Patient Preferences and the Ironic Nature of Randomized Trials

Medical Decision Making (MDM)
March/April 2011; 31 (2)

Jacob A. Udell and Donald A. Redelmeier
Patient Preferences and the Ironic Nature of Randomized Trials
Med Decis Making March/April 2011 31: 226-228, doi:10.1177/0272989X11399125

Randomized trials are an attractive form of medical research that often contains blemishes when examined carefully. One criticism relates to limited generalizability, because such studies typically include only a fraction of the available patients and often exclude the challenging individuals who have complex comorbidities. 1 Randomized trials can also fail because of practical issues such as insufficient recruitment (inadequate power bias), a limited duration of follow-up (brevity bias), or losses to follow-up (attrition bias). 2 Several other opportunities for misinterpretation arise if the study is not adequately blinded so that outcomes and co-interventions are managed in a slanted manner. 3 Furthermore, the large costs of a randomized trial (both financial and operational) create a potential conflict of interest for investigators and a worrisome reality that the research will not be repeated.

This issue of the journal describes a further blemish in randomized trials that is subtle, pervasive, and rarely mentioned. Specifically, such trials randomize the assignment of patients to treatments and thereby require each person to disregard his or her inherent preferences. Such a behavior style is remarkably strange for a sentient adult, does not occur in usual clinical settings, and typically must be maintained for an extended interval. 4, 5 Of course, patients sometimes feel conflicted when facing a choice, and such indecision may take time to resolve before a subsequent commitment. By definition, however, a randomized trial requires each patient to follow a treatment that has been randomly assigned with no basis. 6 …