The effectiveness of handout assisted versus verbal consent on post-operative recall and understanding – A randomized control study

The effectiveness of handout assisted versus verbal consent on post-operative recall and understanding – A randomized control study
Jun Kit Koong, Retnagowri Rajandram, Naveendran Sidambram, Vairavan Narayana
The Surgeon, 8 May 2021
Abstract
Background
Consent is an important component of surgical care. Poorly attempted consent bears significant ethical and legal implications. We assessed the effectiveness of handouts in improving postoperative consent understanding and recall compared to standard verbal consent during laparoscopic cholecystectomy as a tool that may improve information retention and leads to better treatment satisfaction.
Methods
This is a prospective block randomized, non-blinded study conducted at a single tertiary hospital. Patients undergoing elective laparoscopic cholecystectomy between August 2017 and October 2018 were recruited and randomized into Handout Assisted Consent (HC) and Verbal Consent (VC) group. The HC group was given an adjunct handout on laparoscopic cholecystectomy during consent process in addition to the standard verbal consent. A validated open-ended verbal understanding and recall questionnaire was administered to all patients in both groups at Day 1, 30 and 90 after surgery. Patient satisfaction of the consent process was evaluated with Likert scale.
Results
A total of 79 patients were enrolled, 41 patients and 38 patients in VC and HC groups respectively. Level of understanding among patients were equal and consistent across time in both groups (P > 0.05). There was significant decline (P < 0.0001) for both groups in ability to recall information between Day 1 to Day 30 and Day 30 to Day 90. A slightly higher satisfaction rate was found among patients that received HC (P > 0.05).
Conclusion
There is good consistent understanding of the surgery in both groups. However, recall of specific surgical consent items decreased significantly over time in both groups. Handouts may have increased satisfaction among patients but did not improve recall in this preliminary study.

Psychotropic Medication Informed Consent: A Cross-Specialty Role-Playing Skill Builder

Psychotropic Medication Informed Consent: A Cross-Specialty Role-Playing Skill Builder
Emily Diana, Derrick Hamaoka, Matthew Goldenberg, Kelly L. Cozza
MedEdPORTAL, 5 May 2021; 17(11)
Open Access
Abstract
Introduction
Obtaining informed consent (IC) is an essential medical practice. Utilization of IC role-playing training with medication study cards and self-peer-supervisor review should improve student fund of knowledge and strengthen IC skills for clerkship-level medical students.
Methods
Between 2017 and 2020, approximately 555 clerkship medical students used our formative role-playing exercise tools. Students independently prepared psychotropic medication study cards and role-played IC during group didactics. Peer and supervisor reviews were not recorded but were discussed as a group. Students completed routine anonymous post clerkship surveys regarding the IC exercise. An enhanced IC curriculum was deployed in 2020, adding a training video and peer/supervisor feedback form. Student feedback and specialty shelf exam scores were reviewed to assess the exercise’s effectiveness.
Results
Surveys indicated satisfaction with the exercise and increased confidence in obtaining IC. Interestingly, the student group that received enhanced IC training had fewer shelf exam failures than those without, perhaps indicating improved fund of psychotropic medication knowledge.
Discussion
Peer role-playing IC training is well accepted by students, allows practice of essential elements of IC and shared decision-making, and provides an engaging way to improve medication fund of knowledge. Our clerkship has initiated development of an IC objective structured clinical examination station and is adapting the exercise across specialties for longitudinal learning in response to the positive feedback and ease of use. Structured review of psychotropics and peer IC role-playing can be tailored for other specialties, medications, and procedures and further developed for use in pre- and postclerkship education.

Editor’s note: MedEdPORTAL is the Association of American Medical Colleges journal of teaching and learning resources.

Reaudit and Completing the Audit Cycle of Quality of Informed Consent for Surgery on Neck of Femur Fracture in Royal Stoke University Hospital

Reaudit and Completing the Audit Cycle of Quality of Informed Consent for Surgery on Neck of Femur Fracture in Royal Stoke University Hospital
T Khaleeq, U Hanif, Y Maqsood, K Ahmed, A Patel
British Journal of Surgery, 4 May 2021; 108(Supplement 2)
Abstract
Using guidelines highlighted by the British Orthopaedic Association an reaudit was performed within our department to assess the adequacy of informed consent for NOF fractures to complete the audit cycle. 50 patients were included in the Audit and reaudit. Risk was classified as common, less common, rare and ‘other’. The adequacy of informed consent was evaluated by assessing the quality and accuracy of documentation. Infection, bleeding risks, clots and anaesthetic risks were documented in all patients (100%). Areas of improvement were seen in the documentation of neurovascular injuries (98%), pain (90%) and altered wound healing (87%). There was no significant change in the documentation of failure of surgery (83%) and neurovascular injuries (98%). The Poorly documented risk factors from the initial audit were seen to improve which included mortality (70%), prosthetic dislocation (90%) and limb length discrepancy (50%). There has been a significant improvement in the quality of Informed consent in the department and this could be attributed to the installation of ward posters and verbal dissemination of information to junior doctors. Recommendation for interventions would be to present in the next clinical governance meeting and presenting at the new junior doctors’ induction at August.

The Value of a Support Person During the Surgical Consent Process: A Prospective Cohort Study

The Value of a Support Person During the Surgical Consent Process: A Prospective Cohort Study
Elisabeth C. Sappenfield, David M. O’Sullivan, Adam C. Steinberg
Female Pelvic Medicine & Reconstructive Surgery, 12 April 2021
Abstract
Objective
The objective of this study is to investigate the impact of support person participation during the preoperative appointment.
Methods
This is a prospective cohort study involving patients scheduled to undergo pelvic reconstructive surgery. Eligible patients were enrolled at the preoperative appointment and compared by presence or absence of a support person. Questionnaires were completed before and after the preoperative appointment, 1–3 days before surgery, and at the postoperative appointment. Previsit questionnaires included the Generalized Anxiety Disorder-7, 6-item short form of the Spielberger State-Trait Anxiety Inventory (STAI-6), and Brief Health Literacy screen. Postvisit questionnaires included the STAI-6, satisfaction with decision scale for pelvic floor disorders, preoperative preparedness questionnaire, and knowledge questionnaire. At the postoperative appointment, participants completed the patient global impression of improvement and postoperative symptom and satisfaction questionnaire. Primary outcome was patient anxiety measured by the STAI-6.
Results
Seventy-six patients participated in the study: 37 were categorized in the support person cohort and 39 were categorized in the no support person cohort. The mean scores of the STAI-6 did not differ between the support person and no support person cohorts at all time points (previsit: 42.97 ± 13.23 vs 41.53 ± 17.11, P = 0.68; postvisit: 38.11 ± 12.76 vs 36.33 ± 11.72, P = 0.53, and 1–3 days before surgery: 42.61 ± 13.0 vs 41.05 ± 16.39, P = 0.65). Overall preparedness, satisfaction with decision scale for pelvic floor disorders, and knowledge questionnaire did not differ between cohorts at both time points. Perioperative phone calls were similar between cohorts.
Conclusion
Our study suggests that the presence of a support person at preoperative counseling for pelvic floor surgery should be a personal preference and not a recommendation.

Informed Consent—We Can and Should Do Better

Informed Consent—We Can and Should Do Better
Invited Commentary – Ethics
Stefan C. Grant
JAMA Network Open, 28 April 2021; 4(4)
Open Access
Excerpt
…Informed consent generally is understood to represent a process, with the informed consent document having a central role. The characteristics of a well-designed consent form are well known: the document must contain information, some statutorily defined, necessary to allow a participant to make an informed decision; be written at a reading level appropriate for its audience; and be of a length that enables complete and thorough reading. Yet, the content and structure of this document has been the subject of discussion for at least 3 decades, with a consistent consensus throughout this time that these documents are too difficult to read, too complex, and too long and, as a result, frequently fail to facilitate truly informed consent by study participants. While much of the blame for the failure to provide sufficiently detailed, readable, and brief consent forms has been laid at the feet of sponsors and investigators, the reality is that, while it is possible to incorporate 2 of these 3 elements into a consent form, it is all but impossible to incorporate all 3, ie, concise, sufficiently detailed yet easily readable, for anything but the simplest of clinical trials…

Consent Notices and the Willingness-to-Sell Observational Data: Evidence from User Reactions in the Field [CONFERENCE PAPER]

Consent Notices and the Willingness-to-Sell Observational Data: Evidence from User Reactions in the Field [CONFERENCE PAPER]
Stefan Mager, Johann Kranz
European Conference on Information Systems, 2021; Marrakech
Abstract
Privacy regulations like the EU’s General Data Protection Regulation (GDPR) require e-commerce shops to request opt-in consent for usage data collection from EU website visitors. Despite the regulation’s intentional strengthening of consumer rights, consent notices are often regarded as burdensome by consumers and shops alike. Thus, ever more consumers turn to consent-automating browser extension tools, which decreases opt-in rates for e-commerce shops. To investigate potential for a win-win solution, we examined in cooperation with a fashion retailer in Germany how consumers react when they are presented a coupon for the website’s shop in the moment of cookie consent decision. Using the Becker-DeGroot-Marschak mechanism, we elicited consumers’ willingnesses-to-sell (WTS) for cookie consent. Our unique field dataset of 1274 participants allows us to derive the WTS of consumers for any desired consent rate. For instance, 65.05 % of consumers are ready to trade their consent to cookies for a 10€-coupon value.

Artificial Intelligence, Personal Decisions, Consent, and the Confucian Idea of Oneness [BOOK CHAPTER]

Artificial Intelligence, Personal Decisions, Consent, and the Confucian Idea of Oneness [BOOK CHAPTER]
Pak-Hang Wong
Harmonious Technology, [Routledge 2021]
Abstract
The pervasiveness of artificial intelligence (AI) systems has brought forth a new background condition labeled by the author as “the interconnectedness condition”, where every individual is tightly and seamlessly interconnected. In this chapter, the author shows that personal decision-making and consent have acquired new moral significance due to the changing moral character of these acts in the interconnectedness condition. In particular, he argues that personal decision-making and consent are transformed from self-regarding acts to other-regarding acts, and that the transformation introduces a new moral responsibility for individuals qua users AI systems to account for others’ values and interests in making personal decisions and giving consent. However, the author also admits that the new responsibility can be difficult for Western ethics and political philosophy to understand and accept. Accordingly, he turns to the Confucian idea of oneness to make sense of the new responsibility in the interconnectedness condition.

Informed Consent: A Monthly Review
___________________________

May 2021

This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_May 2021

Editor’s Note:
Posting of Informed Consent Content on Clinical Trials Registries was the latest webinar in the Center’s continuing series held on April 21st 2021. Foundation president David Curry opened the call with a short presentation followed by a panel discussion with Barbara Redman, Director of the Center for Informed Consent Integrity, and Jan Jaeger, Fellow of the GE2P2 Global Foundation. The discussion was focused on issues and opportunities around the posting of informed consent content [ICFs+] on clinical trial registries as a means to enhance transparency and strengthen consent in trials overall.

 

Nursing Home and Vaccination Consent: The Italian Perspective

Nursing Home and Vaccination Consent: The Italian Perspective
Nunzia Cannovo, Roberto Scendoni, Marzia Maria Fede, Federico Siotto, Piergiorgio Fedeli, Mariano Cingolani
Vaccines, 24 April 2021; 4(429)
Open Access
Abstract
Since the beginning of the Covid-19 pandemic, many countries have begun vaccination campaigns, with different methods and timelines, with the goal of vaccinating over 75% of the population and thus achieving herd immunity. Initially it was necessary to identity the categories of citizens who should be the first to receive the vaccines, on the basis of scientific evidence. On the basis of this information, elderly residents in nursing homes and the staff who care for them should be the highest priority subjects for vaccination. In this context, obtaining informed consent to Covid-19 vaccination presents a considerable challenge, as the advanced age and frequent comorbidities of a significant number of the residents may mean that they are incapable of expressing consent themselves. The legislation of various Western nations substantially agrees on the general principle that those capable of judgement must be asked for their consent for healthcare services, and that even those with psychological weaknesses that limit their full ability to decide must be involved in these decision-making processes. The article can help systematize the processes to be implemented to protect the health of individuals as members of a close and fragile community.

Consent in covid: A researcher’s dilemma

Consent in covid: A researcher’s dilemma
Review
Trends in Anaesthesia and Critical Care, 3 April 2021
Heena Garg, Puneet Khanna
Abstract
An informed consent is a vital component of health care and forms an important component of any research study. Informed consent is the process where a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. A proper consent is imperative to ensure safety of the patients. However, obtaining a consent in the hospital settings has become a matter of concern in the times of this coronavirus-19 (COVID-19) pandemic. This brief review describes the additional complexities added to the consent for research and the various modifications needed in view of this pandemic. The current consent proformas need to be modified and individualised to the patient ensuring patient safety during research in the ongoing pandemic. We need to become more familiar with the technology and electronic tools as the acceptable alternative tools of communication in the current scenario. There is a need to incorporate a separate covid consent with due consideration to deferred consent, pre-emptive consent or waiver of a consent.