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化脓性汗腺炎临床试验中的民族种族代表性。

Ethnoracial representation in hidradenitis suppurativa clinical trials.

机构信息

Department of Dermatology, University of California, San Francisco, 515 Spruce Street, San Francisco, CA, 94118, USA.

出版信息

Arch Dermatol Res. 2023 Aug;315(6):1793-1796. doi: 10.1007/s00403-022-02510-4. Epub 2022 Dec 12.

Abstract

BACKGROUND

Hidradenitis suppurativa (HS) is an inflammatory skin disorder characterized by recurring painful and suppurating lesions, with the disease disproportionately affecting black populations in the United States. Ethnoracial representation in clinical trials is vital to ensuring results are generalizable. The purpose of this study is to examine whether ethnic or racial disparities exist in HS clinical trials.

METHODS

The US National Library of Medicine clinical trials database (clinicaltrials.gov) was queried to identify HS clinical trials. Trials that did not present ethnic or racial data on either the website or publication were not considered.

RESULTS

A total of 57 HS trials were identified. Of these, 23 trials, containing 2530 patients, included racial or ethnic data (Table 1). White patients made up 76.1% (1435/1886) of the study population, followed by Blacks or African Americans (13.7% (238/1732)), Hispanics or Latinos (7.2% (20/279), Asians (2.6% (26/1016)), American Indians or Alaska Natives (1.3% (14/1051)), and Native Hawaiians or Other Pacific Islanders (0.4% (4/926)).

DISCUSSION

Our results establish a significant lack of minority ethnoracial representation in HS clinical trials. Since HS prevalence is highest among Blacks or African Americans, it is imperative that future clinical trials are conducted with a larger proportion of this population. Furthermore, clinical trials that did not report racial or ethnic information were conducted in countries with predominantly White populations, which likely skewed the results of this study and caused underreporting of these patients.

摘要

背景

化脓性汗腺炎(HS)是一种炎症性皮肤病,其特征是反复发作的疼痛和化脓性病变,该疾病在美国不成比例地影响着黑人群体。临床试验中的民族代表性对于确保结果具有普遍性至关重要。本研究旨在检查 HS 临床试验中是否存在种族或民族差异。

方法

在美国国家医学图书馆临床试验数据库(clinicaltrials.gov)中查询 HS 临床试验。未在网站或出版物上提供种族或民族数据的试验不被视为研究对象。

结果

共确定了 57 项 HS 试验。其中,23 项试验(包含 2530 名患者)包含种族或民族数据(表 1)。研究人群中白人患者占 76.1%(1435/1886),其次是黑人或非裔美国人(13.7%(238/1732))、西班牙裔或拉丁裔(7.2%(20/279))、亚洲人(2.6%(26/1016))、美洲印第安人或阿拉斯加原住民(1.3%(14/1051))和夏威夷原住民或其他太平洋岛民(0.4%(4/926))。

讨论

我们的结果表明,HS 临床试验中少数民族的代表性严重不足。由于化脓性汗腺炎在黑人或非裔美国人中的患病率最高,因此未来的临床试验必须有更大比例的该人群参与。此外,没有报告种族或民族信息的临床试验是在主要为白人的国家进行的,这可能会导致本研究的结果存在偏差,并导致这些患者的报告不足。

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