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"Geerts, David"
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Personalized and long-term electronic informed consent in clinical research: stakeholder views
by
Geerts, David
,
Borry, Pascal
,
De Sutter, Evelien
in
Access control
,
Clinical trials
,
Computer mediated communication
2021
Background
The landscape of clinical research has evolved over the past decade. With technological advances, the practice of using electronic informed consent (eIC) has emerged. However, a number of challenges hinder the successful and widespread deployment of eIC in clinical research. Therefore, we aimed to investigate the views of various stakeholders on the potential advantages and challenges of eIC.
Methods
Semi-structured interviews were conducted with 39 participants from 5 stakeholder groups from across 11 European countries. The stakeholder groups included physicians, patient organization representatives, regulator representatives, ethics committee members, and pharmaceutical industry representatives, and all were involved in clinical research. Interviews were analyzed using the framework method.
Results
Interviewees identified that a powerful feature of eIC is its personalized approach as it may increase participant empowerment. However, they identified several ethical and practical challenges, such as ensuring research participants are not overloaded with information and offering the same options to research participants who would prefer a paper-based informed consent rather than eIC. According to the interviewees, eIC has the potential to establish efficient long-term interactions between the research participants and the research team in order to keep the participants informed during and after the study. Interviewees emphasized that a personal interaction with the research team is of utmost importance and this cannot be replaced by an electronic platform. In addition, interviewees across the stakeholder groups supported the idea of having a harmonized eIC approach across the European Member States.
Conclusions
Interviewees reported a range of design and implementation challenges which needs to be overcome to foster innovation in informing research participants and obtaining their consent electronically. It was considered important that the implementation of eIC runs alongside the face-to-face contact between research participants and the research team. Moreover, interviewees expect that eIC could offer the opportunity to enable a personalized approach and to strengthen continuous communication over time. If successfully implemented, eIC may facilitate the engagement of research participants in clinical research.
Journal Article
Testing and Practical Implementation of a User-Friendly Personalized and Long-Term Electronic Informed Consent Prototype in Clinical Research: Mixed Methods Study
by
Barbier, Liese
,
Borry, Pascal
,
Huys, Isabelle
in
Application
,
Citizen participation
,
Clinical research
2023
Over the years, there has been increasing interest in electronic informed consent (eIC) in clinical research. The user-friendliness of an eIC application and its acceptance by stakeholders plays a central role in achieving successful implementation.
This study aims to identify insights for the design and implementation of a user-friendly, personalized, and long-term eIC application based on a usability study with (potential) research participants and semistructured interviews with stakeholders on the practical integration of such an application into their daily practice.
An eIC prototype was evaluated and refined through usability testing among Belgian citizens and iterative redesign. On the basis of a digital literacy questionnaire, a heterogeneous sample of participants was established. Participants needed to complete a series of usability tasks related to personalization and long-term interaction with the research team while using the \"think aloud\" technique. In addition, usability tests involved completing the System Usability Scale questionnaire and taking part in a semistructured feedback interview. Furthermore, semistructured interviews were conducted with ethics committee members, health care professionals, and pharmaceutical industry representatives active in Belgium and involved in clinical research. Thematic analysis was undertaken using the NVivo software (Lumivero).
In total, 3 iterations of usability tests were conducted with 10 participants each. Each cycle involved some participants who reported having low digital skills. The System Usability Scale scores related to the tasks on personalization and long-term interaction increased after each iteration and reached 69.5 (SD 8.35) and 71.3 (SD 16.1) out of 100, respectively, which represents above-average usability. Semistructured interviews conducted with health care professionals (n=4), ethics committee members (n=8), and pharmaceutical industry representatives (n=5) identified the need for an eIC system that can be easily set up. For example, a library could be established enabling stakeholders to easily provide background information about a clinical study, presented in the second layer of the interface. In contrast, some functionalities, such as informing participants about new studies through an eIC system, were not considered useful by stakeholders.
This study provides insights for the implementation of a user-friendly personalized and long-term eIC application. The study findings showed that usability testing is key to assessing and increasing the user-friendliness of an eIC application. Although this eIC system has the potential to be usable by a wide audience, participants with low digital literacy may not be able to use it successfully, highlighting the need for additional support for participants or other alternatives to an eIC system. In addition, key lessons emerging from the interviews included ensuring that the application is easy to implement in practice and is interoperable with other established systems.
Journal Article
Analytically estimating the efficiency of high temperature aquifer thermal energy storage
by
Geerts, David
,
Kramer, Gert Jan
,
Bloemendal, Martin
in
Analytical approach
,
Aquifers
,
Curve fitting
2025
High-Temperature Aquifer Thermal Energy Storage (HT-ATES) can be used to reduce greenhouse gas emissions from heating. The thermal recovery efficiency is the main parameter indicating the performance of an HT-ATES system and it is influenced by multiple aquifer properties and storage characteristics. This study presents a method for estimating recovery efficiency through numerical modeling, data analysis, and curve fitting. This method shows the relation between the recovery efficiency and various storage conditions, such as aquifer properties and storage temperature. In addition, this research explores an analytical relationship between energetic efficiency and recovery efficiency and verifies that relationship with the generated data. The proposed method can be used for the purpose of initial screening to estimate the performance of an HT-ATES system and for efficiently using HT-ATES as a component in larger energy system models. This method uses the modified Rayleigh number in combination with aquifer thickness and injected volume and has a
R
2
of 85%. The analytical relation between energetic efficiency and recovery efficiency was shown to be accurate for all calculated energetic efficiency values above 60% and is less accurate with lower calculated energetic efficiency values.
Journal Article
Charge Scheduling of Electric Vehicle Fleets: Maximizing Battery Remaining Useful Life Using Machine Learning Models
by
Geerts, David
,
Medina, Róbinson
,
van Sark, Wilfried
in
Algorithms
,
Automobiles, Electric
,
battery electric vehicles
2024
Reducing greenhouse emissions can be done via the electrification of the transport industry. However, there are challenges related to the electrification such as the lifetime of vehicle batteries as well as limitations on the charging possibilities. To cope with some of these challenges, a charge scheduling method for fleets of electric vehicles is presented. Such a method assigns the charging moments (i.e., schedules) of fleets that have more vehicles than chargers. While doing the assignation, the method also maximizes the total Remaining Useful Life (RUL) of all the vehicle batteries. The method consists of two optimization algorithms. The first optimization algorithm determines charging profiles (i.e., charging current vs time) for individual vehicles. The second algorithm finds the charging schedule (i.e., the order in which vehicles are connected to a charger) that maximizes the RUL in the batteries of the entire fleet. To reduce the computational effort of predicting the battery RUL, the method uses a Machine Learning (ML) model. Such a model predicts the RUL of an individual battery while taking into account common stress factors and fabrication-related differences per battery. Simulation results show that charging a single vehicle as late as possible maximizes the RUL of that single vehicle, due to the lower battery degradation. Simulations also show that the ML model accurately predicts the RUL, while taking into account fabrication-related variability in the battery. Additionally, it was shown that this method schedules the charging moments of a fleet, leading to an increased total RUL of all the batteries in the vehicle fleet.
Journal Article
Use and User Experience of a Preconception Lifestyle App for Couples Undergoing in Vitro Fertilization: Mixed Methods Study
2025
Mobile apps are a promising way to improve healthy lifestyle behavior among people with infertility. However, sufficient engagement with mobile health apps is crucial to influence health outcomes, and identifying features to create more effective interventions is urgently needed.
This study conducted a process evaluation focusing on the use and user experience of the PreLiFe app, a mobile lifestyle app for couples undergoing in vitro fertilization (IVF).
A mixed methods approach was used among heterosexual couples with infertility undergoing IVF. An objective quantitative study using a tracking-based system assessed the actual use of the PreLiFe app over time in relation to partner use and in relation to the specific fertility treatment. A subjective quantitative study using online questionnaires assessed the acceptability (using the Mobile App Rating Scale) and partner support (based on the Social Support for Diet and Exercise Scale) experienced while using the PreLiFe app. A subjective qualitative study using semistructured interviews evaluated in-depth user experiences with the PreLiFe app.
A total of 106 couples used the PreLiFe app for 2 to 365 days. Overall use was low; 18.9% (20/106) of the men and 49.1% (52/106) of the women used all the modules of the PreLiFe app. Mixed-model analyses revealed that higher app use was observed when a partner used the app as well and during fertility treatment. The average acceptability score was 6 (SD 1) of 10, and patients felt supported by their partners while using the app. Semistructured interviews with 10 patients indicated that the PreLiFe app was easy to use.
Our findings showed good acceptability and user experiences but low actual objective use of a preconception lifestyle app for couples undergoing IVF. To increase use of and engagement with such apps, future studies should further focus on personalization and interaction with partners, health care providers, and other patient data systems.
Journal Article
Personalized and longitudinal electronic informed consent in clinical trials: How to move the needle?
2024
Changes in the clinical trials landscape have been driven by advancements in digital technology. The use of electronic informed consent to inform research participants and to obtain their consent electronically has the potential to improve participant–researcher interactions over time, facilitate clinical trial participation, and increase efficiency in clinical trial conduct. A personalized electronic informed consent platform that enables long-term interactions with the research team could function as a tool to empower participant engagement in clinical trials. However, significant challenges persist impeding successful and widespread implementation. This Perspective provides insights into the opportunities and challenges for the implementation of electronic informed consent in clinical trials. It sets out key recommendations to promote the implementation of this innovative approach to the informed consent process, including the creation of uniform electronic informed consent platforms at regional and national level.
Journal Article
Using provocative design to foster electronic informed consent innovation
2022
Background
The development of technological applications in clinical research, such as electronic informed consent (eIC), is on the rise. The involvement of end users throughout the design process of eIC is of utmost importance to improve the current informed consent process.
Methods
Using a provocative design, we conducted interviews with 30 clinical research participants. Provotypes were used as a starting base to discuss various aspects relevant to eIC. By providing a medium to encourage divergent thinking, participants’ views and concerns were solicited. Thematic analysis was undertaken using NVivo.
Results
The majority of participants placed trust in the principal investigator or the hospital to perform the role of eIC hosting party. Differing opinions were reported on the amount of information required related to stakeholders’ access to an eIC system, and thus, to participants’ personal data, to enable trust in an eIC system. Nevertheless, this study indicates a general willingness of participants to share personal data with physicians and pharmaceutical companies on an international level, and to receive requests for new research studies via an eIC system. Participants suggested to tailor an eIC system based upon their preferences, for example, regarding whom they want to share their personal data with. Moreover, they expressed a desire to choose how they can contact the research team, and to indicate which study-related information they would like to receive electronically. In addition, positive opinions were voiced on the integration of a test to assess participants’ understanding before providing their eIC.
Conclusions
Following a research through design approach, insights have been generated which inform the design of eIC. Provotypes were designed to help participants think beyond what is familiar to them. Study findings revealed that not all situations were perceived as provocative, because of participants’ motivation to advance scientific research and the trust they place in the research team. Nevertheless, the use of provocative design resulted in additional insights, generated by clinical research participants, which could be considered in the further design of eIC.
Journal Article
Co-creation with research participants to inform the design of electronic informed consent
2022
Objective
This study aimed to provide recommendations for a personalized electronic informed consent interface that is adapted to research participants’ needs and could enable a longitudinal interaction between the participants and the research team.
Methods
The co-creation process consisted of three co-creation workshops, one focus group discussion, and four semi-structured interviews. In total, 24 participants, who had taken part in four disparate clinical studies in Belgium, were involved. Descriptive statistics and qualitative content analysis were applied to analyze the survey data and audio recordings.
Results
Varying perceptions on the type and amount of information described in an informed consent form were reported. Other findings were related to the structure and presentation of information, setting preferences for data sharing, and electronically signing new informed consent versions. Regarding the long-term interaction, most of the participants wanted to receive progress updates, including the results, of the study in which they had taken part. They proposed to receive a notification, preferably via email, in case new information is made available on the electronic informed consent interface.
Conclusions
To optimally support the design of an electronic informed consent interface, it is key to understand the research participants’ needs. Study findings suggest that an electronic informed consent interface may be a promising technological application to interactively provide study-related information and to keep participants informed during and after the clinical study.
Journal Article
Social experiences within the home using second screen TV applications
by
Geerts, David
,
Vanattenhoven, Jeroen
in
Computer Communication Networks
,
Computer Science
,
Data Structures and Information Theory
2017
Today, using second screen devices while watching TV is quite common, whether related to what happens on TV or not. One area of research looks at using second screen devices to support social interaction. While most research in this area focuses on supporting social interaction between remote viewers, in this article, we focus on social interaction between collocated viewers, using second screen applications that were designed for a specific TV program. We present the results of five studies that were carried out in three different phases of a user-centered design cycle (analysis, design and evaluation) and report on the social interaction that occurs when groups of viewers use such applications in the home and on the factors that have an influence on this social experience. Based on these findings we formulate a number of guidelines for the design of social second screen applications. We found that most participants valued such applications because of the increased interactivity and the social experience. Furthermore, applications that incorporate some form of competition are especially compelling. However, care needs to be taken when introducing competitive elements into an application and when choosing a suitable TV genre.
Journal Article