Publications by authors named "D B Spielman"

197 Publications

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

Otolaryngol Head Neck Surg 2021 Jun 15:1945998211021011. Epub 2021 Jun 15.

Department of Otolaryngology-Head and Neck Surgery, Columbia University Irving Medical Center, New York, New York, USA.

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 ( < .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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http://dx.doi.org/10.1177/01945998211021011DOI Listing
June 2021

Higher Levels of Pro-inflammatory Cytokines Are Associated With Higher Levels of Glutamate in the Anterior Cingulate Cortex in Depressed Adolescents.

Front Psychiatry 2021 15;12:642976. Epub 2021 Apr 15.

Department of Psychology, Stanford University, Stanford, CA, United States.

Animal models of stress and related conditions, including depression, have shown that elevated peripheral levels of inflammatory cytokines have downstream consequences on glutamate (Glu) in the brain. Although studies in human adults with depression have reported evidence of higher inflammation but lower Glu in the anterior cingulate cortex (ACC), the extent to which peripheral inflammation contributes to glutamatergic abnormalities in adolescents with depression is not well-understood. It is also unclear whether antioxidants, such as ascorbate (Asc), may buffer against the effects of inflammation on Glu metabolism. Fifty-five depressed adolescents were recruited in the present cross-sectional study and provided blood samples, from which we assayed pro-inflammatory cytokines, and underwent a short-TE proton magnetic spectroscopy scan at 3T, from which we estimated Glu and Asc in the dorsal ACC. In the 31 adolescents with usable cytokine and Glu data, we found that IL-6 was significantly positively associated with dorsal ACC Glu (β = 0.466 ± 0.199, = 0.029). Of the 16 participants who had usable Asc data, we found that at higher levels of dorsal ACC Asc, there was a negative association between IL-6 and Glu (interaction effect: β = -0.906 ± 0.433, = 0.034). Importantly, these results remained significant when controlling for age, gender, percentage of gray matter in the dorsal ACC voxel, BMI, and medication (antidepressant and anti-inflammatory) usage. While preliminary, our results underscore the importance of examining both immune and neural contributors to depression and highlight the potential role of anti-inflammatory compounds in mitigating the adverse effects of inflammation (e.g., glutamatergic neuroexcitotoxicity). Future studies that experimentally manipulate levels of inflammation, and of ascorbate, and that characterize these effects on cortical glutamate concentrations and subsequent behavior in animals and in humans are needed.
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http://dx.doi.org/10.3389/fpsyt.2021.642976DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8081972PMC
April 2021

Frontal Sinus Fractures: 10-Year Contemporary Experience at a Level 1 Urban Trauma Center.

J Craniofac Surg 2021 Jan 12. Epub 2021 Jan 12.

*Department of Otolaryngology-Head and Neck Surgery, New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY †Department of Otorhinolaryngology-Head and Neck Surgery, Rush University Medical Center, Chicago, IL.

Frontal sinus fractures account for 5% to 15% of all facial fractures, and have traditionally been associated with high kinetic energy blunt injury. Surgical management is largely focused on minimizing potentially serious sequelae including frontal sinus dysfunction, CSF leak, and significant cosmetic deformity. An institutional database of 1944 patients presenting with maxillofacial fractures over a 10-year period was queried. Demographics, mechanism of injury, yearly trends, surgical approaches, and follow-up data were examined. A total of 160 (8.3%) patients presented with at least 1 fracture of the frontal sinus anterior table, posterior table, or frontal sinus outflow tract during the study period. The average annual number of cases was 15.9 ± 5.7 per year with a peak of 21.5 ± 4.0 cases during the 2014 to 2015 period and a decline to 8.5 ± 1.5 cases/year from 2016 to 2017. Among those patients with falls, 61.5% (n = 40) were a result of tripping or fainting at a height of <6 ft. 55.6% of fracture types were isolated to the anterior table, but fracture location was not significantly associated with operative intervention. Cases of operative fracture type had a higher rate of both displacement and comminution compared to nonoperative fractures (P < 0.00001). Of all patients presenting with frontal sinus fractures, 75% of cases were managed nonoperatively. However, many patients presented with falls and other seemingly low energy injuries which are not traditionally associated with frontal sinus trauma. These results highlight the need for continued follow-up even in otherwise low-risk urban populations in order to avoid long term sinus dysfunction.
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http://dx.doi.org/10.1097/SCS.0000000000007426DOI Listing
January 2021

Injury Patterns in Pediatric Facial Fractures Unique to an Urban Environment.

Facial Plast Surg 2021 Feb 23. Epub 2021 Feb 23.

Department of Otolaryngology, Head & Neck Surgery, Joan and Sanford I Weill Medical College of Cornell University, New York, New York.

This study aimed to define better the clinical presentation, fracture patterns, and features predictive of associated injuries and need for surgery in pediatric facial trauma patients in an urban setting. Charts of patients 18 years or younger with International Classification of Disease 9th and 10th revision (ICD-9/ICD-10) codes specific for facial fractures (excluding isolated nasal fractures) at NY-Presbyterian/Weill Cornell Medical Center between 2008 and 2017 were retrospectively reviewed. Of 204 patients, most were referred to the emergency department by a physician's office or self-presented. Children (age 0-6 years) were most likely to have been injured by falls, while more patients 7 to 12 years and 13 to 18 years were injured during sporting activities ( < 0.0001). Roughly half (50.5%) of the patients had a single fracture, and the likelihood of surgery increased with greater numbers of fractures. Older patients with either orbital or mandibular fractures were more likely to undergo surgery than younger ones ( = 0.0048 and  = 0.0053, respectively). Cranial bone fractures, CSF leaks, and intracranial injuries were more common in younger patients ( < 0.0001) than older patients and were more likely after high energy injuries; however, 16.2% of patients sustaining low energy injuries also sustained cranial bone, CSF leak, or intracranial injury. In an urban environment, significant pediatric facial fractures and associated injuries may occur after nonclassic low kinetic energy traumatic events. The age of the patient impacts both the injuries sustained and the treatment rendered. It is essential to maintain a high index of suspicion for associated injuries in all pediatric facial trauma patients.
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http://dx.doi.org/10.1055/s-0041-1724121DOI Listing
February 2021

Race in Rhinology Clinical Trials: A Decade of Disparity.

Laryngoscope 2021 Jan 25. Epub 2021 Jan 25.

Department of Otolaryngology Head and Neck Surgery, Columbia University Irving Medical Center, New York, New York, U.S.A.

Objective/hypothesis: The aim of this study is to assess the ethnic and racial demographics of patients enrolled in prospective chronic rhinosinusitis (CRS) studies relative to the corresponding geographic demographics of the United States (U.S.) census data.

Study Design: Systematic Review and Population analysis.

Methods: A systematic review was performed to identify CRS clinical trials, conducted in the U.S. and published between 2010 and 2020 in which patients were prospectively enrolled. Pooled racial and ethnicity data were compared to national and corresponding regional census data.

Results: Eighty-three studies were included, comprising 12,027 patients. 50.4% were male and the average age was 49.2 years. 8,810 patients underwent a surgical procedure. Of the 12,027 patients, 81.67% were identified as White, 5.35% as Black, 1.27% as Asian, 0.02% as Pacific Islander, 0.12% as American Indian, and 11.57% were classified as Other. The racial and ethnic composition of the pooled study population differs significantly from the national U.S. census data with the underrepresentation of each minority population (P ≤ .0002). Regional sub-analyses yield variable results. In the Northeast and West, there was an underrepresentation of all minority populations. In the South and Midwest, Black enrollment was similar to the U.S. census data, while all other minorities were underrepresented.

Conclusions: The racial and ethnic composition of patients enrolled in prospective CRS clinical trials differs significantly from the demographics of the U.S.

Population: The generalizability and external validity of findings derived from studies comprised of demographically mismatched populations has not been established. Future efforts to enroll more representative populations should be emphasized by the research community, funding bodies, and editorial boards.

Level Of Evidence: N/A Laryngoscope, 2021.
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http://dx.doi.org/10.1002/lary.29371DOI Listing
January 2021