# Inclusivity of the target population in orthopaedic surgical randomised trials: a review of high impact journals

## TL;DR

This study reviews orthopaedic surgical trials to see if they include diverse and under-served populations, finding limited inclusivity and reporting.

## Contribution

The study provides insights into the inclusivity of orthopaedic surgical trials and identifies areas for improvement in recruitment and reporting practices.

## Key findings

- Only two of 26 trials reported the age and gender of all screened patients.
- Reporting on ethnicity and under-served populations was limited in most trials.
- Variation in exclusion rates and insufficient inclusivity mechanisms were identified.

## Abstract

This review examines whether randomised controlled trials (RCTs) of surgery in orthopaedics are inclusive of their target populations, including under-served populations.

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.

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.

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.

Orthopaedic surgical trials often aim to evaluate surgery in real-world settings, including a wide range of participants to reflect the target population. This approach helps ensure the research is relevant to clinical practice and that the findings can be widely applied. The National Institute for Health and Care Research (NIHR) in the United Kingdom is focusing on improving the inclusion of under-represented groups in healthcare research, such as those of different ages, educational backgrounds, and language abilities. Including diverse participants in trials is crucial to avoid missing important findings and to prevent discrimination. This review looked at whether orthopaedic surgical trials are inclusive of their target populations, including under-served groups. It included 26 trials from various countries and hospital settings. The review found that there is variation in how patients are excluded, limited reporting of key patient characteristics, and insufficient attention to under-served populations in the design and conduct of these trials. Training and education on inclusivity is required along with practical guidance about how to implement this. To make trials more inclusive and representative, there should be a focus on the following (i) the criteria for screening and eligibility, (ii) collecting and reporting information to ensure no eligible group is left out, and (iii) create ways for all eligible patients to participate.