TABLE 11 Characteristics of a Well Designed Trial about Therapy

Are the results valid? Was the prognosis of patients in each group similar at the start of the trial? Was the trial randomized?

Was the randomization blinded (concealed allocation)? Were patients analyzed according to the group to which they were randomized?

Were patients similar with respect to demographics and known prognostic factors?

Was the prognosis of patients in each group similar after randomization? Was there double blinding (patients and investigators)? Was follow-up complete? What are the results? How large is the treatment effect? What is the precision of the estimate of the treatment effect? Can the results be applied to patient care? Were the problem, study patients, and interventions similar to your practice? Were all outcomes of interest considered? Are the treatment benefits worth the potential harm and costs?

of the outcome in the other group. It tells us to what degree patients in the experimental group are more (or less) likely to experience the outcome of interest compared with patients in the control group. What it does not tell us is how often patients in either group will experience the outcome. Although it is true that a larger RRR is associated with a larger treatment effect, even a high RRR may be misleading if the control (expected) rate is very small. Because of this, the ARR may be a more useful basis for clinical decisions. The ARR describes the therapeutic yield of the experimental therapy above and beyond the control (expected) rate. It

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