Table 2.
Component | Subcomponent | Included for QOR assessment | ICU example |
---|---|---|---|
Eligibility criteria | – | ✓ | Individuals aged 65 years or older admitted to the ICU meeting Sepsis-3 criteria upon admission. |
Treatment strategies | – | ✓ | 1. Liberal fluid therapy (administration of intravenous fluid boluses during the first several hours of treatment) 2. Restrictive fluid therapy (Intravenous fluid boluses during ICU stay in only in case of severe hypoperfusion) |
Assignment procedures | – | Unblinded, random assignment to one of the treatment strategies. | |
Follow-up period | Start of follow-up | ✓ | Time of ICU admission. |
End of follow-up | ✓ | Death, ICU discharge, or loss to follow-up, whichever occurs first. | |
Time resolution | ✓ | Hourly weights were applied to adjust for the impact of time-varying confounders on the hourly risk of adhering to one of the two treatment strategies. | |
Outcome | – | ✓ | All- cause mortality. |
Causal contrasts of interest | – | Per-protocol effect. | |
Analysis plana | ✓ | Per-protocol effect will be estimated adjusting for pre- and postbaseline confounders by a marginal structural model using IPTW.b |
aThe analysis plan component is subdivided in a specific set of subcomponents depending on the modeling strategy used, these are summarized in Supplementary Table 9.
bThis description would not be considered as sufficient reporting of the analysis plan component, but simply serves as an example.