PURPOSE: To quantify impairment in health-related quality of life (HRQL) of patients of pulmonary tuberculosis (PTB) at diagnosis and during treatment of disease, and to study utility of these assessments as outcome measure under the Revised National Tuberculosis Control Programme (RNTCP).
METHODS: Newly diagnosed patients of PTB being considered for anti-tubercular therapy, provided as directly observed treatment shortcourse (DOTS) under RNTCP, were studied. HRQL was assessed using the DR-12 scale at start, and at end of intensive phase and end of continuation phase, of DOTS. The DR-12 scale, a disease specific HRQL instrument for PTB patients in India, has 12 items over two domains - symptoms (seven items) and sociopsychological / exercise adaptation (five items). Each item was scored on a scale of one to three (with higher scores implying better HRQL), and individual domain scores and total score were calculated at each assessment. Psychometric evaluation was conducted by assessing acceptability, validity, reliability and responsiveness of DR-12.
RESULTS: 2654 HRQL assessments were performed on 1034 patients. Symptom scores were higher among women. Both domain scores, and total score, were better among urban residents, younger patients, those with better socio-economic status, and those with milder disease. DR-12 was acceptable with only six missing item responses. Mean (±SD) domain scores for symptoms and sociopsychological / exercise adaptation domains were 14.4±2.4, and 8.1±3.1 respectively. The content validity was moderate, and items of socio-psychological / exercise adaptation domain showed a floor effect. Construct and convergent validity were good. Cronbach’s alpha coefficient was poor (0.456) for symptom domain, and acceptable (0.885) for socio-psychological / exercise adaptation domain. Effect size exceeded 1.5 for both domains at second visit, and 2.0 for both domains at end of treatment, implying good responsiveness. Residual impairment was noted in some patients across both domains, even after completing treatment.
CONCLUSION: HRQL is significantly impaired in patients with PTB, and improves rapidly and significantly with DOTS.
CLINICAL IMPLICATIONS: HRQL assessment can be used as adjunct outcome measure for patients treated under RNTCP.
DISCLOSURE: Ashutosh Aggarwal, No Financial Disclosure Information; No Product/Research Disclosure Information