Introduction
Methods
Study design
Participant recruitment
Study procedures
Outcome measures
Questionnaires/Forms | Baseline | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 |
---|---|---|---|---|---|---|---|---|---|
Researcher with participant completion | |||||||||
Consent form | X | ||||||||
Patient and GP details form | X | ||||||||
Time Trade Off | X | X | X | ||||||
Participant completion | |||||||||
Demographics questionnaire | X | ||||||||
EuroQol-5 Dimensions-5 Level Questionnaire | X | X | X | X | X | X | X | X | X |
Asthma Quality of Life Questionnaire | X | X | X | ||||||
Peak flow and symptoms diary | Completion of this diary was requested every day from baseline through to week 8 |
EuroQol-5 dimensions 5 levels (EQ-5D-5 L)
Asthma quality of life questionnaire (AQLQ)
Time trade off (TTO)
Peak expiratory flow (PEF) and symptoms diary
Statistical analysis
Results
Demographics
Demographics | N = 121 |
---|---|
Age (mean, years) | 49.68 |
Height (mean, cm) | 167.22 |
Weight (mean, kg) | 85.54 |
Gender (%) | |
Male | 26.45 |
Female | 73.55 |
Ethnicity (%) | |
White | 95.83 |
Mixed White and Black | 0.83 |
White Other | 3.33 |
Smoking Status (%) | |
Never | 42.50 |
Non-Smoker | 1.67 |
Smoker | 15.00 |
Ex-Smoker | 40.83 |
Highest Level of Education (%) | |
School | 47.06 |
College | 33.61 |
Degree | 19.33 |
Employment status (%) | |
Full-time | 27.50 |
Part-time | 15.83 |
Retired | 28.33 |
Stay at home parents | 7.50 |
Student | 3.33 |
Unemployed | 17.50 |
Item | N | Mean | SD | Range | Response rates | Floor effects | Ceiling effects |
---|---|---|---|---|---|---|---|
EQ-5D-5 L (utility) | 120 | 0.635 | 0.274 | −0.102 to 1.00 | 99.2% | 0.00% | 8.30% |
VAS score | 120 | 45.7 | 19.3 | 5.00 to 90.0 | 99.2% | 0.00% | 0.00% |
AQLQ overall score | 120 | 3.28 | 0.963 | 1.18 to 5.30 | 99.2% | 0.00% | 0.00% |
AQLQ Symptoms score | 121 | 2.81 | 1.06 | 0.00 to 5.50 | 100.0% | 0.00% | 2.50% |
AQLQ Activity score | 121 | 3.51 | 1.05 | 0.00 to 5.82 | 100.0% | 0.00% | 0.00% |
AQLQ Emotional score | 121 | 3.14 | 1.51 | 0.00 to 7.00 | 100.0% | 0.00% | 4.10% |
AQLQ Environmental score | 121 | 4.04 | 1.52 | 0.00 to 7.00 | 100.0% | 0.00% | 1.70% |
AQL-5D (utility) | 118 | 0.608 | 0.128 | 0.450 to 0.935 | 97.5% | 0.00% | 0.00% |
TTO (utility) | 112 | 0.626 | 0.277 | 0.100 to 1.00 | 100.0%a | 0.00% | 18.8% |
Utility and QALY loss
Baseline Mean (CI) | Week 1 Mean (CI) | Week 2 Mean (CI) | Week 3 Mean (CI) | Week 4 Mean (CI) | Week 5 Mean (CI) | Week 6 Mean (CI) | Week 7 Mean (CI) | Week 8 Mean (CI) | p Value | |
---|---|---|---|---|---|---|---|---|---|---|
EQ-5D-5L | N = 120 | N = 81 | N = 75 | N = 74 | N = 71 | N = 65 | N = 65 | N = 64 | N = 64 | N = 64 |
0.64 (0.59,0.68) | 0.65 (0.59,0.70) | 0.70 (0.65,0.75) | 0.72 (0.66,0.77) | 0.74 (0.68,0.80) | 0.76 (0.71,0.82) | 0.77 (0.71,0.83) | 0.78 (0.73,0.84) | 0.72 (0.65,0.80) | P<0.007** | |
VAS | N = 120 | N = 81 | N = 75 | N = 75 | N = 73 | N = 66 | N = 65 | N = 64 | N = 64 | N = 64 |
45.68 (42.34,49.02) | 57.70 (53.36,62.05) | 60.79 (56.03,65.54) | 63.21 (59.01,67.42) | 65.95 (61.01,70.88) | 68.09 (63.36,72.83) | 68.75 (64.19,73.32) | 71.56 (66.99,76.14) | 67.88 (62.58,73.17) | P<0.000** | |
AQLQ overall | N = 120 | N = 70 | N = 65 | N = 65 | ||||||
3.28 (3.11,3.45) | 4.09 (3.76,4.42) | 4.48 (4.13,4.83) | P<0.000** | |||||||
AQLQ Symptoms | N = 121 | N = 85 | N = 66 | N = 66 | ||||||
2.81 (2.62,3.00) | 3.33 (2.89,3.77) | 3.64 (3.10,4.18) | P<0.003** | |||||||
AQLQ Activity | N = 121 | N = 85 | N = 66 | N = 66 | ||||||
3.51 (3.33,3.69) | 3.32 (2.90,3.73) | 3.68 (3.17,4.19) | P <0.044* | |||||||
AQLQ Emotional | N = 121 | N = 85 | N = 66 | N = 66 | ||||||
3.14 (2.87,3.40) | 3.36 (2.88,3.84) | 3.72 (3.14,4.31) | P <0.041* | |||||||
AQLQ Environmental | N = 121 | N = 85 | N = 66 | N = 66 | ||||||
4.04 (3.76,4.31) | 3.63 (3.12,4.13) | 3.91 (3.34,4.47) | P <0.089 | |||||||
AQL-5D | N = 118 | N = 70 | N = 64 | N = 62 | ||||||
0.61 (0.59,0.63) | 0.69 (0.65,0.73) | 0.74 (0.69,0.78) | P<0.000** | |||||||
TTO | N = 112 | N = 87 | N = 80 | N = 80 | ||||||
0.63 (0.58,0.68) | 0.82 (0.76,0.88) | 0.79 (0.72,0.85) | P<0.000** |
Outcome measure | N | Baseline Mean ± SD | 8 weeks Mean ± SD | Mean difference (95% CI) | P-value |
---|---|---|---|---|---|
EQ-5D-5 L (utility) | 64 | 0.639 ± 0.267 | 0.725 ± 0.294 | 0.086 (0.153 to 0.019) | 0.007** |
VAS (score) | 64 | 48.81 ± 18.58 | 67.88 ± 22.03 | 19.06 (25.69 to 12.44) | 0.000** |
AQLQ overall (score) | 65 | 3.20 ± 0.955 | 4.48 ± 1.50 | 1.28 (1.60 to 0.963) | 0.000** |
AQL-5D (utility) | 62 | 0.582 ± 0.120 | 0.736 ± 0.178 | 0.154 (0.196 to 0.112) | 0.000** |
TTO (utility) | 80 | 0.655 ± 0.273 | 0.787 ± 0.295 | 0.132 (0.201 to 0.063) | 0.000** |
Outcome measure | N | Baseline Mean ± SD | 4 weeks Mean ± SD | Mean difference (95% CI) | P-value |
---|---|---|---|---|---|
EQ-5D-5 L (utility) | 71 | 0.613 ± 0.275 | 0.740 ± 0.264 | 0.127 (0.193 to 0.061) | 0.000** |
VAS (score) | 73 | 47.38 ± 20.08 | 65.95 ± 21.42 | 18.56 (23.40 to 13.72) | 0.000** |
AQLQ (score) | 70 | 3.16 ± 0.980 | 4.09 ± 1.48 | 0.929 (1.19 to 0.666) | 0.000** |
AQL-5D (utility) | 69 | 0.589 ± 0.126 | 0.687 ± 0.174 | 0.099 (0.134 to 0.063) | 0.000** |
TTO (utility) | 87 | 0.650 ± 0.278 | 0.820 ± 0.264 | 0.170 (0.243 to 0.097) | 0.000** |