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Multicenter clinical trials are essential for evaluating interventions but often face significant challenges in study design, site coordination, participant recruitment, and regulatory compliance. To address these issues, the National Institutes of Health’s National Center for Advancing Translational Sciences established the Trial Innovation Network (TIN). The TIN offers a scientific consultation process, providing access to clinical trial and disease experts who provide input and recommendations throughout the trial’s duration, at no cost to investigators. This approach aims to improve trial design, accelerate implementation, foster interdisciplinary teamwork, and spur innovations that enhance multicenter trial quality and efficiency. The TIN leverages resources of the Clinical and Translational Science Awards (CTSA) program, complementing local capabilities at the investigator’s institution. The Initial Consultation process focuses on the study’s scientific premise, design, site development, recruitment and retention strategies, funding feasibility, and other support areas. As of 6/1/2024, the TIN has provided 431 Initial Consultations to increase efficiency and accelerate trial implementation by delivering customized support and tailored recommendations. Across a range of clinical trials, the TIN has developed standardized, streamlined, and adaptable processes. We describe these processes, provide operational metrics, and include a set of lessons learned for consideration by other trial support and innovation networks.
Although the link between alcohol involvement and behavioral phenotypes (e.g. impulsivity, negative affect, executive function [EF]) is well-established, the directionality of these associations, specificity to stages of alcohol involvement, and extent of shared genetic liability remain unclear. We estimate longitudinal associations between transitions among alcohol milestones, behavioral phenotypes, and indices of genetic risk.
Methods
Data came from the Collaborative Study on the Genetics of Alcoholism (n = 3681; ages 11–36). Alcohol transitions (first: drink, intoxication, alcohol use disorder [AUD] symptom, AUD diagnosis), internalizing, and externalizing phenotypes came from the Semi-Structured Assessment for the Genetics of Alcoholism. EF was measured with the Tower of London and Visual Span Tasks. Polygenic scores (PGS) were computed for alcohol-related and behavioral phenotypes. Cox models estimated associations among PGS, behavior, and alcohol milestones.
Results
Externalizing phenotypes (e.g. conduct disorder symptoms) were associated with future initiation and drinking problems (hazard ratio (HR)⩾1.16). Internalizing (e.g. social anxiety) was associated with hazards for progression from first drink to severe AUD (HR⩾1.55). Initiation and AUD were associated with increased hazards for later depressive symptoms and suicidal ideation (HR⩾1.38), and initiation was associated with increased hazards for future conduct symptoms (HR = 1.60). EF was not associated with alcohol transitions. Drinks per week PGS was linked with increased hazards for alcohol transitions (HR⩾1.06). Problematic alcohol use PGS increased hazards for suicidal ideation (HR = 1.20).
Conclusions
Behavioral markers of addiction vulnerability precede and follow alcohol transitions, highlighting dynamic, bidirectional relationships between behavior and emerging addiction.
Little and Meng (L&M) (2023) question the prevailing narrative of widespread democratic backsliding by showing that various objective indicators of democracy are flat over time. However, because recent democratic decline is concentrated in democracies, the objective indicators can accurately test for backsliding only if they can track democratic quality within democracies. This response article shows that they cannot, for conceptual and empirical reasons. The indicators generally can distinguish democracies from autocracies but are blind to variation in quality within democracies. L&M, therefore, are showing that one form of variation in democracy is stagnant but are systematically missing the very type of variation that has most informed current warnings about backsliding.
Several hypotheses may explain the association between substance use, posttraumatic stress disorder (PTSD), and depression. However, few studies have utilized a large multisite dataset to understand this complex relationship. Our study assessed the relationship between alcohol and cannabis use trajectories and PTSD and depression symptoms across 3 months in recently trauma-exposed civilians.
Methods
In total, 1618 (1037 female) participants provided self-report data on past 30-day alcohol and cannabis use and PTSD and depression symptoms during their emergency department (baseline) visit. We reassessed participant's substance use and clinical symptoms 2, 8, and 12 weeks posttrauma. Latent class mixture modeling determined alcohol and cannabis use trajectories in the sample. Changes in PTSD and depression symptoms were assessed across alcohol and cannabis use trajectories via a mixed-model repeated-measures analysis of variance.
Results
Three trajectory classes (low, high, increasing use) provided the best model fit for alcohol and cannabis use. The low alcohol use class exhibited lower PTSD symptoms at baseline than the high use class; the low cannabis use class exhibited lower PTSD and depression symptoms at baseline than the high and increasing use classes; these symptoms greatly increased at week 8 and declined at week 12. Participants who already use alcohol and cannabis exhibited greater PTSD and depression symptoms at baseline that increased at week 8 with a decrease in symptoms at week 12.
Conclusions
Our findings suggest that alcohol and cannabis use trajectories are associated with the intensity of posttrauma psychopathology. These findings could potentially inform the timing of therapeutic strategies.
Despite their long-held reputation as controlled affairs, autocratic elections continue to surprise. Recent years have seen turnovers in power or unexpected opposition gains in such far-flung places as Guinea-Bissau, Venezuela, Malaysia, and Bhutan. Of course, in many other dictatorships, ruling parties resoundingly win their elections and only increase their aura of dominance. Yet even when turnover is unlikely, elections can loom over autocratic politics like a squall line on the horizon. For instance, many observers claim that Putin’s planned reelection in 2024 makes him less willing to accept defeat in Ukraine. How do we make sense of the inner workings and surprising outcomes of these elections?
Most autocracies restrict emigration yet still allow some citizens to exit. How do these regimes decide who can leave? We argue that many autocracies strategically target anti-regime actors for emigration, thereby crafting a more loyal population without the drawbacks of persistent co-optation or repression. However, this generates problematic incentives for citizens to join opposition activity to secure exit. In response, autocracies simultaneously punish dissidents for attempting to emigrate, screening out all but the most determined opponents. To test our theory, we examine an original data set coded from over 20,000 pages of declassified emigration applications from East Germany's state archives. In the first individual-level test of an autocracy's emigration decisions, we find that active opposition promoted emigration approval but also punishment for applying. Pensioners were also more likely to secure exit, and professionals were less likely. Our results shed light on global migration's political sources and an overlooked strategy of autocratic resilience.
The use of different herbicide-resistant soybean technologies in proximity could lead to injury and yield loss due to an application error. Research was initiated to evaluate the effect of 6.25%, 12.5%, and 100% doses of isoxaflutole and mesotrione field use doses applied postemergence to 4-hyroxyphenylpyruvate (HPPD) inhibitor-susceptible soybean, representing physical drift or misapplication doses. Visible injury manifested as chlorosis with slight necrosis, progressing to necrosis and height reduction, with visible height reduction as the only symptom. Isoxaflutole at 6.25% and 12.5% injured V2 soybean more than V1 or V4 soybean at all evaluation dates. This is supported by soybean height data at 14, 28, and 42 d after treatment (DAT). Following the 100% dose, maximum injury occurred at 28 DAT with V1, V2, and V4 soybean injured 90%, 85%, and 72%, but injury declined over time. All isoxaflutole treatments reduced yield at least 310 kg ha−1, with no differences among application timings or between the two lowest doses for a revenue loss of US$147 ha−1 to US$623 ha−1. Visible injury following mesotrione manifested as chlorosis and necrosis advancing to visible height reduction. Following mesotrione at 6.25% and 12.5%, injury ranged from 20% to 36% among application timings and did not differ at 3 to 21 DAT. Soybean heights at 28 and 42 DAT do not support injury observations; therefore, the greater injury was due to chlorosis and necrosis. Following mesotrione at 100%, sensitivity decreased at 3 to 14 DAT when applied to later growth stages, with no differences at 42 DAT. Yields did not differ among application timings, but yield losses were at least 240 kg ha−1, with revenue losses of US$60 ha−1 and US$373 ha−1. Producers are cautioned to prevent off-target movement or errant application of isoxaflutole or mesotrione to HPPD inhibitor-susceptible soybean.
In 2020 a group of U.S. healthcare leaders formed the National Organization to Prevent Hospital-Acquired Pneumonia (NOHAP) to issue a call to action to address non–ventilator-associated hospital-acquired pneumonia (NVHAP). NVHAP is one of the most common and morbid healthcare-associated infections, but it is not tracked, reported, or actively prevented by most hospitals. This national call to action includes (1) launching a national healthcare conversation about NVHAP prevention; (2) adding NVHAP prevention measures to education for patients, healthcare professionals, and students; (3) challenging healthcare systems and insurers to implement and support NVHAP prevention; and (4) encouraging researchers to develop new strategies for NVHAP surveillance and prevention. The purpose of this document is to outline research needs to support the NVHAP call to action. Primary needs include the development of better models to estimate the economic cost of NVHAP, to elucidate the pathophysiology of NVHAP and identify the most promising pathways for prevention, to develop objective and efficient surveillance methods to track NVHAP, to rigorously test the impact of prevention strategies proposed to prevent NVHAP, and to identify the policy levers that will best engage hospitals in NVHAP surveillance and prevention. A joint task force developed this document including stakeholders from the Veterans’ Health Administration (VHA), the U.S. Centers for Disease Control and Prevention (CDC), The Joint Commission, the American Dental Association, the Patient Safety Movement Foundation, Oral Health Nursing Education and Practice (OHNEP), Teaching Oral-Systemic Health (TOSH), industry partners and academia.
A primary barrier to translation of clinical research discoveries into care delivery and population health is the lack of sustainable infrastructure bringing researchers, policymakers, practitioners, and communities together to reduce silos in knowledge and action. As National Institutes of Healthʼs (NIH) mechanism to advance translational research, Clinical and Translational Science Award (CTSA) awardees are uniquely positioned to bridge this gap. Delivering on this promise requires sustained collaboration and alignment between research institutions and public health and healthcare programs and services. We describe the collaboration of seven CTSA hubs with city, county, and state healthcare and public health organizations striving to realize this vision together. Partnership representatives convened monthly to identify key components, common and unique themes, and barriers in academic–public collaborations. All partnerships aligned the activities of the CTSA programs with the needs of the city/county/state partners, by sharing resources, responding to real-time policy questions and training needs, promoting best practices, and advancing community-engaged research, and dissemination and implementation science to narrow the knowledge-to-practice gap. Barriers included competing priorities, differing timelines, bureaucratic hurdles, and unstable funding. Academic–public health/health system partnerships represent a unique and underutilized model with potential to enhance community and population health.
When autocratic ruling parties accede to democratization, they do not always fade away into history. Following forty-one transitions since 1940, including those in Mexico, Taiwan, Bulgaria and Ghana, the ruling party survived and won power after democratization. Why do some former autocratic parties prosper under democracy while others quickly dissolve? What effect does this have on democratic survival? This article uses original data to predict the post-transition fates of eighty-four autocratic ruling parties through 2015. Whereas extant theories emphasize radical reinvention and outsider struggle, the author argues that success is instead about maintaining ruling-party advantages into the democratic period. Parties succeed when they have authoritarian legacies that easily translate to democratic competition, such as broad programmatic experience, strong organization and policy success. In addition, democratic institutions that disadvantage new parties and actors benefit autocratic parties. Lastly, an instrumental variables design shows that autocratic party success negatively impacts democratic survival and quality.
Species distribution models (SDMs) are statistical tools used to develop continuous predictions of species occurrence. ‘Integrated SDMs’ (ISDMs) are an elaboration of this approach with potential advantages that allow for the dual use of opportunistically collected presence-only data and site-occupancy data from planned surveys. These models also account for survey bias and imperfect detection through the use of a hierarchical modelling framework that separately estimates the species–environment response and detection process. This is particularly helpful for conservation applications and predictions for rare species, where data are often limited and prediction errors may have significant management consequences. Despite this potential importance, ISDMs remain largely untested under a variety of scenarios. We performed an exploration of key modelling decisions and assumptions on an ISDM using the endangered Baird’s tapir (Tapirus bairdii) as a test species. We found that site area had the strongest effect on the magnitude of population estimates and underlying intensity surface and was driven by estimates of model intercepts. Selecting a site area that accounted for the individual movements of the species within an average home range led to population estimates that coincided with expert estimates. ISDMs that do not account for the individual movements of species will likely lead to less accurate estimates of species intensity (number of individuals per unit area) and thus overall population estimates. This bias could be severe and highly detrimental to conservation actions if uninformed ISDMs are used to estimate global populations of threatened and data-deficient species, particularly those that lack natural history and movement information. However, the ISDM was consistently the most accurate model compared to other approaches, which demonstrates the importance of this new modelling framework and the ability to combine opportunistic data with systematic survey data. Thus, we recommend researchers use ISDMs with conservative movement information when estimating population sizes of rare and data-deficient species. ISDMs could be improved by using a similar parameterization to spatial capture–recapture models that explicitly incorporate animal movement as a model parameter, which would further remove the need for spatial subsampling prior to implementation.
Good education requires student experiences that deliver lessons about practice as well as theory and that encourage students to work for the public good—especially in the operation of democratic institutions (Dewey 1923; Dewy 1938). We report on an evaluation of the pedagogical value of a research project involving 23 colleges and universities across the country. Faculty trained and supervised students who observed polling places in the 2016 General Election. Our findings indicate that this was a valuable learning experience in both the short and long terms. Students found their experiences to be valuable and reported learning generally and specifically related to course material. Postelection, they also felt more knowledgeable about election science topics, voting behavior, and research methods. Students reported interest in participating in similar research in the future, would recommend other students to do so, and expressed interest in more learning and research about the topics central to their experience. Our results suggest that participants appreciated the importance of elections and their study. Collectively, the participating students are engaged and efficacious—essential qualities of citizens in a democracy.
What determines citizens’ freedom to exit autocracies? How does this influence global patterns of migration and democratization? Although control over citizen movement has long been central to autocratic power, modern autocracies vary considerably in how much they restrict emigration. This article shows that autocrats strategically choose emigration policy by balancing several motives. Increasing emigration can stabilize regimes by selecting a more loyal population and attracting greater investment, trade and remittances, but exposing their citizens to democracy abroad is potentially dangerous. Using a half-century of bilateral migration data, the study calculates the level and destinations of expected emigration given exogenous geographic and socioeconomic characteristics. It finds that when citizens disproportionately emigrate to democracies, countries are more likely to democratize – and that autocrats restrict emigration freedom in response. In contrast, a larger expected flow of economic emigration predicts autocratic survival and freer emigration policy. These results have important implications for autocratic politics, democratic diffusion and the political sources of migration.
Why do autocrats hold multiparty elections? This article argues that transitions to electoral authoritarianism (EA) follow a strategic calculus in which autocrats balance international incentives to adopt elections against the costs and risks of controlling them. It tests this hypothesis with a multinomial logit model that simultaneously predicts transitions to EA and democracy, using a sample of non-electoral autocracies from 1946–2010. It finds that pro-democratic international leverage – captured by dependence on democracies through trade ties, military alliances, international governmental organizations and aid – predicts EA adoption. Socio-economic factors that make voters easier to control, such as low average income and high inequality, also predict EA transition. In contrast, since democratization entails a loss of power for autocrats, it is mainly predicted by regime weakness rather than international engagement or socio-economic factors. The results demonstrate that different forms of liberalization follow distinct logics, providing insight into autocratic regime dynamics and democracy promotion’s unintended effects.
Democracy is often fragile, especially in states recovering from civil conflict. To protect emerging democracies, many scholars and practitioners recommend political powersharing institutions, which aim to safeguard minority group interests. Yet there is little empirical research on whether powersharing promotes democratic survival, and some concern that it limits electoral accountability. To fill this gap, we differentiate between inclusive, dispersive, and constraining powersharing institutions and analyze their effects on democratic survival from 1975 to 2015 using a global dataset. We find sharp distinctions across types of powersharing and political context. Inclusive powersharing, such as ethnic quotas, promotes democratic survival only in post-conflict settings. In contrast, dispersive institutions such as federalism tend to destabilize post-conflict democracies. Only constraining powersharing consistently facilitates democratic survival regardless of recent conflict. Institution-builders and international organizations should therefore prioritize institutions that constrain leaders, including independent judiciaries, civilian control of the armed forces, and constitutional protections of individual and group rights.
New dating confirms that people occupied the Australian continent before the earliest time inferred from conventional radiocarbon analysis. Many of the new ages were obtained by accelerator mass spectrometry 14C dating after an acid–base–acid pretreatment with bulk combustion (ABA-BC) or after a newly developed acid–base–wet oxidation pretreatment with stepped combustion (ABOX-SC). The samples (charcoal) came from the earliest occupation levels of the Devil's Lair site in southwestern Western Australia. Initial occupation of this site was previously dated 35,000 14C yr B.P. Whereas the ABA-BC ages are indistinguishable from background beyond 42,000 14C yr B.P., the ABOX-SC ages are in stratigraphic order to ∼55,000 14C yr B.P. The ABOX-SC chronology suggests that people were in the area by 48,000 cal yr B.P. Optically stimulated luminescence (OSL), electron spin resonance (ESR) ages, U-series dating of flowstones, and 14C dating of emu eggshell carbonate are in agreement with the ABOX-SC 14C chronology. These results, based on four independent techniques, reinforce arguments for early colonization of the Australian continent.
Johnsongrass control in fallowed sugarcane fields was evaluated with glyphosate and the graminicides quizalofop, fluazifop, and clethodim applied in soybean compared with nonsoybean tillage and glyphosate programs. Glyphosate was applied to glyphosate-resistant soybean as a single early postemergence (EPOST) treatment around 30 d after planting (DAP) at rates of 840, 1,120, or 2,240 g ai/ha; as sequential treatments EPOST and late postemergence (LPOST) around 60 DAP at 560 followed by (fb) 560 or 1,120 fb 1,120 g/ha; or as a single LPOST treatment at 2,240 g/ha. Quizalofop at 77 g ai/ha, fluazifop at 420 g ai/ha, and clethodim at 280 g ai/ha were also evaluated as single EPOST treatments. In 1996 johnsongrass control 7 d after EPOST treatment (DAT) was at least 90% for glyphosate treatments but control was 73 to 77% for the graminicides. In 1997 johnsongrass control 7 DAT was at least 82% for all herbicide treatments. Excellent johnsongrass control approximately 50 DAT was achieved both years with all the glyphosate and graminicide treatments. In the nonsoybean fallow weed control programs where plots were tilled twice or three times fb one or two glyphosate applications, complete control of johnsongrass was obtained both years. In 1996 when glyphosate was applied EPOST or EPOST fb LPOST, soybean yields were equivalent and averaged 3.3 times that of the single LPOST glyphosate application. Soybean yields where the graminicides were used and where glyphosate was applied as a single LPOST treatment were no greater than the nontreated control. Economic analysis on the basis of soybean yield data and variable costs of herbicides, seed, field application, seedbed preparation, tillage, labor, fuel, repairs, and custom harvest expense in 1996 showed a positive net return only for glyphosate applied EPOST at 840 g/ha ($99.82/ha) or 1,120 g/ha ($46.94/ha) and for glyphosate applied at 560 g/ha EPOST fb LPOST ($10.41/ha). Although showing a negative net return, glyphosate applied EPOST at 2,240 g/ha ($−8.32/ha) or EPOST fb LPOST at 1,120 g/ha ($−50.97/ha), the loss was less than that for nonsoybean fallow tillage and glyphosate programs ($−155.70/ha and $−157.78/ha). In 1997, when soybean was not harvested because of environmental conditions, variable costs exceeded those of the nonsoybean programs, indicating that planting soybean strictly as a cover crop would not be economically advantageous. Sugarcane growth and yield the year following the fallow programs was not negatively affected by production of soybean regardless of herbicide program.