Table.
Methodological considerations for randomized trials and observational research |
PROs (eg, angina, functional status) |
Assessment of benefits and risks (ie, safety, radiation exposure) |
Maintenance of representative sampling for targeted priority population subgroups |
Really informed consent, individualized |
Effectiveness |
Clinically representative indications for cardiovascular imaging |
Meaningful effect size |
Heterogeneity of effectiveness |
“Given my characteristics, conditions, and preferences…”* |
Patient-scientist collaborations |
Transparent involvement for setting priorities, proposal development, and valuation of the findings |
PRO indicates patient-reported outcome.
Adapted from the Patient-Centered Outcomes Research Institute.83