Introduction: Clinical investigation is a critical component of clinical medicine. Yet, other than mentorship by an experienced senior physician, young physicians have few formal training opportunities that fit into their clinical training and convey the pre-requisite clinical investigator competencies. To address this training gap, we designed the Clinical Investigator Training Program (CITP); a practical and pragmatic curriculum weaved into the constant pressures of balancing patient care with academic pursuit required of the academic practitioner. Methods: Between January 2016 and December 2018, we conducted four CITP courses, with each comprised of four 4-h sessions that included didactic lectures, group projects including the development of a mock clinical protocol, and expert's panel discussions. Each course enrolled 15 participants from an average of 28 applicants. We assessed the knowledge acquired following each course via a preand post-course test (t-test with positive scores indicating improvement in knowledge base). In addition, we also tracked which participants became first time principal investigator following completion of CITP. Results: A total of 60 participants enrolled in the 4 CITP courses, and there was a statistically significant improvement in mean post-test scores (p < 0.01). The number of participants achieving first time principal investigator status nearly doubled following CITP from 17 to 33. Conversely, applicants not selected for CITP demonstrated no similar improvement during the same follow up period. Conclusion: The improvement in test scores and the substantive uptake in first time principal investigator responsibilities following CITP affirms that CITP provides a viable option to convey investigator competencies and encourage clinicians to take on the role of principal investigators.

While incident elevations in blood pressure (BP) are apparent in preschool years, factors influencing BP in this population have received little attention. The purposes of this pilot study were to determine the feasibility of collecting data from preschoolers and their mothers and to determine effect sizes of relationships between BP and sex, race, birth status, body mass index (BMI), waist circumference (WC), geographic location, serum C-reactive protein (CRP), and salivary cortisol (morning, afternoon). A hypothesis-generating correlational design was used; 56 children, aged 3–5 years, were enrolled from six rural and urban Head Start programs in a southeastern state. On Day 1 of data collection, mothers completed demographic questionnaires and children had blood drawn by finger stick. On Day 2, children gave saliva samples for cortisol, were measured for height by stadiometer, weight by digital scales, and WC by tape measure and had their BP measured by Dinamap. Incident elevations in BP were found in 30% of children (17/56), the majority of which were of systolic BP; 65% of those with elevations were of normal weight. Data collection was feasible with few problems. Small-to-medium effect sizes were noted for BP status (normal, prehypertensive, and hypertensive) and cortisol p.m. and birth status (parent-reported prematurity or term); small effect sizes were seen for BP status and BMI, race, sex, and geographic location. CRP and cortisol had medium- and small-to-medium effect sizes, respectively, with diastolic blood pressure. Studies with larger, more diverse samples need to be conducted to test hypotheses posited from these estimated effect sizes.

To determine the inter-examiner agreement of the manual values of central and peripheral corneal thickness as measured by optical coherence tomography (AS-OCT Visante) and to assess the agreement between AS-OCT Visante pachymetry, Orbscan II and ultrasound pachymetry (USP).Central and peripheral (4.0 mm from the corneal centre to the superior, inferior, nasal and temporal areas) corneal thickness was analyzed in 30 eyes of 15 patients (mean age, 26.8 ± 6.8 years), with the AS-OCT Visante both automatically (Global-Pachymetry Map) and manually (Flap Tool). The Orbscan II and USP (Corneo-Gage Plus) pachymetry were also assessed. Inter-examiner reproducibility for the manual values of the AS-OCT Visante was calculated. Automatic and manual AS-OCT pachymetries were compared for all corneal locations.Good inter-examiner agreement was obtained for the manual values of the AS-OCT Visante for all locations studied (p = 1.00). The automatic value was significantly different from the manual value for both central and inferior pachymetry (37 ± 10 μm and 27 ± 11 μm respectively; p < 0.05). Good linear correlation was found between the automatic AS-OCT Visante, the Orbscan II and USP, although there were statistically significant differences (p < 0.01) between all of the corneal locations, with the exception of the manual values of the AS-OCT Visante and the Orbscan II for the central corneal thickness (CCT) measures.The AS-OCT Visante has high inter-examiner agreement for manual values (Flap Tool). The automatic analysis (Global-Pachymetry Map) provides different corneal thickness values (centrally and peripherally) than those obtained manually for the same corneal scan.Determinar el acuerdo interexaminador de los valores manuales del espesor corneal central y periférico según la medición por tomografía de coherencia óptica (AS-OCT Visante) y evaluar el acuerdo entre paquimetría con AS-OCT Visante, Orbscan II y paquimetría ultrasónica (PUS).Se analizó el espesor corneal central y periférico (4 mm del centro de la córnea a las áreas superior, inferior, nasal y temporal) en 30 ojos de 15 pacientes (media de edad, 26,8 ± 6,8 años) con el instrumento AS-OCT Visante, tanto de manera automática (Global-Pachymetry Map) como manual (Flap Tool). También se evaluó la paquimetría con Orbscan II y PUS (Corneo-Gage Plus). Se calculó la reproducibilidad interexaminador para los valores manuales del AS-OCT Visante. Se compararon las paquimetrías AS-OCT manuales y automáticas de todas las zonas de la córnea.Se obtuvo buena concordancia interexaminador de los valores manuales del AS-OCT Visante en todas las zonas examinadas (p = 1). El valor automático fue significativamente diferente del valor manual para la paquimetría central y para la inferior (37 ± 10 μm y 27 ± 11 μm respectivamente; p < 0,05). Se observó una buena correlación lineal entre el AS-OCT Visante automático, el Orbscan II y la PUS, aunque hubo diferencias estadísticamente significativas (p < 0,01) entre todas las zonas de la córnea, excepto los valores manuales del AS-OCT Visante y el Orbscan II de las mediciones del espesor corneal central (ECC).El AS-OCT Visante presenta alta concordancia interexaminador para valores manuales (Flap Tool). El análisis automático (Global-Pachymetry Map) proporciona valores de espesor corneal (céntricos y periféricos) diferentes de los obtenidos manualmente en el mismo examen corneal.

INTRODUCTION:Due to the increasing number of clinical trials conducted globally, there is a need for quality continuing education for health professionals in clinical research manager (CRM) roles. This article describes the development, implementation, and evaluation of a distance-based continuing education program for CRMs working outside the United States.METHODS:A total of 692 applications were received from CRMs in 50 countries. Of these, 166 were admitted to the program in two cohorts. The program, taught online and in English, included 4 required and 1 optional course. Course materials were also provided as hard copies and on CDs. A pretest/posttest design was used to evaluate the outcome of the program in terms of changes in knowledge, participants' capacity-building activities at their research sites; and participant and supervisor perceptions of program impact.RESULTS:Participants demonstrated significant improvements in knowledge about clinical research, rated course content and teaching strategies positively, and identified the opportunity for interactions with international peers as a major program strength. Challenges for participants were limited time to complete assignments and erratic Internet access. Participants offered capacity-building programs to 5061 individuals at their research sites. Supervisors indicated that they would recommend the program and perceived the program improved CRM effectiveness and site research capacity.DISCUSSION:Results suggest that this type of continuing education program addresses a growing need for education of CRMs working in countries that have previously had limited involvement with global clinical trials.