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Table 1 Details of study visits and telephone calls

From: Effectiveness of compression stockings to prevent the post-thrombotic syndrome (The SOX Trial and Bio-SOX biomarker substudy): a randomized controlled trial

Enrollment visit
• The nurse completes the baseline form (inclusion/exclusion criteria, demographic and clinical variables, results of objective tests for DVT), PTS scale and pain scale
• The patient self-completes the QOL form
• The nurse performs the leg measurements to size the stockings
• The nurse teaches patients how to apply (using a plastic leg model) and care for stockings (handling, washing), and reinforces the importance of daily use
• Study stockings are supplied to the patient (within a few days after enrollment)
• A venous blood sample is taken for markers of inflammation
2-week telephone call
• The nurse reinforces the importance of wearing stockings daily
• Bleeding/Other Adverse Event form and pain scale are completed
For the following visits, the patient does not wear study stocking to prevent unblinding of study nurse:
1-month visit
• The nurse completes the follow-up form (includes data on symptoms and signs of PTS, suspected recurrent VTE, compliance with stockings, pain scale)
• The patient self-completes the QOL form
• Bleeding/Other Serious Adverse Event form is completed
• A venous blood sample is taken for markers of inflammation and genetic thrombophilia
• The nurse reinforces the importance of wearing stockings daily
2-month telephone call
• Same as the 2-week telephone call
6-month visit
• The nurse completes the follow-up form
• The patient self-completes the QOL form
• Bleeding/Other Serious Adverse Event form is completed
• Leg measurements are taken, and a new pair of stockings is supplied
• A venous blood sample is taken for markers of inflammation, d-dimer and coagulation-based assays
• The nurse reinforces the importance of wearing stockings daily
1-year visit
• Same as 6-month visit except no blood sampling
• A venous ultrasound is performed to assess reflux
18-month visit
• Same as 6-month visit except no blood sampling
2-year visit
• The nurse completes the follow-up form
• The patient self-completes the QOL form
• Bleeding/Other Serious Adverse Event form is completed
• The success of blinding (patient, nurse, and investigator) is assessed (or at Study Termination if earlier than 2 years).