A total of 2,240 articles and gray literature were identified, and 48 met the final criteria for inclusion. These studies all assessed SARS-CoV-2, the behavior of mask wearing, and the outcome of disease transmission in various settings. The majority of studies were from the United States (n=22)17-38 while the rest were conducted in China (n=9),37, 39-46 Germany (n=4),47-50 Japan (n=2),51, 52 Denmark (n=1),53 Spain (n=1),54 South Korea (n=1),55 Pakistan (n=1),56 Switzerland (n=1),57 Finland (n=1),58 Israel (n=1),59 Greece (n=1),60 Ethiopia (n=1),61 Thailand (n=1),62 and India (n=1).63 Studies were conducted in healthcare settings (n=21), community and neighborhood settings (n=12), and in schools and universities (n=5; Table 1). Most studies were cross-sectional (n=22) followed by case-control (n=9), case reports (n=7), cohorts (n=6), and other study designs (n=3). COVID-19 infection was the outcome of interest and was primarily identified through lab-verified test results such as polymerase chain reaction (PCR) nasal swab tests (n=42).
Type of Mask
This review identified studies that evaluated various types of masks including cloth masks, respirators, disposable surgical masks, double-layer gaiters, N95 and KN95 masks. The majority of included studies did not address the specific type of masks used by participants (n=23). Studies that looked exclusively at surgical masks included Meylan et al.57and Wang et al.37 Both studies found that adherence to a mask policy within a hospital setting was associated with lower SARS-CoV-2 positivity.37, 57 Gras-Valentí et al.54 also evaluated the impact of the continuous use of a surgical mask among HCWs. The accumulated incidence of COVID-19 among HCWs during the preintervention period until the implementation of the continuous use of a surgical mask was 22.3 for every 1000 HCWs, and the risk during the intervention period was 8.2 for every 1000 HCWs.54
Li et al.27 looked exclusively at cloth masks and the daily cumulative laboratory confirmed cases in New York City and COVID-19 transmissibility. They found that a cloth face covering was effective at reducing transmission capacity by 60% at the individual level for those susceptible to COVID-19.27 Ranjan et al.63 assessed N95 masks exclusively. They found that within a tertiary care setting, adhering to N95 mask fit checks were significantly associated (OR = 0.35, CI: 0.18 – 0.66, p<0.001) with the prevention of transmission of SARS-CoV-2 infection.63 Thompson et al.34 assessed implementation of universal masking with both surgical and cloth face masks. Among 250 potentially exposed patients and staff, 14 confirmed cases of COVID-19 were identified. All transmissions occurred among patients and staff with direct interactions or close contact without use of surgical, cloth, or N95 respirators.34 Hendrix et al.24 assessed the role of source control (i.e., masks) in preventing COVID-19 transmission in a hair salon. Types of face covering used by clients varied; 49 (47.1%) wore cloth face coverings, 48 (46.1%) wore surgical masks, five (4.8%) wore N95 respirators, and two (1.9%) did not know what kind of face covering they wore. When asked what the stylists wore, 64 (61.5%) reported that their stylist wore a cloth face covering (39; 37.5%) or surgical mask (25; 24.0%); 40 (38.5%) clients did not know or remember the type of face covering worn by stylists. They found that among 139 clients exposed to two symptomatic hair stylists with confirmed COVID-19 while both the stylists and the clients wore face masks, no symptomatic secondary cases were reported. Among 67 clients who tested for SARS-CoV-2, all test results were negative, suggesting that wearing a face mask was associated with reduced transmission independent of the type of mask.24
Mask Use and Transmission of SARS-CoV-2
Of a total of 48 included studies, 44 (91.6%) showed that face masks played a role in reducing or preventing transmission of SARS-CoV-2. Each analysis demonstrated that, following directives from organizational and political leadership for universal masking policies, new COVID-19 cases fell significantly. Four studies showed that masks had no clear effect on reducing the wearers’ risk of infection.26, 31, 38, 53 Xie et al.38 noted that mask mandates may not directly increase the adoption of mask wearing behavior in the public. Klompas et al.26 assessed 3 case studies which all resulted in COVID-19 infection despite one or both parties wearing medical masks. Sasser et al.31 found no significant associations between COVID-19 incidence and face mask use during high school sports games (p-values > .05). Bundegaard et al.53 assessed whether recommending surgical mask use outside the home reduces wearers' risk for SARS-CoV-2 infection in a setting where masks were uncommon. The recommendation to wear a surgical mask when outside the home did not reduce incident SARS-CoV-2 infection compared with no mask recommendation. In a per protocol analysis that excluded participants in the mask group who reported nonadherence (7%), SARS-CoV-2 infection occurred in 40 participants (1.8%) in the mask group and 53 (2.1%) in the control group (between-group difference, −0.4 percentage point [CI, −1.2 to 0.5 percentage point]; P = 0.40) (OR, 0.84 [CI, 0.55 to 1.26]; p = 0.40).53
Healthcare Settings
Many studies took place in healthcare settings (n=21; 43.7%). Most of these articles demonstrated a positive association (44 of 48; 91.6%) of a mask wearing intervention on minimizing or controlling transmission of COVID-19 within a healthcare setting (Table 1). Wendt et al. (2020) investigated potential transmissions of a symptomatic SARS-CoV-2–positive physician in a tertiary-care hospital who worked for 15 cumulative hours without wearing a face mask. All high-risk contacts committed to wearing a face mask during work. All 254 potential contacts of the symptomatic positive index physician, 67 patients, and 187 nurses and doctors were assessed. They found that, after day 5, all tested persons were negative for COVID-19. Wang at el.50 assessed the association of hospital masking policies with the SARS-CoV-2 infection rate among HCWs and found that universal masking within the hospital was associated with a significantly lower rate of SARS-CoV-2 positivity among HCWs. During the universal masking intervention period, the positivity rate decreased linearly from 14.65% to 11.46%, with a weighted mean decline of 0.49% per day and a net slope change of 1.65% (95% CI, 1.13%-2.15%; p< .001) decline per day compared with the preintervention period.50 Seidelman et al.32 also found that universal masking within the healthcare setting resulted in a significant decrease in the cumulative incidence rate of healthcare-acquired SARS-CoV-2 infections among HCWs (log-rank test = 4.38, p= 0.03).32 Lastly, Ambrosch et al.47 noted a large decline of nosocomial SARS-CoV-2 infections by almost 80% after the introduction of a strict mask requirement for all employees during the entire shift and the instruction to wear masks on patients.
Community and Neighborhood Settings
Studies were also conducted in various community and neighborhood settings (n=12; 25%). A prospective cohort study by Riley et al.30 which assessed residents of Johnson County, Iowa who tested positive for COVID-19 found that mask use was significantly associated with lower secondary attack rates (SARs) (odds ratio [OR] 0.7, 95% CI 0.57–0.84), and that mask use by both the case-patient and the close contact reduced the SAR by half, from 25.6% to 12.5%. Shaweno et al.61 conducted SARS-CoV-2 serosurveys, a survey designed to measure the seroprevalence of SARS-CoV-2 antibodies among individuals, in overcrowded neighborhoods in Dire Dawa, Ethiopia. They found that individuals who reported wearing a mask reduced had lower risk of seroprevalence. They observed 4.5 times higher prevalence of SARS-CoV-2 antibodies among individuals who did not wear facemasks, 10.1% (95% CI 4.1, 16) prevalence compared to 2.3% (95% CI 1.0, 4.0) prevalence among individuals who reported wearing a face mask when leaving home. Similarly, they found that not using face masks while leaving home showed significant association with SARS-CoV-2 seroprevalence.61 Comparably, Cheng et al.40 assessed the effect of community-wide mask usage to control COVID-19 in Hong Kong Special Administrative Region (HKSAR), a densely populated cosmopolitan city in China. The compliance of face mask usage by HKSAR in the general public was 96.6% (range: 95.7% to 97.2%), which was measured by direct observation. This study observed 11 COVID-19 clusters in recreational ‘mask-off’ settings compared to only 3 in workplace ‘mask-on’ settings (p = 0.036, Chi square test of goodness-of-fit).40
Schools and University Settings
A small number of studies took place in schools and universities (n=5; 10.4%). One study was conducted in a university setting and four were conducted in K-12 schools. Schools and universities have been an area of concern throughout the pandemic due to the inherent difficulty in maintaining physical distance while still providing instruction. Four out of five studies in school-based settings showed that mask policy and/or requirements is an important strategy in decreasing COVID-19 case rates and keeping students, staff, faculty, and visitors safe. Jehn et al.25 found that the odds of a school-associated COVID-19 outbreak in schools with no mask requirement were 3.7 times higher than those in schools with an early mask requirement. Gettings at al.22 noted that in Georgia K-5 schools, COVID-19 incidence was 37% lower in schools that required teachers and staff members to use masks and 39% lower in schools that improved ventilation, compared with schools that did not use these prevention strategies. Budzyn et al.20 found that counties throughout the U.S. with mask requirements for K-12 schools (16.32 cases per 1000,000 children) had a significantly lower number of daily cases of pediatric COVI-19 (18.53 per 100,000 children; β = −1.31; 95% CI = −1.51 to −1.11; p<0.001) than countries with no mask requirements (34.85 per 100,000 per day).
Models
Four of the included studies used a combination of real-world data plus a variation of a compartmental model to analyze the effectiveness of masking interventions on case growth and death rates (n=4). Li et al.27 used the effective reproduction number (Rt) to evaluate the effectiveness of multiple interventions. It was found that after social distancing, the Rt value was reduced by 68%, while after the mask recommendation, it was further reduced to about 59.8%. Zhang et al.46 simulated the spread of COVID-19 in Hong Kong, using actual demographic and geographic data, as well as case reports issued by the Centre for Health Protection of Hong Kong, to analyze the efficiency of several main NPIs. Using an improved agent-based SEIR model, they found that wearing a mask in public places can reduce the infection risk via the close contact route (i.e., short-range airborne transmission). A key finding was that if all people could wear masks in all public indoor environments, the total infection risk could be reduced by 32.5%.46
Other Community Settings
Other settings which were studied included households (n=2),28, 37 airplanes (n=2),52 a hair salon (n=1),24 and an indoor sports facility (n=1).49 A study by Wang et al.37 which examined face masks within households found that face mask use by the primary case and family contacts before the primary case developed symptoms was 79% effective in reducing transmission (OR=0.21, 95% CI 0.06 to 0.79). Similarly, in another study of household transmission, it was found that transmission was significantly lower in households in which the index case wore a face mask compared with those did not [17% (7%–37%) vs. 48% (31%–66%), P = 0.02].28 Toyokawa et al.52 investigated the association between the use of face masks and COVID-19 among passengers and flight attendants exposed to a COVID-19 passenger in a domestic flight. Risk factors for infection included not using a face mask (adjusted odds ratio [aOR]: 7.29, 95% CI 1.86‐28.6) and partial face mask use (aOR: 3.0, 95% CI: 0.83-10.8). Nonuse of face masks was identified as an independent risk factor for contracting COVID-19 on the airplane.
Risk of Bias Assessment
Table 2 – Table 8 shows the risk of bias assessment across all studies included. Seven JBI checklists based on study design were used to assess bias. Risk of bias was classified as low in 1 included study, moderate in 10 studies, and low in 36 studies. In case reports (n=5), there were biases in the description of adverse events (n=3; Table 2). Both the quasi-experimental and RCT studies included in this review were classified as moderate bias due to unclear allocation procedures, blinding issues, and inadequate description of follow up (Table 4 and Table 8). Among the 6 cohort studies included, the majority (83%) were rated as having unclear descriptions of follow up and lacking reasons for loss to follow up (Table 5). Almost all case-control studies (89%) were rated as low risk of bias (Table 6). While the majority of cross sectional studies (95%) were classified as low risk of bias, almost all studies were unreliable in their measurement of SARS-CoV-2 infection as many patients self-reported their COVID-19 status (Table 7).