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. 2024 Feb 28;60(1):145–153. doi: 10.23736/S1973-9087.24.08435-1

Table III. Components of protocol using the target trial emulation framework5, 6, 20, 21 applied to estimating the effect of a type of rehabilitation unit on the risk of fracture in older adults with stroke.

# Protocol component Specification of target trial Emulation of target trial using observational data
1 Eligibility criteria • Inclusion criteria: Older adults (aged ≥65 years) with a diagnosis of stroke or transient ischemic attack
• Exclusion criteria: Adults with subarachnoid hemorrhage or with preexisting hemiparesis (for those with transient ischemic attack)
• Same as specification
• Required in observational data: age, diagnosis of stroke or transient ischemic attack, history of subarachnoid hemorrhage, pre-existing hemiparesis
2 Treatment strategies • Dedicated units for inpatient stroke rehabilitation (units with geographically distinct, stroke-dedicated beds and dedicated therapists).22 This represents one model of service delivery in Ontario
• Non-dedicated units for inpatient stroke rehabilitation, representing a different model of service delivery
• Same as specification
• Required in observational data: dedicated versus non-dedicated units for inpatient stroke rehabilitation
3 Assignment procedures • Participants will be randomly assigned to dedicated units of inpatient stroke rehabilitation or non-dedicated units of inpatient stroke rehabilitation at baseline
• Participants will be aware of treatment assignment (cannot be blinded due to the nature of the intervention)
• Different from specification (i.e., no randomization)
• Eligible persons will be assigned to dedicated versus non-dedicated units of inpatient stroke rehabilitation based on what was documented in observational data at the time of eligibility
4 Follow-up period • Begins at randomization (baseline)
• Ends at fracture, loss to follow-up, death, or 2 years after baseline
• Same as specification
• Required in observational data: date of fracture, date of loss to follow-up, date of death
5 Outcome • Low-trauma fracture that occurred within 2 years of index stroke, defined as any fracture of the femur, forearm, humerus, pelvis, or vertebrae and excludes fractures from trauma, traffic collisions, falls from a height, or in people with active cancer6 • Same as specification
• Required in the observational data source: Fracture, including type of fracture, cancer data
6 Causal contrasts of interest • Intention-to-treat effect
• Per-protocol effect
• Observational analogue of intention-to-treat effect
7 Analysis plan • Comparison of fracture risk among participants assigned to dedicated units versus non-dedicated units of inpatient stroke rehabilitation
• Intention-to-treat or per-protocol analysis
• All analyses adjust for baseline confounders/prognostic factors
• Analyses adjusting for baseline confounders/prognostic factors
• Required in observational data: All baseline confounders/prognostic factors