在原住民和托雷斯海峡岛民初级卫生服务中进行随机临床试验研究：一项定性研究。

Randomised clinical trial research within Aboriginal and Torres Strait Islander primary health services: a qualitative study.

机构信息

School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia

Primary Care Clinical Unit, University of Queensland, Brisbane, Queensland, Australia.

出版信息

BMJ Open. 2021 Dec 24;11(12):e050839. doi: 10.1136/bmjopen-2021-050839.

DOI:10.1136/bmjopen-2021-050839

PMID:34952874

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8710871/

Abstract

OBJECTIVE

To better understand how to undertake valuable, ethical and sustainable randomised controlled clinical trial (RCT) research within Aboriginal and Torres Strait Islander primary health services.

DESIGN

In a qualitative approach, we utilised data collected between 2013 and 2020 during the planning and implementation of two RCTs. The data comprised agreed records of research meetings, and semistructured interviews with clinical trial stakeholders. The stakeholders were parents/carers of child participants, and site-based research officers, healthcare providers and community advisory groups. Our thematic analysis was informed by constructivist grounded theory.

SETTING

The RCTs investigated the management of otitis media in Aboriginal and Torres Strait Islander children, with the first RCT commencing recruitment in 2014 and the second in 2017. They took place in Aboriginal Medical Services (AMSs), large primary health services for Aboriginal and Torres Strait Islander people, based in urban and regional communities across two Australian states and one territory.

RESULTS

We analysed data from 56 meetings and 67 interviews, generating themes on making research valuable and undertaking ethical and sustainable RCTs. Aboriginal and Torres Strait Islander leadership, and support of AMSs in their service delivery function were critical. The broad benefits of the trials were considered important to sustainability, including workforce development, enhanced ear healthcare and multidirectional research capacity building. Participants emphasised the long-term responsibility of research teams to deliver benefits to AMSs and communities regardless of RCT outcomes, and to focus on relationships, reciprocity and creating positive experiences of research.

CONCLUSION

We identify principles and strategies to assist in undertaking ethical and sustainable RCTs within Aboriginal and Torres Strait Islander primary health services. Maintaining relationships with AMSs and focusing on mutual workforce development and capacity building creates opportunities for long-term benefits so that health research and RCTs work for Aboriginal and Torres Strait Islander peoples, services, communities and researchers.

TRIAL REGISTRATION NUMBER

ACTRN12613001068752 (Pre-results); ACTRN12617001652369 (Pre-results).

摘要

目的

更好地了解如何在原住民和托雷斯海峡岛民初级保健服务中开展有价值、符合伦理和可持续的随机对照临床试验（RCT）研究。

设计

在定性方法中，我们利用了 2013 年至 2020 年期间在两项 RCT 规划和实施过程中收集的数据。这些数据包括研究会议的商定记录以及对临床试验利益相关者的半结构化访谈。利益相关者是儿童参与者的父母/照顾者，以及现场研究人员、医疗保健提供者和社区咨询小组。我们的主题分析受到建构主义扎根理论的启发。

地点

两项 RCT 研究了原住民和托雷斯海峡岛民儿童中耳炎的管理，第一项 RCT 于 2014 年开始招募参与者，第二项 RCT 于 2017 年开始招募参与者。这些 RCT 在澳大利亚两个州和一个地区的城市和地区社区的原住民医疗服务机构（AMS）中进行，这些机构是为原住民和托雷斯海峡岛民提供的大型初级保健服务。

结果

我们分析了 56 次会议和 67 次访谈的数据，得出了关于使研究有价值以及开展符合伦理和可持续的 RCT 的主题。原住民和托雷斯海峡岛民的领导力以及 AMS 对其服务提供功能的支持至关重要。试验的广泛利益被认为对可持续性很重要，包括劳动力发展、增强耳部保健和多方向的研究能力建设。参与者强调研究团队有长期责任，无论 RCT 结果如何，都要为 AMS 和社区提供利益，并注重关系、互惠和创造积极的研究体验。