A Digital Decision Support Tool to Enhance Decisional Capacity for Clinical Trial Consent: Design and Development

Furberg, Robert; Ortiz, Alexa; Moultrie, Rebecca; Raspa, Melissa; Wheeler, Anne; McCormack, Lauren; Bailey, Donald B.

doi:10.2196/10525

Cited by 21 publications

(49 citation statements)

References 18 publications

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“…A range of aspects related to the format were identified in the literature review. The majority of research participants, researchers, members of the ethics committee as well as health authorities believed that the ability to incorporate audio, video, or graphics in electronic informed consent is a distinct benefit, especially for vulnerable groups [ 15 , 16 , 28 , 33 , 39 , 43 , 45 , 47 - 49 , 57 ]. Patients who were older adults, for example, expressed the usefulness of graphics and audio [ 45 ].…”

Section: Resultsmentioning

confidence: 99%

“…Important to consider is the length of the video, since research participants highlighted that a 5-minute video was too long [ 33 ]. The use of graphics, including icons, was appreciated by all involved stakeholder groups [ 15 , 16 , 28 , 39 , 43 , 45 , 47 - 49 , 57 ]. For instance, the implementation of a progress bar was advised by researchers to indicate the different steps of the electronic informed consent form [ 43 ].…”

Section: Resultsmentioning

confidence: 99%

“…A pilot study [ 48 ] involving children highlighted the entertainment of graphics, making the electronic informed consent platform a pleasure to use. On the contrary, adult patients with fragile X syndrome, a genetic disorder causing intellectual impairment, had difficulty understanding aspects of clinical research such as blinding and randomization explained by several animations [ 47 ].…”

Section: Resultsmentioning

confidence: 99%

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

Sutter¹,

Zaçe²,

Boccia³

et al. 2020

J Med Internet Res

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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

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

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

Sutter¹,

Zaçe²,

Boccia³

et al. 2020

J Med Internet Res

View full text Add to dashboard Cite

show abstract

“…A small number of interventions have been developed to promote informed decision-making about participation in clinical trials [20][21][22]. Of the small number of DAs that aim to improve decisionmaking for trial participation (rather than aiming to improve the presentation of information or mode of delivery) most focus on specific oncology trials [23].…”

Section: Methodsmentioning

confidence: 99%

Development of a decision support intervention for family members of adults who lack capacity to consent to trials

Shepherd

Wood

Griffith

et al. 2019

Preprint

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Background Informed consent is required for participation in clinical trials, however trials involving adults who lack capacity to consent require different enrolment processes. A family member usually acts as a proxy to make a decision based on the patient’s ‘presumed will’, but they can experience an emotional and decisional burden as a result. Decisions made on behalf of others are conceptually different from those we make for ourselves. Despite innovations to improve informed consent processes for research, including the development of decision aids, there are no interventions for proxies who arguably are faced with more complex decisions. This article outlines the development of a novel decision aid aimed at supporting families making decisions about research participation on behalf of an adult who lacks capacity to consent. Methods Decision support interventions should be developed using rigorous and evidence-based methods. This intervention was developed using the MRC guidance for the development of complex interventions, and a conceptual framework for the development and evaluation of decision aids for people considering taking part in a clinical trial. The intervention was informed by a systematic review and analysis of existing information provision. Previous qualitative research with families who had acted as proxies enabled the development of a theoretical framework to underpin the intervention. The intervention was iteratively developed in conjunction with lay advisors and relevant stakeholders. Results Previous research, theoretical frameworks, and decision aid development frameworks were used to identify and develop the intervention components. The decision aid includes information about the proxy’s role and uses a values clarification exercise and decision support methods to enable a more informed and better-quality decision. Stakeholders, including those representing implementers and receivers of the intervention, contributed to the design and comprehensibility of the decision aid and helped to ensure that it would be acceptable for use. Conclusions Frameworks for the development of decision aids for people considering participating in a clinical trial can be used to develop interventions for family members acting as proxy decision-makers. The decision support tool is acceptable to users but requires feasibility testing and outcome measure development prior to any evaluation of its effectiveness.

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“…Discussions have emerged about how best to design and execute informed consent processes using portable electronic devices and mobile phones (12,14,15) particularly for population-wide studies. In-roads have been made in designing digital informed consent models for clinical care and research (16) but little is documented regarding consent for MPS designed to inform public health policies and practices in LMICs.…”

Section: Original Articlementioning

confidence: 99%

Consent for mobile phone surveys of non-communicable disease risk factors in low-resource settings: an exploratory qualitative study in Uganda

Mwaka¹,

Nakigudde²,

Ali³

et al. 2019

mHealth

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Background: Lack of data for timely decision-making around the prevention and control of noncommunicable diseases (NCDs) presents special challenges for policy makers, especially in resource-limited settings. New data collection methods, including pre-recorded Interactive Voice Response (IVR) phone surveys, are being developed to support rapid compilation of population-level disease risk factor information in such settings. We aimed to identify information that could be used to optimize consent approaches for future mobile phone surveys (MPS) employed in Uganda and, possibly, similar contexts. Methods:We conducted an in-depth qualitative study with key stakeholders in Uganda about consent approaches, and potential challenges, for pre-recorded IVR NCD risk factor surveys. Semi-structured interviews were conducted with 14 key informants. A contextualized thematic approach was used to interpret the results supported by representative quotes.Results: Several potential challenges in designing consent approaches for MPS were identified, including low literacy and the lack of appropriate ways of assessing comprehension and documenting consent.Communication with potential respondents prior to the MPS and providing options for callbacks were suggested as possible strategies for improving comprehension within the consent process. "Opt-in" forms of authorization were preferred over "opt-out". There was particular concern about data security and confidentiality and how matters relating to this would be communicated to MPS respondents. Conclusions:These local insights provide important information to support optimization of consent for MPS, whose use is increasing globally to advance public health surveillance and research in constructive ways.

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A Digital Decision Support Tool to Enhance Decisional Capacity for Clinical Trial Consent: Design and Development

Cited by 21 publications

References 18 publications

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

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

Development of a decision support intervention for family members of adults who lack capacity to consent to trials

Consent for mobile phone surveys of non-communicable disease risk factors in low-resource settings: an exploratory qualitative study in Uganda

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