Appraising randomized controlled trial evidence

Assess experimental benchmarks for causal treatment effects

There are certain empirical benchmarks that RCTs must meet in order to generate causal effects. If any of these experimental benchmarks are not met, the validity of the treatment effect rendered from the study is questionable, especially as it relates to your patient. 

Appraisal criteria for randomized controlled trial evidence

After reading the article, ask the following questions:

1. Were the study participants randomly selected from the population of interest?

2. Were study participants randomly allocated to either the treatment or control group?

3. Was the randomization concealed?

4. Were the groups similar at the start of the trial in regards to prognostic factors?

5. Was the follow-up for outcomes sufficiently long and complete given the clinical and prognostic context?

6. Were all patients analyzed in the groups to which they were randomized (intention-to-treat)?

7. Were patients, clinicians, and study personnel kept blind to treatment?

8. Were the treatment groups treated equally, with the exception of the experimental therapy?

9. Was the treatment effect clinically significant?

10. How precise is the estimate of the treatment effect?
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There are several criteria that have to be met when appraising randomized controlled trials: Random selection, random assignment, concealed randomization, equipoise between treatment groups, sufficient follow-up on outcomes, intention-to-treat analysis, blinding, equal treatment of groups, clinically significant treatment effects, and clinically precise estimates of treatment effects.