The Nocturnal Oxygen Therapy Trial data monitoring experience: Problem with reporting lags

Abstract

The Nocturnal Oxygen Therapy Trial (NOTT) was a randomized controlled trial designed to evaluate the role of continuous oxygen compared to only nocturnal use for patients with advanced chronic obstructive pulmonary disease. The data monitoring committee for the NOTT had to consider issues of multiple outcomes, extension of patient recruitment, and problems with reporting lags in key outcome data. While statistical methods are very useful, they do not address all of the issues that must be considered. The data monitoring committee had to be alert to unanticipated problems and react accordingly. © 2006 Springer-Verlag New York.