Patient preferences toward an interactive e-consent application for research using electronic health records

Harle, Christopher A.; Golembiewski, Elizabeth H.; Rahmanian, Kiarash P.; Krieger, Janice L.; Hagmajer, Dorothy; Mainous, Arch G.; Moseley, Ray

doi:10.1093/jamia/ocx145

Cited by 41 publications

(71 citation statements)

References 46 publications

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“…Quality scores of 2 and 1 were provided to 1 study [ 28 ] and 6 studies [ 29 - 34 ], respectively. The qualitative studies ranged from satisfying 80% or more of the quality criteria (6 studies) [ 35 - 40 ] to satisfying 50% to 60% of the quality criteria (3 studies) [ 41 - 43 ]. Moreover, 3 mixed methods studies met 80% or more of the quality criteria [ 16 , 44 , 45 ], 6 studies met from 57% to 71% of the quality criteria [ 15 , 46 - 50 ], while 1 met only 43% of the quality criteria [ 51 ].…”

Section: Resultsmentioning

confidence: 99%

“…Research participants advised using a bullet point format with access to additional information if desired [ 28 , 34 , 50 ]. Simple, concise language should be used to encourage a sufficient level of understanding [ 15 , 28 , 40 , 50 ]. The possibility of marking information that participants did not understand was considered useful and was viewed as an opportunity to enhance the discussion with the research staff [ 15 ].…”

Section: Resultsmentioning

confidence: 99%

“…Hence, the pressure to give consent immediately was decreased [ 16 ]. An extensive amount of studies investigated barriers related to the use of electronic informed consent which could prevent research participants from achieving a reasonable level of understanding [ 15 , 25 - 28 , 31 - 34 , 39 , 40 , 44 , 45 , 48 , 49 , 52 , 53 , 55 , 60 , 61 ]. For the majority of studies, no barriers were reported [ 25 - 28 , 31 - 34 , 44 , 48 , 52 ].…”

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

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

“…An online questionnaire can test the participants' understanding of the informed consent. In addition to the online information the participants have the opportunity to ask questions and discuss relevant topics with the investigator through a phone or online call before giving the consent [11,12]. Furthermore, a limited number of study sites are involved in VCT.…”

Section: Virtual Clinical Trialsmentioning

confidence: 99%

Virtual Clinical Trials: Perspectives in Dermatology

Ali

Zibert²,

Thomsen

2020

Dermatology

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Background: The cost of developing a new drug is approximately USD 2.6 billion, and over two-thirds of the total cost is embedded in the clinical-testing phase. Patient recruitment is the single biggest cause of clinical trial delays, and these delays can result in up to USD 8 million per day in lost revenue for pharmaceutical companies. Further, clinical trials struggle to keep participants engaged in the study and as many as 40% drop out. To overcome these challenges pharmaceutical companies and research institutions (e.g., universities) increasingly use an emerging concept: virtual clinical trials (VCT) based on a remote approach. Summary: VCT (site-less) are a relatively new method of conducting a clinical trial, taking full advantage of technology (apps, monitoring devices, etc.) and inclusion of web platforms (recruitment, informed consent, counselling, measurement of endpoints, and any adverse reactions) to allow the patient to be home-based at every stage of the clinical trial. Studies have shown that VCT are not only operationally feasible, but also successful. They have higher recruitment rates, better compliance, lower drop-out rates, and are conducted faster than traditional clinical trials. The visual nature of dermatological conditions, the relative ease in evaluating skin diseases virtually, and the fact that skin diseases often are not life-threatening and rarely require complex examinations make VCT very attractive for dermatological research. Further, making correct diagnoses based on photographs and patient symptomatology has always been part of the dermatologist’s routine. Thus, VCT are in many ways made for dermatology. Herein we describe VCT and their implications in dermatological research.

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“…Tablet, mobile, or portal-based systems present new opportunities for effectively providing educational materials necessary for informed patient and research study consent. Qualitative studies assessing user needs and preferences have suggested that these tools might effectively address user concerns and potentially increase participation among under-represented groups [66,67]. However, evaluations have not always found clear wins, with some studies failing to see improvements associated with the use of e-consent [68], and others finding difficulties with complex content [69].…”

Section: Consent Trust and Participant Engagementmentioning

confidence: 99%

Human-Computer Interaction, Ethics, and Biomedical Informatics

Hochheiser

Valdez

2020

Yearb Med Inform

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Objectives: To provide an overview of recent work at the intersection of Biomedical Informatics, Human-Computer Interaction, and Ethics. Methods: Search terms for Human-Computer Interaction, Biomedical Informatics, and Ethics were used to identify relevant papers published between 2017 and 2019.Relevant papers were identified through multiple methods, including database searches, manual reviews of citations, recent publications, and special collections, as well as through peer recommendations. Identified articles were reviewed and organized into broad themes. Results: We identified relevant papers at the intersection of Biomedical Informatics, Human-Computer Interactions, and Ethics in over a dozen journals. The content of these papers was organized into three broad themes: ethical issues associated with systems in use, systems design, and responsible conduct of research. Conclusions: The results of this overview demonstrate an active interest in exploring the ethical implications of Human-Computer Interaction concerns in Biomedical Informatics. Papers emphasizing ethical concerns associated with patient-facing tools, mobile devices, social media, privacy, inclusivity, and e-consent reflect the growing prominence of these topics in biomedical informatics research. New questions in these areas will likely continue to arise with the growth of precision medicine and citizen science.

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Patient preferences toward an interactive e-consent application for research using electronic health records

Cited by 41 publications

References 46 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

Virtual Clinical Trials: Perspectives in Dermatology

Human-Computer Interaction, Ethics, and Biomedical Informatics

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