Table 3 Items included in the core outcome set following the Delphi survey and consensus meeting

Detecting infection

Outcome

Definition

Comments or examples

COVID-19 negative

Negative antigen test for COVID-19

• Antigen testing at individual level or whole care home (e.g. number or proportion of residents and/or staff, or number of days COVID-19 negative)

• Score 0 on WHO Clinical Progression Scale

COVID-19 infection

Positive antigen test for COVID-19

• Antigen testing at individual level or whole care home (e.g. number or proportion of residents and/or staff)

COVID-19 infection with no symptoms

Virological but no clinical evidence of COVID-19

• Antigen testing and clinical assessment

• Score 1 on WHO Clinical Progression Scale

COVID-19 infection with symptoms

Virological and clinical evidence of COVID-19

• Antigen testing and clinical assessment

• Score ≥ 2 on WHO Clinical Progression Scale

Severity of illness

Outcome

Definition

Comments or examples

Recovery from COVID-19 infection

Signs of clinical recovery

• Clinical assessment

Hospitalisation

Moderate-severe COVID-19 disease requiring hospital admission

• Score ≥ 4 on WHO Clinical Progression Scale

Reduced blood oxygen levels

Low oxygen saturation levels according to assessment and treatment protocol

• SpO₂ measurement^a

• Score ≥ 5 on WHO Clinical Progression Scale

Needing treatment with oxygen

Requiring supplemental oxygen in accordance with assessment and treatment protocol

• Requiring oxygen therapy e.g. via mask or nasal prongs

• Score ≥ 5 on WHO Clinical Progression Scale

Organs not functioning as well as expected

Evidence of single or multiple organ dysfunction

• Assessment E.g Murray score, multiple organ dysfunction score

• Score ≥ 5 on WHO Clinical Progression Scale

Admission to Intensive Care Unit (ICU)

Severe COVID-19 disease requiring ICU admission

• Score ≥ 6 on WHO Clinical Progression Scale

Condition getting better

Signs of improvement in clinical course

• Clinical assessment

Mortality

Outcome

Definition

Comments or examples

COVID-19 related death

Death attributable to COVID-19

• Clinical assessment of cause of death

• Score 10 on WHO Clinical Progression Scale

Non-COVID-19 related death^c

Death attributable to causes other than COVID-19

• Clinical assessment of cause of death

• Score 10 on WHO Clinical Progression Scale

Other (intervention specific)

Outcome

Definition

Comments or examples

Has immunity against COVID-19

Evidence of antiviral activity in accordance with assessment protocol

• Measurement of antiviral activity using appropriate assay e.g. number or proportion of residents and/or staff

Uptake of vaccination

Evidence of uptake of vaccination in accordance with recommended schedule

• E.g number or proportion of residents and/or staff who have received vaccination in accordance with recommended schedule

Feasibility of the intervention^b

Evidence of the feasibility of the intervention

• Assessment of the feasibility of implementing the intervention

Compliance with infection prevention guidance

Evidence of compliance with IPC^$ measures

• Assessment of compliance with IPC^$ measures in place

Mental health effects from the intervention

Evidence of changes in mental health (including delirium) attributed to the intervention

• Clinical assessment of mental health status

• E.g delirium assessment tool

Side effects or safety concerns

Adverse events reported

• Reported in accordance with reporting procedures

• E.g number or rates of adverse events reported in residents and/or staff

Staff knowledge and awareness about vaccines^b

Evidence of staff knowledge and awareness about importance and use of vaccines

• Assessed level of staff knowledge and awareness

Staff knowledge and awareness about infection control^b

Evidence of staff knowledge and awareness about importance and use of IPC^d measures

• Assessed level of staff knowledge and awareness

Other (life impact)

Outcome

Definition

Comments or examples

Quality of life and well-being^b

Quality of life and/or well-being experienced by residents

• Assessment of health-related quality of life, or social care-related quality of life, or overall well-being

• E.g measure of quality of life or well-being

Ability for residents to receive visits in the care home and/or for residents to make visits out of the home^bc

Any restriction on the ability for residents to make and receive visits

• Assessment of IPC^d measures in place

Decline in cognitive function (not due to COVID-19 illness)^bc

Decline in cognition attributable to causes other than COVID-19

• Clinical assessment of cognitive function

• E.g cognitive assessment tool