Clinical trials continue to disproportionately underrepresent people of color. Increasing representation of diverse backgrounds among clinical research personnel has the potential to yield greater representation in clinical trials and more efficacious medical interventions by addressing medical mistrust. In 2019, North Carolina Central University (NCCU), a Historically Black College and University with a more than 80% underrepresented student population, established the Clinical Research Sciences Program with support from the Clinical and Translational Science Awards (CTSA) program at neighboring Duke University. This program was designed to increase exposure of students from diverse educational, racial, and ethnic backgrounds to the field of clinical research, with a special focus on health equity education. In the first year, the program graduated 11 students from the two-semester certificate program, eight of whom now hold positions as clinical research professionals. This article describes how leveraging the CTSA program helped NCCU build a framework for producing a highly trained, competent, and diverse workforce in clinical research responsive to the call for increased diversity in clinical trial participation.

The coronavirus disease 2019 (COVID-19) pandemic has placed significant burden on healthcare systems. We compared Clostridioides difficile infection (CDI) epidemiology before and during the pandemic across 71 hospitals participating in the Canadian Nosocomial Infection Surveillance Program. Using an interrupted time series analysis, we showed that CDI rates significantly increased during the COVID-19 pandemic.

Healthcare personnel with severe acute respiratory coronavirus virus 2 (SARS-CoV-2) infection were interviewed to describe activities and practices in and outside the workplace. Among 2,625 healthcare personnel, workplace-related factors that may increase infection risk were more common among nursing-home personnel than hospital personnel, whereas selected factors outside the workplace were more common among hospital personnel.

Research shows that healthy ageing is defined differently by older adults and researchers, who may put more or less weight on the physiological, psychological, societal and personal aspects of ageing. Although there is growing interest in the research literature on lay models of healthy ageing in socio-cultural context, little work has been done to determine how important or feasible the various components of healthy ageing are viewed to be by older adults. This study asked a convenience sample of 54 older adults in the circumpolar North to rate the importance and feasibility of 36 previously identified components of healthy ageing in their community. Results indicate that seniors in the sample place the most importance on aspects of the social and physical environment, while least important concepts included psychological and individual behaviours. However, most feasible aspects were individual behaviours and least feasible were aspects of the social and physical environment. Although older adults are able to construct a model of what healthy ageing should look like in their community, they do not always view the most important aspects of healthy ageing to be the most feasible to achieve, providing ample opportunity for public and social policy change.

Social cognitive deficits can have many negative consequences, spanning social withdrawal to psychopathology. Prior work has shown that child maltreatment may associate with poorer social cognitive skills in later life. However, no studies have examined this association from early childhood into adolescence. Using data from the Avon Longitudinal Study of Parents and Children (ALSPAC; n = 4,438), we examined the association between maltreatment (caregiver physical or emotional abuse; sexual or physical abuse), assessed repeatedly (every 1–3 years) from birth to age 9, and social cognitive skills at ages 7.5, 10.5, and 14 years. We evaluated the role of both the developmental timing (defined by age at exposure) and accumulation of maltreatment (defined as the number of occasions exposed) using a least angle regression variable selection procedure, followed by structural equation modeling. Among females, accumulation of maltreatment explained the most variation in social cognitive skills. For males, no significant associations were found. These findings underscore the importance of early intervention to minimize the accumulation of maltreatment and showcase the importance of prospective studies to understand the development of social cognition over time.

Background: Healthcare services are increasingly shifting from inpatient to outpatient settings. Outpatient settings such as emergency departments (EDs), oncology clinics, dialysis clinics, and day surgery often involve invasive procedures with the risk of acquiring healthcare-associated infections (HAIs). As a leading cause of HAI, Clostridioides difficile infection (CDI) in outpatient settings has not been sufficiently described in Canada. The Canadian Nosocomial Infection Surveillance Program (CNISP) aims to describe the epidemiology, molecular characterization, and antimicrobial susceptibility of outpatient CDI across Canada. Methods: Epidemiologic data were collected from patients diagnosed with CDI from a network of 47 adult and pediatric CNISP hospitals. Patients presenting to an outpatient setting such as the ED or outpatient clinics were considered as outpatient CDI. Cases were considered HAIs if the patient had had a healthcare intervention within the previous 4 weeks, and they were considered community-associated if there was no history of hospitalization within the previous 12 weeks. Clostridioides difficile isolates were submitted to the National Microbiology Laboratory for testing during an annual 2-month targeted surveillance period. National and regional rates of CDI were stratified by outpatient location. Results: Between January 1, 2015, and June 30, 2019, 2,691 cases of outpatient-CDI were reported, and 348 isolates were available for testing. Most cases (1,475 of 2,691, 54.8%) were identified in outpatient clinics, and 72.8% (1,960 of 2,691) were classified as community associated. CDI cases per 100,000 ED visits were highest in 2015, at 10.3, and decreased to 8.1 in 2018. Rates from outpatient clinics decreased from 3.5 in 2016 to 2.7 in 2018 (Fig. 1). Regionally, CDI rates in the ED declined in Central Canada and increased in the West after 2016. Rates in outpatient clinics were >2 times higher in the West compared to other regions. RT027 associated with NAP1 was most common among ED patients (26 of 195, 13.3%), whereas RT106 associated with NAP11 was predominant in outpatient clinics (22 of 189, 11.6%). Overall, 10.4% of isolates were resistant to moxifloxacin, 0.5% were resistant to rifampin, and 24.2% were resistant to clindamycin. No resistance was observed for metronidazole, vancomycin, or tigecycline. Compared to CNISP inpatient CDI data, outpatients with CDI were younger (51.8 ± 23.3 vs 64.2 ± 21.6; P < .001), included more females (56.4% vs 50.9%; P < .001), and were more often treated with metronidazole (63.0% vs 56.1%; P < .001). Conclusions: For the first time, CDI cases identified in outpatient settings were characterized in a Canadian context. Outpatient CDI rates are decreasing overall, but they vary by region. Predominant ribotypes vary based on outpatient location. Outpatients with CDI are younger and are more likely female than inpatients with CDI.

Funding: None

Disclosures: Susy Hota reports contract research for Finch Therapeutics.

Background: Carbapenemase-producing Enterobacterales (CPE) have rapidly become a global health concern and are associated with substantial morbidity and mortality due to limited treatment options. Travel to endemic areas, especially healthcare exposure in these areas, is an important risk factor for acquisition. We describe the evolving epidemiology, molecular features, and outcomes of CPE in Canada through surveillance by the Canadian Nosocomial Infection Surveillance Program (CNISP). Methods: CNISP has conducted surveillance for CPE among inpatients and outpatients of all ages since 2010. Participating acute-care facilities submit eligible specimens to the National Microbiology Laboratory for detection of carbapenemase production, and epidemiological data are collected. Incidence rates per 10,000 patient days are calculated based on inpatient data. Results: In total, 59 CNISP hospitals in 10 Canadian provinces representing 21,789 beds and 6,785,013 patient days participated in this surveillance. From 2010 to 2018, 118 (26%) CPE-infected and 547 (74%) CPE-colonized patients were identified. Few pediatric cases were identified (n = 18). Infection incidence rates remain low and stable (0.02 per 10,000 patient days in 2010 to 0.03 per 10,000 patient days in 2018), and colonization incidence rates have increased by 89% over the surveillance period. Overall, 92% of cases were acquired in a healthcare facility: 61% (n = 278) in a Canadian healthcare facility and 31% (n = 142) in a healthcare facility outside Canada. Of the 8% of cases not acquired in a healthcare facility, 50% (16 of 32) reported travel outside of Canada in the 12 months prior to positive culture. The distribution of carbapenemases varied by region; New Delhi metallo-B-lactamase (NDM) was dominant (59%) in western Canada and Klebsiella pneumoniae carbapenemase (KPC) (66%) in central Canada. NDM and class D carbapenemase OXA-48 were more commonly identified among those who traveled outside of Canada, whereas KPC was more commonly identified among patients without travel. In addition, 30-day all-cause mortality was 14% (25 of 181) among CPE infected patients and 32% (14 of 44) among those with bacteremia. Conclusions: CPE rates remain low in Canada; however, national surveillance data suggest that the increase in CPE in Canada is now being driven by local nosocomial transmission as well as travel and healthcare within endemic areas. Changes in screening practices may have contributed to the increase in colonizations; however, these data are currently lacking and will be collected moving forward. These data highlight the need to intensify surveillance and coordinate infection control measures to prevent further spread of CPE in Canadian acute-care hospitals.

Funding: None

Disclosures: Susy Hota reports contracted research for Finch Therapeutics. Allison McGeer reports funds to her institution for projects for which she is the principal investigator from Pfizer and Merck, as well as consulting fees from the following companies: Sanofi-Pasteur, Sunovion, GSK, Pfizer, and Cidara.

OBJECTIVES/GOALS: Active surveillance (AS) is a recognized strategy to manage low-risk prostate cancer (PCa) in the absence of cancer progression. Little prospective data exists on the decisional factors associated with selecting and adhering to AS in the absence of cancer progression. We developed a survey instrument to predict AS uptake and adherence. METHODS/STUDY POPULATION: We utilized a three-step process to develop and refine a survey instrument designed to predict AS uptake and adherence among men with low-risk PCa: 1) We identified relevant conceptual domains based on prior research and a literature review. 2) We conducted 21 semi-structured concept elicitation interviews to identify patient-perceived barriers and facilitators to AS uptake and adherence among men with a low-risk PCa who had been on AS for ≥1 year. The identified concepts became the basis of our draft survey instrument. 3) We conducted two rounds of cognitive interviews with men with low-risk PCa (n = 12; n = 6) to refine and initially validate the instrument. RESULTS/ANTICIPATED RESULTS: Relevant concepts identified from the initial interviews included the importance of patient: knowledge of their PCa risk, value in delaying treatment, trust in urologist and the AS surveillance protocol, and perceived social support. Initially, the survey was drafted as a single instrument to be administered after a patient had selected AS comprising sections on patient health, AS selection, and AS adherence. Based on the first round of cognitive interviews, we revised the single instrument into two surveys to track shifts in patient preference and experience. The first, administered at diagnosis, focuses on selection, and the second, a 6-month follow up, focuses on adherence. Following revisions, participants indicated the revised 2-part instrument was clear and not burdensome to complete. DISCUSSION/SIGNIFICANCE OF IMPACT: The instrument’s content validity was evaluated through cognitive interviews, which supported that the survey items’ intended and understood meanings were isomorphic. In the next phase, we plan to conduct a large-scale prospective cohort study to evaluate the predictive validity, after which it will be available for public research use.

The Mediterranean diet is rich in bioactive nutrients and may be effective at preventing cardiovascular disease and dementia. However, long-term sustainability could be limited in non-Mediterranean populations with different nutrient requirements and food preferences. To address this issue, our research group conducted two randomised controlled trials to examine whether the Mediterranean diet can be adapted to increase sustainability for an Australian population, while still providing cardiovascular and cognitive benefits. In our first trial (n = 41), we examined a Mediterranean diet designed to meet the calcium requirements of older adults by including 3–4 daily serves of dairy foods (milk, cheese and yoghurt) (MedDairy). In our second trial (n = 33), we tested a Mediterranean diet supplemented with 2–3 weekly serves of fresh, lean pork (MedPork), designed to provide an alternate source of protein. Both trials employed a low-fat control diet (LF) and a 24-week parallel crossover design, consisting of two 8-week intervention periods and an 8-week washout separating interventions. We found that the MedDairy intervention significantly increased dairy food (mean difference = 1.0 ± 0.2 serves, P < 0.001) and calcium intake (mean difference = 25.9 ± 6.8 mg/MJ, P < 0.001) compared to LF. Further, MedDairy led to greater improvements in morning home systolic blood pressure (mean difference = -1.6 ± 0.6 mmHg, P = 0.01), triglycerides (mean difference = -0.05 ± 0.02 mmol/L, P < 0.01), HDL (mean difference = 0.04 ± 0.01 mmol/L, P = < 0.01), and total cholesterol to HDL ratio (mean difference = -0.4 ± 0.10 mmol/L, P = < 0.001). The MedDairy intervention also led to greater improvements in processing speed (P = 0.04), a measure of cognitive function, as well as self-reported mood (P = 0.01). No significant differences were observed between MedPork and LF for blood pressure or other markers of cardiometabolic health. However, the MedPork intervention led to greater improvements in processing speed (P = 0.01) and mood (P = 0.03). Our findings demonstrate that a Mediterranean diet with added dairy foods is capable of delivering adequate calcium to ageing populations while providing cardiovascular and cognitive benefits. Further, a Mediterranean diet supplemented with fresh, lean pork offers comparable cardiovascular benefits to a low-fat diet and greater improvements to cognitive function and mood. Our findings are of particular relevance to non-Mediterranean populations at risk of cardiovascular disease and dementia, and offer two options for modifying the Mediterranean diet depending on dietary priorities.

The Blue Zones are known for healthy longevity and low rates of chronic disease. Common denominators between blue zones include social, environmental and spiritual foundations for good health, however there are key dietary contributors including mindful eating and a predominantly plant-based diet. the Mediterranean diet (MedDiet) is a plant-based diet and is reported to reduce the risk of overall mortality and cancer incidence, diabetes, neurodegenerative disease, heart attack and cardiovascular disease (CVD). Populations have enjoyed the health benefits of a MedDiet, for years, which could offer better health to Western countries which suffer from lifestyle diseases like obesity and heart disease. But how feasible is it to implement such a pattern beyond the Mediterranean sea? The MedLey study explored whether a MedDiet could be adhered to for 6 months and would improve CVD risk factors compared with habitual diet (HabDiet) in a population of older Australian adults. Volunteers were assessed at 3 points during the study (0, 3, 6 months) and12 months after the intervention had finished (18 months). 137 volunteers completed the trial and 128 volunteers completed the follow-up study. Participants completed a food frequency questionnaire and a 15-point MedDiet adherence score (MDAS; greater score = greater adherence) was calculated. Home BP was measured over 6 days, and cardiometabolic health outcomes were assessed. Data were analysed using intention-to-treat LMEM with a group x time interaction term comparing data at 0, 3, 6 and 18-months (12-months post-trial). At baseline the MedDiet score was 6.7 ± 0.2, 9.6 ± 0.2 at 4 months and 7.9 ± 0.3 at 18-months (p < .0001 to baseline and 4 months). The MedDiet resulted in improved systolic BP, endothelial dilatation, oxidative stress and plasma triglycerides in comparison with HabDiet, after 6 months (p < .05). These changes were not sustained at 18-months but did not completely return to baseline values. Principles of the MedDiet appeared to be somewhat maintained. Consumption of olive oil, legumes, fish and vegetables (p < .01) remained higher and discretionary food consumption (p = .02) remained lower at 18-months than baseline in the MedDiet group. We have shown that following a MedDiet for 6-months is feasible and results improvements in markers of CVD risk. Some principles of the MedDiet were maintained following trial completion, but ongoing support may be helpful in maintaining MedDiet adherence and improved health. To implement such a pattern on a population level, several considerations are required including provision of resources and information, ongoing support, creating supportive environments through a multi-settings approach.

Perinatal depression is a depressive illness that affects 10–15% of women in the UK with an estimated cost of £1.8 billion/year. Zinc deficiency is associated with the development of mood disorders and zinc supplementation has been shown to help reduce the symptoms of depression. Women who are pregnant and breastfeeding are at risk of lower levels of zinc because of the high demand from the developing and feeding baby. However, studies in the perinatal period are limited. With a long-term aim of designing a randomised controlled trial (RCT) to examine if zinc supplementation reduces depressive symptoms in pregnant and lactating women;the objective of this review was to systematically evaluate previous RCTs assessing zinc supplementation and depressive symptoms, in order to establish a zinc dosing regimen with regards to Galenic formulation, unit dose and frequency. The review was conducted by independent reviewers in accordance with PRISMA guidelines and is registered at Prospero (CRD42017059205). The Allied and Complimentary Medicine, CINAHL, Embase, MEDLINE, PsycINFO, PubMed, and Cochrane databases were searched since records began, with no restrictions, for intervention trials assessing Galenic formulation, unit dose and frequency of zinc supplementation to reduce the symptoms of depression. From a total of 66 identified records, 7 articles met the inclusion and exclusion criteria; all assessed the effect of zinc supplementation on mood. Risk of bias was independently assessed using the standard ‘Cochrane risk of bias tool’. Overall, 5 of the 7 papers were rated as high-quality trials; of the other two, one was rated poor and the other fair but both had a number of learning points. Preliminary findings indicate at the end of supplementing zinc, depression scores were reduced significantly. In one study, the Beck score decreased in the placebo group, but this reduction was not significant compared to the baseline. In two of the studies there was a significant correlation between serum zinc and self-reported mood questionnaires. Results also suggest that 25 mg zinc supplementation combined with antidepressant drugs can be effective in the treatment of major depression in women. This supports other work where researchers supplemented 25 mg of elemental zinc for 12 weeks or longer and found a reduction of symptoms in both pregnant and non-pregnant women. Thus, an early conclusion is that 25 mg of elemental zinc is an effective dose for improving low mood and is achievable in a trial setting.

The Arizona Twin Project is an ongoing longitudinal study designed to elucidate gene–environment interplay underlying the development of risk and resilience to common mental and physical health problems during infancy, childhood and adolescence. Specificity of risk is carefully examined across mental and physical health and how these influences vary across socioeconomic and sociocultural environments. Participants are a sample of approximately 700 twins (31% Latinx) recruited from birth records in the state of Arizona, USA. Twins are 32% monozygotic twins, 36% same-sex dizygotic (DZ), 32% opposite-sex DZ, currently 10–11 years of age. Primary caregivers were interviewed on twins’ development and early physical and social environments when twins were 1, 2 and 5 years of age. In-depth objective measurement commenced in middle childhood, with in-person assessments at 8–11 years of age, with plans to continue to follow the sample across adolescence. Middle childhood measures focus on children’s physical and mental health, including diurnal cortisol, actigraphy-based measures of sleep and activity, cold pressor task assessing acute pain, and reaction time tasks assessing executive functioning. Preliminary findings illustrate that objective assessments of children’s health are highly heritable, but they do not always share genetic etiology with more commonly used subjective assessments. Exposure to early adversity moderates genetic influences on both executive functioning and health, with higher heritability typically seen under adverse conditions. Future directions include an examination of how pubertal stage affects genetic and environmental influences on diurnal cortisol, sleep, chronic pain, and mental health.

The Mediterranean diet offers a range of health benefits. However, previous studies indicate that the restricted consumption of red meat in the diet may affect long-term sustainability in non-Mediterranean countries. A 24-week randomised controlled parallel cross-over design compared a Mediterranean diet supplemented with 2–3 serves per week of fresh, lean pork (MedPork) with a low-fat control diet (LF). Thirty-three participants at risk of CVD followed each intervention for 8 weeks, with an 8-week washout period separating interventions. The primary outcome was home-measured systolic blood pressure. Secondary outcomes included diastolic blood pressure, fasting lipids, glucose, insulin, C-reactive protein (CRP), body composition and dietary adherence. During the MedPork intervention, participants achieved high adherence to dietary guidelines. Compared with the MedPork intervention, the LF intervention led to greater reductions in weight (Δ = −0·65; 95 % CI −0·04, −1·25 kg, P = 0·04), BMI (Δ = −0·25; 95 % CI −0·03, −0·47 kg/m2, P = 0·01) and waist circumference (Δ = −1·40; 95 % CI −0·45, −2·34 cm, P < 0·01). No significant differences were observed for blood pressure, lipids, glucose, insulin or CRP. These findings indicate that Australians are capable of adhering to a Mediterranean diet with 2–3 weekly serves of fresh, lean pork. Larger intervention studies are now required to demonstrate clinical efficacy of the diet in populations with elevated blood pressure.

Community advisory boards (CABs) are a valuable strategy for engaging and partnering with communities in research. Eighty-nine percent of Clinical and Translational Science Awardees (CTSA) responding to a 2011 survey reported having a CAB. CTSAs’ experiences with CABs are valuable for informing future practice. This study was conducted to describe common CAB implementation practices among CTSAs; document perceived benefits, challenges, and contributions; and examine their progress toward desirable outcomes. A cross-CTSA collaborative team collected survey data from respondents representing academic and/or community members affiliated with CTSAs with CABs. Data representing 44 CTSAs with CABs were analyzed using descriptive statistics. A majority of respondents reported practices reflecting respect for CAB members’ expertise and input such as compensation (75%), advisory purview beyond their CTSA’s Community Engagement program (88%), and influence over CAB operations. Three-quarters provide members with orientation and training on roles and responsibilities and 89% reported evaluating their CAB. Almost all respondents indicated their CTSA incorporates the feedback of their CABs to some degree; over half do so a lot or completely. This study profiles practices that inform CTSAs implementing a CAB and provide an evaluative benchmark for those with existing CABs.