Multisite Prospective Cohort Study Research Articles

Prospective validation of genetic predictors of aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) in a racially diverse cohort: Results from ECOG-ACRIN E1Z11.

12003 Background: AIMSS are common and frequently lead to early discontinuation of adjuvant AI therapy. Single nucleotide polymorphisms (SNPs) in candidate genes have been associated with AIMSS and AI discontinuation. The primary objective of E1Z11 was to validate previously identified associations between 10 specific SNPs in candidate genes and AI discontinuation due to AIMSS in a community-based, racially diverse cohort. Methods: Postmenopausal women with hormone receptor-positive stage I-III breast cancer enrolled onto a prospective multi-site cohort study, the majority through the NCI Community Oncology Research Program (NCORP). Participants received anastrozole 1 mg oral daily, and completed patient-reported outcomes (PROs) at baseline, 3, 6, 9, and 12 months. AIMSS was defined as >20% increase in Stanford Health Assessment Questionnaire (HAQ) score over baseline occurring within 1 year of AI therapy. We projected 40% would develop AIMSS and 25% would discontinue AI treatment within 1 year, informing a planned enrollment of 1000 women with a fixed number per strata (600 Caucasian, 200 African-American [AA] & 200 Asian) to provide 80% power to detect an effect size of 1.5-4. SNPs include ESR1 (rs2234693, rs2347868, rs9340835), CYP19A1 (rs1062033, rs4646), TCL1A (rs11849538, rs2369049, rs7158782, rs7159713), and HTR2A (rs2296972). Hardy-Weinberg equilibrium (HWE) was evaluated within each racial subset. SNP genotypes were coded as additive effects on the log odds ratio by coding as 0, 1 or 2 for the count of the minor allele. A Cochran-Armitage trend test was used with a 1-sided alpha of 0.0025 (Bonferroni correction for 10 tests). Results: We enrolled 999 evaluable women (616 Caucasian, 184 AA, 199 Asian). Genotyping was successful in 974 (98%). AIMSS developed in 43%, and AI therapy was discontinued in 12% within 1 year. While more AA and Asians developed AIMSS compared to Caucasians (48% vs 38%, p=0.017; 50% vs 38%, p=0.004), AI discontinuation rates were similar across racial groups. HWE was satisfied for all SNPs at the 5% alpha level, except for TCL1A/rs11849538 (p=0.002) in the AA cohort. None of the 10 SNPs were significantly associated with AI discontinuation or development of AIMSS in the overall population, or in any of the 3 cohorts. Conclusions: Although AIMSS were more common in AA and Asians, AI discontinuation rates were similar in the 3 cohorts. We were unable to prospectively validate 10 SNPs in 4 genes previously associated with AI discontinuation due to AIMSS. Future analyses will include other predictors of AIMSS, PROs, and additional genetic markers for the entire cohort and by race. Support: NCI UG1CA189828, UG1CA233196, UG1CA233277, UG1CA233320, UG1CA233178, UG1CA233160, UG1CA232760, UG1CA233341, UG1CA233329, U10CA180821, UG1CA189821, UG1CA189830, U10CA180888, UG1CA189859, UG1CA189863, UG1CA189971. Clinical trial information: NCT01824836.

Variability in How Canadian Pediatric Weight Management Clinics Deliver Care: Evidence from the CANadian Pediatric Weight Management Registry.

Background: Clinical practice guidelines for pediatric weight management highlight the importance of family-based behavioral strategies to enhance health behaviors. Little is known, however, of how clinics implement these programs. The study objectives were to (1) describe how Canadian pediatric weight management clinics deliver care and (2) evaluate change in services over time. Methods: The CANadian Pediatric Weight management Registry (CANPWR) is a multisite prospective cohort study of participants enrolled in a Canadian pediatric weight management clinic. Clinical program characteristics (e.g., referral process, inclusion criteria, funding, program characteristics, patient interaction methods, and follow-up) were collected at the start and end of the CANPWR recruitment period (2015-2019). Results: Entrance into the nine clinics varied with limiting criteria based on geographic proximity, age, weight status, and presence of health conditions. The clinics varied in size (50-220 new patients/year). The planned length of intervention varied widely, from 10 weeks to open-ended (median 2 years). Behavior modification strategies were delivered with a mix of individual and group-based sessions and most were delivered in person, complemented by use of virtual care. Over time, more clinics saw patients under the age of 5 years and all clinics defined a program length. Conclusion: Although all clinics offered family-based behavioral weight management services, these varied considerably, especially in program entrance criteria, size of clinic, and the length of intervention. The influence of the variability in delivery of services on health outcomes will be addressed in future studies.

P0490 / #1769: THE CARING INTENSIVELY STUDY: FAMILY MEMBERS’ PERCEPTIONS OF PSYCHOLOGICAL OUTCOMES ONE YEAR FOLLOWING PEDIATRIC INTENSIVE CARE UNIT HOSPITALIZATION

Aims & Objectives: There is a dearth of research exploring family members’ perceptions of long-term psychological outcomes following PICU hospitalization. The aim of this study was to explore children and parents’ perceptions of long-term psychological and behavioral responses one year following PICU hospitalization. Methods: A secondary data analysis of qualitative outcome data collected as part of a Canadian mixed methods, multi-site prospective cohort study; the Caring Intensively Study. An interpretive descriptive design using semi-structured interviews with parents and children was conducted. Families were purposively selected to represent the larger cohort sample. Data were analyzed collectively to uncover themes within participants’ narratives. Results: We interviewed 16 mothers, 6 fathers, and 9 children (17 families). Participants reported their desire to re-establish a sense of family normalcy expressed in 5 themes: 1) PICU reminders and memories, 2) Changing perceptions of health and illness, 3) Re-establishing a family routine, 4) I am not the same, and 5) Altered relationships. Participants described significant emotional/behavioural changes during the year following hospital discharge. They experienced ongoing memories and reminders of the child’s PICU admission. Their experiences resulted in changed perceptions of their child’s health, with heightened vigilance regarding health and safety among parents and siblings. Participants described efforts to readapt to routine life once the child returned home, and found disruptions related to the illness and associated parental absence caused changes in family relationships. Conclusions: PICU hospitalization impacts the psychological well-being of all members of the family as they seek to re-establish a sense of normalcy one year following discharge.

1072 Early pregnancy BMI and angiogenesis-related biomarkers (sFlt-1/PlGF): a pathway for adverse pregnancy outcomes?

Obesity is a risk factor for adverse pregnancy outcomes, but it is unclear whether this is mediated through placental angiogenic factors. We examined the relationship between early pregnancy body mass index (BMI) and 1st- and 2nd-trimester concentrations of sFlt-1/PlGF as a potential biologic pathway for placental insufficiency. We conducted secondary analyses of data and samples from a large, multi-site prospective cohort study of nulliparous pregnant women conducted in the U.S. First- and 2nd-trimester blood samples, 1st-trimester BMI, demographic, lifestyle, and pregnancy data were gathered for all participants. sFlt-1 and PlGF concentrations were measured for a subsample of 1,502 cases (delivery<37weeks, preeclampsia or eclampsia, birthweight for gestational age <5th%, or stillbirth) and 911 controls. We used one-way ANOVA and multivariable linear and logistic regression models to test the association of BMI and sFlt-1/PlGF ratio, using a previously published ratio cutoff of ≥38 in logistic regression. We identified potential confounders a priori and used backward elimination to determine the best-fit model. Plots of mean sFlt-1/PlGF ratios by BMI category and gestational week showed lower ratios in overweight and obese groups in the 1st trimester, which reversed to higher ratios among overweight and obese groups in the 2nd trimester (Fig. 1). After controlling for clinical and demographic factors, women in all high BMI groups had significantly lower mean sFlt-1/PlGF ratios than normal weight women in the 1st trimester (Table 1). In the 2nd trimester, women with BMI ≥35 had a 35% higher mean sFlt-1/PlGF ratio than normal weight women (p=0.009). Logistic regression suggested increased odds of a 2nd-trimester ratio ≥38 among women with BMI ≥35, though not statistically different from 1.0 (OR 2.59, 95% CI 0.95-7.08). Early pregnancy BMI is associated with alterations in first- and second-trimester sFlt-1/PlGF ratios. Findings suggest a potential physiologic pathway between obesity and placental insufficiency.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Incidence of influenza during pregnancy and association with pregnancy and perinatal outcomes in three middle-income countries: a multisite prospective longitudinal cohort study

Influenza vaccination during pregnancy prevents influenza among women and their infants but remains underused among pregnant women. We aimed to quantify the risk of antenatal influenza and examine its association with perinatal outcomes. We did a prospective cohort study in pregnant women in India, Peru, and Thailand. Before the 2017 and 2018 influenza seasons, we enrolled pregnant women aged 18 years or older with expected delivery dates 8 weeks or more after the season started. We contacted women twice weekly until the end of pregnancy to identify illnesses with symptoms of myalgia, cough, runny nose or nasal congestion, sore throat, or difficulty breathing and collected mid-turbinate nasal swabs from symptomatic women for influenza real-time RT-PCR testing. We assessed the association of antenatal influenza with preterm birth, late pregnancy loss (≥13 weeks gestation), small for gestational age (SGA), and birthweight of term singleton infants using Cox proportional hazards models or generalised linear models to adjust for potential confounders. Between March 13, 2017, and Aug 3, 2018, we enrolled 11 277 women with a median age of 26 years (IQR 23-31) and gestational age of 19 weeks (14-24). 1474 (13%) received influenza vaccines. 310 participants (3%) had influenza (270 [87%] influenza A and 40 [13%] influenza B). Influenza incidences weighted by the population of women of childbearing age in each study country were 88·7 per 10 000 pregnant woman-months (95% CI 68·6 to 114·8) during the 2017 season and 69·6 per 10 000 pregnant woman-months (53·8 to 90·2) during the 2018 season. Antenatal influenza was not associated with preterm birth (adjusted hazard ratio [aHR] 1·4, 95% CI 0·9 to 2·0; p=0·096) or having an SGA infant (adjusted relative risk 1·0, 95% CI 0·8 to 1·3, p=0·97), but was associated with late pregnancy loss (aHR 10·7, 95% CI 4·3 to 27·0; p<0·0001) and reduction in mean birthweight of term, singleton infants (-55·3 g, 95% CI -109·3 to -1·4; p=0·0445). Women had a 0·7-0·9% risk of influenza per month of pregnancy during the influenza season, and antenatal influenza was associated with increased risk for some adverse pregnancy outcomes. These findings support the added value of antenatal influenza vaccination to improve perinatal outcomes. US Centers for Disease Control and Prevention. For the Thai, Hindi, Marathi and Spanish translations of the abstract see Supplementary Materials section.

Self-perception of assisting with future injection drug initiation: The influence of relationships in the process of drug injecting initiation.

People who inject drugs (PWID) play critical roles in assisting others into injection drug use (IDU) initiation. Understanding perceptions of PWID's risk of initiating others is needed to inform interventions for prevention. The objective was to examine factors associated with self-perception of assisting with future IDU initiation events. The primary variables of interest are the relationships of PWID with the person(s) they assisted and their reasons for previously providing initiation assistance. Data from Preventing Injecting by Modifying Existing Responses, a multi-site prospective community-recruited cohort study, were analysed. Analyses were restricted to PWID who reported ever providing IDU initiation assistance. Site-specific (Vancouver, Canada [n = 746]; San Diego, USA [n = 95] and Tijuana, Mexico [n = 92]) multivariable logistic regression analyses were performed to determine factors associated with self-perception of assisting with future IDU initiation. Having provided IDU initiation assistance to a family member or intimate partner decreased the odds of self-perception of assisting with future IDU initiation in Vancouver (AOR = 0.4; 95% CI 0.2-0.8); however, previous IDU initiation assistance to an 'other' increased the odds of self-perception of assisting with future IDU in Tijuana (AOR = 12.0; 95% CI 2.1-70.3). Daily IDU (Vancouver: AOR = 3.7; 95% CI 2.1-6.4) and less than daily IDU (San Diego: AOR = 5.9; 95% CI 1.3-27.1) (Vancouver: AOR = 2.6; 95% CI 1.4-2.9) were associated with increased self-perception of assisting with future IDU compared to current non-injectors. Relationship to past initiates and IDU frequency might increase PWID's self-perception of assisting with future IDU. Interventions focused on social support and reducing IDU frequency may decrease occurrences of IDU initiation assistance.

Ontario Neurodegenerative Disease Research Initiative (ONDRI): Structural MRI Methods and Outcome Measures

The Ontario Neurodegenerative Research Initiative (ONDRI) is a 3 years multi-site prospective cohort study that has acquired comprehensive multiple assessment platform data, including 3T structural MRI, from neurodegenerative patients with Alzheimer's disease, mild cognitive impairment, Parkinson's disease, amyotrophic lateral sclerosis, frontotemporal dementia, and cerebrovascular disease. This heterogeneous cross-section of patients with complex neurodegenerative and neurovascular pathologies pose significant challenges for standard neuroimaging tools. To effectively quantify regional measures of normal and pathological brain tissue volumes, the ONDRI neuroimaging platform implemented a semi-automated MRI processing pipeline that was able to address many of the challenges resulting from this heterogeneity. The purpose of this paper is to serve as a reference and conceptual overview of the comprehensive neuroimaging pipeline used to generate regional brain tissue volumes and neurovascular marker data that will be made publicly available online.

Universal test-and-treat in Zambian and South African correctional facilities: a multisite prospective cohort study

Despite the global scale-up of antiretroviral therapy (ART), incarcerated people have not benefited equally from test-and-treat recommendations for HIV. To improve access to ART for incarcerated people with HIV, we introduced a universal test-and-treat (UTT) intervention in correctional facilities in South Africa and Zambia, and aimed to assess UTT feasibility and clinical outcomes. Treatment as Prevention (TasP) was a multisite, mixed methods, implementation research study done at three correctional complexes in South Africa (Johnannesburg and Breede River) and Zambia (Lusaka). Here, we report the clinical outcomes for a prospective cohort of incarcerated individuals who were offered the TasP UTT intervention. Incarcerated individuals were eligible for inclusion if they were aged 18 years or older, with new or previously diagnosed HIV, not yet on ART, and were expected to remain incarcerated for 30 days or longer. To enable the implementation of UTT at the included correctional facilities, we first strengthened on-site HIV service delivery. All participants were offered same-day ART initiation, and had two study-specific follow-up visits scheduled to coincide with routine clinic visits at 6 and 12 months. The main outcomes were ART uptake, time from cohort enrolment to ART initiation, and retention in care and viral suppression at 6 and 12 months. We estimated the association between baseline demographic characteristics and time to ART initiation using Cox proportional hazard models, and, in a post-hoc analysis, we used logistic regression models to assess the association between demographic and clinical variables, including time to ART initiation, and the proportion of participants with a composite poor outcome (defined as viral load >50 copies per mL, or for participants with a missing viral load, lack of retention in care in the on-site ART programme) at 6 months. This study is registered at ClinicalTrials.gov, NCT02946762. Between June 23, 2016, and Dec 31, 2017, we identified 1562 incarcerated people with HIV, of whom 1389 (89%) were screened, 1021 (74%) met eligibility criteria, and 975 (95%) were enrolled and followed up to March 31, 2018. At the end of follow-up, 835 (86%) of 975 participants had started ART. Median time from enrolment to ART initiation was 0 days (IQR 0-8). Of 346 participants who remained incarcerated at 6 months, 327 (95%) were retained in care and 269 (78%) had a documented viral load, of whom 262 (97%) achieved viral suppression (<1000 copies per mL). The mortality rate among the 835 participants who had initiated ART was 1·9 per 100 person-years (95% CI 0·9-3·9). No statistically significant associations were identified between any baseline characteristics and time to ART initiation or composite poor outcome. UTT implementation is feasible in correctional settings, and can achieve levels of same-day ART uptake, retention in care, and viral suppression among incarcerated people with HIV that are comparable to those observed in community settings. UK Department for International Development, Swedish International Development Cooperation Agency, Norwegian Agency for Development Cooperation.

Identifying Adolescent Girls and Young Women at High Risk for HIV Acquisition: A Risk Assessment Tool From the Girl Power-Malawi Study.

Prioritizing HIV prevention for adolescent girls and young women (AGYW) at high risk for HIV acquisition in sub-Saharan Africa (typically considered ≥3 per 100 person-years [PYs]) is urgently needed, but identifying these AGYW is challenging. We sought to assess and, if needed, enhance a risk assessment tool from the VOICE trial for identifying AGYW at high risk for HIV in Lilongwe, Malawi. A multisite prospective cohort study was conducted among sexually active AGYW 15 to 24 years old at 4 health centers in 2016 to 2017. The VOICE tool was first applied and then updated by excluding variables that were not predictive and adding variables that were. Incidence rates (IRs), incidence rate ratios, 95% confidence intervals (CIs), area under the receiver operating characteristic curve (AUC), sensitivity, and specificity were calculated. Seven hundred ninety-five participants experienced 14 seroconversions for 672 PYs (IR, 2.08 per 100 PYs; 95% CI, 1.23-3.52). The VOICE tool had moderate predictive ability (AUC, 0.64; 95% CI, 0.52-0.75). Maintaining 2 variables (genital ulcers and vaginal discharge), removing 5 sociodemographic variables, and adding 2 variables (ever pregnant and >5-year male-female age gap) enhanced performance (AUC, 0.79; 95% CI, 0.69-0.89). Thirty-five percent had a score of 0, 41% had a score of 1 to 2, and 24% had a score >3. A score >1 resulted in 100% sensitivity, 35.9% specificity, and an IR of 3.25 per 100 PYs. A score >3 resulted in 64.3% sensitivity, 76.8% specificity, and an IR of 5.89 per 100 PYs. A simple risk assessment tool identified a subset of AGYW in Malawi at high risk for HIV acquisition who may benefit from biomedical HIV prevention.

Regional variations in medical trainee diet and nutrition counseling competencies: Machine learning-augmented propensity score analysis of a prospective multi-site cohort study.

Medical professionals and students are inadequately trained to respond to rising global obesity and nutrition-related chronic disease epidemics, primarily focusing on cardiovascular disease. Yet, there are no multi-site studies testing evidence-based nutrition education for medical students in preventive cardiology, let alone establishing student dietary and competency patterns. Cooking for Health Optimization with Patients (CHOP; NIH NCT03443635) was the first multi-national cohort study using hands-on cooking and nutrition education as preventive cardiology, monitoring and improving student diets and competencies in patient nutrition education. Propensity-score adjusted multivariable regression was augmented by 43 supervised machine learning algorithms to assess students outcomes from UT Health versus the remaining study sites. 3,248 medical trainees from 20 medical centers and colleges met study criteria from 1 August 2012 to 31 December 2017 with 60 (1.49%) being from UTHealth. Compared to the other study sites, trainees from UTHealth were more likely to consume vegetables daily (OR 1.82, 95%CI 1.04-3.17, p=0.035), strongly agree that nutrition assessment should be routine clinical practice (OR 2.43, 95%CI 1.45-4.05, p=0.001), and that providers can improve patients' health with nutrition education (OR 1.73, 95%CI 1.03-2.91, p=0.038). UTHealth trainees were more likely to have mastered 12 of the 25 competency topics, with the top three being moderate alcohol intake (OR 1.74, 95%CI 0.97-3.11, p=0.062), dietary fats (OR 1.26, 95%CI 0.57-2.80, p=0.568), and calories (OR 1.26, 95%CI 0.70-2.28, p=0.446). This machine learning-augmented causal inference analysis provides the first results that compare medical students nationally in their diets and competencies in nutrition education, highlighting the results from UTHealth. Additional studies are required to determine which factors in the hands-on cooking and nutrition curriculum for UTHealth and other sites produce optimal student - and, eventually, preventive cardiology - outcomes when they educate patients in those classes.

Multiparous Black and Latinx Women Face More Barriers to Prenatal Care than White Women.

Women who are late to prenatal care miss opportunities for health interventions and are at increased risk for pregnancy-related complications. Black women have the lowest rates of first trimester care compared with White or Latinx women. We sought to describe barriers to prenatal care experienced by race/ethnicity in a multi-site, prospective cohort. We performed a secondary analysis of the Community Child Health Research Network Study, a multi-site prospective cohort study of pregnant women from 2008 to 2012. Women were recruited at the time of delivery and followed prospectively for 2years. Participants who experienced a repeat pregnancy in the 2-year follow-up period had a prospective assessment of prenatal care barriers. A multilevel mixed effects Poisson regression was performed to evaluate the association between race/ethnicity and number of prenatal barriers. Of the 298 participants in the sample, 43% of Black, 35% of Latinx, and 23% of White participants reported barriers to prenatal care. After adjustment for confounders, Black and Latinx women reported almost twice as many barriers to prenatal care as White women (adjusted rate ratio 1.89 [1.2, 3.0]; 2.00 [1.1, 3.8], respectively). In our analysis, multiparous Black and Latinx women reported encountering more barriers to prenatal care than White women. Additional reforms and policy change are needed at the clinic, local, and state levels to support women in accessing early quality prenatal care to achieve racial equity in prenatal care.

Anemia in Critically Ill Patients With Acute Respiratory Distress Syndrome and Posthospitalization Physical Outcomes.

Anemia is common during critical illness and often persists after hospital discharge; however, its potential association with physical outcomes after critical illness is unclear. Our objective was to assess the associations between hemoglobin at intensive care unit (ICU) and hospital discharge with physical status at 3-month follow-up in acute respiratory distress syndrome (ARDS) survivors. This is a secondary analysis of a multisite prospective cohort study of 195 mechanically ventilated ARDS survivors from 13 ICUs at 4 teaching hospitals in Baltimore, Maryland. Multivariable regression was utilized to assess the relationships between ICU and hospital discharge hemoglobin concentrations with measures of physical status at 3 months, including muscle strength (Medical Research Council sumscore), exercise capacity (6-minute walk distance [6MWD]), and self-reported physical functioning (36-Item Short-Form Health Survey [SF-36v2] Physical Function score and Activities of Daily Living [ADL] dependencies). Median (interquartile range) hemoglobin concentrations at ICU and hospital discharge were 9.5 (8.5-10.7) and 10.0 (9.0-11.2) g/dL, respectively. In multivariable regression analyses, higher ICU discharge hemoglobin concentrations (per 1 g/dL) were associated with greater 3-month 6MWD mean percent of predicted (3.7% [95% confidence interval 0.8%-6.5%]; P = .01) and fewer ADL dependencies (-0.2 [-0.4 to -0.1]; P = .02), but not with percentage of maximal muscle strength (0.7% [-0.9 to 2.3]; P = .37) or SF-36v2 normalized Physical Function scores (0.8 [-0.3 to 1.9]; P = .15). The associations of physical outcomes and hospital discharge hemoglobin concentrations were qualitatively similar, but none were statistically significant. In ARDS survivors, higher hemoglobin concentrations at ICU discharge, but not hospital discharge, were significantly associated with improved exercise capacity and fewer ADL dependencies. Future studies are warranted to further assess these relationships.

A dual perspective on first-session therapeutic alliance: strong predictor of youth mental health and addiction treatment outcome

We investigated the potential role of first-session therapeutic alliance ratings to serve as an early marker of treatment outcome in youth mental health and addiction treatment. The present study is among the first to incorporate both a youths’ and a therapists’ perspective of the therapeutic alliance in order to maximize predictive value of the alliance for treatment outcome. One hundred and twenty-seven adolescents participated in a multi-site prospective naturalistic clinical cohort study, with assessments at baseline and at 4 months post-baseline. Main outcome measure was favorable or unfavorable treatment outcome status at 4-month follow-up. Early therapeutic alliance had a medium and robust association with treatment outcome for youth’ (b = 1.29) and therapist’ (b = 1.12) perspectives and treatment setting. Based on the two alliance perspectives four subgroups were distinguished. Incorporating the alliance-ratings from both perspectives provided a stronger predictor of treatment outcome than using one perspective. Youth with a strong alliance according to both perspectives had an eightfold odds of favorable treatment outcome compared with youth with a weak alliance according to both perspectives. The association between therapeutic alliance and treatment outcome in youth mental health and addiction treatment may be substantially stronger than earlier assumed when both a youths’ and therapists’ perspective on alliance is considered.

Healthcare worker knowledge and skills following coaching in WHO early essential newborn care program in the Solomon Islands: a prospective multi-site cohort study

BackgroundNewborn mortality in Oceania declined slower than other regions in the past 25 years. The World Health Organization (WHO) introduced the Early Essential Newborn Care program (EENC) in 2015 in Solomon Islands, a Small Island Developing State, to address high newborn mortality. We explored knowledge and skills retention among healthcare workers following EENC coaching.MethodsBetween March 2015 and December 2017, healthcare workers in five hospitals were assessed: pre- and post-clinical coaching and at a later evaluation. Standardised written and clinical skills assessments for breathing and non-breathing baby scenarios were used. Additionally, written surveys were completed during evaluation for feedback on the EENC experience.ResultsFifty-three healthcare workers were included in the evaluation. Median time between initial coaching and evaluation was 21 months (IQR 18–26). Median written score increased from 44% at baseline to 89% post-coaching (p < 0.001), and was 61% at evaluation (p < 0.001). Skills assessment score was 20% at baseline and 95% post-coaching in the Breathing Baby scenario (p < 0.001). In the Non-Breathing Baby scenario, score was 63% at baseline and 86% post-coaching (p < 0.001). At evaluation, median score in the Breathing Baby scenario was 82% a reduction of 13% from post-coaching (p < 0.001) and 72% for the Non-Breathing Baby, a reduction of 14% post-coaching (p < 0.001). Nurse aides had least reduction in evaluation scores of − 2% for the Breathing Baby and midwives − 10% for the Non-Breathing Baby respectively from post-coaching to evaluation.ConclusionsEENC coaching resulted in immediate improvements in knowledge and skills but declined over time. Healthcare workers who used the skills in regular practice had higher scores. Complementary quality improvement strategies are needed to sustain resuscitation skills following training over time.Trial registrationAustralia New Zealand Trial Registry, Retrospective Registration (12/2/2019), registration number ACTRN12619000201178.

Diet and Food-Purchasing Habits among Black and White Children with Food Allergy

Previous studies indicate racial differences in the prevalence of food allergies among children. However, little is known about how race impacts the daily life experiences of families of children diagnosed with FA. The prospective multi-site cohort study, FORWARD, recruits Black and White children 0-12 years of age with physician-diagnosed IgE-mediated food allergies in Chicago, Cincinnati and Washington DC. Guardians of the children completed follow-up surveys (at 6 months post-enrollment) assessing diet and purchasing habits (N=175). Pearson’s chi-squared tests were used to assess variability in responses between Black and White families. When asked about grocery purchases, survey results indicated a clear disparity in access to allergy-free foods (p < 0.001), with White families reporting greater access to allergy-free foods (89.76%) compared to Black families (60.47%). Although both White and Black families reported checking food labels with comparable frequency (p=0.367), there was a noticeable difference in concern for making a purchasing mistake when grocery shopping that would lead to an allergic reaction. Nearly half of White families expressed concern (48.82%), while less than a quarter of Black families (20.93%) felt similarly (p=0.001). With respect to children eating food prepared outside of the home, fewer Black families (48.84%) were fearful of an allergic reaction than White families (78.74%; p< 0.001). Results of this study indicate several differences in the diet and purchasing habits between Black and White families of children with food allergies. Further analysis is necessary to determine whether these differences are related to race, socioeconomic status, or other factors.

Trivalent inactivated influenza vaccine (IIV3) during pregnancy and six-month infant development

ObjectiveDespite recommendations by professional organizations that all pregnant women receive inactivated influenza vaccine, safety concerns remain a barrier. Our objective was to assess the effect of trivalent influenza vaccines (IIV3) during pregnancy on parent report 6-month infant development. MethodsWe conducted a multi-site prospective birth cohort study during the 2010–2011 influenza season and followed pregnant women and their newborns through 6 months of age. Information on IIV3 during pregnancy was ascertained from the EHR and self-report. The Ages and Stages Questionnaire-3 (ASQ-3) was completed by the mother to assess 6-month infant neurodevelopment in five domains (communication, gross motor, fine motor, problem-solving, and personal adaptive skills). Scores for each domain above the cut-off point indicating typical development were categorized as “on schedule” while scores in the zones indicating the need for either monitoring or further assessment were categorized as “not on schedule”. Multivariable logistic regression was conducted. ResultsOf the 1225 infant-mother pairs, 65% received IIV3 during pregnancy. In bivariate analysis, infants of women who received IIV3 during pregnancy were moderately-less likely to need monitoring or further assessment in the personal social domain compared with infants of unvaccinated women (10.0% vs. 14.1%, p = 0.033; crude OR (cOR): 0.68(95%CI:0.48,0.97)). However, after controlling for potential confounders, the findings were no longer statistically significant (aOR:0.72,95%CI: 0.49,1.06,p = 0.46). No significant unadjusted or adjusted associations emerged in any other ASQ-3 domain. ConclusionThere was no significant association between IIV3 exposure during pregnancy and 6-month infant development. Studies of IIV3 during pregnancy to assess longer-term developmental outcomes are indicated.

Multisite Medical Student-Led Community Culinary Medicine Classes Improve Patients' Diets: Machine Learning-Augmented Propensity Score-Adjusted Fixed Effects Cohort Analysis of 1381 Subjects.

Background. Healthy diet represents one of the largest single modifiable risk factors proven to decrease rates of obesity and associated chronic disease, but practical approaches to improving dietary habits through nutritional intervention are limited. Objective. To evaluate the effectiveness of a medical student-led, 6-week culinary course on participants' dietary knowledge and behaviors, particularly focusing on the tenets of the Mediterranean diet (MedDiet). Design. This study is a prospective multisite cohort study evaluating the effects of a 6-week, hands-on community culinary education course offered at 3 sites. Participants' knowledge of cooking skills, eating habits, and adherence to the MedDiet were evaluated using a survey prior to beginning and 6 weeks after the completion of the course. Analysis was conducted using multivariable regression to assess subjects' diets, associated behaviors, and nutrition beliefs according to the number of classes to which they were exposed (0 to >6). Statistical results were then compared with the machine learning results to check statistical validity after selection of the top-performing algorithm from 43 supervised algorithms using 10-fold cross-validation with performance assessed according to accuracy, root relative square error, and root mean square error. Results. Among the 1381 participants, cooking classes significantly improved patients' overall 9-point MedDiet adherence (β = 0.62, 95% CI 0.23-1.00, P = .002). Participants were more likely to meet MedDiet point requirements for fruit intake (odds ratio [OR] 2.77, 95% CI 1.46-5.23, P = .002), vegetable intake (OR 4.61, 95% CI 1.85-11.53, P = .001), legume intake (OR 2.48, 95% CI 1.45-4.26, P = .001), and olive oil use (OR 2.87, 95% CI 1.44-5.74, P = .003), and were less likely to believe that cooking takes excessive time (OR 0.31, 95% CI 0.16-0.59, P < .001). Conclusion. Hands-on culinary education courses were associated with increased MedDiet adherence and improved knowledge of healthful eating. Such interventions thus represent a cost-effective option for addressing rates of obesity and obesity-related chronic illness.

Prevalence and correlates of mild cognitive impairment among diverse Hispanics/Latinos: Study of Latinos-Investigation of Neurocognitive Aging results

IntroductionWe estimated the prevalence and correlates of mild cognitive impairment (MCI) among middle-aged and older diverse Hispanics/Latinos. MethodsMiddle-aged and older diverse Hispanics/Latinos enrolled (n = 6377; 50–86 years) in this multisite prospective cohort study were evaluated for MCI using the National Institute on Aging–Alzheimer's Association diagnostic criteria. ResultsThe overall MCI prevalence was 9.8%, which varied between Hispanic/Latino groups. Older age, high cardiovascular disease (CVD) risk, and elevated depressive symptoms were significant correlates of MCI prevalence. Apolipoprotein E4 (APOE) and APOE2 were not significantly associated with MCI. DiscussionMCI prevalence varied among Hispanic/Latino backgrounds, but not as widely as reported in the previous studies. CVD risk and depressive symptoms were associated with increased MCI, whereas APOE4 was not, suggesting alternative etiologies for MCI among diverse Hispanics/Latinos. Our findings suggest that mitigating CVD risk factors may offer important pathways to understanding and reducing MCI and possibly dementia among diverse Hispanics/Latinos.

American Cohort to Study HIV Acquisition Among Transgender Women in High-Risk Areas (The LITE Study): Protocol for a Multisite Prospective Cohort Study in the Eastern and Southern United States.

BackgroundIn the United States, transgender women (TW) are disproportionately burdened by HIV infection. Cohort studies are needed to evaluate factors driving HIV acquisition among TW over time. These will require implementation strategies that are acceptable to the TW community and feasible to implement.ObjectiveThis study aims to investigate the rate and correlates of HIV acquisition and other health outcomes among TW in eastern and southern United States.MethodsLITE is a multisite prospective cohort in 6 eastern and southern US cities, which will be followed across 24 months of technology-enhanced biobehavioral follow-up. Adult TW, regardless of HIV status, are recruited via convenience sampling (eg, peer referrals, social media, and dating apps). Participants are enrolled in a baseline study visit, complete a sociobehavioral survey, and test for HIV and sexually transmitted infections. Participants who are not living with HIV at baseline are offered enrollment into the cohort (N=1100); follow-up assessments occur quarterly.ResultsCohort assembly was informed by synchronous Web-based focus group discussions with TW (n=41) and by continuing engagement with community advisory board members from each site. Enrollment launched in March 2018. The study is underway in the Atlanta; Baltimore; Boston; Miami; New York City; and Washington, DC, metro areas. As of March 2019, 795 TW completed a baseline visit (mean age 35 years). The majority of the participants are racial/ethnic minorities, with 45% of the TW identifying as black and 28% of the TW identifying as Hispanic/Latinx. More than one-quarter (28%) of the TW are living with HIV infection (laboratory-confirmed). Online recruitment methods support engagement with TW, although peer referral and referral through trusted health facilities and organizations remain most effective.ConclusionsThis study is responsive to increasing research interest in technology-enhanced methods for cohort research, particularly for hard-to-reach populations. Importantly, the diversity of literacy, technology use, and overall socioeconomic situations in this sample of TW highlights the need to leverage technology to permit a flexible, adaptive methodology that enhances engagement of potential participants living in marginalized contexts while still ensuring rigorous and sound study design.International Registered Report Identifier (IRRID)DERR1-10.2196/14704

Frailty phenotype and self-reported crashes and driving space: Baseline AAA LongROAD

IntroductionThe present study uses data from the American Automobile Association (AAA) Longitudinal Research on Aging Drivers (LongROAD) study to assess the association of the frailty phenotype with reduced driving space and involvement in motor vehicle crashes. MethodsThe LongROAD study is a multisite prospective cohort study of participants aged 65–79 years. Fried's frailty phenotype status at baseline and self-reported restricted driving space in the past three months and at least one self-reported crash in the recent year are examined. Multivariable logistic regression was used to obtain odds ratios, adjusting for covariates and clustering by site. ResultsPre-frail (i.e. only 1–2 indicators of frailty) participants had 30% higher odds (adjusted OR = 1.3, 95% CI:1.0–1.8) of reporting involvement in a crash in the prior year than non-frail participants after adjusting for sex, age, depression, word recall, average miles driven per week, and site. No association for reduced driving space for frail older drivers was found. ConclusionsThe frailty phenotype is associated with motor vehicle crashes, but not reduced driving space. Our findings suggest that future research should be focused on the identification of pre-frail older adult drivers to improve the health and quality of life of older adult drivers.