Table 3.
Test | Year 1 | Year 2 | Year 3 | Year 4 | Year 5 | |||||||||||||||
|
Qa2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | |
Stanford 25 comprehensive clinical assessment |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
|
Spirometry (FVCb, FEVc, FEV1d, FEV1/ FVC, FEFe 25-75, MEFf), bronchodilation test using salbutamol |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
|
CATg |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
|
6MWTg |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
|
Short form-12 Quality of Life questionnaire |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
|
ECGg |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
|
Body mass index |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
|
Smoking status, exposures |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
|
Laboratory testing for blood cholesterol level, CBCj (25 parameters); HDLk, LDLl, triglycerides, C-reactive protein, fibrinogen, glucose, glycosylated hemoglobin |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
|
Biomarker testing for sRAGEm, ICAM1n, and CCL20o |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
|
Lung computer tomography |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
X |
|
|
|
|
Continuous health status monitoring, including home visits, phone, email, telemedicine, and COPDp Center visits as necessary | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |
Monitoring COPD exacerbations based on use of inhaled steroids, antibiotics, inhaled bronchodilators, steroids, health care visits (office visits, emergency department, or hospital) | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |
Monitoring adverse events and serious adverse events using SymptoMaster self-assessment that triggers notification | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
aQ: quarter.
bFVC: forced vital capacity.
cFEV: forced expiratory volume.
dFEV1: forced expiratory volume in 1 second.
eFEF: forced expiratory flow.
fMEF: maximum expiratory flow.
gCAT: COPD Assessment Test.
h6MWT: 6-Minute Walk Test.
iECG: electrocardiogram.
jCBC: complete blood count.
kHDL: high-density lipoproteins.
lLDL: low-density lipoproteins.
msRAGE: advanced glycosylation end-product receptor.
nICAM1: intercellular adhesion molecule 1.
oCCL20: macrophage inhibitory protein 3a.
pCOPD: chronic obstructive pulmonary disease.