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Reporting, representation, and subgroup analysis of race and ethnicity in published clinical trials of atopic dermatitis
Reporting, representation, and subgroup analysis of race and ethnicity in published clinical trials of atopic dermatitis
Role of gender in academic dermatology: Productivity, advancement, income, and career satisfaction-Results from a national survey.
(Poster reference number 5551)
(Poster reference number 4797)
Valerie Harvey, MD, Eastern Virginia Medical School, Norfolk, VA, United States; Stephanie Hirano, MD, Eastern Virginia Medical School, Norfolk, VA, United States; Sue Bouchard, MD, Eastern Virginia Medical School, Norfolk, VA, United States Objective: To review the literature of atopic dermatitis (AD) clinical trials published in the United States (US) between the years of 2000-2009 and to: (1) examine the representation of racial and ethnic minorities in those trials; and (2) determine whether investigators reported on demographic variables and performed a sub analysis.
Mona Sadeghpour, Yale University School of Medicine, New Haven, CT, United States; Christine Ko, MD, Yale University School of Medicine, New Haven, CT, United States; Heidi Jacobe, MD, UT Southwestern Medical Center, Dallas, TX, United States; Ira Bernstein, PhD, UT Southwestern Medical Center, Dallas, TX, United States Background: Gender gaps in academic medicine are well documented in the literature, but remain poorly understood in academic dermatology. The current study examines the role of gender in today’s academic workforce by assessing for gaps in promotion, academic productivity, salary, and career satisfaction.
Design: A PubMed search was performed to include clinical trials for prevention, treatment, or management of AD published between 2000-2009. Analysis was performed by three independent reviewers. Data recorded for each article included country of origin, publication year, study design, treatment/management type, subject number, subject age range, and sponsorship. Data were collected for reporting of race/ethnicity, socioeconomic status (SES), gender, and incorporation of the demographic data in the analysis and result interpretations Results: Of 645 PubMed articles, 402 were reviewed. Of these, 363 articles best fit our search criteria and were included in the analysis. Seventy-eight of the 363 articles originated in the US. Of these articles, 81.0% reported gender, 59.5% included reports of race/ethnicity, and 1.3% reported SES. Within these studies, 10.3% mentioned demographics in their results interpretation and none mentioned possible clinical implications. Only two studies documented the method by which race/ethnicity was assigned (self- vs investigator-reported). Of the studies reporting race/ethnicity, the subject population included 62.1% white/Caucasian, 18.0% black/African American, 6.8% ‘‘other,’’ 6.9% Asian, 3.8% ‘‘nonwhite,’’ and 2.0% Hispanic.
Methods: In January 2009, a cross-sectional, anonymous survey was mailed to a directory of US academic dermatologists as provided by the AAD. Only full-time academic dermatologists holding an MD degree were included. Participants were questioned on: demographics, academic positions, training, salary, academic productivity, work effort, and career satisfaction. Assessments for gender disparities in relation to rank distribution, academic productivity, salary, and career satisfaction were made. Results: Of 1263 distributed surveys, 343 (27.2%) responded, and 259 (75.5%) met inclusion criteria, 159 (61.4%) of which were men. Men were significantly older than women [49.9 years (SD ¼ 10.9) vs 42.6 years (SD ¼ 9.2), respectively; P\.001]. There was no significant difference in the weekly hours worked between men and women [52.9 hours (SD ¼ 10.0) vs 50.2 (SD ¼ 11.9), respectively; P ¼ .052], nor were there significant gender differences in the distribution of effort devoted to specific academic activities (ie, time devoted to patient care, research, teaching, mentoring, and administration). After controlling for academic rank and years out after residency, there was no difference in number of publications (P ¼.06) or grants received (P ¼.19). Men held more senior positions (P \.001) even after controlling for number of years in practice after residency (P \.05). Men made an average of $37,367 more than women (P ¼.001); however, this difference became insignificant when adjusted for rank, age, work-hours, position, specialty, and academic productivity. Men had higher job satisfaction than women [90.3% vs 83.0%, respectively; P ¼.02,] and women were 23.4% more likely to leave academia (P \.001). Of those considering leaving, reasons included ‘‘higher salary,’’ cited by 40.9% of men and 55% of women (P ¼ .04), ‘‘institutional pressures,’’ cited by 34% of men and 56% of women (P\.001) and ‘‘desire to spend more time with family,’’ reported by 23.9% of men and 41% of women (P \.006). Conclusion: While many gender gaps in academic dermatology have closed, significant differences persist with regards to rank distribution, satisfaction, and motivation for attrition.
Discussion: Race and ethnicity are commonly used variables in biomedical research. Researchers studying health disparities believe that ignoring an individual’s racial/ethnic background has extensive downstream ramifications on: (1)understanding contributors of disease; (2) determining racial/ethnic variations in disease presentation, response to therapy, or outcomes; and (3) determining whether biology differs between or within racial and ethnic groups. Given evidence supporting a link between AD with race/ethnicity, SES/environmental factors, it is surprising that in the US they are rarely used in the analysis of outcomes. Accurate reporting of data on race/ethnicity and subgroup analysis is important for determining the generalization of the clinical trial results to all populations. Our study supports the need for improved reporting and subgroup analyses in AD. Commercial support: None identified.
Commercial support: None identified.
Risk of second primary malignancies following a diagnosis of cutaneous melanoma and/or nonmelanoma skin cancer in Alberta, Canada from 1979 through 2009
(Poster reference number 5403)
Gordon Jung, MD, Division of Dermatology and Cutaneous Sciences, Department of Medicine, University of Alberta, Edmonton, Canada; Douglas Dover, MS, Alberta Health and Wellness, Public Health Division, Surveillance and Environmental Health, Edmonton, Canada; Thomas Salopek, MD, Division of Dermatology and Cutaneous Sciences, Department of Medicine, University of Alberta, Edmonton, Canada Background: Several international studies have revealed a heightened risk of second primary malignancies (SPMs) following a diagnosis of cutaneous tumors. Objectives: The objective of this study was to provide an updated Canadian analysis of the association between cutaneous and internal malignancies in Alberta, Canada from 1979 through 2009. Methods: Incidence rates and relative risks for the development of SPM following a diagnosis of cutaneous melanoma (CM) and/or nonmelanoma skin cancers (NMSCs) were calculated via a retrospective analysis of data retrieved from the Alberta Cancer Registry. Results: From 1979 to 2009, 6884 and 85,967 patients were diagnosed with cutaneous melanoma and nonmelanoma skin cancer, respectively. The incidences of CM (O/E, 32.74; 95% CI, 18.38-47.10 [males]; O/E, 68.84; 95% CI, 53.05-84.64 [females]) and malignances of the female genitalia (O/E, 5.15; 95% CI, 1.99-8.32) were significantly elevated following CM while the incidences of CM (O/E, 4.06; 95% CI, 3.17-4.94 [males]; O/E, 7.23; 95% CI, 2.66-11.80 [females]), hematologic malignancies (O/E, 1.44; 95% CI, 1.21-1.68 [males]; O/E, 1.18; 95% CI, 1.05-1.32 [females]), female genitalia cancers (O/E, 4.61; 95% CI, 2.92-6.31), and tumors of the oral cavity and pharynx (O/E, 1.51; 95% CI 1.25-1.77 [males]) were significantly elevated after NMSC. Conversely, the incidences of malignancies affecting the digestive system (O/E, 0.78; 95% CI, 0.57-0.99), respiratory system (O/E, 0.53; 95% CI 0.32-0.73), and male genitalia (O/E, 0.78; 95% CI, 0.61-0.94) in males, and the urinary system (O/E, 0.49; 95% CI, 0.09-0.89) in females were significantly decreased following CM. Lower incidences of cancers affecting the digestive system (O/E, 0.87; 95% CI, 0.81-0.94 [males]; O/E, 0.88; 95% CI, 0.81-0.96 [females]) and respiratory system (O/E, 0.89; 95% CI, 0.83-0.96 [males]; O/E, 0.88; 95% CI, 0.77-0.98 [females]) were identified following NMSC.
Seasonal variation in the diagnosis of cutaneous malignancies
(Poster reference number 5048)
Charles Phillips, MD, Brody School of Medicine at East Carolina University, Greenville, NC, United States; Harris Green, MD, Brody School of Medicine at East Carolina University, Greenville, NC, United States; Jennifer Defazio, MD, Brody School of Medicine at East Carolina University, Greenville, NC, United States; Tracy McLean, MD, Brody School of Medicine at East Carolina University, Greenville, NC, United States; Vos Paul, PhD, Department of Biostatistics, Greenville, NC, United States Background: Many authors have reported seasonal variations in the detection of skin cancers, with a particular increase of melanoma detection within the summer months.
Conclusion: The increased or decreased incidences of SPMs following cutaneous malignancies suggest an association amongst such cancers. Because such results appear to differ geographically, both genetic and environmental factors likely contribute to the link between skin cancers and other malignancies, warranting closer examination.
Objective: We sought to determine if there is a seasonal variation in the detection of skin cancers in our institutional clinic in eastern North Carolina. Methods: Biopsy results from patients seen in our clinics from January 2001 to December 2010 were reviewed. The number of malignant melanoma (MM), basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and other cutaneous malignancy diagnoses were recorded along with biopsy dates. Because there were increasingly more biopsies performed each year with an increasing number of providers, an analysis of individual skin cancers type per 100 biopsies was performed for each season across the 10-year span. Pearson x 2 and Fisher exact tests were used to evaluate for significance in seasonal variation among the tumors. Results: A review of 13,399 biopsy results revealed 182 MMs, 3233 BCCs, 2261 SCCs, and 121 other malignancies. MMs were diagnosed more frequently in spring and summer months, during which the odds of melanoma were 1.53 times greater than during fall and winter months (95% CI, 1.13-2.10). The odds of SCC diagnoses were 1.14 times greater during winter/spring than during summer/fall (95% CI, 1.041.24), while the odds of BCC diagnoses were 1.13 times greater during summer/fall than during winter/spring (95% CI, 1.05-1.23). No statistically significant seasonality among other malignancy diagnoses was discovered. Conclusion: Consistent with reports from various regions worldwide, this study showed a seasonal variation of melanoma detection among the patient group of eastern North Carolina represented in our clinic over a 10-year period. The seasonal variation of BCC and SCC diagnoses were of statistical yet questionable clinical significance. Possible explanations for the spring and summer diagnostic peak of melanoma include warmer weather phenomena, such as increased visibility with clothing habits, increased sunburns incurred, and increased public skin cancer screenings.
Commercial support: None identified.
Commercial support: None identified.
AB90
J AM ACAD DERMATOL
APRIL 2012
Role of gender in academic dermatology: Productivity, advancement, income, and career satisfaction-Results from a national survey.
(Poster reference number 5551)
(Poster reference number 4797)
Valerie Harvey, MD, Eastern Virginia Medical School, Norfolk, VA, United States; Stephanie Hirano, MD, Eastern Virginia Medical School, Norfolk, VA, United States; Sue Bouchard, MD, Eastern Virginia Medical School, Norfolk, VA, United States Objective: To review the literature of atopic dermatitis (AD) clinical trials published in the United States (US) between the years of 2000-2009 and to: (1) examine the representation of racial and ethnic minorities in those trials; and (2) determine whether investigators reported on demographic variables and performed a sub analysis.
Mona Sadeghpour, Yale University School of Medicine, New Haven, CT, United States; Christine Ko, MD, Yale University School of Medicine, New Haven, CT, United States; Heidi Jacobe, MD, UT Southwestern Medical Center, Dallas, TX, United States; Ira Bernstein, PhD, UT Southwestern Medical Center, Dallas, TX, United States Background: Gender gaps in academic medicine are well documented in the literature, but remain poorly understood in academic dermatology. The current study examines the role of gender in today’s academic workforce by assessing for gaps in promotion, academic productivity, salary, and career satisfaction.
Design: A PubMed search was performed to include clinical trials for prevention, treatment, or management of AD published between 2000-2009. Analysis was performed by three independent reviewers. Data recorded for each article included country of origin, publication year, study design, treatment/management type, subject number, subject age range, and sponsorship. Data were collected for reporting of race/ethnicity, socioeconomic status (SES), gender, and incorporation of the demographic data in the analysis and result interpretations Results: Of 645 PubMed articles, 402 were reviewed. Of these, 363 articles best fit our search criteria and were included in the analysis. Seventy-eight of the 363 articles originated in the US. Of these articles, 81.0% reported gender, 59.5% included reports of race/ethnicity, and 1.3% reported SES. Within these studies, 10.3% mentioned demographics in their results interpretation and none mentioned possible clinical implications. Only two studies documented the method by which race/ethnicity was assigned (self- vs investigator-reported). Of the studies reporting race/ethnicity, the subject population included 62.1% white/Caucasian, 18.0% black/African American, 6.8% ‘‘other,’’ 6.9% Asian, 3.8% ‘‘nonwhite,’’ and 2.0% Hispanic.
Methods: In January 2009, a cross-sectional, anonymous survey was mailed to a directory of US academic dermatologists as provided by the AAD. Only full-time academic dermatologists holding an MD degree were included. Participants were questioned on: demographics, academic positions, training, salary, academic productivity, work effort, and career satisfaction. Assessments for gender disparities in relation to rank distribution, academic productivity, salary, and career satisfaction were made. Results: Of 1263 distributed surveys, 343 (27.2%) responded, and 259 (75.5%) met inclusion criteria, 159 (61.4%) of which were men. Men were significantly older than women [49.9 years (SD ¼ 10.9) vs 42.6 years (SD ¼ 9.2), respectively; P\.001]. There was no significant difference in the weekly hours worked between men and women [52.9 hours (SD ¼ 10.0) vs 50.2 (SD ¼ 11.9), respectively; P ¼ .052], nor were there significant gender differences in the distribution of effort devoted to specific academic activities (ie, time devoted to patient care, research, teaching, mentoring, and administration). After controlling for academic rank and years out after residency, there was no difference in number of publications (P ¼.06) or grants received (P ¼.19). Men held more senior positions (P \.001) even after controlling for number of years in practice after residency (P \.05). Men made an average of $37,367 more than women (P ¼.001); however, this difference became insignificant when adjusted for rank, age, work-hours, position, specialty, and academic productivity. Men had higher job satisfaction than women [90.3% vs 83.0%, respectively; P ¼.02,] and women were 23.4% more likely to leave academia (P \.001). Of those considering leaving, reasons included ‘‘higher salary,’’ cited by 40.9% of men and 55% of women (P ¼ .04), ‘‘institutional pressures,’’ cited by 34% of men and 56% of women (P\.001) and ‘‘desire to spend more time with family,’’ reported by 23.9% of men and 41% of women (P \.006). Conclusion: While many gender gaps in academic dermatology have closed, significant differences persist with regards to rank distribution, satisfaction, and motivation for attrition.
Discussion: Race and ethnicity are commonly used variables in biomedical research. Researchers studying health disparities believe that ignoring an individual’s racial/ethnic background has extensive downstream ramifications on: (1)understanding contributors of disease; (2) determining racial/ethnic variations in disease presentation, response to therapy, or outcomes; and (3) determining whether biology differs between or within racial and ethnic groups. Given evidence supporting a link between AD with race/ethnicity, SES/environmental factors, it is surprising that in the US they are rarely used in the analysis of outcomes. Accurate reporting of data on race/ethnicity and subgroup analysis is important for determining the generalization of the clinical trial results to all populations. Our study supports the need for improved reporting and subgroup analyses in AD. Commercial support: None identified.
Commercial support: None identified.
Risk of second primary malignancies following a diagnosis of cutaneous melanoma and/or nonmelanoma skin cancer in Alberta, Canada from 1979 through 2009
(Poster reference number 5403)
Gordon Jung, MD, Division of Dermatology and Cutaneous Sciences, Department of Medicine, University of Alberta, Edmonton, Canada; Douglas Dover, MS, Alberta Health and Wellness, Public Health Division, Surveillance and Environmental Health, Edmonton, Canada; Thomas Salopek, MD, Division of Dermatology and Cutaneous Sciences, Department of Medicine, University of Alberta, Edmonton, Canada Background: Several international studies have revealed a heightened risk of second primary malignancies (SPMs) following a diagnosis of cutaneous tumors. Objectives: The objective of this study was to provide an updated Canadian analysis of the association between cutaneous and internal malignancies in Alberta, Canada from 1979 through 2009. Methods: Incidence rates and relative risks for the development of SPM following a diagnosis of cutaneous melanoma (CM) and/or nonmelanoma skin cancers (NMSCs) were calculated via a retrospective analysis of data retrieved from the Alberta Cancer Registry. Results: From 1979 to 2009, 6884 and 85,967 patients were diagnosed with cutaneous melanoma and nonmelanoma skin cancer, respectively. The incidences of CM (O/E, 32.74; 95% CI, 18.38-47.10 [males]; O/E, 68.84; 95% CI, 53.05-84.64 [females]) and malignances of the female genitalia (O/E, 5.15; 95% CI, 1.99-8.32) were significantly elevated following CM while the incidences of CM (O/E, 4.06; 95% CI, 3.17-4.94 [males]; O/E, 7.23; 95% CI, 2.66-11.80 [females]), hematologic malignancies (O/E, 1.44; 95% CI, 1.21-1.68 [males]; O/E, 1.18; 95% CI, 1.05-1.32 [females]), female genitalia cancers (O/E, 4.61; 95% CI, 2.92-6.31), and tumors of the oral cavity and pharynx (O/E, 1.51; 95% CI 1.25-1.77 [males]) were significantly elevated after NMSC. Conversely, the incidences of malignancies affecting the digestive system (O/E, 0.78; 95% CI, 0.57-0.99), respiratory system (O/E, 0.53; 95% CI 0.32-0.73), and male genitalia (O/E, 0.78; 95% CI, 0.61-0.94) in males, and the urinary system (O/E, 0.49; 95% CI, 0.09-0.89) in females were significantly decreased following CM. Lower incidences of cancers affecting the digestive system (O/E, 0.87; 95% CI, 0.81-0.94 [males]; O/E, 0.88; 95% CI, 0.81-0.96 [females]) and respiratory system (O/E, 0.89; 95% CI, 0.83-0.96 [males]; O/E, 0.88; 95% CI, 0.77-0.98 [females]) were identified following NMSC.
Seasonal variation in the diagnosis of cutaneous malignancies
(Poster reference number 5048)
Charles Phillips, MD, Brody School of Medicine at East Carolina University, Greenville, NC, United States; Harris Green, MD, Brody School of Medicine at East Carolina University, Greenville, NC, United States; Jennifer Defazio, MD, Brody School of Medicine at East Carolina University, Greenville, NC, United States; Tracy McLean, MD, Brody School of Medicine at East Carolina University, Greenville, NC, United States; Vos Paul, PhD, Department of Biostatistics, Greenville, NC, United States Background: Many authors have reported seasonal variations in the detection of skin cancers, with a particular increase of melanoma detection within the summer months.
Conclusion: The increased or decreased incidences of SPMs following cutaneous malignancies suggest an association amongst such cancers. Because such results appear to differ geographically, both genetic and environmental factors likely contribute to the link between skin cancers and other malignancies, warranting closer examination.
Objective: We sought to determine if there is a seasonal variation in the detection of skin cancers in our institutional clinic in eastern North Carolina. Methods: Biopsy results from patients seen in our clinics from January 2001 to December 2010 were reviewed. The number of malignant melanoma (MM), basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and other cutaneous malignancy diagnoses were recorded along with biopsy dates. Because there were increasingly more biopsies performed each year with an increasing number of providers, an analysis of individual skin cancers type per 100 biopsies was performed for each season across the 10-year span. Pearson x 2 and Fisher exact tests were used to evaluate for significance in seasonal variation among the tumors. Results: A review of 13,399 biopsy results revealed 182 MMs, 3233 BCCs, 2261 SCCs, and 121 other malignancies. MMs were diagnosed more frequently in spring and summer months, during which the odds of melanoma were 1.53 times greater than during fall and winter months (95% CI, 1.13-2.10). The odds of SCC diagnoses were 1.14 times greater during winter/spring than during summer/fall (95% CI, 1.041.24), while the odds of BCC diagnoses were 1.13 times greater during summer/fall than during winter/spring (95% CI, 1.05-1.23). No statistically significant seasonality among other malignancy diagnoses was discovered. Conclusion: Consistent with reports from various regions worldwide, this study showed a seasonal variation of melanoma detection among the patient group of eastern North Carolina represented in our clinic over a 10-year period. The seasonal variation of BCC and SCC diagnoses were of statistical yet questionable clinical significance. Possible explanations for the spring and summer diagnostic peak of melanoma include warmer weather phenomena, such as increased visibility with clothing habits, increased sunburns incurred, and increased public skin cancer screenings.
Commercial support: None identified.
Commercial support: None identified.
AB90
J AM ACAD DERMATOL
APRIL 2012