The primary endpoint was the validated 16-item Decisional Conflict Scale (DCS) at 1 month. Participants were randomized in a 1:1 ratio to either Usual Care (UC) or the SDM Toolkit. The study population included English or Spanish speakers with non-valvular AF and a CHA2DS2-VASc stroke score ≥1 for men or ≥2 for women. Available in English and Spanish, the toolkit included the following: 1) a brief animated video 2) interactive questions with answers 3) a quiz to check on understanding 4) a worksheet to be used by the patient during the encounter and 5) an online guide for clinicians. The digital AF SDM Toolkit was developed using patient-centered design with clear health communication principles (e.g. Methods and Results We designed and evaluated a new digital decision aid in a multicenter, randomized, comparative effectiveness trial, ENHANCE-AF (Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AF Stroke Prevention). We evaluated the effects of a novel patient-clinician shared decision-making (SDM) tool in reducing OAC patient's decisional conflict as compared to usual care. 2022 : E582-E583īackground Oral anticoagulation (OAC) reduces stroke and disability in atrial fibrillation (AF) but is underutilized. J., Sanders, L., Turakhia, M., Stafford, R. T., Berube, C., Pundi, K., Baykaner, T., Garay, G., Lhamo, K., Rice, E., Shah, R., Newswanger, P., DeSutter, K., Nunes, J., Albert, M. Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared DecisionMaking Pathway Wang, P.The proposed method is illustrated via real data examples on anaphylaxis and examined by extensive simulationstudies. More importantly, we proposed to construct a confidence interval for the relative AE risk between the exposed and control groups at the end of the study, which can be used to quantify the safety of the vaccine. In this paper, we proposed a new group sequential test procedure fully accounting for both seasonality and variation from the historical controls. Furthermore, not rejecting the null could be due to a lack of power and cannot always be interpreted as proof of safety. Such an approach doesn't account for either the variation in determining the reference risk from a control population or the seasonality effect. If the null hypothesis is never rejected, the vaccine is considered safe. When the number of AEs is "too high", a safety signal is identified. Specifically, it compares the post-vaccination incidence of adverse event (AE) in a vaccinated population with a pre-specified reference level by sequentially conducting hypothesis testing during the surveillance. The group sequential analysis is a common method employed in safety surveillance. Post-market active safety monitoring is important for the timely capture of safety signals associated with exposure to a new vaccine or drug. Vice Provost for Undergraduate Education.Office of Vice President for Business Affairs and Chief Financial Officer.Office of VP for University Human Resources.Stanford Woods Institute for the Environment.Stanford Institute for Economic Policy Research (SIEPR).Institute for Stem Cell Biology and Regenerative Medicine.Institute for Human-Centered Artificial Intelligence (HAI).Institute for Computational and Mathematical Engineering (ICME).
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