Aims
We aimed to analyze prevalence and predictors of NOAC off-label under-dosing in AF patients before and after the index stroke.
Methods
The post hoc analysis included 1080 patients of the investigator-initiated, multicenter prospective Berlin Atrial Fibrillation Registry, designed to analyze medical stroke prevention in AF patients after acute ischemic stroke.
Results
At stroke onset, an off-label daily dose was prescribed in 61 (25.5%) of 239 NOAC patients with known AF and CHA2DS2-VASc score ≥ 1, of which 52 (21.8%) patients were under-dosed. Under-dosing was associated with age ≥ 80 years in patients on rivaroxaban [OR 2.90, 95% CI 1.05–7.9, P = 0.04; n = 29] or apixaban [OR 3.24, 95% CI 1.04–10.1, P = 0.04; n = 22]. At hospital discharge after the index stroke, NOAC off-label dose on admission was continued in 30 (49.2%) of 61 patients. Overall, 79 (13.7%) of 708 patients prescribed a NOAC at hospital discharge received an off-label dose, of whom 75 (10.6%) patients were under-dosed. Rivaroxaban under-dosing at discharge was associated with age ≥ 80 years [OR 3.49, 95% CI 1.24–9.84, P = 0.02; n = 19]; apixaban under-dosing with body weight ≤ 60 kg [OR 0.06, 95% CI 0.01–0.47, P < 0.01; n = 56], CHA2DS2-VASc score [OR per point 1.47, 95% CI 1.08–2.00, P = 0.01], and HAS-BLED score [OR per point 1.91, 95% CI 1.28–2.84, P < 0.01].
Conclusion
At stroke onset, off-label dosing was present in one out of four, and under-dosing in one out of five NOAC patients. Under-dosing of rivaroxaban or apixaban was related to old age. In-hospital treatment after stroke reduced off-label NOAC dosing, but one out of ten NOAC patients was under-dosed at discharge.
Clinical trial registration
NCT02306824.
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
In this paper, we describe a proof-of-concept for the implementation of a wearable auditory biofeedback system based on a sensor-instrumented insole. Such a system aims to assist everyday users with static and dynamic exercises for gait rehabilitation interventions by providing auditory feedback based on plantar pressure distribution and automated classification of functional gait disorders. As ground reaction force (GRF) data are frequently used in clinical practice to quantitatively describe human motion and have been successfully used for the classification of gait patterns into clinically relevant classes, a feed-forward neural network was implemented on the firmware of the insoles to estimate the GRFs using pressure and acceleration data. The estimated GRFs approximated well the GRF measurements obtained from force plates. To distinguish between physiological gait and gait disorders, we trained and evaluated a support vector machine with labeled data from a publicly accessible dataset. The automated gait classification was then sonified for auditory feedback. The potential of the implemented auditory feedback for preventive and supportive applications in physical therapy was finally assessed with both expert and non-expert participants. A focus group revealed experts’ expectations for the proposed system, while a usability study assessed the clarity of the auditory feedback to everyday users. The evaluation shows promising results regarding the usefulness of our system in this application area.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.