2.5. Study Outcomes and Their Assessment

The primary endpoint was the 30-day incidence of severe complications. These were defined as clinically relevant events that either led to the premature interruption of the procedure or posed a threat to the patient’s health status. Such events encompassed active problems necessitating intervention to avert further damage (e.g., pneumonia, esophageal laceration, respiratory failure) and unforeseen occurrences that, while not causing significant harm in all instances, held substantial potential to do so (e.g., pneumothorax) [11,23,24]. Secondary endpoints included: 30-day incidence of any complication; 30-day incidence of unplanned hospital encounters (UHE—emergency department (ED) visits and/or inpatient admissions); 30-day mortality; time of onset of adverse events (immediate (within 1 h of the procedure), early (1 h to 24 h), late (1 to 30 days)); and risk factors for an adverse event.

Immediate complications were assessed during bronchoscopy and in the recovery room after the procedure. To capture early and late complications, patients were systematically contacted for a telephone interview on days 1 and 30 after the procedure. To minimize the risk of missing follow-up in the case of unforeseen events (e.g., ICU admission, death), a designated “backup” person chosen by each enrolled patient was instructed about the aims of the study and the nature of the follow-up. Furthermore, patients (and back-up persons, if needed) were encouraged to contact the investigators by telephone and/or by email at any time within 30 days after the procedure to report any change in their health status and/or any UHE. The medical charts of each outpatient diagnostic visit/work-up, as well as the ED or the hospital discharge report from patients who experienced health problems within 30 days, were systematically retrieved to obtain a reliable evaluation of the occurrence and time of onset of any adverse event possibly related to the procedure.

The assignment of an adverse event to the procedure was determined through consensus between two interventional pulmonologists, with one of them being the performing physician. In the case of a disagreement, a third interventional pulmonologist, who was unbiased to the opinions of the others, was consulted to provide a resolution.