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

Penelope Abbott; Deborah Askew; Chelsea Watego; Wendy C.Y. Hu; Letitia Campbell; Claudette Tyson; Robyn Walsh; Sylvia Hussey; Kerrie Doyle; Hasantha Gunasekera; Amanda Jane Leach; Tim Usherwood; Jessica Armstrong-Kearns; Jennifer Reath

doi:10.1136/bmjopen-2021-050839

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

Penelope Abbott, Deborah Askew, Chelsea Watego, Wendy C.Y. Hu, Letitia Campbell, Claudette Tyson, Robyn Walsh, Sylvia Hussey, Kerrie Doyle, Hasantha Gunasekera, Amanda Jane Leach, Tim Usherwood, Jessica Armstrong-Kearns, Jennifer Reath

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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).

Original language	English
Article number	e21050839
Number of pages	9
Journal	BMJ Open
Volume	11
Issue number	12
DOIs	https://doi.org/10.1136/bmjopen-2021-050839
Publication status	Published - 24 Dec 2021

Bibliographical note

Funding Information:
Each AMS was funded to employ a research officer (RO) supported by university-based research staff. Choices related to RO recruitment were made by individual AMSs. Most AMSs employed ROs from their local community and 14 of 16 ROs were Aboriginal and Torres Strait Islander people. Multiple other AMS staff were involved in the RCTs, including an AMS-nominated Associate Investigator, and healthcare providers, primarily general practitioners, practice nurses and audiologists. Each AMS was offered funding for a community advisory group.

Publisher Copyright:
©

Copyright:
Copyright 2022 Elsevier B.V., All rights reserved.

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49649910-oaFinal published version, 335 KBLicence: CC BY-NC

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Abbott, P., Askew, D., Watego, C., Hu, W. C. Y., Campbell, L., Tyson, C., Walsh, R., Hussey, S., Doyle, K., Gunasekera, H., Leach, A. J., Usherwood, T., Armstrong-Kearns, J., & Reath, J. (2021). Randomised clinical trial research within Aboriginal and Torres Strait Islander primary health services: A qualitative study. BMJ Open, 11(12), Article e21050839. https://doi.org/10.1136/bmjopen-2021-050839

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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). ",

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author = "Penelope Abbott and Deborah Askew and Chelsea Watego and Hu, {Wendy C.Y.} and Letitia Campbell and Claudette Tyson and Robyn Walsh and Sylvia Hussey and Kerrie Doyle and Hasantha Gunasekera and Leach, {Amanda Jane} and Tim Usherwood and Jessica Armstrong-Kearns and Jennifer Reath",

note = "Funding Information: Each AMS was funded to employ a research officer (RO) supported by university-based research staff. Choices related to RO recruitment were made by individual AMSs. Most AMSs employed ROs from their local community and 14 of 16 ROs were Aboriginal and Torres Strait Islander people. Multiple other AMS staff were involved in the RCTs, including an AMS-nominated Associate Investigator, and healthcare providers, primarily general practitioners, practice nurses and audiologists. Each AMS was offered funding for a community advisory group. Publisher Copyright: {\textcopyright} Copyright: Copyright 2022 Elsevier B.V., All rights reserved.",

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doi = "10.1136/bmjopen-2021-050839",

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Abbott, P, Askew, D, Watego, C, Hu, WCY, Campbell, L, Tyson, C, Walsh, R, Hussey, S, Doyle, K, Gunasekera, H, Leach, AJ, Usherwood, T, Armstrong-Kearns, J & Reath, J 2021, 'Randomised clinical trial research within Aboriginal and Torres Strait Islander primary health services: A qualitative study', BMJ Open, vol. 11, no. 12, e21050839. https://doi.org/10.1136/bmjopen-2021-050839

TY - JOUR

T1 - Randomised clinical trial research within Aboriginal and Torres Strait Islander primary health services

T2 - A qualitative study

AU - Abbott, Penelope

AU - Askew, Deborah

AU - Watego, Chelsea

AU - Hu, Wendy C.Y.

AU - Campbell, Letitia

AU - Tyson, Claudette

AU - Walsh, Robyn

AU - Hussey, Sylvia

AU - Doyle, Kerrie

AU - Gunasekera, Hasantha

AU - Leach, Amanda Jane

AU - Usherwood, Tim

AU - Armstrong-Kearns, Jessica

AU - Reath, Jennifer

N1 - Funding Information: Each AMS was funded to employ a research officer (RO) supported by university-based research staff. Choices related to RO recruitment were made by individual AMSs. Most AMSs employed ROs from their local community and 14 of 16 ROs were Aboriginal and Torres Strait Islander people. Multiple other AMS staff were involved in the RCTs, including an AMS-nominated Associate Investigator, and healthcare providers, primarily general practitioners, practice nurses and audiologists. Each AMS was offered funding for a community advisory group. Publisher Copyright: © Copyright: Copyright 2022 Elsevier B.V., All rights reserved.

PY - 2021/12/24

Y1 - 2021/12/24

N2 - 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).

AB - 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).

KW - primary care

KW - qualitative research

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

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