| Methods |
|
| Participants |
|
| Interventions |
|
| Outcomes |
|
| Notes |
See Table 8
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"A computer‐generated list was used for permuted block random assignment" |
| Allocation concealment (selection bias) |
Low risk |
"A biostatistician and research assistant who did not participate in data collection conducted the randomization procedures and prepared sequentially numbered sealed envelopes containing the random assignment for each consenting patient" |
| Blinding (performance bias and detection bias)
Subjective outcomes |
High risk |
Patients aware of group allocation. |
| 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 |
"there were no drop‐outs" |
| Selective reporting (reporting bias) |
Unclear risk |
Unknown if selective outcome reporting. |
| Protection from contamination? |
Low risk |
Interventions administered on an individual basis. |
