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1.  A Pharmacogenetic versus a Clinical Algorithm for Warfarin Dosing 
The New England journal of medicine  2013;369(24):2283-2293.
The clinical utility of genotype-guided (pharmacogenetically based) dosing of warfarin has been tested only in small clinical trials or observational studies, with equivocal results.
We randomly assigned 1015 patients to receive doses of warfarin during the first 5 days of therapy that were determined according to a dosing algorithm that included both clinical variables and genotype data or to one that included clinical variables only. All patients and clinicians were unaware of the dose of warfarin during the first 4 weeks of therapy. The primary outcome was the percentage of time that the international normalized ratio (INR) was in the therapeutic range from day 4 or 5 through day 28 of therapy.
At 4 weeks, the mean percentage of time in the therapeutic range was 45.2% in the genotype-guided group and 45.4% in the clinically guided group (adjusted mean difference, [genotype-guided group minus clinically guided group], −0.2; 95% confidence interval, −3.4 to 3.1; P=0.91). There also was no significant between-group difference among patients with a predicted dose difference between the two algorithms of 1 mg per day or more. There was, however, a significant interaction between dosing strategy and race (P=0.003). Among black patients, the mean percentage of time in the therapeutic range was less in the genotype-guided group than in the clinically guided group. The rates of the combined outcome of any INR of 4 or more, major bleeding, or thromboembolism did not differ significantly according to dosing strategy.
Genotype-guided dosing of warfarin did not improve anticoagulation control during the first 4 weeks of therapy. (Funded by the National Heart, Lung, and Blood Institute and others; COAG number, NCT00839657.)
PMCID: PMC3942158  PMID: 24251361
2.  Genetics InFormatics Trial (GIFT) of Warfarin to Prevent Deep Vein Thrombosis (DVT): Rationale and Study Design 
The pharmacogenomics journal  2011;12(5):417-424.
The risk of venous thromboembolism (VTE) is higher after total hip or knee replacement surgery than after almost any other surgical procedure; warfarin sodium is commonly prescribed to reduce this peri-operative risk. Warfarin has a narrow therapeutic window with high inter-individual dose variability and can cause hemorrhage. The Genetics-InFormatics Trial (GIFT) of Warfarin to Prevent Deep Vein Thrombosis (DVT) is a 2×2 factorial-design, randomized controlled trial designed to compare the safety and effectiveness of warfarin-dosing strategies. GIFT will answer two questions: (1) Does pharmacogenetic (PGx) dosing reduce the rate of adverse events in orthopedic patients; and (2) Is a lower target International Normalized Ratio (INR) non-inferior to a higher target INR in orthopedic participants? The composite primary endpoint of the trial is symptomatic and asymptomatic VTE (identified on screening ultrasonography), major hemorrhage, INR ≥ 4, and death.
PMCID: PMC3175019  PMID: 21606949
pharmacogenetics; warfarin; randomized controlled trial; dosing algorithm
3.  Physician Alerts to Prevent Symptomatic Venous Thromboembolism in Hospitalized Patients 
Circulation  2009;119(16):2196-2201.
Venous thromboembolism (VTE) prophylaxis remains underutilized among hospitalized patients. We designed and carried out a large multicenter randomized controlled trial to test the hypothesis that an alert from a hospital staff member to the Attending Physician will reduce the rate of symptomatic VTE among high-risk patients not receiving prophylaxis.
Methods and Results
We enrolled patients using a validated point score system to detect hospitalized patients at high risk for symptomatic VTE who were not receiving prophylaxis. 2,493 patients (82% on Medical Services) from 25 study sites were randomized to the intervention group (n=1,238), in which the responsible physician was alerted by another hospital staff member, versus the control group (n=1,255), in which no alert was issued. The primary end point was symptomatic, objectively confirmed VTE within 90 days. Patients whose physicians were alerted were more than twice as likely to receive VTE prophylaxis as controls (46.0% versus 20.6%, p<0.0001). The symptomatic VTE rate was lower in the intervention group (2.7% versus 3.4%; hazard ratio, 0.79; 95% confidence interval, 0.50 to 1.25), but the difference did not achieve statistical significance. The rate of major bleeding at 30 days in the alert group was similar to the control group (2.1% versus 2.3%, p=0.68).
A strategy of direct staff member to physician notification increases prophylaxis utilization and leads toward reducing the rate of symptomatic VTE in hospitalized patients. However, VTE prophylaxis continues to be underutilized even after physician notification, especially among Medical Service patients.
PMCID: PMC2901546  PMID: 19364975
Deep vein thrombosis; Prevention; Prophylaxis; Pulmonary embolism; Venous thromboembolism
4.  Computer Surveillance of Patients at High Risk for and with Venous Thromboembolism 
Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), may be the number one preventable cause of death associated with hospitalization. Numerous evidence-based guidelines for effective VTE prophylaxis therapy exist. However, underuse is common due to the difficulty in integrating VTE risk assessment into routine patient care. Previous studies utilizing computer decision support to identify high-risk patients report improved use of prophylaxis therapy and reduced VTE. However, those studies did not report the sensitivity, specificity or positive predictive value of their methods to identify patients at high risk. We report an evaluation of a computerized tool to identify patients at high risk for VTE that found a sensitivity of 98% and positive predictive value of 99%. Another computer program used to detect VTE had a sensitivity of 92%, specificity of 99% and a positive predictive value of 97% to identify DVT and a sensitivity of 100%, specificity of 98% and positive predictive value of 89% to identify PE. These tools were found to provide a dependable method to identify patients at high risk for and with VTE.
PMCID: PMC3041332  PMID: 21346972
5.  Resident-to-Resident Aggression in Long-Term Care Facilities: Insights from Focus Groups of Nursing Home Residents and Staff 
To more fully characterize the spectrum of RRA.
A focus group study of nursing home staff members and residents who could reliably self-report.
A large urban, not-for-profit long-term care facility in New York City
7 residents and 96 staff members from multiple clinical and non-clinical occupational groups.
16 focus groups were conducted. Content was analyzed with nVivo 7 software for qualitative data.
35 different types of physical, verbal and sexual RRA were described, with screaming and/or yelling being the most common. Calling out and making noise were the most frequent of 29 antecedents identified as instigating episodes of RRA. RRA was most frequent in dining and residents’ rooms, and in the afternoon, though it occurred regularly throughout the facility at all times. While no proven strategies exist to manage RRA, staff described 25 self-initiated techniques to address the issue.
RRA is a ubiquitous phenomenon in nursing home settings with important consequences for affected individuals and facilities. Further epidemiologic research is necessary to more fully describe the phenomenon and identify risk factors and preventative strategies.
PMCID: PMC2755096  PMID: 18637979
nursing home; dementia-related behaviors; focus groups

Results 1-5 (5)