OBJECTIVES: In recent years, increasing efforts have been dedicated to assess the health-related quality of life (HRQL) in people infected with tuberculosis (TB). A variety of generic instruments exist to assess quality of life (QoL) in TB patients, but a psychometrically sound TB-specific HRQL instrument is lacking. The current study aimed to develop a self-reported HRQL measure specific for pulmonary TB patients in Iraq. METHODS: The core, general HRQL questionnaire is comprised of the Functional Assessment of Cancer Therapy- General (FACT-G) items. The FACT-G was selected because of its established psychometrics and history in measuring HRQL symptoms in patients with a variety of chronic illnesses. A modular approach was followed for the development of Functional Assessment of Chronic Illness Therapy- Tuberculosis (FACIT-TB) questionnaire in which a set of items assessing QoL issues not sufficiently covered by the core FACT-G items, but considered to be relevant to the target population, were added. The development process of an additional concerns subscale of the FACIT-TB instrument consisted of several stages, including: 1) Concept clarification; 2) Item pool generation; 3) Item reduction; 4) Refinement.  RESULTS: In addition to the 27 items of the core questionnaire, a set of 20 items referring to disease symptoms related to the site of infection (Pulmonary TB); side effects and other issues related to treatment; and additional QoL dimensions such as fatigue, fear of disease transmission, and economic burden of the illness were included in the additional subscale of FACIT-TB.  CONCLUSIONS: A rigorous method was applied in the development of FACIT-TB to fully understand the impact of the illness on QoL of TB patients. However, further linguistic validation and psychometric testing should be conducted to ensure conceptual equivalence, validity and reliability of the instrument and its relevance among Arabic-speaking patients in Iraq.