Reporting results of obstructive sleep apnea syndrome surgery trials.

Abstract

Obstructive sleep apnea syndrome surgery studies largely evaluate single procedures or procedure combinations in case series designs, but it can be difficult to compare results across studies. The authors present a standardized format for presentation of surgical study results to facilitate pooled analyses and subgroup analyses. The format includes thorough characterization of baseline subject characteristics and the use of outcome measures that reflect the spectrum of obstructive sleep apnea and its consequences. As the apnea-hypopnea index is the most common, albeit controversial, primary outcome measure in obstructive sleep apnea syndrome surgery studies, the authors propose analysis and reporting standards to facilitate understanding its role as an outcome measure. Because surgical outcomes vary according to subject characteristics, investigators should also evaluate the potential association between baseline subject characteristics and outcomes.