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Appropriate thromboprophylaxis for patients with atrial fibrillation or atrial flutter (AF) remains a national challenge.We hypothesized that a shared decision-making interaction facilitated by an Atrial Fibrillation Shared Decision Making Tool (AFSDM) would improve patient knowledge about atrial fibrillation, and the risks and benefits of various treatment options for stroke prevention; increase satisfaction with the decision-making process; improve the therapeutic alliance between patient and the clinical care team; and increase medication adherence. Using a pre- and post-visit study design, we enrolled 76 patients and completed 2 office visits and 1-month telephone follow-up for 65 patients being seen in our Arrhythmia Clinic over the 1-year period (July 2016 through June 2017). Our primary outcome measure was change in decisional conflict between the first and second clinical visit.Decisional conflict decreased from an average of 31 to 9. Mean change was 22.3 (95% CI, 25.7 - 37.1), corresponding to an effect size of 0.94 standard deviations. Satisfaction with decision increased from 4.0 to 4.5, measures of therapeutic alliance with the care team (Kim Alliance scale) increased from 100.1 to 103.1, and satisfaction with provider increased from 4.2 to 4.5 (P.0001 for all measures). AF knowledge assessment scores increased from 8.4 to 9.1, and knowledge about personal stroke and bleeding risk increased from 1 to 1.5 (P.0001). Finally, medication adherence improved as reflected by an increase in the Morisky Medication Adherence scale from 5.9 to 6.4 (P.0001).A shared decision-making interaction, facilitated by an AFSDM can significantly improve multiple measures of decision-making quality, leading to improved medication adherence and patient satisfaction.

Background Appropriate thromboprophylaxis for patients with atrial fibrillation (AF) remains a national challenge. Methods We hypothesized that provision of decision support in the form of an Atrial Fibrillation Decision Support Tool (AFDST) would improve thromboprophylaxis for AF patients. We conducted a cluster randomized trial involving 15 primary care practices and 1,493 adults with nonvalvular AF in an integrated health care system between April 2014 and February 2015. Physicians in the intervention group received patient-level treatment recommendations made by the AFDST. Our primary outcome was the proportion of patients with antithrombotic therapy that was discordant from AFDST recommendation. Results Treatment was discordant in 42% of 801 patients in the intervention group. Physicians reviewed reports for 240 patients. Among these patients, thromboprophylaxis was discordant in 63%, decreasing to 59% 1 year later ( P = .02). In nonstratified analyses, changes in discordant care were not significantly different between the intervention group and control groups. In multivariate regression models, assignment to the intervention group resulted in a nonsignificant trend toward decreased discordance ( P = .29), and being a patient of a resident physician ( P = .02) and a higher HAS-BLED score predicted decreased discordance ( P = .03), whereas female gender ( P = .01) and a higher CHADSVASc score ( P = .10) predicted increased discordance. Conclusions Among patients whose physicians reviewed recommendations of the decision support tool discordant therapy decreased significantly over 1 year. However, in nonstratified analyses, the intervention did not result in significant improvements in discordant antithrombotic therapy.

Objectives To assess the appropriateness of oral anticoagulant therapy (OAT) in women and elderly adults, looking for patterns of undertreatment or unnecessary treatment. Design Retrospective cohort study. Setting Primary care practices of an academic healthcare system. Participants Adults (aged 28–93) with nonvalvular atrial fibrillation (AF) seen between March 2013 and February 2014 (N = 1,585). Measurements Treatment recommendations were made using an AF decision support tool (AFDST) based on projections of quality-adjusted life expectancy calculated using a decision analytical model that integrates individual-specific risk factors for stroke and hemorrhage. Results Treatment was discordant from AFDST-recommended treatment in 45% (326/725) of women and 39% (338/860) of men (P = .02). Although current treatment was discordant from recommended in 35% (89/258) of participants aged 85 and older and in 43% (575/1,328) of those younger than 85 (P = .01), many undertreated elderly adults were receiving aspirin as the sole antithrombotic agent. Conclusion Physicians should understand that female sex is a significant risk factor for AF-related stroke and incorporate this into decision-making about thromboprophylaxis. Treating older adults with aspirin instead of OAT exposes them to significant risk of bleeding with little to no reduction in AF-related stroke risk.

Background Appropriate thromboprophylaxis for patients with atrial fibrillation or atrial flutter (AF) remains a national challenge. The recent availability of direct oral anticoagulants (DOACs) with comparable efficacy and improved safety compared with warfarin alters the balance between risk factors for stroke and benefit of anticoagulation. Our objective was to examine the impact of DOACs as an alternative to warfarin on the net benefit of oral anticoagulant therapy (OAT) in a real-world population of AF patients. Methods This is a retrospective cohort study of patients with paroxysmal or persistent nonvalvular AF. We updated an A trial F ibrillation D ecision S upport T ool (AFDST) to include DOACs as treatment options. The tool generates patient-specific recommendations based upon individual patient risk factor profiles for stroke and major bleeding using quality-adjusted life-years (QALYs) calculated for each treatment strategy by a decision analytic model. The setting included inpatient and ambulatory sites in an academic health center in the midwestern United States. The study involved 5,121 adults with nonvalvular AF seen for any ambulatory visit or inpatient hospitalization over the 1-year period (January through December 2016). Outcome measure was net clinical benefit in QALYs. Results When DOACs are a therapeutic option, the AFDST recommends OAT for 4,134 (81%) patients and no antithrombotic therapy or aspirin for 489 (9%). A strong recommendation for OAT could not be made in 498 (10%) patients. When warfarin is the only option, OAT is recommended for 3,228 (63%) patients and no antithrombotic therapy or aspirin for 973 (19%). A strong recommendation for OAT could not be made in 920 (18%) patients. In total, 1,508 QALYs could be gained if treatment were changed to that recommended by the AFDST. Conclusions Availability of DOACs increases the proportion of patients for whom oral anticoagulation therapy is recommended in a real-world cohort of AF patients and increased projected QALYs by more than 1,500 when all patients are receiving thromboprophylaxis as recommended by the AFDST compared with current treatment.

Background— Guidelines for anticoagulant therapy in patients with atrial fibrillation are based on stroke risk as calculated by either the CHADS 2 or the CHA 2 DS 2 VASc scores and do not integrate bleeding risk in an explicit, quantitative manner. Our objective was to quantify the net clinical benefit resulting from improved decision making about antithrombotic therapy. Methods and Results— This study is a retrospective cohort study of 1876 adults with nonvalvular atrial fibrillation or flutter seen in primary care settings of an integrated healthcare delivery system between December 2012 and January 2014. Projections for quality-adjusted life expectancy reported as quality-adjusted life-years were calculated by a decision analytic model that integrates patient-specific risk factors for stroke and hemorrhage and examines strategies of no antithrombotic therapy, aspirin, or oral anticoagulation with warfarin. Net clinical benefit was defined by the gain or loss in quality-adjusted life expectancy between current treatment and treatment recommended by an Atrial Fibrillation Decision Support Tool. Current treatment was discordant from treatment recommended by the Atrial Fibrillation Decision Support Tool in 931 patients. A clinically significant gain in quality-adjusted life expectancy (defined as ≥0.1 quality-adjusted life-years) was projected in 832 patients. Subgroups were examined. For example, oral anticoagulant therapy was recommended for 188 who currently were receiving no antithrombotic therapy. For the entire cohort, a total of 736 quality-adjusted life-years could be gained were treatment changed to that recommended by the Atrial Fibrillation Decision Support Tool. Conclusions— Use of a decision support tool that integrates patient-specific stroke and bleeding risk could result in significant gains in quality-adjusted life expectancy for a primary care population of patients with atrial fibrillation.

Background Severely obese patients considering bariatric surgery face a difficult decision given the tradeoff between the benefits and risks of surgery. The objectives of this study was to study the forces driving this decision and improve our understanding of the decision-making process. Methods A 64-item survey was developed to assess factors in the decision-making process for bariatric surgery. The survey included the decisional conflict scale, decision self-efficacy scale, EuroQol 5D, and the standard gamble. Patients were recruited from a regularly scheduled bariatric surgery interest group meeting associated with a large, university-based bariatric practice and administered a survey at the conclusion of the interest group. Logistic regression models were used to predict who pursued or still planned to pursue surgery at 12 months. Results 200 patients were recruited over an 8-month period. Mean age was 45 years; mean BMI was 48 kg/m 2 , and 77% were female. The 12-month follow-up rate was 95%. At 12 months, 33 patients (17.6%) had surgery and 30 (16.0%) still planned to have surgery. There was no association between age, gender, or obesity-associated conditions and surgery or plan to have surgery. Patients having surgery or still planning to have surgery had significantly worse scores for quality of life and better scores for decisional conflict (indicating readiness to make a decision). Conclusion The decision to have bariatric surgery is strongly associated with patientsʼ perceptions of their current quality of life. In addition, lower decisional conflict and higher self-efficacy are predictive of surgery. Interestingly, factors that clinicians might consider important, such as gender, age, and the presence of obesity-associated co-morbidities did not influence patientsʼ decisions.

Objective Study impact of health literacy on educational intervention for patients "Living with Coronary Artery Disease." Methods 187 patients were randomized to: VHS/DVD plus printed booklet; or booklet alone prior to scheduled visit. Main outcome measures included CAD knowledge assessment, clinical outcomes (weigh and blood pressure) and health behaviors (diet, exercise, and smoking); while functional health literacy was assessed as a possible predictor variable. Results Knowledge scores and health behaviors improved following both interventions. Those receiving the booklet and video also had a significant improvement in exercise, and weight loss. There was a trend ( p =0.07) towards greater improvement in test scores among those receiving the booklet plus video. Patients with lower health literacy benefited as much as higher literacy patients. Conclusions Incorporation of an educational program into clinical visits for patients with chronic disease improved disease-specific knowledge and prompted patients to become activated and involved in their care, improving health behaviors and outcomes. Lower health literacy was not a barrier to this beneficial effect. Practice implications Patients with lower health literacy may also benefit from educational, shared decision-making interventions.

Patient values and preferences are an important component to decision making when tradeoffs exist that impact quality of life, such as tradeoffs between stroke prevention and hemorrhage in patients with atrial fibrillation (AF) contemplating anticoagulant therapy. Our objective is to describe the development of an Atrial Fibrillation Guideline Support Tool (AFGuST) to assist the process of integrating patients' preferences into this decision.CHA2DS2VASc and HAS-BLED were used to calculate risks for stroke and hemorrhage. We developed a Markov decision analytic model as a computational engine to integrate patient-specific risk for stroke and hemorrhage and individual patient values for relevant outcomes in decisions about anticoagulant therapy.Individual patient preferences for health-related outcomes may have greater or lesser impact on the choice of optimal antithrombotic therapy, depending upon the balance of patient-specific risks for ischemic stroke and major bleeding. These factors have been incorporated into patient-tailored booklets which, along with an informational video, were developed through an iterative process with clinicians and patient focus groups.Current risk prediction models for hemorrhage, such as the HAS-BLED, used in the AFGuST, do not incorporate all potentially significant risk factors. Novel oral anticoagulant agents recently approved for use in the United States, Canada, and Europe have not been included in the AFGuST. Rather, warfarin has been used as a conservative proxy for all oral anticoagulant therapy.We present a proof of concept that a patient-tailored decision-support tool could bridge the gap between guidelines and practice by incorporating individual patient's stroke and bleeding risks and their values for major bleeding events and stroke to facilitate a shared decision making process. If effective, the AFGuST could be used as an adjunct to published guidelines to enhance patient-centered conversations about the anticoagulation management.

Bariatric surgery is being conducted more often for morbid obesity, but little evidence exists about how it affects the risk of future cardiovascular events. The goal of this study was to quantify the change in predicted 10-year cardiovascular risk following laparoscopic Roux-en-Y gastric bypass (LRYGBP).We conducted a prospective clinical study of morbidly obese adults undergoing LRYGBP at a university hospital in the USA. Our primary outcome measure was mean change in 10-year cardiovascular risk at 12 months. We estimated cardiovascular risk by using the Framingham risk equation, which calculates the absolute risk of cardiovascular events for patients with no known history of heart disease, stroke, or peripheral vascular disease by using information on age, sex, blood pressure, total and high-density lipoprotein cholesterol levels, smoking status, and history of diabetes.Ninety-two participants underwent LRYGBP between December 2004 and October 2005. Their predicted baseline 10-year cardiovascular risk was 6.7%. At 6 and 12 months, their predicted risk had decreased to 5.2% and 5.4%, respectively. Assuming no change in risk among untreated patients, this represents an absolute risk reduction of 1.3%; which suggests that 77 morbidly obese patients would have to undergo LRYGBP to avert one new case of cardiovascular disease over the ensuing 10 years (number needed to treat = 77).Our findings indicate that LRYGBP is associated with improvements in cardiovascular risk factors and a corresponding decrease in predicted 10-year risk of cardiovascular disease.