Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial

Abujarad, Fuad; Peduzzi, Peter; Mun, Sophia; Carlson, Kristina; Edwards, Chelsea; Dziura, James; Brandt, Cynthia; Alfano, Sandra L.; Chupp, Geoffrey

doi:10.2196/20458

Cited by 22 publications

(43 citation statements)

References 31 publications

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“…The positive feedback from the clinical routine is in line with the performance of other systems in the literature. For example, Abujarad et al [ 19 ] reported in a randomized controlled trial that participants had higher satisfaction, higher ability to complete the consent independently, and shorter perceived time to complete the consent process using a different D-IPC system. Hess et al showed that most primary care patients (84%) had no difficulties using a tablet computer-based questionnaire with routine screening content.…”

Section: Discussionmentioning

confidence: 99%

Digitized and structured informed patient consent before contrast-enhanced computed tomography: feasibility and benefits in clinical routine

et al. 2022

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Background To evaluate the feasibility and benefits of digitized informed patient consent (D-IPC) for contrast-enhanced CT and compare digitized documentation with paper-based, conventional patient records (C-PR). Methods We offered D-IPC to 2016 patients scheduled for a CT. We assessed patient history (e.g., CT examinations, malignant or cardiovascular diseases) and contraindications (red flags) for a CT (e.g., thyroid hyperfunction, allergies) using a tablet device. We evaluated the success rate of D-IPC and compared patient age between the subgroups of patients who were able or unable to complete D-IPC. We analyzed the prevalence of marked questions and red flags (RF). RF were compared with the documentation from C-PR. We estimated greenhouse gas (GHG) emissions for paperless workflow and provide a cost–benefit analysis. Results Overall, 84.4% of patients completed D-IPC. They were younger (median 61 years) than unsuccessful patients (65 years; p < 0.001). Patients who marked questions (21.7%) were older than patients without inquiries (median 63.9 vs 59.5 years; p < 0.001). The most prevalent RF was thyroid disease (23.8%). RF were considered critical for contrast-agent injection in 13.7%, requiring personalized preparation. The detection rate for RF documented with D-IPC was higher than for C-PR (n = 385 vs. 43). GHG emissions for tablet production are 80–90 times higher than for paper production. The estimated costs were slightly higher for D-IPC (+ 8.7%). Conclusion D-IPC is feasible, but patient age is a relevant factor. Marked questions and RF help personalize IPC. The availability of patient history by D-IPC was superior compared to C-PR.

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Section: Discussionmentioning

confidence: 99%

Digitized and structured informed patient consent before contrast-enhanced computed tomography: feasibility and benefits in clinical routine

et al. 2022

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“…Improvements in user comprehension of consent notices were attributed to the overall user satisfaction with and usability of eConsent systems. These systems were described as easy to use, well organized, and more engaging [47,50,53,54,58,[80][81][82][83][84][85][86][87][88][89]. Specifically, a video eConsent system was favored in 7% (1/15) of the studies as participants felt that they could move forward through the video at their own pace, improving their understanding of what they were consenting to [82].…”

Section: User Comprehension Of Consent Notices and Consent Informatio...mentioning

confidence: 99%

Patient Perspectives and Preferences for Consent in the Digital Health Context: State-of-the-art Literature Review

Kassam¹,

Ilkina²,

Kemp³

et al. 2023

J Med Internet Res

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Background The increasing integration of digital health tools into care may result in a greater flow of personal health information (PHI) between patients and providers. Although privacy legislation governs how entities may collect, use, or share PHI, such legislation has not kept pace with digital health innovations, resulting in a lack of guidance on implementing meaningful consent. Understanding patient perspectives when implementing meaningful consent is critical to ensure that it meets their needs. Consent for research in the context of digital health is limited. Objective This state-of-the-art review aimed to understand the current state of research as it relates to patient perspectives on digital health consent. Its objectives were to explore what is known about the patient perspective and experience with digital health consent and provide recommendations on designing and implementing digital health consent based on the findings. Methods A structured literature search was developed and deployed in 4 electronic databases—MEDLINE, IEEE Xplore, Scopus, and Web of Science—for articles published after January 2010. The initial literature search was conducted in March 2021 and updated in March 2022. Articles were eligible for inclusion if they discussed electronic consent or consent, focused on the patient perspective or preference, and were related to digital health or digital PHI. Data were extracted using an extraction template and analyzed using qualitative content analysis. Results In total, 75 articles were included for analysis. Most studies were published within the last 5 years (58/75, 77%) and conducted in a clinical care context (33/75, 44%) and in the United States (48/75, 64%). Most studies aimed to understand participants’ willingness to share PHI (25/75, 33%) and participants’ perceived usability and comprehension of an electronic consent notice (25/75, 33%). More than half (40/75, 53%) of the studies did not describe the type of consent model used. The broad open consent model was the most explored (11/75, 15%). Of the 75 studies, 68 (91%) found that participants were willing to provide consent; however, their consent behaviors and preferences were context-dependent. Common patient consent requirements included clear and digestible information detailing who can access PHI, for what purpose their PHI will be used, and how privacy will be ensured. Conclusions There is growing interest in understanding the patient perspective on digital health consent in the context of providing clinical care. There is evidence suggesting that many patients are willing to consent for various purposes, especially when there is greater transparency on how the PHI is used and oversight mechanisms are in place. Providing this transparency is critical for fostering trust in digital health tools and the innovative uses of data to optimize health and system outcomes.

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Section: User Comprehension Of Consent Notices and Consent Informatio...mentioning

confidence: 99%

Patient Perspectives and Preferences for Consent in the Digital Health Context: State-of-the-art Literature Review (Preprint)

Kassam¹,

Ilkina²,

Kemp³

et al. 2022

Preprint

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BACKGROUND The increasing integration of digital health tools into care may result in a greater flow of personal health information (PHI) between patients and providers. Though privacy legislation governs how entities may collect, use, or share PHI, such legislation has not kept pace with digital health innovations, resulting in a lack of guidance on implementing meaningful consent. Understanding patient perspectives when implementing meaningful consent is critical to ensure it meets their needs. Research on patient perspectives on consent is limited to the context of biobanks, registries, and secondary uses. There is limited consent research in the broader context of digital health. OBJECTIVE This state-of-the-art review aims to understand the current state of research as it relates to patient perspectives on digital health consent. Its objectives are to explore what is known about the patient perspective and experience with digital health consent and provide recommendations on designing and implementing digital health consent based on the findings. METHODS A structured literature search was developed and deployed in four electronic databases: Medline, IEEE Explore, Scopus and Web of Science for articles published after January 2010. The initial literature search was conducted in March 2021 and updated in March 2022. Articles were eligible for inclusion if they: discussed eConsent or consent, focused on the patient perspective or preference, and related to digital health or digital PHI. Data were extracted using an extraction templated and analyzed through qualitative content analysis. RESULTS Seventy-five articles were included for analysis. Most studies were published within the last five years (58/75, 77.3%), conducted in a clinical care context (33/75, 44.0%), and set in the United States (48/75, 64.0%). Most studies aimed to understand participants' willingness to share PHI (25/75, 33.3%) and participants perceived usability and comprehension of an eConsent notice (25/75, 33.3%). More than half of the studies did not describe the type of consent model used (40/75, 53.3%). A Broad open consent model was the most explored (11/75, 14.7%). Sixty-eight studies (90.7%) found that participants were willing to provide consent; however, their consent behaviours and preferences were context dependent. Common patient consent requirements include clear and digestible information detailing who can access PHI, for what purpose their PHI will be used, and how privacy will be ensured. CONCLUSIONS There is growing interest in understanding the patient perspective on digital health consent in the context of providing clinical care. The evidence suggests that many patients are willing to consent for various purposes, especially when there is greater transparency on how the PHI is used and oversight mechanisms are in place. Providing this transparency is critical in fostering trust in digital health tools and the innovative uses of data in optimizing health and system outcomes.

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Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial

Cited by 22 publications

References 31 publications

Digitized and structured informed patient consent before contrast-enhanced computed tomography: feasibility and benefits in clinical routine

Digitized and structured informed patient consent before contrast-enhanced computed tomography: feasibility and benefits in clinical routine

Patient Perspectives and Preferences for Consent in the Digital Health Context: State-of-the-art Literature Review

Patient Perspectives and Preferences for Consent in the Digital Health Context: State-of-the-art Literature Review (Preprint)

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