Table 3 Target trial specification and emulation
Element | Specification of the hypothetical target trial | Emulation using real-world data sources |
|---|---|---|
Eligibility Criteria | Patients with type 2 diabetes mellitus, no use of study medications before randomization, no history of end stage renal disease (ESRD), no history of HIV, no history of acute pancreatitis, no history of GLP-1 receptor agonist use | Same as target trial |
Continuous health plan enrollment and at least one recorded encounter in EHRs in 6 months prior to treatment initiation | ||
Treatment Strategies | 1. Initiation SGLT-2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, bexagliflozin) | Same as target trial |
2. Initiation of DPP-4 inhibitors (alogliptin, linagliptin, saxagliptin, sitagliptin) | ||
Treatment Assignment | Randomized non-blinded | Non-blinded and assumed to be randomized within levels of measured confounders |
Follow-Up Start (Time 0) | At assignment | Same as target trial |
Follow-Up End | First of administrative end of follow-up (most recent data), loss to follow-up, death, or outcome occurrence | Same as target trial |
Primary Outcome | Acute pancreatitis | Same as target trial |
Causal Contrast | Intent to treat effect (effect of being assigned to the treatment) | Observational analogue of intent to treat effect |
Per protocol effect (effect of staying on the treatment) | Observational analogue of per protocol effect |
