Anticoagulation: patients on warfarin felt as healthy as patients who were not.

Clinical bottom line (level 1b)

  1. Patients on warfarin scored no differently from control patients on a questionnaire asking about functional status, well-being and health perception.
  2. Only patients who had a bleed on warfarin became more concerned about their health.
Lancaster et al: Archives of Internal Medicine 1991; 151: 1944-1949
Expires June 2003

The study

Unblinded concealed randomised trial with intention-to-treat
Setting: outpatients, university hospital, USA

357 patients (aged mean 68 years, 76% male) non-rheumatic atrial fibrillation

Excluded if
  • unable to speak English
  • cognitive or sensory deficits preventing them understanding questionnaire


    • Control Group: (n = 156, 156 analysed): 'normal medical care' with or without aspirin or other NSAIDs
    Experimental Group: (n = 177, 177 analysed): warfarin adjusted so that prothrombin ratio 1.2 to 1.5 (roughly INR 2.4 to 3.0). Checked every two to three weeks
    Patients completed a 36-item health questionnaire on functional status, well-being and health perception.
    93% followed for ?

    The evidence

    all patients
    Outcome Control Group
    (SD)    		 Experimental Group
    (SD)    		 Mean Difference
    (95% CI)
    social 82.6
    ()     		83.2
    ()     		0.6
    (-2.8 to 4.0)
    energy/fatigue 55.2
    ()     		57.9
    ()     		2.7
    (-2.5 to 7.7)
    health perceptions 66.6
    ()     		68.8
    ()     		2.2
    (-1.6 to 6.0)

    in patients that bled on warfarin (23) compared with other patients on warfarin
    Outcome Control Group
    (SD)    		 Experimental Group
    (SD)    		 Mean Difference
    (95% CI)
    bled on warfarin vs others on warfarin: health distress 19.6
    ()     		34.9
    ()     		15.3
    (3.7 to 26.9)
    health concern 52.9
    ()     		66.3
    ()     		13.4
    (2.1 to 24.8)
    current health status 62.5
    ()     		53.7
    ()     		-8.6
    (-19.6 to 1.9)

  • No significant difference found between patients on warfarin and control group for functional status, well-being or health perception. Little change in response to questionnaire over time.

    • Comments

    1. High proportion of male respondents - do omens' perceptions vary?
    2. Do control patients who suffer a stroke or a bleed also become concerned about their health like patients on warfarin who bleed?

    Citation

    1. Lancaster TR, Singer DE, Sheehan MA, et al: The impact of long-term warfarin therapy on quality of life: evidence from a randomized trial. Archives of Internal Medicine 1991; 151: 1944-1949
    Contributor: Chris Ball and Clare Wotton, June 2000
    Reviewer: Daniel Sontheimer

    Clinical Question.
    Patient atrial fibrillation
    Intervention or Exposure adjusted warfarin
    Comparison normal medical care
    Outcome functional status, well-being, health perception