Anticoagulation: self-management of INR was as effective as anticoagulation clinic-based care.

Clinical bottom line (level 1b)

  1. Patients on long-term anticoagulation who self-managed anticoagulation compared with clinic-based management were not clearly less likely to have a therapeutic INR.
  2. Patients on self-management were more satisfied with self-efficacy, social issues, and daily worries.
Cromheecke et al: Lancet 2000; 356 : 97-102
Expires June 2003

The study

Unblinded ?concealed randomised cross-over trial without intention-to-treat
Setting: anticoagulation clinic, university hospital, Holland

49 patients (aged 22 to 72; mean 42, 59% male) on long-term anticoagulation with vitamin K antagonists

Excluded if
  • not self-supporting

    Note:
  • Patients ranked their satisfaction with each treatment option using a subjective quality of case assessment measuring treatment satisfaction, self-efficacy, daily worries and social issues on a scale of 1 (total dissatisfaction) to 6 (complete satisfaction).

Control Group: (n = 49, 49 analysed): anticoagulation-clinic based management
Experimental Group: (n = 49, 49 analysed): self-management of anticoagulation. Patients underwent a structured educational programme of 2x 2 hour sessions, during which they were trained to use a portable INR capillary fingerstick monitor, and taught using a nomogram how to adjust their INR.
INR was monitored every 1-2 weeks.
100% followed for 3 months

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNT
(95% CI)
50% or more of time with therapeutic INR 3 months 29
(51.0%)		 29
(59.2%)		 -16%
(-66% to 19%)		 -8.16%
(-27.8% to 11.5%)		 12
(NNT = 9 to infinity;
NNH = 4 to infinity)
75% or more of time in therapeutic range 3 months 6
(12.2%)		 13
(26.5%)		 -120%
(-420% to 10%)		 -14.3%
(-29.7% to 1.11%)		 -7
(NNT = 90 to infinity;
NNH = 3 to infinity)

subjective quality-of-case assessment
Outcome Control Group
(SD)		 Experimental Group
(SD)		 Mean Difference
(95% CI)
self-efficacy 4.5
(1.0) 		5.4
(0.6) 		0.9
(0.6 to 1.2)
daily worries 2.8
(0.5) 		1.8
(0.5) 		1.0
(0.8 to 1.2)
social issues 2.7
(0.9) 		1.7
() 		1.0
(0.7 to 1.3)

Comments

  1. K value for agreement between clinic INR and self-measured INR = 0.64. 5% of cases were more than 1.0 units different - only 2% would have led to a different dosing scheme
  2. No major bleeding events (defined as bleeding requiring hospital admission or transfuion or any CNS bleeding) were seen in either group.

Citation

  1. Cromheecke ME, Levi M, Colly LP, et al: oral anticoagulation self-management and management by specialist anticoagulation clinic: a randomised cross-over comparison. Lancet 2000; 356 : 97-102
Search Terms: from EBM journal
Contributor: Chris Ball, June 2001
Reviewer: Clare Wotton

Clinical Question.
Patient
Intervention or Exposure
Outcome