| Random sequence generation (selection bias) |
Unclear risk |
|
| Allocation concealment (selection bias) |
Unclear risk |
|
| Blinding of participants and personnel (performance bias) |
Unclear risk |
|
| Blinding of outcome assessment (detection bias) |
Unclear risk |
|
| Incomplete outcome data (attrition bias) |
Unclear risk |
|
| Selective reporting (reporting bias) |
Unclear risk |
|
| Other bias |
Unclear risk |
|
| Was the allocation sequence adequately generated? |
Low risk |
Quote: “Participants were randomly assigned into the intervention group and control group according to the sequence of enrolment and randomised numbers produced by SPSS 19.0 software” |
|
Comment: Adequately done |
| Was the allocation adequately concealed? |
Unclear risk |
Comment: Insufficient information to permit judgement |
| Were baseline outcome measurements similar? |
Low risk |
Comment: Baseline outcomes were similar across groups |
| Were baseline characteristics similar? |
Low risk |
Comment: Baseline characteristics were similar across groups |
| Were incomplete outcome data adequately addressed? |
High risk |
Comment: 11/101 × 100 = 10.9% lost to follow‐up |
| Was knowledge of the allocated intervention adequately prevented during the study? |
Unclear risk |
Comment: Insufficient information to permit judgement |
| Was the study adequately protected against contamination? |
Unclear risk |
Comment: Insufficient information to permit judgement |
| Was the study free from selective outcome reporting? |
Unclear risk |
Comment: Published protocol not found. The outcomes specified in the methodology section have been reported in the results section |
| Was the study free from other risk of bias? |
Low risk |
Comment: No other potential sources of bias reported |