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. 2020 Nov 20;2020(11):CD006207. doi: 10.1002/14651858.CD006207.pub5

Aiello 2012.

Study characteristics
Methods During the 2007 to 2008 influenza season, 1111 students residing in university residence halls were cluster‐randomised by residence house (N = 37) to either face mask and hand hygiene, face mask only, or control arms. Discrete time survival analysis using generalised models estimated rate ratios according to study arm, each week and cumulatively over the 6‐week intervention period, for clinically verified ILI and laboratory‐confirmed influenza A or B.
Participants A total of 1187 young adults living in 37 residence halls, randomly assigned to 1 of 3 groups for 6 weeks: face mask use (n = 392), face masks with hand hygiene (n = 349), control (n = 370)
Inclusion criteria: aged 18 or more, willing to wear mask and use alcohol‐based hand sanitiser, have a throat swab specimen collected when ill, and complete the baseline and weekly surveys over the 6‐week study period
Exclusion criteria: individuals reporting a skin allergy to alcohol were excluded
Interventions Participants were assigned to face mask and hand hygiene, face mask only, or control group during the study. See Table 4 for details.
Outcomes Clinically verified ILI: case definition (presence of cough and at least 1 or more of fever/feverishness, chills, or body aches)
Laboratory‐confirmed influenza A or B. Throat swab specimens were tested for influenza A or B using RT‐PCR.
No safety outcomes reported.
Notes This study has the same trial registration number as the Aiello 2010 study; the study was funded by government and pharmaceutical industry.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generation of sequence described.
Allocation concealment (selection bias) Low risk All residence houses in each of the residence halls were randomised prior to the intervention implementation.
Blinding of participants and personnel (performance bias)
All outcomes High risk No blinding for study participants and personnel
Blinding of outcome assessment (detection bias)
All outcomes Low risk Outcome assessors blinded.
Incomplete outcome data (attrition bias)
All outcomes Low risk Attrition low and similar in each group
Selective reporting (reporting bias) Low risk 2 outcomes specified and reported.