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

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 i...

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Main Authors: Abrar Ahmad Chughtai, Chandini Raina MacIntyre, Yi Zhang, Quanyi Wang, Bayzidur Rahman, Haiyan Zhang, Holly Seale, Daitao Zhang, Yanhui Chu
Format: Article
Language:English
Published: BMJ Publishing Group 2016-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/6/12/e012330.full
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author Abrar Ahmad Chughtai
Chandini Raina MacIntyre
Yi Zhang
Quanyi Wang
Bayzidur Rahman
Haiyan Zhang
Holly Seale
Daitao Zhang
Yanhui Chu
author_facet Abrar Ahmad Chughtai
Chandini Raina MacIntyre
Yi Zhang
Quanyi Wang
Bayzidur Rahman
Haiyan Zhang
Holly Seale
Daitao Zhang
Yanhui Chu
author_sort Abrar Ahmad Chughtai
collection DOAJ
description 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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spelling doaj-art-25e8cf047079422c995d8d1f54524f8c2025-02-06T00:55:09ZengBMJ Publishing GroupBMJ Open2044-60552016-12-0161210.1136/bmjopen-2016-012330Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illnessAbrar Ahmad Chughtai0Chandini Raina MacIntyre1Yi Zhang2Quanyi Wang3Bayzidur Rahman4Haiyan Zhang5Holly Seale6Daitao Zhang7Yanhui Chu83 School of Public Health and Community Medicine, UNSW, Sydney, NSW, AustraliaBiosecurity Program, The Kirby Institute, Kensington, New South Wales, Australia3The Beijing Centre for Disease Prevention and Control Beijing China, XiCheng district CDC Beijing China, Dongcheng district CDC Beijing, Beijing, China1 Institute for Infectious Disease and Endemic Disease Control, Beijing Center for Disease Prevention and Control, Beijing Research Center for Preventive medicine, Beijing, ChinaKirby Institute, University of New South Wales, Sydney, New South Wales, AustraliaGuangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, ChinaSchool of Population Health, University of New South Wales, Sydney, New South Wales, Australia3The Beijing Centre for Disease Prevention and Control Beijing China, XiCheng district CDC Beijing China, Dongcheng district CDC Beijing, Beijing, China3The Beijing Centre for Disease Prevention and Control Beijing China, XiCheng district CDC Beijing China, Dongcheng district CDC Beijing, Beijing, ChinaRationale 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.https://bmjopen.bmj.com/content/6/12/e012330.full
spellingShingle Abrar Ahmad Chughtai
Chandini Raina MacIntyre
Yi Zhang
Quanyi Wang
Bayzidur Rahman
Haiyan Zhang
Holly Seale
Daitao Zhang
Yanhui Chu
Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness
BMJ Open
title Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness
title_full Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness
title_fullStr Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness
title_full_unstemmed Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness
title_short Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness
title_sort cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness
url https://bmjopen.bmj.com/content/6/12/e012330.full
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