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. 2011 Feb 24;29(3):265–271. doi: 10.1007/s00345-011-0658-3

Table 1.

Specialized classifications of randomized controlled trials

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