Use of biomarkers to assess tissue specific androgen adequacy: defining male hypogonadism.

Purpose: The criteria for normal testosterone have been established by expert consensus rather than by evidence. We determined whether a cutoff point for normal could be established using biomarkers.

Materials And Methods: We performed an exploratory investigation of 1,492 hypogonadal men pooled from 7 registration trials.

Proton pump inhibitor use in infants: FDA reviewer experience.

The Food and Drug Administration has completed its review of 4 clinical trials evaluating the use of proton pump inhibitors (PPIs) in infants (ages 1 month to <12 months) for the treatment of gastroesophageal reflux disease (GERD). An Advisory Committee meeting was held in November 2010 to discuss the potential reasons why PPI use in these trials failed to show a benefit in infants with GERD, and directions for future study. The present review summarizes the findings from the clinical trials.

Incomplete event documentation in medical records of lung transplant recipients.

Context: The medical record is frequently used in clinical studies as a source of information on illness events experienced by patients; however, it may be incomplete.

Objective: To estimate the extent of incompletely documented acute bronchopulmonary events in a transplant clinic medical record at a single university medical center, using home monitoring data.

Design, Setting, And Subjects: Trends in daily home monitoring data were compared to contemporaneous medical record documentation at 150 different times in 30 lung transplant recipients over 45 subject-years.

Comparison of Bayesian, classical, and heuristic approaches in identifying acute disease events in lung transplant recipients.

This study compares a typical heuristic algorithm with classical and Bayesian regression models in ascertaining the presence of acute bronchopulmonary disease events in lung transplant recipients. These models attempt to predict whether an epoch will end in an event, based on the preceding two weeks of data. The data consist of 150 two-week epochs of daily to biweekly spirometry and symptom covariates for 30 subjects over 60 subject-years.