Diverse Research Teams and Underrepresented Groups in Clinical Studies.

Importance: Several ophthalmic diseases disproportionately affect racial and ethnic minority patients, yet most clinical trials struggle to enroll cohorts that are demographically representative of disease burden; some barriers to recruitment include time and transportation, language and cultural differences, and fear and mistrust of research due to historical abuses. Incorporating diversity within the research team has been proposed as a method to increase trust and improve engagement among potential study participants. Objective: To examine how demographic factors of potential research participants and personnel may be associated with patient consent rates to participate in prospective ophthalmic clinical studies. Design, Setting, and Participants: This retrospective cohort study included patients from an urban, academic hospital who were approached for consent to participate in prospective ophthalmic clinical studies conducted between January 2015 and December 2021. Main Outcomes and Measures: Multivariable logistic regression assessing associations between patient and research personnel demographics and rates of affirmative consent to participate was used. Results: In total, 1380 patients (mean [SD] age, 58.6 [14.9] years; 50.3% male) who were approached for consent to participate in 10 prospective ophthalmic clinical studies were included. Of prospective patients, 566 (43.5%) were Black; 327 (25.1%), Hispanic or Latino; 373 (28.6%), White; 36 (2.8%), other race and ethnicity; and 78 (5.8%) declined to answer. Black patients (odds ratio [OR], 0.32; 95% CI, 0.24-0.44; P < .001) and Hispanic or Latino patients (OR, 0.31; 95% CI, 0.20-0.47; P < .001) were less likely to consent compared with White patients. Patients with lower socioeconomic status were less likely to consent than patients with higher socioeconomic status (OR, 0.43; 95% CI, 0.33-0.53; P < .001). Concordance between patient and research staff race and ethnicity was associated with increased odds of affirmative consent (OR, 2.72; 95% CI, 1.99-3.73; P < .001). Conclusions and Relevance: In this cohort study, patients from underrepresented racial and ethnic groups and those with lower socioeconomic status were less likely to participate in ophthalmic clinical studies. Concordance of race and ethnicity between patients and research staff was associated with improved participant enrollment. These findings underscore the importance of increasing diversity in clinical research teams to improve racial and ethnic representation in clinical studies.

Socioeconomic Disparities in Patients Receiving Intravitreal Injections for Age-Related Macular Degeneration Amid the COVID-19 Pandemic.

Purpose: To determine the effects of socioeconomic factors on visit adherence and the resultant visual outcomes for patients receiving intravitreal injections for neovascular age-related macular degeneration during the COVID-19 pandemic. Methods: In this retrospective case-control study, medical records were reviewed to collect appointment attendance, age, sex, self-reported race/ethnicity, primary language, marital status, insurance, distance from clinic, and Area Deprivation Index (ADI), a measure of socioeconomic disadvantage. Multivariate regression models were created to determine differences in socioeconomic factors between individuals who attended (show group) and those who did not attend (no-show group) appointments. Results: The study enrolled 126 patients in the show group and 115 in the no-show group. On univariate analysis, nonadherence was significantly higher in non-White patients than in White patients (P = .04), urban sites than in suburban sites (P = 1.7 × 10-4), and non-English-speaking patients than in English-speaking patients (P = 4.0 × 10-3). The associations remained significant in multivariate analysis for non-English-speaking patients (P = .03) and urban-site patients (P = .01) after adjusting for age, sex, self-reported race/ethnicity, primary language, marital status, insurance, distance from clinic, site of visit, and ADI. At 6 months and 1 year, a 1-, 2-, and 3-line vision loss was significantly higher in the no-show group than in the show group on univariate and multivariate analysis after adjusting for age, sex, race, lens status, and presence of glaucoma and diabetic retinopathy. Conclusions: Non-English-speaking patients and urban-based patients were less likely to present for intravitreal injection appointments during the initial peak of the COVID-19 pandemic. This disparity translated to worse vision outcomes at 6 months and 1 year.

Frailty Index is Associated with Treatment Decisions for Stage I Non-Small Cell Lung Cancer at a High-Burden Safety-Net Hospital.

BACKGROUND: Lobectomy remains the cornerstone of care for stage I NSCLC while sublobar resection and stereotactic body radiation therapy (SBRT) are reserved for patients with smaller tumors and/or poor operative risk. Herein, we investigate the effect of patient frailty on treatment modality for stage I NSCLC at a safety-net hospital. PATIENTS AND METHODS: A retrospective chart review was performed of stage I NSCLC patients between 2006 and 2015. Demographics, patient characteristics, and treatment rates were compared to a National Cancer Database cohort of stage 1 NSCLC patients. Patient frailty was assessed using the MSK-FI. RESULTS: In our cohort of 304 patients, significantly fewer patient were treated via lobectomy compared to national rates (P < .001). Advanced age (P = .02), lower FEV1 (P < .001) and DLCO (P < .001), not socioeconomic factors, were associated with higher utilization of non-lobectomy (sublobar resection or SBRT). Patients with lower MSK-FI were more likely to receive any surgical treatment (P = .01) and lobectomy (P = .03). Lower MSK-FI was an independent predictor for use of lobectomy over other modalities (OR 0.75, P = .04). MSK-FI (OR 0.64, P = .02), and FEV1 (OR 1.03, P < .001) were independently associated with use of SBRT over any surgery. CONCLUSION: Our safety-net hospital performed fewer lobectomies and lung resections compared to national rates. Patient frailty and clinical factors were associated with use of SBRT or sublobar resection suggesting that the increased illness burden of a safety-net population may drive the lower use of lobectomy. The MSK-FI may help physicians stratify patient risk to guide stage I NSCLC management.

The Role of Vitamin D as a Prognostic Marker in Papillary Thyroid Cancer.

The role of vitamin D in modulating several cancer-related pathways has received an increasing amount of attention in the past several years. Previous literature has found an abundance of evidence of vitamin D exerting an anti-proliferative, anti-inflammatory, and pro-differentiation effect in various types of cancers including breast, colon, prostate, and pancreatic cancer. Although the link between vitamin D and thyroid cancer remains controversial, both biochemical evidence and clinical studies have attempted to establish a link between papillary thyroid carcinoma (PTC) and vitamin D status. Furthermore, the use of vitamin D as a prognostic marker has received increased attention, both in regards to clinical outcomes and cancer staging. In this review, we briefly discuss the metabolism and proposed mechanism of action of vitamin D in the context of PTC, and explore links between modulators in the vitamin D pathway and progression of PTC. We provide evidence from both clinical studies as well as molecular studies of metabolic targets, including vitamin D receptor and activating enzymes exerting an effect on PTC tissue, which indicate that vitamin D may play a significant prognostic role in PTC.

Does Prematurity Play a Role in Newborn Microtia-Anotia?

OBJECTIVE: Microtia-anotia (MA) describes a range of external ear anomalies which is commonly associated with various syndromes and malformations of the head and neck. Previous studies have suggested a strong association between MA and male sex, maternal diabetes, and Hispanic race/ethnicity. This study seeks to evaluate the associations between MA and preterm newborns in the United States. METHODS: Population-based inpatient registry analysis was conducted. Kids' Inpatient Database (2016) was used to identify weighted in-hospital births with diagnosis of prematurity or MA. Demographic information was obtained, and odds ratios (ORs) were used to determine associations between prematurity and MA. RESULTS: Among patients included in our dataset, 8.655% (326 285) were preterm and 0.016% (523) had MA. 0.003% (109) of patients were preterm and had MA. Preterm infants had 2.19 times the odds (95% C.I. = 1.78-2.69) of having MA when compared to the full-term population. The binary logistic regression model accounting for possible confounding variables produced an aOR of 1.48 (95% C.I. = 1.17-1.87) for the association between prematurity and MA. CONCLUSION: Infants who are born preterm are more likely to have MA than full term infants. The current results will allow for improved risk stratification, maternal counseling, and interventions in the case of prematurity.

Cleft Palate in Newborns Diagnosed With Prematurity.

OBJECTIVE: Cleft lip and/or palate (CLP) is the most common major congenital malformation of the head and neck. Although numerous genetic features, syndromes, nutritional deficiencies, and maternal exposures have been implicated in the etiology of CLP, the impact of prematurity on the pathogenesis remains incompletely understood. This study seeks to evaluate the associations between prematurity and the development of CLP in the United States. STUDY DESIGN: Cross-sectional. SETTING: Academic medical center. METHODS: The Kids' Inpatient Database (2016) was used to identify weighted in-hospital births with diagnoses of prematurity or CLP. Demographic information was obtained. Odds ratios were used to determine associations between prematurity and CLP. RESULTS: Among patients included in our data set, 8.653% (n = 326,147) were preterm; 0.136% (n = 5115) had CLP; and 0.021% (n = 808) were preterm and had CLP. Preterm infants had 1.90 times the odds (95% CI, 1.74-2.07) of developing CLP when compared with the nonpreterm population. The binary logistic regression model accounting for possible confounding variables produced an odds ratio of 1.83 (95% CI, 1.66-2.01) for the association between prematurity and CLP. CONCLUSION: Infants who are born preterm are more likely to have CLP than full-term infants. The current results will allow for improved risk stratification, maternal counseling, and interventions in the case of prematurity. LEVEL OF EVIDENCE: 4.

Predictors of a Normal Sleep Study in Healthy Children with Sleep Disordered Breathing Symptoms.

OBJECTIVE: To determine the prevalence and characteristics of children with normal elective polysomnography for obstructive sleep disordered breathing (oSDB) based on the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) guidelines. STUDY DESIGN: In this retrospective cohort study, we identified patients ages 2 to 18 who underwent diagnostic polysomnography (PSG) ordered by our otolaryngology department for SDB between 2012 and 2018. SETTING: All patients were seen by otolaryngologists at an urban tertiary safety net hospital. SUBJECTS AND METHODS: There were a total of 456 patients studied (average age 5.66 ± 3.19; 263 (57.7%) males, 193 (42.3%) females. Demographic factors (age, gender, race, ethnicity, language, insurance status) and clinical findings (symptom severity, tonsil size) were recorded. The data were analyzed by univariate and multivariate analysis. RESULTS: Two hundred four patients (44.7%) had no obstructive sleep apnea (OSA) based on AHI<2 on PSG. Children with a larger tonsil size had 3.18 times the odds of OSA compared to those with a medium tonsil size (95% CI 1.64, 6.19) when adjusting for symptoms, age category, and race (P = .0007). Children ages 4 to 6 years had 0.25 times the odds of OSA compared to those ages 2-3 years (95% CI 0.12, 1.54) when adjusting for symptoms, tonsil size, and race (P = .0011). White children had 0.28 times the odds of OSA compared to Black children (95% CI 0.14, 0.57) when adjusting for symptoms, tonsil size, and age category (P = .0004). CONCLUSION: Among our patient population, 44.7% had normal sleep studies. Younger children (ages 2-3) were less likely to have normal polysomnography. This research demonstrates that obtaining sleep studies in otherwise healthy children with SDB can affect management decisions, and they should be discussed with families with a focus on patient centered decision making.

Barriers to timely tympanostomy tube placement in trisomy 21.

OBJECTIVES: Trisomy 21 is the most common chromosomal abnormality in the United States with an incidence of 1 in 700 in live-born children. Children with trisomy 21 are at increased risk for chronic ear disease, as well as other medical issues that may complicate healthcare access. In this study, we investigate whether children with trisomy 21 experience delays in tympanostomy tube insertion, and if there are any factors that contribute to a delay in care. METHODS: We performed a retrospective analysis on patients with trisomy 21 undergoing tympanostomy tube insertion at Boston Medical Center between 2005 and 2019 by analyzing the electronic medical record. This cohort was matched to patients without trisomy 21 by age, gender, surgery date and surgeon. The primary outcome was time elapsed between surgery decision date and date of tympanostomy tube insertion. RESULTS: A total of 20 patients with trisomy 21 underwent tympanostomy tube insertion at Boston Medical Center between 2005 and 2019. The trisomy 21 cohort was matched to 39 patients in the general population. The average time elapsed from decision to undergo surgery to tympanostomy tube insertion was 43.1 days in the general population and 119.0 days in the trisomy 21 cohort (p < .01). CONCLUSION: Patients with trisomy 21 experience greater delays in tympanostomy tube insertion than the general population, which may be due to the increased burden of comorbid conditions in people with trisomy 21.

Characteristics and Frequency of Children With Severe Obstructive Sleep Apnea Undergoing Elective Polysomnography.

OBJECTIVE: To determine the prevalence and demographics features of pediatric patients with severe obstructive sleep apnea (OSA) who would not undergo preoperative polysomnography (PSG) under current American Academy of Otolaryngology (AAO) guidelines. STUDY DESIGN: In this retrospective cohort study, we identified patients from the electronic medical record who underwent elective polysomnography for evaluation of sleep-disordered breathing between 2012 and 2018. SETTING: Urban tertiary safety net hospital. SUBJECTS AND METHODS: A total of 456 patients with a mean (SD) age of 5.7 (3.2) years (263 male, 193 female). Demographic factors (age, sex, race, language, insurance status) and clinical findings (symptom severity, tonsil size) were recorded. The data were analyzed by univariate analysis. RESULTS: Of 456 patients identified, 66 (14.5%) were found to have severe OSA. African American patients had 3.7 times the odds of severe OSA compared to white patients (95% CI, 1.2-10.8). Patients aged 2 to 3 years had 2.2 times the odds of severe OSA compared to patients aged 4 to 6 years (95% CI, 1.2-4.0). Sex, ethnicity, language, and insurance type were not significantly associated with severity of OSA. The presence of apneic episodes and tonsil size were not found to be statistically significant. CONCLUSION: Up to 14.5% of healthy pediatric patients with sleep-disordered breathing may have severe OSA; young age and African American race are statistically significant predictors. Clinical findings, such as tonsil size and symptom severity, were not found to be statistically significant predictors.