Background

The devastating impact of COVID-19 on care home residents is all too well known. This is both in terms of the impact of the disease itself leading to increased morbidity and mortality, and also measures intended to control the infection – such as visiting restrictions – which affected the health and well-being of residents and those who care for them.

By mid-2020, the first clinical trials were being registered to investigate effective ways of preventing COVID-19 in care homes in an attempt to reduce the impact. These trials primarily investigated pharmacological interventions, including testing existing vaccines and re-purposed drugs, and focused solely on clinical outcomes. As individual trials often measured different outcomes, it was also difficult to compare the interventions being tested to see what was most effective.

Why did we do our study?

As a group of care home researchers, we wanted to know what outcomes matter most to care home residents and those who care for them, and which should be used in future trials looking at pharmacological and non-pharmacological interventions to prevent COVID-19 in care homes.

A core outcome set (or COS) is ‘an agreed standardised set of outcomes that should be measured and reported, as a minimum, in all clinical trials in specific areas of health or health care’.  A video is available from the COMET Initiative which explains why core outcome sets are needed, what they are and how they are developed.

What did we do?

At the start of 2021 we used the COMET approach to establish a core outcome set for the evaluation of interventions to prevent COVID-19 in care homes (COS-COVID-PCARE Study). It followed a core outcome set for COVID-19 prevention in the general population (COS COVID P), but focused on care homes as the potential benefits and harms of prevention interventions are likely to be different in this setting.

The first stage was to review what outcomes were included in existing trials, both in the UK and internationally. This gave us a longlist of 25 outcomes. We then asked people with an interest in preventing COVID-19 in care homes (residents, family members, researchers, care home staff, healthcare professionals, and others such as third sector organisations) to complete an online Delphi survey. In the first round of the survey, they were asked to score each item on the longlist according to importance and could suggest additional outcomes not already included. In the second round they were invited to rescore all outcomes and if they changed a score they were asked to comment on why.

After the survey, 21 items had reached agreement to be included in the COS, and 9 items needed further discussion. These items were discussed and voted on at an online consensus meeting in July 2021, which led to 3 of the items three reaching the threshold for inclusion in the final COS.

What did we find?

The final COS consists of 24 outcomes grouped across four domains of infection, severity of illness, mortality, and ‘other’ (intervention-specific or related to life impact). This reflects the need for future trials to include outcomes that are not just changes in a resident’s clinical condition, such as whether they need oxygen treatment or admission to hospital or die, but also the impact on residents’ quality of life and ability to maintain social connections.

Whilst conducting the study at the height of the pandemic made it difficult to involve care home residents and staff as much as we wanted to, the findings show how important it is for trials to consider the wider benefits and harms of prevention interventions. It also highlights the need to consider such interventions as part of a package of measures where COVID-19 vaccines, treatments and infection control policies all play a part in helping to optimise the health and well-being of those who live in care homes and those who care for them.

What next?

Now that COS-COVID-PCARE has been developed and we know what we need to measure, the next stage is to determine how the outcomes should be measured. However, as care homes, residents, and the nature of interventions differ, this may need to be tailored to specific interventions and contexts and may be through a combination of measures. For example, while many of the items relate to indicators of clinical improvement, others are intervention-specific or have a broader impact on life, including quality of life and well-being.

The COS may have relevance beyond COVID-19 as interventions to prevent COVID-19 may also reduce the rates of other infections in care homes such as flu. The ‘rapid response approach’ we used to develop the COS may also be useful when facing future pandemics.

The development of the core outcome set has been published in an open access paper

For more information about the project see the Centre for Trials Research website

Acknowledgement

We would like to thank all those who generously gave up their time to take part in the Delphi survey and consensus meeting. We would also like to thank the members of the Steering Committee who include (in addition to the authors of the paper – Victoria Shepherd, Ishrat Islam, Fiona Wood, Kerry Hood, Paula Williamson, Claire Goodman, Philip Bath, Carl Thompson, Martin Knapp, and Adam Gordon) Lesley Bethell, Richard Hastings, Christine Bond, and Anna Marriott.