| Methods |
|
| Participants |
|
| Interventions |
|
| Outcomes |
|
| Notes |
See Table 8
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
"A biostatistician prepared a randomization list using a computer" |
| Allocation concealment (selection bias) |
Low risk |
"Only one member of the research team had access to this list of case numbers and randomization assignments, which was maintained in a locked filing cabinet. The nursing staff [...] presented the study to potential participants. At the time the patient agreed to participate in the study and the consent form was signed, the research associate called the registrar to obtain the patient's assigned case number and randomizaion group." |
| Blinding (performance bias and detection bias)
Subjective outcomes |
High risk |
Participants aware of group assignment. |
| Blinding (performance bias and detection bias)
Objective outcomes |
Unclear risk |
Study did not address objective outcomes. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
"Two patients, one from each group, were excluded from final analysis because of incomplete data". |
| Selective reporting (reporting bias) |
Unclear risk |
Not known. |
| Protection from contamination? |
Unclear risk |
"patients in both groups may have interacted with each other or nonstudy individuals in the waiting room before or after treatment" |
