| Bias | Author's judgement | Support for judgement |
| Randomization |
Some concerns |
Quote: "An electronically generated randomization 2:1 list was prepared by independent statisticians" "The list was accessible only to nonmasked specialists in the study in an attempt to minimize observation bias" Comment: It was not clear whether the allocation was concealed or not. Baseline characteristics between intervention groups were comparable (except for high blood pressure and diabetes mellitus, known risk factors for unfavorable disease progression, which were more frequent in patients not treated with calcifediol); any differences appear to be compatible with chance. |
| Deviations from intervention |
Some concerns |
Quote:"This pilot study has several limitations as it is not double-blind placebo controlled"
No indication of participant cross-over. Comment: Information on key co-interventions such as antivirals and corticosteroids was not reported Outcome data were analyzed using intention-to-treat analysis. |
| Missing outcome data |
Low |
Comment: 76 randomized/76 analyzed for all outcomes (pilot study).
Risk assessed to be low for outcome: Mortality. WHO score 7 or above. |
| Measurement of the outcome |
Low |
Comment: Open label trial. Mortality is an observer reported outcome not involving judgement. For WHO score 7 and above, we consider that it cannot be influenced by knowledge of intervention assignment. Risk assessed to be low for the outcomes: Mortality. WHO score 7 and above |
| Selection of the reported results |
Low |
Comment: Neither the protocol nor the statistical analysis plan was available. The registry was available and utilized.
Mortality was registered as an outcome and reported as such in the paper. WHO score 7 and above was neither registered nor reported as an outcome in the paper. Results were probably not selected from multiple outcome measurements or analyses of the data. Trial probably analyzed as pre-specified. Risk assessed to be low for the outcome: Mortality. WHO score 7 and above. |
| Overall risk of bias |
Some concerns |