dissemination of EPV is underway. Infrastructure and guides are downloadable free of charge, with advice from the EPV team. In 2023, a sixth site began piloting a lower literacy survey version and syncing data to the consortium dashboard. DISCUSSION/SIGNIFICANCE: The EPV RPPS/REDCap infrastructure enabled sites to collect participant feedback, identify actionable findings and benchmark with peers. Stakeholders and collaborators designed and tested local initiatives to increase responses and diversity, address disparities, and discover better practices.
The name volkonskoite was first used in 1830 to describe a bright blue-green, chromiumbearing clay material from the Okhansk region, west of the Ural Mountains, U.S.S.R. Since that time, the name has been applied to numerous members of the smectite group of clay minerals, although the reported chromium content has ranged from 1% to about 30% Cr2O3. The name has also been applied to some chromian chlorites. Because volkonskoite has been used for materials that differ not only in their chromium content but also in their basic structure, the species status of the mineral has been unclear.
To resolve this uncertainty, two specimens of volkonskoite from (1) Mount Efimiatsk, the type locality in the Soviet Union (USNM 16308) and (2) the Okhansk region in the Perm Basin, U.S.S.R. (USNM R4820), were examined by several mineralogical techniques. Neotype sample 16308 has the following structural formula:
Sample R4820 has the following structural formula:
Mössbauer spectroscopy indicates that 91% and 98% of the iron is present as Fe3+ in samples 16308 and R4820, respectively. X-ray powder diffraction patterns of both samples have broad lines corresponding to minerals of the smectite group.
On the basis of these data, volkonskoite appears to be a dioctahedral member of the smectite group that contains chromium as the dominant cation in the octahedral layer. Smectites containing less than this amount of octahedral chromium should not be called volkonskoite, but should be named by chemical element adjectives, e.g., chromian montmorillonite, chromian nontronite.
Empowering the Participant Voice (EPV) is an NCATS-funded six-CTSA collaboration to develop, demonstrate, and disseminate a low-cost infrastructure for collecting timely feedback from research participants, fostering trust, and providing data for improving clinical translational research. EPV leverages the validated Research Participant Perception Survey (RPPS) and the popular REDCap electronic data-capture platform. This report describes the development of infrastructure designed to overcome identified institutional barriers to routinely collecting participant feedback using RPPS and demonstration use cases. Sites engaged local stakeholders iteratively, incorporating feedback about anticipated value and potential concerns into project design. The team defined common standards and operations, developed software, and produced a detailed planning and implementation Guide. By May 2023, 2,575 participants diverse in age, race, ethnicity, and sex had responded to approximately 13,850 survey invitations (18.6%); 29% of responses included free-text comments. EPV infrastructure enabled sites to routinely access local and multi-site research participant experience data on an interactive analytics dashboard. The EPV learning collaborative continues to test initiatives to improve survey reach and optimize infrastructure and process. Broad uptake of EPV will expand the evidence base, enable hypothesis generation, and drive research-on-research locally and nationally to enhance the clinical research enterprise.
The fragility index represents the minimum number of patients required to convert an outcome from statistically significant to insignificant. This report assesses the fragility index of head and neck cancer randomised, controlled trials.
Methods
Studies were extracted from PubMed/Medline, Scopus, Embase and Cochrane databases.
Results
Overall, 123 randomised, controlled trials were included. The sample size and fragility index medians (interquartile ranges) were 103 (56–213) and 2 (0–5), respectively. The fragility index exceeded the number of patients lost to follow up in 42.3 per cent (n = 52) of studies. A higher fragility index correlated with higher sample size (r = 0.514, p < 0.001), number of events (r = 0.449, p < 0.001) and statistical significance via p-value (r = −0.367, p < 0.001).
Conclusion
Head and neck cancer randomised, controlled trials demonstrated low fragility index values, in which statistically significant results could be nullified by altering the outcomes of just two patients, on average. Future head and neck oncology randomised, controlled trials should report the fragility index in order to provide insight into statistical robustness.
While in the United Kingdom, the government was initially slow to recognize the profound dangers of the COVID-19 pandemic, soon after Prime Minister Boris Johnson's initial plea to the public to ‘stay at home’, in March 2021, emergency legislation was rushed through parliament. On 25 March, the 350-page Coronavirus Act 2020 received royal assent, bringing the biggest restrictions on civil liberties in a generation into law the following day. Overnight, the Coronavirus Act, along with the broader raft of legal restrictions under The Health Protection (Coronavirus) Regulations 2020, made it unlawful to undertake a wide range of hitherto economically essential, prosocial and noncriminal activities. Even as the Act was rushed through parliament, civil liberties organizations were alerting parliamentarians to its dangers (Gidda, 2020).
As antiracist commentators and academics forewarned (Frazer-Carroll, 2020; Khan, 2020), racial disproportionality in policing has endured and often increased through the pandemic. As the first ‘lockdown’ came into effect, stop and search practices ‘surged’ despite the steep drop in crime rates (Grierson, 2020). Limited and prone to undercounting as they may be, Home Office data show that in the year ending March 2021, stop and search practices (under Section 1 of the Police and Criminal Evidence Act 1984) increased significantly to reach their highest level in seven years, impacting most on racially minoritized men (Home Office, 2022). Home Office data (2021) also show an increase in use of force for the year ending March 2021. This was racially disproportionate too, with Black people accounting for 16 per cent of those affected (though they make up just 3 per cent of the population according to the 2011 Census), and Asian people accounting for 8 per cent (7 per cent of the population according to the 2011 Census). In the summer of 2020, these patterns coalesced with mass global protests against racist police violence. The police murder of George Floyd in the United States catalyzed millions to march under the banner of Black Lives Matter (BLM) and spoke to the ongoing police brutality faced by racially minoritized people in Britain (Joseph-Salisbury et al, 2020).
OBJECTIVES/GOALS: Empowering the Participant Voice (EPV) is a Rockefeller-led 6-CTSA consortium that aims to collect research participant feedback through new Research Participant Perception Survey (RPPS)/REDCap infrastructure and data aggregation to a national database. Here we describe diverse Use Cases and launch dissemination to other hubs. METHODS/STUDY POPULATION: The EPV team refined the RPPS-S and developed fielding and data standards, a multi-lingual RPPS/REDCap project XML, At-a-Glance Dashboard, EPV Consortium Database, and Use Cases to align with local initiatives and stakeholder input. Sites ran full thread tests of the infrastructure before launch. To demonstrate RPPS/REDCap, 5 sites implemented Use Cases, surveyed diverse populations via email, patient portal or SMS, and analyzed results using the At-a-Glance Dashboard External module (which provides visual analytics and enables filtering by participant/study characteristics). Sites continue to collect, synthesize and respond to actionable data. To disseminate infrastructure, we will invite early adopters to implement the RPPS/REDCap infrastructure locally, joining the EPV learning collective. RESULTS/ANTICIPATED RESULTS: To date, 5 sites surveyed 10,199 research participants, at post-consent or end of study. 2833 (26%) research participants responded, from diverse demographic groups. More than 90% gave the Top Box score response regarding courtesy, respect for cultural background, privacy, and lack of pressure to join a study. Disparities were apparent in the informed consent experience, with a Top Box score range of 38-78% in different demographics. Dissatisfaction with out-of-pocket research costs was a recurring theme. Top Box scores varied for feeling like a valued partner in research (69-93%), would recommend research participation to friends or family (56%-81%), and Overall Experience (64%-90%) questions. Sites identified actionable findings in areas of consent, communication, partnership, and study conduct. DISCUSSION/SIGNIFICANCE: The EPV RPPS/REDCap infrastructure enabled sites to broadly collect participant feedback, identify actionable findings and make inter-institutional comparisons. Collaborators are designing local initiatives to increase response rate and diversity, address disparities in research participation experiences, and discover better practices.
This study examined associations between multiple dietary supplement (DS) categories and medical conditions diagnosed by health professionals.
Design:
Cross-sectional.
Setting:
Volunteers completed an online questionnaire on DS use and demographic/lifestyle factors. Medical diagnoses were obtained from a comprehensive military electronic medical surveillance system and grouped into twenty-four clinically diagnosed medical conditions (CDMC).
Participants:
A stratified random sample of US service members (SM) from all military services (n 26 680).
Results:
After adjustment for demographic/lifestyle factors (logistic regression), higher risk was found for 92 % (22/24) of CDMC among individual vitamins/minerals users, 58 % (14/24) of CDMC among herbal users, 50 % (12/24) of CDMC among any DS users and 46 % (11/24) of CDMC among multivitamins/multiminerals (MVM) users. Among protein/amino acid (AA) users, risk was lower in 25 % (6/24) of CDMC. For combination products, risk was higher in 13 % (3/24) of CDMC and lower in 8 % (2/24). The greater the number of CDMC, the higher the prevalence of DS use in most DS categories except proteins/AA where prevalence decreased.
Conclusions:
Users in many DS categories had a greater number of CDMC, but protein/AA users had fewer CDMC; results for combination products were mixed. These data indicate those with certain CDMC were also users in some DS categories, especially individual vitamins/minerals, herbals and MVM. Data are consistent with the perception that use of DS enhances health, especially in those with CDMC. Protein/AA and combination product users were more likely to be younger, more physically active men, factors that likely reduced CDMC.
An abiding concern throughout Molière’s works, masculinity is a more multivalent, complex and nuanced phenomenon than one might expect. Focussing primarily on various external signifiers coded as masculine – particularly elements of appearance and dress such as swords, hairstyles, and beards – this chapter outlines the various forms that seventeenth-century masculinity can take when it intersects with other variables of age, social class, biological sex and so forth. For example, while the barbons of the older generation regard their beards as an unassailable symbol of male authority, they are troubled by their younger blondin rivals, whose gallantry and blond wigs strike them as effeminate. An even more affected mode of masculinity can be found in the bodily stylisations and verbal uncouthness of the aristocratic petits marquis. As this chapter demonstrates, masculinity in Molière emerges as something largely performed or asserted in relation to others – through domination of women or competition with other men (in duels, warfare or seduction). Such issues are starkly flagged up when cross-dressing or cross-casting are involved: in many of Molière’s plays, women’s success at passing as men, and men’s failure to pass as women, can often demonstrate the fragility of both social gender roles and men’s authority.
Quizzes are a ubiquitous part of the dementia social care landscape. This article explores why. Using an ethnographic approach which draws on close analysis of communication, we examine dementia quizzes as a ‘social practice’, and what such a lens can tell us about their popularity in social care settings. Vignettes of real interactions drawn from ten different quizzes recorded in four different group settings attended by 28 people living with dementia and 15 staff members are presented to highlight particular issues. We show that the conditions of post-diagnosis dementia social care are uniquely well suited to an activity such as quizzes which are malleable, requiring little preparation or materials, and impose a communication framework which can help to organise the interactional space. Quizzes also draw on previously forged interactional competences, such as turn-taking and question–answer sequences, a skill that has been shown to persist even as dementia progresses. Finally, we argue that the meaning of quizzes with people with dementia feeds into wider societal values and associations attached to memory, dementia and personhood. The extent to which quizzes are akin to a ‘test’ or a fun and enjoyable social activity rests in how they are enacted. We suggest that practice can be adapted, developed and made more inclusive through input from people living with dementia themselves.
OBJECTIVES/GOALS: Six CTSA sites formed a collaboration to DEVELOP, DEMONSTRATE, AND DISSEMINATE new infrastructure to streamline collection and analysis of research participant feedback, using the Research Participant Perception Survey (RPPS), common standards, and customized REDCap-based tools, to improve the clinical research enterprise. METHODS/STUDY POPULATION: DEVELOP charter, consensus approach, core survey, deployment standards, data-use agreements; define meta-data, system requirements for the infrastructure, use-cases. Engage stakeholders for broad institutional and community input. Build RPPS/REDCap project, visual analytics Dashboard External Module, and Program Dashboard module for evaluation. Configure to use with Multilingual Module. DEMONSTRATE by implementing site-based use cases that reflect local priorities and span diverse populations, testing different methods of survey deployment (REDCap, patient portal, SMS) to showcase utility and flexibility. Generate data for local and inter-institutional benchmarking. Refine, then DISSEMINATE new infrastructure across the Consortium and REDCap community for broader testing and uptake. RESULTS/ANTICIPATED RESULTS: The project team refined the RPPS survey for inclusivity and mode of informed consent; defined standards for survey timing, sampling, and study metadata; configured the data dictionary in English and Spanishfor use with the multi-lingual module ; developed tools for project evaluation. Stakeholder engagement identified themes of anticipated value and fears about feedback. We designed an At-a-Glance Dashboard to display survey results with detailed analytics and filters. A REDCap application programming interface will send de-identified site data to the EPV Consortium Database to support benchmarking. Full implementation began November 2021 and will scale in 2022. Dissemination to Consortium and REDCap users is ongoing through presentations and a project website (www.Rockefeller.edu/research/epv). DISCUSSION/SIGNIFICANCE: Direct feedback from representative populations about their experiences in research is essential to understand and resolve barriers to broad participation in research. Streamlined RPPS/REDCap infrastructure provides a platform for local and national benchmarking, and collection of actionable data to improve clinical research.
To improve maternal health outcomes, increased diversity is needed among pregnant people in research studies and community surveillance. To expand the pool, we sought to develop a network encompassing academic and community obstetrics clinics. Typical challenges in developing a network include site identification, contracting, onboarding sites, staff engagement, participant recruitment, funding, and institutional review board approvals. While not insurmountable, these challenges became magnified as we built a research network during a global pandemic. Our objective is to describe the framework utilized to resolve pandemic-related issues.
Methods:
We developed a framework for site-specific adaptation of the generalized study protocol. Twice monthly video meetings were held between the lead academic sites to identify local challenges and to generate ideas for solutions. We identified site and participant recruitment challenges and then implemented solutions tailored to the local workflow. These solutions included the use of an electronic consent and videoconferences with local clinic leadership and staff. The processes for network development and maintenance changed to address issues related to the COVID-19 pandemic. However, aspects of the sample processing/storage and data collection elements were held constant between sites.
Results:
Adapting our consenting approach enabled maintaining study enrollment during the pandemic. The pandemic amplified issues related to contracting, onboarding, and IRB approval. Maintaining continuity in sample management and clinical data collection allowed for pooling of information between sites.
Conclusions:
Adaptability is key to maintaining network sites. Rapidly changing guidelines for beginning and continuing research during the pandemic required frequent intra- and inter-institutional communication to navigate.