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. 2023 Nov 27;6:221. doi: 10.1038/s41746-023-00961-1

Table 2.

Components of the target trial framework included in the reporting quality assessment with examples for the ICU setting.

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.