Leveraging information from secondary endpoints to enhance dynamic borrowing across subpopulations.

Randomized trials seek efficient treatment effect estimation within target populations, yet scientific interest often also centers on subpopulations. Although there are typically too few subjects within each subpopulation to efficiently estimate these subpopulation treatment effects, one can gain precision by borrowing strength across subpopulations, as is the case in a basket trial. While dynamic borrowing has been proposed as an efficient approach to estimating subpopulation treatment effects on primary endpoints, additional efficiency could be gained by leveraging the information found in secondary endpoints.

Commentary on Chen et al. (2022): The need for continued methodological research on leveraging information in secondary endpoints for more efficient RCTs.

Chen et al. (2022) recently proposed a set of estimating equations that incorporate data from secondary endpoints to improve precision in parameter estimates related to a primary endpoint. We were motivated to translate their methodology to the context of randomized controlled trials to gain precision in treatment effect estimation using data from secondary endpoints.

A two-stage bayesian model for assessing the geography of racialized economic segregation and premature mortality across US counties.

Racialized economic segregation, a key metric that simultaneously accounts for spatial, social and income polarization in communities, has been linked to adverse health outcomes, including morbidity and mortality. Due to the spatial nature of this metric, the association between health outcomes and racialized economic segregation could also change with space. Most studies assessing the relationship between racialized economic segregation and health outcomes have always treated racialized economic segregation as a fixed effect and ignored the spatial nature of it.

Restricted spatial models for the analysis of geographic and racial disparities in the incidence of low birthweight in Pennsylvania.

The incidence of low birthweight is a common measure of public health due to the increased risk of complications associated with infants having low and very low birthweights. Moreover, many factors that increase the risk of an infant having a low birthweight can be linked to the mother's socioeconomic status, leading to large racial/ethnic disparities in its incidence. Our objective is thus to analyze the incidence of low and very low birthweight in Pennsylvania counties by race/ethnicity.

How well do participants in clinical trials represent the U.S. population with chronic neck or back pain?

Background: Randomized clinical trials (RCTs) are the gold standard for assessing treatment effectiveness; however, they have been criticized for generalizability issues such as how well trial participants represent those who receive the treatments in clinical practice. We assessed the representativeness of participants from eight RCTs for chronic spine pain in the U.S.

Uncertainty directed factorial clinical trials.

The development and evaluation of novel treatment combinations is a key component of modern clinical research. The primary goals of factorial clinical trials of treatment combinations range from the estimation of intervention-specific effects, or the discovery of potential synergies, to the identification of combinations with the highest response probabilities. Most factorial studies use balanced or block randomization, with an equal number of patients assigned to each treatment combination, irrespective of the specific goals of the trial.

Discrimination and bladder health among women in the CARDIA cohort study: Life course and intersectionality perspectives.

Objective: This study examines whether discriminatory experiences are associated with lower urinary tract symptoms (LUTS) and their impact among 972 women in the Coronary Artery Risk Development in Young Adults (CARDIA) cohort study, which recruited participants from 4 cities in the United States.

Method: Exposure to discrimination was assessed 3 times (1992-93, 2000-01, 2010-11) and averaged across assessments. Participants separately reported whether they experienced discrimination on the basis of their gender, race or color, and socioeconomic position or social class.

Association between psychosocial factors and co-morbid cigarette smoking and alcohol use in a population experiencing homelessness.

The prevalence of combustible cigarette smoking in populations experiencing homelessness in the United States is five times that of the general population. The psychosocial well-being of persons who smoke and experience homelessness is poorer if such persons also use alcohol heavily. The PTQ2 study was a randomized clinical trial among persons experiencing homelessness who were also current smokers and heavy alcohol consumers.

The Minnesota attributable risk of kidney donation (MARKD) study: a retrospective cohort study of long-term (> 50 year) outcomes after kidney donation compared to well-matched healthy controls.

Background: There is uncertainty about the long-term risks of living kidney donation. Well-designed studies with controls well-matched on risk factors for kidney disease are needed to understand the attributable risks of kidney donation.

Methods: The goal of the Minnesota Attributable Risk of Kidney Donation (MARKD) study is to compare the long-term (> 50 years) outcomes of living donors (LDs) to contemporary and geographically similar controls that are well-matched on health status.

Oral health-related quality of life after radiation therapy for head and neck cancer: the OraRad study.

Purpose: Head and neck cancer (HNC) treatment results in morbidity impacting quality of life (QOL) in survivorship. This analysis evaluated changes in oral health-related QOL (OH-QOL) up to 2 years after curative intent radiation therapy (RT) for HNC patients and factors associated with these changes.

Methods: 572 HNC patients participated in a multicenter, prospective observational study (OraRad).

Learning from women: Improving experiences of respectful maternity care during unplanned caesarean birth for women with diverse ethnicity and racial backgrounds.

Problem: Women from diverse ethnicity and racial backgrounds have few opportunities to share birth experiences to inform improvements in care.

Background: Respectful maternity care is recognised as a global women's health priority. Integrating that framework into diverse care systems and models may help bridge care gaps for women who had unexpected birth experiences, including unplanned caesarean birth.

Racial and Ethnic Differences in Self-Rated Health Among Rural Residents.

This study examines racial and ethnic differences in self-rated health among rural residents and whether these differences can be explained by socio-demographic characteristics. We used data from the 2011-2017 National Health Interview Survey to assess differences in self-rated health by race and ethnicity among rural residents (living in non-metropolitan counties; n = 46,883). We used logistic regression analyses to estimate the odds of reporting fair/poor health after adjusting for individual socio-demographic characteristics.

Chronic obstructive pulmonary disease upper airway microbiota alpha diversity is associated with exacerbation phenotype: a case-control observational study.

Background: Chronic obstructive pulmonary disease (COPD) frequent exacerbators (FE) suffer increased morbidity and mortality compared to infrequent exacerbators (IE). The association between the oral and sputum microbiota and exacerbation phenotype is not well defined. The objective of this study was to determine key features that differentiate the oral and sputum microbiota of FEs from the microbiota of IEs during periods of clinical stability.

The impact of high BMI on acute changes in body composition following 90 minutes of running.

Objectives: Although physical activity ameliorates the metabolic impact of high body mass index (BMI), runners with BMI≥25 kg/m are relatively understudied.This study had two goals: 1) Identify differences in body composition, as measured by dual X-ray absorptiometry (DXA), between overweight (BMI≥25 kg/m) runners (OWR) and normal weight (BMI<25 kg/m) runners (NWR) and 2) Examine whether an 90 minute run alters total or regional fat mass, as measured by DXA, in OWR and NWR. We hypothesized that OWR would have higher total body fat than NWR and OWR with greater changes in visceral fat after a prolonged run.

Differences by Sexual Orientation in Perceptions of Neighborhood Cohesion: Implications for Health.

A large body of research documents the relationship between health and place, including the positive association between neighborhood cohesion and health. However, very little research has examined neighborhood cohesion by sexual orientation. This paper addresses that gap by examining differences in perceived neighborhood cohesion by sexual orientation.

Region-specific aging of the human brain as evidenced by neurochemical profiles measured noninvasively in the posterior cingulate cortex and the occipital lobe using H magnetic resonance spectroscopy at 7 T.

The concentrations of fourteen neurochemicals associated with metabolism, neurotransmission, antioxidant capacity, and cellular structure were measured noninvasively from two distinct brain regions using H magnetic resonance spectroscopy. Seventeen young adults (age 19-22years) and sixteen cognitively normal older adults (age 70-88years) were scanned. To increase sensitivity and specificity, H magnetic resonance spectra were obtained at the ultra-high field of 7T and at ultra-short echo time.

Clinical registry of dental outcomes in head and neck cancer patients (OraRad): rationale, methods, and recruitment considerations.

Background: Most head and neck (H&N) cancer patients receive high-dose external beam radiation therapy (RT), often in combination with surgery and/or chemotherapy. Unfortunately, high-dose RT has significant adverse effects on the oral and maxillofacial tissues, some of which persist for the life of the patient. However, dental management of these patients is based largely on individual and expert opinion, as few studies have followed patients prospectively to determine factors that predict adverse oral sequelae.

Comparing errors in Medicaid reporting across surveys: evidence to date.

Objective: To synthesize evidence on the accuracy of Medicaid reporting across state and federal surveys.

Data Sources: All available validation studies.

Study Design: Compare results from existing research to understand variation in reporting across surveys.

Use of the integrated health interview series: trends in medical provider utilization (1972-2008).

The Integrated Health Interview Series (IHIS) is a public data repository that harmonizes four decades of the National Health Interview Survey (NHIS). The NHIS is the premier source of information on the health of the U.S.

Considerations for Endpoint Selection When Designing HIV Clinical Trials.

Selecting the primary endpoint is one of the most important decisions in designing clinical trials. Many HIV trials are powered for surrogate markers, often virologic suppression. Among 49 recently published Phase 3 or higher randomized HIV trials only 14% were powered for clinical outcomes such as the progression to AIDS, death, or serious non-AIDS diseases.

Counting uninsurance and means-tested coverage in the American community survey: a comparison to the current population survey.

Objective: To compare health insurance coverage estimates from the American Community Survey (ACS) to the Current Population Survey (CPS-ASEC).

Data Sources/study Setting: The 2008 ACS and CPS-ASEC, 2009.

Study Design: We compare age-specific national rates for all coverage types and state-level rates of uninsurance and means-tested coverage.

Health care coverage and the health care industry.

Objectives: We examined rates of uninsurance among workers in the US health care workforce by health care industry subtype and workforce category.

Methods: We used 2004 to 2006 National Health Interview Survey data to assess health insurance coverage rates. Multivariate logistic regression analyses were conducted to estimate the odds of uninsurance among health care workers by industry subtype.