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Evidence From a Randomized Trial

Tim R. Lancaster, MRCP; Daniel E. Singer, MD; Mary A. Sheehan, RN; Lynn B. Oertel, RN-C, MS; Sue W. Maraventano, RN; Robert A. Hughes, MD; J. Philip Kistler, MD

Arch Intern Med. 1991;151(10):1944-1949.

Abstract
To determine the effect of long-term warfarin sodium therapy on quality of life, we surveyed 333 patients participating in a randomized, controlled trial of warfarin for the prevention of stroke in nonrheumatic atrial fibrillation. No significant differences between warfarin-treated and control patients were found on well-validated measures of functional status, well-being, and health perceptions. For example, the summary score for health perceptions was 68.8 in the warfarin-treated vs 66.6 in the control group (scale of 0 to 100; 95% confidence intervals for the difference, —1.6 to 6.0). In contrast, patients taking warfarin who had a bleeding episode had a significant decrease in health perceptions (-11.9; 95% confidence interval, —4.1 to — 19.6 Warfarin therapy is not usually associated with a significant decrease in perceived health, unless a bleeding episode has occurred. Negative effects of warfarin treatment on health perceptions may be balanced by confidence in its protective effects.

(Arch Intern Med. 1991;151:1944-1949)

Author Affiliations
for the Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators

From the General Internal Medicine Unit (Drs Lancaster, Singer, and Hughes), Boston Area Anticoagulation Trial in Atrial Fibrillation, Wang Ambulatory Care Center (Mss Sheehan, Oertel, and Maraventano), and Neurology Service (Dr Kistler), Massachusetts General Hospital, Boston. Dr Lancaster was a fellow of the Harvard General Internal Medicine Fellowship Program. Dr Singer was a Henry J. Kaiser Family Foundation Faculty Scholar in General Internal Medicine.

Footnotes
Accepted for publication May 31, 1991.

Reprint requests to General Internal Medicine Unit, Bulfinch 1, Massachusetts General Hospital, Boston, MA 02114 (Dr Singer).

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