Responsiveness of three subjective report of outcome measures for chronic heart failure.

Objective: To compare the responsiveness of a newly designed symptom scale, the Chinese Medical Symptom Rating Scale for Heart Failure (CMSRS-HF), with the Chinese version of Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the Medical Outcomes Study Short-form 36 (SF-36), and provide basis for the selection of subjective outcome measures for clinical evaluation of treatment of chronic heart failure by integrated traditional Chinese and Western medicine.

Methods: One hundred and fifty-six patients with chronic heart failure were recruited from three clinical centers and were treated with Chinese herbal medicine based on syndrome classification. The patients were classified with standard of New York Heart Association and evaluated with CMSRS-HF, MLHFQ and SF-36. Three techniques for the quantification of responsiveness were utilized: paired t-test, effect sizes (ES) and standardized response means (SRM).

Results: a) After 2-week treatment, patients scored significantly lower in CMSRS-HF, while scores of each dimension on MLHFQ and SF-36 increased significantly (P=0.000). b) ES of CMSRS-HF was greater than 0.8. ES of physical and emotional dimensions and comprehensive scores of MLHFQ were between 0.37 and 0.61; ES of each dimension, physical and emotional domains, and comprehensive scores were between 0.14 and 0.49. c) SRM of CMSRS-HF was greater than 0.8; SRM of physical and emotional dimensions and comprehensive scores of MLHFQ ranged from 0.53 to 0.92; SRM of each dimension, physical and emotional domains, and comprehensive scores were between 0.23 and 0.83. d) By stratified analysis according to NYHA classification, the acute patients (NYHA III, IV) were more sensitive to subjective outcome measures.

Conclusion: Responsiveness of the newly designed CMSRS-HF is high. However, responsiveness of MLHFQ and most dimensions in SF-36 is moderate. When evaluating clinical effects of integrated traditional Chinese and Western medicine on chronic heart failure, different scales can be applied according to actual clinical presentations.