REPORTING OF HEALTH EQUITY CONSIDERATIONS IN VACCINE TRIALS FOR COVID-19: A METHODOLOGICAL REVIEW

Abstract

BACKGROUND: During the COVID-19 pandemic, vaccines were developed in randomized controlled trials (RCTs). While RCT data informed decision-making, it may not apply to all populations. It is recommended that health equity stratifiers (HES) be used in RCT reporting, but their use in COVID-19 vaccine trials remains unclear.

OBJECTIVES: To review the importance of HES reporting in primary research, examine the use of HES in COVID-19 vaccine trials, and discuss areas for improvements of health equity reporting.

METHODS: This paper consists of three chapters. First, a literature review on social determinants of health, health equity during COVID-19, and research reporting practices was conducted. Second, COVID-19 vaccine trials consolidated in the COVID-NMA systematic review database from January 1, 2020, to February 8, 2023, were assessed for HES usage based on three criteria: 1) describing participants, 2) reporting equity-relevant results, and 3) discussing equity-relevant implications. Third, our findings are linked to literature on strategies to enhance health equity reporting.

Results: Chapter One highlighted how reported data influenced vaccine prioritization with subsequent effects on health inequities. In Chapter Two, 144 RCTs were reviewed, where age (100%), place of residence (100%), and gender/sex (99%) were the most used HES to describe participants. Age was most often used to disaggregate or adjust results (67%), followed by gender or sex (35%). Discussions of equity implications typically described generalizability concerning age (40% of studies). Nearly half (47%) considered at least one HES for all three criteria. No trials reported on religion, socioeconomic status, sexual orientation, or features of relationships. Chapter Three identified ways authors, journals, and other groups can improve reporting.

CONCLUSIONS: Effective reporting in primary research has an impact on health equity. Our review identified the state of health equity reporting in COVID-19 vaccine RCTs and proposed approaches to improve the reporting of HES.