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 |
Low |
Quote: “The randomization was generated by a website (http://randomization.com/) and performed by a participating researcher not involved with the recruitment, assessment or treatment of patients. Concealed allocation was achieved through the use of sequentially numbered, sealed and opaque envelopes.”
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: “A researcher not involved with the recruitment, assessment or treatment of patients … was responsible for programming the PBMT-sMF device according to the result of the randomization, as active or placebo mode. The assessors, patients and therapists were blinded throughout the treatment. The active and placebo PBMT-sMF were performed using the same device and the irradiated sites were the same to both therapies. To ensure blinding for therapists the device emitted the same sounds and the same information on the display regardless of the programmed mode (active or placebo).”
Comment: Blinded study (patients, personnel/carers) No cross-over reported. Data were analyzed using intention-to-treat analysis. Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more).Clinical improvement (D28). Clinical improvement (D60 or more).Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 30 patients randomized; 30 patients analyzed.
Data available for all or nearly all participants. Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more). Clinical improvement (D28). Clinical improvement (D60 or more). Adverse events. Serious adverse events. |
| Measurement of the outcome |
Low |
Quote: “The assessors, patients and therapists were blinded throughout the treatment.”
Comment: Appropriate method of measuring the outcome. Measurement or ascertainment of outcome does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more).Clinical improvement (D28). Clinical improvement (D60 or more). Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The trial registry was available.
AE and SAE not specified in the registry. No information on whether the results were selected from multiple outcome measurements or analyses of the data. Risk assessed to be some concerns for outcomes: Adverse events. Serious adverse events Outcome data acquired from contact with authors. Trial analyzed as pre-specified. Risk assessed to be low for outcomes:Mortality (D28). Mortality (D60 or more).Clinical improvement (D28. Clinical improvement (D60 or more). |
| Overall risk of bias |
Some concerns |