scholarly journals 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

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.

scholarly journals 160 Informed Consent for Surgery at Resumption of Elective Activity After the First Wave of COVID-19

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
N Darwish ◽  
M Iqbal ◽  
Adeel A Dhahri ◽  
N Jacob ◽  
J Jebamani ◽  
...  
Keyword(s):  
Informed Consent ◽  
Royal College ◽  
General Surgery ◽  
Primary Outcome ◽  
Informed Consent Process ◽  
Consent Process ◽  
Princess Alexandra Hospital ◽  
International Guidelines ◽  
Consent Forms ◽  
American Society

Abstract Aim The Royal College of Surgeons of England published guidance on consent during COVID-19. Through this study, we aimed to assess our local consent adherence to these guidelines on the resumption of elective activity after the first wave of COVID-19. Method This prospective review of consecutive elective surgical consent forms was conducted from 20 July 2020 to 16 August 2020 at the Princess Alexandra Hospital NHS Trust, England. The primary outcome was evidence of COVID-19 risk documentation on the consent forms. Results A total of 116 patients’ consent forms were reviewed. Most patients were American Society of Anaesthesiologists (ASA) grade 2 (n = 70; 60.34%). Only 25 consent forms (21.55%) had COVID -19 and its associated risks documented, with registrars being the most compliant (19/46; 41.3%) followed by consultants (6/51; 11.7%). With regards to the surgical sub-specialities, general surgery, orthopaedics and ENT had the highest compliance with the guidance. Conclusions As the elective activity resumes, peri-operative risks of COVID-19 should be weighted in during the informed consent process, as mentioned in the latest international guidelines on consent to avoid litigation and negligence claims.

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 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.

Seeking Ways to Inform the Uninformed: Improving the Informed Consent Process in Online Social Science Research

2017 ◽  
Vol 13 (1) ◽  
pp. 50-60 ◽  
Author(s):  
Evan K. Perrault ◽  
David M. Keating
Keyword(s):  
Informed Consent ◽  
Social Science ◽  
Information Needs ◽  
Daily Life ◽  
Social Science Research ◽  
Science Research ◽  
Informed Consent Process ◽  
Consent Process ◽  
Consent Forms ◽  
Line Spacing

Participants often do not read consent forms in social science research. This is not surprising, especially for online studies, given they do not typically offer greater risk than what is encountered in daily life. However, if no one is reading, are participants really informed? This study used previous research to craft experimentally manipulated consent forms utilizing different visual presentations (e.g., greater use of line spacing, bullets, bolding, diagrams). Participants ( n = 547) were randomly exposed to one of seven form variations. Results found no significant differences between forms in reading or comprehension. Open-ended questions asked participants why they do not read consent forms and what would influence them to read the forms. Participants most frequently stated forms need to be shorter, and important information needs to be highlighted. We suggest improvements to informed consent forms, including removing much of the information that is constant across forms, and only including unique aspects of studies.

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.

scholarly journals EP.WE.628The Challenges of Consent and COVID-19: Analysis of Documentation of Risk of Hospital Acquired COVID-19 Infection in a District General Hospital

2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Shashwat Mishra ◽  
Heather Davis ◽  
Wei Jian Tan ◽  
Joanne Cooke
Keyword(s):  
General Hospital ◽  
Surgical Procedures ◽  
Hospital Admissions ◽  
District General Hospital ◽  
Case Note ◽  
Teaching Session ◽  
Retrospective Case ◽  
Consent Forms ◽  
New Material ◽  
Hospital Acquired

Abstract Aims The COVID-19 pandemic poses a new material risk to hospital admissions and we must modify consenting practice accordingly. This study assessed documentation of the risk of COVID-19 infection and associated morbidity in consenting practice for patients undergoing general surgical procedures under general anaesthesia at a district general hospital. Methods This is was a two-cycle study design. An initial retrospective case-note analysis of 41 inpatient consent forms and operation notes during April 2020 was performed. Data were gathered on points from the Royal College of Surgeons (RCS) guidance, including documentation of risk of COVID-19 infection. Recommendations were then offered including a teaching session from the departmental lead into the importance of documenting risk of COVID-19 infection. A prospective case-note analysis of 45 inpatient consent forms and operation notes during November to December 2020 was then performed. Results In cycle one, of 41 cases, 39% (16) had risk of chest infection documented. Of these, 16 (63%) specified COVID-19 in risk documentation. Morbidity related to COVID-19 was documented in 4 (25%) of these 16 cases. Following interventions, of 45 cases, 93% had risk of COVID-19 infection and associated morbidity documented (χ2 = 89.3646, p < 0.00001 significant at p < 0.05). Conclusion We initially identified a deviation from RCS consent guidance. The second cycle results show a significant improvement in consenting practice for the risk of contracting COVID-19 for inpatient surgical procedures. We aim to further refine our recommendations to ensure that this material risk is communicated to patients during the initial consent process.

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