Digital tools in the Informed Consent process: a systematic review

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.

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Digital tools in the Informed Consent process: a systematic review

10.21203/rs.2.10223/v3 ◽

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

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Digital tools in the informed consent process: a systematic review

BMC Medical Ethics ◽

10.1186/s12910-021-00585-8 ◽

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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The effectiveness of health literacy interventions on the informed consent process of health care users: a systematic review protocol

The JBI Database of Systematic Reviews and Implementation Reports ◽

10.11124/jbisrir-2015-2304 ◽

2015 ◽

Vol 13 (10) ◽

pp. 82-94 ◽

Cited By ~ 14

Author(s):

Beatrice Perrenoud ◽

Venetia-Sofia Velonaki ◽

Patrick Bodenmann ◽

Anne-Sylvie Ramelet

Keyword(s):

Systematic Review ◽

Health Care ◽

Informed Consent ◽

Health Literacy ◽

Informed Consent Process ◽

Consent Process ◽

Systematic Review Protocol ◽

Literacy Interventions ◽

Review Protocol

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Systematic review of bibliography about barriers and difficulties in informed consent process in pediatric clinical trials.

10.26226/morressier.5c377885f0ad58000b0d3966 ◽

2019 ◽

Author(s):

Laurene Couderc

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Informed Consent ◽

Informed Consent Process ◽

Consent Process

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

BMC Medical Ethics ◽

10.1186/1472-6939-14-28 ◽

2013 ◽

Vol 14 (1) ◽

Cited By ~ 213

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

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EP.WE.568Compliance with the Royal College of Surgeons of England Guidelines on the Surgical Consenting Process in the Era of the COVID-19 Pandemic

British Journal of Surgery ◽

10.1093/bjs/znab308.068 ◽

2021 ◽

Vol 108 (Supplement_7) ◽

Author(s):

Boluwatife Ayantunde ◽

Danielle Clyde ◽

Gregory Ekatah

Keyword(s):

Informed Consent ◽

General Hospital ◽

Surgical Procedures ◽

Royal College ◽

District General Hospital ◽

Informed Consent Process ◽

Consent Process ◽

Prospective Audit ◽

Consent Forms

Abstract Aims Due to the current COVID-19 pandemic, The Royal College of Surgeons of England released guidelines advising on additional considerations which should be discussed with patients as part of the informed consent process prior to surgery. We conducted a prospective audit on whether COVID-19 infection was mentioned as a possible complication during the consenting process for patients undergoing emergency and elective general surgical procedures at a District General Hospital. Methodology We prospectively collected data on the patients admitted for surgical procedures over a 2-week period. Consent forms were reviewed noting whether COVID-19 infection was listed as a possible complication. Results 35 patients were audited with a median age of 54 (12-94) years including 17 males and 18 females. Patients presented with varying surgical diagnoses, with 16 and 19 undergoing emergency and elective operations, respectively. 77.1% (27) of patients had COVID-19 infection mentioned as a possible complication on their consent forms. Five out of six consent forms completed by Clinical Fellows or CT trainees, 10 out of 13 by Registrars, 12 out of 16 by Consultants mentioned COVID-19 infection. We found no significant correlation between the grade of the consent taker and COVID-19 infection being mentioned as a possible complication. Conclusion Most of the consent takers were aware of the guidelines and mentioned COVID-19 infection as a possible complication during consenting. However, this awareness could be expanded. The results will be presented to the department before a plan to re-audit and close the loop in a few weeks.

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