Background
Methods
Sample
HRQL and clinical measures
Criteria for clinical change
Analysis
Results
Characteristic (n = 298) | Number (%) or Mean ± SD |
---|---|
Demographics
| |
Age | 60 ± 13 |
Sex (male) | 223 (75) |
Race | |
Caucasian | 216 (73) |
African-American | 69 (23) |
Other | 13 (4) |
Body mass index | 29.0 ± 6.5* |
Co-Morbidities
| |
History Hypertension | 159 (53) |
History of angina | 66 (22) |
History of myocardial infarction | 112 (38) |
History of percutaneous coronary intervention | 41 (14) |
History of coronary artery bypass graph | 82 (28) |
History of hyperlipidemia | 135 (45) |
History of diabetes | 99 (33) |
History of renal failure | 15 (5) |
History of COPD/Asthma | 56 (19) |
Heart Failure
| |
Etiology † | |
- Ischemia | 146 (50) |
- Hypertensive | 25 (8) |
- Valvular heart disease | 8 (3) |
- Other | 110 (38) |
Ejection fraction | 25 ± 8.1 |
Heart Rate | 73 ± 14 |
Systolic blood pressure | 121 ± 24 |
Diastolic blood pressure | 69 ± 13 |
Receiving ACE inhibitors | 242 (81) |
Receiving beta-blockers | 224 (75) |
Receiving spironolactone | 106 (36) |
Health Status Measure (n = 298) | Number (%) or Mean ± SD |
---|---|
RAND12–PCS | 35.0 ± 10.7 |
RAND12–MCS | 48.4 ± 11.4 |
EQ5D–UK Valuation | 0.66 ± 0.26 |
EQ5D–US Valuation | 0.74 ± 0.17 |
EQ–VAS | 62.6 ± 20.5* |
KCCQ–Clinical Summary Score | 65.8 ± 23.3 |
KCCQ–Overall Summary Score | 61.4 ± 24.1 |
NYHA Class | |
I | 34 (11) |
II | 129 (43) |
III | 122 (41) |
IV | 13 (4) |
Six minute walk distance (m) | 305 ± 112 |
Classification according to clinical criteria
n | Baseline Score ± Standard Deviation | 6 Week Score ± Standard Deviation | Mean Change Score ± Standard Deviation | |
---|---|---|---|---|
EQ5D–US Scoring
| ||||
+2 NYHA Classes
| 2 | 0.78 ± 0.11 | 0.82 ± 0.06 | 0.04 ± 0.05 |
+1 NYHA Class
| 50 | 0.76 ± 0.16 | 0.77 ± 0.16 | 0.01 ± 0.13 |
No change in NYHA Class
| 206 | 0.74 ± 0.18 | 0.77 ± 0.16 | 0.03 ± 0.13 |
-1 NYHA Class
| 40 | 0.73 ± 0.18 | 0.74 ± 0.17 | 0.01 ± 0.12 |
-2 NYHA Classes
| 0 | - | - | - |
EQ5D–UK Scoring
| ||||
+2 NYHA Classes
| 2 | 0.75 ± 0.19 | 0.79 ± 0.14 | 0.04 ± 0.05 |
+1 NYHA Class
| 50 | 0.68 ± 0.25 | 0.70 ± 0.24 | 0.02 ± 0.19 |
No change in NYHA Class
| 206 | 0.66 ± 0.27 | 0.71 ± 0.22 | 0.05 ± 0.20 |
-1 NYHA Class
| 40 | 0.65 ± 0.27 | 0.65 ± 0.25 | 0.00 ± 0.19 |
-2 NYHA Classes
| 0 | - | - | - |
EQ–VAS
| ||||
+2 NYHA Classes
| 2 | 71.00 ± 12.73 | 77.50 ± 10.61 | 6.50 ± 2.12 |
+1 NYHA Class
| 46 | 59.83 ± 21.05 | 62.10 ± 21.32 | 1.09 ± 23.84 |
No change in NYHA Class
| 198 | 63.95 ± 20.05 | 65.74 ± 20.62 | 1.45 ± 16.17 |
-1 NYHA Class
| 37 | 58.88 ± 21.88 | 60.38 ± 22.31 | 2.68 ± 18.56 |
-2 NYHA Classes
| 0 | - | - | - |
KCCQ OVERALL SUMMARY SCORE
| ||||
+2 NYHA Classes
| 2 | 72.27 ± 1.66 | 78.65 ± 12.52 | 6.38 ± 14.18 |
+1 NYHA Class
| 50 | 60.87 ± 24.30 | 65.65 ± 21.39 | 4.77 ± 15.60 |
No change in NYHA Class
| 206 | 61.87 ± 24.25 | 63.84 ± 24.23 | 1.97 ± 11.49 |
-1 NYHA Class
| 40 | 58.93 ± 23.63 | 54.56 ± 22.48 | -4.37 ± 13.05 |
-2 NYHA Classes
| 0 | - | - | - |
KCCQ CLINCAL SUMMARY SCORE
| ||||
+2 NYHA Classes
| 2 | 73.18 ± 8.47 | 76.04 ± 10.31 | 2.86 ± 18.78 |
+1 NYHA Class
| 50 | 65.98 ± 23.24 | 71.10 ± 18.64 | 5.11 ± 15.75 |
No change in NYHA Class
| 206 | 65.85 ± 23.63 | 67.50 ± 23.74 | 1.65 ± 11.59 |
-1 NYHA Class
| 40 | 64.70 ± 22.37 | 59.59 ± 22.02 | -5.1 ± 11.51 |
-2 NYHA Classes
| 0 | - | - | - |
RAND12 PCS
| ||||
+2 NYHA Classes
| 2 | 40.15 ± 9.86 | 37.39 ± 6.53 | -2.77 ± 3.33 |
+1 NYHA Class
| 50 | 33.69 ± 10.4 | 35.08 ± 9.87 | 1.40 ± 9.20 |
No change in NYHA Class
| 206 | 35.69 ± 11.09 | 36.58 ± 11.02 | 0.89 ± 6.47 |
-1 NYHA Class
| 40 | 32.71 ± 8.89 | 33.02 ± 8.28 | 0.31 ± 6.22 |
-2 NYHA Classes
| 0 | - | - | - |
RAND12 MCS
| ||||
+2 NYHA Classes
| 2 | 45.44 ± 22.36 | 51.01 ± 17.25 | 5.57 ± 5.11 |
+1 NYHA Class
| 50 | 50.40 ± 9.98 | 49.43 ± 10.61 | -0.97 ± 10.19 |
No change in NYHA Class
| 206 | 48.03 ± 11.55 | 48.45 ± 11.24 | 0.41 ± 8.35 |
-1 NYHA Class
| 40 | 48.22 ± 12.18 | 46.00 ± 11.80 | -2.21 ± 9.89 |
-2 NYHA Classes
| 0 | - | - | - |
n | Baseline Score ± Standard Deviation | 6 Week Score ± Standard Deviation | Mean Change Score ± Standard Deviation | |
---|---|---|---|---|
EQ5D–US Scoring
| ||||
Substantial Increase (+ 5,6,7)
| 7 | 0.74 ± 0.18 | 0.88 ± 0.12 | 0.14 ± 0.17 |
Moderate Increase (+2,+3,+4)
| 53 | 0.76 ± 0.15 | 0.79 ± 0.13 | 0.02 ± 0.12 |
No Change (-1,0,+1)
| 206 | 0.74 ± 0.18 | 0.77 ± 0.16 | 0.03 ± 0.13 |
Moderate Decrease (-2,-3,-4)
| 30 | 0.74 ± 0.15 | 0.73 ± 0.12 | -0.01 ± 0.11 |
Substantial Decrease (-5,-6,-7)
| 2 | 0.46 ± 0.19 | 0.43 ± 0.24 | -0.03 ± 0.05 |
EQ5D–UK Scoring
| ||||
Substantial Increase (+ 5,6,7)
| 7 | 0.65 ± 0.28 | 0.86 ± 0.16 | 0.21 ± 0.26 |
Moderate Increase (+2,+3,+4)
| 53 | 0.70 ± 0.23 | 0.73 ± 0.18 | 0.03 ± 0.20 |
No Change (-1,0,+1)
| 206 | 0.66 ± 0.27 | 0.70 ± 0.24 | 0.04 ± 0.19 |
Moderate Decrease (-2,-3,-4)
| 30 | 0.66 ± 0.22 | 0.65 ± 0.18 | -0.01 ± 0.19 |
Substantial Decrease (-5,-6,-7)
| 2 | 0.27 ± 0.34 | 0.22 ± 0.42 | -0.05 ± 0.07 |
ED–VAS
| ||||
Substantial Increase (+ 5,6,7)
| 5 | 54.80 ± 34.28 | 75.71 ± 25.24 | 19.2 ± 22.26 |
Moderate Increase (+2,+3,+4)
| 51 | 64.66 ± 20.96 | 67.25 ± 20.37 | 2.90 ± 23.39 |
No Change (-1,0,+1)
| 196 | 63.05 ± 20.27 | 65.16 ± 20.52 | 1.70 ± 15.92 |
Moderate Decrease (-2,-3,-4)
| 29 | 58.07 ± 18.91 | 55.00 ± 20.31 | -2.66 ± 15.64 |
Substantial Decrease (-5,-6,-7)
| 2 | 55.00 ± 7.07 | 30.00 ± 14.14 | -25.00 ± 21.21 |
KCCQ OVERALL SUMMARY SCORE
| ||||
Substantial Increase (+ 5,6,7)
| 7 | 51.26 ± 30.57 | 70.98 ± 27.65 | 19.72 ± 17.24 |
Moderate Increase (+2,+3,+4)
| 53 | 63.79 ± 20.38 | 68.47 ± 18.43 | 4.69 ± 15.84 |
No Change (-1,0,+1)
| 206 | 62.33 ± 24.81 | 63.86 ± 24.16 | 1.52 ± 10.82 |
Moderate Decrease (-2,-3,-4)
| 30 | 55.54 ± 21.12 | 48.82 ± 19.80 | -6.72 ± 11.61 |
Substantial Decrease (-5,-6,-7)
| 2 | 21.88 ± 8.84 | 13.28 ± 6.26 | -8.59 ± 2.58 |
KCCQ CLINCAL SUMMARY SCORE
| ||||
Substantial Increase (+ 5,6,7)
| 7 | 56.55 ± 31.08 | 74.40 ± 21.88 | 17.86 ± 16.53 |
Moderate Increase (+2,+3,+4)
| 53 | 69.24 ± 20.42 | 72.54 ± 16.59 | 3.30 ± 16.58 |
No Change (-1,0,+1)
| 206 | 66.38 ± 23.78 | 67.74 ± 23.71 | 1.36 ± 10.83 |
Moderate Decrease (-2,-3,-4)
| 30 | 60.46 ± 19.73 | 54.94 ± 18.96 | -5.52 ± 11.55 |
Substantial Decrease (-5,-6,-7)
| 2 | 22.92 ± 14.73 | 14.58 ± 7.37 | -8.33 ± 7.37 |
RAND12 PCS
| ||||
Substantial Increase (+ 5,6,7)
| 7 | 29.29 ± 12.53 | 41.00 ± 13.79 | 11.71 ± 10.41 |
Moderate Increase (+2,+3,+4)
| 53 | 35.66 ± 10.99 | 36.66 ± 9.64 | 1.00 ± 7.82 |
No Change (-1,0,+1)
| 206 | 35.51 ± 10.81 | 36.34 ± 10.69 | 0.83 ± 6.43 |
Moderate Decrease (-2,-3,-4)
| 30 | 32.66 ± 8.00 | 31.00 ± 8.06 | -1.66 ± 5.72 |
Substantial Decrease (-5,-6,-7)
| 2 | 17.76 ± 1.36 | 19.21 ± 2.99 | 1.45 ± 4.36 |
RAND12 MCS
| ||||
Substantial Increase (+ 5,6,7)
| 7 | 54.23 ± 13.01 | 49.04 ± 12.92 | -5.19 ± 10.47 |
Moderate Increase (+2,+3,+4)
| 53 | 48.41 ± 11.40 | 51.61 ± 10.00 | 3.20 ± 10.61 |
No Change (-1,0,+1)
| 206 | 48.73 ± 11.49 | 48.26 ± 11.27 | -0.47± 8.11 |
Moderate Decrease (-2,-3,-4)
| 30 | 45.40 ± 10.54 | 42.98 ± 11.17 | -2.41 ± 9.46 |
Substantial Decrease (-5,-6,-7)
| 2 | 44.56 ± 10.15 | 42.43 ± 7.13 | -2.14 ± 3.03 |
n | Baseline Score ± Standard Deviation | 6 Week Score ± Standard Deviation | Mean Change Score ± Standard Deviation | |
---|---|---|---|---|
EQ5D–US Scoring
| ||||
<= -200
| 7 | 0.69 ± 0.11 | 0.68 ± 0.14 | -0.02 ± 0.09 |
-199 to -100
| 16 | 0.66 ± 0.24 | 0.68 ± 0.20 | 0.02 ± 0.12 |
-99 to -25
| 60 | 0.72 ± 0.17 | 0.75 ± 0.16 | 0.04 ± 0.15 |
-24 to +24
| 114 | 0.77 ± 0.17 | 0.77 ± 0.15 | 0.00 ± 0.11 |
25 to 49
| 33 | 0.77 ± 0.16 | 0.80 ± 0.13 | 0.04 ± 0.13 |
50 to 99
| 40 | 0.72 ± 0.18 | 0.78 ± 0.16 | 0.05 ± 0.14 |
>= 100 | 28 | 0.76 ± 0.16 | 0.80 ± 0.16 | 0.04 ± 0.11 |
EQ5D–UK Scoring
| ||||
<= -200
| 7 | 0.59 ± 0.18 | 0.59 ± 0.22 | 0.00 ± 0.12 |
-199 to -100
| 16 | 0.53 ± 0.35 | 0.56 ± 0.32 | 0.03 ± 0.20 |
-99 to -25
| 60 | 0.62 ± 0.26 | 0.68 ± 0.24 | 0.06 ± 0.23 |
-24 to +24
| 114 | 0.70 ± 0.25 | 0.71 ± 0.22 | 0.01 ± 0.17 |
25 to 49
| 33 | 0.70 ± 0.23 | 0.75 ± 0.19 | 0.05 ± 0.17 |
50 to 99
| 40 | 0.63 ± 0.28 | 0.71 ± 0.23 | 0.08 ± 0.23 |
>= 100 | 28 | 0.69 ± 0.24 | 0.74 ± 0.24 | 0.05 ± 0.16 |
EQ–VAS
| ||||
= -200
| 7 | 60.43 ± 15.04 | 50.71 ± 21.30 | -9.71 ± 20.95 |
-199 to -100
| 15 | 58.38 ± 27.40 | 49.00 ± 31.12 | -8.60 ± 23.21 |
-99 to -25
| 56 | 60.53 ± 19.33 | 63.92 ± 21.71 | 2.32 ± 18.94 |
-24 to +24
| 109 | 64.94 ± 19.06 | 66.13 ± 20.19 | 1.24 ± 17.59 |
25 to 49
| 31 | 66.41 ± 18.46 | 68.84 ± 17.37 | 2.52 ± 13.28 |
50 to 99
| 38 | 60.89 ± 23.83 | 65.60 ± 17.66 | 3.82 ± 17.46 |
>= 100 | 27 | 58.41 ± 22.41 | 64.86 ± 20.93 | 5.89 ± 15.84 |
KCCQ OVERALL SUMMARY SCORE
| ||||
<= -200
| 7 | 45.44 ± 22.81 | 45.44 ± 22.81 | -7.75 ± 13.19 |
-199 to -100
| 16 | 53.42 ± 24.82 | 53.42 ± 24.82 | -5.00 ± 6.20 |
-99 to -25
| 60 | 61.54 ± 24.20 | 61.54 ± 24.20 | 0.08 ± 13.99 |
-24 to +24
| 114 | 62.82 ± 23.30 | 62.82 ± 23.30 | 1.47 ± 10.94 |
25 to 49
| 33 | 67.41 ± 23.69 | 67.41 ± 23.69 | 0.17 ± 12.09 |
50 to 99
| 40 | 59.35 ± 26.26 | 59.35 ± 26.26 | 3.74 ± 16.69 |
>= 100 | 28 | 59.48 ± 21.64 | 59.48 ± 22.89 | 10.3 ± 14.08 |
KCCQ CLINCAL SUMMARY SCORE
| ||||
<= -200
| 7 | 45.64 ± 26.24 | 37.28 ± 25.84 | -8.36 ± 11.76 |
-199 to -100
| 16 | 58.93 ± 22.54 | 55.89 ± 25.92 | -3.03 ± 9.85 |
-99 to -25
| 60 | 65.01 ± 23.73 | 65.54 ± 23.94 | 0.53 ± 13.30 |
-24 to +24
| 114 | 67.07 ± 22.07 | 67.72 ± 21.66 | 0.65 ± 11.68 |
25 to 49
| 33 | 72.41 ± 22.48 | 72.39 ± 22.91 | -0.02 ± 10.96 |
50 to 99
| 40 | 64.45 ± 25.65 | 68.61 ± 20.59 | 4.16 ± 13.72 |
>= 100 | 28 | 65.10 ± 22.37 | 73.41 ± 19.31 | 8.31 ± 14.24 |
RAND12 PCS
| ||||
<= -200
| 7 | 25.49 ± 9.07 | 25.74 ± 6.88 | 0.25 ± 8.15 |
-199 to -100
| 16 | 32.28 ± 12.07 | 34.7 ± 12.05 | 2.42 ± 5.58 |
-99 to -25
| 60 | 35.10 ± 10.31 | 25.55 ± 10.45 | 0.45 ± 6.91 |
-24 to +24
| 114 | 34.79 ± 10.05 | 35.99 ± 10.24 | 1.20 ± 6.38 |
25 to 49
| 33 | 38.28 ± 11.51 | 37.90 ± 10.4 | -0.38 ± 5.94 |
50 to 99
| 40 | 36.03 ± 10.94 | 35.80 ± 10.91 | -0.23 ± 7.29 |
>= 100 | 28 | 34.09 ± 11.65 | 36.81 ± 10.64 | 2.72 ± 9.72 |
RAND12 MCS
| ||||
<= -200
| 7 | 47.28 ± 5.87 | 43.74 ± 9.05 | -3.53 ± 6.21 |
-199 to -100
| 16 | 46.65 ± 13.15 | 38.56 ± 11.92 | -8.09 ± 14.05 |
-99 to -25
| 60 | 47.66 ± 11.96 | 46.92 ± 11.38 | -0.74 ± 7.87 |
-24 to +24
| 114 | 49.47 ± 11.14 | 49.67 ± 10.91 | 0.19 ± 8.55 |
25 to 49
| 33 | 47.74 ± 11.38 | 48.82 ± 10.86 | 1.08 ± 7.33 |
50 to 99
| 40 | 46.85 ± 11.22 | 48.38 ± 10.52 | 1.54 ± 8.71 |
>= 100 | 28 | 50.27 ± 12.16 | 51.37 ± 11.06 | 1.40 ± 9.43 |
HRQL responsiveness to change
Improved +2 NYHA Classes | n | T-Statistic (Rank) | Effect Size (Rank) | Guyatt's Responsiveness Statistic (Rank) | Standardized Response Mean (Rank) | Median Rank |
---|---|---|---|---|---|---|
EQ5D–US Scoring | 2 | 1.00 (3) | 0.36 (3) | 0.31 (4) | 0.80 (3) | 3.00 |
EQ5D–UK Scoring | 2 | 1.00 (3) | 0.21 (6) | 0.20 (6) | 0.80 (3) | 4.50 |
EQ–VAS | 2 | 4.33 (1) | 0.51 (2) | 0.40 (3) | 3.07 (1) | 1.50 |
KCCQ Overall Summary Score | 2 | 0.64 (5) | 3.84 (1) | 0.56 (2) | 0.45 (5) | 3.50 |
KCCQ Clinical Summary Score | 2 | 0.22(6) | 0.34 (4) | 0.25 (5) | 0.15 (6) | 5.50 |
RAND12 PCS | 2 | -1.17 (7) | -0.28 (7) | -0.43 (7) | -0.83 (7) | 7.00 |
RAND12 MCS | 2 | 1.54 (2) | 0.25 (5) | 0.67 (1) | 1.09 (2) | 2.00 |
Improved +1 NYHA Classes
| ||||||
EQ5D–US Scoring | 50 | 0.80 (4) | 0.06 (5) | 0.08 (5) | 0.08 (5) | 5.00 |
EQ5D–UK Scoring | 50 | 0.73 (5) | 0.08 (4) | 0.10 (4) | 0.11 (4) | 4.00 |
EQ–VAS | 46 | 0.31 (6) | 0.05 (6) | 0.07 (6) | 0.05 (6) | 6.00 |
KCCQ Overall Summary Score | 50 | 2.16 (2) | 0.20 (2) | 0.42 (2) | 0.31 (2) | 2.00 |
KCCQ Clinical Summary Score | 50 | 2.30 (1) | 0.22 (1) | 0.44 (1) | 0.32 (1) | 1.00 |
RAND12 PCS | 50 | 1.07 (3) | 0.13 (3) | 0.22 (3) | 0.15 (3) | 3.00 |
RAND12 MCS | -0.67 (7) | -0.10 (7) | -0.12 (7) | -0.10 (7) | 7.00 | |
No Change in NHYA Class
| ||||||
EQ5D–US Scoring | 206 | 3.43 | 0.17 | 0.23 | 0.23 | - |
EQ5D–UK Scoring | 206 | 3.45 | 0.19 | 0.25 | 0.25 | - |
EQ–VAS | 198 | 1.27 | 0.07 | 0.09 | 0.09 | - |
KCCQ Overall Summary Score | 206 | 2.46 | 0.08 | 0.17 | 0.17 | - |
KCCQ Clinical Summary Score | 206 | 2.05 | 0.07 | 0.14 | 0.14 | - |
RAND12 PCS | 206 | 1.97 | 0.08 | 0.14 | 0.14 | - |
RAND12 MCS | 206 | 0.71 | 0.04 | 0.05 | 0.05 | - |
Deteriorated -1 NYHA Classes
| ||||||
EQ5D–US Scoring | 40 | 0.26 (5) | 0.06 (6) | 0.08 (6) | 0.08 (6) | 6.00 |
EQ5D–UK Scoring | 40 | 0.12 (4) | 0.00 (4) | 0.00 (4) | 0.00 (4) | 4.00 |
EQ–VAS | 37 | 0.88 (7) | 0.12 (7) | 0.17 (7) | 0.14 (7) | 7.00 |
KCCQ Overall Summary Score | 40 | -2.12 (2) | -0.18 (2) | -0.38 (2) | -0.33 (2) | 2.00 |
KCCQ Clinical Summary Score | 40 | -2.80 (1) | -0.23 (1) | -0.44 (1) | -0.44 (1) | 1.00 |
RAND12 PCS | 40 | 0.31 (6) | 0.03 (5) | 0.05 (5) | 0.05 (5) | 5.00 |
RAND12 MCS | 40 | -1.41 (3) | -0.18 (3) | -0.26 (3) | -0.22 (3) | 3.00 |
Deteriorated -2 NYHA Classes
| 0 | Not Calculated Due to No subjects |
Global Change Score – Substantial Increase +5,+6,+7 | n | T-Statistic (Rank) | Effect Size (Rank) | Guyatt's Responsiveness Statistic (Rank) | Standardized Response Mean (Rank) | Median Rank |
---|---|---|---|---|---|---|
EQ5D–US Scoring | 7 | 2.13 (4) | 0.78 (2) | 1.08 (6) | 0.82 (5) | 4.50 |
EQ5D–UK Scoring | 7 | 2.10 (5) | 0.75 (3) | 1.11 (5) | 0.81 (6) | 5.00 |
EQ–VAS | 5 | 1.93 (6) | 0.56 (6) | 1.21 (4) | 0.86 (4) | 5.00 |
KCCQ Overall Summary Score | 7 | 3.03 (1) | 0.65 (4) | 1.82 (1) | 1.14 (1) | 1.00 |
KCCQ Clinical Summary Score | 7 | 2.86 (3) | 0.57 (5) | 1.65 (3) | 1.08 (3) | 3.00 |
RAND12 PCS | 7 | 2.98 (2) | 0.93 (1) | 1.82 (2) | 1.12 (2) | 2.00 |
RAND12 MCS | 7 | -1.31 (7) | -0.40 (7) | -0.64 (7) | -0.50 (7) | 7.00 |
Global Change Score – Moderate Increase +2,+3,+4
| ||||||
EQ5D–US Scoring | 53 | 1.37 (4) | 0.13 (5) | 0.15 (7) | 0.17 (4) | 4.50 |
EQ5D–UK Scoring | 53 | 1.23 (5) | 0.13 (6) | 0.16 (5) | 0.15 (5) | 5.00 |
EQ–VAS | 51 | 0.89 (7) | 0.14 (4) | 0.18 (4) | 0.12 (7) | 5.50 |
KCCQ Overall Summary Score | 53 | 2.15 (2) | 0.23 (2) | 0.43 (1) | 0.30 (2) | 2.00 |
KCCQ Clinical Summary Score | 53 | 1.45 (3) | 0.16 (3) | 0.30 (3) | 0.20 (3) | 3.00 |
RAND12 PCS | 53 | 0.93 (6) | 0.09 (7) | 0.16 (6) | 0.13 (6) | 6.00 |
RAND12 MCS | 53 | 2.20 (1) | 0.28 (1) | 0.39 (2) | 0.30 (1) | 1.00 |
Global Change Score – No Change -1,0,+1
| ||||||
EQ5D–US Scoring | 206 | 2.94 | 0.17 | 0.23 | 0.23 | - |
EQ5D–UK Scoring | 206 | 3.00 | 0.15 | 0.21 | 0.21 | - |
EQ–VAS | 196 | 1.49 | 0.08 | 0.11 | 0.11 | - |
KCCQ Overall Summary Score | 206 | 2.02 | 0.06 | 0.14 | 0.14 | - |
KCCQ Clinical Summary Score | 206 | 1.80 | 0.06 | 0.13 | 0.13 | - |
RAND12 PCS | 206 | 1.85 | 0.08 | 0.13 | 0.13 | - |
RAND12 MCS | 206 | -0.83 | -0.04 | -0.06 | -0.06 | - |
Global Change Score – Moderate Deterioration -2,-3,-4
| ||||||
EQ5D–US Scoring | 30 | -0.31 (6) | -0.07 (6) | -0.08 (6) | -0.09 (6) | 6.00 |
EQ5D–UK Scoring | 30 | -0.29 (7) | -0.05 (7) | -0.05 (7) | -0.05 (7) | 7.00 |
EQ–VAS | 29 | -0.91 (5) | -0.14 (5) | -0.17 (5) | -0.17 (5) | 5.00 |
KCCQ Overall Summary Score | 30 | -3.17 (1) | -0.32 (1) | -0.62 (1) | -0.58 (1) | 1.00 |
KCCQ Clinical Summary Score | 30 | -2.62 (2) | -0.28 (2) | -0.51 (2) | -0.48 (2) | 2.00 |
RAND12 PCS | 30 | -1.59 (3) | -0.21 (4) | -0.26 (4) | -0.29(3) | 3.50 |
RAND12 MCS | 30 | -1.40 (4) | -0.23 (3) | -0.30 (3) | -0.25 (4) | 3.50 |
Global Change Score – Substantial Deterioration -5,-6,-7
| ||||||
EQ5D–US Scoring | 2 | -1.00 (4) | -0.16 (5) | -0.23 (6) | -0.60 (6) | 5.50 |
EQ5D–UK Scoring | 2 | -1.00 (4) | -0.15 (6) | -0.26 (5) | -0.71 (4) | 4.50 |
EQ–VAS | 2 | -1.67 (2) | -3.54 (1) | -1.57 (1) | -1.18 (2) | 1.50 |
KCCQ Overall Summary Score | 2 | -4.71 (1) | -0.97 (2) | -0.79 (2) | -3.33 (1) | 1.50 |
KCCQ Clinical Summary Score | 2 | -1.60 (3) | -0.57 (3) | -0.77 (3) | -1.13 (3) | 3.00 |
RAND12 PCS | 2 | 0.47 (7) | 1.07 (7) | 0.23 (7) | 0.33 (7) | 7.00 |
RAND12 MCS | 2 | -1.00 (4) | -0.21 (4) | -0.26 (4) | -0.71 (5) | 4.00 |
6 Minute Walk – Deteriorated <= -200 | n | T-Statistic (Rank) | Effect Size (Rank) | Guyatt's Responsiveness Statistic (Rank) | Standardized Response Mean (Rank) | Median Rank |
---|---|---|---|---|---|---|
EQ5D–US Scoring | 7 | -0.45 (5) | -0.18 (5) | -0.18 (5) | -0.22 (5) | 5.00 |
EQ5D–UK Scoring | 7 | -0.06 (6) | 0.00 (6) | 0.00 (6) | 0.00 (6) | 6.00 |
EQ–VAS | 7 | -1.23 (4) | -0.65 (1) | -0.55 (3) | -0.46 (4) | 3.50 |
KCCQ Overall Summary Score | 7 | -1.56 (2) | -0.34 (3) | -0.71 (2) | -0.59 (2) | 2.00 |
KCCQ Clinical Summary Score | 7 | -1.88 (1) | -0.32 (4) | -0.72 (1) | -0.71 (1) | 1.00 |
RAND12 PCS Score | 7 | 0.08 (7) | 0.03 (7) | 0.04 (7) | 0.03 (7) | 7.00 |
RAND12 MCS Score | 7 | -1.51 (3) | -0.60 (2) | -0.41 (4) | -0.57 (3) | 3.00 |
6 Minute Walk – Deteriorated -199 to -100
| ||||||
EQ5D–US Scoring | 16 | 0.59 (5) | 0.08 (5) | 0.18 (6) | 0.17 (6) | 5.50 |
EQ5D–UK Scoring | 16 | 0.59 (5) | 0.09 (6) | 0.18 (5) | 0.15 (5) | 5.00 |
EQ–VAS | 15 | -1.44 (3) | -0.31 (2) | -0.49 (2) | -0.37 (3) | 2.50 |
KCCQ Overall Summary Score | 16 | -3.23 (1) | -0.20 (3) | -0.46 (3) | -0.81 (1) | 2.00 |
KCCQ Clinical Summary Score | 16 | -1.23 (4) | -0.13 (4) | -0.26 (4) | -0.31 (4) | 4.00 |
RAND12 PCS | 16 | 1.74 (7) | 0.20 (7) | 0.38 (7) | 0.43 (7) | 7.00 |
RAND12 MCS | 16 | -2.30 (2) | -0.62 (1) | -0.95 (1) | -0.58 (2) | 1.50 |
6 Minute Walk – Deteriorated -99 to -25
| ||||||
EQ5D–US Scoring | 60 | 1.83 (6) | 0.24 (7) | 0.36 (7) | 0.27 (7) | 7.00 |
EQ5D–UK Scoring | 60 | 1.83 (6) | 0.23 (6) | 0.35 (6) | 0.26 (6) | 6.00 |
EQ–VAS | 58 | 0.92 (5) | 0.12 (5) | 0.13 (5) | 0.12 (5) | 5.00 |
KCCQ Overall Summary Score | 60 | 0.04 (2) | 0.00 (2) | 0.01 (2) | 0.01 (2) | 2.00 |
KCCQ Clinical Summary Score | 60 | 0.31 (3) | 0.02 (3) | 0.05 (3) | 0.04 (3) | 3.00 |
RAND12 PCS | 60 | 0.51 (4) | 0.04 (4) | 0.07 (4) | 0.07 (4) | 4.00 |
RAND12 MCS | 60 | -0.73 (1) | -0.06 (1) | -0.09 (1) | -0.09 (1) | 1.00 |
6 Minute Walk – No Change -24 to 24
| ||||||
EQ5D–US Scoring | 114 | 0.58 | 0.00 | 0.00 | 0.00 | - |
EQ5D–UK Scoring | 114 | 0.58 | 0.04 | 0.06 | 0.06 | - |
EQ–VAS | 109 | 0.74 | 0.07 | 0.07 | 0.07 | - |
KCCQ Overall Summary Score | 114 | 1.44 | 0.06 | 0.13 | 0.13 | - |
KCCQ Clinical Summary Score | 114 | 0.59 | 0.03 | 0.06 | 0.06 | - |
RAND12 PCS | 114 | 2.01 | 0.12 | 0.19 | 0.19 | - |
RAND12 MCS | 114 | 0.24 | 0.02 | 0.02 | 0.02 | - |
6 Minute Walk – Improved +25 to +49
| ||||||
EQ5D–US Scoring | 33 | 1.66 (1) | 0.25 (1) | 0.36 (1) | 0.31 (1) | 1.00 |
EQ5D–UK Scoring | 33 | 1.66 (1) | 0.22 (2) | 0.29 (2) | 0.29 (2) | 2.00 |
EQ–VAS | 31 | 1.06 (3) | 0.14 (3) | 0.14 (3) | 0.19 (3) | 3.00 |
KCCQ Overall Summary Score | 33 | 0.08 (5) | 0.01 (5) | 0.02 (5) | 0.01 (5) | 5.00 |
KCCQ Clinical Summary Score | 33 | -0.01 (6) | 0.00 (6) | 0.00 (6) | 0.00 (6) | 6.00 |
RAND12 PCS | 33 | -0.04 (7) | -0.03 (7) | -0.06 (7) | -0.06 (7) | 7.00 |
RAND12 MCS | 33 | 0.85 (4) | 0.09 (4) | 0.13 (4) | 0.15 (4) | 4.00 |
6 Minute Walk – Improved +50 to +99
| ||||||
EQ5D–US Scoring | 40 | 2.10 (1) | 0.28 (2) | 0.45 (2) | 0.36 (1) | 1.50 |
EQ5D–UK Scoring | 40 | 2.10 (1) | 0.29 (1) | 0.47 (1) | 0.35 (2) | 1.00 |
EQ–VAS | 38 | 1.35 (5) | 0.16 (4) | 0.22 (5) | 0.22 (5) | 5.00 |
KCCQ Overall Summary Score | 40 | 1.73 (4) | 0.14 (5) | 0.34 (4) | 0.22 (4) | 4.00 |
KCCQ Clinical Summary Score | 40 | 1.92 (3) | 0.16 (3) | 0.36 (3) | 0.30 (3) | 3.00 |
RAND12 PCS | 40 | -0.20 (7) | -0.02 (7) | -0.04 (7) | -0.03 (7) | 7.00 |
RAND12 MCS | 40 | 1.12 (6) | 0.14 (6) | 0.18 (6) | 0.18 (6) | 6.00 |
6 Minute Walk – Improved >= +100
| ||||||
EQ5D–US Scoring | 28 | 1.68 (4) | 0.25 (4) | 0.36 (4) | 0.36 (4) | 4.00 |
EQ5D–UK Scoring | 28 | 1.68 (4) | 0.21 (6) | 0.29 (6) | 0.31 (5) | 5.50 |
EQ–VAS | 27 | 1.93 (3) | 0.26 (3) | 0.33 (5) | 0.37 (3) | 3.00 |
KCCQ Overall Summary Score | 28 | 3.87 (1) | 0.48 (1) | 0.94 (1) | 0.73 (1) | 1.00 |
KCCQ Clinical Summary Score | 28 | 3.09 (2) | 0.37 (2) | 0.71 (2) | 0.58 (2) | 2.00 |
RAND12 PCS | 28 | 1.48 (6) | 0.23 (5) | 0.43 (3) | 0.28 (6) | 5.50 |
RAND12 MCS | 28 | 0.79 (7) | 0.12 (7) | 0.16 (7) | 0.15 (7) | 7.00 |