Randomize, then consent: a strategy for improving patient acceptance of participation in randomized controlled trials.

Abstract

When arthroscopic surgeons are attempting to resolve questions of a therapeutic or clinical nature, randomized controlled trials (Level I evidence) are most helpful. However, patients may be reluctant or unwilling to participate in randomized controlled trials. To improve the feasibility of conducting a randomized controlled trial, a strategy for improving patients' willingness to participate is proposed. The strategy is simple: randomize, then consent. This strategy allows for an informed consent process more specifically focused on the specific treatment to which the patient has been assigned. This may be less confusing, daunting, and frightening to patients, who thus may be more willing to participate in the randomized controlled trial. A disadvantage of randomization before consent is that randomization, temporally, is more distant from the actual treatment or intervention. However, randomization before consent may represent a compromise promoting both better quality consent and increased patient willingness to participate in randomized controlled trials.