Wearable devices and digital health technologies have enabled the exchange of urgent clinical trial information. We developed an application to improve the functioning of decentralized clinical trials and performed a heuristic evaluation to reflect the user demands of existing clinical trial workers. The waterfall model of the software life cycle was used to guide the development. Focus group interviews (N = 7) were conducted to reflect the needs of clinical research professionals, and Wizard of Oz prototyping was performed to ensure high usability and completeness. Unit tests and heuristic evaluation (N = 11) were used. Thematic analysis was performed using the focus group interview data. Based on this analysis, the main menu was designed to include health management, laboratory test results, medications, concomitant medications, adverse reactions, questionnaires, meals, and My Alarm. Through role-playing, the functions and configuration of the prototype were adjusted and enhanced, and a heuristic evaluation was performed. None of the heuristic evaluation items indicated critical usability errors, suggesting that the revised prototype application can be practically applied to clinical trials. The application is expected to increase the efficiency of clinical trial management, and the development process introduced in this study will be helpful for researchers developing similar applications in the future.

Monitoring cerebral circulation during cardiopulmonary resuscitation (CPR) is essential to improve patients’ prognosis and quality of life. We assessed the feasibility of non-invasive electroencephalography (EEG) parameters as predictive factors of cerebral resuscitation in a ventricular fibrillation (VF) swine model. After 1 min untreated VF, four cycles of basic life support were performed and the first defibrillation was administered. Sustained return of spontaneous circulation (ROSC) was confirmed if a palpable pulse persisted for 20 min. Otherwise, one cycle of advanced cardiovascular life support (ACLS) and defibrillation were administered immediately. Successfully defibrillated animals were continuously monitored. If sustained ROSC was not achieved, another cycle of ACLS was administered. Non-ROSC was confirmed when sustained ROSC did not occur after 10 ACLS cycles. EEG and hemodynamic parameters were measured during experiments. Data measured for approximately 3 s right before the defibrillation attempts were analyzed to investigate the relationship between the recovery of carotid blood flow (CBF) and non-invasive EEG parameters, including time- and frequency-domain parameters and entropy indices. We found that time-domain magnitude and entropy measures of EEG correlated with the change of CBF. Further studies are warranted to evaluate these EEG parameters as potential markers of cerebral circulation during CPR.

Treatment adherence is an underestimated determinant of treatment success. Poor treatment adherence can also affect the efficacy of clinical trials. A combination of multiple adherence‐monitoring methods is required to ensure robustness. We investigated whether multiple adherence‐monitoring methods, including a novel smartwatch‐based monitoring method, would yield reliable and concordant results. In this open, randomized, decentralized clinical trial, vitamin D‐deficient individuals were randomized to an App − only group (an electronic medication diary) or an App + Watch group (i.e., App and smartwatch‐based monitoring) groups after a week run‐in period. The participants received vitamin D supplements (1000 IU) for 12 weeks (two consecutive periods of 6 weeks) with two pill counts (at the sixth week) and biweekly blood samplings for serum 25(OH) vitamin D concentration. Adherence was assessed and compared between the methods. Sixteen participants were enrolled, of which 13 completed the study. Serum 25(OH) vitamin D levels comparably increased in both groups until the first 7 weeks but trended higher in the App + Watch group in the second period. The number of doses recorded by the pill count and App did not differ significantly between the run‐in and Period 1 (p = 0.5534) but became significantly discrepant in Period 2 (p = 0.0225). In contrast, the concordance for smartwatch‐based monitoring was consistent in either period (p = 0.5898 and p = 0.5839, respectively). We explored multiple adherence‐monitoring methods in this pilot feasibility clinical study. Smartwatch‐based adherence monitoring may be an objective and sensitive method for measuring treatment adherence.

The analysis of the electrocardiogram (ECG) is critical for the diagnosis of arrhythmias. Recent advances in information and communications technology (ICT) have led to the development of wearable ECG devices and arrhythmia-detection algorithms. This study aimed to develop an ICT-based clinical trial service platform using a self-reporting technique for real-time arrhythmia detection. To establish a clinical-trial service platform, a mobile application (app), a demilitarized zone (DMZ), an internal network, and Amazon web services virtual private cloud (AWS-VPC) were developed. The ECG data acquired by a wearable device were transmitted to the mobile app, which collected the participants’ self-reported information. The mobile app transmitted raw ECG and self-reported data to the AWS-VPC and DMZ, respectively. In the AWS-VPC, the live-streaming and playback-reviewer services were operational to display the currently and previously acquired ECG data to clinicians through the web client. All the measured data were transmitted to the internal network, in which the arrhythmia-detection algorithm was executed and all the data were saved. The self-reporting technique and arrhythmia-detection algorithm are the key elements of this platform. In particular, subjective information of participants can be easily collected using a self-reporting technique. These features are particularly of critical importance for treating painless, sparsely occurring arrhythmias.

Continuous and non-invasive measurement of intracranial pressure (ICP) in traumatic brain injury (TBI) is important to recognize increased ICP (IICP), which can reduce treatment delays. The purpose of this study was to develop an electroencephalogram (EEG)-based prediction model for IICP in a porcine TBI model. Thirty swine were anaesthetized and underwent IICP by inflating a Foley catheter in the intracranial space. Single-channel EEG data were collected every 6 min in 10 mmHg increments in the ICP from baseline to 50 mmHg. We developed EEG-based models to predict the IICP (equal or over 25 mmHg) using four algorithms: logistic regression (LR), naive Bayes (NB), support vector machine (SVM), and random forest (RF). We assessed the performance of each model based on the accuracy, sensitivity, specificity, and AUC values. The accuracy of each prediction model for IICP was 0.773 for SVM, 0.749 for NB, 0.746 for RF, and 0.706 for LR. The AUC of each model was 0.860 for SVM, 0.824 for NB, 0.802 for RF, and 0.748 for LR. We developed a machine learning prediction model for IICP using single-channel EEG signals in a swine TBI experimental model. The SVM model showed good predictive power with the highest AUC value.