Holmes 2002.
Methods | ||
Participants | ||
Interventions | ||
Outcomes | ||
Notes | See Table 1 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | “The communal area of the unit was diffused [...], on alternate days [...].” |
Allocation concealment (selection bias) | High risk | Not described‐ although CCT design means the sequence was predictable. |
Blinding (performance bias and detection bias) Subjective outcomes | Low risk | Agitation measured by "an experienced independent blinded (using nose callipers prior to entry onto the ward) rater, unaware of the study design" |
Blinding (performance bias and detection bias) Objective outcomes | Unclear risk | The study did not address this outcome. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Fifteen patients were recruited [...]. For each subject 10 total PAS scores were obtained." Results were obtained from all the patients that were recruited and therefore it is indicated that there were no dropouts or withdrawals. |
Selective reporting (reporting bias) | Unclear risk | Not known. |
Protection from contamination? | High risk | Cross‐over trial. |