Methods | Design: Randomised parallel group trial Setting: USA |
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Participants | N=30, male and female, healthy, adult volunteers aged 19‐30 years Laboratory‐based simulated night shift schedule for 5 consecutive nights |
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Interventions |
All participants received 300ml of decaffeinated coffee between 22.20 and 22.50 and again between 01.20 and 01.50 hours on each of the 5 nights. For participants in the caffeine group, caffeine was added to the coffee for the first 3 nights. |
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Outcomes | SALT performance measure (measured every 2 hours throughout the shift) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | Correspondence with author ‐ table of random numbers. |
Allocation concealment? | High risk | Correspondence with author ‐ allocation was not concealed. |
Blinding? All outcomes | Low risk | Participants and laboratory‐based personnel were blind to allocation status. |
Incomplete outcome data addressed? All outcomes | Unclear risk | Insufficient reporting of attrition/exclusions to permit judgement of 'Yes' or 'No'. |
Free of selective reporting? | Unclear risk | All outcomes described in Methods section are reported in the Results. |
Free of other bias? | Low risk | The study appears to be free of other sources of bias. |