A psychological perspective for double-blind trials.

Abstract

Blind breaking is likely to occur in a long-term clinical trial involving subjects at risk. Double-blind conditions require subjects to live with ambiguity regarding their health status. It is unrealistic to expect them to tolerate this ambiguity over an extended period of time. A logical step for a subject is to break the blind and surreptitiously seek the best medical care available. Moreover, the staff assigned to monitor protocol adherence may further contribute to blind breaking because of ambiguity regarding their proper clinical role. Several steps are recommended to manage blind breaking within a trial, including improving the quality of medical care, more rigorous screening procedures, and maintaining a clinical environment that promotes accurate disclosure of blind breaking.