Recommendations for the development, implementation, and reporting of control interventions in efficacy and mechanistic trials of physical, psychological, and self-management therapies: the CoPPS Statement

Randomised controlled trials (RCTs) that test the efficacy of a drug against a “placebo control” are well established in drug research. In principle, placebo controls mimic the treatment under investigation but lack its supposed active ingredient (for example, as pharmacologically inert sugar pills or saline injections).1 Such specifically designed control interventions control for the natural course of the disease and regression to the mean. Importantly, these interventions also account for context-dependent effects, such as those produced by patient-provider interactions and treatment related rituals. Researchers can use such interventions to blind trial participants, treatment providers, and outcome assessors to trial participants’ group allocation, concealing whether the investigational treatment or the control is administered. Through the indistinguishability of drug and control, all trial participants are exposed to similar treatment contexts, which should lead to comparable expectations of treatment benefit.In non-pharmacological trials, methodological criticism of control interventions (often called “sham” controls, representing the…
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