Selection bias |
Random sequence generation |
Unclear risk |
Low risk |
Low risk |
Unclear risk |
Low risk |
Allocation concealment |
Unclear risk |
Low risk |
Low risk |
Unclear risk |
Low risk |
Performance bias |
Blinding of participants |
Unclear risk |
Unclear risk (high risk for medication management group) |
Unclear risk |
High risk |
Low risk (high risk for suprathreshold stimulation) |
Blinding of study personnel |
Unclear risk |
Unclear risk |
Unclear risk |
High risk |
Low risk |
Detection bias |
Blinding of outcome assessment: patient reported outcomes |
Unclear risk |
Unclear risk (high risk for medication management group) |
Unclear risk |
High risk |
Low risk (high risk for suprathreshold stimulation) |
Blinding of outcome assessment: investigator assessed outcomes |
Low risk |
Low risk |
Low risk |
High risk |
Low risk |
Attrition bias |
Incomplete outcome data |
Unclear risk |
High risk |
Low risk |
Low risk |
Low risk |
Reporting bias |
Selective reporting |
Unclear risk |
High risk |
Unclear |
Low risk |
Low risk |
Other bias |
Any other important concerns about bias not covered in the other domains above |
Based on conference abstract with very limited information; manufacturer-sponsored study |
Manufacturer-sponsored study |
Manufacturer-sponsored study |
High risk (weakness related to crossover design—see below) |
High risk (patients already had good treatment response; lack of washout—see below) |
Measurement of effectiveness of blinding and/or patients’ expectation of treatment effectiveness |
Not done |
Not done |
Not done |
Not done |
Not done |
Crossover design |
Analysis of paired data |
Not applicable |
Not applicable |
Not applicable |
Not done |
Yes |
Assessment of carryover effects and/or justification of washout period |
Not applicable |
Not applicable |
Not applicable |
Not done |
Not done |