Physician Adherence to Fondaparinux Prescribing Information for Patients with Superficial Vein Thrombosis (SVT) of the Lower Limbs (115280)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Retrospective chart review
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective chart review

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FONDAPARINUX SODIUM

Population studied

• Short description of the study population:
  Patients prescribed fondaparinux to treat their superficial vein thrombosis (SVT).; Inclusion Criteria; (1) Diagnosis of SVT; (2) Prescribed fondaparinux for the treatment of SVT; (3) Age 18 years or older; Exclusion Criteria; (1) Patients should not have been involved in any clinical trial that could influence SVT treatment during the observational period
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Superficial vein thrombosis (SVT) patients
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  The primary objective is to evaluate physicians’ adherence to fondaparinux prescribing information for the treatment of patients with Superficial Vein Thrombosis (SVT) without concomitant Deep Vein Thrombosis (DVT)
• Outcomes:
  The primary outcome measure will be the percentage of patients for whom both an ultrasound (or other objective measure) was performed in order to rule out concomitant DVT prior to patients commencing fondaparinux therapy and who were prescribed the recommended dose (2.5mg, or 1.5mg) of fondaparinux. This will be evaluated overall and per country. The proportion of patients with SVT of the lower limbs treated with fondaparinux, for whom an ultrasound, or other diagnostic imaging procedure, was performed in order to rule out concomitant DVT prior to patients commencing fondaparinux therapy and the proportion of patients with SVT of the lower limbs treated with fondaparinux, for whom either 2.5mg or 1.5mg fondaparinux was prescribed.
• Data analysis plan:
  All statistical analyses will be conducted in Statistical Analysis Software (SAS) v9.1 or later. The proportion of patients treated according to the prescribing information for fondaparinux (the adherence rate) will be estimated using generalized estimating equations (GEEs). Adherence estimates with confidence intervals will be derived using GEEs overall and for each country. The GEE will explicitly take into account the nesting of patients, per physician, within a medical practice.