Protocol of a Nationwide Observational Cohort Study for Long-Term Impacts on Lung Health and Life after Tuberculosis in Korea (LIFE-TB)

Abstract

Background: Growing concern has emerged regarding the disease burden and longterm outcomes associated with post-tuberculosis lung disease (PTLD). This study is designed to assess the long-term effects of tuberculosis (TB) on lung health and quality of life, aiming to fill the critical evidence gap in PTLD research. Methods: This investigation utilizes a nationwide, prospective, multicenter observational cohort design. Seven tertiary healthcare centers in Korea will recruit at least 350 participants in the treatment-phase group (with a minimum of 50 participants per site) between June 2025 and December 2026. Eligible participants are individuals aged >= 19 years who are either in the course of anti-TB treatment (treatment-phase group), or have previously completed treatment for pulmonary TB (post-treatment group). Exclusion criteria are diagnosis limited to extrapulmonary TB, age <19 years, or refusal to provide consent. Data will be gathered at baseline and annually for up to 5 years until December 2031. Baseline assessments will capture demographic characteristics, TB-related clinical history, relevant comorbidities, and medication use. Initial laboratory evaluations will cover blood analysis, urinalysis, and electrocardiographic measurements. Comprehensive clinical evaluations include symptom scoring, spirometry, chest imaging, and administration of quality of life questionnaires. Annual follow-up will involve repeating spirometry, chest imaging, and quality of life assessments. No additional interventions beyond routine clinical care will be mandated by the study protocol. All collected data will be anonymized and managed securely, adhering to both institutional and ethical regulatory standards (ClinicalTrials.gov: NCT06946784). Conclusion: This will be the first nationwide observational cohort investigating PTLD in Korea, delivering key real-world evidence to inform national and international post-TB management policies.