Towards equitable reporting of Indigenous status, ethnicity, language and country of birth in Australian paediatric clinical studies: A scoping review.

Aim: This scoping review aims to expansively review the reporting of Indigenous status, ethnicity, culture, language and country of birth in Australian paediatric clinical studies.

Methods: Scoping review of Australian clinical studies, including randomised controlled trials, non-randomised controlled trials, cluster randomised controlled trials and quasi-experimental studies, with paediatric participants (<18 years) or mixed adult and paediatric participants. PubMed, Cumulated Index to Nursing and Allied Health Literature and Embase databases were searched for clinical studies published 1 January 2018 to 28 November 2022.

Results: Of the 2717 studies identified in the search, 209 clinical studies were included. Overall, 131 (62.7%) clinical studies captured in this review did not report any of the variables of interest. When reported, terms used by study authors varied extensively and subsequently five study-defined categories emerged 'Indigenous status', 'race', 'race and ethnicity', 'ethnicity', or 'natural skin colour'. 'Indigenous status' was most reported (n = 37, 17.7%), followed by 'ethnicity and/or cultural background' (n = 15, 7.2%), 'race and ethnicity' (n = 4, 1.9%), race (n = 1, 0.5%) and 'natural skin colour' (n = 1, 0.5%). Furthermore, language used at home was reported in 27 studies (12.9%) and country of birth in 23 studies (11.0%).

Conclusions: This review demonstrated very low reporting of Indigenous status, ethnicity, culture, language and country of birth in Australian paediatric clinical studies. Poor reporting has raised concerns surrounding generalisability of findings from these trials in addition to equity. The recent international shift encompassing improved clinical trial reporting requirements, for ethnicity and race, require prompt establishment in the Australian clinical trial domain.