Demographic Diversity of Clinical Trials for Therapeutic Drug Products: A Systematic Review of Recently Published Articles, 2017-2022.

The US Food and Drug Administration (FDA) encourages the use of enrollment practices that will lead to clinical trials that reflect the population most likely to use the therapeutic product (drug or biologic), if approved. In doing so, the benefit-risk profile of the product may be assessed more completely and offer patients and their health care providers a better understanding of the drug profile and greater confidence in clinical trial results. The objective of this systematic review was to assess recent literature on the demographic diversity of clinical trial participants, describe the methods used in defining clinical trial diversity, and address knowledge gaps to enhance clinical trial diversity. Our literature search initially yielded 246 articles. After applying our eligibility criteria, we conducted a full-text review and analyzed the contents of the 28 remaining articles in our systematic review. Eleven (39%) of the 28 articles used a reference standard to compare the participation of populations in clinical trials to assess diversity. The majority of the 28 articles reported on adult participants; only 5 included pediatric populations. Most articles found that women and minority populations were underrepresented in clinical trials. Some articles proposed solutions to improve clinical trial diversity; however, several did not comment on clinical trial diversity. Despite a growing emphasis on demographic diversity in research, certain populations continue to be underrepresented in clinical trials. There is a need to standardize the definition of diversity in clinical trials. Future research into effective enrollment approaches and appropriate reference standards could improve demographic diversity.

Understanding COVID-19 Vaccine Hesitancy Among K-12 Staff, Parents, and Students: District of Columbia, February to April, 2022.

OBJECTIVE: Despite widespread availability of COVID-19 vaccines, millions of Americans have not received the recommended vaccine doses. In the District of Columbia (DC), COVID-19 vaccination rates are lowest among residents who are Non-Hispanic (NH) Black and among school-aged children. We assessed COVID-19 vaccine hesitancy among staff and parents of students in DC K-12 public and public charter schools. METHODS: We conducted a telephone-based survey from February 6 to April 16, 2022 to staff, students, and parents of students who participated in school-based COVID-19 screening testing. COVID-19-related survey items included: vaccination status, reasons for not getting vaccinated, perceived vaccine access, and trusted COVID-19 information sources. Utilizing time-to-event analyses, we evaluated differences across demographic groups. RESULTS: The interview response rate was 25.8% (308/1193). Most unvaccinated participants were NH Black and ages 5 to 11 years. Median time from vaccine eligibility to uptake was 236 days for NH Black participants vs. 10 days for NH White participants. Vaccine safety was the top concern among unvaccinated participants. Government and healthcare providers were the most trusted COVID-19 information sources. CONCLUSIONS: Differences in timing of vaccine uptake among respondents and greater vaccine hesitancy among NH Black participants compared to other racial/ethnic groups highlight a need for continued tailored outreach and communication using trusted sources to convey the importance, benefits, and safety of COVID-19 vaccination.

Promising Practices Observed in High-Throughput COVID-19 Vaccination Sites in the United States, February-May 2021.

Objectives. To identify promising practices for implementing COVID-19 vaccination sites. Methods. The Centers for Disease Control and Prevention (CDC) and Federal Emergency Management Agency (FEMA) assessed high-throughput COVID-19 vaccination sites across the United States, including Puerto Rico, after COVID-19 vaccinations began. Site assessors conducted site observations and interviews with site staff. Qualitative data were compiled and thematically analyzed. Results. CDC and FEMA conducted 134 assessments of high-throughput vaccination sites in 25 states and Puerto Rico from February 12 to May 28, 2021. Promising practices were identified across facility, clinical, and cross-cutting operational areas and related to 6 main themes: addressing health equity, leveraging partnerships, optimizing site design and flow, communicating through visual cues, using quick response codes, and prioritizing risk management and quality control. Conclusions. These practices might help planning and implementation of future vaccination operations for COVID-19, influenza, and other vaccine-preventable diseases. Public Health Implications. These practices can be considered by vaccination planners and providers to strengthen their vaccination site plans and implementation of future high-throughput vaccination sites. (Am J Public Health. 2023;113(8):909-918. https://doi.org/10.2105/AJPH.2023.307331).

COVID-19 Outbreaks Linked to Workplaces, 23 US Jurisdictions, August-October 2021.

OBJECTIVES: Early in the COVID-19 pandemic, several outbreaks were linked with facilities employing essential workers, such as long-term care facilities and meat and poultry processing facilities. However, timely national data on which workplace settings were experiencing COVID-19 outbreaks were unavailable through routine surveillance systems. We estimated the number of US workplace outbreaks of COVID-19 and identified the types of workplace settings in which they occurred during August-October 2021. METHODS: The Centers for Disease Control and Prevention collected data from health departments on workplace COVID-19 outbreaks from August through October 2021: the number of workplace outbreaks, by workplace setting, and the total number of cases among workers linked to these outbreaks. Health departments also reported the number of workplaces they assisted for outbreak response, COVID-19 testing, vaccine distribution, or consultation on mitigation strategies. RESULTS: Twenty-three health departments reported a total of 12 660 workplace COVID-19 outbreaks. Among the 12 470 workplace types that were documented, 35.9% (n = 4474) of outbreaks occurred in health care settings, 33.4% (n = 4170) in educational settings, and 30.7% (n = 3826) in other work settings, including non-food manufacturing, correctional facilities, social services, retail trade, and food and beverage stores. Eleven health departments that reported 3859 workplace outbreaks provided information about workplace assistance: 3090 (80.1%) instances of assistance involved consultation on COVID-19 mitigation strategies, 1912 (49.5%) involved outbreak response, 436 (11.3%) involved COVID-19 testing, and 185 (4.8%) involved COVID-19 vaccine distribution. CONCLUSIONS: These findings underscore the continued impact of COVID-19 among workers, the potential for work-related transmission, and the need to apply layered prevention strategies recommended by public health officials.

Utility of a Test-to-Return Strategy to Identify Individuals With Coronavirus Disease 2019 (COVID-19) in the Prekindergarten Through Grade 12 School Setting-District of Columbia, January 2022.

The highly transmissible severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant led to increased hospitalizations, staffing shortages, and increased school closures. To reduce spread in school-aged children during the Omicron peak, the District of Columbia implemented a test-to-return strategy in public and public charter schools after a 2-week break from in-person learning.

Vitamin B-12 malabsorption and renal function are critical considerations in studies of folate and vitamin B-12 interactions in cognitive performance: NHANES 2011-2014.

BACKGROUND: Cognitive health is a public health concern among older adults. Dietary supplement (SUP) use is common and concerns have been raised about high folic acid intake among those with vitamin B-12 deficiency and exacerbation of poor cognitive performance (PCP). OBJECTIVES: We evaluated SUP use, usual folic acid intake, and blood folate and vitamin B-12 concentrations in relation to cognitive performance. METHODS: We used NHANES 2011-2014 data on adults aged ≥60 y (n = 2867) and estimated total usual folic acid intake from diet and supplements, vitamin B-12 intake from SUPs, blood folates, vitamin B-12 concentrations, vitamin B-12 insufficiency (≤258 pmol/L), high folate (serum folate ≥59 nmol/L or RBC folate ≥1609 nmol/L), and PCP (<34 on the Digit Symbol Substitution Test). We assessed folate distributions adjusted for multiple variables, including renal function. RESULTS: Compared with persons without PCP, adults with PCP were less likely to use supplements containing folic acid (mean ± SEE: 34.4% ± 2.4%) or vitamin B-12 (mean ± SEE: 47.5% ± 1.6%). Among vitamin B-12-insufficient adults, 18.0% ± 1.6% (mean ± SEE) reported taking a vitamin B-12 supplement. Among participants with high folate and insufficient vitamin B-12 concentrations, 34.3% ± 11.5% (mean ± SEE) reported taking vitamin B-12-containing supplements. Persons with high folate and normal vitamin B-12 concentrations had lower odds of PCP [aOR (adjusted odds ratio): 0.61; 95% CI: 0.45, 0.83] than persons with normal folate and vitamin B-12. Persons with high folate and normal methylmalonic acid (MMA) had lower odds of PCP (OR: 0.56; 95% CI: 0.40, 0.78) than those with normal folate and MMA concentrations. After adjustment for renal function, elevated risk of PCP was attenuated among persons with high folate and MMA. Concurrent high folate and insufficient vitamin B-12 concentrations were not associated with PCP. CONCLUSIONS: Differential associations between vitamin B-12 and MMA highlight the need to consider renal function in studies of high folate and low vitamin B-12 status. Consumption of vitamin B-12 supplements concurrent with low vitamin B-12 status may indicate vitamin B-12 malabsorption.

Evaluation of an active population-based surveillance system for major birth defects in South Carolina.

INTRODUCTION: Birth defects are common, costly, and contribute substantially to infant mortality. The South Carolina Birth Defects Program (SCBDP) employs active population-based surveillance to monitor major birth defects statewide. We evaluated SCBDP's system attributes using published CDC guidelines. METHODS: To determine timeliness, completeness, and accuracy of birth defects information, we examined SCBDP's reports, program and education materials, advisory group meeting minutes, and strategic plan. We also met with program staff and stakeholders (n = 10) to discuss program goals and data utilization. We calculated the percentage of birth defects cases found 6 months after a birth cohort year for 2016-2018. RESULTS: SCBDP identifies 900-1,200 birth defects cases for a birth population of approximately 55,000 live births annually through active case reviews. SCBDP uses trained medical staff to abstract detailed information from maternal and infant medical records; SCBDP also has established auto-linkage with state vital statistics to capture demographic and birth data. SCBDP is timely and captures 97.1% (range 96.7-97.6%) of birth defects cases within 6 months after the birth cohort year closes. Active case identification using medical records as the primary data source improves quality assurance and completeness, while prepopulating demographic information improves timeliness. CONCLUSIONS: Given that birth defects significantly contribute to infant morbidity and mortality, monitoring these conditions is important to understand their impact on communities and to drive public health actions. SCBDP active surveillance and rigorous data quality practices provide the program with timely, complete, and accurate birth defects data.

Types of oral contraceptives and breast cancer survival among women enrolled in Medicaid: A competing-risk model.

INTRODUCTION: Oral contraceptive pills have been implicated in the pathophysiology of breast cancer. Although many studies have examined the relationship between combined oral contraceptives (COCs) and breast cancer, there is a paucity of literature that discusses progestin-only oral contraceptives (POCs) and breast cancer. The purpose of this investigation is to examine potential associations between different types of oral contraceptives and breast cancer mortality in the South Carolina Medicaid population among different racial/ethnic groups. METHODS: Subjects included 4816 women diagnosed with breast cancer between 2000 and 2013. Kaplan-Meier curves were calculated to determine time-to-mortality rates among users of oral contraceptives. Competing-risks models and Cox multivariate survival models were used to estimate the hazard ratios (HRs) and 95% confidence intervals (CIs) of breast cancer and other-cause mortality, as well as all-cause mortality. RESULTS: POCs were associated with a significantly decreased risk of breast cancer mortality (HR: 0.07; 95% CI: 0.01, 0.52) and a non-significant increased risk of all-cause mortality (HR: 1.04; 95% CI: 0.52, 2.07). COCs increased the risk of breast cancer mortality (HR: 1.61; 95% CI: 1.14, 2.28) and all-cause mortality (HR: 1.83; 95% CI: 1.30, 2.57). CONCLUSION: Use of POCs may be associated with a decreased risk of breast cancer mortality. Due to the small sample size of POC users in the current study, additional research is needed to confirm these findings.

Cardiovascular disease incidence among females in South Carolina by type of oral contraceptives, 2000-2013: a retrospective cohort study.

INTRODUCTION: Certain types of oral contraceptives can produce favorable effects on lipid metabolism and vascular tone, while others have potentially detrimental effects. Endogenous and exogenous hormones exert different effects on high-density lipoprotein (HDL) and low-density lipoprotein (LDL) depending on the type, combination, and dose of the hormone. The estrogenic and progestogenic effects of exogenous hormones on HDL and LDL are inconsistent. Studying surrogate end points (LDL, HDL levels) may provide a misleading picture of OCs. METHODS: Medicaid data from 2000 to 2013 were used to assess the relationship between the type of OCs and CVD incidence. Multivariable logistic regression was used to model relationships between cardiovascular disease and OC use adjusting for potential confounders. RESULTS: Compared to combined oral contraceptives (COC), progestin-only oral contraceptives (POC) were associated with decreased heart disease and stroke incidence after adjusting for important covariates (OR 0.74; 95 % CI 0.57, 0.97 and OR 0.39; 95 % CI 0.16, 0.95, respectively). However, there was a positive association between POC + COC and both heart disease and stroke incidence (OR 2.28; 95 % CI 1.92, 2.70 and OR 2.12; 95 % CI 1.34, 3.35, respectively). CONCLUSION: In light of an association between POC use and decreased heart disease and stroke, women's CVD risk factors should be carefully considered when choosing which OC to use. Baseline CVD risk should be a part of the discussion between women and their primary care providers when making choices regarding OCs.

Understanding the Association of Type 2 Diabetes Mellitus in Breast Cancer Among African American and European American Populations in South Carolina.

BACKGROUND: In South Carolina, the co-occurrence of diabetes mellitus (DM) and breast cancer (BrCA) is much more prevalent among African American populations than among European American populations. The underlying relationship between diabetes and breast cancer may influence breast cancer survival. The purpose of this investigation is to examine the effect of diabetes on developing breast cancer and to reduce racial disparities in breast cancer outcomes. METHODS: Study participants included women of European American (EA) and African American (AA) ethnicity from both the Medicaid ICD-9 designations and the South Carolina Central Cancer Registry (SCCCR). A historical prospective cohort design was used to determine the risk of developing breast cancer among women of different ethnicities with and without DM. The chi-square test was used to determine the significance of the association; the logistic model was used to assess the relationship between breast cancer and other factors among EA and AA women. RESULTS: Menopause may have protective properties for AA compared to EA women. AA women have twice the odds of not surviving from each breast cancer stage compared to EA women with respect to their breast cancer stage. Adherence to diabetes medication may contribute to lower breast cancer death in EA. CONCLUSION: This study illustrates the discrepancy between EA and AA women in terms of breast cancer survival. AA women bear a higher disease burden than EA women. To create ethnic-appropriate public health policies, it is imperative that we understand the effect of comorbidities on breast cancer and how we can prevent them from occurring.

The Impact of Obesity on Surgical Outcome in Endometrial Cancer Patients: A Systematic Review.

Background: Obesity is a significant public health problem in the United States, and many studies have established obesity as a significant risk factor for endometrial cancer. Surgery is the standard of care in staging and treatment of endometrial cancer, and obesity may influence surgical outcomes because of its attendant comorbid conditions. Therefore, assessment of the impact of obesity on surgical outcome is important for decreasing morbidity and improving survival in patients with endometrial cancer. Objective: The aims of this research were to evaluate and review epidemiologic data systematically on the impact of obesity on surgical outcomes and to assess safety and feasibility of newer surgical techniques in obese patients. Materials and Methods: A systematic search of PubMed was conducted to identify articles between 2004 and 2013 that focused on the impact of obesity on surgical outcome. Reference lists of retrieved articles were also used to identify other relevant articles. Thirteen relevant articles were reviewed. Results: Evidence from epidemiologic studies showed that obesity impacts surgical outcome adversely. On average, obese patients have worse surgical outcomes than their nonobese counterparts. In addition, surgical outcome worsens as level of obesity increases. However, surgical procedure also influences this association. Minimally invasive surgeries are more useful and are accompanied with fewer complications than conventional laparotomy and can be performed safely in obese patients. Conclusions: Obesity is a significant risk in the etiology, treatment, and surgical outcomes of patients with endometrial cancer. Future research will need more randomized controlled trials and prospective studies to identify the best procedures for maximal outcomes. (J GYNECOL SURG 32:149).

Diabetes Status and Being Up-to-Date on Colorectal Cancer Screening, 2012 Behavioral Risk Factor Surveillance System.

INTRODUCTION: Although screening rates for colorectal cancer are increasing, 22 million Americans are not up-to-date with recommendations. People with diabetes are an important and rapidly growing group at increased risk for colorectal cancer. Screening status and predictors of being up-to-date on screening are largely unknown in this population. METHODS: This study used logistic regression modeling and data from the 2012 Behavioral Risk Factor Surveillance System to examine the association between diabetes and colorectal cancer screening predictors with being up-to-date on colorectal cancer screening according to criteria of the US Preventive Services Task Force for adults aged 50 or older. State prevalence rates of up-to-date colorectal cancer screening were also calculated and mapped. RESULTS: The prevalence of being up-to-date with colorectal cancer screening for all respondents aged 50 or older was 65.6%; for respondents with diabetes, the rate was 69.2%. Respondents with diabetes were 22% more likely to be up-to-date on colorectal cancer screening than those without diabetes. Among those with diabetes, having a routine checkup within the previous year significantly increased the odds of being up-to-date on colorectal cancer screening (odds ratio, 1.90). Other factors such as age, income, education, race/ethnicity, insurance status, and history of cancer were also associated with up-to-date status. CONCLUSION: Regardless of diabetes status, people who had a routine checkup within the past year were more likely to be up-to-date than people who had not. Among people with diabetes, the duration between routine checkups may be of greater importance than the frequency of diabetes-related doctor visits. Continued efforts should be made to ensure that routine care visits occur regularly to address the preventive health needs of patients with and patients without diabetes.

Disparities in Breast Cancer Incidence, Mortality, and Quality of Care among African American and European American Women in South Carolina.

OBJECTIVES: Breast cancer is the most frequently diagnosed cancer among women and the second-leading cause of female cancer deaths in the United States. African Americans and other minorities in the United States experience lower survival rates and have a worse prognosis than European Americans despite European Americans having a much higher incidence of the disease. Adherence to breast cancer treatment-quality measures is limited, particularly when the data are stratified by race/ethnicity. METHODS: We aimed to examine breast cancer incidence and mortality trends in South Carolina by race and explore possible racial disparities in the quality of breast cancer treatment received in South Carolina. RESULTS: African Americans have high rates of mammography and clinical breast examination screenings yet suffer lower survival compared with European Americans. For most treatment-quality metrics, South Carolina fairs well in comparison to the United States as a whole; however, South Carolina hospitals overall lag behind South Carolina Commission on Cancer-accredited hospitals for all measured quality indicators, including needle biopsy utilization, breast-conserving surgeries, and timely use of radiation therapy. Accreditation may a play a major role in increasing the standard of care related to breast cancer diagnosis and treatment. CONCLUSIONS: These descriptive findings may provide significant insight for future interventions and policies aimed at eliminating racial/ethnic disparities in health outcomes. Further risk-reduction approaches are necessary to reduce minority group mortality rates, especially among African American women.