Adam Ofri BMed, MS, FRACS, MAdvSurg, Andrew J. Spillane BMBS, MD, FRACS
{"title":"在澳大利亚建立外科多中心登记处的复杂性:挑战和可能的解决方案。","authors":"Adam Ofri BMed, MS, FRACS, MAdvSurg, Andrew J. Spillane BMBS, MD, FRACS","doi":"10.1111/ans.19157","DOIUrl":null,"url":null,"abstract":"<p>Multi-institutional research gives a more representative appraisal of surgical practice and enables statistical power to answer relevant questions in randomized controlled trials and other research methodologies. In Australia, breast cancer is the most common non-skin malignancy and significant multi-institutional research is consistently being undertaken, predominantly under the auspices of the collaborative clinical trials group Breast Cancer Trials (BCT). A major project underwritten by the BCT Clinical Research Fellowship was to develop the Australian and New Zealand (ANZ) Targeted Axillary Dissection (TAD) Registry. TAD is the localisation and removal of previously metastatic axillary lymph nodes usually marked at diagnosis with a radiologically visible marker clip, as well as the removal of identified sentinel nodes, after neoadjuvant systemic therapy. The aim of the TAD Registry was to create a de-identified record of all TAD procedures across ANZ, to facilitate an understanding of how as a relatively new and nuanced technique, TAD is being implemented and interpreted. This was conceptualized with the BreastSurgANZ leadership team as a priority area for research and BreastSurgANZ has been strongly supportive in its development and implementation.</p><p>However, what the investigators considered to be a low-risk, easy to facilitate short-term registry, has taken over 12 months of significant effort, and have still fallen short at this current time. The registry was planned to be running across multiple BreastSurgANZ-affiliated ANZ institutions from the fifth of February 2024. Unfortunately at this date, half of the individual site approvals were still progressing. Plans to roll the 12 month pilot registry into an ongoing audit seem extremely improbable because of the challenges.</p><p>This article aims to draw attention to the difficulties in establishing a simple multi-centre de-identified finite duration registry. By flagging a few key issues, the hope is that this could prompt discussions that leads to significant improvement and efficiencies in the way we share de-identified data between institutions and states. By achieving that, we could easily improve Australia's international research representation and improve patient care.</p><p>When applying for Australian ethical approval in multi-centre research, an excellent development is the National Mutual Acceptance (NMA) scheme.<span><sup>1</sup></span> This scheme, for multi-centre ethical and scientific research, enables a single ethics application that once approved, is applicable for other Australian state and territory-certified public health organizations. After Ethical approval, for investigators to open their study at their institution, they require local research governance, administered by the process of site specific assessment (SSA) which signs off local willingness, resources and capabilities to participate.<span><sup>2</sup></span></p><p>Most patients want to be treated by the current best-practice; practices that have been developed based on evidence from clinical trials. We have a wealth of information potentially available, so why is Australia so far behind in establishing data registries, compared to other developed areas in the world? The American National Cancer Database (NCDB) and Surveillance, Epidemiology, and End-Results (SEER) databases produce volumes of research and publications, consistently improving the international management of breast cancer. The ability for non-affiliated international institutional users to apply for access to the SEER data, has resulted in even greater data utilization.</p><p>Why do we need to have different SSA models per state, and in some cases, per institution, especially for low-risk studies? Why do we not have a centralized platform that enables progression of studies such as low-risk, low-cost registries that investigators at academic hospitals can apply to be involved in? National privacy, data protection and ethical principles could be monitored in giving that central approval. These issues when associated with Clinical Quality Registries (CQR) in Australia have been previously identified.<span><sup>3</sup></span> Thankfully, the Australian Commission on Safety and Quality in Health Care are focused on improving them. The recently developed Framework for Australian CQR Second Edition is working towards national arrangements (with guidance on governance).<span><sup>4</sup></span> The National CQR and Virtual Strategy (a 10-year plan from 2020 to 2030) has a number of actions aimed to address CQR shortcomings. Finally, the National One Stop Shop, is a proposed central platform to ‘integrate key approval processes and existing national systems for trials and research to reduce administration and navigation burden for investigators, sponsors, sites and administrators’. This would streamline and improve application and approval processes, as well as management, monitoring, and reporting across the full project life cycle. However consultations to develop the One Stop Shop closed in 2022, with no current trajectory of if, or when, it will become available.</p><p>Multi-centre research projects hold great promise for advancing scientific understanding and addressing complex research questions. However, the path to success is often riddled with obstacles that can significantly deflate the most enthusiastic researcher. By developing an Australian centralized ethics and governance committee for low-risk registries, we could significantly enhance our available research output. This would result in greater powered studies, increase Australian-researcher engagement and output, and thus improve patient outcomes not only in Breast Cancer, but in all surgical streams.</p><p><b>Adam Ofri:</b> Conceptualization; data curation; formal analysis; funding acquisition; investigation; methodology; project administration; resources; software; supervision; validation; visualization; writing – original draft; writing – review and editing. <b>Andrew J. Spillane:</b> Conceptualization; data curation; formal analysis; funding acquisition; investigation; methodology; project administration; resources; software; supervision; validation; visualization; writing – original draft; writing – review and editing.</p>","PeriodicalId":8158,"journal":{"name":"ANZ Journal of Surgery","volume":null,"pages":null},"PeriodicalIF":1.5000,"publicationDate":"2024-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/ans.19157","citationCount":"0","resultStr":"{\"title\":\"The complexities of establishing a surgical multi-centre registry in Australia: challenges, and possible solution\",\"authors\":\"Adam Ofri BMed, MS, FRACS, MAdvSurg, Andrew J. Spillane BMBS, MD, FRACS\",\"doi\":\"10.1111/ans.19157\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p>Multi-institutional research gives a more representative appraisal of surgical practice and enables statistical power to answer relevant questions in randomized controlled trials and other research methodologies. In Australia, breast cancer is the most common non-skin malignancy and significant multi-institutional research is consistently being undertaken, predominantly under the auspices of the collaborative clinical trials group Breast Cancer Trials (BCT). A major project underwritten by the BCT Clinical Research Fellowship was to develop the Australian and New Zealand (ANZ) Targeted Axillary Dissection (TAD) Registry. TAD is the localisation and removal of previously metastatic axillary lymph nodes usually marked at diagnosis with a radiologically visible marker clip, as well as the removal of identified sentinel nodes, after neoadjuvant systemic therapy. The aim of the TAD Registry was to create a de-identified record of all TAD procedures across ANZ, to facilitate an understanding of how as a relatively new and nuanced technique, TAD is being implemented and interpreted. This was conceptualized with the BreastSurgANZ leadership team as a priority area for research and BreastSurgANZ has been strongly supportive in its development and implementation.</p><p>However, what the investigators considered to be a low-risk, easy to facilitate short-term registry, has taken over 12 months of significant effort, and have still fallen short at this current time. The registry was planned to be running across multiple BreastSurgANZ-affiliated ANZ institutions from the fifth of February 2024. Unfortunately at this date, half of the individual site approvals were still progressing. Plans to roll the 12 month pilot registry into an ongoing audit seem extremely improbable because of the challenges.</p><p>This article aims to draw attention to the difficulties in establishing a simple multi-centre de-identified finite duration registry. By flagging a few key issues, the hope is that this could prompt discussions that leads to significant improvement and efficiencies in the way we share de-identified data between institutions and states. By achieving that, we could easily improve Australia's international research representation and improve patient care.</p><p>When applying for Australian ethical approval in multi-centre research, an excellent development is the National Mutual Acceptance (NMA) scheme.<span><sup>1</sup></span> This scheme, for multi-centre ethical and scientific research, enables a single ethics application that once approved, is applicable for other Australian state and territory-certified public health organizations. After Ethical approval, for investigators to open their study at their institution, they require local research governance, administered by the process of site specific assessment (SSA) which signs off local willingness, resources and capabilities to participate.<span><sup>2</sup></span></p><p>Most patients want to be treated by the current best-practice; practices that have been developed based on evidence from clinical trials. We have a wealth of information potentially available, so why is Australia so far behind in establishing data registries, compared to other developed areas in the world? The American National Cancer Database (NCDB) and Surveillance, Epidemiology, and End-Results (SEER) databases produce volumes of research and publications, consistently improving the international management of breast cancer. The ability for non-affiliated international institutional users to apply for access to the SEER data, has resulted in even greater data utilization.</p><p>Why do we need to have different SSA models per state, and in some cases, per institution, especially for low-risk studies? Why do we not have a centralized platform that enables progression of studies such as low-risk, low-cost registries that investigators at academic hospitals can apply to be involved in? National privacy, data protection and ethical principles could be monitored in giving that central approval. These issues when associated with Clinical Quality Registries (CQR) in Australia have been previously identified.<span><sup>3</sup></span> Thankfully, the Australian Commission on Safety and Quality in Health Care are focused on improving them. The recently developed Framework for Australian CQR Second Edition is working towards national arrangements (with guidance on governance).<span><sup>4</sup></span> The National CQR and Virtual Strategy (a 10-year plan from 2020 to 2030) has a number of actions aimed to address CQR shortcomings. Finally, the National One Stop Shop, is a proposed central platform to ‘integrate key approval processes and existing national systems for trials and research to reduce administration and navigation burden for investigators, sponsors, sites and administrators’. This would streamline and improve application and approval processes, as well as management, monitoring, and reporting across the full project life cycle. However consultations to develop the One Stop Shop closed in 2022, with no current trajectory of if, or when, it will become available.</p><p>Multi-centre research projects hold great promise for advancing scientific understanding and addressing complex research questions. However, the path to success is often riddled with obstacles that can significantly deflate the most enthusiastic researcher. By developing an Australian centralized ethics and governance committee for low-risk registries, we could significantly enhance our available research output. This would result in greater powered studies, increase Australian-researcher engagement and output, and thus improve patient outcomes not only in Breast Cancer, but in all surgical streams.</p><p><b>Adam Ofri:</b> Conceptualization; data curation; formal analysis; funding acquisition; investigation; methodology; project administration; resources; software; supervision; validation; visualization; writing – original draft; writing – review and editing. <b>Andrew J. 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The complexities of establishing a surgical multi-centre registry in Australia: challenges, and possible solution
Multi-institutional research gives a more representative appraisal of surgical practice and enables statistical power to answer relevant questions in randomized controlled trials and other research methodologies. In Australia, breast cancer is the most common non-skin malignancy and significant multi-institutional research is consistently being undertaken, predominantly under the auspices of the collaborative clinical trials group Breast Cancer Trials (BCT). A major project underwritten by the BCT Clinical Research Fellowship was to develop the Australian and New Zealand (ANZ) Targeted Axillary Dissection (TAD) Registry. TAD is the localisation and removal of previously metastatic axillary lymph nodes usually marked at diagnosis with a radiologically visible marker clip, as well as the removal of identified sentinel nodes, after neoadjuvant systemic therapy. The aim of the TAD Registry was to create a de-identified record of all TAD procedures across ANZ, to facilitate an understanding of how as a relatively new and nuanced technique, TAD is being implemented and interpreted. This was conceptualized with the BreastSurgANZ leadership team as a priority area for research and BreastSurgANZ has been strongly supportive in its development and implementation.
However, what the investigators considered to be a low-risk, easy to facilitate short-term registry, has taken over 12 months of significant effort, and have still fallen short at this current time. The registry was planned to be running across multiple BreastSurgANZ-affiliated ANZ institutions from the fifth of February 2024. Unfortunately at this date, half of the individual site approvals were still progressing. Plans to roll the 12 month pilot registry into an ongoing audit seem extremely improbable because of the challenges.
This article aims to draw attention to the difficulties in establishing a simple multi-centre de-identified finite duration registry. By flagging a few key issues, the hope is that this could prompt discussions that leads to significant improvement and efficiencies in the way we share de-identified data between institutions and states. By achieving that, we could easily improve Australia's international research representation and improve patient care.
When applying for Australian ethical approval in multi-centre research, an excellent development is the National Mutual Acceptance (NMA) scheme.1 This scheme, for multi-centre ethical and scientific research, enables a single ethics application that once approved, is applicable for other Australian state and territory-certified public health organizations. After Ethical approval, for investigators to open their study at their institution, they require local research governance, administered by the process of site specific assessment (SSA) which signs off local willingness, resources and capabilities to participate.2
Most patients want to be treated by the current best-practice; practices that have been developed based on evidence from clinical trials. We have a wealth of information potentially available, so why is Australia so far behind in establishing data registries, compared to other developed areas in the world? The American National Cancer Database (NCDB) and Surveillance, Epidemiology, and End-Results (SEER) databases produce volumes of research and publications, consistently improving the international management of breast cancer. The ability for non-affiliated international institutional users to apply for access to the SEER data, has resulted in even greater data utilization.
Why do we need to have different SSA models per state, and in some cases, per institution, especially for low-risk studies? Why do we not have a centralized platform that enables progression of studies such as low-risk, low-cost registries that investigators at academic hospitals can apply to be involved in? National privacy, data protection and ethical principles could be monitored in giving that central approval. These issues when associated with Clinical Quality Registries (CQR) in Australia have been previously identified.3 Thankfully, the Australian Commission on Safety and Quality in Health Care are focused on improving them. The recently developed Framework for Australian CQR Second Edition is working towards national arrangements (with guidance on governance).4 The National CQR and Virtual Strategy (a 10-year plan from 2020 to 2030) has a number of actions aimed to address CQR shortcomings. Finally, the National One Stop Shop, is a proposed central platform to ‘integrate key approval processes and existing national systems for trials and research to reduce administration and navigation burden for investigators, sponsors, sites and administrators’. This would streamline and improve application and approval processes, as well as management, monitoring, and reporting across the full project life cycle. However consultations to develop the One Stop Shop closed in 2022, with no current trajectory of if, or when, it will become available.
Multi-centre research projects hold great promise for advancing scientific understanding and addressing complex research questions. However, the path to success is often riddled with obstacles that can significantly deflate the most enthusiastic researcher. By developing an Australian centralized ethics and governance committee for low-risk registries, we could significantly enhance our available research output. This would result in greater powered studies, increase Australian-researcher engagement and output, and thus improve patient outcomes not only in Breast Cancer, but in all surgical streams.
Adam Ofri: Conceptualization; data curation; formal analysis; funding acquisition; investigation; methodology; project administration; resources; software; supervision; validation; visualization; writing – original draft; writing – review and editing. Andrew J. Spillane: Conceptualization; data curation; formal analysis; funding acquisition; investigation; methodology; project administration; resources; software; supervision; validation; visualization; writing – original draft; writing – review and editing.
期刊介绍:
ANZ Journal of Surgery is published by Wiley on behalf of the Royal Australasian College of Surgeons to provide a medium for the publication of peer-reviewed original contributions related to clinical practice and/or research in all fields of surgery and related disciplines. It also provides a programme of continuing education for surgeons. All articles are peer-reviewed by at least two researchers expert in the field of the submitted paper.