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. Competing interests: all authors have completed the Unified Competing Interests form (available on request from the corresponding author) and declare that: CRM has held an Australian Research Council Linkage Grant with 3M as the industry partner, for investigator driven research. 3M have also contributed supplies of masks and respirators for investigator‐driven clinical trials. She has received research grants and laboratory testing as in‐kind support from Pfizer, GSK and Bio‐CSL for investigator‐driven research. HS had an NHMRC Australian based Public Health Training Fellowship at the time of the study (1012631). She has also received funding from vaccine manufacturers GSK, bio‐CSL and Saniofi Pasteur for investigator‐driven research and presentations. AAC had testing of filtration of masks by 3M for PhD. | |
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. |