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. 2023 Jan 30;2023(1):CD006207. doi: 10.1002/14651858.CD006207.pub6

MacIntyre 2013.

Study characteristics
Methods A cluster‐RCT
Participants A total of 1669 nurses and doctors from 68 emergency departments and respiratory wards of 19 Beijing hospitals were included. Inclusion criteria: any nurse or doctor aged 18 years or older who worked full time in the emergency or respiratory wards was eligible. Exclusion: HCWs if they (1) were unable or refused to consent; (2) had beards, long moustaches, or long facial hair stubble; (3) had a current respiratory illness, rhinitis, and/or allergy; or (4) worked part time or did not work in the aforementioned wards or departments
Final analysis was performed on 572 staff and 24 wards in medical mask group, 516 staff and 20 wards in the targeted N95 mask group, and 581 staff and 24 wards in the N95 mask group.
Interventions Quote: "Masks used in the study were the 3M Standard Tie‐On Surgical Mask (catalog number mask 1817; 3M, St. Paul, MN) and the 3M Health Care N95 Particulate Respirator (catalog number 1860; 3M)... . Participants wore the mask or respirator on every shift after being shown how to fit and wear it. Participants were supplied daily with either three masks for the medical mask arm or two N95 respirators. Participants using N95 respirators underwent a fit testing procedure using a 3M FT‐30 Bitrex Fit Test Kit according to the manufacturer’s instructions (3M)." See Table 4 for details.
Outcomes Laboratory:
  1. Laboratory‐confirmed viral respiratory infection in symptomatic participants, defined as detection of adenoviruses; human metapneumovirus; coronaviruses 229E/NL63 and OC43/HKU1; parainfluenza viruses 1, 2, and 3; influenza viruses A and B; respiratory syncytial viruses A and B; or rhinoviruses A/B by nucleic acid testing (NAT) using a commercial multiplex polymerase chain reaction (Seegen, Inc., Seoul, Korea).

  2. Laboratory‐confirmed influenza A or B in symptomatic participants.

  3. Laboratory‐confirmed bacterial colonisation in symptomatic participants, defined as detection of Streptococcus pneumoniae, Legionella, Bordetella pertussis, chlamydia, Mycoplasma pneumoniae, or Haemophilus influenzae type B by multiplex polymerase chain reaction (Seegen, Inc.).


Effectiveness: CRI, defined as 2 or more respiratory symptoms or 1 respiratory symptom and a systemic symptom. ILI, defined as fever (38 °C) plus 1 respiratory symptom
Safety: adverse effects measured using a semi‐structured questionnaire. Investigators stated that there was higher reported adverse effects and discomfort of N95 respirators compared with the other 2 arms. In terms of comfort, 52% (297 of 571) of the medical mask arm reported no problems, compared with 62% (317 of 512) of the targeted arm and 38% (217 of 574) of the N95 arm (P < 0.001).
Notes Compliance with the product was highest in the targeted N95 arm (82%; 422 of 516), then the medical mask arm (66%; 380 of 572), and the N95 arm (57%; 333 of 581); these differences were statistically significant (P < 0.001). 
The period study conducted: 28 December 2009 to 7 February 2010
Funding: unclear
Declaration of interests: none declared.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "using a secure computerized randomization program", but sequence generation not described
Allocation concealment (selection bias) Unclear risk No information provided.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Outcome was objectively assessed with lab confirmation in addition to clinical illness.
Blinding of outcome assessment (detection bias)
All outcomes Low risk "Laboratory outcomes are reported for all subjects (with at least one respiratory symptom or fever) tested, and then for the subset meeting the CRI definition"
Incomplete outcome data (attrition bias)
All outcomes Low risk No loss to follow‐up. Flow chart and text match, investigators conducted ITT and PP analysis. All the outcomes were accounted for amongst all participants.
Selective reporting (reporting bias) Low risk All outcomes were reported as planned.