Fretheim 2022a.
Study characteristics | ||
Methods | Pragmatic RCT | |
Participants | 3717 participants in Norway (glasses n = 1852; no glasses n = 1865) Inclusion criteria:
Exclusion criteria:
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Interventions | Intervention group: wearing eyeglasses (any type) when close to other people outside their home (on public transport, in shopping malls etc.), over a 14‐day period. The control: encouraged not to wear glasses when close to others outside their home. See TIDieR Table (Table 4) for details. | |
Outcomes | Primary outcome
Secondary outcomes
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Notes | The study did not report on the latter 4 outcomes due to lack of access to this data at the time of publication. Negative experiences of using the eyeglasses were reported: fogging, feeling uncomfortable and tiring, reduced vision, fall, feeling silly when wearing glasses indoor, headache. Funding: the costs of running the trial were covered by the Centre for Epidemic Interventions Research (CEIR), Norwegian Institute of Public Health. Competing interests: all authors declare: no competing interests. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Automatically randomised after signing the consent form in the online recruitment platform (Nettskjema). |
Allocation concealment (selection bias) | High risk | A digital recruitment platform (Nettskjema) was used to generate allocation. However, more participants in the intervention group wore face masks. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | An open‐label study. Participants and investigators were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome is self‐reported positive COVID‐19 test result reported to the Norwegian Surveillance System for Communicable Diseases (MSIS). However, the public policy requiring confirmatory PCR‐test had changed during the study conduct which may have affected case detection. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Participants flow chart was provided. |
Selective reporting (reporting bias) | Low risk | No deviation from the published protocol. |