Social determinants of health in clinical trials examining long-term oral antibiotics in COPD: a systematic review.

Introduction: Social determinants of health (SDH) including age, sex, ethnicity, socioeconomic status, education, occupation and rural status impact the development and prognosis of COPD. Nevertheless, it is unclear whether SDH are reported or considered in clinical trials examining the efficacy of long-term oral antibiotics (LTOA) in people with COPD. Methods: A search of three clinical trial registries (clinicaltrials.gov, ANZCTR, ISRCTN) and Cochrane CENTRAL was conducted for trials involving LTOA prescribed to people with COPD registered between 1 January 2000 and 7 May 2023. Data were extracted regarding trial location, recruitment strategies and eligibility criteria. Where available, reporting of SDH data and relevant subgroup analyses were extracted. Results: From 781 trials identified, 17 trials were included in this review. Most (94.1%) were conducted in high-income countries alone. 94.1% of trials described age and gender, and 12.5% described ethnicity within recruitment strategies or eligibility criteria. No other SDH were reported in recruitment or eligibility criteria. Of seven completed trials with publicly available results (n=2888), all reported age and gender and 42.9% reported ethnicity; no other SDH were reported. Participants were predominantly male (66.3%) and white (72.6% to 99.0%). Conclusion: There was limited reporting of SDH in clinical trials investigating the efficacy of LTOA in people with COPD, and those that did report this information demonstrated limited participant diversity. Consequently, the safety and effectiveness of LTOA in under-represented patient populations remain unclear. Proactive recruitment of diverse populations and greater transparency in trials' reporting of participant demographics is needed.