Objectives and Outcomes
SECONDARY, RECRUITMENT, COMPLICATIONS
The primary objective was to determine the feasibility of the proposed study algorithm comparing IPFT and surgical intervention as measured by percentage of enrollment to completion of the study algorithm and percentage of multidisciplinary participation in adherence to the algorithm. There were multiple secondary objectives evaluated in an effort to maximize successful recruitment, assist with multicenter study design, and obtain preliminary information for sample size estimates. We evaluated patient identification strategies (number of and reason for inadequate screening of eligible patients and failure of screening to enrollment) and collected accrual times (time to accrual of 20 patients or number of patients accrued in 1 year, whichever occurred first). Preliminary clinical data on the proposed chest tube management algorithm were also collected, including number of chest tube and hospital days. Supplementary clinical end points (radiographic improvement, treatment failures, additional procedures, complications, and 30- and 90-day mortality) were collected to inform on the efficacy and safety of the algorithm.