Patient attitudinal and behavioral factors associated with warfarin non-adherence at outpatient anticoagulation clinics.

BACKGROUND: Warfarin is an anticoagulant effective in preventing stroke, but it has a narrow therapeutic range requiring optimal adherence to achieve the most favorable effects. PURPOSE: The goal of this study was to examine specific patient factors that might help explain warfarin non-adherence at outpatient anticoagulation clinics. METHOD: In a prospective cohort study of 156 adults, we utilized logistic regression analyses to examine the relationship between the five Treatment Prognostics scales from the Millon Behavioral Medicine Diagnostic (MBMD), as well as three additional MBMD scales (Depression, Future Pessimism, and Social Isolation), and daily warfarin non-adherence assessed using electronic medication event monitoring systems caps over a median of 139 days. RESULTS: Four of the five Treatment Prognostic scales and greater social isolation were associated with warfarin non-adherence. When controlling for pertinent demographic and medical variables, the Information Discomfort scale remained significantly associated with warfarin non-adherence over time. CONCLUSION: Although several factors were related to warfarin non-adherence, patients reporting a lack of receptivity to details regarding their medical illness seemed most at risk for warfarin non-adherence. This information might aid in the development of interventions to enhance warfarin adherence and perhaps reduce adverse medical events.

Can we predict daily adherence to warfarin?: Results from the International Normalized Ratio Adherence and Genetics (IN-RANGE) Study.

BACKGROUND: Warfarin is the primary therapy to prevent stroke and venous thromboembolism. Significant periods of nonadherence frequently go unreported by patients and undetected by providers. Currently, no comprehensive screening tool exists to help providers assess the risk of nonadherence at the time of initiation of warfarin therapy. METHODS: This article reports on a prospective cohort study of adults initiating warfarin therapy at two anticoagulation clinics (university- and Veterans Affairs-affiliated). Nonadherence, defined by failure to record a correct daily pill bottle opening, was measured daily by electronic pill cap monitoring. A multivariable logistic regression model was used to develop a point system to predict daily nonadherence to warfarin. RESULTS: We followed 114 subjects for a median of 141 days. Median nonadherence of the participants was 14.4% (interquartile range [IQR], 5.8-33.8). A point system, based on nine demographic, clinical, and psychosocial factors, distinguished those demonstrating low vs high levels of nonadherence: four points or fewer, median nonadherence 5.8% (IQR, 2.3-14.1); five points, 9.1% (IQR, 5.9-28.6); six points, 14.5% (IQR, 7.1-24.1); seven points, 14.7% (IQR, 7.0-34.7); and eight points or more, 29.3% (IQR, 15.5-41.9). The model produces a c-statistic of 0.66 (95% CI, 0.61-0.71), suggesting modest discriminating ability to predict day-level warfarin nonadherence. CONCLUSIONS: Poor adherence to warfarin is common. A screening tool based on nine demographic, clinical, and psychosocial factors, if further validated in other patient populations, may help to identify groups of patients at lower risk for nonadherence so that intensified efforts at increased monitoring and intervention can be focused on higher-risk patients.

Risk factors for nonadherence to warfarin: results from the IN-RANGE study.

BACKGROUND: Warfarin is widely used to prevent stroke and venous thromboembolism despite its narrow therapeutic window. Warfarin nonadherence is a substantial problem, but risk factors have not been well elucidated. METHODS: A prospective cohort study of adults initiating warfarin at two anticoagulation clinics (University and VA-affiliated) was performed to determine factors affecting nonadherence to warfarin. Nonadherence, defined by failure to record a correct pill bottle opening each day, was measured daily via electronic medication event monitoring systems (MEMS) caps. A multivariable explanatory model using logistic regression for longitudinal data was used to identify risk factors for nonadherence. RESULTS: One hundred eleven subjects were followed for a median of 137 days. Warfarin nonadherence was common (4787 of 22,425 or 21% of patient-days observed). Factors independently associated with higher odds of nonadherence included education beyond high school (odds ratio (OR) 1.8 (95%CI 1.2-2.7)), lower Short Form (SF)-36 mental component score (OR 1.4 (1.1-1.6) for each 10 point decrease); and impaired cognition (< or =19 points) on the Cognitive Capacity Screening Examination (CCSE) (OR 2.9 (1.7-4.8)). Compared to currently employed subjects, unemployed (OR 0.6 (0.3-1.2)) and retired (OR 0.5 (0.3-0.8)) subjects had somewhat improved adherence; disabled subjects over age 55 had worse adherence (OR 1.8 (1.1-3.1)) than younger disabled subjects (OR 0.8 (0.4-1.5)). CONCLUSIONS: Poor adherence to warfarin is common and risk factors are related to education level, employment status, mental health functioning, and cognitive impairment. Within the carefully controlled anticoagulation clinic setting, such patient-specific factors may be the basis of future interventions to improve nonadherence.

Adherence to warfarin assessed by electronic pill caps, clinician assessment, and patient reports: results from the IN-RANGE study.

BACKGROUND: Patient adherence to warfarin may influence anticoagulation control; yet, adherence among warfarin users has not been rigorously studied. OBJECTIVE: Our goal was to quantify warfarin adherence over time and to compare electronic medication event monitoring systems (MEMS) cap measurements with both self-report and clinician assessment of patient adherence. DESIGN: We performed a prospective cohort study of warfarin users at 3 Pennsylvania-based anticoagulation clinics and assessed pill-taking behaviors using MEMS caps, patient reports, and clinician assessments. RESULTS: Among 145 participants, the mean percent of days of nonadherence by MEMS was 21.8% (standard deviation+/-21.1%). Participants were about 6 times more likely to take too few pills than to take extra pills (18.8 vs. 3.3%). Adherence changed over time, initially worsening over the first 6 months of monitoring, which was followed by improvement beyond 6 months. Although clinicians were statistically better than chance at correctly labeling a participant's adherence (odds ratio = 2.05, p = 0.015), their estimates often did not correlate with MEMS-cap data; clinicians judged participants to be "adherent" at 82.8% of visits that were categorized as moderately nonadherent using MEMS-cap data (>or=20% nonadherence days). Similarly, at visits when participants were moderately nonadherent by MEMS, they self-reported perfect adherence 77.9% of the time. CONCLUSIONS: These results suggest that patients may benefit from adherence counseling even when they claim to be taking their warfarin or the clinician feels they are doing so, particularly several months into their course of therapy.

The influence of patient adherence on anticoagulation control with warfarin: results from the International Normalized Ratio Adherence and Genetics (IN-RANGE) Study.

BACKGROUND: Warfarin sodium is a highly efficacious drug, but proper levels of anticoagulation are difficult to maintain. Conflicting data exist on the influence of patient adherence on anticoagulation control. METHODS: We performed a prospective cohort study at 3 anticoagulation clinics to determine the effect of adherence on anticoagulation control. Patients treated with warfarin with a target international normalized ratio of 2.0 to 3.0 were monitored with electronic Medication Event Monitoring System (MEMS) medication bottle caps. Detailed information was collected on other factors that might alter warfarin response. RESULTS: Among 136 participants observed for a mean of 32 weeks, 92% had at least 1 missed or extra bottle opening; 36% missed more than 20% of their bottle openings; and 4% had more than 10% extra bottle openings. In multivariable analyses, there was a significant association between underadherence and underanticoagulation. For each 10% increase in missed pill bottle openings, there was a 14% increase in the odds of underanticoagulation (P<.001); participants with more than 20% missed bottle openings (1-2 missed days each week) had more than a 2-fold increase in the odds of underanticoagulation (adjusted odds ratio, 2.10; 95% confidence interval, 1.48-2.96). Participants who had extra pill bottle openings on more than 10% of days had a statistically significant increase in overanticoagulation (adjusted odds ratio, 1.73; 95% confidence interval, 1.09-2.74). CONCLUSION: Patients have substantial difficulties maintaining adequate adherence with warfarin regimens, and this poor adherence has a significant effect on anticoagulation control.