The Childhood Adenotonsillectomy Trial (CHAT): Rationale, Design, and Challenges of a Randomized Controlled Trial Evaluating a Standard Surgical Procedure in a Pediatric Population

This paper addresses key elements in the design and implementation of a controlled trial for a widely used “standard practice” surgical intervention in a pediatric population, that include establishment of standardized data collection procedures across sites for a wide variety of data types, establishment of equipoise, and approaches for minimizing unblinding of selected key personnel.

http://www.ncbi.nlm.nih.gov/pubmed/22043122