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Abstract Incorporating external data, such as external controls, holds the promise of improving the efficiency of traditional randomized controlled trials especially when treating rare diseases or diseases with unmet needs. To this end, we propose novel weighting estimators grounded in the causal inference framework. As an alternative framework, Bayesian methods are also discussed. From trial design perspective, operating characteristics including Type I error and power are particularly important and are assessed in our realistic simulation studies representing a variety of practical scenarios. Our proposed weighting estimators achieve significant power gain, while maintaining Type I error close to the nominal value of 0.05. An empirical application of the methods is demonstrated through a Phase III clinical trial in rare disease. 

Abstract BackgroundRoughly a quarter of the US population suffers from moderate to severe chronic pain for at least six months in any given year. The complexity of managing chronic pain has encouraged providers to use innovative methods to address it. Research has shown that problem lists are potential tools that support the care of patients with diabetes and chronic kidney disease. ObjectivesTo examine the extent to which the inclusion of chronic pain in a problem list is associated with follow-up specialty pain care. MethodsThe association between chronic pain documentation on the problem list and specialty pain care was investigated in this retrospective cohort study using 4531 patient records. ResultsChronic pain documentation in the problem list was associated with higher odds of receiving specialty pain care. The most common diagnosis was chronic pain (69.7%). A migraine diagnosis was associated with decreased odds of receiving specialty care, and chronic pain syndrome was associated with increased odds of receiving specialty care compared with the other chronic pain groups. ConclusionDocumenting chronic pain on the problem list was associated with a higher likelihood of patients receiving specialty pain care. 

Abstract BackgroundCOVID-19 mitigation strategies such as masking, social distancing, avoiding group gatherings, and vaccination uptake are crucial interventions to preventing the spread of COVID-19. At present, COVID-19 data are aggregated and fail to identify subgroup variation in Asian American communities such as Hmong Americans. To understand the acceptance, adoption, and adherence to COVID-19 mitigation behaviors, an investigation of Hmong Americans’ contextual and personal characteristics was conducted. MethodsThis study aims to describe COVID-19 mitigation behaviors among Hmong Americans and the contextual and personal characteristics that influence these behaviors. A cross-sectional online survey was conducted from April 8 till June 1, 2021, with Hmong Americans aged 18 and over. Descriptive statistics were used to summarize the overall characteristics and COVID-19 related behaviors of Hmong Americans. Chi-square and Fisher’s Exact Test were computed to describe COVID-19 mitigation behaviors by gender and generational status (a marker of acculturation). ResultsThe sample included 507 participants who completed the survey. A majority of the Hmong American participants in our study reported masking (449/505, 88.9%), social distancing (270/496, 55.3%), avoiding group gatherings (345/505, 68.3%), avoiding public spaces (366/506, 72.3%), and obtaining the COVID-19 vaccination (350/506, 69.2%) to stay safe from COVID-19. Women were more likely to socially distance (P = .005), and avoid family (P = .005), and social gatherings (P = .009) compared to men. Social influence patterns related to mitigation behaviors varied by sex. Men were more likely compared to women to be influenced by Hmong community leaders to participate in family and group gatherings (P = .026), masking (P = .029), social distancing (P = .022), and vaccination uptake (P = .037), whereas healthcare providers and government officials were social influencers for social distancing and masking for women. Patterns of social distancing and group gatherings were also influenced by generational status. ConclusionContextual and personal characteristics influence COVID-19 mitigation behaviors among English speaking Hmong Americans. These findings have implications for identifying and implementing culturally appropriate health messages, future public health interventions, policy development, and ongoing research with this population. 

Abstract Associations between household social needs, acculturation, and emotional health remain understudied, particularly among Latinx mothers. We analyzed baseline survey data from 455 Latinx mothers in a previous study. Using multinomial regression, we examined whether emotional problems and perceived stress were associated with household social needs and acculturation. Almost half the sample reported four or more household social needs. Social needs cumulatively and independently predicted increased odds of frequent emotional problems or perceived stress. Lower acculturation predicted lower odds of frequent emotional problems. There is increased risk for emotional problems and stress in low-income Latinx mothers who experience high social need. Integrated social service and mental health care models may be one way to improve health outcomes. More research is needed to understand how clinical settings can leverage unique cultural protective factors to address the social and emotional health needs of Latinx mothers. 

The purpose is to examine validity and reliability for an obesity risk assessment tool developed in Spanish for immigrant families with children, 3–5 years old using an 8-week cross-sectional design with data collected over 1 year at Head Start and Special Supplemental Nutrition Program for Women, Infants and Children [WIC]. Parent/child dyads (206) provided a child obesity risk assessment, three child modified 24 h dietary recalls, three child 36+ h activity logs and one parent food behavior checklist. Main outcome measures were convergent validity with nutrients, cup equivalents, and diet quality and three assessments of reliability that included item difficulty index, item discrimination index, and coefficient of variation. Validity was demonstrated for assessment tool, named Niños Sanos. Scales were significantly related to variables in direction hypothesized [p ≤ 0.05]: Healthy Eating Index, fruit/vegetable cup equivalents, folate, dairy cup equivalents, vitamins D, β-carotene, fiber, saturated fat, sugar, time at screen/ sleep/physical activity and parent behaviors. Three measures of reliability were acceptable. The addition of nutrient values as an analytical validation approach adds strength and consistency to previously reported Niños Sanos validation results using children’s blood biomarkers and body mass index. This tool can be used by health professionals as an assessment of obesity risk in several capacities: (1) screener for counseling in a clinic, (2) large survey, (3) guide for participant goal setting and tailoring interventions, and (4) evaluation. 

The odds ratio is a common measure to assess the association between abinary predictor variable and a binary outcome. In epidemiology, the outcome is often the dis- ease status, and the predictor of interest is a suspected risk factor for the disease. The purpose of the study is an attempt to establish a causal association between exposure and disease. If the object of a study is the estimation of a marginal odds ratio, defined as the ratio of the odds that would be observed in a population if everyone were exposed versus the odds in the same population if no one were exposed, methods such as the Mantel–Haenszel estimator are commonly used. When it is necessary to adjust for many confounders and/or continuous confounders, this approach results in a biased and incon- sistent estimator, including matching and stratification by the propensity score. An alter- native to matching is inverse probability weighting by the propensity score. The resulting estimator is consistent, provided the propensity score model is correct and adjusts for all confounders. 

Abstract Latinx families may be particularly vulnerable to emotional dysfunction, due to higher rates of economic hardship and complex social influences in this population. Little is known about the impact of environmental stressors such as unmet social needs and maternal stress on the emotional health of Latinx children from low-income families. We conducted secondary analyses using survey and biomarker data from 432 Latinx children and mothers collected in a separate study. We used binomial and multinomial logistic regression to test if household social needs, or maternal perceived stress or hair cortisol concentration (HCC), predicted child measures of emotional functioning or child HCC, independent of relevant sociodemographic factors. Approximately 40% of children in the sample had symptoms consistent with emotional dysfunction, and over 37% of households reported five or more social needs. High perceived maternal stress predicted higher odds of child emotional dysfunction (OR = 2.15; 95% CI [1.14, 4.04];p = 0.01), and high maternal HCC was positively associated with high child HCC (OR = 10.60; 95% CI [4.20, 26.74];p < 0.01). Most individual household social needs, as well as the level of household social need, were not independently associated with child emotional dysfunction or child HCC. Our findings begin to define a framework for understanding emotional health, stress, and resilience when caring for Latinx children and mothers living with high levels of social need, and the need for integrated mental health and social needs screening and interventions in settings that serve this population.