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      Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness

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          Abstract

          Rationale

          Medical masks are commonly used by sick individuals with influenza-like illness (ILI) to prevent spread of infections to others, but clinical efficacy data are absent.

          Objective

          Determine whether medical mask use by sick individuals with ILI protects well contacts from related respiratory infections.

          Setting

          6 major hospitals in 2 districts of Beijing, China.

          Design

          Cluster randomised controlled trial.

          Participants

          245 index cases with ILI.

          Intervention

          Index cases with ILI were randomly allocated to medical mask (n=123) and control arms (n=122). Since 43 index cases in the control arm also used a mask during the study period, an as-treated post hoc analysis was performed by comparing outcomes among household members of index cases who used a mask (mask group) with household members of index cases who did not use a mask (no-mask group).

          Main outcome measure

          Primary outcomes measured in household members were clinical respiratory illness, ILI and laboratory-confirmed viral respiratory infection.

          Results

          In an intention-to-treat analysis, rates of clinical respiratory illness (relative risk (RR) 0.61, 95% CI 0.18 to 2.13), ILI (RR 0.32, 95% CI 0.03 to 3.13) and laboratory-confirmed viral infections (RR 0.97, 95% CI 0.06 to 15.54) were consistently lower in the mask arm compared with control, although not statistically significant. A post hoc comparison between the mask versus no-mask groups showed a protective effect against clinical respiratory illness, but not against ILI and laboratory-confirmed viral respiratory infections.

          Conclusions

          The study indicates a potential benefit of medical masks for source control, but is limited by small sample size and low secondary attack rates. Larger trials are needed to confirm efficacy of medical masks as source control.

          Trial registration number

          ACTRN12613000852752; Results.

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          Most cited references21

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          Facemasks and hand hygiene to prevent influenza transmission in households: a cluster randomized trial.

          Few data are available about the effectiveness of nonpharmaceutical interventions for preventing influenza virus transmission. To investigate whether hand hygiene and use of facemasks prevents household transmission of influenza. Cluster randomized, controlled trial. Randomization was computer generated; allocation was concealed from treating physicians and clinics and implemented by study nurses at the time of the initial household visit. Participants and personnel administering the interventions were not blinded to group assignment. (ClinicalTrials.gov registration number: NCT00425893) Households in Hong Kong. 407 people presenting to outpatient clinics with influenza-like illness who were positive for influenza A or B virus by rapid testing (index patients) and 794 household members (contacts) in 259 households. Lifestyle education (control) (134 households), hand hygiene (136 households), or surgical facemasks plus hand hygiene (137 households) for all household members. Influenza virus infection in contacts, as confirmed by reverse-transcription polymerase chain reaction (RT-PCR) or diagnosed clinically after 7 days. Sixty (8%) contacts in the 259 households had RT-PCR-confirmed influenza virus infection in the 7 days after intervention. Hand hygiene with or without facemasks seemed to reduce influenza transmission, but the differences compared with the control group were not significant. In 154 households in which interventions were implemented within 36 hours of symptom onset in the index patient, transmission of RT-PCR-confirmed infection seemed reduced, an effect attributable to fewer infections among participants using facemasks plus hand hygiene (adjusted odds ratio, 0.33 [95% CI, 0.13 to 0.87]). Adherence to interventions varied. The delay from index patient symptom onset to intervention and variable adherence may have mitigated intervention effectiveness. Hand hygiene and facemasks seemed to prevent household transmission of influenza virus when implemented within 36 hours of index patient symptom onset. These findings suggest that nonpharmaceutical interventions are important for mitigation of pandemic and interpandemic influenza. Centers for Disease Control and Prevention.
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            Face Mask Use and Control of Respiratory Virus Transmission in Households

            Highly pathogenic avian influenza virus A (H5N1) continues to spread globally, posing a serious human pandemic threat. In the event of an influenza pandemic or other emerging respiratory disease such as severe acute respiratory syndrome (SARS), it is likely that antiviral drugs and vaccines will be in short supply or that delivery could be delayed. Therefore, nonpharmaceutical interventions such as mask use, handwashing, and other hygiene measures or school closure might be effective early control strategies. In contrast to pharmaceutical interventions, little is known about the effectiveness of nonpharmaceutical interventions in the community. A recent analysis gives estimates of the effect of school closure ( 1 ), and several prospective, randomized controlled trials of handwashing have been published ( 2 – 11 ). However, clinical trial data on the ability of face masks to reduce respiratory virus transmission in the community are limited to 1 published prospective trial, which showed lack of efficacy ( 12 ). In addition, adverse effects of wearing masks (particularly respirators) may affect compliance and effectiveness ( 13 – 15 ). Despite the lack of quantitative evidence, many countries have included recommendations in their pandemic plans on the use of face masks ( 16 – 18 ). We present the results of a cluster-randomized household study of the effectiveness of using face masks to prevent or reduce transmission of influenza-like illness (ILI). Methods A prospective, cluster-randomized trial of mask use in households was conducted during the 2 winter seasons of 2006 and 2007 (August to the end of October 2006 and June to the end of October 2007) in Sydney, Australia. Enrollment in the study was restricted to households with >2 healthy adults >16 years of age; the adults had known exposure within the household to a child with fever and respiratory symptoms. Suitable households were identified at a pediatric health service comprising the emergency department of a pediatric hospital and a pediatric primary care practice in Sydney, New South Wales, Australia. The study protocol was approved by the local institutional review board. Randomization and Intervention Participating households were randomized to 1 of 3 arms by a secure computerized randomization process: 1) surgical masks (3M surgical mask, catalogue no. 1820; St. Paul, MN, USA) for 2 adults, to be worn at all times when in the same room as the index child, regardless of the distance from the child; 2) P2 masks (3M flat-fold P2 mask, catalogue no. 9320; Bracknell, Berkshire, UK), for 2 adults, to be worn at all times when in the same room as the index child, regardless of the distance from the child; and 3) a control group (no masks used). The P2 masks used have an almost identical specification as N95 masks used in the United States ( 19 ). According to New South Wales Health guidelines, pamphlets about infection control were provided to participants in all arms. Study participants and trial staff were not blinded, as it is not technically possible to blind the mask type to which participants were randomized. However, laboratory staff were blinded to the arm of randomization. Figure 1 shows the flow diagram for the trial as suggested by CONSORT guidelines ( 20 ). Figure 1 Flow diagram of recruitment for the prospective cluster-randomized trial, Sydney, New South Wales, Australia, 2006 and 2007 winter influenza seasons. Recruitment and Follow-up Children 0–15 years of age seeking treatment at pediatric health services with fever (temperature >37.8oC) and either cough or sore throat were identified by an electronic triage system. Parents or primary caregivers were approached in the waiting room, and that household was invited to join the study if all of the following criteria were satisfied: 1) the household contained >2 adults >16 years of age and 1 child 0–15 years of age; 2) the index child had fever (temperature >37.8oC) and either a cough or sore throat; 3) the child was the first and only person to become ill in the family in the previous 2 weeks; 4) adult caregivers consented to participate in the study; and 5) the index child was not admitted to the hospital. If eligibility criteria were satisfied, adults from the household were enrolled in the study. Enrolled adults and any siblings of the index child were then evaluated for respiratory symptoms and signs (fever, history of fever or feeling feverish in the past week, myalgia, arthralgia, sore throat, cough, sneezing, runny nose, nasal congestion, headache). If any of these symptoms were present, the family and household were excluded. Sociodemographic and medical information including influenza vaccination history (both the index child and participating adults) was obtained using a researcher-administered questionnaire. Medication use was also recorded. The index case-patient had combined nasal (each nostril) and throat swabs collected for multiplex reverse transcription–PCR (RT-PCR) testing. The household was randomized to 1 of the 3 arms, allocated the appropriate mask type, and educated about infection prevention. Formal fit testing of the P2 masks was not performed, but information pertaining to the correct method for fitting and disposing of the masks was provided. Over the next week, participants were contacted by telephone daily to determine if symptoms had developed and to record adherence to mask use throughout the day. Each household was supplied with a thermometer to measure the temperature of symptomatic adult participants twice daily. If study staff determined that a participant had developed respiratory disease symptoms at follow-up, a home visit was conducted on the same day and the participant was swabbed and tested for respiratory viruses (see methods described below). Symptomatic participants were then followed up daily for 2 weeks. Because all respiratory pathogens share similar transmission mechanisms—aerosol, droplet, and fomite spread (although the relative role of these factors may vary among different viruses and in different clinical situations)—we deliberately considered a broad definition of clinical cases consistent with a wide range of common respiratory viruses. Respiratory viruses detected in the study included influenza A and B, respiratory syncytial virus (RSV), adenovirus, parainfluenza viruses (PIV) types 1–3, coronaviruses 229E and OC43, human metapneumovirus (hMPV), enteroviruses, and rhinoviruses. Adherence to face mask use was specifically monitored during each household follow-up. Measuring adherence and reasons for nonadherence is critical for evaluating the efficacy of mask use for reducing treatment and for providing practical advice on future use of face masks. Exit interviews with participants in the surgical mask and the P2 mask arms were conducted to gain further insights into adherence. Sample Collection and Laboratory Testing Rayon-tipped, plastic-shafted swabs were inserted separately into each participant’s nostrils and pharynx, placed into viral transport media, and transported immediately to the laboratory or stored at 4oC if transport was delayed. Nose and throat swabs of index children and adult participants with symptoms of respiratory illness were tested by using nucleic acid and a series of multiplex RT-PCR tests ( 21 ) to detect influenza A and B and RSV, PIV types 1–3, picornaviruses (enteroviruses or rhinoviruses), adenoviruses, coronaviruses 229E and OC43, and hMPV. Case Definition To include the broadest possible spectrum of clinical syndromes occurring among enrolled adults ( 22 ), during follow-up we defined ILI by the presence of fever (temperature >37.8°C), feeling feverish or a history of fever, >2 symptoms (sore throat, cough, sneezing, runny nose, nasal congestion, headache), or 1 of the symptoms listed plus laboratory confirmation of respiratory viral infection. The choice of a relatively broad clinical case definition was dictated by our interest in interrupting transmission of a broad range of respiratory viruses. Laboratory-confirmed cases during the follow-up were defined by the presence of >1 of the symptoms listed above plus laboratory detection of a respiratory virus. Study Outcomes and Analysis The primary study outcomes in enrolled adults were the presence of ILI or a laboratory diagnosis of respiratory virus infection within 1 week of enrollment. Given that we demonstrated some dual infections and that there may be a variable sensitivity of RT-PCR for different respiratory viruses, we included all incident infections in adults (by clinical case definition and laboratory testing) in the analysis. We also measured the time from recruitment to infection. Causal linking of the outcomes of ILI and adherence to use of face masks required consideration of the timing of both. Analysis of primary outcomes was by intention to treat. We performed a multivariate Cox proportional-hazards survival analysis to study secondary outcomes and determine how time lag from recruitment to infection of a secondary case-patient was affected by explanatory covariates ( 23 ). Gaussian random effects were incorporated in the model to account for the natural clustering of persons in households ( 24 ). The day of infection was reconstructed from the day of symptom onset under the assumption that the incubation period was 1–2 days. To account for exposures that occurred before recruitment, the time when survival analysis started was defined as the maximum value between the day of recruitment minus the incubation period and the start of illness in the index case. (For example, assume a household recruited on day 0 and an incubation period of 2 days. If illness in the index case began on day –3, then the survival analysis began on day –2; if illness in the index case began on day –1, then the survival analysis began the same day.) The following variables were included in the models: daily adherence to use of P2 or surgical masks, number of adults in the household, number of siblings in the household, and index case 75% of P2 or surgical masks at 80% power and with a p value of 0.05. Our efficacy estimate was a conservative assumption based on observational data for the combined effects of all mask types during the SARS epidemic in Hong Kong ( 25 ). Results Study Population We recruited 290 adults from 145 families; 47 households (94 enrolled adults and 180 children) were randomized to the surgical mask group, 46 (92 enrolled adults and 172 children) to the P2 mask group, and 52 (104 enrolled adults and 192 children) to the no-mask (control) group. Two families in the control group were lost to follow-up during the study. Characteristics of the families who participated are shown in Table 1, with no significant differences noted among the 3 arms. Table 1 Demographic characteristics of each household by arm of randomization in the study, Sydney, New South Wales, Australia, 2006 and 2007 winter influenza seasons Variable Control group, no. (%), n = 50 Surgical mask group P2 mask group No. (%), n = 47 p value No. (%), n = 46 p value Living arrangement Reside in house 38 (76) 32 (68) 0.39 33 (72) 0.64 >4 persons in house 13 (26) 18 (38) 0.20 19 (41) 0.11 >3 adults in house 8 (16) 11 (23) 0.36 12 (26) 0.23 Demographics Caucasian race* 28 (56) 20 (43) 0.18 17 (37) 0.06 Both adults work 28 (56) 25 (53) 0.78 27 (59) 0.79 Smoker in house 12 (24) 12 (26) 0.86 4 (9) 0.046 Index child fully immunized 45 (90) 45 (96) 0.28 39 (85) 0.44 Index child attends childcare 37 (74) 34 (72) 0.85 27 (59) 0.11 Influenza vaccination Index child 1 (2) 1 (2) 0.97 0 0.34 1 adult vaccinated 2 (4) 2 (4) 0.95 0 0.17 Duration of child sickness† 4 5 4 Siblings reporting illness 3 (6) 1 (1) 0.34 0 0.09 *Information relates to the participating adult interviewed.
†Median no. days. Samples were collected from 141 children; respiratory viruses were detected in 90 (63.8%) children. In 79 (56.0%) of 141 cases, a single pathogen was detected: influenza A in 19/141 (13.5%); influenza B in 7/141 (4.9%); adenoviruses in 7/141 (4.9%); RSV in 5/141 (3.5%); PIV in 8/141 (5.5%) (PIV-1 in 1/141 [0.70%]; PIV-2 in 2/141 [1.4%]; PIV-3 in 5/141 [3.5%]); hMPV in 8/141 (5.7%); and coronavirus OC43 in 3/141 (2.1%). Other viruses detected included picornaviruses in 22/141 (15.6%): rhinoviruses in 11/22 (50.0%); enteroviruses in 5/22 (22.7%) (enterovirus 68 in 1/5 [20.0%] and others in 4/5 [80.0%]); and uncharacterized nonsequenced picornaviruses in 6/22 (27.0%). An additional 11 children (7.8%) had dual or co-infection: 4 (2.8%) with adenovirus and rhinovirus, 2 (1.4%) with rhinovirus and coronavirus; and 1 each with influenza A and enterovirus, influenza A and PIV-2, influenza A and rhinovirus, RSV and enterovirus, and adenovirus and hMPV. Adherence Characteristics of the adherent versus nonadherent participants who were recruited are shown in Table 2; no significant differences were noted between the 2 groups except for the presence of >3 adults in the household. On day 1 of mask use, 36 (38%) of the 94 surgical mask users and 42 (46%) of the 92 P2 mask users stated that they were wearing the mask “most or all” of the time. Other participants were wearing face masks rarely or never. The difference between the groups was not significant (p = 0.37). Adherence dropped to 29/94 (31%) and 23/92 (25%), respectively, by day 5 of mask use (Figure 2). Table 2 Characteristics of adherent versus nonadherent mask wearers in the study, Sydney, New South Wales, Australia, 2006 and 2007 winter influenza seasons * Variable Fully adherent mask users, no. (%), 
n = 30 Nonadherent mask users, no. (%), 
n = 156 p value Living arrangement Reside in house 22 (73) 108 (69) 0.66 >4 persons in house 11 (37) 64 (41) 0.66 >3 adults in house 3 (10) 43 (28) 0.04 Demographics Caucasian race† 10 (33) 29 (19) 0.07 Working adult 22 (73) 118 (76) Smoker in house Daily handwashing 14 (45) 54 (34) 0.21 Use of soap when handwashing 13 (43) 65 (42) 0.87 Index child fully immunized 15 (50) 69 (44) 0.56 Index child attends childcare 6 (20) 51 (33) 0.17 Influenza vaccination Index child 0 1 (0.5) 0.66 Adult 1 0 2 (1) 0.53 Adult 2 0 2 (1%) 0.53 Median days of child sickness 5 5 Siblings reporting illness 0 1 (0.5) 0.66 *Adherence to mask use and handwashing measured by daily self-reports and exit interviews.
†Information relates to the participating adult interviewed. Figure 2 Compliance with mask use by day over 5 consecutive days during the study, Sydney, New South Wales, Australia, 2006 and 2007 winter influenza seasons. Table 3 shows reported problems with mask use. There were no significant differences in difficulties with mask use between the P2 and surgical mask groups, but >50% reported concerns, the main one being that wearing a face mask was uncomfortable. Other concerns were that the child did not want the parent wearing a mask and the parent forgot to wear the mask. Additional comments made by some included that the mask did not fit well and that it was not practical to wear at meal time or while asleep. Some adults wore the mask during the day but not at night, even though the sick child was sleeping beside them in their bed. Table 3 Problems with face mask use reported by participants in the study, Sydney, New South Wales, Australia, 2006 and 2007 winter influenza seasons Reported problem Surgical mask users, no. (%), n = 94 P2 mask users, no. (%), n = 92 p value None 46 (49) 42 (46) 0.66 Uncomfortable 16 (17) 14 (15) 0.74 Forgot to wear it 8 (9) 8 (9) 0.96 Child did not like it 6 (6) 8 (9) 0.55 Other 18 (19) 20 (22) 0.66 Intention-to-Treat Analysis ILI was reported in 21/94 (22.3%) in the surgical group, 14/92 (15.2%) in the P2 group, and 16/100 (16.0%) in the control group, respectively. Samples were collected from 43/51 (84%) sick adults, with respiratory viruses isolated in 17/43 (40%) sick adults. Viral pathogens were isolated from 6/94 (6.4%) in the surgical mask group, 8/92 (8.7%) in the P2 group, and 3/100 (3.0%) in the control group. In 10/17 laboratory-positive cases, the same respiratory virus was isolated in the adult and the child (surgical, 3/94; P2 group, 5/92; and control, 2/100). In 2 cases, the adult was the only person with a laboratory-confirmed virus (1 each from the P2 and surgical groups); in the remaining 5 adults, the virus detected in the child differed from that in the adult (surgical, 2; P2 group, 2; and control group, 1). No dual infections were detected in the adults. Intention-to-treat analysis by households and by participants showed no significant difference between the groups (Table 4). Table 4 Intention-to-treat analysis used in the study* Data Control group, no. (%) All masks Surgical masks P2 masks No. (%) RR (95% CI)† p value† No. (%) RR
(95% CI)† p value† No. (%) RR
(95% CI)† p
value† By house n = 50 n = 93 n = 47 n = 46 ILI 12 (24) 25 (27) 1.12
(0.62–2.03) 0.84 15 (32) 1.33
(0.70–2.54) 0.50 10 (22) 0.91
(0.43–1.89) 0.81 By individual n = 100 n = 186 n = 94 n = 92 ILI 16 (16) 33 (18) 1.11
(0.64–1.91) 0.75 19 (20) 1.29
(0.69–2.31) 0.46 14 (15) 0.95
(0.49-1.84) 1 Laboratory confirmed infections Influenza A 0 3 (2) 1 (1) 2 (2) Influenza B 0 1 (0.5) 0 1 (1) RSV 1 (1) 1 (0.5) 0 0 hMPV 0 0 0 0 Adenoviruses 0 2 (1) 0 2 (2) PIV‡ 1 (1) 1 (0.5) 1 (1) 0 Coronaviruses§ 1 (1) 0 0 0 Rhinoviruses 0 5 (3) 3 (3) 2 (2) Enteroviruses 0 0 0 0 Picornoviruses 0 1 (0.5) 0 1 (1) Total 3 (3) 14 (8) 2.51
(0.74–8.5) 0.19 6 (6) 2.13
(0.55–8.26) 0.32 8 (9) 2.90
(0.79–10.6) 0.12 *RR, relative risk; CI, confidence interval; ILI, influenza-like illness; RSV, respiratory syncytial virus; hMPV, human metapneumovirus; PIV, parainfluenza virus.
†Reference group is the control group.
‡Types 1–3; 229E/OC43.
§Types 1–3. Risk Factors for ILI Under the assumption that the incubation period is equal to 1 day (the most probable value for the 2 most common viruses isolated, influenza [ 21 ] and rhinovirus [ 26 ]), adherent use of P2 or surgical masks significantly reduces the risk for ILI infection, with a hazard ratio equal to 0.26 (95% CI [confidence interval] 0.09–0.77; p = 0.015). No other covariate was significant. Under the less likely assumption that the incubation period is equal to 2 days, the quantified effect of complying with P2 or surgical mask use remains strong, although borderline significant; hazard ratio was 0.32 (95% CI 0.11–0.98; p = 0.046). The study was underpowered to determine if there was a difference in efficacy between P2 and surgical masks (Table 5). Table 5 Estimates of hazard ratios for ILI in the study* Variable Global effect of mask use Effect per mask type Hazard ratio (95% CI) p value Hazard ratio (95% CI) p value 1-d incubation period Adherence to use of surgical or P2 mask† 0.26 (0.09–0.77) 0.015‡ Adherence to use of surgical mask† 0.27 (0.06–1.24) 0.09 Adherence to use of P2 mask† 0.24 (0.05–1.08) 0.06 No. adults 1.07 (0.66–1.71) 0.80 1.06 (0.66–1.71) 0.80 No. siblings 0.86 (0.55–1.35) 0.52 0.86 (0.55–1.35) 0.52 Index patient <5 y of age 0.88 (0.41–1.89) 0.75 0.88 (0.41–1.89) 0.74 Frailty§ 0.005‡ 0.004‡ 2-d incubation period Adherence to use of surgical or P2 mask† 0.32 (0.11–0.98) 0.046‡ Adherence to use of surgical mask† 0.18 (0.02–1.38) 0.099 Adherence to use of P2 mask† 0.45 (0.12–1.62) 0.22 No. adults 1.13 (0.71–1.81) 0.60 1.14 (0.71–1.82) 0.59 No. siblings 0.80 (0.51–1.27) 0.34 0.80 (0.50–1.27) 0.34 Index patient <5 y of age 1.02 (0.46–2.24) 0.96 1.02 (0.47–2.25) 0.95 Frailty§ 0.004‡ 0.004‡ *ILI, influenza-like illness; CI, confidence interval.
†Time-dependent variable.
‡p<0.05 significant (indicates that the outcome for 1 person is correlated with the outcome of other persons in the household).
§This term measures if the clustering of subjects in households is relevant to quantify the risk of ILI infection. Discussion We present the results of a prospective clinical trial of face mask use conducted in response to an urgent need to clarify the clinical benefit of using masks. The key findings are that <50% of participants were adherent with mask use and that the intention-to-treat analysis showed no difference between arms. Although our study suggests that community use of face masks is unlikely to be an effective control policy for seasonal respiratory diseases, adherent mask users had a significant reduction in the risk for clinical infection. Another recent study that examined the use of surgical masks and handwashing for the prevention of influenza transmission also found no significant difference between the intervention arms ( 12 ). Our study found that only 21% of household contacts in the face mask arms reported wearing the mask often or always during the follow-up period. Adherence with treatments and preventive measures is well known to vary depending on perception of risk ( 27 ) and would be expected to increase during an influenza pandemic. During the height of the SARS epidemic of April and May 2003 in Hong Kong, adherence to infection control measures was high; 76% of the population wore a face mask, 65% washed their hands after relevant contact, and 78% covered their mouths when sneezing or coughing ( 28 ). In addition, adherence may vary depending on cultural context; Asian cultures are more accepting of mask use ( 29 ). Therefore, although we found that distributing masks during seasonal winter influenza outbreaks is an ineffective control measure characterized by low adherence, results indicate the potential efficacy of masks in contexts where a larger adherence may be expected, such as during a severe influenza pandemic or other emerging infection. We estimated that, irrespective of the assumed value for the incubation period (1 or 2 days), the relative reduction in the daily risk of acquiring a respiratory infection associated with adherent mask use (P2 or surgical) was in the range of 60%–80%. Those results are consistent with those of a simpler analysis in which persons were stratified according to adherence (Technical Appendix ). We emphasize that this level of risk reduction is dependent on the context, namely, adults in the household caring for a sick child after exposure to a single index case. We urge caution in extrapolating our results to school, workplace, or community contexts, or where multiple, repeated exposures may occur, such as in healthcare settings. The exact mechanism of potential clinical effectiveness of face mask use may be the prevention of inhalation of respiratory pathogens but may also be a reduction in hand-to-face contact. Our study could not determine the relative contributions of these mechanisms. In this study, it is only possible to talk about a statistical association between adherent mask use and reduction in the risk of ILI-infection. The causal link cannot be demonstrated because adherence was not randomized in the trial. Although we found no significant difference in handwashing practices between adherent and non-adherent mask users, it is possible that adherent mask use is correlated with other, unobserved variables that reduce the risk of infection. Further work will therefore be needed to definitively demonstrate that adherent mask use reduces the risk of ILI-infection. In our study, fit testing for P2 masks was not conducted because this is unlikely to be feasible in the general community during a pandemic. As such, we felt it was more appropriate to determine the efficacy of non–fit-tested masks. We found no difference in adherence between P2 and surgical masks, an important finding, as there is a common belief among healthcare workers that P2 masks are less comfortable. The size of the study did not permit conclusive comparison of the relative efficacy of P2 masks and surgical masks. Given the 5- to 10-fold cost difference between the 2 mask types, quantifying any difference in efficacy between surgical masks and particulate respirators remains a priority that needs to be addressed by a larger trial. A possible limitation of the study is that some adults may have been incubating infection at the time of enrollment. However, this effect would have biased the results toward the null in the intention-to-treat analysis. The survival analysis explicitly accounted for the existence of a fixed incubation period and incubating infections at the time of enrollment. A potential alternative study design would be to enroll participants from asymptomatic households, do follow-up for development of infection, and then immediately intervene with masks. For such a design, given that only 15%–20% of closely exposed adults will develop illness after exposure to an ill child, thousands of households (rather than hundreds) would be required to afford the same study power. In addition, such a design would have been fraught with underascertainment of incident infections and delayed implementation of mask intervention. We believe ours is a more efficient design. A further limitation is that some parents may have acquired infection outside the home. We identified 5 child–parent pairs with discordant viral infections. The randomization process should have ensured that outside exposure was equally distributed between arms, and this effect would have biased the results toward the null. In retrospect, relying on laboratory-confirmed cases as the primary outcome may have been unrealistic for a study of this size. ILI in enrolled adults was 17.1%, but laboratory confirmation was modest; the virus was identified in only 34.7% of adult ILI cases (the rate of laboratory diagnosis in children was high at 63.8%). However, even intention-to-treat analysis using ILI outcome shows no significant difference between the groups. We used self-reporting to determine adherence; previous research indicates that patient self-reporting is more reliable than judgments by doctors or nurses when compared against urine drug levels ( 30 ). In addition, the significant association between adherence and clinical protection provides internal validation of self-reporting as a measure. An important aspect of this study is that we included respiratory viruses other than influenza. Although these viruses may differ in their relative dependence (accurate quantitation of this relativity is uncertain for the various viruses) on different transmission mechanisms (i.e., large droplet, aerosol, or fomite), all are transmitted by the respiratory route. Therefore, face mask use should have some effect on virus transmission (e.g., interference with hand-nose contact), given that participants in all arms of the study received the same infection control advice. In addition, we argue that assessing multiple respiratory viruses allows our results to be generalized more broadly to other infections, including new respiratory viruses that may emerge in the future. Conversely, the low rate of confirmed influenza A or B infection (18.4%) in the study could mean that our findings are not directly applicable to a scenario in which influenza predominates. If influenza is more likely than the other viruses in our study to be transmitted by the respiratory route, the prevalence of mixed infections would tend to bias our results toward the null. However, it is possible that a pandemic strain may have different transmission characteristics than seasonal strains as demonstrated by attack rates in different age groups in pandemics compared with seasonal outbreaks and by the detection of influenza virus in different clinical samples in human influenza virus A (H5N1) cases. Results of our study have global relevance to respiratory disease control planning, especially with regard to home care. During an influenza pandemic, supplies of antiviral drugs may be limited, and there will be unavoidable delays in the production of a matched pandemic vaccine ( 31 ). For new or emerging respiratory virus infections, no pharmaceutical interventions may be available. Even with seasonal influenza, widespread oseltamivir resistance in influenza virus A (H1N1) strains have recently been reported ( 32 ). Masks may therefore play an important role in reducing transmission. Supplementary Material Technical Appendix Face Mask Use and Control of Respiratory Virus Transmission in Households
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              A cluster randomized clinical trial comparing fit‐tested and non‐fit‐tested N95 respirators to medical masks to prevent respiratory virus infection in health care workers

              Please cite this paper as: MacIntyre et al. (2011) A cluster randomized clinical trial comparing fit‐tested and non‐fit‐tested N95 respirators to medical masks to prevent respiratory virus infection in health care workers. Influenza and Other Respiratory Viruses DOI: 10.1111/j.1750‐2659.2010.00198.x. Background  We compared the efficacy of medical masks, N95 respirators (fit tested and non fit tested), in health care workers (HCWs). Methods  A cluster randomized clinical trial (RCT) of 1441 HCWs in 15 Beijing hospitals was performed during the 2008/2009 winter. Participants wore masks or respirators during the entire work shift for 4 weeks. Outcomes included clinical respiratory illness (CRI), influenza‐like illness (ILI), laboratory‐confirmed respiratory virus infection and influenza. A convenience no‐mask/respirator group of 481 health workers from nine hospitals was compared. Findings  The rates of CRI (3·9% versus 6·7%), ILI (0·3% versus 0·6%), laboratory‐confirmed respiratory virus (1·4% versus 2·6%) and influenza (0·3% versus 1%) infection were consistently lower for the N95 group compared to medical masks. By intention‐to‐treat analysis, when P values were adjusted for clustering, non‐fit‐tested N95 respirators were significantly more protective than medical masks against CRI, but no other outcomes were significant. The rates of all outcomes were higher in the convenience no‐mask group compared to the intervention arms. There was no significant difference in outcomes between the N95 arms with and without fit testing. Rates of fit test failure were low. In a post hoc analysis adjusted for potential confounders, N95 masks and hospital level were significant, but medical masks, vaccination, handwashing and high‐risk procedures were not. Interpretation  Rates of infection in the medical mask group were double that in the N95 group. A benefit of respirators is suggested but would need to be confirmed by a larger trial, as this study may have been underpowered. The finding on fit testing is specific to the type of respirator used in the study and cannot be generalized to other respirators. Trial registration  Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: ACTRN12609000257268 (http://www.anzctr.org.au).
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2016
                30 December 2016
                : 6
                : 12
                Affiliations
                [1 ]School of Public Health and Community Medicine UNSW Medicine University of New South Wales , Sydney, New South Wales, Australia
                [2 ]College of Public Service & Community Solutions, Arizona State University , Phoenix, Arizona, USA
                [3 ]The Beijing Centre for Disease Prevention and Control Beijing China, XiCheng district CDC Beijing China , Dongcheng district CDC Beijing , Beijing, China
                Author notes
                [Correspondence to ] Prof Raina MacIntyre; r.macintyre@ 123456unsw.edu.au
                Article
                bmjopen-2016-012330
                10.1136/bmjopen-2016-012330
                5223715
                28039289
                b5bc90ca-cb8d-44b3-a466-c0baaa322325
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

                This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

                Product
                Categories
                Infectious Diseases
                Research
                1506
                1706
                1706

                Medicine
                mask,influenza
                Medicine
                mask, influenza

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