Enhancing Patient Understanding of Cardiac Catheterisation Prior to Procedural Consent
J. Reynolds, R. Newcombe, G. Armstrong, S. El-Jack, T. Wijohn
Heart, Lung and Circulation, August 2024
Abstract
Background
People with reduced health literacy are at higher risk of not sufficiently understanding informed consent prior to procedures. Approximately 44% of adults read at or below the age of an average 12-13-year-old, indicating they may struggle to understand basic health information during the consent process. This is magnified in indigenous peoples, older adults and those with English as a second language in both countries.
Methods
We designed a procedural graphic comic booklet to be shared prior to the consent process, aiming to increase understanding in all patient groups. Pilot research on patients’ understanding of basic probability was conducted using non-medical questions confirmed poor understanding of risk. The comic booklet was developed with patient and health literacy group input and subjected to several cycles of feedback to reach the final version utilised in our audit.
Results
We audited patient and staff perceptions of the graphic comic booklet to the commonly used Heart Foundation information booklet. In 15 patients and 12 health-workers, the graphic comic booklet format was felt to be more succinct and understandable and was preferred by the majority of respondents. A small group preferred more detailed information.
Discussion
The use of a graphic comic booklet can therefore be an important educational tool, aiding patient understanding of procedures prior to the consent process. We intend to use it in addition to the current pre-angiography education provided to patients.
Year: 2024
Informed consent in neurosurgery – Evaluation of current practice and implementation of future strategies
Informed consent in neurosurgery – Evaluation of current practice and implementation of future strategies
Francesca Colombo, Ross McLeod, Rohit Ravindranath Nambiar, Helen Maye, Sam Dickens, K Joshi George
Surgical Neurology International, 19 July 2024
Abstract
Background
In recent times, clinical negligence claims against National Health Service hospitals have doubled, with 8% of claims being made due to “failure to warn/informed consent.” This study aimed to assess the current compliance of the neurosurgical division within a large tertiary neuroscience center with the national legal framework and professional guidelines around the issue of surgical consent and to develop strategies to improve the consent process.
Methods
Electronic patient records (EPR) were accessed to collect demographic data and information regarding the surgical procedures. Telephone questionnaires were carried out. Neurosurgical registrars were interviewed. The author met with the trust’s Legal team, the neuropsychology lead, and the trust’s consent lead.
Results
Fifty-eight patients were included in the analysis. Of the respondents to the questionnaire, 98% felt that they were adequately informed during the consent process. When consenting patients, all registrars felt that they explained the reason for the procedure, detailed benefits, and major risks, including uncommon and rare risks. However, 50% admitted to not specifically discussing the postoperative recovery time or alternatives. Only 15% admitted to documenting on the EPR or through a letter to the patient’s General Practitioner.
Conclusion
Informed consent is a delicate moment of communication between a clinician and the patient. Regular training and good communication skills help staff to focus on the most relevant aspects of consent, which should be delivered in an appropriate environment and with family support. Audio-visual aids can support the process but do not replace good communication.
LLM Doc: An Assessment of ChatGPT’s Ability to Consent Patients for IR Procedures
LLM Doc: An Assessment of ChatGPT’s Ability to Consent Patients for IR Procedures
Research Article
Hayden Hofmann, Jenanan Vairavamurthy
CVIR Endovascular, 17 June 2024
Abstract
Purpose
The study aims to evaluate how current interventional radiologists view ChatGPT in the context of informed consent for interventional radiology (IR) procedures.
Methods
ChatGPT-4 was instructed to outline the risks, benefits, and alternatives for IR procedures. The outputs were reviewed by IR physicians to assess if outputs were 1) accurate, 2) comprehensive, 3) easy to understand, 4) written in a conversational tone, and 5) if they were comfortable providing the output to the patient. For each criterion, outputs were measured on a 5-point scale. Mean scores and percentage of physicians rating output as sufficient (4 or 5 on 5-point scale) were measured. A linear regression correlated mean rating with number of years in practice. Intraclass correlation coefficient(ICC) measured agreement among physicians.
Results
The mean rating of the ChatGPT responses was 4.29, 3.85, 4.15, 4.24, 3.82 for accuracy, comprehensiveness, readability, conversational tone, and physician comfort level, respectively. Percentage of physicians rating outputs as sufficient was 84%, 71%, 85%, 85%, and 67% for accuracy, comprehensiveness, readability, conversational tone, and physician comfort level, respectively. There was an inverse relationship between years in training and output score (coeff = -0.03413, p=0.0128); ICC measured 0.39 (p=0.003).
Conclusions
GPT-4 produced outputs that were accurate, understandable, and in a conversational tone. However, GPT-4 had a decreased capacity to produce a comprehensive output leading some physicians to be uncomfortable providing the output to patients. Practicing IRs should be aware of these limitations when counseling patients as ChatGPT-4 continues to develop into a clinically usable AI tool.
Calls for Public Consultation
CURRENT CALLS FOR PUBLIC CONSULTATION
We will selectively include calls for public consultation from multilateral agencies, governments, INGOs and other sources where there is a clear intersection with consent/assent. This might be obvious from the title of the draft guidance, regulations, etc., but more often, it will be a thematic area or topic – if properly addressed at all. If you would like to explore participation with our working group developing submissions for these calls, please contact us [david.r.curry@ge2p2global.org].
Agency Information Collection Request; 30-Day Public Comment Request
A Notice by the Health and Human Services Department on 08/19/2024 Comments on the ICR must be received on or before September 18, 2024.
[IRB Review/IRB Recordkeeping/Informed Consent/Consent Documentation]
Abstract:
The Office of the Assistant Secretary for Health, Office for Human Research Protections is requesting a three-year extension of the Protection of Human Subjects: Assurance of Compliance with Federal Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent Documentation, OMB No. 0990-0260.
Information reported to the Federal departments and agencies under the Common Rule with respect to a satisfactory assurance is used to ensure that an institution engaged in non-exempt research involving human subjects conducted or supported by a Common Rule department or agency has (1) established adequate administrative policies and procedures for protecting the rights and welfare of human subjects in research, and (2) accepts that responsibility. Other reporting requirements are used to: assess whether the institution is following the established procedures; ensure that Federal funds are not expended for unapproved human subjects research; and determine if the approved status of an awarded grant, contract, or cooperative agreement should be reviewed, with the ultimate goal of maintaining or increasing human subject protections.
Patient Engagement Advisory Committee; Notice of Meeting-Patient-Centered Informed Consent in Clinical Study
A Notice by the Food and Drug Administration on 08/28/2024
Written submissions may be made to the contact person on or before October 3, 2024. Oral presentations on or before September 25, 2024
The meeting will be held on October 30, 2024, from 10 a.m. to 5 p.m. Eastern Time.
Agenda:
On October 30, 2024, the Committee will discuss and make recommendations on “Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products.” The individuals who volunteer to participate in clinical research play an integral role in advancing scientific knowledge and supporting the development of potentially life-saving therapies for patients in need. Informed consent is a key element in clinical studies and can be one of a patient’s first interactions with the clinical community. Too often, however, informed consent forms are lengthy and difficult for potential research participants to understand. FDA has worked to improve informed consent over the years, including several recent activities such as developing a draft guidance in identifying key information in informed consent.
The Committee will provide recommendations on the informed consent process and the areas of focus of the informed consent. The Committee will also provide recommendations on factors to consider when communicating informed consent to clinical study participants to increase the likelihood of participants understanding the key elements of research.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting.
Background material and the link to the online teleconference and/or video conference meeting will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm
Procedure:
Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee. Written submissions may be made to the contact person on or before October 3, 2024. Oral presentations from the public will be scheduled between approximately 2 p.m. and 3 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person (and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 25, 2024. Letise Williams, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5407, Silver Spring, MD 20993-0002, Letise.Williams@fda.hhs.gov.
Informed Consent: A Monthly Review
_________________
August 2024 :: Issue 68
In preparing this digest, we monitor a broad range of academic journals and utilize Google Scholar to search articles referencing informed consent or assent. After careful consideration, a selection of these results appear in the digest. We also monitor other research, analysis, guidance and commentary beyond the academic literature globally, including calls for public consultation and symposia/conferences which address consent/assent in whole or in part. We recognize that some of the arguments presented in this edition may be controversial and may warrant closer scrutiny. We have elected to be generous in our inclusion with the goal of presentating of a wholistic landscape of informed consent literature as it is being published. 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: Center for Informed Consent Integrity – A Monthly Review_August 2024
Spotlight
In this month’s Spotlight, we feature two legal milestones involving consent and social media platforms. One involves the European Commission, its Digital Markets Act, and Meta’s “pay or consent” model. The other involves the U.S. state of Texas and a record legal settlement of US$1.4 billion over Meta’s deployment of facial recognition software over a decade without consent. We assess that the intersection of consent and advanced data collection technologies implemented on global social media platforms deserves a continuing close examination.
Commission sends preliminary findings to Meta over its “Pay or Consent” model for breach of the Digital Markets Act
Press Release
European Commission, 1 July 2024
Excerpt
Today, the Commission has informed Meta of its preliminary findings that its “pay or consent” advertising model fails to comply with the Digital Markets Act (DMA). In the Commission’s preliminary view, this binary choice forces users to consent to the combination of their personal data and fails to provide them a less personalised but equivalent version of Meta’s social networks…
Due to their significant position in digital markets, gatekeepers have been able to impose terms of services on their large user base allowing them to collect vast amounts of personal data. This has given them potential advantages compared to competitors who do not have access to such a vast amount of data, thereby raising high barriers to providing online advertising services and social network services.
Under Article 5(2) of the DMA, gatekeepers must seek users’ consent for combining their personal data between designated core platform services and other services, and if a user refuses such consent, they should have access to a less personalised but equivalent alternative. Gatekeepers cannot make use of the service or certain functionalities conditional on users’ consent…
The Commission takes the preliminary view that Meta’s “pay or consent” advertising model is not compliant with the DMA as it does not meet the necessary requirements set out under Article 5(2). In particular, Meta’s model
:: Does not allow users to opt for a service that uses less of their personal data but is otherwise equivalent to the “personalised ads” based service.
:: Does not allow users to exercise their right to freely consent to the combination of their personal data.
To ensure compliance with the DMA, users who do not consent should still get access to an equivalent service which uses less of their personal data, in this case for the personalisation of advertising…
In case of non-compliance, the Commission can impose fines up to 10% of the gatekeeper’s total worldwide turnover. Such fines can go up to 20% in case of repeated infringement. Moreover, in case of systematic non-compliance, the Commission is also empowered to adopt additional remedies such as obliging a gatekeeper to sell a business or parts of it or banning the gatekeeper from acquisitions of additional services related to the systemic non-compliance.
The Commission continues its constructive engagement with Meta to identify a satisfactory path towards effective compliance.
”… $1.4 Billion Settlement with Meta Over Its Unauthorized Capture of Personal Biometric Data In Largest Settlement Ever Obtained From An Action Brought By A Single State
Press Release
Attorney General of Texas, 30 July 2024
[Excerpt]
…This settlement is the largest ever obtained from an action brought by a single State…This is the first lawsuit brought and first settlement obtained under Texas’s “Capture or Use of Biometric Identifier” Act and serves as a warning to any companies engaged in practices that violate Texans’ privacy rights…
In February 2022, Attorney General Paxton sued Meta for unlawfully capturing the biometric data of millions of Texans without obtaining their informed consent as required by Texas law…
In 2011, Meta rolled out a new feature, initially called Tag Suggestions, that it claimed would improve the user experience by making it easier for users to “tag” photographs with the names of people in the photo.
Meta automatically turned this feature on for all Texans without explaining how the feature worked. Unbeknownst to most Texans, for more than a decade Meta ran facial recognition software on virtually every face contained in the photographs uploaded to Facebook, capturing records of the facial geometry of the people depicted. Meta did this despite knowing that CUBI forbids companies from capturing biometric identifiers of Texans, including records of face geometry, unless the business first informs the person and receives their consent to capture the biometric identifier…
Quality of Informed Consent in Phase III Clinical Trials in Portugal: The Participants’ Perspective
Quality of Informed Consent in Phase III Clinical Trials in Portugal: The Participants’ Perspective
Pedro L. Ferreira, Ana Barradas, Inês Ribeiro
Acta Médica Portuguesa, 19 July 2024
Abstract
Introduction
Some studies show that participants do not always fully understand the informed consent form (ICF), which is one of the reasons for dropouts. This study aimed to adapt the Quality of Informed Consent (QuIC) questionnaire into a valid instrument to be applied to the Portuguese population and to measure its reliability and validity in the Portuguese population, by applying it to a sample of participants in controlled trials.
Methods
The QuIC questionnaire was developed to assess the quality of informed consent in clinical trials and consists of two parts, addressing both the objective (part A) and the subjective (part B) understanding. After being translated and validated into Portuguese, it was implemented in 100 cardiac participants of phase III clinical trials in a University Hospital Center.
Results
The QuIC-PT questionnaire showed excellent stability over time and good validity. All patients evaluated their participation and their health positively and recognized the main purpose of the clinical trial. Almost all participants understood their role in helping future patients and the purpose of the trial and realized that, by signing the ICF, they were participating in a clinical trial. However, none of them knew that their experimental treatment was not proven to be the best alternative for their condition.
Conclusion
The QuIC-PT questionnaire seems to be a valid and useful instrument to evaluate the participants’ understanding of the ICF. In this study, we found that some concepts, like ‘study protocol’ or ‘randomization’, were not well understood by participants when signing the ICF, especially by participants with lower education levels. They also believed that the experimental intervention would solve their health condition. Greater awareness about the importance of the informed consent process and ICF is necessary so that participants can fully understand the protocol, especially the risks involved, and their rights as participants.
Characteristics, consent patterns, and challenges of randomized trials using the Trials within Cohorts (TwiCs) design A scoping review
Characteristics, consent patterns, and challenges of randomized trials using the Trials within Cohorts (TwiCs) design A scoping review
Original Research
Alain Amstutz, Christof M. Schönenberger, Benjamin Speich, Alexandra Griessbach, Johannes M. Schwenke, Jan Glasstetter, Sophie James, Helena M. Verkooijen, Beverley Nickolls, Clare Relton, Lars G. Hemkens, Frédérique Chammartin, Felix Gerber, Niklaus D. Labhardt, Stefan Schandelmaier, Matthias Briel
Journal of Clinical Epidemiology, 19 July 2024
Open Access
Abstract
Objective
Trials within Cohorts (TwiCs) is a pragmatic design approach that may overcome frequent challenges of traditional randomized trials such as slow recruitment, burdensome consent procedures, or limited external validity. This scoping review aims to identify all randomized controlled trials using the TwiCs design and to summarize their design characteristics, ways to obtain informed consent, output, reported challenges and mitigation strategies.
Study design and setting
Systematic search of Medline, Embase, Cochrane, trial registries and citation tracking up to December 2022. TwiCs were defined as randomized trials embedded in a cohort with post-randomization consent for the intervention group and no specific post-randomization consent for the usual care control group. Information from identified TwiCs were extracted in duplicate from protocols, publications, and registry entries. We analyzed the information descriptively and qualitatively to highlight methodological challenges and solutions related to non-uptake of interventions and informed consent procedure.
Results
We identified a total of 46 TwiCs conducted between 2005 and 2022 in 14 different countries by a handful of research groups. The most common medical fields were oncology (11/46; 24%), infectious diseases (8/46;17%), and mental health (7/46; 15%). A typical TwiCs was investigator-initiated (46/46;100%), publicly funded (36/46; 78%), and recruited outpatients (27/46; 59%). Excluding eight pilot trials, only 16/38 (42%) TwiCs adjusted their calculated sample size for non-uptake of the intervention, anticipating a median non-uptake of 25% (interquartile range 10%-32%) in the experimental arm. Seventeen TwiCs (45%) planned analyses to adjust effect estimates for non-uptake. Regarding informed consent, we observed three patterns: 1) three separate consents for cohort participation, randomization, and intervention (17/46; 37%); 2) combined consent for cohort participation and randomization and a separate intervention consent (10/46; 22%); and 3) consent only for cohort participation and intervention (randomization consent not mentioned; 19/46; 41%).
Conclusions
Existing TwiCs are globally scattered across a few research groups covering a wide range of medical fields and interventions. Despite the potential advantages, the number of TwiCs remains small. The variability in consent procedures and the possibility of substantial non-uptake of the intervention warrants further her research to guide the planning, implementation, and analysis of TwiCs.
Waiving the consent requirement to mitigate bias in observational precision medicine research
Waiving the consent requirement to mitigate bias in observational precision medicine research
Comment
Ruifeng Song
International Journal for Equity, 18 July 2024
Open Access
Abstract
Consent bias is a type of selection bias in biomedical research where those consenting to the research differ systematically from those not consenting. It is particularly relevant in precision medicine research because the complexity of these studies prevents certain subgroups from understanding, trusting, and consenting to the research. Because consent bias distorts research findings and causes inequitable distribution of research benefits, scholars propose two types of schemes to reduce consent bias: reforming existing consent models and removing the consent requirement altogether. This study explores the possibility of waiving consent in observational studies using existing data, because they involve fewer risks to participants than clinical trials if privacy safeguards are strengthened. It suggests that data protection mechanisms such as security enhancement and data protection impact assessment should be conducted to protect data privacy of participants in observational studies without consent.
Editor’s note: In reflecting on the argument as presented in the abstract, we are reaching out to explore and assess further in dialogue with the author.
Coerced consent in clinical research: study protocol for a randomized controlled trial
Coerced consent in clinical research: study protocol for a randomized controlled trial
Study Protocol
Connor T. A. Brenna, Nancy Walton, Melanie Cohn, Urooj Siddiqui, Ella Huszti, Richard Brull
Trials, 4 July 2024
Open Access
Abstract
Background
Despite the low-risk nature of participation in most clinical anesthesia trials, subject recruitment on the same day as surgery is often restricted due to the concerns of researchers and local research ethics boards that same-day consent may not afford adequate time and opportunity for patients to weigh and make decisions, as well as perceptions of patient vulnerability immediately prior to surgery that could impact the voluntary nature and the rigor of the informed consent process. However, specialties such as anesthesiology, critical care, interventional radiology, and emergency medicine have a varied pattern of practice and patient acquaintance that does not typically afford the luxury of time or, in many cases, advance consent for participation in research. Indeed, the initial encounter between anesthesiologists and patients undergoing elective procedures routinely occurs on the day of surgery. Concerns of coercion related to same-day consent for clinical anesthesia research trials have not been borne out in the literature, and represent a significant obstacle to clinical researchers, as well as to the patients who are denied opportunities for potential benefit through participation in research studies.
Methods
We describe the protocol for a prospective randomized controlled trial examining the voluntariness of patient consent, solicited either in advance of surgery or on the same day, to participate in an anesthesia research study at Women’s College Hospital [Toronto, Canada]. One hundred fourteen patients scheduled to undergo ambulatory anterior cruciate ligament repair facilitated by general anesthesia with an adductor canal block will be randomized for recruitment either (a) in the pre-operative assessment clinic before the day of surgery or (b) on the day of surgery, to be approached for consent to participate in a fabricated research study of adjunct medications in adductor canal blocks. Regardless of allocation, patients in both groups will receive the same routine standard of care and will complete a post-operative questionnaire to signal perceptions of undue influence in the process of providing informed consent for the fabricated trial.
Discussion
This study will inform trial design and practice guidelines surrounding the amount of time patients ought to be afforded in order to make durable decisions to participate (or not) in clinical research studies. This is expected to impact trial recruitment in a variety of clinical settings where researchers have only brief opportunities to interface with patients.
Center for Informed Consent Integrity 