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

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e050839
Author(s):  
Penelope Abbott ◽  
Deborah Askew ◽  
Chelsea Watego ◽  
Wendy CY Hu ◽  
Letitia Campbell ◽  
...  

ObjectiveTo better understand how to undertake valuable, ethical and sustainable randomised controlled clinical trial (RCT) research within Aboriginal and Torres Strait Islander primary health services.DesignIn 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.SettingThe 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.ResultsWe 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.ConclusionWe 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 numberACTRN12613001068752 (Pre-results); ACTRN12617001652369 (Pre-results).

2008 ◽  
Vol 44 (2) ◽  
pp. 195-204 ◽  
Author(s):  
Nada F. Khan ◽  
Alison Ward ◽  
Eila Watson ◽  
Joan Austoker ◽  
Peter W. Rose

2021 ◽  
Vol 6 (Suppl 5) ◽  
pp. e005242
Author(s):  
Sunita Nadhamuni ◽  
Oommen John ◽  
Mallari Kulkarni ◽  
Eshan Nanda ◽  
Sethuraman Venkatraman ◽  
...  

In its commitment towards Sustainable Development Goals, India envisages comprehensive primary health services as a key pillar in achieving universal health coverage. Embedded in siloed vertical programmes, their lack of interoperability and standardisation limits sustainability and hence their benefits have not been realised yet. We propose an enterprise architecture framework that overcomes these challenges and outline a robust futuristic digital health infrastructure for delivery of efficient and effective comprehensive primary healthcare. Core principles of an enterprise platform architecture covering four platform levers to facilitate seamless service delivery, monitor programmatic performance and facilitate research in the context of primary healthcare are listed. A federated architecture supports the custom needs of states and health programmes through standardisation and decentralisation techniques. Interoperability design principles enable integration between disparate information technology systems to ensure continuum of care across referral pathways. A responsive data architecture meets high volume and quality requirements of data accessibility in compliance with regulatory requirements. Security and privacy by design underscore the importance of building trust through role-based access, strong user authentication mechanisms, robust data management practices and consent. The proposed framework will empower programme managers with a ready reference toolkit for designing, implementing and evaluating primary care platforms for large-scale deployment. In the context of health and wellness centres, building a responsive, resilient and reliable enterprise architecture would be a fundamental path towards strengthening health systems leveraging digital health interventions. An enterprise architecture for primary care is the foundational building block for an efficient national digital health ecosystem. As citizens take ownership of their health, futuristic digital infrastructure at the primary care level will determine the health-seeking behaviour and utilisation trajectory of the nation.


2021 ◽  
Vol 27 (1) ◽  
pp. 57
Author(s):  
Ailsa Munns

Comprehensive primary health care is integral to meaningful client-centred care, with nurses and midwives central to partnership approaches with individuals, families and communities. A primary health model of antenatal care is needed for Aboriginal and Torres Strait Islander women in rural and remote areas, where complex social determinants of health impact on pregnancy outcomes, early years and lifelong health. Staff experiences from a community midwifery-led antenatal program in a remote Western Australian setting were explored, with the aim of investigating program impacts from health service providers’ perspectives. Interviews with 19 providers, including community midwives, child health nurses, program managers, a liaison officer, doctors and community agency staff, examined elements comprising a culturally safe community antenatal program for Aboriginal and Torres Strait Islander women, exploring program benefits and challenges. Thematic analysis derived five themes: Organisational and Accessibility Factors; Culturally Appropriate Support; Staff Availability and Competencies; Collaboration; and Sustainability. The ability of program staff to work in culturally safe partnerships with clients in collaboration with community agencies was essential to building meaningful and sustainable antenatal strategies. Midwifery primary health care competencies were viewed as a strong enabling factor, with potential to reduce health disparities in accordance with Australian Government and research recommendations.


2020 ◽  
Vol 98 (2) ◽  
pp. 20-24
Author(s):  
P. N. Novoselov ◽  
V. V. Tinkova ◽  
M. V. Lekhlyayder ◽  
I. A. Denisenko ◽  
T. P. Dudarova ◽  
...  

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Juan Jose Rodriguez Arias ◽  
Josep Gomez-Lara ◽  
Juan Caballero-Borrego ◽  
Luis Ortega-Paz ◽  
Luis Teruel ◽  
...  

Background: Coronary vascular function of a chronic coronary total occlusion (CTO) immediately after recanalization is known to be poor and to be partially improved by pre-treatment with loading dose of ticagrelor vs. clopidogrel. It is unknown if this vascular dysfunction is maintained at long-term follow-up and may be improved by 1-year dual antiplatelet therapy (DAPT) with ticagrelor vs. clopidogrel. Methods: The TIGER is a prospective, open-label, two parallel-group controlled clinical trial, which 1:1 randomized 50 CTO patients to pre-PCI loading dose and subsequent 1-year DAPT with ticagrelor vs. clopidogrel. Coronary blood flow (CBF) under stepwise adenosine infusion was assessed after drug loading dose and at follow-up and compared between the two drug groups, adjusting for time of follow-up. Results: Out of 50 patients with index CBF evaluation, 38 (76%) patients underwent angiographic follow-up (23 and 15 at 1 and 3-year, respectively). A higher CBF area under the curve (AUC), already observed after loading dose in ticagrelor vs. clopidogrel group (p=0.027), was maintained at follow-up (AUC 34815.22±24206.06 vs. AUC 22712.47±13768.95; p=0.071). Specifically, whereas high ticagrelor loading dose-related CBF was sustained at follow-up (p=0.933), clopidogrel loading dose-related CBF increased at follow-up (p=0.039). Conclusion: The TIGER trial showed that DAPT with ticagrelor may maintain a higher CBF in a recanalized CTO as compared to clopidogrel, whose treated patients exhibit a lower CBF immediately after PCI with slight increase at follow-up. The clinical value of such sustained higher coronary flow should be evaluated in a larger group of patients.


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