Page 126 - Comprehensive treatment of patients with glucocorticoid-dependent severe asthma

Chapter 7
Secondary and additional outcomes
Changes in FEV1, number of asthma exacerbation, days of hospitalizations and patients’ global satisfaction with the strategy were not different between the two groups (Table 3).
The median (range) change in doses of inhaled corticosteroid was 125 (-250 to 250) μg/day in the conventional management group versus no change (0 to 250) μg/day in the internet strategy group (p<0.01).
Table 3. Primary and secondary outcomes according to treatment group
Variable
Sparing of prednisone in 6 months – mg (median,25th-75th percentile)†
Mean(SE) ACQ change from baseline ‡§ Mean(SE) AQLQ - change from baseline ‡║ Slope FEV1(L) ‡
Exacerbations per patient
(median, 25th-75th percentile)
Exacerbations per year (median, 25th-75th percentile)**
Days of hospitalization per patient (median(25th-75th percentile)
Days of hospitalizations per patient/ year (median, (25th-75th percentile) ‡‡
Global satisfaction scale (mean(SE)) §§
Internet group
n=51
205 (-221 to 777)
0.26 (0.09)
-0.03 (0.10)
-0.0009
1
(0 to 1)
1.68 (0 to 3.9)
0
(0 to 17)
0
(0 to 37)
5.58 (0.2)
Conventional Absolute management difference* group (95% CI)
n=38
0 205 (-497.5 to 282) (45 to 365)
0.12 (0.12) 0.14 (-0.14 to 0.42)
0.14 (0.13) 0.17 (-0.14 to 0.48)
-0.0007 0.0002 (-0.0012 to 0.0018)
1 0 (0 to 1)
1.82 -0.14 (0 to 2.5)
0 0 (0 to 7)
0 0 (0 to 18)
6.08 (0.18) 0.5 (-0.07 to 1.06)
p- value
0.02 0.37 0.30 0.73 0.78 0.95 0.25 0.25 0.09
Footnote table 3. * Absolute difference is the difference in medians or means between the groups.
† Sparing of prednisone is the difference between the expected cumulative dose (daily dose at study entry multiplied by the number of days in the study) and the actual cumulative dose. For the calculation of the actual cumulative dose we used the dose registered daily on the website by each patient. ‡ Values are model estimates of mixed-effects regression models. § The Juniper Asthma Control Questionnaire (ACQ) score ranges from 0 to 7, with higher scores indicating worse control. ║ The Juniper Quality of Life Questionnaire (AQLQ) score ranges from 1 to 7, with higher scores indicating better quality of life. ** Incidence of exacerbations/year (number of exacerbations per patient divided by the number of days in the study and multiplied by 365). ‡‡ Incidence of days of hospitalizations/patient/year (number of days of hospitalization per patient divided by the number of days in the study multiplied by 365). §§ Patients’ rate for their satisfaction with the tapering strategy, from 1 (absolutely not satisfied) to 7 (really satisfied).
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