Protocol and Statistical Analysis Plan for a Comparative Interrupted Time Series Evaluation of the Impact of Deemed Consent for Organ Donation Legislative Reform in Nova Scotia, Canada
The Canadian province of Nova Scotia recently became the first North American jurisdiction to implement deemed consent for deceased organ donation as part of a comprehensive legislative reform of their donation and transplantation system. This study will examine the performance metrics and effective...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer
2024-12-01
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| Series: | Transplantation Direct |
| Online Access: | http://journals.lww.com/transplantationdirect/fulltext/10.1097/TXD.0000000000001706 |
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| author | Matthew J. Weiss, MD Kristina Krmpotic, MD Stephen Beed, MD Sonny Dhanani, MD Jade Dirk, BSc David Hartell, MA Cynthia Isenor, RN, MScN Nick Lahaie Scott T. Leatherdale, PhD Kara Matheson, MSc Karthik Tennankore, MD, SM Gail Tomblin-Murphy, PhD, BN, MN Amanda Vinson, MD Hans Vorster, BASc Caroline King, PhD |
| author_facet | Matthew J. Weiss, MD Kristina Krmpotic, MD Stephen Beed, MD Sonny Dhanani, MD Jade Dirk, BSc David Hartell, MA Cynthia Isenor, RN, MScN Nick Lahaie Scott T. Leatherdale, PhD Kara Matheson, MSc Karthik Tennankore, MD, SM Gail Tomblin-Murphy, PhD, BN, MN Amanda Vinson, MD Hans Vorster, BASc Caroline King, PhD |
| author_sort | Matthew J. Weiss, MD |
| collection | DOAJ |
| description | The Canadian province of Nova Scotia recently became the first North American jurisdiction to implement deemed consent for deceased organ donation as part of a comprehensive legislative reform of their donation and transplantation system. This study will examine the performance metrics and effectiveness of this policy in comparison with other Canadian provinces via a natural experiment evaluation. We will use a cross-sectional controlled interrupted time series quasi-experimental design. Our primary outcome will be consent for deceased donation as confirmed at the time of eligibility (prior registered intent to donate will be noted but not be considered positive unless affirmed at the time of eligibility). Secondary outcomes will include identification and referral of patients who are potential donors, rates of family override of previously registered intent to donate, and donation and transplantation rates per million population. Data will be collected from potential donor audits in Nova Scotia and 3 control provinces (provinces in Canada without deemed consent policies). Study outcomes will be compared in Nova Scotia relative to control provinces in the 3 y before and 3 y after the implementation of legislative reform. These provinces were selected as having systems resembling those of Nova Scotia but without deemed consent.Using controlled interrupted time series methodology compared with other Canadian provinces with otherwise similar systems, we aim to isolate the impact of the deemed consent aspect of legislative reform in Nova Scotia using a robust natural experiment evaluation design as much as possible. Careful selection of outcome measures will allow donation and transplantation stakeholders to properly evaluate if similar reforms should be considered in their jurisdictions. |
| format | Article |
| id | doaj-art-e494daea428143a4a230934b62dbf801 |
| institution | OA Journals |
| issn | 2373-8731 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Wolters Kluwer |
| record_format | Article |
| series | Transplantation Direct |
| spelling | doaj-art-e494daea428143a4a230934b62dbf8012025-08-20T02:23:11ZengWolters KluwerTransplantation Direct2373-87312024-12-011012e170610.1097/TXD.0000000000001706202412000-00005Protocol and Statistical Analysis Plan for a Comparative Interrupted Time Series Evaluation of the Impact of Deemed Consent for Organ Donation Legislative Reform in Nova Scotia, CanadaMatthew J. Weiss, MD0Kristina Krmpotic, MD1Stephen Beed, MD2Sonny Dhanani, MD3Jade Dirk, BSc4David Hartell, MA5Cynthia Isenor, RN, MScN6Nick Lahaie7Scott T. Leatherdale, PhD8Kara Matheson, MSc9Karthik Tennankore, MD, SM10Gail Tomblin-Murphy, PhD, BN, MN11Amanda Vinson, MD12Hans Vorster, BASc13Caroline King, PhD141 Transplant Québec, Montréal, QC, Canada.4 Legacy of Life Provincial Organ Donation, Nova Scotia Health, Halifax, NS, Canada.4 Legacy of Life Provincial Organ Donation, Nova Scotia Health, Halifax, NS, Canada.3 Canadian Donation and Transplant Research Program, Edmonton, AB, Canada.8 Department of Research and Innovation, Nova Scotia Health, Halifax, NS, Canada.9 Hartell Consulting, Ottawa, ON, Canada.10 Nova Scotia Health, Critical Care, Provincial Organ Donation Program, Respiratory Therapy, Burns and Plastics, Central Zone, Halifax, NS, Canada.11 Deceased Donation, Canadian Blood Services, Ottawa, ON, Canada.12 School of Public Health Sciences, University of Waterloo, Waterloo, ON, Canada.13 Research Methods Unit, Research, Innovation and Discovery, Nova Scotia Health, Halifax, NS, Canada.14 Department of Medicine, Division of Nephrology, Nova Scotia Health, Halifax, NS, Canada.16 Nova Scotia Health, Research, Innovation and Discovery, Halifax, NS, Canada.14 Department of Medicine, Division of Nephrology, Nova Scotia Health, Halifax, NS, Canada.17 Patient Partner, Canadian Donation and Transplant Research Program, Edmonton, AB, Canada.8 Department of Research and Innovation, Nova Scotia Health, Halifax, NS, Canada.The Canadian province of Nova Scotia recently became the first North American jurisdiction to implement deemed consent for deceased organ donation as part of a comprehensive legislative reform of their donation and transplantation system. This study will examine the performance metrics and effectiveness of this policy in comparison with other Canadian provinces via a natural experiment evaluation. We will use a cross-sectional controlled interrupted time series quasi-experimental design. Our primary outcome will be consent for deceased donation as confirmed at the time of eligibility (prior registered intent to donate will be noted but not be considered positive unless affirmed at the time of eligibility). Secondary outcomes will include identification and referral of patients who are potential donors, rates of family override of previously registered intent to donate, and donation and transplantation rates per million population. Data will be collected from potential donor audits in Nova Scotia and 3 control provinces (provinces in Canada without deemed consent policies). Study outcomes will be compared in Nova Scotia relative to control provinces in the 3 y before and 3 y after the implementation of legislative reform. These provinces were selected as having systems resembling those of Nova Scotia but without deemed consent.Using controlled interrupted time series methodology compared with other Canadian provinces with otherwise similar systems, we aim to isolate the impact of the deemed consent aspect of legislative reform in Nova Scotia using a robust natural experiment evaluation design as much as possible. Careful selection of outcome measures will allow donation and transplantation stakeholders to properly evaluate if similar reforms should be considered in their jurisdictions.http://journals.lww.com/transplantationdirect/fulltext/10.1097/TXD.0000000000001706 |
| spellingShingle | Matthew J. Weiss, MD Kristina Krmpotic, MD Stephen Beed, MD Sonny Dhanani, MD Jade Dirk, BSc David Hartell, MA Cynthia Isenor, RN, MScN Nick Lahaie Scott T. Leatherdale, PhD Kara Matheson, MSc Karthik Tennankore, MD, SM Gail Tomblin-Murphy, PhD, BN, MN Amanda Vinson, MD Hans Vorster, BASc Caroline King, PhD Protocol and Statistical Analysis Plan for a Comparative Interrupted Time Series Evaluation of the Impact of Deemed Consent for Organ Donation Legislative Reform in Nova Scotia, Canada Transplantation Direct |
| title | Protocol and Statistical Analysis Plan for a Comparative Interrupted Time Series Evaluation of the Impact of Deemed Consent for Organ Donation Legislative Reform in Nova Scotia, Canada |
| title_full | Protocol and Statistical Analysis Plan for a Comparative Interrupted Time Series Evaluation of the Impact of Deemed Consent for Organ Donation Legislative Reform in Nova Scotia, Canada |
| title_fullStr | Protocol and Statistical Analysis Plan for a Comparative Interrupted Time Series Evaluation of the Impact of Deemed Consent for Organ Donation Legislative Reform in Nova Scotia, Canada |
| title_full_unstemmed | Protocol and Statistical Analysis Plan for a Comparative Interrupted Time Series Evaluation of the Impact of Deemed Consent for Organ Donation Legislative Reform in Nova Scotia, Canada |
| title_short | Protocol and Statistical Analysis Plan for a Comparative Interrupted Time Series Evaluation of the Impact of Deemed Consent for Organ Donation Legislative Reform in Nova Scotia, Canada |
| title_sort | protocol and statistical analysis plan for a comparative interrupted time series evaluation of the impact of deemed consent for organ donation legislative reform in nova scotia canada |
| url | http://journals.lww.com/transplantationdirect/fulltext/10.1097/TXD.0000000000001706 |
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