Randomized clinical trials (RCTs) yield essential information about potential therapeutic interventions when the optimal treatment for a condition is unknown. They provide a basis for a causal inference about the effects of medication on quality of life by virtue of their experimental design. The authors discuss the various ways that the emphasis of effectiveness research studies, which observes what takes place under existing circumstances, differ from that of a typical RCT, with particular focus on selection of participants, assessment of study variables, and analyses of outcomes data.
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