Inclusivity of the target population in orthopaedic surgical randomised trials: a review of high impact journals [version 3; peer review: 2 approved, 1 approved with reservations, 1 not approved]

Background This review examines whether randomised controlled trials (RCTs) of surgery in orthopaedics are inclusive of their target populations, including under-served populations. Methods The BMJ, Journal of the American Medical Association, The Lancet, and The New England Journal of Medicine were electronically searched in February 2022 for eligible RCTs published from 1 January 2014. Screening, key baseline patient characteristics, the inclusion of under-served groups and whether patient recruitment was pragmatic in design were key data extracted. The findings were tabulated and reported narratively. Results There were 26 RCTs included that were parallel in design and conducted across a range of countries in different hospital settings. Four RCTs did not report the complete CONSORT statement. There was variation in the percentage of the screened population who were randomised into the studies ranging from 5.8% to 74.7%. Most RCTs were pragmatic in design regarding patient selection but this did not necessarily translate to an inclusive trial population. Only two RCTs reported the age and gender of all screened patients. All 26 RCTs reported the age and gender of randomised patients but only four studies reported ethnicity. Reporting about the consideration and inclusion of under-served populations was limited. Conclusions There is variation in the exclusion of patients of the target population. Reporting of key patient characteristics during screening and attention given to under-served populations in the design, conduct and reporting of these trials is limited. Training and education on inclusivity is required along with practical guidance about how to implement this. To improve inclusivity in the screening and recruitment of patients there should be a focus on (i) screening and eligibility criteria, (ii) collection and reporting on attributes to ensure no section of the eligible population is inadvertently excluded, and (iii) embedding mechanisms to allow all eligible patients the opportunity to participate.