Signalling questions | Description | Response options |
---|---|---|
2.1. Were participants aware of their assigned intervention during the trial? |
None (participants) indicated that they guessed the actual study aims Study coordinators guessed that 52%, 51%, 41% and 44% of participants who received caffeine described as caffeine, caffeine described as placebo, placebo described as placebo and placebo described as caffeine, respectively, received caffeine, indicating the success of blinding |
PN |
2.2. Were carers and people delivering the interventions aware of participants' assigned intervention during the trial? | PN | |
2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context? | NA | |
2.4. If Y/PY to 2.3: Were these deviations from intended intervention balanced between groups? | NA | |
2.5 If N/PN/NI to 2.4: Were these deviations likely to have affected the outcome? | NA | |
2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention? | PY | |
2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized? | NA | |
Risk‐of‐bias judgement | Low |
Note: N, No; NI, No Information; PN, Probably No; PY, Probably Yes; Y, Yes.