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How inclusive were UK-based randomised controlled trials of COVID-19 vaccines? A systematic review investigating enrolment of Black adults and adult ethnic minorities
Trials ( IF 2.5 ) Pub Date : 2024-04-12 , DOI: 10.1186/s13063-024-08054-4
Hibba Herieka, Daphne Babalis, Evangelia Tzala, Shyam Budhathoki, Nicholas A. Johnson

To establish if Black adults and adult ethnic minorities, defined as any group except White British, were represented in UK-based COVID-19 vaccination randomised controlled trials (RCTs) when compared to corresponding UK population proportions, based on 2011 census data. Systematic review of COVID-19 Randomised Controlled Vaccine Trials United Kingdom Randomised Controlled Trials of COVID-19 vaccines conducted in the UK were systematically reviewed following PRISMA guidelines. MeSH terms included “Covid-19 vaccine”, “Ad26COVS1”, and “BNT162 Vaccine” with keywords such as [covishield OR coronavac OR Vaxzevria OR NVX-CoV2373] also used. Studies that provided (A) participant demographics and (B) full eligibility criteria were included. The following key data was extracted for analysis: number of participants analysed, number of Black adults and number of adult minority ethnicity participants. The primary outcome is the mean percentage of Black adults randomised to COVID-19 vaccine trials deemed eligible within this review. The secondary outcome is the mean percentage of adult ethnic minorities randomised. The final review included 7 papers and a total of 87 sets of data collated from trial sites across the UK. The standard mean percentage of Black adults included in the trials (0.59%, 95% CI: 0.13% - 1.05%) was significantly lower compared to the recorded Black adult population (2.67%) indicating that they were under-served in UK based COVID-19 vaccine RCTs (p < 0.001). Adult ethnic minority presence (8.94%, 95% CI: 2.07% - 15.80%) was also lower than census data (16.30%), indicating they were also under-served (p = 0.039). The findings show that COVID-19 vaccine trials failed to adequately randomise proportionate numbers of Black adults and adult minority ethnicities. More inclusive practices must be developed and implemented in the recruitment of underserved groups to understand the true impact of COVID-19.

中文翻译:

英国的 COVID-19 疫苗随机对照试验的包容性如何?调查黑人成年人和成年少数族裔入学情况的系统评价

根据 2011 年人口普查数据,确定黑人成年人和成年少数族裔(定义为除英国白人之外的任何群体)是否在英国的 COVID-19 疫苗接种随机对照试验 (RCT) 中与相应的英国人口比例进行比较。英国 COVID-19 随机对照疫苗试验的系统审查 根据 PRISMA 指南,对在英国进行的 COVID-19 疫苗随机对照试验进行了系统审查。 MeSH 术语包括“Covid-19 疫苗”、“Ad26COVS1”和“BNT162 疫苗”,还使用了 [covishield OR coronavac OR Vaxzevria OR NVX-CoV2373] 等关键词。包括提供 (A) 参与者人口统计数据和 (B) 完整资格标准的研究。提取以下关键数据进行分析:分析的参与者数量、黑人成年人数量和成年少数族裔参与者数量。主要结果是随机参加本次审查中被认为符合资格的 COVID-19 疫苗试验的黑人成年人的平均百分比。次要结果是随机分组的成年少数族裔的平均百分比。最终审查包括 7 篇论文和从英国各地试验站点整理的总共 87 组数据。试验中黑人成年人的标准平均百分比(0.59%,95% CI:0.13% - 1.05%)明显低于记录的黑人成年人口(2.67%),这表明他们在英国的新冠疫情中得不到充分的服务-19 项疫苗随机对照试验 (p < 0.001)。成年少数族裔的存在率(8.94%,95% CI:2.07% - 15.80%)也低于人口普查数据(16.30%),表明他们也得不到充分服务(p = 0.039)。研究结果表明,COVID-19 疫苗试验未能充分随机分配黑人成年人和成年少数族裔的比例。在招募服务不足的群体时必须制定和实施更具包容性的做法,以了解 COVID-19 的真正影响。
更新日期:2024-04-12
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