Clinical Science Research Articles

Developmental psychopathology as a meta-paradigm: From zero-sum science to epistemological pluralism in theory and research.

In a thoughtful commentary in this journal a decade ago, Michael Rutter reviewed 25 years of progress in the field before concluding that developmental psychopathology (DP) initiated a paradigm shift in clinical science. This deduction requires that DP itself be a paradigm. According to Thomas Kuhn, canonical paradigms in the physical sciences serve unifying functions by consolidating scientists' thinking and scholarship around single, closed sets of discipline-defining epistemological assumptions and methods. Paradigm shifts replace these assumptions and methods with a new field-defining framework. In contrast, the social sciences are multiparadigmatic, with thinking and scholarship unified locally around open sets of epistemological assumptions and methods with varying degrees of inter-, intra-, and subdisciplinary reach. DP challenges few if any of these local paradigms. Instead, DP serves an essential pluralizing function, and is therefore better construed as a metaparadigm. Seen in this way, DP holds tremendous untapped potential to move the field from zero-sum thinking and scholarship to positive-sum science and epistemological pluralism. This integrative vision, which furthers Dante Cicchetti's legacy of interdisciplinarity, requires broad commitment among scientists to reject zero-sum scholarship in which portending theories, useful principles, and effective interventions are jettisoned based on confirmation bias, errors in logic, and ideology.

Introduction to Bayesian Analyses for Clinical Research.

Bayesian analyses are becoming more popular as a means of analyzing data, yet the Bayesian approach is novel to many members of the broad clinical audience. While Bayesian analyses are foundational to anesthesia pharmacokinetic/pharmacodynamic modeling, they also can be used for analyzing data from clinical trials or observational studies. The traditional null hypothesis significance testing (frequentist) approach uses only the data collected from the current study to make inferences. On the other hand, the Bayesian approach quantifies the external information or expert knowledge and combines the external information with the study data, then makes inference from this combined information. We introduce to the clinical and translational science researcher what it means to do Bayesian statistics, why a researcher would choose to perform their analyses using the Bayesian approach, when it would be advantageous to use a Bayesian instead of a frequentist approach, and how Bayesian analyses and interpretations differ from the more traditional frequentist methods. Throughout this paper, we use various pain- and anesthesia-related examples to highlight the ideas and statistical concepts that should be relatable to other areas of research as well.

Livestock Vaccines: Principles, Types, and Important Factors to Consider

This publication presents information on the basic mechanisms and types of livestock vaccines available, as well as a few best practices for vaccine management. This information can help improve your herd health and success in your next herd vaccination. Written by Juan M. Campos Krauer and João H. J. Bittar, and published by the Veterinary Medicine—Department of Large Animal Clinical Sciences, UF/IFAS Extension, January 2024.

An early-curricular team learning activity to foster integration of biochemical concepts and clinical sciences in undergraduate medical education.

The ability to connect key concepts of biochemistry with clinical presentations is essential for the development of clinical reasoning skills and adaptive expertise in medical trainees. To support the integration of foundational and clinical sciences in our undergraduate health science curricula, we developed a small group active learning exercise during which interprofessional groups of students use clinical cases to explore the biochemistry, diagnostic strategy, and evidence-based treatment options of inborn errors of metabolism (IEM). We designed multistage learning modules consisting of (1.) low-fidelity case simulations of pediatric patients presenting with IEMs, (2.) guided group discussions on clinical biochemistry, differential diagnoses, and diagnostic strategies, (3.) oral presentations of clinical reasoning strategies, and (4.) discussion of relevant evidence-based medicine topics related to the cases. These modules Scientific Knowledge Integrated in Patient Presentations (SKIPPs) were added to a first-semester foundational sciences course serving five health professions programs. The assessment of learning outcomes by students and faculty shows that SKIPPs sessions are well-received activities that significantly improve trainees' ability to integrate foundational science concepts into clinical scenarios, to practice interprofessional teamwork and to develop clinical reasoning skills.

The One Health Concept.

The concept of One Health has been developed as the appreciation that human health is intricately connected to those of other animals and the environment that they inhabit. In recent years, the COVID-19 pandemic and noticeable effects of climate change have encouraged national and international cooperation to apply One Health strategies to address key issues of health and welfare. The United Nations (UN) Sustainable Development Goals have established targets for health and wellbeing, clean water and sanitation, climate action, as well as sustainability in marine and terrestrial ecosystems. The One Health Quadripartite comprises the World Health Organization (WHO), the World Organization for Animal Health (WOAH-formerly OIE), the United Nations Food and Agriculture Organization (FAO) and the United Nations Environment Programme (UNEP). There are six areas of focus which are Laboratory services, Control of zoonotic diseases, Neglected tropical diseases, Antimicrobial resistance, Food safety and Environmental health. This article discusses the concept of One Health by considering examples of infectious diseases and environmental issues under each of those six headings. Biomedical Scientists, Clinical Scientists and their colleagues working in diagnostic and research laboratories have a key role to play in applying the One Health approach to key areas of healthcare in the 21st Century.

A Descriptive Analysis of Therapeutic Drug Monitoring In India

Therapeutic drug monitoring (TDM) has evolved into therapeutic drug management throughout the past three to four decades, becoming a crucial facet of precision medicine. Even though India has one of the fastest-growing economies in the world, TDM is not widely used there. At the moment, it is restricted to a small number of teaching hospitals and academic medical institutes. Other therapeutic domains, such anticancer, antifungal, antibacterial, and antitubercular medications, have shown considerable promise to enhance patient outcomes in Indian settings, aside from immunosuppressive pharmaceuticals. The population of this subcontinent is unique in terms of the importance of TDM due to factors like the higher prevalence of nutritional deficiencies, tropical diseases, the widespread adoption of alternative medicines, unlike pharmacogenomics, and the scarcity of population-specific data on the therapeutic ranges of multiple drugs.TDM has not gotten the interest it merits in India, despite its vast applicability and influence on clinical science. This study aims to present a SWOT (strength, weakness, opportunity, and threats) analysis of TDM in India so that suitable measures for promoting TDM growth can be envisaged. Forming a collaborative group with all the stakeholders—including TDM experts, physicians, and the government—and coming up with a National Action Plan to support TDM are urgent needs. To determine the country's TDM focus areas, nodal TDM facilities should be formed, and pilot programmes should be launched. Capacity development and awareness rising are also important steps towards integrating TDM into traditional clinical practice.

Research impact training and development support for doctoral students

This research-in-progress case study in one UK university setting looks at how supportive PhD supervisors are of impact work, what motivates PhD students to access impact support and whether there are barriers to PhD students from carrying out impact plans and what those barriers are. A mixed-method approach was used to collect quantitative data on student participation in impact training and qualitative data on their thoughts on impact work, supervisory support and motivators and barriers for doing impact work. Clinical science students found it easier to understand the direct impacts of their work compared to life science students. Over time, students developed a better understanding of the potential impacts of their work. The majority of students discussed their impact with their supervisors but did not discuss time, budget or monitoring plans for impact activities. The majority of students talked about a lack of supervisor support for impact work and a need for better supervisor training. Students identified motivators and barriers for doing impact work. The study suggests that there is a gap in training and support for doctoral students to develop the societal impact of their research. Impact work helps students to develop skills and experience valued by employers. However, PhD students may not receive impact training as part of their degrees. Supervisors may be unsupportive of PhD students doing impact work because it may distract from core research activities. Based on the study findings, the author has made recommendations for addressing this gap.

The Scientific Basis for the Regulation of Flavors in Tobacco Products.

Effective tobacco policies are important for reducing the harm of tobacco use and can have a broad impact at the population level. This review provides an overview of how clinical science can inform tobacco policies with a focus on policies related to flavored tobacco products, using menthol cigarettes as an illustrative example. Specifically, this review summarizes the role of flavors in tobacco use and the history of regulation of flavored tobacco products by the US Food and Drug Administration (FDA), provides an overview of clinical research methods used to contribute to the scientific evidence to inform FDA tobacco policies, discusses key findings related to menthol tobacco products using these methods, and proposes future directions for clinical research. As the tobacco marketplace continues to evolve with new products and flavor chemicals, ongoing clinical science will be essential for establishing evidence-based policies to protect public health and reduce tobacco-related health disparities. Expected final online publication date for the Annual Review of Clinical Psychology, Volume 20 is May 2024. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

The American Heart Association at 100: A Century of Scientific Progress and the Future of Cardiovascular Science: A Presidential Advisory From the American Heart Association.

In 1924, the founders of the American Heart Association (AHA) envisioned an international society focused on the heart and aimed at facilitating research, disseminating information, increasing public awareness, and developing public health policy related to heart disease. This presidential advisory provides a comprehensive review of the past century of cardiovascular and stroke science, with a focus on the AHA's contributions, as well as informed speculation about the future of cardiovascular science into the next century of the organization's history. The AHA is a leader in fundamental, translational, clinical, and population science, and it promotes the concept of the "learning health system," in which a continuous cycle of evidence-based practice leads to practice-based evidence, permitting an iterative refinement in clinical evidence and care. This advisory presents the AHA's journey over the past century from instituting professional membership to establishing extraordinary research funding programs; translating evidence to practice through clinical practice guidelines; affecting systems of care through quality programs, certification, and implementation; leading important advocacy efforts at the federal, state and local levels; and building global coalitions around cardiovascular and stroke science and public health. Recognizing an exciting potential future for science and medicine, the advisory offers a vision for even greater impact for the AHA's second century in its continued mission to be a relentless force for longer, healthier lives.

Centering equity in a longitudinal health systems science curricula

What was the educational challenge? Health inequity impedes care at every level of the health care system. Despite this, health equity is not the foundation for most health systems science (HSS) curricula. What was the solution? We reframed our HSS curricula to focus on health equity. How was the solution implemented? We integrated equity concepts into all HSS content areas. First-year content emphasizes structural competency and is delivered through didactics, discussions, interprofessional education, panels, and service-learning requirements. Second-year content applies HSS principles in the clinical space through direct patient care and assignments. Third- and fourth-year content focuses on HSS advocacy and leadership. What lessons were learned that are relevant to a wider global audience? It is crucial to center health equity in medical curricula to improve patient outcomes. Proper faculty development, non-judgmental discussions, and integration with clinical and medical sciences are critical to successful implementation. What are the next steps? We will address feedback, emphasize relevance to patients and populations, and refine outcome measures.

Is it coping or is it a vice? Understanding stereotypic behaviors in horses

This article will share what science has revealed about stereotypic behaviors, and how this information can be applied to better manage and thus improve the welfare of horses with stereotypic behavior. Written by Carissa Wickens and Camie Heleski, and published by the Veterinary Medicine—Department of Large Animal Clinical Sciences, UF/IFAS Extension, January 2024.

CDC Laboratory Recommendations for Syphilis Testing, United States, 2024.

This report provides new CDC recommendations for tests that can support a diagnosis of syphilis, including serologic testing and methods for the identification of the causative agent Treponema pallidum. These comprehensive recommendations are the first published by CDC on laboratory testing for syphilis, which has traditionally been based on serologic algorithms to detect a humoral immune response to T. pallidum. These tests can be divided into nontreponemal and treponemal tests depending on whether they detect antibodies that are broadly reactive to lipoidal antigens shared by both host and T. pallidum or antibodies specific to T. pallidum, respectively. Both types of tests must be used in conjunction to help distinguish between an untreated infection or a past infection that has been successfully treated. Newer serologic tests allow for laboratory automation but must be used in an algorithm, which also can involve older manual serologic tests. Direct detection of T. pallidum continues to evolve from microscopic examination of material from lesions for visualization of T. pallidum to molecular detection of the organism. Limited point-of-care tests for syphilis are available in the United States; increased availability of point-of-care tests that are sensitive and specific could facilitate expansion of screening programs and reduce the time from test result to treatment. These recommendations are intended for use by clinical laboratory directors, laboratory staff, clinicians, and disease control personnel who must choose among the multiple available testing methods, establish standard operating procedures for collecting and processing specimens, interpret test results for laboratory reporting, and counsel and treat patients. Future revisions to these recommendations will be based on new research or technologic advancements for syphilis clinical laboratory science.

Enhancing the clinical research workforce: a collaborative approach with human resources.

Jobs for clinical research professionals (CRPs) have grown increasingly complex over the past 20+ years. This is due largely to additional administrative burden for investigators, study teams, sponsors, Clinical Research Organizations (CROs), and sites, particularly Academic Medical Centers (AMCs). Furthermore, National Institutes of Health (NIH) has reduced capacity to effectively fund research recognizing this is dependent on the overall congressional budget, which creates greater pressure for clinician scientists to secure external support. It is widely known clinical research will continue to become increasingly more complex for clinician scientists. This manuscript explores adoption of a clinical research competency-based job classification framework from the Joint Task Force for Clinical Trial Competency (JTFCTC) across several AMCs and the role of Human Resources (HR) in facilitating this process. This collaboration focuses on fostering successful projects tied to the business case in order to address equity and improve support for the clinical research enterprise.

Facts about Wildlife Diseases: Capture Myopathy in Farmed White-Tailed Deer

This publication discusses causes, clinical signs, and ways to reduce risk of capture myopathy in farmed white-tailed deer. Written by Juan M. Campos Krauer, and published by the Veterinary Medicine—Department of Large Animal Clinical Sciences, UF/IFAS Extension, January 2024.

Attitude of clinical teachers towards the use of innovative technology in teaching and learning in the university of Port Harcourt medical school, South Nigeria

The 21st century has seen a rapid increase in the use of various innovative technologies in pedagogy. The attitude of the clinical teachers affects the use of these innovative technologies in teaching and learning. The aim of this research is to find out the attitude of clinical teachers using “The Tripartite Theory of Attitude” consisting of affective, cognitive, and behavioral domains, to the use of innovative technology. A descriptive survey research design with correlational studies was done with a purposive sampling method used. A 24 item Likert questionnaire was used and distributed using Google Form. The population of the study was made up of clinical teachers in the Faculty of Clinical Sciences University of Port Harcourt. A total of 90 clinical teachers took part in the study comprising of 48 males and 42 females. 23 were professors while 51 were senior lecturers. Analysis showed the overall attitude of clinical teachers to the use of innovative technology in teaching and learning was positive. No significant correlation was seen between gender, cadre, and years of service of the clinical teacher to the use of innovative technology. Thus, incorporation of innovative technology into the classroom should be encouraged as this would aid the clinical teachers in improving learning in the classroom.

Facts about Wildlife Diseases: Antler Infections and Cranial Abscess Disease in White-Tailed Deer

This article provides valuable insights into antler infections and cranial abscess disease in white-tailed deer. It emphasizes the importance of addressing these concerns for the species’ conservation and well-being. Written by Michael A. Lyons, Amira M. Richardson, Merrie P. Urban, and Juan M. Campos Krauer, and published by the Veterinary Medicine—Department of Large Animal Clinical Sciences, UF/IFAS Extension, January 2024.

Ethical preparedness in genomic medicine: how NHS clinical scientists navigate ethical issues

Much has been published about the ethical issues encountered by clinicians in genetics/genomics, but those experienced by clinical laboratory scientists are less well described. Clinical laboratory scientists now frequently face...

(127) Sexual Health Implications Associated with Psychotropic Medication Use Among Adolescents During the COVID-19 Pandemic

Abstract Introduction The use of psychotropic medications has a notable effect on sexual well-being. Prolonged use is closely linked to dyspareunia, reduced sexual desire, hypogonadism, and erectile dysfunction. We hypothesized that there was an increase in the prescription rates of psychotropic medications among adolescent patients during the COVID-19 pandemic due to the unprecedented stress experienced by isolated youth. Objective We examined the prescription rates of psychotropic medications and the simultaneous usage of PDE5 inhibitors in adolescent patients during the COVID-19 pandemic in order to compare usage of these medications prior to the pandemic. Methods To conduct our retrospective matched cohort study, we utilized data obtained from the TriNetX Research Network. The study focused on adolescent patients aged 10-19 presenting for outpatient evaluation, and were placed into two cohorts: 1) those evaluated before the COVID-19 pandemic, and 2) those evaluated during the pandemic. Patients with previous psychiatric diagnoses or prior use of psychotropic medications were excluded from the study. Our primary interest was to examine new prescription patterns within 90 days of the outpatient evaluation. To ensure balanced cohorts, propensity score matching was conducted using logistic regression, resulting in cohorts of equal size. Results A total of 1,612,283 adolescents pre-COVID-19 and 1,008,161 adolescents presenting during the COVID-19 pandemic for outpatient evaluations were identified. After propensity matching, a total of 1,005,408 adolescents were included in each cohort each with an average age of 14.7 ± 2.84 and 52% female and 48% male. Prescribing of antipsychotics and benzodiazepines were more frequent during the pandemic for adolescents (RR: 1.58, 95% CI 1.01-2.2). However, they were less likely to receive antidepressants (Risk Ratio (RR): 0.6, 95% Confidence Interval (CI) 0.57-0.63), anxiolytics (RR: 0.78, 95% CI 0.75-0.81), stimulants (RR: 0.26, 95% CI 0.25-0.27), as well as mood stabilizers (RR: 0.44, 95% CI 0.39-0.49). Erectile dysfunction requiring oral PDE5i in this cohort was more frequent during the pandemic for adolescents (RR: 1.53, 95% CI 1.05-2.01). Conclusions During the global COVID-19 pandemic, there was a notable rise in the prescription rates of antipsychotic and benzodiazepine medications compared to previous years. Interestingly, this increase aligned with a statistically significant rise in the prescription of PDE5 inhibitors (PDE5i) for treating erectile dysfunction. These findings indicate that clinicians need to be aware of the potential increased risk of medication-related sexual dysfunction among adolescents. Disclosure Yes, this is sponsored by industry/sponsor: NIH health grant RO1 DK130991 and Clinician Scientist Development Grant from the American Cancer Society. Clarification: Industry funding only - investigator initiated and executed study.

How to Start a Microsurgery Practice: Success and Sustainability in Academic Practice.

Starting an academic microsurgery practice is a daunting task for plastic surgery graduates. Despite this, academic practice provides many advantages as a starting point for a career. Microsurgical faculty can make use of several unique benefits within an academic center. These include vast resources of clinical and basic science departments, communications and public affairs divisions, and quality improvement teams. Building a multi-disciplinary microsurgery practice with specific focus will jumpstart research questions and outcome data. Using residents and students to their full potential is both rewarding and efficient as a microsurgeon. Finally, peer faculty in an academic environment provide a stimulating resource for growth and assistance when needed. This special topic provides insight into starting a microsurgery practice for any resident considering a career in academics.

Molnupiravir: Mechanism of action, clinical, and translational science.

Molnupiravir is an oral prodrug of the broadly active, antiviral ribonucleoside analog N-hydroxycytidine (NHC). The primary circulating metabolite NHC is taken up into cells and phosphorylated to NHC-triphosphate (NHC-TP). NHC-TP serves as a competitive substrate for viral RNA-dependent RNA polymerase (RdRp), which results in an accumulation of errors in the viral genome, rendering virus replication incompetent. Molnupiravir has demonstrated activity against SARS-CoV-2 both clinically and preclinically and has a high barrier to development of viral resistance. Little to no molnupiravir is observed in plasma due to rapid hydrolysis to NHC. Maximum concentrations of NHC are reached at 1.5 h following administration in a fasted state. The effective half-life of NHC is 3.3 h, reflecting minimal accumulation in the plasma following twice-daily (Q12H) dosing. The terminal half-life of NHC is 20.6 h. NHC-TP exhibits a flatter profile with a lower peak-to-trough ratio compared with NHC, which supports Q12H dosing. Renal and hepatic pathways are not major routes of elimination, as NHC is primarily cleared by metabolism to uridine and cytidine, which then mix with the endogenous nucleotide pools. In a phase III study of nonhospitalized patients with COVID-19 (MOVe-OUT), 5 days of treatment with 800 mg molnupiravir Q12H significantly reduced the incidence of hospitalization or death compared with placebo. Patients treated with molnupiravir also had a greater reduction in SARS-CoV-2 viral load and improved clinical outcomes, compared with those receiving placebo. The clinical effectiveness of molnupiravir has been further demonstrated in several real-world evidence studies. Molnupiravir is currently authorized or approved in more than 25 countries.