| Methods |
|
| Participants |
|
| Interventions |
|
| Outcomes |
|
| Notes |
See Table 8
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"Patients were assigned using a table of random numbers to either group" |
| Allocation concealment (selection bias) |
Unclear risk |
"Patients who consented to participate were then given a number that had been preassigned [...]. Patients became aware of their assigned group after they signed the consent." No description of whether the person recruiting patients knew the assignments in advance. |
| Blinding (performance bias and detection bias)
Subjective outcomes |
High risk |
"The patients and staff were not blinded to assignment" |
| Blinding (performance bias and detection bias)
Objective outcomes |
High risk |
"The patients and staff were not blinded to assignment" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
"A total of 190 persons were recruited, 20 refused, and 170 persons completed the study." Does not describe if the 20 refusals occurred before or after randomisation, or reasons for refusal. Data reported for 170 participants. |
| Selective reporting (reporting bias) |
Unclear risk |
Unknown if selective outcome reporting. |
| Protection from contamination? |
Low risk |
Interventions administered on an individual basis. |
