A Core Outcome Set for studies evaluating interventions for the prevention of COVID-19 transmission in care homes (COS-COVID-PCARE)

COVID-19 has had a particularly devastating impact on people living in care homes who account for over half of the excess deaths during the pandemic. Reducing transmission in care homes is essential to reduce morbidity and mortality from COVID-19. Prevention of COVID-19 infection in care home residents and reducing transmission within care homes is currently dependent on behavioural and environmental interventions such as infection control measures (including the use of PPE) and visiting restrictions which potentially have a significant impact on the quality of life of care home residents and their families.

Methods to minimise transmission currently being developed, such as vaccines, may not be as effective in older people who may produce a lesser immune response and may have higher rates of immunosuppression from underlying diseases and medicines. Other pharmacological interventions to help prevent infection and transmission in a care home setting such as prophylaxis (drugs or antibody preparations) are in the early stages of development. Developing effective interventions to prevent transmission in this vulnerable population is the current target of urgent public health research.

However, there are challenges with evidence synthesis due to inconsistent selection, measurement, and reporting of outcomes (Chu et al, Lancet 2020; https://www.cochranelibrary.com/covid-19). This leads to research waste and inefficiency, slowing worldwide implementation of methods to prevent disease spread. A solution to this issue is to develop a COS for studies of interventions to prevent COVID-19 infection. This approach led to the development of a ‘core’ COS (COS-COVID-P https://www.comet-initiative.org/Studies/Details/1594) with the planned addition of specific COS ‘modules’ to tackle key areas of relevance, such as the prevention of transmission in care homes. This ‘module’ for COVID-19 prevention in care homes will therefore use a rapid response approach that follows on from the development of COS-COVID-P.

Aim

Building on a core COS that includes a minimum set of outcomes relevant to all studies of COVID-19 disease prevention, we propose to develop a supplementary specific module for COVID-19 prevention in care homes.

Contributors

• Kerry Hood, Director of Centre for Trials Research, Cardiff University (PI)
• Paula Williamson, Institute of Translational Medicine, University of Liverpool
• Fiona Wood, Division of Population Medicine, Cardiff University
• Vicky Shepherd, Centre for Trials Research, Cardiff University
• Richard Hastings, Centre for Educational Development, Appraisal & Research, University of Warwick
• Lesley Bethell, Public Representative
• Claire Goodman, Centre for Research in Public Health and Community Care, University of Hertfordshire
• Anna Marriott, National Development Team for Inclusion (NDTi)
• Carl Thompson, School of Healthcare, University of Leeds
• Martin Knapp, Department of Health Policy, LSE
• Christine Bond, The Institute of Applied Health Sciences, University of Aberdeen
• Philip Bath, Faculty of Medicine & Health Sciences, University of Nottingham
• Adam Gordon, Faculty of Medicine & Health Sciences, University of Nottingham
• Ishrat Islam, PRIME Centre wales and Cardiff University

Further Study Information

Current Stage: Ongoing
Date: February 2021 - May 2021
Funding source(s): Not funded


Health Area

Disease Category: Infectious disease

Disease Name: Coronavirus

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention: Prevention

Stakeholders Involved

- Consumers (caregivers)
- Consumers (patients)

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process

(i) Establish a subgroup steering committee for the COS-COVID-PCARE ‘module’
(ii) Steering committee to review the long list of studies and outcomes identified during COS-COVID-P review of registered trials and identify those from studies involving care homes or relevant to the care home context
(iii) Undertake Delphi surveys over multiple rounds with a range of relevant stakeholder groups
(iv) Hold online consensus meeting to establish COS

Linked Studies

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