Updated. Masks in care homes: a benefit risk analysis for residents and their carers

Use of Surgical Masks in Care Homes to Control Respiratory Virus Infection: a formal benefit-risk analysis for people with dementia and other cognitive and sensory impairments and their carers

Feb 11, 2024

Authors: Valerie Nelson, Mental Health Trainer & Consultant & Richard Ennos, Retired Professor of Evolutionary Biology

Introduction

From April 2020 until May 2022, UK government infection, prevention and control (IPC) guidance specified universal masking with face coverings or surgical masks (Type II or IIR) for all staff, residents and visitors in care settings (1). These measures were justified on the basis that they would confer a benefit, the prevention of transmission of SARS-CoV-2 and other respiratory infectious agents. Although face masks are no longer routinely required in health and social care settings, current guidance continues to recommend their use in specific situations (2), and there are reports of mask wearing being practiced outwith the remit of the guidance.

Since April 2020, mask wearing has been communicated as a relatively risk-free intervention with life-saving benefits. Mask wearing should, however, be understood as a medical treatment (see section s47(4) of the Adults with Incapacity (Scotland) Act 2000) which therefore requires informed consent from the wearer. Informed consent cannot be given if, in addition to the benefits, the risks of wearing masks have not been assessed and communicated to the mask wearer. In this case the risks should be understood as the potential harms arising from the wearing of masks in care homes by residents, their carers and visitors. This should prompt councils to make inquiries into the circumstances of individuals who may be defined as an ‘adult at risk' under the Adult Support & Protection (Scotland) Act 2007.

To date there has been no formal benefit-risk assessment of mask wearing in care home settings. In this paper we remedy this deficiency by first assessing the strength of the evidence that mask wearing reduces rates of respiratory infection. We then conduct a thorough assessment of the risks associated with wearing masks in care homes as they affect residents, carers and visitors. Finally, we compare benefits and risks. Based on our analysis, we conclude that there is little evidence that wearing masks in care home settings confers a significant benefit. In contrast, mask wearing is associated with very significant risks of harm to residents, carers and visitors.

Benefits of Wearing Surgical Masks in Care Homes

Wearing surgical masks in care homes to prevent respiratory infection only confers a benefit to residents, staff and visitors if this practice reduces infection by viruses and other agents causing respiratory illness. Infection by respiratory viruses such as SARS-Cov2 is primarily by means of aerosol spread. The Health and Safety executive are clear that surgical masks provide very limited protection against viruses spread by aerosol. To quote their report directly they say, “Whilst they [surgical masks] will provide a physical barrier to large projected droplets, they [surgical masks] do not provide full respiratory protection against smaller suspended droplets and aerosols [and as such] are not regarded as personal protective equipment (PPE) under the European Directive 89/686/EEC (PPE Regulation 2002 SI 2002 No. 1144)” (3). It therefore follows that surgical masks are unlikely to provide protection against infection by SARS-CoV2 that is typically dispersed by aerosol.

Evidence supporting this conclusion was available in 2020, before the advent of COVID-19. The prestigious Cochrane review, which utilised data from 67 randomised controlled trials (RCTs), showed that the use of medical/surgical masks during seasonal influenza resulted in no clear reduction in respiratory viral infection (4). At the same time in the United States, the Centre for Disease Control (CDC) provided evidence from 14 randomised controlled trials that wearing of masks did not have any substantial effect on the transmission of laboratory-confirmed influenza (5). Given that influenza is spread primarily by aerosols in the same way as SARS-CoV2, these results suggest that the use of surgical masks is likely to be ineffective in preventing the spread of SARS-CoV2.

A small number of RCT studies conducted during the SARS-CoV2 epidemic itself reinforce this conclusion. During 2020, when SARS-COV2 was actively spreading in Denmark, a large RCT involving 4862 participants concluded that there was no significant difference in the rate of infection between those with and without masks (6). Likewise, a critical analysis of the spread of SARS-CoV2 in Bangladesh in 2020/21, involving comparison of 300 masked and 300 unmasked villages, showed no discernible effect of masking on COVID-19 infection (7). These conclusions about the ineffectiveness of masks were also reached in a study conducted in a clinical setting within a London hospital. During a general community surge in SARS-CoV-2 infection in June 2022, removal of an existing mask policy was not associated with a statistically significant change in the rate of hospital-acquired SARS-CoV-2 infection; SARS-CoV-2 infection was no higher when masks were removed than when masks were obligatory (8).

In 2023 it was possible to include studies involving SARS-CoV2 in an updated Cochrane review into the effectiveness of masks in preventing the spread of viruses and other agents causing respiratory diseases. The inclusion of the data on SARS-CoV2 did not alter the conclusion that had been drawn in the previous review, that the use of medical/surgical masks does not result in a clear reduction in respiratory viral infection (9).

Taken together, these critical studies based on gold standard RCT experimental designs provide no evidence to support the contention that the use of surgical masks reduces the spread of respiratory viruses, such as SARS-CoV2, in a community setting. In terms of respiratory disease prevention there is therefore no evidence supporting the contention that it is beneficial for residents, staff or visitors to wear surgical masks within care homes.

Risks of Wearing Surgical Masks in Care Homes

The decision to impose mask wearing on an individual is a serious medical intervention. Serious because it impedes normal breathing and communication, and obliterates the facial expression and individuality of the wearer; medical because its only justification is a medical one. The risks arising from wearing masks cannot be assessed with a single blanket assessment because they depend very much on the individual involved and their physical and - especially - mental capacity. This is particularly so in a care home where residents are challenged both physically and mentally, and their wellbeing is often particularly fragile to interventions that place extra burdens on their frail physical and mental health. For these reasons the risk assessment conducted below considers the effects of the mask intervention separately for residents, carers, relatives and the care home community as a whole. These assessments are not theoretical, but are based on the real-world experience of nurses and carers working to support residents with dementia and other cognitive and sensory impairments

Benefit-Risk Analysis of Wearing Surgical Masks in Care Homes

It is clear from the analyses set out above that the medical benefits of mask wearing in reducing the spread of respiratory diseases in care homes are minimal to non-existent. In contrast wearing surgical masks is associated with manifold and serious risks to the physical and mental health of residents, carers and visitors. In the most extreme cases the life of residents may be threatened when serious medical conditions are missed or there is failure to meet care needs through miscommunication. Less acute, but equally important are those risks that destroy the quality of life enjoyed by residents, carers and visitors/family members in a situation where the mental health of all parties can be very fragile.

Conclusions

This formal benefit-risk analysis of the use of surgical masks in care homes to control respiratory diseases demonstrates, unequivocally, that the vanishingly small benefits of mask wearing in terms of infection reduction are dwarfed by the multitude of harms that mask wearing may cause. The risks of harm to care home residents are particularly high because of their physical and mental vulnerability to the effects of mask wearing. The clear take home message is that mask wearing should never be mandated in care home settings to control respiratory diseases.

Despite the clarity of this conclusion, it is the case that in 2020 mask wearing was imposed in care homes and applied to residents, employees and visitors to the facilities. Organisations focused on their perceived Health and Safety obligations to supply and enforce the use of Personal Protection Equipment (PPE) without conducting any assessment either of the efficacy of the PPE, in this case masks, or of the risks posed by deployment of this PPE to the vulnerable individuals in their care. Furthermore, they failed to recognise that by mandating mask wearing they were imposing a medical intervention on the health and social care workers in their care homes.

This brief benefit-risk analysis relates specifically to surgical masks and their impact on people with dementia and other cognitive and sensory impairments. The results cannot and should not be applied to other mask types and other groups and individuals affected by their use. However, this study should prompt a complete rethink of the framework within which risk assessments for medical interventions are conducted. Proposed medical interventions, such as mask wearing, should never be assumed to be beneficial. The evidence for their effectiveness should always be assessed using the best possible data. Furthermore, all the potential risks, both medical and non-medical, posed by the interventions must be analysed in the widest possible context, treating those who receive the intervention as individuals with particular physical and mental vulnerabilities, who live within a particular family and social context.

References

Valerie Nelson Radical Practitioner

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