TRITRIAL: The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease in an Italian Context of Real Life.

Purpose: The TRITRIAL study assessed the effects of beclometasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G) fixed combination in patients with chronic obstructive pulmonary disease (COPD) in a real-world setting, focusing on patient's experience and perspective through the use of patients reported outcomes. Patients and Methods: TRITRIAL was a multicenter, prospective, observational study conducted on patients with moderate-severe COPD treated with BDP/FF/G fixed therapy for 12 months. The main objective was to evaluate the impact of BDP/FF/G on health status through the COPD Assessment Test (CAT) score. Additional assessments included adherence and satisfaction, measured by the TAI-10/12 questionnaire and a specifically designed eight-item questionnaire, quality of life through the EQ-5D-5L test, sleep quality through the COPD and Asthma Sleep Impact Scale (CASIS), as well as safety and disease-related outcomes. Results: Data from 655 patients were analyzed in the study. The mean total CAT score significantly improved (from 22.8 at baseline to 18.1 at 6 months and 16.5 at 12 months; p < 0.0001), as well as all the eight CAT sub-items, which decreased on average by 0.5-0.9 points during the study. Adherence and usability of the inhaler also improved during the study, with a decrease in poor compliance (from 30.1% to 18.3%) and an increase in good compliance (from 51.8% to 58.3%) according to the TAI score. Patients also benefited from significantly improved quality of life (EQ Index from 0.70 to 0.80; EQ-5D VAS score from 55.1 to 63.1) and sleep quality (CASIS score from 41.1 to 31.8). Finally, patients reported a significant reduction in exacerbation during the study. Conclusion: TRITRIAL showed that the BDP/FF/G fixed combination is effective and safe in patients with moderate-severe COPD and poorly controlled disease, improving patients' HRQoL, sleep quality, adherence and inhaler usability and reducing COPD symptoms and the risk of exacerbation in a real-life setting.

En bloc spondylectomy in patients older than 60 years: indications, results and complications in a series of 37 patients.

PURPOSE: To review a series of patients > 60 years affected by primary spine bone tumors, who have undergone surgery, and to describe their clinical presentation, results and complications associated with surgical treatment. METHODS: A review of all patients > 60 years affected by primary spine bone tumor surgically treated with en bloc spondylectomy from 1993 to 2015 was performed. Thirty-seven cases were identified, and clinical and radiological characteristics, therapy, complications and survival were evaluated. RESULTS: Only 14/37 cases were not previously treated. Complications were quite frequent: 64% of patients experienced almost one early complication; 48% and 27% experienced 2 and ≥ 3 early complications, respectively; 37% of patients experienced almost one late complication; and 10% and 8% experienced 2 and ≥ 3 late complications, respectively. Massive blood loss and dural tear were the more frequent surgical complications; no deaths were reported during surgeries; one patient died during the first postoperative day due to hemorrhage and cardiac complications, one during the third postoperative day for the same cause despite of a savage surgery, and another one died at 7 days from index surgery due to myocardial infarction. The 5-year disease-related survival and global survival were 62.8% and 52.1%, respectively. Nineteen patients are still alive, 15 of whom without any evidence of disease. CONCLUSIONS: Primary malignant or locally aggressive bone tumors of the spine should be treated with wide surgery also in the older age, although the complications rate and the risk of patient survival can be considered high. These slides can be retrieved under Electronic Supplementary Material.