Development and validation of an instrument to determine patient knowledge: the oral anticoagulation knowledge test.

Background: Studies examining the relationship between patient knowledge regarding warfarin therapy and its safe and effective use are limited by the lack of validated knowledge assessment tools.

Objective: To develop and validate an instrument to assess patient knowledge regarding oral anticoagulation therapy.

Methods: Four nationally recognized anticoagulation experts participated in the instrument development process to ensure content validity. The Oral Anticoagulation Knowledge (OAK) test was administered to subjects on warfarin and a group of age-matched subjects not on warfarin to assess construct validity. A subgroup of warfarin subjects were retested approximately 2-3 months after initial testing to assess test-retest reliability. Internal consistency reliability was assessed by calculating a Kuder-Richardson 20 value. Item analysis was used to assess performance of individual questions.

Results: An initial 23 item instrument was pilot tested for readability and comprehension. The OAK test was administered to 74 subjects taking warfarin and 27 age-matched subjects not on warfarin. Thirty-two subjects on warfarin repeated the OAK test an average of 75 days following initial administration. Subjects taking warfarin scored significantly higher than those not on warfarin (72% vs 52%, respectively; p < 0.001), supporting the construct validity of the instrument. Test-retest reliability was acceptable, with a Pearson's correlation coefficient of 0.81. Internal consistency reliability was confirmed by a calculated Kuder-Richardson 20 value of 0.76.

Conclusions: The OAK test is a brief, valid, and reliable knowledge assessment instrument that may be a useful tool for research and clinical practice to augment patient education programs.