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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.
The trade war with China has cost US producers and consumers hundreds of billions of dollars since 2018. Yet relatively few US businesses took action to oppose it. This study reports the results of an elite survey experiment on business political activity toward trade policy. Researchers presented business managers with information about the input costs of the new tariffs to their bottom line—information that most subjects acknowledged that they lacked—and invited them to take political action to express support or opposition to these tariffs. The results suggest that the novel information on economic costs did not significantly increase managers’ propensity to contact members of Congress, donate to political campaigns, sign petitions, or join social media groups. We also found that the firm’s political culture (liberal or conservative) did not significantly influence the effectiveness of the treatment. However, descriptive analysis showed that firm political culture was strongly related to the company’s support for the trade war, suggesting that these preexisting political beliefs were resistant to new information provided in our experiment even if that information could affect the company’s bottom line.
Various electrocardiogram (ECG)-based devices are available for home monitoring, but the reliability in adults with CHD is unknown. Therefore, we determined the accuracy of different ECG-based devices compared to the standard 12-lead ECG in adult CHD.
Methods and results:
This is a single-centre, prospective, cross-sectional study in 176 consecutive adults with CHD (54% male, age 40 ± 16.6 years, 24% severe CHD, 84% previous surgery, 3% atrial fibrillation (AF), 24% right bundle branch block). Diagnostic accuracy of the Withings Scanwatch (lead I), Eko DUO (precordial lead), and Kardia 6L (six leads) was determined in comparison to the standard 12-lead ECG on several tasks: 1) AF classification (percentage correct), 2) QRS-morphology classification (percentage correct), and 3) ECG intervals calculation (QTc time ≤ 40 ms difference). Both tested AF algorithms had high accuracy (Withings: 100%, Kardia 6L: 97%) in ECGs that were classified. However, the Withings algorithm classified fewer ECGs as inconclusive (5%) compared to 31% of Kardia (p < 0.001). Physician evaluation of Kardia correctly classified QRS morphology more frequently (90% accuracy) compared to Eko DUO (84% accuracy) (p = 0.03). QTc was underestimated on all ECG-based devices (p < 0.01). QTc duration accuracy was acceptable in only 51% of Withings versus 70% Eko and 74% Kardia (p < 0.001 for both comparisons).
Conclusions:
Although all devices demonstrated high accuracy in AF detection, the Withings automatic algorithm had fewest uninterpretable results. Kardia 6L was most accurate in overall evaluation such as QRS morphology and QTc duration. These findings can inform both patients and caregivers for optimal choice of home monitoring.
The Trial Innovation Network (TIN) is a collaborative initiative within the National Center for Advancing Translational Science (NCATS) Clinical and Translational Science Awards (CTSA) Program. To improve and innovate the conduct of clinical trials, it is exploring the uses of gamification to better engage the trial workforce and improve the efficiencies of trial activities. The gamification structures described in this article are part of a TIN website gamification toolkit, available online to the clinical trial scientific community.
Methods:
The game designers used existing electronic trial platforms to gamify the tasks required to meet trial start-up timelines to create friendly competitions. Key indicators and familiar metrics were mapped to scoreboards. Webinars were organized to share and applaud trial and game performance.
Results:
Game scores were significantly associated with an increase in achieving start-up milestones in activation, institutional review board (IRB) submission, and IRB approval times, indicating the probability of completing site activation faster by using games. Overall game enjoyment and feelings that the game did not apply too much pressure appeared to be an important moderator of performance in one trial but had little effect on performance in a second.
Conclusion:
This retrospective examination of available data from gaming experiences may be a first-of-kind use in clinical trials. There are signals that gaming may accelerate performance and increase enjoyment during the start-up phase of a trial. Isolating the effect of gamification on trial outcomes will depend on a larger sampling from future trials, using well-defined, hypothesis-driven statistical analysis plans.
Perfectionism, low self-esteem and external locus of control are psychological constructs linked to insomnia, anxiety and depression. Examining how these constructs impact mental health and serve as risk factors for the development of clinically significant symptoms may help direct psychological support resources and preventative measures for university students.
Aims
To longitudinally examine associations between the aforementioned psychological constructs and symptoms of insomnia, anxiety and depression in a large representative sample of first-year university students.
Method
Electronic surveys including validated measures of the predictors and outcomes were emailed to all first-year undergraduate students at entry to a major Canadian university, and followed up on at conclusion of the academic year.
Results
Compared with healthy sleepers, students screening positive for insomnia had lower self-esteem, higher self-evaluative perfectionism and increased external locus of control (all P < 0.001). Self-evaluative perfectionism (standardised β = 0.13, P < 0.01), self-esteem (β = −0.30, P < 0.001) and external locus of control (β = 0.07, P = 0.02) measured at entry were significantly associated with insomnia symptoms at follow-up. Insomnia symptoms at entry were strong predictors of symptoms of depression (β = 0.15, P < 0.001) and anxiety (β = 0.16, P < 0.001) at follow-up, even after controlling for baseline symptoms of those disorders.
Conclusions
Perfectionism, low self-esteem and external locus of control may predispose the development of insomnia symptoms in university students. In turn, insomnia symptoms appear to be robust predictors for depressive and anxiety symptoms. Sleep may be an important prevention target in university students.
The 2020 update of the Canadian Stroke Best Practice Recommendations (CSBPR) for the Secondary Prevention of Stroke includes current evidence-based recommendations and expert opinions intended for use by clinicians across a broad range of settings. They provide guidance for the prevention of ischemic stroke recurrence through the identification and management of modifiable vascular risk factors. Recommendations address triage, diagnostic testing, lifestyle behaviors, vaping, hypertension, hyperlipidemia, diabetes, atrial fibrillation, other cardiac conditions, antiplatelet and anticoagulant therapies, and carotid and vertebral artery disease. This update of the previous 2017 guideline contains several new or revised recommendations. Recommendations regarding triage and initial assessment of acute transient ischemic attack (TIA) and minor stroke have been simplified, and selected aspects of the etiological stroke workup are revised. Updated treatment recommendations based on new evidence have been made for dual antiplatelet therapy for TIA and minor stroke; anticoagulant therapy for atrial fibrillation; embolic strokes of undetermined source; low-density lipoprotein lowering; hypertriglyceridemia; diabetes treatment; and patent foramen ovale management. A new section has been added to provide practical guidance regarding temporary interruption of antithrombotic therapy for surgical procedures. Cancer-associated ischemic stroke is addressed. A section on virtual care delivery of secondary stroke prevention services in included to highlight a shifting paradigm of care delivery made more urgent by the global pandemic. In addition, where appropriate, sex differences as they pertain to treatments have been addressed. The CSBPR include supporting materials such as implementation resources to facilitate the adoption of evidence into practice and performance measures to enable monitoring of uptake and effectiveness of recommendations.
A large proportion of antibiotic use associated with hospitalization occurs immediately after discharge, representing an important focus for antimicrobial stewardship programs. This review identified few studies evaluating the effect of interventions aimed at improving discharge antibiotic prescribing. Antimicrobial stewardship to improve postdischarge antibiotic prescribing is an unmet need warranting further study.
General practices play an important role in the detection and treatment of depressive symptoms in older adults. An adapted version of the indicated preventive life review therapy group intervention called Looking for Meaning (LFM) was developed for general practice and a pilot evaluation was conducted.
Design:
A pretest-posttest design was used. One week before and one week after the intervention participants filled out questionnaires.
Setting:
In six general practices in the Netherlands the adapted intervention was given.
Participants:
Inclusion criteria were > 60 years and a score of 5 or higher on the Center for Epidemiological Studies Depression Scale (CES-D).
Intervention:
The length and number of LFM sessions were shortened and the intervention was given by one mental health care nurse practitioner (MHCNP).
Measurements:
The impact on mental health was analyzed by depressive symptoms (CES-D) as the primary outcome and anxiety symptoms (HADS-A), psychological well-being (PGCMS) and mastery (PMS) as secondary outcomes. An evaluative questionnaire was included to evaluate the feasibility and acceptability.
Results:
Most participants were satisfied with the adaptations of the number (72%) and length (72%) of sessions. The overall sample showed a significant decrease in depressive symptoms after the intervention. No impact was found on psychological well-being, anxiety symptoms and mastery.
Conclusions:
The intervention is feasible and acceptable for older adults with depressive symptoms and has an impact on their depressive symptoms.
Prior optical coherence tomography (OCT) studies of schizophrenia have identified thinning of retinal layers. However, findings have varied across reports, and most studies have had serious methodological limitations. To address unresolved issues, we determined whether: (1) retinal thinning in schizophrenia occurs independently of comorbid medical conditions that affect the retina; (2) thinning is independent of antipsychotic medication dose; (3) optic nerve parameters are abnormal in schizophrenia; and (4) OCT indices are related to visual and cognitive impairments common in schizophrenia.
Methods
A total of 32 people with schizophrenia and 32 matched controls participated. Spectral domain OCT generated data on retinal nerve fiber layer (RNFL), macula, and ganglion cell-inner plexiform layer (GCL-IPL) thickness, in addition to cup volume and the cup-to-disc ratio at the optic nerve head. Subjects with schizophrenia also completed measures of symptoms, visual processing, and IQ.
Results
The groups did not differ on RNFL, macula, or GCL-IPL thickness. However, thinning of these layers was related to the presence of diabetes or hypertension across the sample as a whole. The schizophrenia group demonstrated enlarged cup volume and an enlarged cup-to-disc ratio in both eyes, which were unrelated to medical comorbidity, but were related to increased cognitive symptoms.
Conclusions
Past reports of retinal thinning may be artifacts of medical comorbidity that is over-represented in schizophrenia, or other confounds. However, optic nerve head abnormalities may hold promise as biomarkers of central nervous system abnormality, including cognitive decline, in schizophrenia.
Retrospective voting is a central explanation for voters’ support of incumbents. Yet, despite the variety of conditions facing American cities, past research has devoted little attention to retrospective voting for mayors. This paper first develops hypotheses about how local retrospective voting might differ from its national analog, due to both differing information sources and the presence of national benchmarks. It then analyzes retrospective voting using the largest data set on big-city mayoral elections between 1990 and 2011 to date. Neither crime rates nor property values consistently influence incumbent mayors’ vote shares, nor do changes in local conditions. However, low city-level unemployment relative to national unemployment correlates with higher incumbent support. The urban voter is a particular type of retrospective voter, one who compares local economic performance to conditions elsewhere. Moreover, these effects appear to be present only in cities that dominate their media markets, suggesting media outlets’ role in facilitating retrospective voting.
Hospital Ebola preparation is underway in the United States and other countries; however, the best approach and resources involved are unknown.
OBJECTIVE
To examine costs and challenges associated with hospital Ebola preparation by means of a survey of Society for Healthcare Epidemiology of America (SHEA) members.
DESIGN
Electronic survey of infection prevention experts.
RESULTS
A total of 257 members completed the survey (221 US, 36 international) representing institutions in 41 US states, the District of Columbia, and 18 countries. The 221 US respondents represented 158 (43.1%) of 367 major medical centers that have SHEA members and included 21 (60%) of 35 institutions recently defined by the US Centers for Disease Control and Prevention as Ebola virus disease treatment centers. From October 13 through October 19, 2014, Ebola consumed 80% of hospital epidemiology time and only 30% of routine infection prevention activities were completed. Routine care was delayed in 27% of hospitals evaluating patients for Ebola.
LIMITATIONS
Convenience sample of SHEA members with a moderate response rate.
CONCLUSIONS
Hospital Ebola preparations required extraordinary resources, which were diverted from routine infection prevention activities. Patients being evaluated for Ebola faced delays and potential limitations in management of other diseases that are more common in travelers returning from West Africa.
Children born preterm are at risk for experiencing significant deleterious developmental outcomes throughout their childhood and adolescence. However, individual variation and resilience are hallmarks of the preterm population. The present study examined pathways to resilience across multiple domains (e.g., social activities, peer relations, attention-deficit/hyperactivity disorder symptomology, externalizing and internalizing behavior, and sleep quality) as children born preterm reached school age. The study also examined early child and family predictors of resilience. Using a prospective longitudinal design, 173 infants born preterm and without significant neurological complications were assessed at five time points: neonatal intensive care unit discharge, 9 months, 16 months, 24 months, and 6 years. Three pathways of adaptation emerged at 6 years: children who were resilient, those who remained at-risk, and children who exhibited significant difficulties. Resilient children were less likely to have experienced negative parenting at 9 and 16 months, more likely to delay gratification at 24 months, and more likely to experience neonatal health complications than nonresilient children.
Nutrigenomics is the study of how constituents of the diet interact with genes, and their products, to alter phenotype and, conversely, how genes and their products metabolise these constituents into nutrients, antinutrients, and bioactive compounds. Results from molecular and genetic epidemiological studies indicate that dietary unbalance can alter gene–nutrient interactions in ways that increase the risk of developing chronic disease. The interplay of human genetic variation and environmental factors will make identifying causative genes and nutrients a formidable, but not intractable, challenge. We provide specific recommendations for how to best meet this challenge and discuss the need for new methodologies and the use of comprehensive analyses of nutrient–genotype interactions involving large and diverse populations. The objective of the present paper is to stimulate discourse and collaboration among nutrigenomic researchers and stakeholders, a process that will lead to an increase in global health and wellness by reducing health disparities in developed and developing countries.
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