| Methods |
|
| Participants |
|
| Interventions |
|
| Outcomes |
|
| Notes |
See Table 4
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
‘‘Participants were randomly assigned using computer‐generated numbers into three groups’’ |
| Allocation concealment (selection bias) |
Unclear risk |
Not described. |
| Blinding (performance bias and detection bias)
Subjective outcomes |
High risk |
Patients could not be blinded to this intervention. Patients reported pain and satisfaction and controlled the level of sedation. |
| Blinding (performance bias and detection bias)
Objective outcomes |
Low risk |
"Group 1 patients wore the same Eyetrek system with earphones even though they had no music to listen to. As a result, the endoscopists did not know whether patients were in group 1 or group 2". Endoscopists were not blinded to patients in group 3 (patient‐controlled sedation alone). Unclear who assessed number of hypotensive episodes and oxygen desaturation. Recovery nurses assessed recovery time. "All recovery nurses were blinded as to the sedation group to which patients had been assigned". |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
‘‘Eight patients were excluded after randomization: four patients had incomplete assessment forms and four patients did not receive proper PCS due to mechanical failure during the procedure.’’ Unclear from which groups participants were withdrawn, but reasons given. More than 80% of outcome data were obtained. |
| Selective reporting (reporting bias) |
Unclear risk |
Not known. |
| Protection from contamination? |
Low risk |
Interventions administered on an individual basis. |
