Development and validation of heart failure-specific quality-of-life measurement tool in India

Objective: To develop and validate a sensitive tool for assessment of quality of life (QoL) in heart failure (HF) patients in Indian settings. Methods: The authors conducted literature review, in depth interviews, clinical observations and designed the first draft of the QoL tool. The tool was validated using content and face validity by a panel of experts. For internal consistency reliability, the questionnaire was administered among 270 HF patients. Test-retest reliability was assessed in 20 HF patients. Principal component factor analysis with varimax rotation was employed to assess the dimensionality and to reduce the number of items. Cronbach's alpha, and Intra-class correlation coefficients (ICCs) were employed to investigate reliability of questionnaire. The responsiveness data were collected 6 months after the baseline data collection from 30 HF patients. IBM (R) SPSS (R) Statistics Version 21 was used for statistical analysis. Results: The principal component factor analysis revealed mainly 5 domains. The final tool included 25 items. Cronbach's alpha (alpha) for the overall tool was 0.915. Intra-class correlation coefficients (ICCs) based on test-retest was 0.734. The final tool showed good responsiveness to changes with a mean +/- SD of the change in response of 46 +/- 12.4 and a standardized mean response of 3.7 within six-months. Conclusion: The HF specific QoL tool developed for Indian patients is a valid and reliable instrument and it can be applied in daily clinical practice, and research. Short summary: We had developed and validated a quality-of-life tool for heart failure patients in India. This is the first ever attempt to develop a measure for heart failure patients in India. We had used a mixed methodology approach to identify all the domains in the tool. The newly developed tool is a valid, reliable, sensitive and responsive tool to measure quality of life in HF patients in India. This tool can be applied in daily clinical practice, research and health system for patients with HF in India.