Table 1. Protocol of a Target Trial on ADHD Medication on Mortality in Individuals With ADHD and Emulation Using Observational Data.

Protocol component	Target randomized trial	Emulation using observational data
Eligibility criteria	Individuals aged 6-64 y with an incident clinic diagnosis of ADHD from January 2007 through December 2018 No prior dispensation of ADHD medication	Same as the target trial
Treatment strategies	Initiate ADHD medication within 3 months after diagnosis and continue the prescribed medication Do not initiate ADHD medication during the follow-up	Same as the target trial
Assignment procedures	Eligible individuals are randomly assigned to either strategy at baseline and are aware of the assigned strategy	Randomization is emulated by cloning eligible individuals and assigning each copy to 1 treatment strategy
Follow-up period	Follow-up starts at treatment assignment and ends at death, loss to follow-up (emigration), or administrative end of follow-up (December 31, 2020, or 2 years after baseline), whichever occurs first	Same as the target trial
Outcomes	All-cause and cause-specific mortality within 2 years after baseline	Same as the target trial
Causal contrasts of interest	Effect of adhering to the treatment strategies (per protocol) during follow-up	Observational analogue of the per-protocol effect
Analysis plan	Effect estimates are calculated from an inverse probability-weighted, pooled-logistic regression model, with censoring at deviation from the protocol and adjustment for baseline and postbaseline covariates	Same as the target trial, except that the analyses are conducted in an expanded data set that includes copies of each eligible individual

Abbreviation: ADHD, attention-deficit/hyperactivity disorder.