Physical interventions to interrupt or reduce the spread of respiratory viruses. Part 1 - Face masks, eye protection and person distancing: systematic review and meta-analysis

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Abstract

OBJECTIVE

To examine the effectiveness of eye protection, face masks, or person distancing on interrupting or reducing the spread of respiratory viruses.

DESIGN

Update of a Cochrane review that included a meta-analysis of observational studies during the SARS outbreak of 2003.

DATA SOURCES

Eligible trials from the previous review; search of Cochrane Central Register of Controlled Trials, PubMed, Embase and CINAHL from October 2010 up to 1 April 2020; and forwardand backward citation analysis.

DATA SELECTION

Randomised and cluster-randomised trials of people of any age, testing the use ofeye protection, face masks, or person distancing against standard practice, or a similar physical barrier. Outcomes included any acute respiratory illness and its related consequences.

DATA EXTRACTION AND ANALYSIS

Six authors independently assessed risk of bias using the Cochrane tool and extracted data. We used a generalised inverse variance method for pooling using a random-effects model and reported results with risk ratios and 95% Confidence Intervals (CI).

RESULTS

We included 15 randomised trials investigating the effect of masks (14 trials) in healthcare workers and the general population and of quarantine (1 trial). We found no trials testing eye protection. Compared to no masks there was no reduction of influenza-like illness (ILI) cases (Risk Ratio 0.93, 95%CI 0.83 to 1.05) or influenza (Risk Ratio 0.84, 95%CI 0.61-1.17) for masks in the general population, nor in healthcare workers (Risk Ratio 0.37, 95%CI 0.05 to 2.50). There was no difference between surgical masks and N95 respirators: for ILI (Risk Ratio 0.83, 95%CI 0.63 to 1.08), for influenza (Risk Ratio 1.02, 95%CI 0.73 to 1.43). Harms were poorly reported and limited to discomfort with lower compliance. The only trial testing quarantining workers with household ILI contacts found a reduction in ILI cases, but increased risk of quarantined workers contracting influenza. All trials were conducted during seasonal ILI activity.

CONCLUSIONS

Most included trials had poor design, reporting and sparse events. There was insufficient evidence to provide a recommendation on the use of facial barriers without other measures. We found insufficient evidence for a difference between surgical masks and N95 respirators and limited evidence to support effectiveness of quarantine. Based on observational evidence from the previous SARS epidemic included in the previous version of our Cochrane review we recommend the use of masks combined with other measures.

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  1. SciScore for 10.1101/2020.03.30.20047217: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementConsent: Low risk of bias for the method of random sequence generation indicates that the method was well-described and is likely to produce balanced and truly random groups; for allocation concealment that the next treatment allocation was not known to participant/cluster or treating staff until after consent to join the study; for blinding of participants and personnel that the method is likely to maintain blinding throughout the study; for blinding of outcome assessors that all assessing outcomes were unaware of treatment allocation; for outcome reporting that participant attrition through the study is reported and reasons for loss are appropriately described; and for selective reporting that all likely planned and collected outcomes have been reported.
    RandomizationLow risk of bias for the method of random sequence generation indicates that the method was well-described and is likely to produce balanced and truly random groups; for allocation concealment that the next treatment allocation was not known to participant/cluster or treating staff until after consent to join the study; for blinding of participants and personnel that the method is likely to maintain blinding throughout the study; for blinding of outcome assessors that all assessing outcomes were unaware of treatment allocation; for outcome reporting that participant attrition through the study is reported and reasons for loss are appropriately described; and for selective reporting that all likely planned and collected outcomes have been reported.
    BlindingRisk of bias assessment: Risk of bias was assessed by three author pairs independently (TJ, EB, LA, GB, MJ, EF) for the method of random sequence generation and allocation concealment (selection bias), blinding of participants and personnel (performance bias), blinding of outcome assessment (detection bias), outcome reporting (attrition bias), and selective reporting (reporting bias).
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    8 These earlier studies were analysed using word frequency to create a new search string that was run in PubMed.
    PubMed
    suggested: (PubMed, RRID:SCR_004846)
    10 This search string was converted using the Polyglot Search Translator11 and run in the following additional databases; the Cochrane Central Register of Controlled Trials, Embase and CINAHL.
    Cochrane Central Register of Controlled Trials
    suggested: (Cochrane Central Register of Controlled Trials, RRID:SCR_006576)
    Embase
    suggested: (EMBASE, RRID:SCR_001650)
    Descriptions of the interventions were extracted using the Template for Intervention Description and Replication (TIDieR) template. 14 We entered outcome data in RevMan software and used a generalised inverse variance random effects method for pooling.
    RevMan
    suggested: (RevMan, RRID:SCR_003581)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).


    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Limitations: Though the trials in this review provide a reasonable body of evidence, there are several important limitations. First, there is considerable clinical heterogeneity between the designs, and substantial statistical heterogeneity for some analyses. The latter is not readily explained by differences in the study questions. Second, the range of viral infections studied is limited, with a particular focus on influenza; no studies include SARS-CoV-2. None of the studies in health care worker included undertaking aerosol-generating procedures for which WHO currently recommends the N95 or equivalent mask. Finally, the studies provide sparse and unsystematic data on any harms, such as the discomfort, dehydration, facial dermatitis, distress, headaches, exhaustion or other problems caused by masks such as the N95. Some studies measured adherence which was generally high despite the mask discomfort. Conclusion: Despite the lack of evidence, we would still recommend using facial barriers in the setting of epidemic and pandemic viral respiratory infections, but there does not appear to be a difference between surgical and full respirator wear. Despite the methodological concerns, our review of the available studies demonstrates consistency in the finding of no difference between surgical and N95 or equivalent masks as a physical intervention to interrupt or reduce the spread of respiratory viruses, mainly influenza. The consistency of the finding across multiple studies of va...

    Results from TrialIdentifier: No clinical trial numbers were referenced.


    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.


    Results from JetFighter: We did not find any issues relating to colormaps.


    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  2. SciScore for 10.1101/2020.03.30.20047217: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementLow risk of bias for the method of random sequence generation indicates that the method was well-described and is likely to produce balanced and truly random groups; for allocation concealment that the next treatment allocation was not known to participant/cluster or treating staff until after consent to join the study; for blinding of participants and personnel that the method is likely to maintain blinding throughout the study; for blinding of outcome assessors that all assessing outcomes were unaware of treatment allocation; for outcome reporting that participant attrition through the study is reported and reasons for loss are appropriately described; and for selective reporting that all likely planned and collected outcomes have been reported.RandomizationRESULTS: We included 15 randomised trials investigating the effect of masks (14 trials) in healthcare workers and the general population and of quarantine (1 trial).BlindingRisk of bias assessment Risk of bias was assessed by three author pairs independently ( TJ , EB , LA , GB , MJ , EF ) for the method of random sequence generation and allocation concealment ( selection bias) , blinding of participants and personnel ( performance bias) , blinding of outcome assessment ( detection bias) , outcome reporting ( attrition bias) , and selective reporting ( reporting bias) .Power Analysisnot detected.Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    DATA SOURCES: Eligible trials from the previous review; search of Cochrane Central Register of Controlled Trials, PubMed, Embase and CINAHL from October 2010 up to 1 April 2020; and forwardand backward citation analysis.
    Cochrane Central Register of Controlled Trials
    suggested: (Cochrane Central Register of Controlled Trials, SCR_006576)
    DATA EXTRACTION AND ANALYSIS: Six authors independently assessed risk of bias using the Cochrane tool and extracted data.
    Cochrane
    suggested: (Cochrane Library, SCR_013000)
    8 These earlier studies were analysed using word frequency to create a new search string that was run in PubMed.
    PubMed
    suggested: (PubMed, SCR_004846)
    10 This search string was converted using the Polyglot Search Translator 11 and run in the following additional databases; the Cochrane Central Register of Controlled Trials , Embase and CINAHL .
    Embase
    suggested: (EMBASE, SCR_001650)
    TIDieR ) template.14 We entered outcome data in RevMan software and used a generalised inverse variance random effects method for pooling .
    RevMan
    suggested: (RevMan, SCR_003581)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).


    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore is not a substitute for expert review. SciScore checks for the presence and correctness of RRIDs (research resource identifiers) in the manuscript, and detects sentences that appear to be missing RRIDs. SciScore also checks to make sure that rigor criteria are addressed by authors. It does this by detecting sentences that discuss criteria such as blinding or power analysis. SciScore does not guarantee that the rigor criteria that it detects are appropriate for the particular study. Instead it assists authors, editors, and reviewers by drawing attention to sections of the manuscript that contain or should contain various rigor criteria and key resources. For details on the results shown here, including references cited, please follow this link.