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: "Eligible individuals were assigned (1:1) to one of the treatment groups using the blocked-balanced randomisation method (block size: 4): 1) the experimental group (received six sessions PPT in addition to basic care interventions) or 2) the control group (received basic care only). Randomization was done manually using sealed envelopes. One of the researchers assigned each patient to the next available randomised number based on the randomised list number." Comment: Allocation sequence probably random. Unclear allocation concealment (opacity and sequential numbering of envelopes not reported). |
| Deviations from intervention |
Low |
Quote: “The assessor and statistical analysis team were masked to treatment allocation. The assessor had not any access to patient’s medical record. As PPT consists of some techniques required the patient's cooperation actively; therefore, participants masking was impossible.”
Comment: Unblinded study (participants) No information on administration of co-interventions of interest: antivirals, biologics and corticosteroids Hence, no information on whether deviations arose because of the trial context. 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). Mortality (D60 or more). WHO score 7 and above (D28). |
| Missing outcome data |
Low |
Comment: 40 participants randomized; 40 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more). WHO score 7 and above (D28). |
| Measurement of the outcome |
Low |
Quote: “The assessor and statistical analysis team were masked to treatment allocation."
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). Mortality (D60 or more). WHO score 7 and above (D28). |
| Selection of the reported results |
Some concerns |
Comment: The protocol and statistical analysis plan were not available. The registry was available but retrospective (dated April 22nd, 2020).
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 outcome: Mortality (D28). Mortality (D60 or more). WHO score 7 and above (D28). |
| Overall risk of bias |
Some concerns |