Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
2-year medico-economic impact of the implementation of early care in obese patients with OSA |
incremental cost-effectiveness ratio at 24 months calculated from the difference in healthcare costs between the 2 groups (early care vs usual care) adjusted to the difference in the number of quality adjusted life years |
24 months |
|
Secondary |
Economic impact of the implementation of early care in obese patients with OSA over 3 years on the healthcare costs |
The economic impact on healthcare costs from the Health Insurer's perspective will be calculated from the difference in healthcare costs between the two groups (early care vs usual care) |
3 years |
|
Secondary |
To evaluate the sensitivity of the screening tool |
The sensitivity will be evaluated by comparison with polysomnography |
24 months |
|
Secondary |
To evaluate the specificity of the screening tool |
The specificity will be evaluated by comparison with polysomnography |
24 months |
|
Secondary |
To evaluate the negative Predictive Value |
The negative predictive value will be evaluated by comparison with polysomnography |
24 months |
|
Secondary |
To evaluate the positive predictive value of the screening tool |
The positive predictive value will be evaluated by comparison with polysomnography |
24 months |
|
Secondary |
Clinical impact of the early care pathway on blood pressure at 12 months |
Blood pressure at home |
12 months |
|
Secondary |
Clinical impact of the early care pathway on blood pressure at 24 months |
Blood pressure at home |
24 months |
|
Secondary |
Clinical impact of the early care pathway on quality of life at 12 months |
The EQ-5D-5L health status questionnaire, This scale is numbered from 0 to 100. 100 means the best health status. 0 means the worst health status. |
12 months |
|
Secondary |
Clinical impact of the early care pathway on quality of life at 24 months |
The EQ-5D-5L health status questionnaire, This scale is numbered from 0 to 100. 100 means the best health status. 0 means the worst health status. |
24 months |
|
Secondary |
Clinical impact of the early care pathway (early care) on quality of life at 12 months |
Stroke and Aphasia Quality of Life Scale (SAQOL), This questionnaire is intended to study the relationship between sleep and the quality of life. This scale is numbered from 0 to 4. higher values represent a worse outcome |
12 months |
|
Secondary |
Clinical impact of the early care pathway (early care) on quality of life at 24 months |
Stroke and Aphasia Quality of Life Scale (SAQOL), This questionnaire is intended to study the relationship between sleep and the quality of life. This scale is numbered from 0 to 4. higher values represent a worse outcome |
24 months |
|
Secondary |
Clinical impact of the early care pathway on pharmacological treatments at 12 months |
number of pharmacological treatments |
12 months |
|
Secondary |
Clinical impact of the early care pathway on pharmacological treatments at 24 months |
number of pharmacological treatments |
24 months |
|
Secondary |
Impact on laboratory test results (troponin) at 12 months |
troponin |
12 months |
|
Secondary |
Impact on laboratory test results (troponin) at 24 months |
troponin |
24 months |
|
Secondary |
Impact on laboratory test results (NT-proBNP) at 12 months |
NT-proBNP |
12 months |
|
Secondary |
Impact on laboratory test results (NT-proBNP) at 24 months |
NT-proBNP |
24 months |
|
Secondary |
Impact on laboratory test results on cholesterol at 12 months |
cholesterol |
12 months |
|
Secondary |
Impact on laboratory test results on cholesterol at 24 months |
cholesterol |
24 months |
|
Secondary |
Impact on laboratory test results on triglycerides at 12 months |
triglycerides |
12 months |
|
Secondary |
Impact on laboratory test results on triglycerides at 24 months |
triglycerides |
24 months |
|
Secondary |
Impact on laboratory test results on glycaemia at 12 months |
glycaemia |
12 months |
|
Secondary |
Impact on laboratory test results on glycaemia at 24 months |
glycaemia |
24 months |
|
Secondary |
Impact on laboratory test results on Homeostasis model assessment (HOMA)-index at 12 months |
Homeostasis model assessment (HOMA)-index |
12 months |
|
Secondary |
Impact on laboratory test results on Homeostasis model assessment (HOMA)-index at 24 months |
Homeostasis model assessment (HOMA)-index |
24 months |
|
Secondary |
Impact on laboratory test results on hepatic transaminases at 12 months |
transaminases (ASAT, ALAT) |
12 months |
|
Secondary |
Impact on laboratory test results on hepatic transaminases at 24 months |
transaminases (ASAT, ALAT) |
24 months |
|
Secondary |
Impact on laboratory test results on creatinine at 12 months |
creatinine |
12 months |
|
Secondary |
Impact on laboratory test results on creatinine at 24 months |
creatinine |
24 months |
|
Secondary |
Impact on laboratory test results on C-Reactive Protein (CRP) at 12 months |
C-Reactive Protein (CRP) |
12 months |
|
Secondary |
Impact on laboratory test results on C-Reactive Protein (CRP) at 24 months |
C-Reactive Protein (CRP) |
24 months |
|
Secondary |
Impact on laboratory test results on alpha2-macroglobulin at 12 months |
alpha2-macroglobulin |
12 months |
|
Secondary |
Impact on laboratory test results on alpha2-macroglobulin at 24 months |
alpha2-macroglobulin |
24 months |
|