Table 1.
Type | Description | Strengths | Limitations |
---|---|---|---|
Cluster | Randomization of subjects as a group rather than on individual basis |
Can study interventions that cannot be directed toward selected individuals Can control for contamination across individuals (i.e., when one individual’s behavior can influence another’s) |
Needs more subjects to reach statistical power than standard RCT |
Explanatory | Individual randomization of very selective subjects in a highly controlled setting |
Useful to test efficacy (i.e., whether an intervention causes a specific biologic response) Patients blinded Excellent internal validity Good for acute disease processes |
External validity and applicability to clinical practice is limited due to subject selection |
Pragmatic | Individual randomization of non-selective group of patients in a regular clinical setting |
Useful to test effectiveness of an intervention in everyday practice Good for chronic disease processes and complex interventions Excellent external validity and directly applicable to clinical practice |
Patients unblinded Internal validity limited due to broad inclusion criteria |
Expertise-based | Individual randomization of subjects to an expertise in the intervention in question | Useful when intervention is non-pharmacologic (i.e., surgical procedures) | External validity limited to only those patients receiving care from a physician with expertise skills |