Association between the Publication of the Initiating Dialysis Early and Late Trial and the Timing of Dialysis Initiation in Canada

Thomas W. Ferguson; Amit X. Garg; Manish M. Sood; Claudio Rigatto; Elaine Chau; Paul Komenda; David Naimark; Gihad E. Nesrallah; Steven D. Soroka; Monica Beaulieu; Ahsan Alam; S. Joseph Kim; Stephanie Dixon; Braden Manns; Navdeep Tangri

doi:10.1001/jamainternmed.2019.0489

Association between the Publication of the Initiating Dialysis Early and Late Trial and the Timing of Dialysis Initiation in Canada

Thomas W. Ferguson, Amit X. Garg, Manish M. Sood, Claudio Rigatto, Elaine Chau, Paul Komenda, David Naimark, Gihad E. Nesrallah, Steven D. Soroka, Monica Beaulieu, Ahsan Alam, S. Joseph Kim, Stephanie Dixon, Braden Manns, Navdeep Tangri

Medicine

Medicine

Résultat de recherche: Article › examen par les pairs

13 Citations (Scopus)

Résumé

Importance: Published in 2010, the Initiating Dialysis Early and Late (IDEAL) randomized clinical trial, which randomized patients with an estimated glomerular filtration rate (GFR) between 10 and 15 mL/min/1.73 m² to planned initiation of dialysis with an estimated GFR between 10 and 14 mL/min/1.73 m² (early start) or an estimated GFR between 5 and 7 mL/min/1.73 m² (late start), concluded that early initiation was not associated with improved survival or clinical outcomes. Objective: To assess the association between the IDEAL trial results and the proportion of early dialysis starts over time. Design, Setting, and Participants: This interrupted time series analysis used data from the Canadian Organ Replacement Register to study adult (≥18 years of age) patients with incident chronic dialysis between January 1, 2006, and December 31, 2015, in Canada, which has a universal health care system. Patients from the province of Quebec were excluded because its privacy laws preclude submission of deidentified data without first-person consent. The patients included in the study (n = 28468) had at least 90 days of nephrologist care before starting dialysis and a recorded estimated GFR at dialysis initiation. Data analyses were performed from November 2016 to January 2019. Main Outcomes and Measures: The primary outcome was the proportion of early dialysis starts (estimated GFR >10.5 mL/min/1.73 m²), and the secondary outcomes included the proportions of acute inpatient dialysis starts, patients who started dialysis using a home modality, and patients receiving hemodialysis who started with an arteriovenous access. Measures included the trend prior to the IDEAL trial publication, the change in this trend after publication, and the immediate consequence of publication. Results: The final cohort comprised 28468 patients, of whom 17 342 (60.9%) were male and the mean (SD) age was 64.8 (14.6) years. Before the IDEAL trial, a statistically significant increasing trend was observed in the monthly proportion of early dialysis starts (adjusted rate ratio, 1.002; 95% CI, 1.001-1.004; P =.004). After the IDEAL trial, an immediate decrease was observed in the proportion of early dialysis starts (rate ratio, 0.874; 95% CI, 0.818-0.933; P <.001), along with a statistically significant change in trend between the pretrial and posttrial periods (rate ratio, 0.994; 95% CI, 0.992-0.996; P <.001). No statistically significant differences were found in acute inpatient dialysis initiations, the proportion of patients receiving home dialysis as the initial modality, or the proportion of arteriovenous access creation at hemodialysis initiation after the IDEAL trial publication. Conclusions and Relevance: The publication of the IDEAL trial appeared to be associated with an immediate and meaningful change in the timing of dialysis initiation in Canada.

Langue d'origine	English
Pages (de-à)	934-941
Nombre de pages	8
Journal	JAMA Internal Medicine
Volume	179
Numéro de publication	7
DOI	https://doi.org/10.1001/jamainternmed.2019.0489
Statut de publication	Published - juill. 2019

Note bibliographique

Funding Information:
Author Contributions: Dr Tangri and Mr Ferguson had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: Ferguson, Sood, Komenda, Naimark, Nesrallah, Dixon, Manns, Tangri. Acquisition, analysis, or interpretation of data: Ferguson, Garg, Sood, Rigatto, Chau, Nesrallah, Soroka, Beaulieu, Alam, Kim, Dixon, Manns, Tangri. Drafting of the manuscript: Ferguson, Sood, Chau, Naimark, Manns, Tangri. Critical revision of the manuscript for important intellectual content: Ferguson, Garg, Sood, Rigatto, Komenda, Nesrallah, Soroka, Beaulieu, Alam, Kim, Dixon, Tangri. Statistical analysis: Ferguson, Dixon, Tangri. Obtained funding: Manns, Tangri. Administrative, technical, or material support: Sood, Chau, Komenda, Soroka, Beaulieu, Alam, Kim, Tangri. Supervision: Komenda, Manns, Tangri. Other - study intervention and practice guideline: Nesrallah. Conflict of Interest Disclosures: Dr Komenda reported honoraria from Boehringer Ingelheim Canada Ltd, Otsuka Pharmaceutical Inc, and AstraZeneca Inc as well as membership on the scientific advisory board for NxStage Medical Inc. Dr Alam reported honoraria from Otsuka Pharmaceutical Inc. Dr Kim reported support from Astellas Pharma Canada Inc. Dr Tangri reported grants from Research Manitoba and from Canadian Institute of Health Research (CIHR) during the conduct of the study, grants from Astra Zeneca Inc, personal fees from Otsuka Pharmaceutical Inc, and personal fees and other support from Tricida Inc outside of the submitted work. No other disclosures were reported.

Funding Information:
part by a grant from the Dr Adam Linton Chair in Kidney Health Analytics and a Clinician Investigator Award from the Canadian Institutes of Health Research (Dr Garg); funding from the Jindal Research Chair for the Prevention of Kidney Disease (Dr Sood); and funding from the CIHR New Investigator Award and a CIHR Foundation Award from the Canadian Institute of Health Research (Dr Tangri).

Publisher Copyright:
© 2019 American Medical Association. All rights reserved.

ASJC Scopus Subject Areas

Internal Medicine

Accès au document

10.1001/jamainternmed.2019.0489

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Citer

Ferguson, T. W., Garg, A. X., Sood, M. M., Rigatto, C., Chau, E., Komenda, P., Naimark, D., Nesrallah, G. E., Soroka, S. D., Beaulieu, M., Alam, A., Kim, S. J., Dixon, S., Manns, B., & Tangri, N. (2019). Association between the Publication of the Initiating Dialysis Early and Late Trial and the Timing of Dialysis Initiation in Canada. JAMA Internal Medicine, 179(7), 934-941. https://doi.org/10.1001/jamainternmed.2019.0489

Ferguson, TW, Garg, AX, Sood, MM, Rigatto, C, Chau, E, Komenda, P, Naimark, D, Nesrallah, GE, Soroka, SD, Beaulieu, M, Alam, A, Kim, SJ, Dixon, S, Manns, B & Tangri, N 2019, 'Association between the Publication of the Initiating Dialysis Early and Late Trial and the Timing of Dialysis Initiation in Canada', JAMA Internal Medicine, vol. 179, n° 7, pp. 934-941. https://doi.org/10.1001/jamainternmed.2019.0489

@article{ff3ccd30e1054006ba1be1ef311b2cab,

title = "Association between the Publication of the Initiating Dialysis Early and Late Trial and the Timing of Dialysis Initiation in Canada",

abstract = "Importance: Published in 2010, the Initiating Dialysis Early and Late (IDEAL) randomized clinical trial, which randomized patients with an estimated glomerular filtration rate (GFR) between 10 and 15 mL/min/1.73 m2 to planned initiation of dialysis with an estimated GFR between 10 and 14 mL/min/1.73 m2 (early start) or an estimated GFR between 5 and 7 mL/min/1.73 m2 (late start), concluded that early initiation was not associated with improved survival or clinical outcomes. Objective: To assess the association between the IDEAL trial results and the proportion of early dialysis starts over time. Design, Setting, and Participants: This interrupted time series analysis used data from the Canadian Organ Replacement Register to study adult (≥18 years of age) patients with incident chronic dialysis between January 1, 2006, and December 31, 2015, in Canada, which has a universal health care system. Patients from the province of Quebec were excluded because its privacy laws preclude submission of deidentified data without first-person consent. The patients included in the study (n = 28468) had at least 90 days of nephrologist care before starting dialysis and a recorded estimated GFR at dialysis initiation. Data analyses were performed from November 2016 to January 2019. Main Outcomes and Measures: The primary outcome was the proportion of early dialysis starts (estimated GFR >10.5 mL/min/1.73 m2), and the secondary outcomes included the proportions of acute inpatient dialysis starts, patients who started dialysis using a home modality, and patients receiving hemodialysis who started with an arteriovenous access. Measures included the trend prior to the IDEAL trial publication, the change in this trend after publication, and the immediate consequence of publication. Results: The final cohort comprised 28468 patients, of whom 17 342 (60.9%) were male and the mean (SD) age was 64.8 (14.6) years. Before the IDEAL trial, a statistically significant increasing trend was observed in the monthly proportion of early dialysis starts (adjusted rate ratio, 1.002; 95% CI, 1.001-1.004; P =.004). After the IDEAL trial, an immediate decrease was observed in the proportion of early dialysis starts (rate ratio, 0.874; 95% CI, 0.818-0.933; P <.001), along with a statistically significant change in trend between the pretrial and posttrial periods (rate ratio, 0.994; 95% CI, 0.992-0.996; P <.001). No statistically significant differences were found in acute inpatient dialysis initiations, the proportion of patients receiving home dialysis as the initial modality, or the proportion of arteriovenous access creation at hemodialysis initiation after the IDEAL trial publication. Conclusions and Relevance: The publication of the IDEAL trial appeared to be associated with an immediate and meaningful change in the timing of dialysis initiation in Canada.",

author = "Ferguson, {Thomas W.} and Garg, {Amit X.} and Sood, {Manish M.} and Claudio Rigatto and Elaine Chau and Paul Komenda and David Naimark and Nesrallah, {Gihad E.} and Soroka, {Steven D.} and Monica Beaulieu and Ahsan Alam and Kim, {S. Joseph} and Stephanie Dixon and Braden Manns and Navdeep Tangri",

note = "Funding Information: Author Contributions: Dr Tangri and Mr Ferguson had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: Ferguson, Sood, Komenda, Naimark, Nesrallah, Dixon, Manns, Tangri. Acquisition, analysis, or interpretation of data: Ferguson, Garg, Sood, Rigatto, Chau, Nesrallah, Soroka, Beaulieu, Alam, Kim, Dixon, Manns, Tangri. Drafting of the manuscript: Ferguson, Sood, Chau, Naimark, Manns, Tangri. Critical revision of the manuscript for important intellectual content: Ferguson, Garg, Sood, Rigatto, Komenda, Nesrallah, Soroka, Beaulieu, Alam, Kim, Dixon, Tangri. Statistical analysis: Ferguson, Dixon, Tangri. Obtained funding: Manns, Tangri. Administrative, technical, or material support: Sood, Chau, Komenda, Soroka, Beaulieu, Alam, Kim, Tangri. Supervision: Komenda, Manns, Tangri. Other - study intervention and practice guideline: Nesrallah. Conflict of Interest Disclosures: Dr Komenda reported honoraria from Boehringer Ingelheim Canada Ltd, Otsuka Pharmaceutical Inc, and AstraZeneca Inc as well as membership on the scientific advisory board for NxStage Medical Inc. Dr Alam reported honoraria from Otsuka Pharmaceutical Inc. Dr Kim reported support from Astellas Pharma Canada Inc. Dr Tangri reported grants from Research Manitoba and from Canadian Institute of Health Research (CIHR) during the conduct of the study, grants from Astra Zeneca Inc, personal fees from Otsuka Pharmaceutical Inc, and personal fees and other support from Tricida Inc outside of the submitted work. No other disclosures were reported. Funding Information: part by a grant from the Dr Adam Linton Chair in Kidney Health Analytics and a Clinician Investigator Award from the Canadian Institutes of Health Research (Dr Garg); funding from the Jindal Research Chair for the Prevention of Kidney Disease (Dr Sood); and funding from the CIHR New Investigator Award and a CIHR Foundation Award from the Canadian Institute of Health Research (Dr Tangri). Publisher Copyright: {\textcopyright} 2019 American Medical Association. All rights reserved.",

year = "2019",

month = jul,

doi = "10.1001/jamainternmed.2019.0489",

language = "English",

volume = "179",

pages = "934--941",

journal = "JAMA Internal Medicine",

issn = "2168-6106",

publisher = "American Medical Association",

number = "7",

}

TY - JOUR

T1 - Association between the Publication of the Initiating Dialysis Early and Late Trial and the Timing of Dialysis Initiation in Canada

AU - Ferguson, Thomas W.

AU - Garg, Amit X.

AU - Sood, Manish M.

AU - Rigatto, Claudio

AU - Chau, Elaine

AU - Komenda, Paul

AU - Naimark, David

AU - Nesrallah, Gihad E.

AU - Soroka, Steven D.

AU - Beaulieu, Monica

AU - Alam, Ahsan

AU - Kim, S. Joseph

AU - Dixon, Stephanie

AU - Manns, Braden

AU - Tangri, Navdeep

N1 - Funding Information: Author Contributions: Dr Tangri and Mr Ferguson had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: Ferguson, Sood, Komenda, Naimark, Nesrallah, Dixon, Manns, Tangri. Acquisition, analysis, or interpretation of data: Ferguson, Garg, Sood, Rigatto, Chau, Nesrallah, Soroka, Beaulieu, Alam, Kim, Dixon, Manns, Tangri. Drafting of the manuscript: Ferguson, Sood, Chau, Naimark, Manns, Tangri. Critical revision of the manuscript for important intellectual content: Ferguson, Garg, Sood, Rigatto, Komenda, Nesrallah, Soroka, Beaulieu, Alam, Kim, Dixon, Tangri. Statistical analysis: Ferguson, Dixon, Tangri. Obtained funding: Manns, Tangri. Administrative, technical, or material support: Sood, Chau, Komenda, Soroka, Beaulieu, Alam, Kim, Tangri. Supervision: Komenda, Manns, Tangri. Other - study intervention and practice guideline: Nesrallah. Conflict of Interest Disclosures: Dr Komenda reported honoraria from Boehringer Ingelheim Canada Ltd, Otsuka Pharmaceutical Inc, and AstraZeneca Inc as well as membership on the scientific advisory board for NxStage Medical Inc. Dr Alam reported honoraria from Otsuka Pharmaceutical Inc. Dr Kim reported support from Astellas Pharma Canada Inc. Dr Tangri reported grants from Research Manitoba and from Canadian Institute of Health Research (CIHR) during the conduct of the study, grants from Astra Zeneca Inc, personal fees from Otsuka Pharmaceutical Inc, and personal fees and other support from Tricida Inc outside of the submitted work. No other disclosures were reported. Funding Information: part by a grant from the Dr Adam Linton Chair in Kidney Health Analytics and a Clinician Investigator Award from the Canadian Institutes of Health Research (Dr Garg); funding from the Jindal Research Chair for the Prevention of Kidney Disease (Dr Sood); and funding from the CIHR New Investigator Award and a CIHR Foundation Award from the Canadian Institute of Health Research (Dr Tangri). Publisher Copyright: © 2019 American Medical Association. All rights reserved.

PY - 2019/7

Y1 - 2019/7

N2 - Importance: Published in 2010, the Initiating Dialysis Early and Late (IDEAL) randomized clinical trial, which randomized patients with an estimated glomerular filtration rate (GFR) between 10 and 15 mL/min/1.73 m2 to planned initiation of dialysis with an estimated GFR between 10 and 14 mL/min/1.73 m2 (early start) or an estimated GFR between 5 and 7 mL/min/1.73 m2 (late start), concluded that early initiation was not associated with improved survival or clinical outcomes. Objective: To assess the association between the IDEAL trial results and the proportion of early dialysis starts over time. Design, Setting, and Participants: This interrupted time series analysis used data from the Canadian Organ Replacement Register to study adult (≥18 years of age) patients with incident chronic dialysis between January 1, 2006, and December 31, 2015, in Canada, which has a universal health care system. Patients from the province of Quebec were excluded because its privacy laws preclude submission of deidentified data without first-person consent. The patients included in the study (n = 28468) had at least 90 days of nephrologist care before starting dialysis and a recorded estimated GFR at dialysis initiation. Data analyses were performed from November 2016 to January 2019. Main Outcomes and Measures: The primary outcome was the proportion of early dialysis starts (estimated GFR >10.5 mL/min/1.73 m2), and the secondary outcomes included the proportions of acute inpatient dialysis starts, patients who started dialysis using a home modality, and patients receiving hemodialysis who started with an arteriovenous access. Measures included the trend prior to the IDEAL trial publication, the change in this trend after publication, and the immediate consequence of publication. Results: The final cohort comprised 28468 patients, of whom 17 342 (60.9%) were male and the mean (SD) age was 64.8 (14.6) years. Before the IDEAL trial, a statistically significant increasing trend was observed in the monthly proportion of early dialysis starts (adjusted rate ratio, 1.002; 95% CI, 1.001-1.004; P =.004). After the IDEAL trial, an immediate decrease was observed in the proportion of early dialysis starts (rate ratio, 0.874; 95% CI, 0.818-0.933; P <.001), along with a statistically significant change in trend between the pretrial and posttrial periods (rate ratio, 0.994; 95% CI, 0.992-0.996; P <.001). No statistically significant differences were found in acute inpatient dialysis initiations, the proportion of patients receiving home dialysis as the initial modality, or the proportion of arteriovenous access creation at hemodialysis initiation after the IDEAL trial publication. Conclusions and Relevance: The publication of the IDEAL trial appeared to be associated with an immediate and meaningful change in the timing of dialysis initiation in Canada.

AB - Importance: Published in 2010, the Initiating Dialysis Early and Late (IDEAL) randomized clinical trial, which randomized patients with an estimated glomerular filtration rate (GFR) between 10 and 15 mL/min/1.73 m2 to planned initiation of dialysis with an estimated GFR between 10 and 14 mL/min/1.73 m2 (early start) or an estimated GFR between 5 and 7 mL/min/1.73 m2 (late start), concluded that early initiation was not associated with improved survival or clinical outcomes. Objective: To assess the association between the IDEAL trial results and the proportion of early dialysis starts over time. Design, Setting, and Participants: This interrupted time series analysis used data from the Canadian Organ Replacement Register to study adult (≥18 years of age) patients with incident chronic dialysis between January 1, 2006, and December 31, 2015, in Canada, which has a universal health care system. Patients from the province of Quebec were excluded because its privacy laws preclude submission of deidentified data without first-person consent. The patients included in the study (n = 28468) had at least 90 days of nephrologist care before starting dialysis and a recorded estimated GFR at dialysis initiation. Data analyses were performed from November 2016 to January 2019. Main Outcomes and Measures: The primary outcome was the proportion of early dialysis starts (estimated GFR >10.5 mL/min/1.73 m2), and the secondary outcomes included the proportions of acute inpatient dialysis starts, patients who started dialysis using a home modality, and patients receiving hemodialysis who started with an arteriovenous access. Measures included the trend prior to the IDEAL trial publication, the change in this trend after publication, and the immediate consequence of publication. Results: The final cohort comprised 28468 patients, of whom 17 342 (60.9%) were male and the mean (SD) age was 64.8 (14.6) years. Before the IDEAL trial, a statistically significant increasing trend was observed in the monthly proportion of early dialysis starts (adjusted rate ratio, 1.002; 95% CI, 1.001-1.004; P =.004). After the IDEAL trial, an immediate decrease was observed in the proportion of early dialysis starts (rate ratio, 0.874; 95% CI, 0.818-0.933; P <.001), along with a statistically significant change in trend between the pretrial and posttrial periods (rate ratio, 0.994; 95% CI, 0.992-0.996; P <.001). No statistically significant differences were found in acute inpatient dialysis initiations, the proportion of patients receiving home dialysis as the initial modality, or the proportion of arteriovenous access creation at hemodialysis initiation after the IDEAL trial publication. Conclusions and Relevance: The publication of the IDEAL trial appeared to be associated with an immediate and meaningful change in the timing of dialysis initiation in Canada.

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Association between the Publication of the Initiating Dialysis Early and Late Trial and the Timing of Dialysis Initiation in Canada

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