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Journal of Chinese Integrative Medicine ›› 2011, Vol. 9 ›› Issue (8): 857-865.doi: 10.3736/jcim20110807

• Original Clinical Research • Previous Articles     Next Articles

Development of a patient-reported outcome scale for stable chronic obstructive pulmonary disease and its clinical applicability

Yan-bo Zhu1(), You-lin Li2(), Wei Wang3, Fang-chao Jiang2   

  1. 1. School of Administration, Beijing University of Chinese Medicine, Beijing 100029, China
    2. Department of Respiration, China-Japan Friendship Hospital, Beijing 100029, China
    3. Postgraduate School, Beijing University of Chinese Medicine, Beijing 100029, China
  • Received:2011-02-01 Accepted:2011-03-25 Online:2011-08-20 Published:2011-08-15

Objective: To develop a patient-reported outcome (PRO) scale for patients with stable chronic obstructive pulmonary disease (sCOPD) and to study its clinical applicability in traditional Chinese medicine (TCM).
Methods: According to standardized procedures, the test version of PRO scale for sCOPD (sCOPD-PRO scale) was developed based on the theory of “unity of body and spirit” and was used to test 324 patients selected from six clinical centers. Five methods were used to analyze the items; the reliability, validity and responsiveness of the remaining items of the scale were evaluated.
Results: (1) sCOPD-PRO consisted of 23 items after item analysis, and according to the content of each item, these items could be grouped into four domains, namely, lung and kidney deficiency symptom, spleen deficiency symptom, functional activities and emotional impact. (2) Cronbach’s alpha coefficient for sCOPD-PRO scale was more than 0.75 in four domains and total scores. (3) sCOPD-PRO scale and St. George’s Respiratory Questionnaire (SGRQ) were moderately correlated or highly correlated in corresponding domains: the correlation coefficient between the total score of sCOPD-PRO scale and the total score of SGRQ was 0.72 (P<0.01), the correlation coefficient between functional activities domain of sCOPD-PRO scale and activity domain of SGRQ was 0.77 (P<0.01), and the correlation coefficient between emotional impact domain of sCOPD-PRO scale and impact domain of SGRQ was 0.51 (P<0.01). Factor analysis revealed that four factors could explain 65.06% of the total variance. (4) The four domains and total scores of sCOPD-PRO scale were significantly different before and after intervention in TCM group and Western medicine group (P<0.01); moreover, the effect size and standardized response mean of two groups were more than 0.4.
Conclusion: The development process and method of sCOPD-PRO scale, which is based on the theories of “unity of body and spirit”, are standard, and the reliability, validity and responsiveness of the scale are sound and can be relied upon for sCOPD clinical efficacy evaluation of TCM.

Key words: pulmonary disease,chronic obstructive, program evaluation, patient-reported outcome, controlled clinical trial

Table 1

General characteristics of research objects among different groups"

Variable TCM group (n=106) Western medicine group
(n=106)
Placebo group
(n=107)
Statistical value P value
Age (x±s, years) 62.05±9.96 62.75±10.00 63.52±8.22 0.65 0.52
Gender 0.68 0.71
Male (n, %) 73 (66.87) 78 (73.58) 78 (72.90)
Female (n, %) 33 (31.13) 28 (26.42) 29 (27.10)
Marital status 2.02 0.37
Married (n, %) 106 (100.00) 105 (99.06) 107 (100.00)
Unmarried (n, %) 0 (0.00) 1 (0.94) 0 (0.00)
Culture degree 6.86 0.55
Elementary school or below (n, %) 11 (10.38) 13 (12.26) 13 (12.14)
Junior high school (n, %) 41 (38.68) 36 (33.96) 27 (25.23)
High school (n, %) 27 (25.47) 34 (32.08) 40 (37.38)
University (n, %) 26 (24.53) 23 (21.70) 26 (24.30)
Master degree or above (n, %) 1 (0.94) 0 (0.00) 1 (0.93)
COPD classification 0.14 0.93
Mild (n, %) 5 (4.72) 6 (5.66) 5 (4.67)
Moderate (n, %) 101 (95.28) 100 (94.34) 102 (95.33)

Table 2

Summary of five methods which were used to screen items"

Item Item
distribution
Related coefficient
method
Cronbach’s alpha
coefficient method
Factor analysis
method
Subjective evaluation
method
Elected
frequency
Remained
item
1 2
2 3
3 5
4 5
5 5
6 5
7 2
8 1
9 5
10 5
11 2
12 3
13 2
14 4
15 4
16 2
17 5
18 5
19 5
20 4
21 4
22 5
23 5
24 5
25 5
26 1
27 5
28 2
29 1
30 5
31 5
32 5
33 5
34 5

Table 3

Correlation of domains between sCOPD-PRO scale and SGRQ"

Domain of sCOPD-PRO scale Domain of SGRQ
Symptoms Activities Impacts Total score
Lung and kidney deficiency symptoms 0.31** 0.62** 0.47** 0.58**
Spleen deficiency symptoms 0.20** 0.24** 0.30** 0.27**
Functional activities 0.34** 0.77** 0.52** 0.69**
Emotional impacts 0.37** 0.25** 0.51** 0.43**
Total score 0.37** 0.66** 0.59** 0.72**

Table 4

Discriminant validity of sCOPD-PRO scale ($\bar{x}$±s)"

Lung
function classification
n Lung and kidney
deficiency symptoms
Spleen deficiency
symptoms
Functional
activities
Emotional impacts Total score
Mild 16 36.20±17.40 26.56±17.60 32.50±18.60 38.13±19.05 33.35±15.18
Moderate 303 48.83±16.83 37.87±21.13 47.19±20.38 38.32±16.15 43.05±13.35
t value –2.92 –2.10 –2.82 –0.05 –2.81
P value 0.004 0.036 0.005 0.963 0.005

Table 5

Factor analysis of sCOPD-PRO scale"

Domain Item Factor 1 Factor 2 Factor 3 Factor 4
Functional activities
17 0.79 - - -
18 0.69 0.31 - -
19 0.71 0.20 - -
20 0.84 0.21 - -
21 0.73 0.35 - -
22 0.45 0.55 - -
23 0.64 0.50 - -
24 0.81 0.32 - -
25 0.64 0.30 - -
27 0.77
Lung and kidney deficiency symptoms
3 0.34 0.77 - -
4 0.39 0.78 - -
5 0.41 0.71 - -
6 0.52 - - 0.49
9 0.41 0.45 - -
10 0.65 0.22 - 0.29
Emotional impacts
30 - 0.33 0.65 -
31 - 0.37 0.66 0.26
32 0.47 - 0.67 -
33 - - 0.85 -
34 - - 0.81 0.24
Spleen deficiency symptoms
14 - - - 0.88
15 - - 0.34 0.77

Table 6

Comparison of sCOPD-PRO scale scores among groups before and after intervention"

Domain Group n Score (x±s) t value P value ES SRM
Before treatment After treatment Difference value
Lung and kidney deficiency symptoms
TCM 106 50.16±16.40 35.46±12.46 14.70±13.10 11.55 <0.001 0.90 1.12
Western medicine 106 47.56±15.77 38.01±13.74 9.55±10.45 9.41 <0.001 0.61 0.91
Placebo 107 46.88±18.82 44.31±25.08 2.57±14.19 1.87 0.064 0.14 0.18
Spleen deficiency symptoms
TCM 106 37.74±19.05 27.71±17.68 10.02±19.09 5.41 <0.001 0.53 0.52
Western medicine 106 35.38±18.21 26.89±14.90 8.49±15.19 5.75 <0.001 0.47 0.56
Placebo 107 38.78±25.29 38.55±29.25 0.23±17.84 0.14 0.893 0.01 0.01
Functional activities
TCM 106 47.92±20.45 39.58±17.13 8.35±9.93 8.65 <0.001 0.41 0.84
Western medicine group 106 47.10±20.25 40.97±18.03 6.13±10.48 6.02 <0.001 0.30 0.58
Placebo 107 44.34±20.87 43.06±22.87 1.29±11.83 1.12 0.264 0.06 0.11
Emotional impacts
TCM 106 39.58±15.49 32.03±12.38 7.55±10.94 7.10 <0.001 0.49 0.69
Western medicine 106 37.22±16.59 30.05±11.33 7.17±11.81 6.25 <0.001 0.43 0.61
Placebo 107 38.13±16.77 42.48±26.31 –4.35±18.42 –2.44 0.016 –0.26 –0.24
Total score
TCM 106 43.85±13.23 33.69±9.87 10.16±9.00 11.62 <0.001 0.77 1.13
Western medicine 106 41.81±12.36 33.98±8.93 7.84±8.69 9.29 <0.001 0.63 0.90
Placebo 107 42.04±15.05 42.10±22.18 –0.06±11.43 –0.06 0.954 0.00 –0.01
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