背景:在整个研究过程中与消费者和社区的参与和伙伴关系产生了满足社区需求的高质量研究,并促进了研究转化为改进的政策和实践。伙伴关系对于涉及原住民和/或托雷斯海峡岛民(原住民)的研究至关重要,以确保文化安全。我们从设计中吸取教训,国家卫生和医学研究委员会资助的实施和进展为FERRitin水平较高的澳大利亚原住民患者进行血液透析(INFERR)临床试验。
方法:该试验旨在了解澳大利亚原住民在贫血和高铁蛋白血症的血液透析中使用铁疗法的益处和危害。与潜在参与者的患者讨论了缺乏治疗证据。确保INFERR试验安全进行的关键要素是建立土著参考小组(IRG),该小组由位于澳大利亚高端和澳大利亚中部的透析患者组成。根据原住民社区和研究人员/学者对该项目有关当地文化差异和试验方法的建议,需要两个IRG。IRGs通过为研究材料提供投入并将研究结果转化为原住民透析患者的有效信息和政策,从而为文化安全的试验行为提供支持。在整个审判过程中,IRGs的作用已经发展到为本研究和更广泛的研究行为提供建议和指导的关键机制。由试验第一民族研究官员和简化研究概念的独立第一民族研究人员/学者向IRG提供的支持至关重要。IRG已经为参与者制定了反馈文件和流程,利益相关者,和肾脏单位。他们保证将试验结果纳入临床实践指南的文化安全建议,以确保基于证据的方法来管理高铁蛋白血症的血液透析患者的贫血。
结论:积极的消费者和社区伙伴关系对于确保研究影响的研究行为至关重要。在INFERR临床试验中与消费者的牢固合作表明,原住民消费者将参与他们了解的研究,解决了他们的健康优先事项以及他们感到受到尊重的地方,听,并有权实现变革。
在本文中,我们强调让消费者积极参与规划的重要性,在患有肾脏疾病且目前正在接受血液透析的原住民和/或托雷斯海峡澳大利亚人(澳大利亚原住民)中进行临床试验的实施和进行研究。该研究评估了透析患者在贫血和高水平血液检测铁蛋白时,在透析期间通过静脉接受铁的安全性和有效性。常规用于测量铁水平的测试。两个第一民族患者透析的消费者参考组,一个位于澳大利亚的顶端,另一个位于澳大利亚中部,得到第一民族研究官员和研究学者的支持,以确保研究以涉及的方式进行,尊重和重视第一民族的参与,文化,和知识。在这项研究中,积极的消费者和社区合作伙伴关系支持了强大的研究治理流程,我们认为这些流程对于知识转化对患者产生积极影响至关重要。
BACKGROUND: Engagement and
partnership with consumers and communities throughout research processes produces high quality research meeting community needs and promoting translation of research into improved policy and practice.
Partnership is critical in research involving Aboriginal and/or Torres Strait Islander people (First Nations Peoples) to ensure cultural safety. We present lessons from the design, implementation and progress of the National Health and Medical Research Council funded INtravenous iron polymaltose for First Nations Australian patients with high FERRitin levels on hemodialysis (INFERR) clinical trial.
METHODS: The trial was designed to understand the benefits and harms of iron therapy in First Nations Australians on haemodialysis with anaemia and hyperferritinaemia. The lack of evidence for treatment was discussed with patients who were potential participants. A key element ensuring safe conduct of the INFERR trial was the establishment of the Indigenous Reference Groups (IRGs) comprising of dialysis patients based in the Top End of Australia and Central Australia. Two IRGs were needed based on advice from First Nations communities and researchers/academics on the project regarding local cultural differences and approaches to trial conduct. The IRGs underpin culturally safe trial conduct by providing input into study materials and translating study findings into effective messages and policies for First Nations dialysis patients. Throughout the trial conduct, the IRGs\' role has developed to provide key mechanisms for advice and guidance regarding research conduct both in this study and more broadly. Support provided to the IRGs by trial First Nations Research Officers and independent First Nations researchers/academics who simplify research concepts is critical. The IRGs have developed feedback documents and processes to participants, stakeholders, and the renal units. They guarantee culturally safe advice for embedding findings from the trial into clinical practice guidelines ensuring evidence-based approaches in managing anaemia in haemodialysis patients with hyperferritinaemia.
CONCLUSIONS: Active consumer and community
partnership is critical in research conduct to ensure research impact. Strong
partnership with consumers in the INFERR clinical trial has demonstrated that First Nations Consumers will engage in research they understand, that addresses health priorities for them and where they feel respected, listened to, and empowered to achieve change.
In this paper, we present the importance of actively involving consumers in the planning, implementation and conduct of research using the example of a clinical trial among Aboriginal and/or Torres Strait Australians (First Nations Australians) who have kidney disease and are currently receiving haemodialysis. The study assesses how safe and effective it is for people on dialysis to receive iron given through the vein during dialysis when they have anaemia and high levels of a blood test called ferritin, a test used routinely to measure iron levels. Two consumer reference groups of First Nations patients on dialysis, one based in the Top End of Australia and the other based in Central Australia, are supported by First Nations Research Officers and Research Academics to make sure that the research is performed in a way that involves, respects and values First Nations participation, culture, and knowledge. Active consumer and community
partnership in this study has supported robust research governance processes which we believe are crucial for knowledge translation to have a positive impact for patients.