MacIntyre 2016.
Study characteristics | ||
Methods | Cluster‐RCT to examine medical mask use as source control for people with respiratory illness in 6 major hospitals in 2 districts of Beijing, China. 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 amongst 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). | |
Participants | 245 index cases with ILI (medical mask = 123, control group = 122) and 597 household contacts (medical mask = 302, control group = 295) | |
Interventions | Medical mask versus no mask (control). See Table 4 for details. | |
Outcomes | Clinical respiratory illness, ILI, and laboratory‐confirmed viral respiratory infection
No safety outcomes reported. |
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Notes | Government funded | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random allocation sequence using Microsoft Excel |
Allocation concealment (selection bias) | High risk | Doctors enrolled the participants randomly to intervention and control arms. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unblinded study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Clinical endpoints assessed unblinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
Selective reporting (reporting bias) | Low risk | Specified outcomes reported. |