At the cultural interface: A systematic review of study characteristics and cultural integrity from twenty years of randomised controlled trials with Indigenous participants.

Purpose And Aim: To identify and describe characteristics of Randomised Control Trial (RCT) design, implementation, and interpretation with a view tostrengtheningen the cultural integrity and scientific quality of this genre of research when used with, for and by Indigenous peoples.

Issue: RCTs are widely regarded as the 'gold standard' method for evaluating the efficacy of an intervention. However, issues of cultural acceptability and higher attrition rates among RCT participants from diverse populations, including Indigenous participants, have been reported. A better understanding of cultural acceptability and attrition rates of RCTs has the potential to impact the translation of findings into effective policies, programs and practice.

Method: A search of four electronic databases identified papers describing RCTs enrolling exclusively Australian Indigenous peoples over a 20-year period. The RCTs were assessed using: The Effective Public Health Practice Project's Quality Assessment Tool (EPHPP) and the Aboriginal & Torres Strait Islander Quality Appraisal Tool (QAT). The scores for each paper and the average scores of all papers were visualised using a Microsoft Excel™ Filled Radar Plot.

Results: Seventeen trials met the inclusion criteria. There was wide variation in the quality of the included trials as assessed by the EPHPP and almost universally poor results when assessed for cultural appropriateness and integrity by the QAT.

Conclusion: The value of the RCT research method, when applied to ultimately improve Australian Indigenous peoples' health, is diminished if issues of cultural integrity are not intrinsic to study design and execution. Our review found that it is feasible to have an RCT with both strong cultural integrity and high scientific quality. Attention to cultural integrity and community engagement, along with methodological rigour, may strengthen community ownership and contribute to more successful study adherence and potentially more effective translation of study findings into policy and practice.