Patient diversity and author representation in clinical studies supporting the Surviving Sepsis Campaign guidelines for management of sepsis and septic shock 2021: a systematic review of citations.

BACKGROUND: The generalizability of the Surviving Sepsis Campaign (SSC) guidelines to various patient populations and hospital settings has been debated. A quantitative assessment of the diversity and representation in the clinical evidence supporting the guidelines would help evaluate the generalizability of the recommendations and identify strategic research goals and priorities. In this study, we evaluated the diversity of patients in the original studies, in terms of sex, race/ethnicity, and geographical location. We also assessed diversity in sex and geographical representation among study first and last authors. METHODS: All clinical studies cited in support of the 2021 SSC adult guideline recommendations were identified. Original clinical studies were included, while editorials, reviews, non-clinical studies, and meta-analyses were excluded. For eligible studies, we recorded the proportion of male patients, percentage of each represented racial/ethnic subgroup (when available), and countries in which they were conducted. We also recorded the sex and location of the first and last authors. The World Bank classification was used to categorize countries. RESULTS: The SSC guidelines included six sections, with 85 recommendations based on 351 clinical studies. The proportion of male patients ranged from 47 to 62%. Most studies did not report the racial/ ethnic distribution of the included patients; when they did so, most were White patients (68-77%). Most studies were conducted in high-income countries (77-99%), which included Europe/Central Asia (33-66%) and North America (36-55%). Moreover, most first/last authors were males (55-93%) and from high-income countries (77-99%). CONCLUSIONS: To enhance the generalizability of the SCC guidelines, stakeholders should define strategies to enhance the diversity and representation in clinical studies. Though there was reasonable representation in sex among patients included in clinical studies, the evidence did not reflect diversity in the race/ethnicity and geographical locations. There was also lack of diversity among the first and last authors contributing to the evidence.

Sociodemographic disparities in ophthalmological clinical trials.

INTRODUCTION: In ophthalmology, clinical trials (CTs) guide the treatment of diseases such as diabetic retinopathy, myopia, age-related macular degeneration, glaucoma and keratoconus with distinct presentations, pathological characteristics and responses to treatment in minority populations.Reporting gender and race and ethnicity in healthcare studies is currently recommended by National Institutes of Health (NIH) and Food and Drug Administration (FDA) guidelines to ensure representativeness and generalisability; however, CT results that include this information have been limited in the past 30 years.The objective of this review is to analyse the sociodemographic disparities in ophthalmological phases III and IV CT based on publicly available data. METHODS: This study included phases III and IV complete ophthalmological CT available from clinicaltrials.org, and describes the country distribution, race and ethnicity description and gender, and funding characteristics. RESULTS: After a screening process, we included 654 CTs, with findings that corroborate the previous CT reviews' findings that most ophthalmological participants are white and from high-income countries. A description of race and ethnicity is reported in 37.1% of studies but less frequently included within the most studied ophthalmological specialty area (cornea, retina, glaucoma and cataracts). The incidence of race and ethnicity reporting has improved during the past 7 years. DISCUSSION: Although NIH and FDA promote guidelines to improve generalisability in healthcare studies, the inclusion of race and ethnicity in publications and diverse participants in ophthalmological CT is still limited. Actions from the research community and related stakeholders are necessary to increase representativeness and guarantee generalisability in ophthalmological research results to optimise care and reduce related healthcare disparities.