Clinical Investigator Training Program (CITP) - A practical and pragmatic approach to conveying clinical investigator competencies and training to busy clinicians.

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 pre- and 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.

Factors That Influence Blood Pressure in 3- to 5-Year-Old Children: A Pilot Study.

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.

Assessment of vascular function in low socioeconomic status preschool children: a pilot study.

Elevated brachial blood pressure (BP) in childhood tracks into adulthood. Central BP and measures of arterial stiffness, such as aortic augmentation index (AIx) and pulse wave velocity (PWV), have been associated with future cardiovascular disease. This pilot study assessed the feasibility of noninvasively measuring these parameters in preschool children and explored factors that may be associated with elevated BP in this age group. Brachial BP was measured using an electronic oscillometric unit (Dinamap PRO 100) and defined as elevated when systolic BP (SBP) and/or diastolic BP (DBP) was ≥ the 90th percentile for age, gender, and height. Central BP, AIx, and PWV were measured using applanation tonometry (SphygmoCor). C-reactive protein (CRP) was measured in serum samples. Sixteen African-American preschool children were recruited (4.4 ± 0.8 years, 69% males), 6 (38%) of whom had an elevated brachial BP (110 ± 10/69 ± 4 vs. 96 ± 8/55 ± 6 mm Hg, Cohen's d = 2.2). Children with elevated brachial BP had higher central SBP (d = 1.6) and DBP (d = 1.96) (97 ± 6/68 ± 4 vs. 85 ± 8/57 ± 6 mm Hg), AIx (d = 0.88) (31 ± 8 vs. 18 ± 16%, standardized to heart rate), and CRP (3.1 [2.3-6.3] vs. 0.1 [0.1-0.3] mg/dL, d = 2). There was no significant difference in PWV between groups (d = 0.26). CRP and SBP (Spearman r = 0.70), DBP (r = 0.68), central SBP (r = 0.58), and central DBP (r = 0.71) were positively correlated. Wide confidence intervals for the estimated effect sizes indicated a large degree of uncertainty about all estimates due to the small sample size. Noninvasive assessment of central BP and arterial stiffness is feasible in preschool children. Vascular inflammation may be an important factor that influences BP at an early age. Further studies in preschool children are needed to elucidate mechanisms of early onset hypertension.

A Single-Center Randomized Controlled Trial Evaluating Timing of Preparation for Capsule Enteroscopy.

BACKGROUND/AIMS: Intestinal lavage (IL) administration immediately before capsule enteroscopy (CE) is superior to lavage the day before the procedure. We aimed to determine the effect of IL timing on CE diagnostic yield. METHODS: Patients referred for CE were randomized prospectively into two equal groups according to the timing of IL with 2 L of polyethylene glycol solution. Group A and B underwent IL over 2 hours beginning 14 and 4 hours, respectively, before the scheduled CE. The primary outcome measure was preparation quality, measured with a predetermined validated grading scale. RESULTS: A total of 34 patients were randomized. The frequency of mucosal abnormalities (77% vs. 82%, p=not significant [NS]) and diagnostic yield (47% vs. 53%, p=NS) were similar between the two groups. Moreover, no significant association between the quality of small bowel preparation and the timing at which the purgative for IL was administered was observed (overall fluid transparency, p=0.936; overall mucosal invisibility, p=0.091). CONCLUSIONS: Day-before IL is equivalent to same-day IL in terms of overall preparation quality, proportion of complete studies to cecum, small bowel transit time, frequency of identified mucosal abnormalities, and overall diagnostic yield.

Enhancing research capacity for global health: evaluation of a distance-based program for international study coordinators.

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.