scholarly journals Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials

2013 ◽  
Vol 14 (1) ◽  
Author(s):  
Adam Nishimura ◽  
Jantey Carey ◽  
Patricia J Erwin ◽  
Jon C Tilburt ◽  
M Hassan Murad ◽  
...  
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Informed Consent Process ◽  
Consent Process ◽  
Randomized Control Trials ◽  
Randomized Control

Facilitators, barriers, and recommendations related to the informed consent of Marshallese in a randomized control trial

2020 ◽  
Vol 15 (2) ◽  
pp. 75-83
Author(s):  
Rachel S Purvis ◽  
Leah R Eisenberg ◽  
Christopher R Trudeau ◽  
Christopher R Long ◽  
Pearl A McElfish
Keyword(s):  
Informed Consent ◽  
Randomized Control Trial ◽  
Diabetes Management ◽  
Community Based Participatory Research ◽  
Informed Consent Process ◽  
Consent Process ◽  
Research Approach ◽  
Community Based ◽  
Randomized Control ◽  
Participatory Research Approach

Background The Pacific Islander population is the second fasting growing population in the United States and Arkansas is home to the largest Marshallese population in the continental US. The Marshallese community have significant health disparities with high prevalence of diabetes, heart disease, and obesity compared to the general US population. Using a community-based participatory research approach, researchers and Marshallese community stakeholders identified diabetes as the top health issue for research. Methods From 2014 to 2018, a randomized control trial was conducted comparing standard diabetes management education with a culturally adapted family model of standard diabetes management education delivered in participants’ homes by Marshallese community health workers and certified diabetes educators. Interviews were held with Marshallese participants to document their experiences with and perceptions of the informed consent process for this randomized control trial. Results Participants provided feedback on the process of enrolling in the study, describing barriers and facilitators to giving informed consent from their perspective, and offering recommendations for improving the informed consent process. Conclusion Findings suggest that informed consent with underserved communities, including immigrant and migrant populations who do not speak English or have limited English proficiency, is possible, and that using a community-based participatory research approach can help facilitate the informed consent process.

Multimedia in the informed consent process for endoscopic sinus surgery: A randomized control trial

2015 ◽  
Vol 126 (6) ◽  
pp. 1273-1278 ◽  
Author(s):  
Jennifer M. Siu ◽  
Brian W. Rotenberg ◽  
Jason H. Franklin ◽  
Leigh J Sowerby
Keyword(s):  
Informed Consent ◽  
Endoscopic Sinus Surgery ◽  
Randomized Control Trial ◽  
Informed Consent Process ◽  
Sinus Surgery ◽  
Consent Process ◽  
Randomized Control

scholarly journals Digital tools in the Informed Consent process: a systematic review

2019 ◽  
Author(s):  
Gesualdo Francesco ◽  
Laura Palazzani ◽  
Dimitris Dimitriou ◽  
Javier Diez Domingo ◽  
Jaime Fons-Martinez ◽  
...  
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Surgical Procedures ◽  
Interactive Multimedia ◽  
Digital Technologies ◽  
Informed Consent Process ◽  
Digital Tools ◽  
Consent Process ◽  
Multimedia Tools ◽  
Positive Effect

Abstract Background: Providing understandable information to patients is necessary to achieve the two main aims of the Informed Consent process: respecting and promoting patients’ autonomy and protecting patients from harm. In recent decades, new, primarily digital, technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical care and clinical trials. Understanding, comprehension, satisfaction and participation were compared for digital tools versus the traditional Informed Consent process. Methods: We searched for studies on available electronic databases, including Pubmed, ISI web of science (WoS), and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to April 2018, that focused on the use of digital Informed Consent tools for surgery, diagnostic procedures, therapeutic interventions, and clinical research. Digital interventions were defined as interventions that used multimedia or audio-video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia. Results: Our search yielded 1046 publications. After title and abstract screening 182 studies were retained for full-text analysis, of which 38 publications were included. Studies examined interactive multimedia (17/38), non-interactive multimedia (11/38), and videos (10/38), and most (34/38) studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures (26/38) and RCTs (12/38). For RCTs, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes. Conclusions: Digital technologies for informed consent were not found to affect negatively any of the outcomes, and overall, interactive multimedia tools seem desirable. Interactive multimedia tools indicated a higher impact than passive videos. Presence of a researcher may potentially enhance efficacy of different outcomes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardisation is needed to conclusively assess impact.

scholarly journals Digital tools in the Informed Consent process: a systematic review

2019 ◽  
Author(s):  
Gesualdo Francesco ◽  
Laura Palazzani ◽  
Dimitris Dimitriou ◽  
Javier Diez Domingo ◽  
Jaime Fons-Martinez ◽  
...  
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Surgical Procedures ◽  
Interactive Multimedia ◽  
Digital Technologies ◽  
Informed Consent Process ◽  
Digital Tools ◽  
Consent Process ◽  
Multimedia Tools ◽  
Positive Effect

Abstract Background: Providing understandable information to patients is necessary to achieve the two main aims of the Informed Consent process: respecting and promoting patients’ autonomy and protecting patients from harm. In recent decades, new, primarily digital, technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical care and clinical trials. Understanding, comprehension, satisfaction and participation were compared for digital tools versus the traditional Informed Consent process. Methods: We searched for studies on available electronic databases, including Pubmed, ISI web of science (WoS), and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to April 2018, that focused on the use of digital Informed Consent tools for surgery, diagnostic procedures, therapeutic interventions, and clinical research. Digital interventions were defined as interventions that used multimedia or audio-video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia. Results: Our search yielded 1046 publications. After title and abstract screening 182 studies were retained for full-text analysis, of which 38 publications were included. Studies examined interactive multimedia (17/38), non-interactive multimedia (11/38), and videos (10/38), and most (34/38) studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures (26/38) and RCTs (12/38). For RCTs, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes. Conclusions: Digital technologies for informed consent were not found to affect negatively any of the outcomes, and overall, interactive multimedia tools seem desirable. Interactive multimedia tools indicated a higher impact than passive videos. Presence of a researcher may potentially enhance efficacy of different outcomes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardisation is needed to conclusively assess impact.

scholarly journals Digital tools in the Informed Consent process: a systematic review

2021 ◽  
Author(s):  
Gesualdo Francesco ◽  
Margherita Daverio ◽  
Laura Palazzani ◽  
Dimitris Dimitriou ◽  
Javier Diez Domingo ◽  
...  
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Clinical Research ◽  
Surgical Procedures ◽  
Interactive Multimedia ◽  
Digital Technologies ◽  
Informed Consent Process ◽  
Digital Tools ◽  
Consent Process ◽  
Positive Effect

Abstract Background: Providing understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients’ autonomy and protecting patients from harm. In recent decades, new, primarily digital, technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice.. Understanding, satisfaction and participation were compared for digital tools versus the non-digital Informed Consent process.Methods: We searched for studies on available electronic databases, including Pubmed, EMBASE, and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to October 2020, that focused on the use of digital Informed Consent tools for clinical research, or clinical procedures. Digital interventions were defined as interventions that used multimedia or audio-video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia.Results: Our search yielded 19,579 publications. After title and abstract screening 100 studies were retained for full-text analysis, of which 73 publications were included. Studies examined interactive multimedia (29/73), non-interactive multimedia (13/73), and videos (31/73), and most (34/38) studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures (26/38) and clinical research (12/38). For research IC, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes. Conclusions: Digital technologies for informed consent were not found to negatively affect any of the outcomes, and overall, multimedia tools seem desirable. Multimedia tools indicated a higher impact than videos only. Presence of a researcher may potentially enhance efficacy of different outcomes in research IC processes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardization is needed to conclusively assess impact. Trial registration: NA

scholarly journals Digital tools in the informed consent process: a systematic review

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Francesco Gesualdo ◽  
Margherita Daverio ◽  
Laura Palazzani ◽  
Dimitris Dimitriou ◽  
Javier Diez-Domingo ◽  
...  
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Clinical Research ◽  
Surgical Procedures ◽  
Interactive Multimedia ◽  
Digital Technologies ◽  
Informed Consent Process ◽  
Digital Tools ◽  
Consent Process ◽  
Positive Effect

Abstract Background Providing understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients’ autonomy and protecting patients from harm. In recent decades, new, primarily digital technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice. Understanding, satisfaction and participation were compared for digital tools versus the non-digital Informed Consent process. Methods We searched for studies on available electronic databases, including Pubmed, EMBASE, and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to October 2020, that focused on the use of digital Informed Consent tools for clinical research, or clinical procedures. Digital interventions were defined as interventions that used multimedia or audio–video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia. Results Our search yielded 19,579 publications. After title and abstract screening 100 studies were retained for full-text analysis, of which 73 publications were included. Studies examined interactive multimedia (29/73), non-interactive multimedia (13/73), and videos (31/73), and most (34/38) studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures (26/38) and clinical research (12/38). For research IC, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes. Conclusions Digital technologies for informed consent were not found to negatively affect any of the outcomes, and overall, multimedia tools seem desirable. Multimedia tools indicated a higher impact than videos only. Presence of a researcher may potentially enhance efficacy of different outcomes in research IC processes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardization is needed to conclusively assess impact.

Comparing a Multimedia Digital Informed Consent Tool to Traditional Paper-based Methods Among GenEx Trial Participants: Randomized Control Trial (Preprint)

2020 ◽  
Author(s):  
Fuad Abujarad ◽  
Peter Peduzzi ◽  
Sophia Mun ◽  
Kristina Carlson ◽  
Siyuan Ma ◽  
...  
Keyword(s):  
Informed Consent ◽  
Randomized Control Trial ◽  
Cognitive Theory ◽  
Digital Health ◽  
Informed Consent Process ◽  
Ease Of Use ◽  
Consent Process ◽  
New Haven ◽  
Randomized Control ◽  
The Impact

BACKGROUND The traditional informed consent process rarely emphasizes research participants’ comprehension of medical information, leaving them vulnerable to unknown risks and consequences associated with procedures or studies. OBJECTIVE This paper explores how we evaluated the feasibility of a digital health tool called ‘VIC’ for advancing the informed consent process and compared the results to traditional paper-based methods of informed consent. METHODS By utilizing Digital Health and virtual coaching, we developed the ‘Virtual multimedia interactive Informed Consent’ (VIC) tool that uses multimedia and other interactive digital features to improve the current informed consent process. Development of the tool was based on the user-centered design (UCD) process and on Mayer’s cognitive theory of multimedia learning. In a randomized control trial, we compared VIC’s feasibility against standard paper consent to understand the impact of interactive digital consent. Participants were recruited from the Winchester Chest Clinic (WCC) at Yale New Haven Hospital in New haven, CT, as well as from the community using fliers. The trial was coordinator-assisted, and participants were randomized to complete the informed consent process using VIC on the iPad or with traditional paper consent. The study was conducted at WCC and the outcomes were self-assessed through coordinator-administrated questionnaires. RESULTS Overall 50 participants were recruited in the study (VIC: n=25; Paper: n=25). Participant comprehension was high in both groups. VIC participants reported higher satisfaction, higher perceived ease of use, higher ability to complete the consent independently, and a shorter perceived time for completing the consent process. CONCLUSIONS The use of dynamic, interactive audiovisual elements in VIC may improve participants satisfaction and facilitate the informed consent process. We believe that using VIC in an ongoing, real-world study rather than a hypothetical study improved the reliability of our findings which demonstrate VIC’s potential to improve research participant’s comprehension as well as the overall process of the informed consent. CLINICALTRIAL ClinicalTrials.gov NCT02537886; https://clinicaltrials.gov/ct2/show/NCT02537886.

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