title: Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial.
abstract: BACKGROUND
  Control of oral anticoagulant treatment has been reported to be suboptimal, but previous studies suggest that patient self-management improves control.
  
  
  OBJECTIVE
  To compare the quality of control and the clinical outcomes of oral anticoagulant treatment in self-managed patients versus patients following conventional management.
  
  
  METHODS
  Randomized, controlled trial.
  
  
  METHODS
  University-affiliated hospital in Spain.
  
  
  METHODS
  737 patients with indications for anticoagulant treatment.
  
  
  METHODS
  The self-management group (n = 368) received simple instructions for using a portable coagulometer weekly and self-adjusting treatment dose. The conventional management group (n = 369) received usual care in an anticoagulation clinic (monthly measurement and control of international normalized ratio [INR], managed by hematologists).
  
  
  METHODS
  Percentage of INR values within the target range and major related complications.
  
  
  RESULTS
  The median follow-up period was 11.8 months (range, 0.3 to 16.9 months). The unadjusted percentages of in-range INRs were 58.6% in the self-management group and 55.6% in the conventional management group (difference, 3.0 percentage points [95% CI, 0.4 to 5.4 percentage points]). Twenty-seven patients (7.3%) in the conventional management group and 8 (2.2%) in the self-management group had major complications related to anticoagulant treatment. The unadjusted risk difference for major complications between groups was 5.1 percentage points (exact 95% CI, 1.7 to 8.5 percentage points). Fewer patients had minor hemorrhages in the self-management group (14.9%) than in the conventional management group (36.4%). Fifteen patients (4.1%) in the conventional management group and 6 (1.6%) in the self-management group died (unadjusted risk difference, 2.5 percentage points [exact 95% CI, 0.0 to 5.1 percentage points]).
  
  
  CONCLUSIONS
  The trial was performed at only 1 center and was not blinded. The dropout rate in the intervention group was 21%.
  
  
  CONCLUSIONS
  Compared with conventional management by an anticoagulation clinic, self-management of oral anticoagulant treatment achieved a similar level of control. Of note, major complications and minor hemorrhages were less common in the self-management group.
authors.affiliation: Hospital de la Santa Creu i Sant Pau and Fundació Puigvert, Barcelona, Spain.
authors.forename: Bárbara
authors.initials: B
authors.lastname: Menéndez-Jándula
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Souto
authors.forename: Arturo
authors.initials: A
authors.lastname: Oliver
authors.forename: Isabel
authors.initials: I
authors.lastname: Montserrat
authors.forename: Mireia
authors.initials: M
authors.lastname: Quintana
authors.forename: Ignasi
authors.initials: I
authors.lastname: Gich
authors.forename: Xavier
authors.initials: X
authors.lastname: Bonfill
authors.forename: Jordi
authors.initials: J
authors.lastname: Fontcuberta
mesh_terms: D000074:Acenocoumarol / Q000008:administration & dosage* / Q000009:adverse effects; D000284:Administration, Oral; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods*; D010349:Patient Compliance; D010352:Patient Dropouts; D010353:Patient Education as Topic; D012307:Risk Factors; D012648:Self Care / Q000592:standards*; D013923:Thromboembolism / Q000517:prevention & control; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000074:Acenocoumarol