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Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness.
BMJ Open. 2016 12 30; 6(12):e012330.BO

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.

Authors+Show Affiliations

School of Public Health and Community Medicine UNSW Medicine University of New South Wales, Sydney, New South Wales, Australia. College of Public Service & Community Solutions, Arizona State University, Phoenix, Arizona, USA.The Beijing Centre for Disease Prevention and Control Beijing China, XiCheng district CDC Beijing China, Dongcheng district CDC Beijing, Beijing, China.School of Public Health and Community Medicine UNSW Medicine University of New South Wales, Sydney, New South Wales, Australia. College of Public Service & Community Solutions, Arizona State University, Phoenix, Arizona, USA.School of Public Health and Community Medicine UNSW Medicine University of New South Wales, Sydney, New South Wales, Australia. College of Public Service & Community Solutions, Arizona State University, Phoenix, Arizona, USA.The Beijing Centre for Disease Prevention and Control Beijing China, XiCheng district CDC Beijing China, Dongcheng district CDC Beijing, Beijing, China.The Beijing Centre for Disease Prevention and Control Beijing China, XiCheng district CDC Beijing China, Dongcheng district CDC Beijing, Beijing, China.The Beijing Centre for Disease Prevention and Control Beijing China, XiCheng district CDC Beijing China, Dongcheng district CDC Beijing, Beijing, China.School of Public Health and Community Medicine UNSW Medicine University of New South Wales, Sydney, New South Wales, Australia. College of Public Service & Community Solutions, Arizona State University, Phoenix, Arizona, USA.The Beijing Centre for Disease Prevention and Control Beijing China, XiCheng district CDC Beijing China, Dongcheng district CDC Beijing, Beijing, China.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

28039289

Citation

MacIntyre, Chandini Raina, et al. "Cluster Randomised Controlled Trial to Examine Medical Mask Use as Source Control for People With Respiratory Illness." BMJ Open, vol. 6, no. 12, 2016, pp. e012330.
MacIntyre CR, Zhang Y, Chughtai AA, et al. Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness. BMJ Open. 2016;6(12):e012330.
MacIntyre, C. R., Zhang, Y., Chughtai, A. A., Seale, H., Zhang, D., Chu, Y., Zhang, H., Rahman, B., & Wang, Q. (2016). Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness. BMJ Open, 6(12), e012330. https://doi.org/10.1136/bmjopen-2016-012330
MacIntyre CR, et al. Cluster Randomised Controlled Trial to Examine Medical Mask Use as Source Control for People With Respiratory Illness. BMJ Open. 2016 12 30;6(12):e012330. PubMed PMID: 28039289.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness. AU - MacIntyre,Chandini Raina, AU - Zhang,Yi, AU - Chughtai,Abrar Ahmad, AU - Seale,Holly, AU - Zhang,Daitao, AU - Chu,Yanhui, AU - Zhang,Haiyan, AU - Rahman,Bayzidur, AU - Wang,Quanyi, Y1 - 2016/12/30/ PY - 2017/1/1/entrez PY - 2017/1/1/pubmed PY - 2018/1/2/medline KW - Influenza KW - Mask SP - e012330 EP - e012330 JF - BMJ open JO - BMJ Open VL - 6 IS - 12 N2 - 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. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/28039289/Cluster_randomised_controlled_trial_to_examine_medical_mask_use_as_source_control_for_people_with_respiratory_illness_ L2 - https://bmjopen.bmj.com/lookup/pmidlookup?view=long&pmid=28039289 DB - PRIME DP - Unbound Medicine ER -