Université de Sherbrooke, Sherbrooke, Quebec, Canada.
ISARIC, Pandemic Sciences Institute, University of Oxford, Oxford, United Kingdom.
JAMA Netw Open. 2023 Dec 1;6(12):e2346502. doi: 10.1001/jamanetworkopen.2023.46502.
Research diversity and representativeness are paramount in building trust, generating valid biomedical knowledge, and possibly in implementing clinical guidelines.
To compare variations over time and across World Health Organization (WHO) geographic regions of corticosteroid use for treatment of severe COVID-19; secondary objectives were to evaluate the association between the timing of publication of the RECOVERY (Randomised Evaluation of COVID-19 Therapy) trial (June 2020) and the WHO guidelines for corticosteroids (September 2020) and the temporal trends observed in corticosteroid use by region and to describe the geographic distribution of the recruitment in clinical trials that informed the WHO recommendation.
DESIGN, SETTING, AND PARTICIPANTS: This prospective cohort study of 434 851 patients was conducted between January 31, 2020, and September 2, 2022, in 63 countries worldwide. The data were collected under the auspices of the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC)-WHO Clinical Characterisation Protocol for Severe Emerging Infections. Analyses were restricted to patients hospitalized for severe COVID-19 (a subset of the ISARIC data set).
Corticosteroid use as reported to the ISARIC-WHO Clinical Characterisation Protocol for Severe Emerging Infections.
Number and percentage of patients hospitalized with severe COVID-19 who received corticosteroids by time period and by WHO geographic region.
Among 434 851 patients with confirmed severe or critical COVID-19 for whom receipt of corticosteroids could be ascertained (median [IQR] age, 61.0 [48.0-74.0] years; 53.0% male), 174 307 (40.1%) received corticosteroids during the study period. Of the participants in clinical trials that informed the guideline, 91.6% were recruited from the United Kingdom. In all regions, corticosteroid use for severe COVID-19 increased, but this increase corresponded to the timing of the RECOVERY trial (time-interruption coefficient 1.0 [95% CI, 0.9-1.2]) and WHO guideline (time-interruption coefficient 1.9 [95% CI, 1.7-2.0]) publications only in Europe. At the end of the study period, corticosteroid use for treatment of severe COVID-19 was highest in the Americas (5421 of 6095 [88.9%]; 95% CI, 87.7-90.2) and lowest in Africa (31 588 of 185 191 [17.1%]; 95% CI, 16.8-17.3).
The results of this cohort study showed that implementation of the guidelines for use of corticosteroids in the treatment of severe COVID-19 varied geographically. Uptake of corticosteroid treatment was lower in regions with limited clinical trial involvement. Improving research diversity and representativeness may facilitate timely knowledge uptake and guideline implementation.
研究的多样性和代表性对于建立信任、产生有效的生物医学知识以及可能实施临床指南至关重要。
比较在世界卫生组织（WHO）地理区域范围内，随时间推移治疗严重 COVID-19 时皮质类固醇使用的变化；次要目标是评估 RECOVERY（COVID-19 治疗的随机评估）试验的发布时间（2020 年 6 月）和 WHO 皮质类固醇指南（2020 年 9 月）与区域皮质类固醇使用的时间趋势之间的关系，并描述为 WHO 建议提供信息的临床试验中招募的地理分布。
设计、设置和参与者：这是一项在全球 63 个国家进行的前瞻性队列研究，共纳入了 434851 例患者，研究时间为 2020 年 1 月 31 日至 2022 年 9 月 2 日。该数据是在国际严重急性呼吸和新兴感染联盟（ISARIC）-WHO 严重新兴感染临床特征化方案的主持下收集的。分析仅限于因严重 COVID-19 住院的患者（ISARIC 数据集的一个子集）。
皮质类固醇的使用情况，如向 ISARIC-WHO 严重新兴感染临床特征化方案报告的那样。
按时间和 WHO 地理区域划分的严重 COVID-19 住院患者中接受皮质类固醇治疗的患者数量和百分比。
在 434851 例有确诊严重或危急 COVID-19 且皮质类固醇使用情况可确定的患者中（中位数[IQR]年龄，61.0[48.0-74.0]岁；53.0%为男性），174307 例（40.1%）在研究期间接受了皮质类固醇治疗。在为指南提供信息的临床试验参与者中，91.6%来自英国。在所有地区，皮质类固醇治疗严重 COVID-19 的使用率都有所增加，但这种增加与 RECOVERY 试验（时间中断系数 1.0[95%CI，0.9-1.2]）和 WHO 指南（时间中断系数 1.9[95%CI，1.7-2.0]）的发布时间相对应，仅在欧洲如此。在研究结束时，治疗严重 COVID-19 时皮质类固醇的使用率在美洲最高（6095 例中有 5421 例[88.9%]；95%CI，87.7-90.2），在非洲最低（185191 例中有 31588 例[17.1%]；95%CI，16.8-17.3）。
这项队列研究的结果表明，在治疗严重 COVID-19 时皮质类固醇使用指南的实施在地理上存在差异。在皮质类固醇治疗参与有限的地区，皮质类固醇治疗的采用率较低。提高研究的多样性和代表性可能有助于及时获取知识和实施指南。
