背景:新兴的COVID-19疫苗随机对照试验(RCT)已成为公共卫生决策的证据基础。虽然建议RCT通过健康公平分层器报告结果,以减少医疗保健方面的偏见和研究差距,尚不清楚这是否在COVID-19疫苗试验中进行。
目的:严格审查健康公平性分层器在COVID-19疫苗试验中的使用。
方法:我们对COVID-NMA系统评价数据库中已发布的COVID-19疫苗试验进行了方法学评价,直至2023年2月8日。基于PROGRESS-Plus框架,我们检查了以下健康公平分层:居住地,种族/民族,职业,性别/性别,宗教,教育,社会经济地位,社会资本,年龄,残疾,关系的特征,临时情况。我们根据全面健康公平性报告的三个标准对每项研究进行了一式两份的评估:1)描述参与者,2)报告与股权相关的结果,3)讨论试验结果的公平相关含义。
结果:我们回顾了144份试验手稿。描述参与者最常用的PROGRESS-Plus分层器是年龄(100%),居住地(100%)性别/性别(99%),和种族/族裔(64%)。年龄最常用于分解或调整结果(67%),其次是性别(35%)。对公平相关含义的讨论通常表明有关年龄的结果的可概括性有限(40%的研究)。一半(47%)的研究认为所有三个标准至少有一个健康公平性分层。没有试验包括与宗教有关的分层,社会经济地位,性取向,或关系的特征。
结论:COVID-19疫苗试验提供了对PROGRESS-Plus定义的健康公平性分层器的有限描述,以及不经常分解的结果,或讨论了与健康公平性相关的研究含义。考虑到大流行期间加剧的健康差距,在RCT中增加对PROGRESS-Plus的使用将支持对健康差异的更细致入微的理解,并更好地为改善健康公平的行动提供信息。
OBJECTIVE: An emerging body of randomized controlled trials (RCTs) on COVID-19 vaccines has served as the evidence base for public health decision-making. While it is recommended that RCTs report results by health equity stratifiers to reduce bias in health care and gaps in research, it is unknown whether this was done in COVID-19 vaccine trials. To critically examine the use of health equity stratifiers in COVID-19 vaccine trials.
METHODS: We conducted a methodological review of published COVID-19 vaccine trials available in the COVID-19 living Network Meta-Analysis systematic review database through February 8, 2023. Based on the PROGRESS-Plus framework, we examined the following health equity stratifiers: place of residence, race/ethnicity, occupation, gender/sex, religion, education, socio-economic status, social capital, age, disability, features of relationships, and temporary situations. We assessed each study in duplicate according to three criteria for comprehensive health-equity reporting: 1) describing participants, 2) reporting equity-relevant results, and 3) discussing equity-relevant implications of trial findings.
RESULTS: We reviewed 144 trial manuscripts. The most frequently used PROGRESS-Plus stratifiers to describe participants were age (100%), place of residence (100%), gender/sex (99%), and race/ethnicity (64%). Age was most often used to disaggregate or adjust results (67%), followed by gender or sex (35%). Discussions of equity-relevant implications often indicated limited generalizability of results concerning age (40% of studies). Half (47%) of the studies considered at least one health equity stratifier for all three criteria. No trials included stratifiers related to religion, socioeconomic status, sexual orientation, or features of relationships.
CONCLUSIONS: COVID-19 vaccine trials provided a limited description of health equity stratifiers as defined by PROGRESS-Plus and infrequently disaggregated results or discussed the study implications as they related to health equity. Considering the health disparities exacerbated during the pandemic, increased uptake of PROGRESS-Plus in RCTs would support a more nuanced understanding of health disparities and better inform actions to improve health equity.