Treatment Outcomes and Loss to Follow-Up in Tuberculosis: A Real-World Cohort Study from Sicily, Italy

Abstract Background Tuberculosis (TB) remains a major cause of morbidity and mortality worldwide. Its management is frequently complicated by prolonged treatment, drug-related toxicity, antimicrobial resistance, and difficulties in maintaining long-term follow-up. We aimed to describe the clinical characteristics, management, and treatment outcomes of patients with TB treated at a tertiary referral center in Sicily, Italy. Methods We conducted a retrospective observational study of consecutive patients with TB managed between January 2021 and December 2023. Demographic, clinical, microbiological, treatment-related, and outcome data were collected. Outcomes included treatment completion, loss to follow-up (LTFU), transfer to another center, treatment failure, relapse, and death. Factors associated with treatment completion were evaluated using multivariable logistic regression. Results Among 164 patients, 130 (79.2%) were male, and 105 (64.0%) were born outside Italy. Pulmonary TB was diagnosed in 141 patients (86.0%), including 82 (58.2%) with concomitant extrapulmonary involvement. Microbiological confirmation was obtained in 106 (64.6%). Phenotypic drug susceptibility testing was available for 50 patients, of whom 17 (34.0%) showed resistance to at least one drug tested. Adverse drug reactions occurred in 37 patients (22.6%), most commonly hepatotoxicity, and led to treatment modification in 35. By the end of follow-up, 95 patients (57.9%) had completed treatment, 53 (32.3%) were LTFU, 5 (3.0%) had been transferred to another center, and 11 (6.7%) had died. Treatment failure and relapse were each documented in one patient. Five deaths were directly attributable to TB, whereas six were related to underlying or concomitant comorbidities. Foreign-born status was independently associated with lower likelihood of treatment completion (adjusted OR, 0.260; 95% CI, 0.106–0.641; p = 0.003). Conclusions In this real-world cohort, TB management was characterized by substantial clinical complexity and a high rate of LTFU. Foreign-born patients were significantly less likely to complete treatment, underscoring the need for patient-centered strategies to strengthen long-term engagement and reduce LTFU.

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Journal
Research Square
Published
2026-11-09
DOI
https://doi.org/10.21203/rs.3.rs-11085404/v1
Primary Topic
Tuberculosis Research and Epidemiology
Type
preprint
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preprint

Treatment Outcomes and Loss to Follow-Up in Tuberculosis: A Real-World Cohort Study from Sicily, Italy

Salvatore Antonino Distefano, Rita Immordino, Luca Pipitò, Domenico Graceffa et al.
Research Square
Tuberculosis Research and Epidemiology
preprint

Treatment Outcomes and Loss to Follow-Up in Tuberculosis: A Real-World Cohort Study from Sicily, Italy

Salvatore Antonino Distefano, Rita Immordino, Luca Pipitò, Domenico Graceffa, Eleonora Bono, Antonio Cascio, Chiara Vincenza Mazzola, Annamaria Vitale, Paola Di Carlo, Celestino Bonura, Silvia Bonura, Giulio D’Agati, Floriana Di Figlia, Antonella Bartolone, Claudia Conti, Sofia Urso, Giovanni M. Giammanco, Edoardo Mandalà, Costanza Giordano, Sara Cannella, Laura Causa, Gaetano D'Alessandro
preprint en

Abstract

Abstract Background Tuberculosis (TB) remains a major cause of morbidity and mortality worldwide. Its management is frequently complicated by prolonged treatment, drug-related toxicity, antimicrobial resistance, and difficulties in maintaining long-term follow-up. We aimed to describe the clinical characteristics, management, and treatment outcomes of patients with TB treated at a tertiary referral center in Sicily, Italy. Methods We conducted a retrospective observational study of consecutive patients with TB managed between January 2021 and December 2023. Demographic, clinical, microbiological, treatment-related, and outcome data were collected. Outcomes included treatment completion, loss to follow-up (LTFU), transfer to another center, treatment failure, relapse, and death. Factors associated with treatment completion were evaluated using multivariable logistic regression. Results Among 164 patients, 130 (79.2%) were male, and 105 (64.0%) were born outside Italy. Pulmonary TB was diagnosed in 141 patients (86.0%), including 82 (58.2%) with concomitant extrapulmonary involvement. Microbiological confirmation was obtained in 106 (64.6%). Phenotypic drug susceptibility testing was available for 50 patients, of whom 17 (34.0%) showed resistance to at least one drug tested. Adverse drug reactions occurred in 37 patients (22.6%), most commonly hepatotoxicity, and led to treatment modification in 35. By the end of follow-up, 95 patients (57.9%) had completed treatment, 53 (32.3%) were LTFU, 5 (3.0%) had been transferred to another center, and 11 (6.7%) had died. Treatment failure and relapse were each documented in one patient. Five deaths were directly attributable to TB, whereas six were related to underlying or concomitant comorbidities. Foreign-born status was independently associated with lower likelihood of treatment completion (adjusted OR, 0.260; 95% CI, 0.106–0.641; p = 0.003). Conclusions In this real-world cohort, TB management was characterized by substantial clinical complexity and a high rate of LTFU. Foreign-born patients were significantly less likely to complete treatment, underscoring the need for patient-centered strategies to strengthen long-term engagement and reduce LTFU.

Research Square
University of Messina (IT), Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" di Palermo (IT), University of Palermo (IT)
Tuberculosis Research and Epidemiology
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