ABSTRACT
BACKGROUND: Clinical trials often face challenges in efficient data collection and participant monitoring. To address these issues, we developed the IMPACT platform, comprising a real-time mobile application for data collection and a web-based dashboard for remote monitoring and management. METHODS: This article presents the design, development, and usability assessment of the IMPACT platform customized for patients with post-bariatric surgery hypoglycemia (PBH). We focus on adapting key IMPACT components, including continuous glucose monitoring (CGM), symptom tracking, and meal logging, as crucial elements for user-friendly and efficient PBH monitoring. RESULTS: The adapted IMPACT platform demonstrated effectiveness in data collection and remote participant monitoring. The mobile application allowed patients to easily track their data, while the clinician dashboard provided a comprehensive overview of enrolled patients, featuring filtering options and alert mechanisms for identifying data collection issues. The platform incorporated various visual representations, including time plots and category-based visualizations, which greatly facilitated data interpretation and analysis. The System Usability Scale questionnaire results indicated a high level of usability for the web dashboard, with an average score of 86.3 out of 100. The active involvement of clinicians throughout the development process ensured that the platform allowed for the collection and visualization of clinically meaningful data. CONCLUSIONS: By leveraging IMPACT's existing features and infrastructure, the adapted version streamlined data collection, analysis, and trial customization for PBH research. The platform's high usability underscores its alignment with the requirements for conducting research using continuous real-world data in PBH patients and other populations of interest.
ABSTRACT
AIMS: We aimed to prospectively investigate the effectiveness of a standardized follow-up for AF-detection after common atrial flutter (cAFL) ablation. METHODS: A total of 309 patients after cAFL ablation without known AF, from 5 centers, and at least one completed, standardized follow-up at 3, 6 and 12 months, including a 24 h Holter-electrocardiogram (ECG), were included. The primary outcome was incident atrial fibrillation (AF), or atrial tachycardia (AT). Predictors were investigated by Cox proportional-hazards models. RESULTS: The mean age was 67.9 years; 15.2% were female and the mean CHA2DS2-VASc (Congestive heart failure, Hypertension, Age, Diabetes, Stroke, Vascular disease, Sex category) score was 2.4 points. The great majority of patients (90.3%) were anticoagulated. Over a mean follow-up of 12.2 months with a standardized approach, AF/AT was detected in 73 patients, corresponding to 11.7% at 3 months, 18.4% at 6 months and 28.2% at 12 months of follow-up. AF was found in 64 patients, AT in 9 and both in 2 patients. Occurrence of AF was recorded in 40 (60.6%) patients by Holter-ECG and in the remaining 26 (39.4%) by clinical follow-up only. There was no difference in male versus female (p = 0.08), or in younger versus older patients (p = 0.96) for AF/AT detection. Only coronary artery disease (hazard ratio [95% confidence intervals] 1.03 [1.01-1.05], p = 0.01) was associated with the primary outcome. CONCLUSIONS: AF or AT was detected in a large proportion of cAFL patients after cavotricuspid-isthmus (CTI) ablation, using a standardized follow-up over 1 year. This standardized screening can be easily implemented with high patient acceptance. The high proportion of post-ablation AF needs to be taken into consideration when deciding on long-term oral anticoagulation.
