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A cluster randomised trial of cloth masks compared with medical masks in healthcare workers.

ABSTRACT: OBJECTIVE:The aim of this study was to compare the efficacy of cloth masks to medical masks in hospital healthcare workers (HCWs). The null hypothesis is that there is no difference between medical masks and cloth masks. SETTING:14 secondary-level/tertiary-level hospitals in Hanoi, Vietnam. PARTICIPANTS:1607 hospital HCWs aged ?18?years working full-time in selected high-risk wards. INTERVENTION:Hospital wards were randomised to: medical masks, cloth masks or a control group (usual practice, which included mask wearing). Participants used the mask on every shift for 4 consecutive weeks. MAIN OUTCOME MEASURE:Clinical respiratory illness (CRI), influenza-like illness (ILI) and laboratory-confirmed respiratory virus infection. RESULTS:The rates of all infection outcomes were highest in the cloth mask arm, with the rate of ILI statistically significantly higher in the cloth mask arm (relative risk (RR)=13.00, 95% CI 1.69 to 100.07) compared with the medical mask arm. Cloth masks also had significantly higher rates of ILI compared with the control arm. An analysis by mask use showed ILI (RR=6.64, 95% CI 1.45 to 28.65) and laboratory-confirmed virus (RR=1.72, 95% CI 1.01 to 2.94) were significantly higher in the cloth masks group compared with the medical masks group. Penetration of cloth masks by particles was almost 97% and medical masks 44%. CONCLUSIONS:This study is the first RCT of cloth masks, and the results caution against the use of cloth masks. This is an important finding to inform occupational health and safety. Moisture retention, reuse of cloth masks and poor filtration may result in increased risk of infection. Further research is needed to inform the widespread use of cloth masks globally. However, as a precautionary measure, cloth masks should not be recommended for HCWs, particularly in high-risk situations, and guidelines need to be updated. TRIAL REGISTRATION NUMBER:Australian New Zealand Clinical Trials Registry: ACTRN12610000887077.

SUBMITTER: MacIntyre CR

PROVIDER: S-EPMC4420971 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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A cluster randomised trial of cloth masks compared with medical masks in healthcare workers.

MacIntyre C Raina CR Seale Holly H Dung Tham Chi TC Hien Nguyen Tran NT Nga Phan Thi PT Chughtai Abrar Ahmad AA Rahman Bayzidur B Dwyer Dominic E DE Wang Quanyi Q

BMJ open 20150422 4

<h4>Objective</h4>The aim of this study was to compare the efficacy of cloth masks to medical masks in hospital healthcare workers (HCWs). The null hypothesis is that there is no difference between medical masks and cloth masks.<h4>Setting</h4>14 secondary-level/tertiary-level hospitals in Hanoi, Vietnam.<h4>Participants</h4>1607 hospital HCWs aged ≥18 years working full-time in selected high-risk wards.<h4>Intervention</h4>Hospital wards were randomised to: medical masks, cloth masks or a contr ...[more]

PMID: 25903751

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Project description:BackgroundIn a previous randomised controlled trial (RCT) in hospital healthcare workers (HCWs), cloth masks resulted in a higher risk of respiratory infections compared with medical masks. This was the only published RCT of cloth masks at the time of the COVID-19 pandemic.ObjectiveTo do a post hoc analysis of unpublished data on mask washing and mask contamination from the original RCT to further understand poor performance of the two-layered cotton cloth mask used by HCWs in that RCT.Setting14 secondary-level/tertiary-level hospitals in Hanoi, Vietnam.ParticipantsA subgroup of 607 HCWs aged ≥18 years working full time in selected high-risk wards, who used a two-layered cloth mask and were part of a randomised controlled clinical trial comparing medical masks and cloth masks.InterventionWashing method for cloth masks (self-washing or hospital laundry). A substudy of contamination of a sample of 15 cloth and medical masks was also conducted.Outcome measureInfection rate over 4 weeks of follow up and viral contamination of masks tested by multiplex PCR.ResultsViral contamination with rhinovirus was identified on both used medical and cloth masks. Most HCW (77% of daily washing) self-washed their masks by hand. The risk of infection was more than double among HCW self-washing their masks compared with the hospital laundry (HR 2.04 (95% CI 1.03 to 4.00); p=0.04). There was no significant difference in infection between HCW who wore cloth masks washed in the hospital laundry compared with medical masks (p=0.5).ConclusionsUsing self-reported method of washing, we showed double the risk of infection with seasonal respiratory viruses if masks were self-washed by hand by HCWs. The majority of HCWs in the study reported hand-washing their mask themselves. This could explain the poor performance of two layered cloth masks, if the self-washing was inadequate. Cloth masks washed in the hospital laundry were as protective as medical masks. Both cloth and medical masks were contaminated, but only cloth masks were reused in the study, reiterating the importance of daily washing of reusable cloth masks using proper method. A well-washed cloth mask can be as protective as a medical mask.Trial resgistration numberACTRN12610000887077.

Project description:IntroductionAchieving a sustained improvement in hand-hygiene compliance is the WHO's first global patient safety challenge. There is no RCT evidence showing how to do this. Systematic reviews suggest feedback is most effective and call for long term well designed RCTs, applying behavioural theory to intervention design to optimise effectiveness.MethodsThree year stepped wedge cluster RCT of a feedback intervention testing hypothesis that the intervention was more effective than routine practice in 16 English/Welsh Hospitals (16 Intensive Therapy Units [ITU]; 44 Acute Care of the Elderly [ACE] wards) routinely implementing a national cleanyourhands campaign). Intervention-based on Goal & Control theories. Repeating 4 week cycle (20 mins/week) of observation, feedback and personalised action planning, recorded on forms. Computer-generated stepwise entry of all hospitals to intervention. Hospitals aware only of own allocation.Primary outcomedirect blinded hand hygiene compliance (%).ResultsAll 16 trusts (60 wards) randomised, 33 wards implemented intervention (11 ITU, 22 ACE). Mixed effects regression analysis (all wards) accounting for confounders, temporal trends, ward type and fidelity to intervention (forms/month used). INTENTION TO TREAT ANALYSIS: Estimated odds ratio (OR) for hand hygiene compliance rose post randomisation (1.44; 95% CI 1.18, 1.76;p<0.001) in ITUs but not ACE wards, equivalent to 7-9% absolute increase in compliance. PER-PROTOCOL ANALYSIS FOR IMPLEMENTING WARDS: OR for compliance rose for both ACE (1.67 [1.28-2.22]; p<0.001) & ITUs (2.09 [1.55-2.81]; p<0.001) equating to absolute increases of 10-13% and 13-18% respectively. Fidelity to intervention closely related to compliance on ITUs (OR 1.12 [1.04, 1.20]; p = 0.003 per completed form) but not ACE wards.ConclusionDespite difficulties in implementation, intention-to-treat, per-protocol and fidelity to intervention, analyses showed an intervention coupling feedback to personalised action planning produced moderate but significant sustained improvements in hand-hygiene compliance, in wards implementing a national hand-hygiene campaign. Further implementation studies are needed to maximise the intervention's effect in different settings.Trial registrationControlled-Trials.com ISRCTN65246961.

Project description:BackgroundIt is uncertain if medical masks offer similar protection against COVID-19 compared with N95 respirators.ObjectiveTo determine whether medical masks are noninferior to N95 respirators to prevent COVID-19 in health care workers providing routine care.DesignMulticenter, randomized, noninferiority trial. (ClinicalTrials.gov: NCT04296643).Setting29 health care facilities in Canada, Israel, Pakistan, and Egypt from 4 May 2020 to 29 March 2022.Participants1009 health care workers who provided direct care to patients with suspected or confirmed COVID-19.InterventionUse of medical masks versus fit-tested N95 respirators for 10 weeks, plus universal masking, which was the policy implemented at each site.MeasurementsThe primary outcome was confirmed COVID-19 on reverse transcriptase polymerase chain reaction (RT-PCR) test.ResultsIn the intention-to-treat analysis, RT-PCR-confirmed COVID-19 occurred in 52 of 497 (10.46%) participants in the medical mask group versus 47 of 507 (9.27%) in the N95 respirator group (hazard ratio [HR], 1.14 [95% CI, 0.77 to 1.69]). An unplanned subgroup analysis by country found that in the medical mask group versus the N95 respirator group RT-PCR-confirmed COVID-19 occurred in 8 of 131 (6.11%) versus 3 of 135 (2.22%) in Canada (HR, 2.83 [CI, 0.75 to 10.72]), 6 of 17 (35.29%) versus 4 of 17 (23.53%) in Israel (HR, 1.54 [CI, 0.43 to 5.49]), 3 of 92 (3.26%) versus 2 of 94 (2.13%) in Pakistan (HR, 1.50 [CI, 0.25 to 8.98]), and 35 of 257 (13.62%) versus 38 of 261 (14.56%) in Egypt (HR, 0.95 [CI, 0.60 to 1.50]). There were 47 (10.8%) adverse events related to the intervention reported in the medical mask group and 59 (13.6%) in the N95 respirator group.LimitationPotential acquisition of SARS-CoV-2 through household and community exposure, heterogeneity between countries, uncertainty in the estimates of effect, differences in self-reported adherence, differences in baseline antibodies, and between-country differences in circulating variants and vaccination.ConclusionAmong health care workers who provided routine care to patients with COVID-19, the overall estimates rule out a doubling in hazard of RT-PCR-confirmed COVID-19 for medical masks when compared with HRs of RT-PCR-confirmed COVID-19 for N95 respirators. The subgroup results varied by country, and the overall estimates may not be applicable to individual countries because of treatment effect heterogeneity.Primary funding sourceCanadian Institutes of Health Research, World Health Organization, and Juravinski Research Institute.

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A cluster randomised trial of cloth masks compared with medical masks in healthcare workers.

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A cluster randomised trial of cloth masks compared with medical masks in healthcare workers.

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