Among all the myriad sampling, design, and analysis questions that need to be addressed in proposing an RCT, the most contentious continues to be: What is C?; that is, what is the appropriate control group (or set of groups) in a particular RCT? More specifically, when is a placebo control group the appropriate choice? If not a placebo control group, then what? These are the questions to which we here turn our attention, questions that continue to be the focus of much disagreement and argument, even among experts in RCT methodology or application, ranging from many who propose that a placebo control group always be included in an RCT to some others who propose that it never be included.
In what follows we consider a variety of options for a control group, beginning with a few options that are, by strict definition, not RCTs. It is important to realize why these options are considered unacceptable, for those are the same considerations that apply when considering other possible choices for control groups, particularly that of a placebo control group. Then we discuss the choice of the placebo control group in some detail, ending with consideration of the treatment-as-usual (TAU) control group and the standard-of-treatment control group, the most common alternatives to the placebo control group.
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