Topic: Retrospective or Prospective Cohort Study
Canada-DONATE: a National Program of Research in Deceased Organ Donation
D'Aragon, Frederick1; Dhanani, Sonny2; Arseneau, Erika3; Cook, Deborah3,4; Ribic, Christine4, Lamontagne, Francois5; Guyatt, Gordon3,4, Meade, Maureen3,4
1Department of Anaesthesia, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke QC Canada
2CHEO Research Institute, Children's Hospital of Eastern Ontario, Ottawa ON Canada
3Clinical Epidemiology & Biostatistics, McMaster University, Hamilton ON Canada
4Department of Medicine, McMaster University, Hamilton ON Canada
5Department of Medicine, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke QC Canada
Grant acknowledgements:
Canadian Blood ServicesRFA Program - Research Strategic Initiatives, Hamilton Health SciencesNIF Program - Hamilton Health SciencesAssociation Anesthesiologistes du Quebec Canadian Institutes for Health Research
Abstract:
Introduction/Background: Optimizing medical care of deceased donors can improve the number and success of organ transplants. However international organizations highlight the lack of research to support practice guidelines, citing various barriers to research in this field (1). We aim to overcome these barriers through development of a national research platform that will support clinical trials in deceased donation.
Objectives: Through the Canada-DONATE research program we aim to:
- Assess the feasibility of a multi-site prospective cohort study on organ donation,
- Provide a benchmark for clinical care management of organ donors,
- Evaluate the benefit of therapies thought to improve the rate of organ recovery and transplantation, and lastly
- Build sustainable research infrastructure for future clinical trials in organ donation.
Methods: In 2015 we launched the Canada-DONATE research program. Central to this program is a 12-month prospective observational cohort study of deceased donation practices at 20 high-volume centers across Canada. Nested within this program are:
- Projects to investigate and establish a framework for research consent in this field,
- An assessment of the suitability of current provincial data for research uses,
- Knowledge Translation initiatives to enhance clinical practices,
- Development and validation of a generic instrument to measure graft function across organ types,
- A mixed-methods study of clinical barriers to deceased donation in 1 centre with a high volume of organ donors.
Results: In 9 months we have registered 61 participants in our 4-site pilot study whilst collaborating with donation and transplant experts across Canada to advance the program. With legal and bioethics counsel we have overcome barriers, in some provinces, to a waiver of observational research consent and expect our experience will be relevant to other provinces and potentially other study designs. Working with organ procurement organizations (OPOs), we are automatically notified of all newly consented potential donors at participating ICUs; a process applicable elsewhere. As additional ICUs are recruited, we are developing research infrastructure across Canada to facilitate future clinical trials and have formulated a novel generic instrument for measurement of graft function to use in these trials.
Conclusion: Formation of this multidisciplinary deceased organ donation collaborative bodes well for the long term feasibility of multicenter clinical trials in Canada.
References:
References:
- Kotloff RM, Blosser S, Fulda GJ, et al.: Management of the Potential Organ Donor in the ICU. Critical Care Medicine 2015; 43(6): 1291-1325.
Topic: Retrospective or Prospective Cohort Study
Canada-DONATE: a National Program of Research in Deceased Organ Donation
D'Aragon, Frederick1; Dhanani, Sonny2; Arseneau, Erika3; Cook, Deborah3,4; Ribic, Christine4, Lamontagne, Francois5; Guyatt, Gordon3,4, Meade, Maureen3,4
1Department of Anaesthesia, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke QC Canada
2CHEO Research Institute, Children's Hospital of Eastern Ontario, Ottawa ON Canada
3Clinical Epidemiology & Biostatistics, McMaster University, Hamilton ON Canada
4Department of Medicine, McMaster University, Hamilton ON Canada
5Department of Medicine, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke QC Canada
Grant acknowledgements:
Canadian Blood ServicesRFA Program - Research Strategic Initiatives, Hamilton Health SciencesNIF Program - Hamilton Health SciencesAssociation Anesthesiologistes du Quebec Canadian Institutes for Health Research
Abstract:
Introduction/Background: Optimizing medical care of deceased donors can improve the number and success of organ transplants. However international organizations highlight the lack of research to support practice guidelines, citing various barriers to research in this field (1). We aim to overcome these barriers through development of a national research platform that will support clinical trials in deceased donation.
Objectives: Through the Canada-DONATE research program we aim to:
- Assess the feasibility of a multi-site prospective cohort study on organ donation,
- Provide a benchmark for clinical care management of organ donors,
- Evaluate the benefit of therapies thought to improve the rate of organ recovery and transplantation, and lastly
- Build sustainable research infrastructure for future clinical trials in organ donation.
Methods: In 2015 we launched the Canada-DONATE research program. Central to this program is a 12-month prospective observational cohort study of deceased donation practices at 20 high-volume centers across Canada. Nested within this program are:
- Projects to investigate and establish a framework for research consent in this field,
- An assessment of the suitability of current provincial data for research uses,
- Knowledge Translation initiatives to enhance clinical practices,
- Development and validation of a generic instrument to measure graft function across organ types,
- A mixed-methods study of clinical barriers to deceased donation in 1 centre with a high volume of organ donors.
Results: In 9 months we have registered 61 participants in our 4-site pilot study whilst collaborating with donation and transplant experts across Canada to advance the program. With legal and bioethics counsel we have overcome barriers, in some provinces, to a waiver of observational research consent and expect our experience will be relevant to other provinces and potentially other study designs. Working with organ procurement organizations (OPOs), we are automatically notified of all newly consented potential donors at participating ICUs; a process applicable elsewhere. As additional ICUs are recruited, we are developing research infrastructure across Canada to facilitate future clinical trials and have formulated a novel generic instrument for measurement of graft function to use in these trials.
Conclusion: Formation of this multidisciplinary deceased organ donation collaborative bodes well for the long term feasibility of multicenter clinical trials in Canada.
References:
References:
- Kotloff RM, Blosser S, Fulda GJ, et al.: Management of the Potential Organ Donor in the ICU. Critical Care Medicine 2015; 43(6): 1291-1325.
Topic: Retrospective or Prospective Cohort Study
Canada-DONATE: a National Program of Research in Deceased Organ Donation
D'Aragon, Frederick1; Dhanani, Sonny2; Arseneau, Erika3; Cook, Deborah3,4; Ribic, Christine4, Lamontagne, Francois5; Guyatt, Gordon3,4, Meade, Maureen3,4
1Department of Anaesthesia, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke QC Canada
2CHEO Research Institute, Children's Hospital of Eastern Ontario, Ottawa ON Canada
3Clinical Epidemiology & Biostatistics, McMaster University, Hamilton ON Canada
4Department of Medicine, McMaster University, Hamilton ON Canada
5Department of Medicine, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke QC Canada
Grant acknowledgements:
Canadian Blood ServicesRFA Program - Research Strategic Initiatives, Hamilton Health SciencesNIF Program - Hamilton Health SciencesAssociation Anesthesiologistes du Quebec Canadian Institutes for Health Research
Abstract:
Introduction/Background: Optimizing medical care of deceased donors can improve the number and success of organ transplants. However international organizations highlight the lack of research to support practice guidelines, citing various barriers to research in this field (1). We aim to overcome these barriers through development of a national research platform that will support clinical trials in deceased donation.
Objectives: Through the Canada-DONATE research program we aim to:
- Assess the feasibility of a multi-site prospective cohort study on organ donation,
- Provide a benchmark for clinical care management of organ donors,
- Evaluate the benefit of therapies thought to improve the rate of organ recovery and transplantation, and lastly
- Build sustainable research infrastructure for future clinical trials in organ donation.
Methods: In 2015 we launched the Canada-DONATE research program. Central to this program is a 12-month prospective observational cohort study of deceased donation practices at 20 high-volume centers across Canada. Nested within this program are:
- Projects to investigate and establish a framework for research consent in this field,
- An assessment of the suitability of current provincial data for research uses,
- Knowledge Translation initiatives to enhance clinical practices,
- Development and validation of a generic instrument to measure graft function across organ types,
- A mixed-methods study of clinical barriers to deceased donation in 1 centre with a high volume of organ donors.
Results: In 9 months we have registered 61 participants in our 4-site pilot study whilst collaborating with donation and transplant experts across Canada to advance the program. With legal and bioethics counsel we have overcome barriers, in some provinces, to a waiver of observational research consent and expect our experience will be relevant to other provinces and potentially other study designs. Working with organ procurement organizations (OPOs), we are automatically notified of all newly consented potential donors at participating ICUs; a process applicable elsewhere. As additional ICUs are recruited, we are developing research infrastructure across Canada to facilitate future clinical trials and have formulated a novel generic instrument for measurement of graft function to use in these trials.
Conclusion: Formation of this multidisciplinary deceased organ donation collaborative bodes well for the long term feasibility of multicenter clinical trials in Canada.
References:
References:
- Kotloff RM, Blosser S, Fulda GJ, et al.: Management of the Potential Organ Donor in the ICU. Critical Care Medicine 2015; 43(6): 1291-1325.
Topic: Retrospective or Prospective Cohort Study
Canada-DONATE: a National Program of Research in Deceased Organ Donation
D'Aragon, Frederick1; Dhanani, Sonny2; Arseneau, Erika3; Cook, Deborah3,4; Ribic, Christine4, Lamontagne, Francois5; Guyatt, Gordon3,4, Meade, Maureen3,4
1Department of Anaesthesia, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke QC Canada
2CHEO Research Institute, Children's Hospital of Eastern Ontario, Ottawa ON Canada
3Clinical Epidemiology & Biostatistics, McMaster University, Hamilton ON Canada
4Department of Medicine, McMaster University, Hamilton ON Canada
5Department of Medicine, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke QC Canada
Grant acknowledgements:
Canadian Blood ServicesRFA Program - Research Strategic Initiatives, Hamilton Health SciencesNIF Program - Hamilton Health SciencesAssociation Anesthesiologistes du Quebec Canadian Institutes for Health Research
Abstract:
Introduction/Background: Optimizing medical care of deceased donors can improve the number and success of organ transplants. However international organizations highlight the lack of research to support practice guidelines, citing various barriers to research in this field (1). We aim to overcome these barriers through development of a national research platform that will support clinical trials in deceased donation.
Objectives: Through the Canada-DONATE research program we aim to:
- Assess the feasibility of a multi-site prospective cohort study on organ donation,
- Provide a benchmark for clinical care management of organ donors,
- Evaluate the benefit of therapies thought to improve the rate of organ recovery and transplantation, and lastly
- Build sustainable research infrastructure for future clinical trials in organ donation.
Methods: In 2015 we launched the Canada-DONATE research program. Central to this program is a 12-month prospective observational cohort study of deceased donation practices at 20 high-volume centers across Canada. Nested within this program are:
- Projects to investigate and establish a framework for research consent in this field,
- An assessment of the suitability of current provincial data for research uses,
- Knowledge Translation initiatives to enhance clinical practices,
- Development and validation of a generic instrument to measure graft function across organ types,
- A mixed-methods study of clinical barriers to deceased donation in 1 centre with a high volume of organ donors.
Results: In 9 months we have registered 61 participants in our 4-site pilot study whilst collaborating with donation and transplant experts across Canada to advance the program. With legal and bioethics counsel we have overcome barriers, in some provinces, to a waiver of observational research consent and expect our experience will be relevant to other provinces and potentially other study designs. Working with organ procurement organizations (OPOs), we are automatically notified of all newly consented potential donors at participating ICUs; a process applicable elsewhere. As additional ICUs are recruited, we are developing research infrastructure across Canada to facilitate future clinical trials and have formulated a novel generic instrument for measurement of graft function to use in these trials.
Conclusion: Formation of this multidisciplinary deceased organ donation collaborative bodes well for the long term feasibility of multicenter clinical trials in Canada.
References:
References:
- Kotloff RM, Blosser S, Fulda GJ, et al.: Management of the Potential Organ Donor in the ICU. Critical Care Medicine 2015; 43(6): 1291-1325.
