Analysis of clinical data with breached blindness

Stat Med. 2004 Apr 30;23(8):1185-93. doi: 10.1002/sim.1694.


In clinical trials, blinding is usually employed to prevent bias that may be introduced due to the knowledge of the identity of the treatment codes. This bias could alter the conclusion of statistical inference on the treatment effect. The purpose of this article is to propose a method for analysing clinical data with breached blindness. The example regarding the study of the effectiveness of an appetite suppressant in weight loss in obese woman as described in Brownell and Stunkard (Am. J. Psychiatry 1982; 139:1487-1489) is used to illustrate the application of the proposed methods.

MeSH terms

  • Analysis of Variance
  • Appetite Depressants / therapeutic use
  • Bias
  • Data Interpretation, Statistical*
  • Double-Blind Method*
  • Female
  • Humans
  • Models, Statistical
  • Obesity / drug therapy
  • Randomized Controlled Trials as Topic / methods*
  • Randomized Controlled Trials as Topic / statistics & numerical data
  • Research Design
  • Treatment Outcome


  • Appetite Depressants