[Skip to Content]
[Skip to Content Landing]
July 6, 2005

Patient Preference and Validity of Randomized Controlled Trials

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2005;294(1):41-42. doi:10.1001/jama.294.1.41-b

To the Editor: Dr King and colleagues1 concluded that there is little evidence that preferences affect trial validity. However, as these were observational comparisons, any preference effects in these trials may have been confounded by characteristics associated with preference. We believe that a better approach to observing the role of patient preferences on study outcomes is to accept that a significant proportion of patients who consent to randomization will have a treatment preference, particularly for the novel therapy.2,3 We ask patients’ preferences before randomization and then randomize all consenting patients irrespective of their baseline preferences. In this way we can examine within the safety of a completely randomized design whether there is an interaction between baseline preference and outcome. We recommend that preferences be measured at baseline before random allocation in all studies where preference may affect the outcome.

First Page Preview View Large
First page PDF preview
First page PDF preview