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July 6, 2005

Patient Preference and Validity of Randomized Controlled Trials—Reply

Author Affiliations

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

JAMA. 2005;294(1):41-42. doi:10.1001/jama.294.1.42-a

In Reply: Dr Cho and colleagues suggest that randomized evaluations of low-technology interventions, such as psychotherapy or health education for weight reduction, may involve stronger participant preferences and greater preference effects on subjective outcomes than the evaluation of highly technical biomedical interventions with objective outcomes. Our review examined whether the outcome was objective or subjective, but did not classify studies according to the nature of the intervention. However, the suggestion of Cho et al may not take full account of participants’ knowledge and experience. For example, people may have preferences between 2 types of surgical interventions. These choices might be informed by medical knowledge or by subjective information (eg, the experiences of family or friends). Furthermore, although few studies in our review showed significant differences in outcome between randomized and preference groups, studies in which such differences were apparent included 2 biomedical trials with objective outcomes. These trials concerned the mortality of people with coronary heart disease who underwent coronary artery bypass surgery or percutaneous coronary angioplasty. However, the decision to accept randomization or choose 1 alternative in these studies was influenced by the physicians’ as well as the patients’ preferences.13

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