Do Federal Regulations Affect Gender, Racial, and Ethnic Disparities in Chronic Rhinosinusitis Research?

2021 ◽  
pp. 019459982110210
Author(s):  
Daniel B. Spielman ◽  
Rodney J. Schlosser ◽  
Andi Liebowitz ◽  
Rahul Sharma ◽  
Jonathan Overdevest ◽  
...  
Keyword(s):  
Clinical Trials ◽  
American Indian ◽  
Chronic Rhinosinusitis ◽  
Census Data ◽  
Ethnic Disparities ◽  
The Us ◽  
And Gender ◽  
Us Census ◽  
Federal Guidelines ◽  
Racial Ethnic

Objective The Food and Drug Administration and the National Institutes of Health (NIH) have asserted that diverse demographic representation in clinical trials is essential. In light of these federal guidelines, the objective of this study is to assess the racial, ethnic, and gender demographics of patients enrolled in clinical trials registered with the NIH that evaluate chronic rhinosinusitis with nasal polyposis (CRSwNP) relative to the demographics of the US population. Study Design Cross-sectional study. Setting Not applicable. Methods ClinicalTrials.gov was queried to identify all prospective clinical trials for CRSwNP. Individual study and pooled data were compared with national US census data. Results Eighteen studies were included comprising 4125 patients and evaluating dupilumab, mepolizumab, omalizumab, fluticasone/OptiNose, MediHoney, mometasone, and SINUVA. Women constituted 42.7% of clinical trial participants. Of the 4125 participants, 69.6% identified as White, 6.6% as Black, 20.8% as Asian, 0.1% as Pacific Islander, 0.4% as American Indian, 8.0% as Hispanic, and 2.4% as other. The racial, ethnic, and gender composition of the pooled study population differs significantly from national US census data, with underrepresentation of Black, Hispanic, Pacific Island, and American Indian individuals, as well as females ( P < .05). Conclusion The racial, ethnic, and gender demographics of patients enrolled in CRSwNP clinical trials registered with the NIH differ significantly from the demographics of the US population, despite federal guidelines advising demographically representative participation. Proactive efforts to enroll participants that better represent anticipated treatment populations should be emphasized by researchers, institutions, and editorial boards.

Abstract 17202: Racial/Ethnic Minority Underreporting and Underrepresentation in Guideline-Driving Blood Cholesterol Clinical Trials

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Ashish Sarraju ◽  
Areli Valencia ◽  
Joshua Knowles ◽  
David J Maron ◽  
Fatima Rodriguez
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Census Data ◽  
The United States ◽  
Blood Cholesterol ◽  
Trial Participation ◽  
Atherosclerotic Cardiovascular Disease ◽  
The Us ◽  
Us Census ◽  
Racial Ethnic

Introduction: Cholesterol management is the cornerstone of atherosclerotic cardiovascular disease prevention. Diverse racial/ethnic participation in high-impact cholesterol trials is essential for the generalizability of trials and guidelines across the United States (US). Methods: We analyzed randomized clinical trials (RCTs) cited in the 2018 American Multi-society Guideline on the Management of Blood Cholesterol for reporting and representation of racial/ethnic minorities. We extracted participant level racial/ethnic data, including non-Hispanic White (NHW), Black, Hispanic, or Asian groups. For each race/ethnicity, we pooled trial data to assess overall representation compared to the general US population based on 2010 US Census and 2019 US Census American Community Survey estimates. Results: Among 71 cited RCTs from 1984 - 2017, 59.1% reported racial/ethnic data. NHW participation was reported in 58%, Black in 34%, Hispanic in 27%, and Asian in 17% (Figure). Four trials disaggregated Hispanic patients and none disaggregated Asians. Black trial representation was significantly lower than the US population per 2010 and 2019 Census data (trial: 5.5%, 2010: 12.6%, 2019: 13.4%, P <0.001). Hispanic trial representation was significantly lower compared to the US population (trial: 10.6%, 2010: 16.3%, 2019: 18.3%, P <0.001). NHW trial participation was lower compared to the US population (trial 69.2%; 2010: 72.4%; 2019: 76.5%, P <0.001), but with smaller relative differences compared to Black and Hispanic representation. Asian participation was higher than US census representation. Conclusion: Among guideline-driving cholesterol RCTs, Black and Hispanic participants are significantly underrepresented compared to the general U.S. population. Few studies disaggregate major racial/ethnic subgroups. These findings represent a source of systemic bias that may limit the generalizability of trials and guidelines and potentiate health inequities.

scholarly journals How differential privacy will affect our understanding of population growth in the United States

2020 ◽  
Author(s):  
Alexis R Santos-Lozada ◽  
Danilo T Perez-Rivera ◽  
Aarti C. Bhat
Keyword(s):  
Population Growth ◽  
Census Data ◽  
Differential Privacy ◽  
The United States ◽  
The Us ◽  
Potential Impact ◽  
Us Census ◽  
Population Counts ◽  
Metropolitan Counties ◽  
Racial Ethnic

The implementation of a proposed differential privacy algorithm to 2020 US Census data releases, and other census products has brought about discussions about the consistency and reliability of the data produced under the proposed disclosure avoidance system. We test the potential impact of this change in disclosure avoidance systems to the tracking of population growth and distribution using county-level population counts. We ask how population counts produced under the differential privacy algorithm might lead to different conclusions regarding population growth for the total population and three major racial/ethnic groups in comparison to counts produced using the traditional methods. Our results suggest that the implementation of differential privacy, as proposed, will impact our understanding of population changes in the US. We find potential for overstating and understating growth and decline, with these effects being more pronounced for non-Hispanic blacks and Hispanics, as well as for non-metropolitan counties. These findings draw attention to the potential local consequences of the implementation of differential privacy for tracking demographic changes of the US population, which is bound to have implications for our understanding of the transformations the nation is going through.

scholarly journals Racial, Ethnic, and Sex Disparities in Nail Psoriasis Clinical Trials: A Systematic Review

2022 ◽  
pp. 1-8
Author(s):  
Jose W. Ricardo ◽  
Yuqing Qiu ◽  
Shari R. Lipner
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Nail Psoriasis ◽  
Treatment Type ◽  
The Us ◽  
Race Ethnicity ◽  
Pharmacologic Treatments ◽  
Us Census ◽  
Racial Ethnic

<b><i>Introduction:</i></b> Nail psoriasis (NP) disproportionally affects quality of life in females versus males. Demographics of NP research cohorts are not well characterized. In this systematic review, we characterize the representation of racial/ethnic groups and women in NP randomized clinical trials (RCTs). <b><i>Methods:</i></b> A systematic search of MEDLINE was performed; RCTs of NP pharmacologic treatments or cutaneous psoriasis/psoriatic arthritis with the number of NP patients described were included. <b><i>Results:</i></b> Overall, 45 RCTs were analyzed, with 91.1% reporting sex, and 67.9% of participants were men. 7/41 (17%) studies reporting sex included ≥45% female participants. Of 45 RCTs, 35.6% reported race and/or ethnicity. Of the 22 studies with ≥1 US-based site, 13 (59%) reported race/ethnicity; 3 out of 23 (13%) studies with &#x3c;1 US-based site reported these data. Enrollment of nonwhite participants was significantly lower than representation within the US census (13.4% vs. 39.9%; <i>p</i> &#x3c; 0.001). Treatment type, route of administration, location with ≥1 US-based site, funding, and journal type were significantly associated with race/ethnicity reporting (<i>p</i> &#x3c; 0.05 all comparisons). <b><i>Discussion/Conclusion:</i></b> Reporting of racial/ethnic demographics is lacking in NP RCTs. Women and racial/ethnic minorities remain underrepresented in NP research. There is a need for increased reporting and diversification of NP clinical trial participants.

scholarly journals Reductions in US life expectancy from COVID-19 by Race and Ethnicity: Is 2021 a repetition of 2020?

2021 ◽  
Author(s):  
Theresa Andrasfay ◽  
Noreen Goldman
Keyword(s):  
Life Expectancy ◽  
Race And Ethnicity ◽  
Ethnic Disparities ◽  
White Population ◽  
Widespread Distribution ◽  
Life Expectancy At Birth ◽  
The Us ◽  
The Impact ◽  
Racial Ethnic ◽  
Black And Latino

COVID-19 had a huge mortality impact in the US in 2020 and accounted for the majority of the 1.5-year reduction in 2020 life expectancy at birth. There were also substantial racial/ethnic disparities in the mortality impact of COVID-19 in 2020, with the Black and Latino populations experiencing reductions in life expectancy at birth over twice the reduction experienced by the White population. Despite continued vulnerability of the Black and Latino populations, the hope was that widespread distribution of effective vaccines would mitigate the overall impact and reduce racial/ethnic disparities in 2021. In this study, we use cause-deleted life table methods to estimate the impact of COVID-19 mortality on 2021 US period life expectancy. Our partial-year estimates, based on provisional COVID-19 deaths for January-early October 2021 suggest that racial/ethnic disparities have persisted and that life expectancy at birth in 2021 has already declined by 1.2 years from pre-pandemic levels. Our projected full-year estimates, based on projections of COVID-19 deaths through the end of 2021 from the Institute for Health Metrics and Evaluation, suggest a 1.8-year reduction in US life expectancy at birth from pre-pandemic levels, a steeper decline than the estimates produced for 2020. The reductions in life expectancy at birth estimated for the Black and Latino populations are 1.6-2.4 times the impact for the White population.

Choice and Conflict about Census Data Adjusting the American Census Count

1991 ◽  
Vol 11 (4) ◽  
pp. 357-398 ◽  
Author(s):  
Michael L. Cohen
Keyword(s):  
Census Data ◽  
Political Representation ◽  
The United States ◽  
Political Conflict ◽  
Census Bureau ◽  
Census Count ◽  
Social Fact ◽  
The Us ◽  
Census Adjustment ◽  
Us Census

ABSTRACTThe census is a social fact, the outcome of a process that involves the interaction of public laws and institutions and citizens' responses to an official inquiry. However, it is not a ‘hard’ fact. Reasons for inevitable defects in the census count are listed in the first section; the second section reports efforts by the US Census Bureau to identify sources of error in census coverage, and make estimates of the size of the errors. The use of census data for policy purposes, such as political representation and allocating funds, makes these defects controversial. Errors may be removed by making adjustments to the initial census count. However, because adjustment reallocates resources between groups, it has become the subject of political conflict. The paper describes the conflict between statistical practices, laws and public policy about census adjustment in the United States, and concludes by considering the extent to which causes in America are likely to be found in other countries.

scholarly journals Sex-Gender Variable: Methodological Recommendations for Increasing Scientific Value of Clinical Studies

Cells ◽  
2019 ◽  
Vol 8 (5) ◽  
pp. 476 ◽  
Author(s):  
Flavia Franconi ◽  
Ilaria Campesi ◽  
Delia Colombo ◽  
Paola Antonini
Keyword(s):  
Clinical Trials ◽  
Environmental Factors ◽  
Gender Gap ◽  
Randomized Clinical Trials ◽  
Real Life ◽  
Sex And Gender ◽  
Key Factors ◽  
And Gender ◽  
Scientific Value ◽  
Racial Ethnic

There is a clear sex–gender gap in the prevention and occurrence of diseases, and in the outcomes and treatments, which is relevant to women in the majority of cases. Attitudes concerning the enrollment of women in randomized clinical trials have changed over recent years. Despite this change, a gap still exists. This gap is linked to biological factors (sex) and psycho-social, cultural, and environmental factors (gender). These multidimensional, entangled, and interactive factors may influence the pharmacological response. Despite the fact that regulatory authorities recognize the importance of sex and gender, there is a paucity of research focusing on the racial/ethnic, socio-economic, psycho-social, and environmental factors that perpetuate disparities. Research and clinical practice must incorporate all of these factors to arrive at an intersectional and system-scenario perspective. We advocate for scientifically rigorous evaluations of the interplay between sex and gender as key factors in performing clinical trials, which are more adherent to real-life. This review proposes a set of 12 rules to improve clinical research for integrating sex–gender into clinical trials.

scholarly journals The prevalence of MS in the United States

Neurology ◽  
2019 ◽  
Vol 92 (10) ◽  
pp. e1029-e1040 ◽  
Author(s):  
Mitchell T. Wallin ◽  
William J. Culpepper ◽  
Jonathan D. Campbell ◽  
Lorene M. Nelson ◽  
Annette Langer-Gould ◽  
...  
Keyword(s):  
United States ◽  
Census Data ◽  
Adult Population ◽  
The United States ◽  
Health Claims ◽  
The North ◽  
Time Period ◽  
The Us ◽  
Group A ◽  
Us Census

ObjectiveTo generate a national multiple sclerosis (MS) prevalence estimate for the United States by applying a validated algorithm to multiple administrative health claims (AHC) datasets.MethodsA validated algorithm was applied to private, military, and public AHC datasets to identify adult cases of MS between 2008 and 2010. In each dataset, we determined the 3-year cumulative prevalence overall and stratified by age, sex, and census region. We applied insurance-specific and stratum-specific estimates to the 2010 US Census data and pooled the findings to calculate the 2010 prevalence of MS in the United States cumulated over 3 years. We also estimated the 2010 prevalence cumulated over 10 years using 2 models and extrapolated our estimate to 2017.ResultsThe estimated 2010 prevalence of MS in the US adult population cumulated over 10 years was 309.2 per 100,000 (95% confidence interval [CI] 308.1–310.1), representing 727,344 cases. During the same time period, the MS prevalence was 450.1 per 100,000 (95% CI 448.1–451.6) for women and 159.7 (95% CI 158.7–160.6) for men (female:male ratio 2.8). The estimated 2010 prevalence of MS was highest in the 55- to 64-year age group. A US north-south decreasing prevalence gradient was identified. The estimated MS prevalence is also presented for 2017.ConclusionThe estimated US national MS prevalence for 2010 is the highest reported to date and provides evidence that the north-south gradient persists. Our rigorous algorithm-based approach to estimating prevalence is efficient and has the potential to be used for other chronic neurologic conditions.

Levels of Employment and Community Engagement among Low-Income Adults: Implications for Medicaid Work Requirements

2020 ◽  
Vol 45 (6) ◽  
pp. 1059-1082
Author(s):  
Aparna Soni ◽  
Cong Gian ◽  
Kosali Simon ◽  
Benjamin D. Sommers
Keyword(s):  
Community Engagement ◽  
Low Income ◽  
Poverty Level ◽  
Work Requirements ◽  
Legal Challenges ◽  
The Us ◽  
Time Use Survey ◽  
Medicaid Beneficiaries ◽  
And Gender ◽  
Us Census

Abstract Context: Twenty states are pursuing community engagement requirements (“work requirements”) in Medicaid, though legal challenges are ongoing. While most nondisabled low-income individuals work, it is less clear how many engage in the required number of hours of qualifying community engagement activities and what heterogeneity may exist by race/ethnicity, age, and gender. The authors' objective was to estimate current levels of employment and other community engagement activities among potential Medicaid beneficiaries. Methods: The authors analyzed the US Census Bureau's national time-use survey data for the years 2015 through 2018. Their main sample consisted of nondisabled adults between 19 and 64 years with family incomes less than 138% of the federal poverty level (N = 2,551). Findings: Nationally, low-income adults who might become subject to Medicaid work requirements already spent an average of 30 hours per week on community engagement activities. However, 22% of the low-income population—particularly women, older adults, and those with less education—would not currently satisfy a 20-hour-per-week requirement. Conclusions: Although the majority of potential Medicaid beneficiaries already meet community engagement requirements or are exempt, 22% would not currently satisfy a 20-hour-per-week requirement and therefore could be at risk for losing coverage.

Demography and Social Epidemiology of Admissions to the Colorado Insane Asylum, 1879–1899

2014 ◽  
Vol 38 (1-2) ◽  
pp. 251-271 ◽  
Author(s):  
Ann L. Magennis ◽  
Michael G. Lacy
Keyword(s):  
Census Data ◽  
Social Epidemiology ◽  
Foreign Born ◽  
Personal Service ◽  
Admission Rates ◽  
Service Category ◽  
The Us ◽  
Males And Females ◽  
Urban Concentration ◽  
Us Census

This paper analyzes admissions to the Colorado Insane Asylum from 1879 to 1900. We estimate and compare admission rates across sex, age, marital, occupation, and immigration status using original admission records in combination with US census data from 1870 to1900. We show the extent to which persons in various status groups, who varied in power and social advantage, differed in their risk of being institutionalized in the context of nineteenth-century Colorado. Our analysis showed that admission or commitment to the Asylum did not entail permanent incarceration, as more than half of those admitted were discharged within six months. Men were admitted at higher rates than women, even after adjusting for age. Marital status also affected the risk of admission; single and divorced persons were admitted at about 1.5 times the rate of their married counterparts. Widows of either sex were even more likely to be admitted to the Asylum, and the risk increased with age. Persons in lower income/lower prestige occupations were more likely to be institutionalized. This included occupations in the domestic and personal service category in the US census, and this was evident for both males and females. Foreign-born men and women were admitted at, respectively, twice and three times the rate of their native counterparts, with particularly elevated rates observed among the Irish. In general, admission to the Colorado Insane Asylum appears to differ only in a slightly greater admission of males when compared to similar contemporaneous institutions in the East, despite the obvious differences in the Colorado population size and urban concentration.

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