Statistical Analysis
deaths, pleural infection, pain
PLEURAL INFECTION, RECRUITMENT
Because this was a feasibility study, a formal sample size was not calculated. A total of 75 patients were planned to be randomized (25 in each arm) over a period of 18 months from six centers based on recruitment to an observational study in pleural infection (PILOT), which recruited 20 participants per month in 20 centers (To assess feasibility, the proportion of eligible participants was compared with the total number of patients screened, and the proportion of participants who consented to randomization was compared with the total number eligible. The proportion of patients who became ineligible as a result of good initial response to standard care (therefore not meeting the criteria for medical treatment failure at 24 h after chest tube insertion) and the recruitment and retention rates to discharge and 2 weeks were measured.All patient-reported and clinical outcomes were analyzed on an intention-to-treat basis. Treatment difference and 95% confidence intervals (CIs) are reported throughout. Hospital LOS was summarized using a Kaplan-Meier plot, with deaths censored. Hospital LOS was defined from the date of randomization to the date of discharge. A mixed effects model adjusting for treatment, RAPID category, size of chest tube inserted, and baseline measurements as fixed effects and recruiting center as a random effect was fitted for continuous outcomes available at multiple time points.Mean HADS score, EQ-5D-5 L utility index, EQ-5D-5 L 100-mm VAS score, and pain score were compared between groups using one-way ANOVA, with 