Browsing by Subject "Scientific community"

Now showing 1 - 3 of 3
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    Essentials of Neonatal–Perinatal Medicine Fellowship: careers in Neonatal–Perinatal Medicine
    (Springer Nature, 2022) Trzaski, Jennifer M.; Kiefer, Autumn S.; Myers, Patrick; ONTPD Fellowship Directors Writing Group; Johnston, Lindsay C.; Pediatrics, School of Medicine
    The clinical and academic landscape of Neonatal-Perinatal Medicine (NPM) is evolving. Career opportunities for neonatologists have been impacted by shifts in compensation and staffing needs in both academic and private settings. The workforce in NPM is changing with respect to age and gender. Recruiting candidates from backgrounds underrepresented in medicine is a priority. Developing flexible positions and ensuring equitable salaries is critically important. Professional niches including administration, education, research, and quality improvement provide many opportunities for scholarly pursuit. Challenges exist in recruiting, mentoring, funding, and retaining physician-scientists in NPM. Creative solutions are necessary to balance the needs of the NPM workforce with the growing numbers, locations, and complexity of patients. Addressing these challenges requires a multi-faceted approach including adapting educational curricula, supporting trainees in finding their niche, identifying novel ways to address work/life integration, and attracting candidates with both diverse backgrounds and academic interests.
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    Methods to address functional unblinding of raters in CNS trials
    (Springer Nature, 2025-02-07) Targum, Steven D.; Horan, William P.; Davis, Vicki G.; Breier, Alan; Brannan, Stephen K.; Psychiatry, School of Medicine
    Treatment-emergent adverse events (TEAEs) associated with the unique properties of a pharmaceutical product may functionally unblind clinician ratings, obscure true medication effects, and affect confidence about clinical trial results. Central nervous system studies are particularly susceptible to functional unblinding because they rely on relatively subjective symptom assessments. Two different methods were used to examine possible functional unblinding in pooled data from three recent five-week, double-blind, placebo-controlled trials of xanomeline and trospium chloride (formerly known as KarXT) in participants with schizophrenia experiencing acute psychosis. Xanomeline/trospium is an M1/M4 muscarinic receptor agonist that may produce cholinergic side effects. First, we compared the scores of remote (site-independent) raters, blinded to TEAEs, who listened to audio recorded, site-based Positive and Negative Syndrome Scale (PANSS) interviews. Second, we conducted a post hoc analysis of participant subgroups with or without reported cholinergic-related TEAEs to ascertain whether cholinergic TEAEs influenced trial outcome. Remote ratings closely replicated 575 available "paired" site-based PANSS total scores at baseline and endpoint (intraclass correlation coefficient = 0.88 and 0.93, respectively). Both site-based and remote PANSS scores yielded significant improvement favouring xanomeline/trospium over placebo (both p < 0.0001) and yielded significantly greater treatment response (≥30% improvement from baseline) than placebo (both p < 0.0001). The significant improvement of PANSS scores favouring xanomeline/trospium over placebo was comparable in magnitude for all subgroups regardless of whether participants reported cholinergic-related TEAEs, or any TEAEs at all (all p < 0.001). In sum, the two different methods used to assess functional unblinding in these studies found no impact of cholinergic TEAEs, or any TEAEs, on the trial results. These methods may have utility across all clinical trials.
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    Part 6: Essentials of Neonatal–Perinatal Medicine fellowship: program administration
    (Springer, 2022) Gillam-Krakauer, Maria; Sharma, Jotishna; Myers, Patrick; ONTPD Fellowship Directors Writing Group; Bonachea, Elizabeth M.; Pediatrics, School of Medicine
    A successful Neonatal–Perinatal Medicine fellowship (NPM-F) program requires presence and insight of national and institutional supervisory organizations as well as effective program-specific leaders: program director (PD), associate program director (APD), program coordinator (PC), and core faculty. It is becoming more common for PDs and APDs to have advanced training in medical education and conduct medical education research. While NPM-F program leaders benefit from a strong national NPM educator community, they face challenges of increased regulatory burden and unclear national guidelines with variable local interpretation for protected time. National and local organizations can support program leaders and promote their academic success while reducing burnout and turnover by providing leadership training, academic mentoring, and adequate protected time for research and program-specific tasks.