Functional Outcomes, Lung health and Livelihood Outcomes among people With Tuberculosis (FOLLOW-TB): study protocol...

Tuberculosis (TB) is a major global cause of morbidity and mortality. Emerging evidence in high-burden settings suggests significant long-term sequelae among people surviving TB; however, evidence from high-income, low-TB burden settings like Canada is lacking. In a person with TB infection, provision of TB preventive treatment (TPT) can prevent TB disease and its sequelae, but remains underused. We propose the Functional Outcomes, Lung health and Livelihood Outcomes among people With Tuberculosis study, a multicentre, prospective cohort study in Canada to help improve our understanding of the impacts of TPT and TB disease on individuals.

This is a prospective cohort study taking place in Montreal and Vancouver, Canada. We aim to recruit and retain at least 120 people with microbiologically confirmed TB disease, 340 people treated for TB infection and 120 without TB disease or infection who will be considered our unexposed group. All participants must be ≥6 years of age. Participants with TB disease or infection will be recruited within 2 weeks of treatment initiation. We will follow-up unexposed participants and participants with TB disease for 24 months, and participants with TB infection for 12 months. Throughout follow-up, participants will complete assessments measuring lung health and function, quality of life, disability, dyspnoea, psychological distress, as well as changes in employment and direct and indirect costs incurred because of treatment. Among participants with TB disease, our primary outcome is the difference in quality-adjusted life years between participants with TB disease and those unexposed at 24 months. For participants with TB infection, our primary outcome is the identification of non-patient characteristics (eg, patient cost, quality of life) associated with participant decision to discontinue treatment. Patient partners have contributed to the design of the study and will be involved with the study through to its dissemination.

This study has been approved by institutional ethics review boards at The Research Institute of the McGill University Health Centre (2025-10344) and The University of British Columbia (H24-02071). All participants will provide informed consent (and assent, if required) prior to participating in the study. We will disseminate study results to participants, national and international organisations, and through open-access peer-reviewed academic journals and conferences.