scholarly journals Improving the Informed Consent Process for Research Subjects with Low Literacy: A Systematic Review

2012 ◽  
Vol 28 (1) ◽  
pp. 121-126 ◽  
Author(s):  
Leonardo Tamariz ◽  
Ana Palacio ◽  
Mauricio Robert ◽  
Erin N. Marcus
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Informed Consent Process ◽  
Consent Process ◽  
Research Subjects ◽  
Low Literacy

Readability of Informed Consent Forms: Analysis and Recommendations for Development of Consent Forms for Use with Communities with Limited or Low Literacy

2016 ◽  
Author(s):  
Miraida Morales ◽  
Sarah Barriage
Keyword(s):  
Informed Consent ◽  
Pilot Study ◽  
Informed Consent Process ◽  
Consent Process ◽  
Measurement Tool ◽  
Low Literacy ◽  
Consent Forms ◽  
Early Readers ◽  
Research With Children ◽  
Consentement Éclairé

This poster presents a pilot study that analyzed a small corpus of informed consent forms used in research with children, adolescents, and adult early readers using Coh-Metrix, a readability measurement tool. Recommendations for increasing readability of consent forms in order to improve the informed consent process are also provided. Cette affiche présente une étude pilote qui a analysé un corpus restreint de formulaires de consentement éclairé utilisés dans la recherche avec les enfants, les adolescents et les lecteurs précoces adultes,  utilisant Coh-Metrix, un outil de mesure de la lisibilité. Nous fournissons également des recommandations pour augmenter la lisibilité des formulaires de consentement afin d'améliorer le processus de consentement éclairé.

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

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

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 Culturally Competent Informed-Consent Process to Evaluate a Social Policy for Older Persons With Low Literacy

SAGE Open ◽  
2016 ◽  
Vol 6 (3) ◽  
pp. 215824401666588 ◽  
Author(s):  
Emma Aguila ◽  
Beverly A. Weidmer ◽  
Alfonso Rivera Illingworth ◽  
Homero Martinez
Keyword(s):  
Informed Consent ◽  
Social Policy ◽  
Older Persons ◽  
Informed Consent Process ◽  
Consent Process ◽  
Culturally Competent ◽  
Low Literacy

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 ◽  
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.

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