Reporting, Representation, and Subgroup Analysis of Race and Ethnicity in Published Clinical Trials of Atopic Dermatitis in the United States Between 2000 and 2009

Hirano, Stefanie A.; Murray, Susan B.; Harvey, Valérie

doi:10.1111/j.1525-1470.2012.01797.x

Cited by 49 publications

(52 citation statements)

References 16 publications

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“…In fact, a study has found the underreporting of patient’s skin type in clinical trials, with only 59.5% of the clinical trials published in the United States between 2000 and 2009 reporting the patient’s race or ethnicity (Hirano et al, 2012). Another systematic review showed that there is a dearth of studies demonstrating efficacy of systemic AD therapy in different racial and ethnic patient subsets in the United States (Bhattacharya and Silverberg, 2014).…”

Section: Introductionmentioning

confidence: 99%

The reliability and validity of outcome measures for atopic dermatitis in patients with pigmented skin: A grey area

Zhao

Wijayanti

Doria

et al. 2015

International Journal of Women's Dermatology

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BackgroundOutcome measures for atopic dermatitis (AD) patients with pigmented skin have neither been developed nor validated.ObjectiveTo compare the reliability and validity of four common AD outcome measures in patients with various levels of skin darkness.MethodThe inter- and intra-rater reliability and construct validity of the EASI (Eczema Area and Severity Index), objective-SCORing Atopic Dermatitis (oSCORAD), Three Items Severity index (TIS) and Six Areas, Six Sites Atopic Dermatitis (SASSAD) were evaluated in 18 patients of various levels of skin darkness, using their full body photographs, by five trained clinicians.ResultsThe inter-rater reliability intraclass coefficient (ICCs) and 95% confidence intervals were poor for highly pigmented patients: EASI -.054(-.200 to .657), oSCORAD -.089(-.206 to .598), TIS -.21(-.24 to .147), SASSAD -.071(-.200 to .631); fair for mildly pigmented patients: EASI .464(.140-.839), oSCORAD .588(.265-.89), TIS.524(.200-.865), SASSAD .41(.045-.775); and fair to good for non-pigmented patients: EASI .64(.330-.908), oSCORAD .586(.263-.889), TIS .403(.09-.809), SASSAD .667(.358-.916). Erythema likely contributed to the inter-rater variability. Construct validity had significant correlations across all measures in non-pigmented patients, but no correlations in highly pigmented patients.ConclusionAD outcome measures have poor reliability and validity in highly pigmented patients, with variations in erythema perception being a contributor.

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Section: Introductionmentioning

confidence: 99%

The reliability and validity of outcome measures for atopic dermatitis in patients with pigmented skin: A grey area

Zhao

Wijayanti

Doria

et al. 2015

International Journal of Women's Dermatology

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“…9 The US Food and Drug Administration (FDA) currently requires that all investigational new drug and new drug applications studies include demographic information prior to approval. 10 Additionally, National Institutes of Health (NIH)-funded clinical research studies must include women and minorities. 11 Despite a call to action to achieve diversity in research, that we know of there has been no systematic evaluation of clinical and research diversity among dermatology research subjects to date.…”

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confidence: 99%

Diversity in Dermatology Clinical Trials

et al. 2017

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he growth of the minority population in the United States is outpacing the growth of the non-Hispanic white population. Current projections estimate that the United States will achieve "majority-minority" status in which minority populations total over 50% of the overall population by 2044. 1 This demographic shift has not been reflected in medical research. African Americans, Hispanic individuals, and women are underrepresented in clinical 2 and randomized controlled trials generally, 3 as well as within specific subspecialties including cancer clinical trials, 4 pulmonary research, 5 vascular surgery trials, 6 and orthopedic research. 7 General reporting of the racial and ethnic demographics of study cohorts is uncommon as well, with less than one-third of papers published in high-impact journals across all fields reporting racial or ethnic demographics. 8 Federal efforts have targeted inclusion of clinical trial and research subjects at levels proportionate with those in the US population. 9 The US Food and Drug Administration (FDA) currently requires that all investigational new drug and new drug applications studies include demographic information prior to approval. 10 Additionally, National Institutes of Health (NIH)funded clinical research studies must include women and minorities. 11 Despite a call to action to achieve diversity in research, that we know of there has been no systematic evaluation of clinical and research diversity among dermatology research subjects to date. Hirano et al 12 examined racial representation in atopic dermatitis research, demonstrating that only 60% of clinical trials of eczema and/or atopic dermatitis reported race.This systematic review of the dermatology literature analyzed the degree of racial, ethnic, and sex representation in recent randomized clinical trials (RCTs) for acne, psoriasis, atopic dermatitis and eczema, vitiligo, alopecia areata, seborrheic dermatitis, and lichen planus (LP). These conditions were selected because they are: IMPORTANCE Though there have been significant shifts in US demographic data over the past 50 years, research cohorts lack full racial and ethnic representation. There is little data available regarding the diversity of dermatology research cohorts with respect to sex, race, and ethnicity.OBJECTIVE To characterize and assess the representation of racial and ethnic minorities and women in randomized controlled trials across a range of dermatologic conditions.EVIDENCE REVIEW All randomized clinical trials (RCTs) were identified between July 2010 and July 2015 within the PubMed database using the following keywords: "psoriasis," "atopic dermatitis," "acne," "vitiligo," "seborrheic dermatitis," "alopecia areata," and "lichen planus." Diverse study populations were defined as including a greater than 20% racial or ethnic minority participants based on US census data. The distributions of sex and race groups in studies were compared by journal type, disease type, and funding source.FINDINGS Of the 626 articles reporting RCTs included in this ...

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“…Previous studies examined European and American (Caucasian) subjects, while the subjects in the present study were Asian. Allergic diseases have different epidemiological 12,16,18,24 and clinical 3,15,16,20 manifestations, and may involve different genetic and epigenetic mechanisms 11,29,32 depending on ethnicity, which may in turn be associated with variable glioma risk Eosinophil counts were found to be higher in cases than controls, while the values were within normal ranges. Moreover, blood eosinophil counts and immunoglobulin E levels are dynamic.…”

Section: Discussionmentioning

confidence: 99%

“…35 Moreover, ethnic differences in the prevalence and manifestation of allergies and related diseases have been reported. 7,15,16 Earlier studies examining the association between allergies and gliomas mostly focused on respiratory and food allergies Increased rate of positive penicillin skin tests among patients with glioma: insights into the association between allergies and glioma risk in European and American Caucasian patients; as such, information on other types of allergies in other patient populations is needed. Unlike allergies such as asthma that can be provoked by a variety of factors, allergic reactions to drugs have a well-defined mechanism, which is useful for evaluating disease associations.…”

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confidence: 99%

Increased rate of positive penicillin skin tests among patients with glioma: insights into the association between allergies and glioma risk

Han

Huang²,

Wang³

et al. 2014

JNS

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Object. Allergy and immunoglobulin E levels are inversely associated with glioma risk. Previous studies have focused on respiratory and food allergies, and little information is available regarding drug allergies. This study evaluated the rate of positive penicillin skin tests (PenSTs) and blood eosinophil counts in a large population of patients with glioma compared with nontumor controls to provide evidence for the relationship between drug allergies and glioma risk.Methods. A retrospective case-control study was conducted in patients diagnosed with glioma (n = 913) between January 2004 and June 2013. The study patients were matched with nontumor controls (n = 1091) for age, sex, and date of admission to the hospital. Preoperative results of the PenST and eosinophil counts were obtained, and odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using conditional logistic regression models, while a Kaplan-Meier analysis was used to assess overall survival.Results. The percentage of positive PenSTs was higher among patients with glioma than in control subjects. The age-, sex-, and admission date-adjusted OR for positive versus negative PenSTs was 2.392 (95% CI 1.891-3.026). Eosinophil counts were also higher in glioma cases than in controls: the OR for eosinophil > 0.06 × 10 9 /L versus ≤ 0.06 × 10 9 /L was 1.923 (95% CI 1.608-2.301). There was no association between positive PenST/eosinophil counts and glioma grade or patient survival (n = 105).Conclusions. In contrast to previously reported relationships between allergy and glioma, in the present study a significantly higher rate of positive PenSTs and higher eosinophil counts were found in patients with glioma than in nontumor controls. These results suggest a complex relationship between allergies and glioma development. (http://thejns.org/doi/abs/10.3171/2014 KeY WorDS • glioma • penicillin • allergy • eosinophil • skin test • case control • oncologyAbbreviations used in this paper: AVM = arteriovenous malformation; CI = confidence interval; OR = odds ratio; PenST = penicillin skin test.

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Reporting, Representation, and Subgroup Analysis of Race and Ethnicity in Published Clinical Trials of Atopic Dermatitis in the United States Between 2000 and 2009

Cited by 49 publications

References 16 publications

The reliability and validity of outcome measures for atopic dermatitis in patients with pigmented skin: A grey area

The reliability and validity of outcome measures for atopic dermatitis in patients with pigmented skin: A grey area

Diversity in Dermatology Clinical Trials

Increased rate of positive penicillin skin tests among patients with glioma: insights into the association between allergies and glioma risk

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