Demographic Gaps and Requirements for Participation: A Systematic Review of Clinical Trial Designs in Hidradenitis Suppurativa.
Demographic Gaps and Requirements for Participation: A Systematic Review of Clinical Trial Designs in Hidradenitis Suppurativa.
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人口统计学差距和参与要求：化脓性汗腺炎临床试验设计的系统评价。
DOI：
10.1159/000526069
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发表时间：
2023
期刊：
影响因子：
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通讯作者：
Orenstein,LaurenAnneVigil
中科院分区：
文献类型：
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作者：
James,JaBreiaFanita;Madray,VictoriaM;Salame,Nicole;Hasan,SamarBabikir;White,MiaSohn;Barron,JasonRichard;Kirby,Joslyn;Ingram,JohnRobert;Orenstein,LaurenAnneVigil
背景：化脓性汗腺炎（HS）是一种慢性炎症性疾病，影响妇女，以及黑人和黑人个体。虽然阿达木单抗仍然是美国食品药品监督管理局批准的唯一一种治疗HS的药物，但许多新型和重新分配治疗的HS临床试验正在进行或即将进行。为了优化治疗公平性，反映患者人群，并促进试验参与，重要的是要阐明方面的临床试验协议，可能会系统地排除特定的患者群体或施加hardens.Objective：本研究旨在系统地审查纳入和排除标准，以及参与者的人口统计学在HS clinical trials.Methods：PubMed，Embase，科克伦中央，和Web的科学数据库进行了文献检索。随机对照试验的同行评议出版物，用英语撰写，并有至少10名参与者被纳入。标题和摘要筛选和数据提取完成了两个独立的审查员，解决了三分之一的分歧。结果：23项研究，共1,496名成年人参与者符合纳入标准。分别有473/1，496（31.6%）和1，420/1，496（94.9%）例试验受试者未报告人种和种族。试验参与者主要为白色（811/1，023，79.3%）和女性（1，057/1，457，72.5%）。每项研究的平均年龄中位数为35.7岁（IQR 33.5-38.0），17/23（73.9%）项试验排除了儿科患者。几乎所有参与者都患有Hurley II期（499/958，52.0%）或Hurley III期（385/958，40.2%）疾病。许多试验排除了妊娠（19/23，82.6%）和哺乳（13/23，56.5%）或HS“太严重”（8/23，34.8%）或“太轻微”（16/23，70.0%）的患者。经常，试验方案需要从HS疗法，相对较长的持续时间在研究的安慰剂手臂，并禁止并发镇痛剂use.Conclusions：这23 HS临床试验的系统性审查，共1,496名参与者确定了大量的困难施加的试验参与，缺失的种族和民族数据的高比率，和低代表性的关键患者群体，包括那些谁确定为黑色。未来的试验采用务实的研究设计、更广泛的纳入标准和不同社区的研究中心，可能会减轻参与试验的负担，并提高不同患者群体的入组率。
Background:Hidradenitis suppurativa (HS) is a chronic inflammatory disease that disproportionally affects women, as well as Black and biracial individuals. While adalimumab remains the only therapy approved by the Food and Drug Administration for HS, many HS clinical trials for novel and re-tasked therapies are ongoing or upcoming. To optimize treatment equity, reflect the patient population, and facilitate trial participation, it is important to elucidate aspects of clinical trial protocols that may systematically exclude specific patient groups or impose hardships.Objective:The study aimed to systematically review inclusion and exclusion criteria as well as participant demographics in HS clinical trials.Methods:A literature search of PubMed, Embase, Cochrane Central, and Web of Science databases was conducted. Peer-reviewed publications of randomized controlled trials that were written in English and had at least 10 participants were included. Title and abstract screening and data extraction were completed by two independent reviewers, with disagreements resolved by a third.Results:Twenty-three studies totaling 1,496 adult participants met the inclusion criteria. Race and ethnicity were not reported in 473/1,496 (31.6%) and 1,420/1,496 (94.9%) trial participants, respectively. Trial participants were predominantly white (811/1,023, 79.3%) and female (1,057/1,457, 72.5%). The median of each study’s average age was 35.7 years (IQR 33.5–38.0), and 17/23 (73.9%) trials excluded pediatric patients. Nearly all participants had Hurley Stage II (499/958, 52.0%) or Hurley Stage III (385/958, 40.2%) disease. Many trials excluded patients who were pregnant (19/23, 82.6%) and breastfeeding (13/23, 56.5%), or who had HS that was “too severe” (8/23, 34.8%) or “too mild” (16/23, 70.0%). Frequently, trial protocols required prolonged washout periods from HS therapies, relatively long duration in the study’s placebo arm, and prohibited concurrent analgesic use.Conclusions:This systematic review of 23 HS clinical trials totaling 1,496 participants identified substantial hardships imposed by trial participation, high rates of missing race and ethnicity data, and low representation of key patient groups, including those who identify as Black. Future trials with pragmatic study designs, broader inclusion criteria, and study sites in diverse communities may alleviate burdens of trial participation and improve enrollment of diverse patient groups.