Esgin Tuguy, Macniven Rona, Crouch Alan, Martiniuk Alexandra
Discipline of Exercise and Sport Science, Faculty of Medicine and Health Sciences, Discipline of Strategy, Innovation and Entrepreneurship, Business School, The University of Sydney, Sydney, New South Wales 2006, Australia.
Exercise Medicine Research Institute, Edith Cowan University, 270 Joondalup Drive, Joondalup, Western Australia 6027, Australia.
Dialogues Health. 2023 Jan 10;2:100097. doi: 10.1016/j.dialog.2023.100097. eCollection 2023 Dec.
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.
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.
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.
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.
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.
识别并描述随机对照试验（RCT）的设计、实施及解读的特点，以期在为原住民开展、由原住民开展以及针对原住民开展此类研究时，增强其文化完整性和科学质量。
随机对照试验被广泛视为评估干预措施效果的“金标准”方法。然而，已有报告指出，包括原住民参与者在内的不同人群的随机对照试验参与者存在文化可接受性问题以及较高的失访率。更好地理解随机对照试验的文化可接受性和失访率，有可能影响研究结果转化为有效的政策、项目和实践。
通过检索四个电子数据库，找出了描述在20年期间专门纳入澳大利亚原住民的随机对照试验的论文。使用有效公共卫生实践项目质量评估工具（EPHPP）和原住民及托雷斯海峡岛民质量评估工具（QAT）对这些随机对照试验进行评估。使用Microsoft Excel™填充雷达图将每篇论文的得分以及所有论文的平均得分可视化。
17项试验符合纳入标准。根据EPHPP评估，纳入试验的质量差异很大，而根据QAT评估文化适宜性和完整性时，结果几乎普遍较差。
如果文化完整性问题在研究设计和实施中不是内在因素，那么随机对照试验研究方法在最终改善澳大利亚原住民健康方面的价值就会降低。我们的综述发现，开展一项兼具强大文化完整性和高科学质量的随机对照试验是可行的。关注文化完整性和社区参与，以及方法的严谨性，可能会增强社区的主人翁意识，并有助于更成功地坚持研究，以及可能更有效地将研究结果转化为政策和实践。
