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Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers: A Randomized Controlled Trial

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Bundgaard, Henning ; Bundgaard, Johan Skov ; Raaschou-Pedersen, Daniel Emil Tadeusz ; von Buchwald, Christian ; Todsen, Tobias ; Norsk, Jakob Boesgaard ; Pries-Heje, Mia M ; Vissing, Christoffer Rasmus ; Nielsen, Pernille B ; Winsløw, Ulrik C ; Fogh, Kamille ; Hasselbalch, Rasmus ; Kristensen, Jonas H ; Ringgaard, Anna ; Porsborg Andersen, Mikkel ; Goecke, Nicole Bakkegård ; Trebbien, Ramona ; Skovgaard, Kerstin ; Benfield, Thomas ; Ullum, Henrik ; Torp-Pedersen, Christian ; Iversen, Kasper. / Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers : A Randomized Controlled Trial. I: Annals of Internal Medicine. 2021 ; Bind 174, Nr. 3. s. 335-343.

Bibtex

@article{49da005b3f5d44d2a6b4a9a19094cb84,
title = "Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers: A Randomized Controlled Trial",
abstract = "BACKGROUND: Observational evidence suggests that mask wearing mitigates transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is uncertain if this observed association arises through protection of uninfected wearers (protective effect), via reduced transmission from infected mask wearers (source control), or both.OBJECTIVE: To assess whether recommending surgical mask use outside the home reduces wearers' risk for SARS-CoV-2 infection in a setting where masks were uncommon and not among recommended public health measures.DESIGN: Randomized controlled trial (DANMASK-19 [Danish Study to Assess Face Masks for the Protection Against COVID-19 Infection]). (ClinicalTrials.gov: NCT04337541).SETTING: Denmark, April and May 2020.PARTICIPANTS: Adults spending more than 3 hours per day outside the home without occupational mask use.INTERVENTION: Encouragement to follow social distancing measures for coronavirus disease 2019, plus either no mask recommendation or a recommendation to wear a mask when outside the home among other persons together with a supply of 50 surgical masks and instructions for proper use.MEASUREMENTS: The primary outcome was SARS-CoV-2 infection in the mask wearer at 1 month by antibody testing, polymerase chain reaction (PCR), or hospital diagnosis. The secondary outcome was PCR positivity for other respiratory viruses.RESULTS: A total of 3030 participants were randomly assigned to the recommendation to wear masks, and 2994 were assigned to control; 4862 completed the study. Infection with SARS-CoV-2 occurred in 42 participants recommended masks (1.8%) and 53 control participants (2.1%). The between-group difference was -0.3 percentage point (95% CI, -1.2 to 0.4 percentage point; P = 0.38) (odds ratio, 0.82 [CI, 0.54 to 1.23]; P = 0.33). Multiple imputation accounting for loss to follow-up yielded similar results. Although the difference observed was not statistically significant, the 95% CIs are compatible with a 46% reduction to a 23% increase in infection.LIMITATION: Inconclusive results, missing data, variable adherence, patient-reported findings on home tests, no blinding, and no assessment of whether masks could decrease disease transmission from mask wearers to others.CONCLUSION: The recommendation to wear surgical masks to supplement other public health measures did not reduce the SARS-CoV-2 infection rate among wearers by more than 50% in a community with modest infection rates, some degree of social distancing, and uncommon general mask use. The data were compatible with lesser degrees of self-protection.PRIMARY FUNDING SOURCE: The Salling Foundations.",
author = "Henning Bundgaard and Bundgaard, {Johan Skov} and Raaschou-Pedersen, {Daniel Emil Tadeusz} and {von Buchwald}, Christian and Tobias Todsen and Norsk, {Jakob Boesgaard} and Pries-Heje, {Mia M} and Vissing, {Christoffer Rasmus} and Nielsen, {Pernille B} and Winsl{\o}w, {Ulrik C} and Kamille Fogh and Rasmus Hasselbalch and Kristensen, {Jonas H} and Anna Ringgaard and {Porsborg Andersen}, Mikkel and Goecke, {Nicole Bakkeg{\aa}rd} and Ramona Trebbien and Kerstin Skovgaard and Thomas Benfield and Henrik Ullum and Christian Torp-Pedersen and Kasper Iversen",
note = "Copyright: This record is sourced from MEDLINE/PubMed, a database of the U.S. National Library of Medicine",
year = "2021",
month = mar,
day = "1",
doi = "10.7326/M20-6817",
language = "English",
volume = "174",
pages = "335--343",
journal = "Annals of Internal Medicine",
issn = "0003-4819",
publisher = "American College of Physicians",
number = "3",

}

RIS

TY - JOUR

T1 - Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers

T2 - A Randomized Controlled Trial

AU - Bundgaard, Henning

AU - Bundgaard, Johan Skov

AU - Raaschou-Pedersen, Daniel Emil Tadeusz

AU - von Buchwald, Christian

AU - Todsen, Tobias

AU - Norsk, Jakob Boesgaard

AU - Pries-Heje, Mia M

AU - Vissing, Christoffer Rasmus

AU - Nielsen, Pernille B

AU - Winsløw, Ulrik C

AU - Fogh, Kamille

AU - Hasselbalch, Rasmus

AU - Kristensen, Jonas H

AU - Ringgaard, Anna

AU - Porsborg Andersen, Mikkel

AU - Goecke, Nicole Bakkegård

AU - Trebbien, Ramona

AU - Skovgaard, Kerstin

AU - Benfield, Thomas

AU - Ullum, Henrik

AU - Torp-Pedersen, Christian

AU - Iversen, Kasper

N1 - Copyright: This record is sourced from MEDLINE/PubMed, a database of the U.S. National Library of Medicine

PY - 2021/3/1

Y1 - 2021/3/1

N2 - BACKGROUND: Observational evidence suggests that mask wearing mitigates transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is uncertain if this observed association arises through protection of uninfected wearers (protective effect), via reduced transmission from infected mask wearers (source control), or both.OBJECTIVE: To assess whether recommending surgical mask use outside the home reduces wearers' risk for SARS-CoV-2 infection in a setting where masks were uncommon and not among recommended public health measures.DESIGN: Randomized controlled trial (DANMASK-19 [Danish Study to Assess Face Masks for the Protection Against COVID-19 Infection]). (ClinicalTrials.gov: NCT04337541).SETTING: Denmark, April and May 2020.PARTICIPANTS: Adults spending more than 3 hours per day outside the home without occupational mask use.INTERVENTION: Encouragement to follow social distancing measures for coronavirus disease 2019, plus either no mask recommendation or a recommendation to wear a mask when outside the home among other persons together with a supply of 50 surgical masks and instructions for proper use.MEASUREMENTS: The primary outcome was SARS-CoV-2 infection in the mask wearer at 1 month by antibody testing, polymerase chain reaction (PCR), or hospital diagnosis. The secondary outcome was PCR positivity for other respiratory viruses.RESULTS: A total of 3030 participants were randomly assigned to the recommendation to wear masks, and 2994 were assigned to control; 4862 completed the study. Infection with SARS-CoV-2 occurred in 42 participants recommended masks (1.8%) and 53 control participants (2.1%). The between-group difference was -0.3 percentage point (95% CI, -1.2 to 0.4 percentage point; P = 0.38) (odds ratio, 0.82 [CI, 0.54 to 1.23]; P = 0.33). Multiple imputation accounting for loss to follow-up yielded similar results. Although the difference observed was not statistically significant, the 95% CIs are compatible with a 46% reduction to a 23% increase in infection.LIMITATION: Inconclusive results, missing data, variable adherence, patient-reported findings on home tests, no blinding, and no assessment of whether masks could decrease disease transmission from mask wearers to others.CONCLUSION: The recommendation to wear surgical masks to supplement other public health measures did not reduce the SARS-CoV-2 infection rate among wearers by more than 50% in a community with modest infection rates, some degree of social distancing, and uncommon general mask use. The data were compatible with lesser degrees of self-protection.PRIMARY FUNDING SOURCE: The Salling Foundations.

AB - BACKGROUND: Observational evidence suggests that mask wearing mitigates transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is uncertain if this observed association arises through protection of uninfected wearers (protective effect), via reduced transmission from infected mask wearers (source control), or both.OBJECTIVE: To assess whether recommending surgical mask use outside the home reduces wearers' risk for SARS-CoV-2 infection in a setting where masks were uncommon and not among recommended public health measures.DESIGN: Randomized controlled trial (DANMASK-19 [Danish Study to Assess Face Masks for the Protection Against COVID-19 Infection]). (ClinicalTrials.gov: NCT04337541).SETTING: Denmark, April and May 2020.PARTICIPANTS: Adults spending more than 3 hours per day outside the home without occupational mask use.INTERVENTION: Encouragement to follow social distancing measures for coronavirus disease 2019, plus either no mask recommendation or a recommendation to wear a mask when outside the home among other persons together with a supply of 50 surgical masks and instructions for proper use.MEASUREMENTS: The primary outcome was SARS-CoV-2 infection in the mask wearer at 1 month by antibody testing, polymerase chain reaction (PCR), or hospital diagnosis. The secondary outcome was PCR positivity for other respiratory viruses.RESULTS: A total of 3030 participants were randomly assigned to the recommendation to wear masks, and 2994 were assigned to control; 4862 completed the study. Infection with SARS-CoV-2 occurred in 42 participants recommended masks (1.8%) and 53 control participants (2.1%). The between-group difference was -0.3 percentage point (95% CI, -1.2 to 0.4 percentage point; P = 0.38) (odds ratio, 0.82 [CI, 0.54 to 1.23]; P = 0.33). Multiple imputation accounting for loss to follow-up yielded similar results. Although the difference observed was not statistically significant, the 95% CIs are compatible with a 46% reduction to a 23% increase in infection.LIMITATION: Inconclusive results, missing data, variable adherence, patient-reported findings on home tests, no blinding, and no assessment of whether masks could decrease disease transmission from mask wearers to others.CONCLUSION: The recommendation to wear surgical masks to supplement other public health measures did not reduce the SARS-CoV-2 infection rate among wearers by more than 50% in a community with modest infection rates, some degree of social distancing, and uncommon general mask use. The data were compatible with lesser degrees of self-protection.PRIMARY FUNDING SOURCE: The Salling Foundations.

UR - http://www.scopus.com/inward/record.url?scp=85102965130&partnerID=8YFLogxK

U2 - 10.7326/M20-6817

DO - 10.7326/M20-6817

M3 - Journal article

C2 - 33205991

VL - 174

SP - 335

EP - 343

JO - Annals of Internal Medicine

JF - Annals of Internal Medicine

SN - 0003-4819

IS - 3

ER -

ID: 61271101