Development of a core outcome set for the evaluation of interventions to prevent COVID-19 in care homes (COS-COVID-PCARE Study)

Abstract Background People living in care homes have experienced devastating impact from COVID-19. As interventions to prevent the transmission of COVID-19 are developed and evaluated, there is an urgent need for researchers to agree on the outcomes used when evaluating their effectiveness. Having a...

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Main Authors: Victoria Shepherd, Ishrat Islam, Fiona Wood, Paula R. Williamson, Claire Goodman, Philip M. Bath, Carl Thompson, Martin Knapp, Adam L. Gordon, Kerenza Hood
Format: Article
Language:English
Published: BMC 2022-08-01
Series:BMC Geriatrics
Subjects:
Online Access:https://doi.org/10.1186/s12877-022-03395-8
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author Victoria Shepherd
Ishrat Islam
Fiona Wood
Paula R. Williamson
Claire Goodman
Philip M. Bath
Carl Thompson
Martin Knapp
Adam L. Gordon
Kerenza Hood
author_facet Victoria Shepherd
Ishrat Islam
Fiona Wood
Paula R. Williamson
Claire Goodman
Philip M. Bath
Carl Thompson
Martin Knapp
Adam L. Gordon
Kerenza Hood
author_sort Victoria Shepherd
collection DOAJ
description Abstract Background People living in care homes have experienced devastating impact from COVID-19. As interventions to prevent the transmission of COVID-19 are developed and evaluated, there is an urgent need for researchers to agree on the outcomes used when evaluating their effectiveness. Having an agreed set of outcomes that are used in all relevant trials can ensure that study results can be compared. Objective The aim of the study was to develop a core outcome set (COS) for trials assessing the effectiveness of pharmacological and non-pharmacological interventions for preventing COVID-19 infection and transmission in care homes. Methods The study used established COS methodology. A list of candidate outcomes was identified by reviewing registered trials to evaluate interventions to prevent COVID-19 in care homes. Seventy key stakeholders participated in a Delphi survey, rating the candidate outcomes on a nine-point scale over two rounds, with the opportunity to propose additional outcomes. Stakeholders included care home representatives (n = 19), healthcare professionals (n = 20), people with personal experience of care homes (n = 7), researchers (n = 15) and others (n = 9). Outcomes were eligible for inclusion if they met an a priori threshold. A consensus meeting with stakeholders resulted in agreement of the final outcome set. Results Following the Delphi and consensus meeting, twenty-four outcomes were recommended for inclusion. These are grouped across four domains of infection, severity of illness, mortality, and ‘other’ (intervention specific or life impact). Due to the considerable heterogeneity between care homes, residents, and interventions, the relevance and importance of outcomes may differ between trial contexts. Intervention-specific outcomes would be included only where relevant to a given trial, thus reducing the measurement burden. Conclusion Using a rapid response approach, a COS for COVID-19 prevention interventions in care homes has been developed. Future work should focus on identifying instruments for measuring these outcomes, and the interpretation and application of the COS across different trial contexts. Beyond COVID-19, the outcomes identified in this COS may have relevance to other infectious diseases in care homes, and the rapid response approach may be useful as preparation for future pandemics.
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spelling doaj.art-246c90453512407690f707ec27e465552022-12-22T01:36:25ZengBMCBMC Geriatrics1471-23182022-08-0122111110.1186/s12877-022-03395-8Development of a core outcome set for the evaluation of interventions to prevent COVID-19 in care homes (COS-COVID-PCARE Study)Victoria Shepherd0Ishrat Islam1Fiona Wood2Paula R. Williamson3Claire Goodman4Philip M. Bath5Carl Thompson6Martin Knapp7Adam L. Gordon8Kerenza Hood9Centre for Trials Research, Cardiff UniversityPRIME Centre WalesPRIME Centre WalesClinical Trials Research Centre, University of LiverpoolCentre for Research in Public Health and Community Care (CRIPACC, University of HertfordshireStroke Trials Unit, Mental Health & Clinical Neuroscience, University of NottinghamSchool of Healthcare, Faculty of Medicine and Health, University of LeedsCare Policy and Evaluation Centre, London School of Economics and Political ScienceUnit of Inflammation, Injury and Recovery Sciences, School of Medicine, University of NottinghamCentre for Trials Research, Cardiff UniversityAbstract Background People living in care homes have experienced devastating impact from COVID-19. As interventions to prevent the transmission of COVID-19 are developed and evaluated, there is an urgent need for researchers to agree on the outcomes used when evaluating their effectiveness. Having an agreed set of outcomes that are used in all relevant trials can ensure that study results can be compared. Objective The aim of the study was to develop a core outcome set (COS) for trials assessing the effectiveness of pharmacological and non-pharmacological interventions for preventing COVID-19 infection and transmission in care homes. Methods The study used established COS methodology. A list of candidate outcomes was identified by reviewing registered trials to evaluate interventions to prevent COVID-19 in care homes. Seventy key stakeholders participated in a Delphi survey, rating the candidate outcomes on a nine-point scale over two rounds, with the opportunity to propose additional outcomes. Stakeholders included care home representatives (n = 19), healthcare professionals (n = 20), people with personal experience of care homes (n = 7), researchers (n = 15) and others (n = 9). Outcomes were eligible for inclusion if they met an a priori threshold. A consensus meeting with stakeholders resulted in agreement of the final outcome set. Results Following the Delphi and consensus meeting, twenty-four outcomes were recommended for inclusion. These are grouped across four domains of infection, severity of illness, mortality, and ‘other’ (intervention specific or life impact). Due to the considerable heterogeneity between care homes, residents, and interventions, the relevance and importance of outcomes may differ between trial contexts. Intervention-specific outcomes would be included only where relevant to a given trial, thus reducing the measurement burden. Conclusion Using a rapid response approach, a COS for COVID-19 prevention interventions in care homes has been developed. Future work should focus on identifying instruments for measuring these outcomes, and the interpretation and application of the COS across different trial contexts. Beyond COVID-19, the outcomes identified in this COS may have relevance to other infectious diseases in care homes, and the rapid response approach may be useful as preparation for future pandemics.https://doi.org/10.1186/s12877-022-03395-8Care homesCOVID-19PandemicPreventionCore outcome set
spellingShingle Victoria Shepherd
Ishrat Islam
Fiona Wood
Paula R. Williamson
Claire Goodman
Philip M. Bath
Carl Thompson
Martin Knapp
Adam L. Gordon
Kerenza Hood
Development of a core outcome set for the evaluation of interventions to prevent COVID-19 in care homes (COS-COVID-PCARE Study)
BMC Geriatrics
Care homes
COVID-19
Pandemic
Prevention
Core outcome set
title Development of a core outcome set for the evaluation of interventions to prevent COVID-19 in care homes (COS-COVID-PCARE Study)
title_full Development of a core outcome set for the evaluation of interventions to prevent COVID-19 in care homes (COS-COVID-PCARE Study)
title_fullStr Development of a core outcome set for the evaluation of interventions to prevent COVID-19 in care homes (COS-COVID-PCARE Study)
title_full_unstemmed Development of a core outcome set for the evaluation of interventions to prevent COVID-19 in care homes (COS-COVID-PCARE Study)
title_short Development of a core outcome set for the evaluation of interventions to prevent COVID-19 in care homes (COS-COVID-PCARE Study)
title_sort development of a core outcome set for the evaluation of interventions to prevent covid 19 in care homes cos covid pcare study
topic Care homes
COVID-19
Pandemic
Prevention
Core outcome set
url https://doi.org/10.1186/s12877-022-03395-8
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