Predictors of oral anticoagulant-associated adverse events in seniors transitioning from hospital to home: a retrospective cohort study protocol

Introduction Oral anticoagulants (OACs) are widely prescribed in older adults. High OAC-related adverse event rates in the early period following hospital discharge argue for an analysis to identify predictors. Our objective is to identify and validate clinical and continuity of care variables among...

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Main Authors: Lehana Thabane, James Douketis, Anne Holbrook, Gary Foster, Harsukh Benipal, J. Michael Paterson
Format: Article
Language:English
Published: BMJ Publishing Group 2020-09-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/10/9/e036537.full
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author Lehana Thabane
James Douketis
Anne Holbrook
Gary Foster
Harsukh Benipal
J. Michael Paterson
author_facet Lehana Thabane
James Douketis
Anne Holbrook
Gary Foster
Harsukh Benipal
J. Michael Paterson
author_sort Lehana Thabane
collection DOAJ
description Introduction Oral anticoagulants (OACs) are widely prescribed in older adults. High OAC-related adverse event rates in the early period following hospital discharge argue for an analysis to identify predictors. Our objective is to identify and validate clinical and continuity of care variables among seniors discharged from hospital on an OAC, which are independently associated with OAC-related adverse events within 30 days.Methods and analysis We propose a population-based retrospective cohort study of all adults aged 66 years or older who were discharged from hospital on an OAC from September 2010 to March 2015 in Ontario, Canada. The primary outcome is a composite of the first hospitalisation or emergency department visit for a haemorrhage or thromboembolic event or mortality within 30 days of hospital discharge. A Cox proportional hazards model will be used to determine the association between the composite outcome and a set of prespecified covariates. A split sample method will be adopted to validate the variables associated with OAC-related adverse events.Ethics and dissemination The use of data in this project was authorised under section 45 of Ontario’s Personal Health Information Protection Act, which does not require review by a research ethics board. Results will be disseminated via peer-reviewed publications and presentations at conferences and will determine intervention targets to improve OAC management in upcoming randomised trials.Trial registration number ClinicalTrials.gov Identifier: NCT02777047; Pre-results.
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spelling doaj-art-da716408986d4e0d9301380738c5b6392025-01-08T06:15:12ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2019-036537Predictors of oral anticoagulant-associated adverse events in seniors transitioning from hospital to home: a retrospective cohort study protocolLehana Thabane0James Douketis1Anne Holbrook2Gary Foster3Harsukh Benipal4J. Michael Paterson5Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada4 Division of General Internal Medicine, Department of Medicine, McMaster University, Hamilton, Ontario, CanadaDepartment of Medicine, Division of Clinical Pharmacology & Toxicology, McMaster University, Hamilton, Ontario, CanadaDepartment of Health Research Methods, Evidence, and Impact (HEI); Medicine, McMaster University, Hamilton, Ontario, CanadaTemerty Faculty of Medicine, University of Toronto, Toronto, Ontario, CanadaICES, Toronto, Ontario, CanadaIntroduction Oral anticoagulants (OACs) are widely prescribed in older adults. High OAC-related adverse event rates in the early period following hospital discharge argue for an analysis to identify predictors. Our objective is to identify and validate clinical and continuity of care variables among seniors discharged from hospital on an OAC, which are independently associated with OAC-related adverse events within 30 days.Methods and analysis We propose a population-based retrospective cohort study of all adults aged 66 years or older who were discharged from hospital on an OAC from September 2010 to March 2015 in Ontario, Canada. The primary outcome is a composite of the first hospitalisation or emergency department visit for a haemorrhage or thromboembolic event or mortality within 30 days of hospital discharge. A Cox proportional hazards model will be used to determine the association between the composite outcome and a set of prespecified covariates. A split sample method will be adopted to validate the variables associated with OAC-related adverse events.Ethics and dissemination The use of data in this project was authorised under section 45 of Ontario’s Personal Health Information Protection Act, which does not require review by a research ethics board. Results will be disseminated via peer-reviewed publications and presentations at conferences and will determine intervention targets to improve OAC management in upcoming randomised trials.Trial registration number ClinicalTrials.gov Identifier: NCT02777047; Pre-results.https://bmjopen.bmj.com/content/10/9/e036537.full
spellingShingle Lehana Thabane
James Douketis
Anne Holbrook
Gary Foster
Harsukh Benipal
J. Michael Paterson
Predictors of oral anticoagulant-associated adverse events in seniors transitioning from hospital to home: a retrospective cohort study protocol
BMJ Open
title Predictors of oral anticoagulant-associated adverse events in seniors transitioning from hospital to home: a retrospective cohort study protocol
title_full Predictors of oral anticoagulant-associated adverse events in seniors transitioning from hospital to home: a retrospective cohort study protocol
title_fullStr Predictors of oral anticoagulant-associated adverse events in seniors transitioning from hospital to home: a retrospective cohort study protocol
title_full_unstemmed Predictors of oral anticoagulant-associated adverse events in seniors transitioning from hospital to home: a retrospective cohort study protocol
title_short Predictors of oral anticoagulant-associated adverse events in seniors transitioning from hospital to home: a retrospective cohort study protocol
title_sort predictors of oral anticoagulant associated adverse events in seniors transitioning from hospital to home a retrospective cohort study protocol
url https://bmjopen.bmj.com/content/10/9/e036537.full
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