Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.
| Bias | Author's judgement | Support for judgement |
| Randomization |
Some concerns |
Quote: "Using the computer-generated randomization method, eligible patients were assigned to the SWD
group and control group at a 2:1 ratio"
Comment: Allocation sequence random. No information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Quote: "The patients did not know whether they were in the SWD group or control group until the study was completed. The physicians who assessed the patients during the study were blind to both groups. Only the SWD operator knew the participants allocated to which group because of the operative requirements of SWD. For the control group, the patients received placebo SWD, electrodes positioned in the same manner as the SWD group but without turning on. The machine’s panel was directed out of the patients’ view"
Comment: Unclear blinding (participants probably blinded, carers blinded, person delivering the treatment was unblinded) Deviations from intended intervention arising because of the study context: No participant cross-over. No information on administration of co-interventions of interest: antivirals, corticosteroids and biologics. MORTALITY AND CLINICAL IMPROVEMENT Data for the outcome were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be some concerns for the outcomes: Mortality (D28). Clinical improvement (D28). Time to clinical improvement. Adverse events. TIME TO CLINICAL IMPROVEMENT Participants were analyzed according to their randomized groups for the outcome. This method was considered appropriate to estimate the effect of assignment to intervention for this outcome. There was probably no substantial impact of failure to analyze participants according to their randomized groups. Risk assessed to be some concerns for the outcomes: Time to clinical improvement. |
| Missing outcome data |
Low |
Comment: 42 participants randomized; 40 participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). Time to clinical improvement. Adverse events. |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). Time to clinical improvement. Adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The protocol, statistical analysis plan and registry were not available.
No information on whether the result was selected from multiple outcome measurements or analyses of the data. No information on whether the trial was analyzed as pre-specified. Risk assessed to be some concerns for the outcomes: Mortality (D28). Clinical improvement (D28). Time to clinical improvement. Adverse events. |
| Overall risk of bias |
Some concerns |