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: "Patients consuming renin-angiotensin-aldosterone system inhibitors were randomized to two groups using computerized-sequence random codes with a 1:1 allocation." (published report)
Quote: "Allocation sequence was concealed and performed according to a computer-based random sequence. The researchers who collected data were blind and assigned the codes according to the blind sequence. The medications were prepared and handed to patients by a pharmacotherapist who were not blind." (answers from authors) Comment: MB is an investigator blinded to the allocation. Allocation sequence random. Allocation sequence concealed. |
Deviations from intervention |
Some concerns |
Quote: "Investigators, outcome assessors, and the data analyzer were blinded to the antihypertensive medications as well as the enrolled participants."
Comment: Blinded study (participants and personnel/carers) MORTALITY (D60). CLINICAL IMPROVEMENT (D60). ADVERSE EVENTS. Our analysis for the binary outcomes is an intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for the outcomes: Mortality (D60 or more). Clinical improvement (D60 or more). Adverse events. TIME TO DEATH. TIME TO CLINICAL IMPROVEMENT. TIME TO WHO SCORE 7 AND ABOVE. Participants were analyzed according to their randomized groups for the outcome. Of note, 2 vs 0 participants did not receive allocated intervention due to early death after inclusion and were not analyzed. This method was considered inappropriate 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 death. Time to clinical improvement. Time to WHO score 7 and above. |
Missing outcome data |
Some concerns |
Comment: 66 participants randomized; 64 participants analyzed.
Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons: 3 vs 4 were lost to follow up for improper cooperation. Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome. Risk assessed to be some concerns for the outcomes: Mortality (D60 or more). Time to death. Clinical improvement (D60 or more). Time to clinical improvement. Time to WHO score 7 and above. 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 (D60 or more). Time to death. Clinical improvement (D60 or more). Time to clinical improvement. Time to WHO score 7 and above. Adverse events. |
Selection of the reported results |
Low |
Comment: The protocol and statistical analysis plan were not available. The prospective registry (dated March 29th, 2020) was available and consulted.
MORTALITY (D60). Outcome pre-specified. Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcome: Mortality (D60 or more). TIME TO DEATH. CLINICAL IMPROVEMENT (D60). TIME TO CLINICAL IMPROVEMENT. TIME TO WHO SCORE 7 AND ABOVE. ADVERSE EVENTS. Outcome data acquired from contact with authors. Results were probably not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Time to death. Clinical improvement (D60 or more). Time to clinical improvement. Time to WHO score 7 and above. Adverse events. |
Overall risk of bias |
Some concerns |