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Physical interventions to interrupt or reduce the spread of respiratory viruses.

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This is the Cochrane report. World renowned Scientists did this study. The complete results can be found here.

 

Physical interventions to interrupt or reduce the spread of respiratory viruses
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Abstract

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Background

Viral epidemics or pandemics of acute respiratory infections (ARIs) pose a global threat. Examples are influenza (H1N1) caused by the H1N1pdm09 virus in 2009, severe acute respiratory syndrome (SARS) in 2003, and coronavirus disease 2019 (COVID‐19) caused by SARS‐CoV‐2 in 2019. Antiviral drugs and vaccines may be insufficient to prevent their spread. This is an update of a Cochrane Review last published in 2020. We include results from studies from the current COVID‐19 pandemic.

Objectives

To assess the effectiveness of physical interventions to interrupt or reduce the spread of acute respiratory viruses.

Search methods

We searched CENTRAL, PubMed, Embase, CINAHL, and two trials registers in October 2022, with backwards and forwards citation analysis on the new studies.

Selection criteria

We included randomised controlled trials (RCTs) and cluster‐RCTs investigating physical interventions (screening at entry ports, isolation, quarantine, physical distancing, personal protection, hand hygiene, face masks, glasses, and gargling) to prevent respiratory virus transmission.

Data collection and analysis

We used standard Cochrane methodological procedures.

Main results

We included 11 new RCTs and cluster‐RCTs (610,872 participants) in this update, bringing the total number of RCTs to 78. Six of the new trials were conducted during the COVID‐19 pandemic; two from Mexico, and one each from Denmark, Bangladesh, England, and Norway. We identified four ongoing studies, of which one is completed, but unreported, evaluating masks concurrent with the COVID‐19 pandemic.

Many studies were conducted during non‐epidemic influenza periods. Several were conducted during the 2009 H1N1 influenza pandemic, and others in epidemic influenza seasons up to 2016. Therefore, many studies were conducted in the context of lower respiratory viral circulation and transmission compared to COVID‐19. The included studies were conducted in heterogeneous settings, ranging from suburban schools to hospital wards in high‐income countries; crowded inner city settings in low‐income countries; and an immigrant neighbourhood in a high‐income country. Adherence with interventions was low in many studies.

The risk of bias for the RCTs and cluster‐RCTs was mostly high or unclear.

Medical/surgical masks compared to no masks

We included 12 trials (10 cluster‐RCTs) comparing medical/surgical masks versus no masks to prevent the spread of viral respiratory illness (two trials with healthcare workers and 10 in the community). Wearing masks in the community probably makes little or no difference to the outcome of influenza‐like illness (ILI)/COVID‐19 like illness compared to not wearing masks (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.84 to 1.09; 9 trials, 276,917 participants; moderate‐certainty evidence. Wearing masks in the community probably makes little or no difference to the outcome of laboratory‐confirmed influenza/SARS‐CoV‐2 compared to not wearing masks (RR 1.01, 95% CI 0.72 to 1.42; 6 trials, 13,919 participants; moderate‐certainty evidence). Harms were rarely measured and poorly reported (very low‐certainty evidence).

N95/P2 respirators compared to medical/surgical masks

We pooled trials comparing N95/P2 respirators with medical/surgical masks (four in healthcare settings and one in a household setting). We are very uncertain on the effects of N95/P2 respirators compared with medical/surgical masks on the outcome of clinical respiratory illness (RR 0.70, 95% CI 0.45 to 1.10; 3 trials, 7779 participants; very low‐certainty evidence). N95/P2 respirators compared with medical/surgical masks may be effective for ILI (RR 0.82, 95% CI 0.66 to 1.03; 5 trials, 8407 participants; low‐certainty evidence). Evidence is limited by imprecision and heterogeneity for these subjective outcomes. The use of a N95/P2 respirators compared to medical/surgical masks probably makes little or no difference for the objective and more precise outcome of laboratory‐confirmed influenza infection (RR 1.10, 95% CI 0.90 to 1.34; 5 trials, 8407 participants; moderate‐certainty evidence). Restricting pooling to healthcare workers made no difference to the overall findings. Harms were poorly measured and reported, but discomfort wearing medical/surgical masks or N95/P2 respirators was mentioned in several studies (very low‐certainty evidence).

One previously reported ongoing RCT has now been published and observed that medical/surgical masks were non‐inferior to N95 respirators in a large study of 1009 healthcare workers in four countries providing direct care to COVID‐19 patients.

Hand hygiene compared to control

Nineteen trials compared hand hygiene interventions with controls with sufficient data to include in meta‐analyses. Settings included schools, childcare centres and homes. Comparing hand hygiene interventions with controls (i.e. no intervention), there was a 14% relative reduction in the number of people with ARIs in the hand hygiene group (RR 0.86, 95% CI 0.81 to 0.90; 9 trials, 52,105 participants; moderate‐certainty evidence), suggesting a probable benefit. In absolute terms this benefit would result in a reduction from 380 events per 1000 people to 327 per 1000 people (95% CI 308 to 342). When considering the more strictly defined outcomes of ILI and laboratory‐confirmed influenza, the estimates of effect for ILI (RR 0.94, 95% CI 0.81 to 1.09; 11 trials, 34,503 participants; low‐certainty evidence), and laboratory‐confirmed influenza (RR 0.91, 95% CI 0.63 to 1.30; 8 trials, 8332 participants; low‐certainty evidence), suggest the intervention made little or no difference. We pooled 19 trials (71, 210 participants) for the composite outcome of ARI or ILI or influenza, with each study only contributing once and the most comprehensive outcome reported. Pooled data showed that hand hygiene may be beneficial with an 11% relative reduction of respiratory illness (RR 0.89, 95% CI 0.83 to 0.94; low‐certainty evidence), but with high heterogeneity. In absolute terms this benefit would result in a reduction from 200 events per 1000 people to 178 per 1000 people (95% CI 166 to 188). Few trials measured and reported harms (very low‐certainty evidence).

We found no RCTs on gowns and gloves, face shields, or screening at entry ports.

Authors’ conclusions

The high risk of bias in the trials, variation in outcome measurement, and relatively low adherence with the interventions during the studies hampers drawing firm conclusions. There were additional RCTs during the pandemic related to physical interventions but a relative paucity given the importance of the question of masking and its relative effectiveness and the concomitant measures of mask adherence which would be highly relevant to the measurement of effectiveness, especially in the elderly and in young children.

There is uncertainty about the effects of face masks. The low to moderate certainty of evidence means our confidence in the effect estimate is limited, and that the true effect may be different from the observed estimate of the effect. The pooled results of RCTs did not show a clear reduction in respiratory viral infection with the use of medical/surgical masks. There were no clear differences between the use of medical/surgical masks compared with N95/P2 respirators in healthcare workers when used in routine care to reduce respiratory viral infection. Hand hygiene is likely to modestly reduce the burden of respiratory illness, and although this effect was also present when ILI and laboratory‐confirmed influenza were analysed separately, it was not found to be a significant difference for the latter two outcomes. Harms associated with physical interventions were under‐investigated.

There is a need for large, well‐designed RCTs addressing the effectiveness of many of these interventions in multiple settings and populations, as well as the impact of adherence on effectiveness, especially in those most at risk of ARIs.

 The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

 

 

 

 

Plain language summary

Do physical measures such as hand‐washing or wearing masks stop or slow down the spread of respiratory viruses?

Key messages
We are uncertain whether wearing masks or N95/P2 respirators helps to slow the spread of respiratory viruses based on the studies we assessed.

Hand hygiene programmes may help to slow the spread of respiratory viruses.

How do respiratory viruses spread?
Respiratory viruses are viruses that infect the cells in your airways: nose, throat, and lungs. These infections can cause serious problems and affect normal breathing. They can cause flu (influenza), severe acute respiratory syndrome (SARS), and COVID‐19.

People infected with a respiratory virus spread virus particles into the air when they cough or sneeze. Other people become infected if they come into contact with these virus particles in the air or on surfaces on which they land. Respiratory viruses can spread quickly through a community, through populations and countries (causing epidemics), and around the world (causing pandemics).

Physical measures to try to prevent respiratory viruses spreading between people include:

· washing hands often;

· not touching your eyes, nose, or mouth;

· sneezing or coughing into your elbow;

· wiping surfaces with disinfectant;

· wearing masks, eye protection, gloves, and protective gowns;

· avoiding contact with other people (isolation or quarantine);

· keeping a certain distance away from other people (distancing); and

· examining people entering a country for signs of infection (screening).

What did we want to find out?
We wanted to find out whether physical measures stop or slow the spread of respiratory viruses from well‐controlled studies in which one intervention is compared to another, known as randomised controlled trials.

What did we do?
We searched for randomised controlled studies that looked at physical measures to stop people acquiring a respiratory virus infection.

We were interested in how many people in the studies caught a respiratory virus infection, and whether the physical measures had any unwanted effects.

What did we find?
We identified 78 relevant studies. They took place in low‐, middle‐, and high‐income countries worldwide: in hospitals, schools, homes, offices, childcare centres, and communities during non‐epidemic influenza periods, the global H1N1 influenza pandemic in 2009, epidemic influenza seasons up to 2016, and during the COVID‐19 pandemic. We identified five ongoing, unpublished studies; two of them evaluate masks in COVID‐19. Five trials were funded by government and pharmaceutical companies, and nine trials were funded by pharmaceutical companies.

No studies looked at face shields, gowns and gloves, or screening people when they entered a country.

We assessed the effects of:

· medical or surgical masks;

· N95/P2 respirators (close‐fitting masks that filter the air breathed in, more commonly used by healthcare workers than the general public); and

· hand hygiene (hand‐washing and using hand sanitiser).

We obtained the following results:

Medical or surgical masks

Ten studies took place in the community, and two studies in healthcare workers. Compared with wearing no mask in the community studies only, wearing a mask may make little to no difference in how many people caught a flu‐like illness/COVID‐like illness (9 studies; 276,917 people); and probably makes little or no difference in how many people have flu/COVID confirmed by a laboratory test (6 studies; 13,919 people). Unwanted effects were rarely reported; discomfort was mentioned.

N95/P2 respirators

Four studies were in healthcare workers, and one small study was in the community. Compared with wearing medical or surgical masks, wearing N95/P2 respirators probably makes little to no difference in how many people have confirmed flu (5 studies; 8407 people); and may make little to no difference in how many people catch a flu‐like illness (5 studies; 8407 people), or respiratory illness (3 studies; 7799 people). Unwanted effects were not well‐reported; discomfort was mentioned.

Hand hygiene

Following a hand hygiene programme may reduce the number of people who catch a respiratory or flu‐like illness, or have confirmed flu, compared with people not following such a programme (19 studies; 71,210 people), although this effect was not confirmed as statistically significant reduction when ILI and laboratory‐confirmed ILI were analysed separately. Few studies measured unwanted effects; skin irritation in people using hand sanitiser was mentioned.

What are the limitations of the evidence?
Our confidence in these results is generally low to moderate for the subjective outcomes related to respiratory illness, but moderate for the more precisely defined laboratory‐confirmed respiratory virus infection, related to masks and N95/P2 respirators. The results might change when further evidence becomes available. Relatively low numbers of people followed the guidance about wearing masks or about hand hygiene, which may have affected the results of the studies.

How up to date is this evidence?
We included evidence published up to October 2022.

Authors’ conclusions

Implications for practice

The evidence summarised in this review on the use of masks is largely based on studies conducted during traditional peak respiratory virus infection seasons up until 2016. Two relevant randomised trials conducted during the COVID‐19 pandemic have been published, but their addition had minimal impact on the overall pooled estimate of effect. The observed lack of effect of mask wearing in interrupting the spread of influenza‐like illness (ILI) or influenza/COVID‐19 in our review has many potential reasons, including: poor study design; insufficiently powered studies arising from low viral circulation in some studies; lower adherence with mask wearing, especially amongst children; quality of the masks used; self‐contamination of the mask by hands; lack of protection from eye exposure from respiratory droplets (allowing a route of entry of respiratory viruses into the nose via the lacrimal duct); saturation of masks with saliva from extended use (promoting virus survival in proteinaceous material); and possible risk compensation behaviour leading to an exaggerated sense of security (Ammann 2022Brosseau 2020Byambasuren 2021Canini 2010Cassell 2006Coroiu 2021MacIntyre 2015Rengasamy 2010Zamora 2006).Our findings show that hand hygiene has a modest effect as a physical intervention to interrupt the spread of respiratory viruses, but several questions remain. First, the high heterogeneity between studies may suggest that there are differences in the effect of different interventions. The poor reporting limited our ability to extract the information needed to assess any ‘dose response’ relationship, and there are few head‐to‐head trials comparing hand hygiene materials (such as alcohol‐based sanitiser or soap and water). Second, the sustainability of hand hygiene is unclear where participants in some studies achieved 5 to 10 hand‐washings per day, but adherence may have diminished with time as motivation decreased, or due to adverse effects from frequent hand‐washing. Third, there is little evidence about the effectiveness of combinations of hand hygiene with other interventions, and how those are best introduced and sustained. Finally, some interventions were intensively implemented within small organisations, and involved education or training as a component, and the ability to scale these up to broader interventions is unclear.

Our findings with respect to hand hygiene should be considered generally relevant to all viral respiratory infections, given the diverse populations where transmission of viral respiratory infections occurs. The participants were adults, children and families, and multiple congregation settings including schools, childcare centres, homes, and offices. Most respiratory viruses, including the pandemic SARS‐CoV‐2, are considered to be predominantly spread via respiratory particles of varying size or contact routes, or both (WHO 2020c). Data from studies of SARS‐CoV‐2 contamination of the environment based on the presence of viral ribonucleic acid and infectious virus suggest significant fomite contamination (Lin 2022Onakpoya 2022bOng 2020Wu 2020). Hand hygiene would be expected to be beneficial in reducing the spread of SARS‐CoV‐2 similar to other beta coronaviruses (SARS‐CoV‐1, Middle East respiratory syndrome (MERS), and human coronaviruses), which are very susceptible to the concentrations of alcohol commonly found in most hand‐sanitiser preparations (Rabenau 2005WHO 2020c). Support for this effect is the finding that poor hand hygiene, despite the use of full personal protective equipment (PPE), was independently associated with an increased risk of SARS‐CoV‐2 transmission to healthcare workers in a retrospective cohort study in Wuhan, China in both a high‐risk and low‐risk clinical unit for patients infected with COVID‐19 (Ran 2020). The practice of hand hygiene appears to have a consistent effect in all settings, and should be an essential component of other interventions.

The highest‐quality cluster‐RCTs indicate that the most effect on preventing respiratory virus spread from hygienic measures occurs in younger children. This may be because younger children are least capable of hygienic behaviour themselves (Roberts 2000), and have longer‐lived infections and greater social contact, thereby acting as portals of infection into the household (Monto 1969). Additional benefit from reduced transmission from them to other members of the household is broadly supported by the results of other study designs where the potential for confounding is greater.

Routine long‐term implementation of some of the interventions covered in this review may be problematic, particularly maintaining strict hygiene and barrier routines for long periods of time. This would probably only be feasible in highly motivated environments, such as hospitals. Many of the trial authors commented on the major logistical burdens that barrier routines imposed at the community level. However, the threat of a looming epidemic may provide stimulus for their inception.

Implications for research

Public health measures and physical interventions can be highly effective to interrupt the spread of respiratory viral infections, especially when they are part of a structured and co‐ordinated programme that includes instruction and education, and when they are delivered together and with high adherence. Our review has provided important insights into research gaps that need to be addressed with respect to these physical interventions and their implementation and have been brought into a sharper focus as a result of the COVID‐19 pandemic. The 2014 WHO document ‘Infection prevention and control of epidemic ‐ and pandemic‐prone acute respiratory infections in health care’ identified several research gaps as part of their GRADE assessment of their infection prevention and control recommendations, which remain very relevant (WHO 2014). Research gaps identified during the course of our review and the WHO 2014 document may be considered from the perspective of both general and specific themes.A general theme identified was the need to provide outcomes with explicitly defined clinical criteria for acute respiratory infections (ARIs) and discrete laboratory‐confirmed outcomes of viral ARIs using molecular diagnostic tools which are now widely available. Our review found large disparities between studies with respect to the clinical outcome events, which were imprecisely defined in several studies, and there were differences in the extent to which laboratory‐confirmed viruses were included in the studies that assessed them. Another general theme identified was the lack of consideration of sociocultural factors that might affect adherence with the interventions, especially those employed in the community setting. A prime example of this latter point was illustrated by the observations of the use of masks versus mask mandates during the COVID‐19 pandemic. In addition, the cost and resource implications of the physical interventions employed in different settings would have important relevance for low‐ to middle‐income countries. Resources have been a major issue with the COVID‐19 pandemic, with global shortages of several components of PPE. Several specific research gaps related to physical interventions were identified within the WHO 2014 document and are congruent with many of the findings of this 2022 update, including the following: transmission dynamics of respiratory viruses from patients to healthcare workers during aerosol‐generating procedures; a continued lack of precision with regards to defining aerosol‐generating procedures; the safety of cohorting of patients with the same suspected but unconfirmed diagnosis in a common unit or ward with patients infected with the same known pathogen in healthcare settings; the optimal duration of the use of physical interruptions to prevent spread of ARI viruses; use of spatial separation or physical distancing (in healthcare and community settings, respectively) alone versus spatial separation or physical distancing with the use of other added physical interventions coupled with examining discrete distance parameters (e.g. one metre, two metres, or > two metres); the effectiveness of respiratory etiquette (i.e. coughing/sneezing into tissues or a sleeved bent elbow); the effectiveness of triage and early identification of infected individuals with an ARI in both hospital and community settings; the utility of entrance screening to healthcare facilities; use of frequent disinfection techniques appropriate to the setting (high‐touch surfaces in the environment, gargling with oral disinfectants, and virucidal tissues or clothing) alone or in combination with facial masks and hand hygiene; the use of visors, goggles or other eyewear; the use of ultraviolet light germicidal irradiation for disinfection of air in healthcare and selected community settings; the use of air scrubbers and /or high‐efficiency particulate absorbing filters and the use of widespread adherence with effective vaccination strategies.

There is a clear requirement to conduct large, pragmatic trials to evaluate the best combinations in the community and in healthcare settings with multiple respiratory viruses and in different sociocultural settings. Randomised controlled trials (RCTs) with a pragmatic design, similar to the Luby 2005 trial or the Bundgaard 2020 trial, should be conducted whenever possible. Similar to what has been observed in pharmaceutical interventions where multiple RCTs were rapidly and successfully completed during the COVID‐19 pandemic, proving they can be accomplished, there should be a deliberate emphasis and directed funding opportunities provided to conduct well‐designed RCTs to address the effectiveness of many of the physical interventions in multiple settings and populations, especially in those most at risk, and in very specific well‐defined populations with monitoring of the adherence to the interventions.

Several specific research gaps deserve expedited attention and may be highlighted within the context of the COVID‐19 pandemic. The use of face masks in the community setting represents one of the most pressing needs to address, given the polarised opinions around the world, and the increasing concerns over widespread microplastic pollution from the discarding of masks (Shen 2021). Both broad‐based ecological studies, adjusting for confounding and high quality RCTs, may be necessary to determine if there is an independent contribution to their use as a physical intervention, and how they may best be deployed to optimise their contribution. The type of fabric and weave used in the face mask is an equally pressing concern, given that surgical masks with their cotton‐polypropylene fabric appear to be effective in the healthcare setting, but there are questions about the effectiveness of simple cotton masks. In addition, any masking intervention studies should focus on measuring not only benefits but also adherence, harms, and risk compensation if the latter may lead to a lower protective effect. In addition, although the use of medical/surgical masks versus N95 respirators demonstrates no differences in clinical effectiveness to date, their use needs to be further studied within the context of a well‐designed RCT in the setting of COVID‐19, and with concomitant measurement of harms, which to date have been poorly studied. The recently published Loeb RCT conducted over a prolonged course in the current pandemic has provided the only evidence to date in this area (Loeb 2022).

Physical distancing represents another major research gap which needs to be addressed expediently, especially within the context of the COVID‐19 pandemic setting as well as in future epidemic settings. The use of quarantine and screening at entry ports needs to be investigated in well‐designed, high‐quality RCTs given the controversies related to airports and travel restrictions which emerged during the COVID‐19 pandemic. We found only one RCT investigating quarantine, and no trials of screening at entry ports or physical distancing. Given that these and other physical interventions are some of the primary strategies applied globally in the face of the COVID‐19 pandemic, future trials of high quality should be a major global priority to be  conducted within the context of this pandemic, as well as in future epidemics with other respiratory viruses of less virulence.

The variable quality and small scale of some studies is known from descriptive studies (Aiello 2002Fung 2006WHO 2006b), and systematic reviews of selected interventions (Meadows 2004). In summary, more high‐quality RCTs are needed to evaluate the most effective strategies to implement successful physical interventions in practice, both on a small scale and at a population level. It is very unfortunate that more rigorous planning, effort and funding was not provided during the current COVID‐19 pandemic towards high‐quality RCTs of the basic public health measures. Finally, we emphasise that more attention should be paid to describing and quantifying the harms of the interventions assessed in this review, and their relationship with adherence.

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