Table 1.
Data documented at baseline and at 1, 3, 6 and 12 months follow-up
| Variable | Baseline | Follow Up | |||
|---|---|---|---|---|---|
| Month 1 | Month 3 | Month 6 | Month 12 | ||
| Eligibility criteria (1) | X | ||||
| Baseline information (2) | X | ||||
| VTE risk factors and co- morbidities (3) | X | ||||
| Baseline information on VTE (4) | X | ||||
| VTE therapy (5) | X | X | X | X | X |
| Current and previous treatment for prevention of stroke and other thromboembolic events (6) | X | X | X | X | X |
| Quality of life (7) | X | X | X | X | X |
| Patient satisfaction (8) | X | X | X | X | X |
| PEmb-QoL Questionnaire (only PE-patients) | X | X | X | X | X |
| Veines-QoL/Sym Questionnaire (only DVT-patients) | X | X | X | X | X |
| Resource utilization (9) | X | X | X | X | X |
| Clinical events and hospitalizations (10) | X | X | X | X | X |
| Number of days in hospital, work days lost due to VTE, need for nursing/informal help | X | X | X | X | X |
Legend
(1) Objectively confirmed first-time or recurrent VTE; age ≥ 18 years, written informed consent
(2) (Socio-) demographic variables: age, gender, height, weight, BMI, blood pressure, graduation, education, employment status, insurance status
(3) Major surgery, bleeding history medical illnesses, multiple trauma, hip fracture, lower extremity paralysis, previous VTE, increasing age, cardiovascular or respiratory failure, prolonged immobility, presence of central venous illness, estrogens, wide Varity of inherited and acquired hematological conditions, cancer, chemotherapy etc
(4) Date of first diagnosis, lead symptoms, diagnostic pathways, severity
(5) Thrombolysis, Heparin, Vitamin K Antagonist, Embolectomy, Catheter, Insertion of V.cava filter
(6) Physician’s clinical impression of the risk of stroke/ thromboembolic events; physician’s use of algorithm to determine risk; current anticoagulation (by drug, with information on continuation after the visit); discontinued anticoagulation (last 12 months); (Relative) contraindications to anticoagulation; INR (target and achieved value, frequency of tests, percentage of values within target range) D
(7) EQ-5D
(8) PACT-Q2
(9) Number of physician contacts (own office, other physicians); VTE related productivity loss and costs; number and type of VTE diagnostic tests since last visit /call
(10) Specifically due to: VTE, stroke, acute coronary syndrome including myocardial infarction, arterial embolism, decompensated heart failure, syncope, bleeding events