Race in Rhinology Clinical Trials: A Decade of Disparity

Spielman, Daniel; Liebowitz, Andi; Kelebeyev, Saveliy; Smith, Timothy L.; McKinney, Kibwei A.; Woodard, Troy D.; Safi, Chetan; Overdevest, Jonathan B.; Gudis, David A.

doi:10.1002/lary.29371

Cited by 21 publications

(29 citation statements)

References 48 publications

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“…Currently, there is evidence of non-representative enrollment in CRS studies with under-representation of minority populations in trials from 2010 to 2020. 52 The implications of this are vast and can cause outcome disparities. For example, in head and neck cancer, non-representative enrollment of Black patients has led to worse survival outcomes compared to White patients.…”

Section: Discussionmentioning

confidence: 99%

Demographic Variation in Chronic Rhinosinusitis by Subtype and Region: A Systematic Review

Mehta

Nguyen

et al. 2021

Am J Rhinol�Allergy

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Background Chronic rhinosinusitis (CRS) describes a heterogenous group of diseases including CRS with (CRSwNP) or without nasal polyps (CRSsNP), aspirin-exacerbated respiratory disease (AERD), and allergic fungal rhinosinusitis (AFRS). It affects 10 to 15% of the US population and is more common in women and White patients. However, these estimates are based on survey and database studies with innate diagnostic inaccuracy. Additionally, few studies report subtype-specific demographics. We explore the demographic differences of CRS in the U.S. by subtype and region. Objective To characterize demographic differences between the CRS population and the overall US population, and also between different CRS subtype populations. Methods We performed a systematic review for articles reporting on US demographics of adults with CRS. Study participants were required to have been diagnosed using consensus criteria. Data on demographics, geographic region, and CRS subtype were analyzed. Results Our study analyzed 31 unique studies representing 8409 patients with 50.7% females and weighted mean age of 48.0 years. Compared to the overall US population, CRS patients were predominantly White (78.5%) and non-Hispanic (94.5%) with under-representation of other races. Grouped by subtype, CRSwNP affected a significantly higher proportion of men (59.8%). AFRS affected a significantly higher proportion of Black patients (53.8%) while CRSsNP was more prevalent in White patients (84.2%). When grouped by region, the South had a significantly higher proportion of female (53%) and Black (17.8%) CRS patients. The West had a significantly higher proportion of Asian (4.5%) and Hispanic (12.3%) patients. Conclusions Significant demographic differences exist in CRS patients based on subtype and region. These data provide an estimation of the demographic make-up of CRS, but further high-level demographic studies are needed.

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Section: Discussionmentioning

confidence: 99%

Demographic Variation in Chronic Rhinosinusitis by Subtype and Region: A Systematic Review

Mehta

Nguyen

et al. 2021

Am J Rhinol�Allergy

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“…Eleven of 79 studies (13.9%) pertained to disparities in head and neck endocrine surgery. Epidemiology (4) and practice patterns (4) were most commonly studied, with most populations consisting of either a statewide or national cohort (7).…”

Section: Endocrine Surgerymentioning

confidence: 99%

“…Social determinants of health (SDOHs) as defined by the Centers for Disease Control and Prevention (CDC), are the “conditions in the places where people live, learn, work, and play that affect a wide range of health risks and outcomes.” 1 The effects of SDOHs on health care have been increasingly recognized in recent literature. Within otolaryngology, scoping and systematic reviews have characterized health care disparities in pediatric otolaryngology, 2,3 head and neck cancer, 4-6 rhinology, 7-9 laryngology, 10 and otology. 11-13 While studies on socioeconomic status, education, and ethnic disparities are relatively well represented, rurality is often left out of these reviews completely 3-9,11 or only narrowly addressed.…”

mentioning

confidence: 99%

Rural Otolaryngology Care Disparities: A Scoping Review

Urban

Shimomura

Shah

et al. 2022

Otolaryngol.--head neck surg.

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Objective To broadly synthesize the literature regarding rural health disparities in otolaryngology, categorize findings, and identify research gaps to stimulate future work. Study Design Scoping review. Data Sources A comprehensive literature search was performed in the following databases: PubMed/MEDLINE, Scopus, Cochrane Central Register of Controlled Trials, Google Scholar, and CINAHL. Review Methods The methods were developed in concordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. Peer-reviewed, English-language, US-based studies examining a rural disparity in otolaryngology-related disease incidence, prevalence, diagnosis, treatment, or outcome were included. Descriptive studies, commentaries, reviews, and letters to the editor were excluded. Studies published prior to 1980 were excluded. Results The literature search resulted in 1536 unique abstracts and yielded 79 studies that met final criteria for inclusion. Seventy-five percent were published after 2010. The distribution of literature was as follows: otology (34.2%), head and neck cancer (20.3%), endocrine surgery (13.9%), rhinology and allergy (8.9%), trauma (5.1%), laryngology (3.8%), other pediatrics (2.5%), and adult sleep (1.3%). Studies on otolaryngology health care systems also accounted for 10.1%. The most common topics studied were practice patterns (41%) and epidemiology (27%), while the Southeast (47%) was the most common US region represented, and database study (42%) was the most common study design. Conclusion Overall, there was low-quality evidence with large gaps in the literature in all subspecialties, most notably facial plastic surgery, laryngology, adult sleep, and pediatrics. Importantly, there were few studies on intervention and zero studies on resident exposure to rural populations, which will be critical to making rural otolaryngology care more equitable in the future.

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“…[16][17][18] Our group recently published a comprehensive analysis demonstrating significant racial and ethnic demographic disparities in prospective chronic rhinosinusitis (CRS) clinical trials relative to national and regional demographics. 19 There is a paucity of literature regarding the effects of race and ethnicity on the presentation and management of CRS. Several studies suggest that race may directly affect disease presentation and outcomes.…”

mentioning

confidence: 99%

“…16-18 Our group recently published a comprehensive analysis demonstrating significant racial and ethnic demographic disparities in prospective chronic rhinosinusitis (CRS) clinical trials relative to national and regional demographics. 19…”

mentioning

confidence: 99%

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

Spielman¹,

Schlosser²,

Liebowitz³

et al. 2021

Otolaryngol.--head neck surg.

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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.

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Race in Rhinology Clinical Trials: A Decade of Disparity

Cited by 21 publications

References 48 publications

Demographic Variation in Chronic Rhinosinusitis by Subtype and Region: A Systematic Review

Demographic Variation in Chronic Rhinosinusitis by Subtype and Region: A Systematic Review

Rural Otolaryngology Care Disparities: A Scoping Review

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

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