Is all that glitters gold? Assessing the quality and ethics of ‘gold standard’ randomised controlled trials conducted in Aboriginal and Torres Strait Islander settings

Abstract

Purpose

Evidence-based practice methods assign randomised controlled trials (RCTs) as the ‘gold standard’ study design for interventional research. However, privileging RCTs on the criterion of study design without consideration of their broader methodology can be problematic, particularly in Aboriginal and Torres Strait Islander settings. This review assessed RCTs conducted in Aboriginal and Torres Strait Islander settings for ‘standard quality’ and ‘ethical quality’.

Methods

The RCTs were retrieved from PubMed, Scopus and the Australian New Zealand Clinical Trials Registry between January 2000 and July 2021. Standard quality was assessed using the revised Cochrane risk-of-bias tool for randomized trials (RoB 2.0). To assess ethical quality, this review assessed whether research incorporated ethical principles of: Aboriginal and/or Torres Strait Islander ethics committee endorsement, organisational endorsement, governance, partnership, data sovereignty, priority setting, worldview, authorship, and involvement in design, implementation and/or evaluation.

Main findings

Seventy-three published RCTs were retrieved. For quality, 85% of RCTs were assessed as having a ‘high’ risk of bias, largely owing to issues with deviations from the intervention, missing outcome data and measurement biases. The RCTs varied greatly in terms of ethical quality, with most attending poorly to ethical principles of priority setting (12%), involving stakeholders in evaluation of intervention (18%) and data sovereignty (7%). The RCTs conducted with Aboriginal and/or Torres Strait Islander co-authors were ranked as having greater ethical quality.

Principal conclusions

This review found notable concerns with the standard and ethical quality of RCTs conducted in these settings. To improve the ethical quality of research there must be a greater focus on control and participation by Aboriginal and Torres Strait stakeholders.