Sviluppo, design e valutazione dell’usabilità di un’interfaccia web amministrativa per il monitoraggio in tempo reale di studi clinici condotti con la piattaforma IMPACT

Grazie ai recenti sviluppi tecnologici, il mercato dei dispositivi indossabili è aumentato significativamente in tutto il mondo. I dispositivi indossabili hanno rivoluzionato la biomedicina grazie ai recenti avanzamenti nel campo della sanità digitale, permettendo non solo il monitoraggio continuo dei dati sullo status fisiologico dei pazienti in ambienti non clinici, ma consentendo anche di condurre studi clinici dedicati in modo da testare degli algoritmi per la gestione delle malattie. Per questo motivo è stata sviluppata la piattaforma Integrated Mobile Platform for Automated Clinical Trials (IMPACT). In questo elaborato andremo a riportare lo sviluppo dell’interfaccia web amministrativa di IMPACT. L’interfaccia è stata sviluppata utilizzando Flutter seguendo un approccio user-centrico e garantendo sicurezza e privacy. L’utilizzo della piattaforma è stato poi valutato tramite il System Usability Scale, mostrando ottimi risultati. Lavori futuri riguarderanno l’utilizzo della piattaforma in ambienti clinici reali.Thanks to the recent technological advancements, the wearable devices market has grown significantly all over the world. Wearable devices have revolutionized biomedicine leveraging the recent advances in the field of digital health, granting not only continuous data monitoring of patients’ physiological status in non-clinical environments, but also enabling to run dedicated clinical studies to test algorithms for the management of diseases. For this purpose, the Integrated Mobile Platform for Automated Clinical Trials (IMPACT) platform is being developed. In this elaborate we are going to report the development of the administrative web-based interface of IMPACT. The interface has been developed using Flutter following a user-centric approach and guaranteeing safety and privacy. Usability of the platform has been evaluated via the System Usability Scale showing good results. Future work will involve the deployment of the interface in a real clinical setting

Web-Based Electronic Data Collection System to Support Electrochemotherapy Clinical Trial

Abstract—Many branches of the healthcare industry are being influenced by information and communication technology (ICT). Clinical trials are not an exception. Despite this fact, more than 75 % of clinical trials data are being collected on paper records. Recent ICT advances, such as broad acceptance of Internet Technology which are rapidly improving electronic data collection (EDC) tools, however, may soon reduce this percentage of “paper ” supported clinical trials. In this paper, we present our Web-based EDC system designed to support a small-scale research-oriented clinical trial for establishing standard operating procedures (SOP) for electrochemotherapy with a new medical device, named Cliniporator. The definition of the SOP can only be based on a comprehensive analysis of collected data and results of clinical trial. Therefore, it is necessary to record treatment efficiency and, in this respect, to carefully follow and collect treatment parameters. We thus established central database and the Web application for filling database with data submitted by users from distant medical centers across Europe. Also, we enabled transmitting of data stored on the local Cliniporator medical devices to the central database as well as submitting of tumor images and marking of tumor nodules on interactive human map developed in Macromedia Flash. We provided users with dynamically generated basic statistics, and, several times during data collection process, we performed statistical data analysis. In order to assure high quality of data in a database, we included several mechanisms: automatic data validation, digital signatures, the form completeness notification system, e-mail alerting of completed forms, and “check tables. ” After 13 months of using the systems, we performed a simple usability evaluation of the system by asking users to answer to a questionnaire, and here we present the results. With this paper, we try to share our experience and encourage others to exploit Internet and Web technologies to improve clinical trials data collection, follow up, and data analysis. Index Terms—Clinical trial, computer applications, electronic data collection, Internet