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Journal of Chinese Integrative Medicine ›› 2012, Vol. 10 ›› Issue (12): 1375-1381.doi: 10.3736/jcim20121207

• Original Clinical Research • Previous Articles     Next Articles

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

Yan-bo Zhu1(), Hideki Origasa2, Xiao-xia Luo3, Yang-yang Wang1, Jie Di1, Lin Lin4   

  1. 1. School of Administration, Beijing University of Chinese Medicine, Beijing 100029, China
    2. Department of Medical Pharmaceutical Research, University of Toyama, Toyama 930-0152, Japan
    3. School of Public Health, Fudan University, Shanghai 200032, China
    4. Department of Quality Management, China-Japan Friendship Hospital, Beijing 100029, China
  • Received:2012-08-15 Accepted:2012-08-30 Online:2012-12-20 Published:2018-12-15

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.

Key words: heart failure, outcome measures, responsiveness, integrated TCM WM, treatment outcome, evaluation studies as topic

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Characteristic Classification n Percentage
(%)
Experimental center
China-Japan Friendship
Hospital
58
37.18
Dongzhimen Hospital 17 10.90
Dongfang Hospital 81 51.92
Gender Male 76 48.72
Female 80 51.28
Age (years) ≤59 32 20.51
60-69 29 18.59
70-79 66 42.31
≥80 29 18.59
Education Primary school 44 28.21
Middle school 89 57.05
College degree or above 23 14.74
Free medical care 28 19.86
Payment (n=141,
15 cases missing)
Social medical insurance 104 73.76
Pay out-of-pocket 6 4.25
Others 3 2.13
Smoking history No 101 64.74
Yes 20 12.82
Quit 35 22.44
Alcohol history No 126 80.77
Yes 15 9.62
Quit 15 9.62
No 120 77.92
Family heart diseases
history (n=154, two
cases missing)
Yes 34 22.08
<1 year 37 24.67
HF course (n=150,
six cases missing)
1-4 years 46 30.67
5-9 years 26 17.33
≥10 years 41 27.33
NYHA classification 48 30.77
75 48.08
33 21.15

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Measure Domain Score (Mean±standard deviation) ES SRM Paired-t test
Before After Difference t value P value
CMSRS-HF CMSRS 16.60±8.45 8.10±5.25 -8.51±6.84 1.01 1.24 -15.52 0.000
MLHFQ Physical health 44.10±30.47 62.56±26.69 18.46±19.97 0.61 0.92 11.54 0.000
Mental health 64.33±26.64 74.10±22.72 9.77±18.49 0.37 0.53 6.60 0.000
Comprehensive score 55.89±24.84 68.53±21.95 12.65±14.97 0.51 0.85 10.560.000
SF-36 Physical functioning 40.03±27.93 46.67±27.68 6.63±13.56 0.24 0.49 6.11 0.000
Role-physical 36.94±31.78 49.60±31.33 12.66±24.00 0.40 0.53 6.59 0.000
Bodily pain 59.98±28.41 73.79±23.62 13.81±23.68 0.49 0.58 7.28 0.000
General health 41.06±21.82 44.10±21.63 3.04±13.41 0.14 0.23 2.84 0.005
Energy/vitality 41.07±25.98 50.60±23.51 9.54±19.38 0.37 0.49 6.14 0.000
Social functioning 58.49±30.02 65.63±26.93 7.13±24.68 0.24 0.29 3.61 0.000
Role-emotional 64.80±32.00 76.66±26.24 11.86±26.37 0.37 0.45 5.62 0.000
Mental health 67.69±24.50 73.94±19.42 6.25±15.25 0.26 0.41 5.12 0.000
Physical health components 44.50±21.11 53.54±18.72 9.04±10.91 0.43 0.83 10.35 0.000
Mental health components 58.01±22.71 66.71±19.25 8.69±14.67 0.38 0.59 7.400.000
Comprehensive score 51.26±20.92 60.12±17.71 8.87±11.21 0.42 0.79 9.87 0.000

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Measure Domain Score (Mean±standard deviation) ES SRM Paired-t test
Before After Difference t value P value
CMSRS-HF CMSRS 10.83±5.97 5.27±3.14 -5.56±5.70 0.93 0.98 -6.76 0.000
MLHFQ Physical health 67.81±26.38 79.53±19.31 11.72±17.80 0.44 0.66 4.56 0.000
Mental health 77.08±22.23 83.42±17.70 6.33±12.70 0.28 0.50 3.46 0.001
Comprehensive score 74.38±20.34 82.08±15.30 7.70±11.96 0.38 0.64 4.46 0.000
SF-36 Physical functioning 65.00±24.88 66.88±24.00 1.88±11.37 0.08 0.17 1.14 0.259
Role-physical 57.68±34.41 68.36±29.69 10.68±31.42 0.31 0.34 2.35 0.023
Bodily pain 62.63±28.26 75.42±23.00 12.79±25.72 0.45 0.50 3.45 0.001
General health 47.63±23.75 48.65±22.72 1.02±11.83 0.04 0.09 0.60 0.553
Energy/vitality 56.25±21.99 60.16±18.93 3.91±18.35 0.18 0.21 1.47 0.147
Social functioning 72.14±27.68 74.48±23.20 2.34±18.71 0.08 0.13 0.87 0.390
Role-emotional 74.13±29.59 83.68±22.54 9.55±29.52 0.32 0.32 2.24 0.030
Mental health 76.35±20.31 79.06±15.39 2.71±13.49 0.13 0.20 1.39 0.171
Physical health components 58.23±22.02 64.82±17.21 6.59±11.20 0.30 0.59 4.08 0.000
Mental health components 69.72±21.12 74.34±15.27 4.63±11.25 0.22 0.41 2.85 0.007
Comprehensive score 63.98±20.36 69.58±15.10 5.61±9.07 0.28 0.62 4.28 0.000

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Measure Domain Score (Mean±standard deviation) ES SRM Paired-t test
Before After Difference t value P value
CMSRS-HF CMSRS 17.13±7.72 8.15±4.01 -8.99±6.34 1.16 1.41 -12.27 0.000
MLHFQ Physical health 37.37±25.83 58.90±23.93 21.53±18.94 0.83 1.14 9.850.000
Mental health 62.88±25.54 72.32±22.54 9.44±19.25 0.37 0.49 4.25 0.000
Comprehensive score 51.33±21.56 65.58±20.17 14.26±14.94 0.66 0.95 8.27 0.000
SF-36 Physical functioning 31.93±21.10 40.27±22.70 8.33±13.29 0.39 0.63 5.43 0.000
Role-physical 32.83±27.13 47.92±27.48 15.08±20.88 0.56 0.72 6.25 0.000
Bodily pain 56.29±27.25 70.72±23.38 14.43±22.02 0.53 0.66 5.67 0.000
General health 39.00±21.85 43.19±21.66 4.19±15.15 0.19 0.28 2.39 0.019
Energy/vitality 36.08±25.35 48.00±24.41 11.92±20.01 0.47 0.60 5.16 0.000
Social functioning 55.67±29.01 64.83±26.69 9.17±26.98 0.32 0.34 2.94 0.004
Role-emotional 63.11±31.10 77.33±24.49 14.22±23.84 0.46 0.60 5.17 0.000
Mental health 64.93±25.05 73.67±19.16 8.73±15.86 0.35 0.55 4.77 0.000
Physical health components 40.02±18.34 50.52±16.70 10.51±10.77 0.57 0.98 8.45 0.000
Mental health components 54.95±21.04 65.96±18.35 11.01±16.15 0.52 0.68 5.90 0.000
Comprehensive score 47.48±18.77 58.24±16.11 10.76±12.25 0.57 0.88 7.61 0.000

"

Measure Domain Score (Mean±standard deviation) ES SRM Paired-t test
Before After Difference t value P value
CMSRS-HF CMSRS 23.79±7.22 12.09±7.31 -11.70±7.88 1.62 1.48 -8.53 0.000
MLHFQ Physical health 24.92±24.55 46.21±28.97 21.29±23.28 0.87 0.91 5.25 0.000
Mental health 49.09±26.42 64.61±25.34 15.52±22.58 0.59 0.69 3.95 0.000
Comprehensive score 39.34±21.47 55.53±24.05 16.19±17.41 0.75 0.93 5.34 0.000
SF-36 Physical functioning 22.12±20.46 31.82±27.12 9.70±15.56 0.47 0.62 3.58 0.001
Role-physical 16.10±17.82 26.14±24.73 10.04±17.47 0.56 0.57 3.30 0.002
Bodily pain 64.51±30.92 78.39±24.78 13.88±24.92 0.45 0.56 3.20 0.003
General health 36.18±16.61 39.58±19.20 3.39±11.16 0.20 0.30 1.75 0.090
Energy/vitality 30.30±23.44 42.61±23.57 12.31±18.19 0.53 0.68 3.89 0.000
Social functioning 45.08±28.46 54.55±28.78 9.47±26.52 0.33 0.36 2.05 0.049
Role-emotional 55.05±34.67 64.90±31.37 9.85±27.36 0.28 0.36 2.07 0.047
Mental health 61.36±26.08 67.12±23.29 5.76±15.62 0.22 0.37 2.12 0.042
Physical health components 34.73±15.51 43.98±17.64 9.25±10.46 0.60 0.88 5.08 0.000
Mental health components 47.95±22.06 57.29±22.21 9.35±14.68 0.42 0.64 3.66 0.000
Comprehensive score 41.34±17.84 50.64±18.67 9.30±10.80 0.52 0.86 4.95 0.000
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