Alternative Control Groups Treatmentas Usual Control Groups

For a variety of reasons, from the perspective of a patient or a clinician, the most attractive choice for a comparison group is one that uses what clinicians are currently using: the TAU (treatment-as-usual) control group. Here patients are recruited into the study and randomly assigned either to T, the new treatment under study, or to the treatment they would have received if they had not entered the RCT. The responses in both groups are monitored using the same protocol, with evaluators blinded to group membership. The research question is whether it can be shown, beyond reasonable doubt, that T produces better results than what community clinicians generally achieve.

Because patients who enter such an RCT receive at least the treatment that they would have received had they not entered the RCT (TAU), or perhaps receive a treatment for which there is a rationale and justification for a belief that it might be better (T), such a control group is an inducement to participation. Moreover, since dropping out of the study generally means getting what is now the control treatment, there is little inducement to drop out. Clearly, patients and treatment providers cannot be blinded to the treatment choice, although assessors of treatment response can be.

Objections to this choice of control group generally come from researchers, who correctly point out that community clinicians do not all use the same treatment, and many use treatments that are known to be far from optimal (or use optimal treatment in a less-than-optimal fashion). Far greater variability in response is likely in a TAU control group than there would be if one particular treatment were specified for a control group, or if placebo were used, and greater variability than in the T group.

Consequently, the sample size has to be larger to achieve adequate power than with a specific choice of comparator treatment or with a placebo as the control intervention.

Clearly, with TAU as the control condition, greater detail is needed in reporting results. It is important to report which treatments were being used by community clinicians and to explore whether some of those treatments were likely to be better or worse than T (hypotheses to perhaps be tested in future RCTs). However, all in all, TAU is a viable choice for a control condition in an RCT to document whether T is a better choice in general than what is already available in the community.

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