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Efficient evidence generation to assess the clinical and economic impact of medical therapies is critical amid rising healthcare costs and aging populations. However, drug development and clinical trials remain far too expensive and inefficient for all stakeholders. On October 25–26, 2023, the Duke Clinical Research Institute brought together leaders from academia, industry, government agencies, patient advocacy, and nonprofit organizations to explore how different entities and influencers in drug development and healthcare can realign incentive structures to efficiently accelerate evidence generation that addresses the highest public health needs. Prominent themes surfaced, including competing research priorities and incentives, inadequate representation of patient population in clinical trials, opportunities to better leverage existing technology and infrastructure in trial design, and a need for heightened transparency and accountability in research practices. The group determined that together these elements contribute to an inefficient and costly clinical research enterprise, amplifying disparities in population health and sustaining gaps in evidence that impede advancements in equitable healthcare delivery and outcomes. The goal of addressing the identified challenges is to ultimately make clinical trials faster, more inclusive, and more efficient across diverse communities and settings.
Coastal wetlands are hotspots of carbon sequestration, and their conservation and restoration can help to mitigate climate change. However, there remains uncertainty on when and where coastal wetland restoration can most effectively act as natural climate solutions (NCS). Here, we synthesize current understanding to illustrate the requirements for coastal wetland restoration to benefit climate, and discuss potential paths forward that address key uncertainties impeding implementation. To be effective as NCS, coastal wetland restoration projects will accrue climate cooling benefits that would not occur without management action (additionality), will be implementable (feasibility) and will persist over management-relevant timeframes (permanence). Several issues add uncertainty to understanding if these minimum requirements are met. First, coastal wetlands serve as both a landscape source and sink of carbon for other habitats, increasing uncertainty in additionality. Second, coastal wetlands can potentially migrate outside of project footprints as they respond to sea-level rise, increasing uncertainty in permanence. To address these first two issues, a system-wide approach may be necessary, rather than basing cooling benefits only on changes that occur within project boundaries. Third, the need for NCS to function over management-relevant decadal timescales means methane responses may be necessary to include in coastal wetland restoration planning and monitoring. Finally, there is uncertainty on how much data are required to justify restoration action. We summarize the minimum data required to make a binary decision on whether there is a net cooling benefit from a management action, noting that these data are more readily available than the data required to quantify the magnitude of cooling benefits for carbon crediting purposes. By reducing uncertainty, coastal wetland restoration can be implemented at the scale required to significantly contribute to addressing the current climate crisis.
Knowledge of sex differences in risk factors for posttraumatic stress disorder (PTSD) can contribute to the development of refined preventive interventions. Therefore, the aim of this study was to examine if women and men differ in their vulnerability to risk factors for PTSD.
Methods
As part of the longitudinal AURORA study, 2924 patients seeking emergency department (ED) treatment in the acute aftermath of trauma provided self-report assessments of pre- peri- and post-traumatic risk factors, as well as 3-month PTSD severity. We systematically examined sex-dependent effects of 16 risk factors that have previously been hypothesized to show different associations with PTSD severity in women and men.
Results
Women reported higher PTSD severity at 3-months post-trauma. Z-score comparisons indicated that for five of the 16 examined risk factors the association with 3-month PTSD severity was stronger in men than in women. In multivariable models, interaction effects with sex were observed for pre-traumatic anxiety symptoms, and acute dissociative symptoms; both showed stronger associations with PTSD in men than in women. Subgroup analyses suggested trauma type-conditional effects.
Conclusions
Our findings indicate mechanisms to which men might be particularly vulnerable, demonstrating that known PTSD risk factors might behave differently in women and men. Analyses did not identify any risk factors to which women were more vulnerable than men, pointing toward further mechanisms to explain women's higher PTSD risk. Our study illustrates the need for a more systematic examination of sex differences in contributors to PTSD severity after trauma, which may inform refined preventive interventions.
Stress and diabetes coexist in a vicious cycle. Different types of stress lead to diabetes, while diabetes itself is a major life stressor. This was the focus of the Chicago Biomedical Consortium’s 19th annual symposium, “Stress and Human Health: Diabetes,” in November 2022. There, researchers primarily from the Chicago area met to explore how different sources of stress – from the cells to the community – impact diabetes outcomes. Presenters discussed the consequences of stress arising from mutant proteins, obesity, sleep disturbances, environmental pollutants, COVID-19, and racial and socioeconomic disparities. This symposium showcased the latest diabetes research and highlighted promising new treatment approaches for mitigating stress in diabetes.
The U.S. Department of Agriculture–Agricultural Research Service (USDA-ARS) has been a leader in weed science research covering topics ranging from the development and use of integrated weed management (IWM) tactics to basic mechanistic studies, including biotic resistance of desirable plant communities and herbicide resistance. ARS weed scientists have worked in agricultural and natural ecosystems, including agronomic and horticultural crops, pastures, forests, wild lands, aquatic habitats, wetlands, and riparian areas. Through strong partnerships with academia, state agencies, private industry, and numerous federal programs, ARS weed scientists have made contributions to discoveries in the newest fields of robotics and genetics, as well as the traditional and fundamental subjects of weed–crop competition and physiology and integration of weed control tactics and practices. Weed science at ARS is often overshadowed by other research topics; thus, few are aware of the long history of ARS weed science and its important contributions. This review is the result of a symposium held at the Weed Science Society of America’s 62nd Annual Meeting in 2022 that included 10 separate presentations in a virtual Weed Science Webinar Series. The overarching themes of management tactics (IWM, biological control, and automation), basic mechanisms (competition, invasive plant genetics, and herbicide resistance), and ecosystem impacts (invasive plant spread, climate change, conservation, and restoration) represent core ARS weed science research that is dynamic and efficacious and has been a significant component of the agency’s national and international efforts. This review highlights current studies and future directions that exemplify the science and collaborative relationships both within and outside ARS. Given the constraints of weeds and invasive plants on all aspects of food, feed, and fiber systems, there is an acknowledged need to face new challenges, including agriculture and natural resources sustainability, economic resilience and reliability, and societal health and well-being.
From 2014 to 2020, we compiled radiocarbon ages from the lower 48 states, creating a database of more than 100,000 archaeological, geological, and paleontological ages that will be freely available to researchers through the Canadian Archaeological Radiocarbon Database. Here, we discuss the process used to compile ages, general characteristics of the database, and lessons learned from this exercise in “big data” compilation.
To describe the cumulative seroprevalence of severe acute respiratory coronavirus virus 2 (SARS-CoV-2) antibodies during the coronavirus disease 2019 (COVID-19) pandemic among employees of a large pediatric healthcare system.
Design, setting, and participants:
Prospective observational cohort study open to adult employees at the Children’s Hospital of Philadelphia, conducted April 20–December 17, 2020.
Methods:
Employees were recruited starting with high-risk exposure groups, utilizing e-mails, flyers, and announcements at virtual town hall meetings. At baseline, 1 month, 2 months, and 6 months, participants reported occupational and community exposures and gave a blood sample for SARS-CoV-2 antibody measurement by enzyme-linked immunosorbent assays (ELISAs). A post hoc Cox proportional hazards regression model was performed to identify factors associated with increased risk for seropositivity.
Results:
In total, 1,740 employees were enrolled. At 6 months, the cumulative seroprevalence was 5.3%, which was below estimated community point seroprevalence. Seroprevalence was 5.8% among employees who provided direct care and was 3.4% among employees who did not perform direct patient care. Most participants who were seropositive at baseline remained positive at follow-up assessments. In a post hoc analysis, direct patient care (hazard ratio [HR], 1.95; 95% confidence interval [CI], 1.03–3.68), Black race (HR, 2.70; 95% CI, 1.24–5.87), and exposure to a confirmed case in a nonhealthcare setting (HR, 4.32; 95% CI, 2.71–6.88) were associated with statistically significant increased risk for seropositivity.
Conclusions:
Employee SARS-CoV-2 seroprevalence rates remained below the point-prevalence rates of the surrounding community. Provision of direct patient care, Black race, and exposure to a confirmed case in a nonhealthcare setting conferred increased risk. These data can inform occupational protection measures to maximize protection of employees within the workplace during future COVID-19 waves or other epidemics.
While evidence-based psychotherapy (EBP) for posttraumatic stress disorder (PTSD) is a first-line treatment, its real-world effectiveness is unknown. We compared cognitive processing therapy (CPT) and prolonged exposure (PE) each to an individual psychotherapy comparator group, and CPT to PE in a large national healthcare system.
Methods
We utilized effectiveness and comparative effectiveness emulated trials using retrospective cohort data from electronic medical records. Participants were veterans with PTSD initiating mental healthcare (N = 265 566). The primary outcome was PTSD symptoms measured by the PTSD Checklist (PCL) at baseline and 24-week follow-up. Emulated trials were comprised of ‘person-trials,’ representing 112 discrete 24-week periods of care (10/07–6/17) for each patient. Treatment group comparisons were made with generalized linear models, utilizing propensity score matching and inverse probability weights to account for confounding, selection, and non-adherence bias.
Results
There were 636 CPT person-trials matched to 636 non-EBP person-trials. Completing ⩾8 CPT sessions was associated with a 6.4-point greater improvement on the PCL (95% CI 3.1–10.0). There were 272 PE person-trials matched to 272 non-EBP person-trials. Completing ⩾8 PE sessions was associated with a 9.7-point greater improvement on the PCL (95% CI 5.4–13.8). There were 232 PE person-trials matched to 232 CPT person-trials. Those completing ⩾8 PE sessions had slightly greater, but not statistically significant, improvement on the PCL (8.3-points; 95% CI 5.9–10.6) than those completing ⩾8 CPT sessions (7.0-points; 95% CI 5.5–8.5).
Conclusions
PTSD symptom improvement was similar and modest for both EBPs. Although EBPs are helpful, research to further improve PTSD care is critical.
Item 9 of the Patient Health Questionnaire-9 (PHQ-9) queries about thoughts of death and self-harm, but not suicidality. Although it is sometimes used to assess suicide risk, most positive responses are not associated with suicidality. The PHQ-8, which omits Item 9, is thus increasingly used in research. We assessed equivalency of total score correlations and the diagnostic accuracy to detect major depression of the PHQ-8 and PHQ-9.
Methods
We conducted an individual patient data meta-analysis. We fit bivariate random-effects models to assess diagnostic accuracy.
Results
16 742 participants (2097 major depression cases) from 54 studies were included. The correlation between PHQ-8 and PHQ-9 scores was 0.996 (95% confidence interval 0.996 to 0.996). The standard cutoff score of 10 for the PHQ-9 maximized sensitivity + specificity for the PHQ-8 among studies that used a semi-structured diagnostic interview reference standard (N = 27). At cutoff 10, the PHQ-8 was less sensitive by 0.02 (−0.06 to 0.00) and more specific by 0.01 (0.00 to 0.01) among those studies (N = 27), with similar results for studies that used other types of interviews (N = 27). For all 54 primary studies combined, across all cutoffs, the PHQ-8 was less sensitive than the PHQ-9 by 0.00 to 0.05 (0.03 at cutoff 10), and specificity was within 0.01 for all cutoffs (0.00 to 0.01).
Conclusions
PHQ-8 and PHQ-9 total scores were similar. Sensitivity may be minimally reduced with the PHQ-8, but specificity is similar.
Different diagnostic interviews are used as reference standards for major depression classification in research. Semi-structured interviews involve clinical judgement, whereas fully structured interviews are completely scripted. The Mini International Neuropsychiatric Interview (MINI), a brief fully structured interview, is also sometimes used. It is not known whether interview method is associated with probability of major depression classification.
Aims
To evaluate the association between interview method and odds of major depression classification, controlling for depressive symptom scores and participant characteristics.
Method
Data collected for an individual participant data meta-analysis of Patient Health Questionnaire-9 (PHQ-9) diagnostic accuracy were analysed and binomial generalised linear mixed models were fit.
Results
A total of 17 158 participants (2287 with major depression) from 57 primary studies were analysed. Among fully structured interviews, odds of major depression were higher for the MINI compared with the Composite International Diagnostic Interview (CIDI) (odds ratio (OR) = 2.10; 95% CI = 1.15–3.87). Compared with semi-structured interviews, fully structured interviews (MINI excluded) were non-significantly more likely to classify participants with low-level depressive symptoms (PHQ-9 scores ≤6) as having major depression (OR = 3.13; 95% CI = 0.98–10.00), similarly likely for moderate-level symptoms (PHQ-9 scores 7–15) (OR = 0.96; 95% CI = 0.56–1.66) and significantly less likely for high-level symptoms (PHQ-9 scores ≥16) (OR = 0.50; 95% CI = 0.26–0.97).
Conclusions
The MINI may identify more people as depressed than the CIDI, and semi-structured and fully structured interviews may not be interchangeable methods, but these results should be replicated.
Declaration of interest
Drs Jetté and Patten declare that they received a grant, outside the submitted work, from the Hotchkiss Brain Institute, which was jointly funded by the Institute and Pfizer. Pfizer was the original sponsor of the development of the PHQ-9, which is now in the public domain. Dr Chan is a steering committee member or consultant of Astra Zeneca, Bayer, Lilly, MSD and Pfizer. She has received sponsorships and honorarium for giving lectures and providing consultancy and her affiliated institution has received research grants from these companies. Dr Hegerl declares that within the past 3 years, he was an advisory board member for Lundbeck, Servier and Otsuka Pharma; a consultant for Bayer Pharma; and a speaker for Medice Arzneimittel, Novartis, and Roche Pharma, all outside the submitted work. Dr Inagaki declares that he has received grants from Novartis Pharma, lecture fees from Pfizer, Mochida, Shionogi, Sumitomo Dainippon Pharma, Daiichi-Sankyo, Meiji Seika and Takeda, and royalties from Nippon Hyoron Sha, Nanzando, Seiwa Shoten, Igaku-shoin and Technomics, all outside of the submitted work. Dr Yamada reports personal fees from Meiji Seika Pharma Co., Ltd., MSD K.K., Asahi Kasei Pharma Corporation, Seishin Shobo, Seiwa Shoten Co., Ltd., Igaku-shoin Ltd., Chugai Igakusha and Sentan Igakusha, all outside the submitted work. All other authors declare no competing interests. No funder had any role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication.
Background: Measurement of cognitive behavioural therapy (CBT) competency is often resource intensive. A popular emerging alternative to independent observers’ ratings is using other perspectives for rating competency. Aims: This pilot study compared ratings of CBT competency from four perspectives – patient, therapist, supervisor and independent observer using the Cognitive Therapy Scale (CTS). Method: Patients (n = 12, 75% female, mean age 30.5 years) and therapists (n = 5, female, mean age 26.6 years) completed the CTS after therapy sessions, and clinical supervisor and independent observers rated recordings of the same session. Results: Analyses of variance revealed that therapist average CTS competency ratings were not different from supervisor ratings, and supervisor ratings were not different from independent observer ratings; however, therapist ratings were higher than independent observer ratings and patient ratings were higher than all other raters. Conclusions: Raters differed in competency ratings. Implications for potential use and adaptation of CBT competency measurement methods to enhance training and implementation are discussed.
Doveweed is a problematic weed of lawns and sod production, as well as golf course roughs, fairways, and tees. End-user reports of selective POST control options are inconsistent and control is often short-lived. In addition, inconsistent control with non-selective herbicides such as glyphosate is common. The goals of this research were: (1) evaluate selective POST doveweed control options in ‘Tifway’ hybrid bermudagrass turf; (2) compare efficacy of single vs. sequential applications of selective POST herbicides; (3) quantify doveweed tolerance to glyphosate; and (4) quantify recovery of foliar applied glyphosate following treatment with a C14-glyphosate solution. A single application of sulfentrazone+metsulfuron; thiencarbazone+iodosulfuron+dicamba or 2,4-D+MCPP+dicamba+carfentrazone; or thiencarbazone+foramsulfuron+halosulfuron provided >60% control 2 weeks after initial treatment (WAIT). A second application of these treatments 3 WAIT improved control 6 WAIT. Two applications of 2,4-D+MCPP+dicamba+carfentrazone or thiencarbazone+foramsulfuron+halosulfuron provided ~80% control 6 WAIT. Doveweed was tolerant to glyphosate application up to 5.68 kgaeha-1. Absorption of 14C-glyphosate was compared between doveweed with cuticle intact, doveweed with a disturbed cuticle, and smooth crabgrass. 14C-glyphosate recovery from the leaf surface of doveweed plants with an intact cuticle was 93.6%. In comparison, 14C-glyphosate recovery from the leaf surface of doveweed plants with a disrupted cuticle and the leaf surface of crabgrass plants was 79.1 and 70.5%, respectively.
A growth chamber study was conducted to evaluate the effects of temperature and soil moisture on the absorption and translocation of the new sulfonylurea herbicide, MON 37500, in wheat, jointed goatgrass, wild oat, and downy brome. Treatment combinations of temperatures—25/23, 15/13, and 5/3 C—and soil moistures of one-third, two-thirds, and full field capacities were assigned to the germinated plants. Radiolabeled MON 37500 was applied to the second leaf of plants at the three-leaf stage. The plants were then harvested at 6, 24, and 96 h after application. The plants absorbed MON 37500 in the greatest quantity during the first 6 h; however, absorption did continue to increase over time. Absorption was highest in wheat and lowest in wild oat. Temperature influenced absorption, while soil moisture status appeared to have no effect. Translocation of radiolabeled material out of the treated leaf increased over time; however, 90 to 97% of absorbed radioactivity remained in the treated leaf 96 h after treatment. Temperature affected translocation differently in each species, but increasing soil moisture increased translocation.
Previous research has examined the extent to which red rice affects both yield and grain quality of cultivated rice. However, this research was conducted over 15 yr ago. Modern long-grain rice cultivars have the potential to produce yields above 10,000 kg ha−1; however, it is unknown whether modern rice cultivars sacrifice competitiveness to achieve higher yields, or if, in fact, they are more competitive. Field studies were conducted in 2002 and 2003 at the Southeast Research and Extension Center near Rohwer, AR, and at the University of Arkansas Pine Bluff Research Farm near Lonoke, AR, to investigate the effect of red rice density on interference between red rice and five rice cultivars (‘CL161’, ‘Cocodrie’, ‘LaGrue’, ‘Lemont’, and ‘XL8’). White rice yield reductions were between 100 and 755 kg ha−1 for every red rice plant m−2. The hybrid rice, XL8, had higher yields than the conventional cultivars. Red rice contamination in milling samples increased linearly as a function of red rice density at Lonoke and Rohwer in 2003. Dockage for each cultivar was calculated on the basis of the relationship between red rice density and red rice contamination. Semidwarf Lemont was the most contaminated and hybrid XL8 the least contaminated by the various densities of red rice.
Although Ptychodus teeth are well known in Late Cretaceous marine deposits in North America and Europe and a few specimens with jaw elements have been discovered, the taxonomic position of the shark genus Ptychodus is enigmatic due to the lack of preservation of diagnostic material other than teeth. These sharks possessed a pavement dentition suited to a diet of hard-shelled macroinvertebrates (durophagy), leading several studies to variously describe Ptychodus as a batoid, a hybodont shark, or a selachimorph. Members of the Selachimorpha share one dental synapomorphy, a triple-layered enameloid (TLE) consisting of an outer shiny-layered enameloid (SLE) of randomly oriented hydroxyapatite crystallites, a middle layer of parallel-bundled enameloid (PBE), and an inner layer of tangled-bundled enameloid (TBE). Batoids and hybodonts both have teeth with single crystallite enameloid (SCE). We examined teeth from Ptychodus collected from the Lincoln Limestone of the Greenhorn Formation of Barton County, Kansas, and compared their enameloid ultrastructure with that of a Carboniferous hybodontiform and the Cretaceous lamniform shark Squalicorax curvatus Williston, 1900. Scanning electron microscopic examination of Ptychodus shows that crystallite bundling in the form of a TLE is evident in these teeth. The PBE is most apparent at transverse enameloid ridges of Ptychodus teeth. Columns of dentine penetrate into the tooth enameloid, and the crystallites near the dentine are randomly oriented. These observations bolster the argument that Ptychodus is a genus of highly specialized selachimorph shark, rather than a hybodont or batoid.