Personalized and longitudinal electronic informed consent in clinical trials: How to move the needle?

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.

Testing and Practical Implementation of a User-Friendly Personalized and Long-Term Electronic Informed Consent Prototype in Clinical Research: Mixed Methods Study.

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.

Using provocative design to foster electronic informed consent innovation.

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.

Co-creation with research participants to inform the design of electronic informed consent.

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.

Personalized and long-term electronic informed consent in clinical research: stakeholder views.

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.

From Initial Encounter With Mid-Air Haptic Feedback to Repeated Use: The Role of the Novelty Effect in User Experience.

Mid-air haptic (MAH) feedback is an interesting means to provide augmented haptic feedback for gesture-based technology as it enables a sense of touch without physical contact with an actuator. Although quite some work already investigated the user experience (UX) of MAH feedback during initial encounter, we are not aware of studies testing the UX after repeated use, with regard to both pragmatic and hedonic UX, as well as emotional reactions. In this article, we tested how the UX of MAH feedback changed over the course of five weeks by collecting both questionnaire as well as interview data of 31 participants. Our results showed that MAH feedback significantly increased the enjoyment, engagement, valence and arousal of the emotional response. However, the added value of valence was due to a novelty effect as it was only significantly elevated during initial use, and not after repeated use. Interestingly, the added value of MAH feedback in terms of enjoyment, engagement and arousal remained elevated over the course of five weeks. Moreover, the interview data hinted at substantial individual differences underlying the global trends from the questionnaire data, showing the importance of combining quantitative and qualitative data when testing the UX of MAH feedback.

Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders' Perspectives: Systematic Review.

BACKGROUND: Informed consent is one of the key elements in biomedical research. The introduction of electronic informed consent can be a way to overcome many challenges related to paper-based informed consent; however, its novel opportunities remain largely unfulfilled due to several barriers. OBJECTIVE: We aimed to provide an overview of the ethical, legal, regulatory, and user interface perspectives of multiple stakeholder groups in order to assist responsible implementation of electronic informed consent in biomedical research. METHODS: We conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library, and PsycARTICLES. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for reporting this work. We included empirical full-text studies focusing on the concept of electronic informed consent in biomedical research covering the ethical, legal, regulatory, and user interface domains. Studies written in English and published from January 2010 onward were selected. We explored perspectives of different stakeholder groups, in particular researchers, research participants, health authorities, and ethics committees. We critically appraised literature included in the systematic review using the Newcastle-Ottawa scale for cohort and cross-sectional studies, Critical Appraisal Skills Programme for qualitative studies, Mixed Methods Appraisal Tool for mixed methods studies, and Jadad tool for randomized controlled trials. RESULTS: A total of 40 studies met our inclusion criteria. Overall, the studies were heterogeneous in the type of study design, population, intervention, research context, and the tools used. Most of the studies' populations were research participants (ie, patients and healthy volunteers). The majority of studies addressed barriers to achieving adequate understanding when using electronic informed consent. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an electronic informed consent platform and usability for specific groups of research participants. CONCLUSIONS: Electronic informed consent has the potential to improve the informed consent process in biomedical research compared to the current paper-based consent. The ethical, legal, regulatory, and user interface perspectives outlined in this review might serve to enhance the future implementation of electronic informed consent. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42020158979; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=158979.

Shedding light on an unknown reality in solid organ transplant patients' self-management: A contextual inquiry study.

Traditional quantitative and qualitative research methods inadequately capture the complexity of patients' daily self-management. Contextual inquiry methodology, using home visits, allows a more in-depth understanding of how patients integrate immunosuppressive medication intake, physical activity, and healthy eating in their daily lives, and which difficulties they experience when doing so. This mixed-method study comprised 2 home visits in 19 purposively selected adult heart, lung, liver, and kidney transplant patients, asking them to demonstrate how they implement the aforementioned health behaviors. Meanwhile, conversations were audio-taped and photographs were taken. Audio-visual materials were coded using directed content analysis. Difficulties and supportive strategies were identified via inductive thematic analysis. We learned that few patients understood what "sufficiently active" means. Physical discomforts and poor motivation created variation across activity levels observed. Health benefits of dietary guidelines were insufficiently understood, and their implementation into everyday life considered difficult. Many underestimated the strictness of immunosuppressive medication intake, and instructions on handling late doses were unclear. Interruptions in routine and busyness contributed to nonadherence. We also learned that professionals often recommend supportive strategies, which patients not always like or need. This contextual inquiry study revealed unique insights, providing a basis for patient-tailored self-management interventions.

Technology Experience of Solid Organ Transplant Patients and Their Overall Willingness to Use Interactive Health Technology.

BACKGROUND: The use of interactive health technology (IHT) is a promising pathway to tackle self-management problems experienced by many chronically ill patients, including solid organ transplant (Tx) patients. Yet, to ensure that the IHT is accepted and used, a human-centered design process is needed, actively involving end users in all steps of the development process. A first critical, predevelopment step involves understanding end users' characteristics. This study therefore aims to (a) select an IHT platform to deliver a self-management support intervention most closely related to Tx patients' current use of information and communication technologies (ICTs), (b) understand Tx patients' overall willingness to use IHT for self-management support, and investigate associations with relevant technology acceptance variables, and (c) explore Tx patients' views on potential IHT features. DESIGN AND METHODS: We performed a cross-sectional, descriptive study between October and December 2013, enrolling a convenience sample of adult heart, lung, liver, and kidney Tx patients from the University Hospitals Leuven, Belgium. Broad inclusion criteria were applied to ensure a representative patient sample. We used a 35-item newly designed interview questionnaire to measure Tx patients' use of ICTs, their overall willingness to use IHT, and their views on potential IHT features, as well as relevant technology acceptance variables derived from the Unified Theory of Acceptance and Use of Technology and a literature review. Descriptive statistics were used as appropriate, and an ordinal logistic regression model was built to determine the association between Tx patients' overall willingness to use IHT, the selected technology acceptance variables, and patient characteristics. FINDINGS: Out of 139 patients, 122 agreed to participate (32 heart, 30 lung, 30 liver, and 30 kidney Tx patients; participation rate: 88%). Most patients were male (57.4%), married or living together (68%), and had a mean age of 55.9 ± 13.4 years. Only 27.9% of Tx patients possessed a smartphone, yet 72.1% owned at least one desktop or laptop PC with wireless Internet at home. On a 10-point numeric scale, asking patients whether they think IHT development is important to support them personally in their self-management, patients gave a median score of 7 (25th percentile 5 points; 75th percentile 10 points). Patients who were single or married or living together were more likely to give a higher rating than divorced or widowed patients; patients who completed only secondary education gave a higher rating than higher educated patients; and patients with prior ICT use gave a higher rating than patients without prior ICT use. Tx patients also had clear preferences regarding IHT features, such as automatic data transfer, as much as possible, visual aids (e.g., graphs) over text messages, and personally deciding when to access the IHT. CONCLUSIONS: By investigating Tx patients' possession and use of ICTs, we learned that computers and the Internet, and not smartphones, are the most suitable IHT platforms to deliver self-management interventions for our Tx patients. Moreover, Tx patients generally are open to using IHT, yet patient acceptance variables and their preferences for certain IHT features should be taken into account in the next steps of IHT development. Designers intending to develop or use existing IHTs should never overlook this critical first step in a human-centered design. CLINICAL RELEVANCE: Before considering using eHealth technology in clinical practice, professionals should always check whether patients are familiar with using information and communication technology, and whether they are willing to use technology for health-related purposes.