Discussion
In this pilot randomized clinical trial, we identified the study algorithm comparing IPFT with surgical management of a CPI to be feasible with 100% patient enrollment to study completion and excellent multidisciplinary protocol adherence following randomization. Patient identification and accrual was adequate, with all eligible patients screened, no screening to enrollment failures, and approximately 9 patients enrolled annually. Clinical characteristics and outcomes were similar to those in previous reports, confirming safety and efficacy of the algorithm. We also conclude that our standardized chest tube removal criteria were effective, as no additional procedures were required in randomized patients following chest tube removal. We believe these findings provide evidence that the proposed algorithm can move forward to a large, multicenter randomized clinical trial.Previous studiesSupporting the primary outcome, we identified the study algorithm to be feasible, safe, and efficacious. As with any randomized trial, equipoise in physician screening of patients and in discussion of the trial with patients is critical to study the algorithm feasibility and implementation. With the proposed algorithm, there were 3 instances of the physician choosing surgery instead of randomization, and these patients were excluded prior to enrollment. This may be prevented in the future by including sites where physicians commit to the algorithm. At the study summation meeting of investigators, all participants voiced support for the study algorithm and to proceed with a multicenter trial.A potential challenge to accrual, which should not affect future trials, was the emergence of the COVID-19 pandemic. Study enrollment was paused briefly in 2020, and while this may have prolonged the overall duration of patient enrollment, enrollment was similar in 2020 and 2021 compared with 2019. Patient clinical follow-up was likely affected, as we noticed patients were not routinely available.This study was not powered to identify differences in clinical outcomes; therefore, the small population size warrants some hesitation in interpretation. However, with that caveat, our outcomes appear relatively similar to the previously published retrospective data.This pilot trial is notable as it is one of the first to assess the feasibility, safety, and efficacy of a study algorithm comparing IPFT with surgical decortication for the management of a CPI. Ongoing trials across the globe