Waiving the consent requirement to mitigate bias in observational precision medicine research.

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.

Principles of digital professionalism for the metaverse in healthcare.

BACKGROUND: Experts are currently investigating the potential applications of the metaverse in healthcare. The metaverse, a groundbreaking concept that arose in the early 21st century through the fusion of virtual reality and augmented reality technologies, holds promise for transforming healthcare delivery. Alongside its implementation, the issue of digital professionalism in healthcare must be addressed. Digital professionalism refers to the knowledge and skills required by healthcare specialists to navigate digital technologies effectively and ethically. This study aims to identify the core principles of digital professionalism for the use of metaverse in healthcare. METHOD: This study utilized a qualitative design and collected data through semi-structured online interviews with 20 medical information and health informatics specialists from various countries (USA, UK, Sweden, Netherlands, Poland, Romania, Italy, Iran). Data analysis was conducted using the open coding method, wherein concepts (codes) related to the themes of digital professionalism for the metaverse in healthcare were assigned to the data. The analysis was performed using the MAXQDA software (VER BI GmbH, Berlin, Germany). RESULTS: The study revealed ten fundamental principles of digital professionalism for the metaverse in healthcare: Privacy and Security, Informed Consent, Trust and Integrity, Accessibility and Inclusion, Professional Boundaries, Evidence-Based Practice, Continuous Education and Training, Collaboration and Interoperability, Feedback and Improvement, and Regulatory Compliance. CONCLUSION: As the metaverse continues to expand and integrate itself into various industries, including healthcare, it becomes vital to establish principles of digital professionalism to ensure ethical and responsible practices. Healthcare professionals can uphold these principles to maintain ethical standards, safeguard patient privacy, and deliver effective care within the metaverse.

Generating Informed Consent Documents Related to Blepharoplasty Using ChatGPT.

PURPOSE: This study aimed to demonstrate the performance of the popular artificial intelligence (AI) language model, Chat Generative Pre-trained Transformer (ChatGPT) (OpenAI, San Francisco, CA, U.S.A.), in generating the informed consent (IC) document of blepharoplasty. METHODS: A total of 2 prompts were provided to ChatGPT to generate IC documents. Four board-certified plastic surgeons and 4 nonmedical staff members evaluated the AI-generated IC documents and the original IC document currently used in the clinical setting. They assessed these documents in terms of accuracy, informativeness, and accessibility. RESULTS: Among board-certified plastic surgeons, the initial AI-generated IC document scored significantly lower than the original IC document in accuracy ( p < 0.001), informativeness ( p = 0.005), and accessibility ( p = 0.021), while the revised AI-generated IC document scored lower compared with the original document in accuracy ( p = 0.03) and accessibility ( p = 0.021). Among nonmedical staff members, no statistical significance of 2 AI-generated IC documents was observed compared with the original document in terms of accuracy, informativeness, and accessibility. CONCLUSIONS: The results showed that current ChatGPT cannot be used as a distinct patient education resource. However, it has the potential to make better IC documents when improving the professional terminology. This AI technology will eventually transform ophthalmic plastic surgery healthcare systematics by enhancing patient education and decision-making via IC documents.

Is there an impact of a video-based patient informed consent in elective hand surgery?

BACKGROUND: Patient informed consent is a crucial subject in preoperative care of patients before elective hand surgery, ensuring that patients have the necessary information and a comprehensive understanding to make autonomous decisions. The use of video-based informed consent systems is an innovative concept to enhance the consent process with multimedia tools. In addition to the conventional process, mostly relying on verbal communication and written documents, the video-based approach aims to present information in a standardized and visually appealing format. METHODS: In this study, 33 patients were asked to watch a video on a tablet about the planned elective hand surgery after a conventional pre-treatment consultation including informed consent throughout verbal explanations and paper forms by an attending physician or resident. All patients were asked to complete a questionnaire after watching the video. RESULTS: An overwhelming majority of participants, specifically 97.0%, stated that the video improved their understanding of the upcoming surgery. 90.9% of the participant would refer the video to other patients undergoing elective hand surgery, while 72.7% of participants indicated that they would have appreciated the opportunity to view an informational video before undergoing different types of surgeries in the past. CONCLUSION: The use of a video-based patient information system in elective hand surgery had a positive impact on patient education and satisfaction with the informed consent process. Therefore, it is a powerful tool in preoperative management to guarantee a standardized and educative informed consent.

[Nationally standardized broad consent in practice: initial experiences, current developments, and critical assessment]. / National standardisierter Broad Consent in der Praxis: erste Erfahrungen, aktuelle Entwicklungen und kritische Betrachtungen.

BACKGROUND: The digitalization in the healthcare sector promises a secondary use of patient data in the sense of a learning healthcare system. For this, the Medical Informatics Initiative's (MII) Consent Working Group has created an ethical and legal basis with standardized consent documents. This paper describes the systematically monitored introduction of these documents at the MII sites. METHODS: The monitoring of the introduction included regular online surveys, an in-depth analysis of the introduction processes at selected sites, and an assessment of the documents in use. In addition, inquiries and feedback from a large number of stakeholders were evaluated. RESULTS: The online surveys showed that 27 of the 32 sites have gradually introduced the consent documents productively, with a current total of 173,289 consents. The analysis of the implementation procedures revealed heterogeneous organizational conditions at the sites. The requirements of various stakeholders were met by developing and providing supplementary versions of the consent documents and additional information materials. DISCUSSION: The introduction of the MII consent documents at the university hospitals creates a uniform legal basis for the secondary use of patient data. However, the comprehensive implementation within the sites remains challenging. Therefore, minimum requirements for patient information and supplementary recommendations for best practice must be developed. The further development of the national legal framework for research will not render the participation and transparency mechanisms developed here obsolete.

Capacity to Consent in Healthcare: A Systematic Review and Meta-Analysis Comparing Patients with Bipolar Disorders and Schizophrenia Spectrum Disorders.

Background: Mental capacity is a fundamental aspect that enables patients to fully participate in various healthcare procedures. To assist healthcare professionals (HCPs) in assessing patients' capacity, especially in the mental health field, several standardized tools have been developed. These tools include the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), and the Competence Assessment Tool for Psychiatric Advance Directives (CAT-PAD). The core dimensions explored by these tools include Understanding, Appreciation, Reasoning, and Expression of a choice. Objective: This meta-analysis aimed to investigate potential differences in decision-making capacity within the healthcare context among groups of patients with bipolar disorders (BD) and schizophrenia spectrum disorders (SSD). Methods: A systematic search was conducted on Medline/Pubmed, and Scopus. Additionally, Google Scholar was manually inspected, and a manual search of emerging reviews and reference lists of the retrieved papers was performed. Eligible studies were specifically cross-sectional, utilizing standardized assessment tools, and involving patients diagnosed with BD and SSD. Data from the studies were independently extracted and pooled using random-effect models. Hedges' g was used as a measure for outcomes. Results: Six studies were identified, with three studies using the MacCAT-CR, two studies the MacCAT-T, and one the CAT-PAD. The participants included 189 individuals with BD and 324 individuals with SSD. The meta-analysis revealed that patients with BD performed slightly better compared to patients with SSD, with the difference being statistically significant in the domain of Appreciation (ES = 0.23, 95% CI: 0.01 to 0.04, p = 0.037). There was no statistically significant difference between the two groups for Understanding (ES = 0.09, 95% CI:-0.10 to 0.27, p = 0.352), Reasoning (ES = 0.18, 95% CI: -0.12 to 0.47, p = 0.074), and Expression of a choice (ES = 0.23, 95% CI: -0.01 to 0.48, p = 0.60). In the sensitivity analysis, furthermore, when considering only studies involving patients in symptomatic remission, the difference for Appreciation also resulted in non-significant (ES = 0.21, 95% CI: -0.04 to 0.46, p = 0.102). Conclusions: These findings indicate that there are no significant differences between patients with BD and SSD during remission phases, while differences are minimal during acute phases. The usefulness of standardized assessment of capacity at any stage of the illness should be considered, both for diagnostic-therapeutic phases and for research and advance directives. Further studies are necessary to understand the reasons for the overlap in capacity between the two diagnostic categories compared in this study.

Key requirements for obtaining valid informed consent to treatment.

Richard Griffith, Senior Lecturer in Health Law at Swansea University, discusses the importance of consent in nursing and outlines the key elements for ensuring the patient has given valid consent before providing treatment.

[Applying consent, in healthcare and beyond]. / Appliquer le consentement, dans les soins et au-delà.

Sexual violence constitutes a form of gender-based violence, to the extent that the victims are mainly women. Other groups of vulnerable people are also more affected, in particular gender and sexual diversity persons. Sexual and gender-based violence can also occur in healthcare. To respect the legal framework and people's rights, but also to promote safety and quality in healthcare, it is essential to obtain and respect consent. Consent must be informed, explicit, freely given, and reiterated throughout the consultation. This article reviews the concept of consent and offers practical tools for its application in healthcare.

Les violences sexuelles constituent une violence de genre, dans la mesure où les victimes sont principalement des femmes et les auteurs des hommes. D'autres groupes de personnes vulnérables sont également davantage concernés, en particulier les personnes de la diversité sexuelle et de genre. Ces violences sexuelles et de genre existent également dans les soins. Afin de respecter le cadre légal et les droits des personnes, mais aussi de favoriser des soins de qualité et en sécurité, il est primordial de recueillir et respecter le consentement. Celui-ci doit être éclairé, explicite, libre et réitéré tout au long de la consultation. Cet article fait le point sur le concept du consentement et offre des outils pratiques pour son application dans les soins.

Applicability and usefulness of the Declaration of Helsinki for forensic research with human cadavers and remains.

Bodies of deceased persons and human remains and their specimens (i.e., organs, bones, tissues, or biological samples) are essential in forensic research but ad hoc worldwide-recognized ethical standards for their use are still lacking. Such standards are needed both to avoid possible unethical practices and to sustain research in the forensic field. Pending consensus within the forensic science community regarding this topic, with this article we aim to stimulate a debate as to the applicability and usefulness of the Declaration of Helsinki in the field of forensic research involving human cadavers and remains. Considering the fundamental differences compared to clinical research involving human beings and the different moral obligations involved, we focus on the risks, burdens, and benefits of research, ethics committee approval, and informed consent requirements. The Declaration of Helsinki framework allows forensic researchers to focus on substantial ethical principles promoting the consistency, integrity, and quality of research. Consensus regarding ethical standards and the adoption of national and supranational laws that clearly regulate the use of human cadavers and remains, including those from autopsies, continues to be of primary importance for the forensic science community.

Deferral of Consent: Recent Lessons From Canadian Acute Stroke Trials.

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Rethinking Consent for Stroke Trials in Time-Sensitive Situations: Insights From the COVID-19 Pandemic.

Informed consent is a key concept to ensure patient autonomy in clinical trials and routine care. The coronavirus disease 2019 (COVID-19) pandemic has complicated informed consent processes, due to physical distancing precautions and increased physician workload. As such, obtaining timely and adequate patient consent has become a bottleneck for many clinical trials. However, this challenging situation might also present an opportunity to rethink and reappraise our approach to consent in clinical trials. This viewpoint discusses the challenges related to informed consent during the COVID-19 pandemic, whether it could be acceptable to alter current consent processes under these circumstances, and outlines a possible framework with predefined criteria and a system of checks and balances that could allow for alterations of existing consent processes to maximize patient benefit under exceptional circumstances such as the COVID-19 pandemic without undermining patient autonomy.

Government Mandated Consent Dramatically Reduces Pediatric Urologist Opioid Utilization for Outpatient and Minor Emergency Surgeries.

PURPOSE: Postoperative opioids are overprescribed in the United States. In November 2016 the State of Pennsylvania required an opioid consent for minors. Our hypothesis is that this mandate decreased postoperative opioid prescriptions in our division. MATERIALS AND METHODS: All patients who received a urological outpatient or minor emergency procedure from August 2015 to August 2019 were identified. Surgeries performed within 6 months after mandate implementation were excluded to account for the transition period. Perioperative data including case type were extracted by a clinical data warehouse from preexisting fields within the health record. The frequencies of postoperative prescriptions, delayed prescriptions and emergency department encounters were assessed. A multivariable logistic regression to identify predictors of opioid prescription at discharge was performed. RESULTS: A total of 4,349 patients were analyzed. The frequency of postsurgical opioid prescriptions decreased from 45.3% to 2.6% (p <0.001). The median morphine milligram equivalent decreased by 22.5 among children prescribed an opioid (p <0.001). Rates of an emergency department visits (3% vs 2.7%) or delayed nonopioid prescriptions (0.8% vs 1.2%) within 30 days of discharge were unchanged (p >0.05). Fewer patients received a delayed opioid prescription after mandate implementation (0.03% vs 0.5%, p <0.001). Female patients were less likely (OR 0.309, 95% CI 0.195-0.491; p <0.001) to receive opioids prior to but not after the mandate (OR 0.309, 95% CI 0.544-2.035; p=0.122). Increasing age was predictive of receiving an opioid before (OR 1.187, 95% CI 1.157-1.218; p <0.001) and after (OR 1.241, 95% CI 1.186-1.299; p <0.001) the mandate. CONCLUSIONS: A state mandated opioid consent for minors greatly reduced post-urological surgery opioid prescription rates without increasing rates of readmission or delayed prescriptions.

Society for Vascular Surgery best practice recommendations for use of social media.

The use of social media (SoMe) in medicine has demonstrated the ability to advance networking among clinicians and other healthcare staff, disseminate research, increase access to up-to-date information, and inform and engage medical trainees and the public at-large. With increasing SoMe use by vascular surgeons and other vascular specialists, it is important to uphold core tenets of our commitment to our patients by protecting their privacy, encouraging appropriate consent and use of any patient-related imagery, and disclosing relevant conflicts of interest. Additionally, we recognize the potential for negative interactions online regarding differing opinions on optimal treatment options for patients. The Society for Vascular Surgery (SVS) is committed to supporting appropriate and effective use of SoMe content that is honest, well-informed, and accurate. The Young Surgeons Committee of the SVS convened a diverse writing group of SVS members to help guide novice as well as veteran SoMe users on best practices for advancing medical knowledge-sharing in an online environment. These recommendations are presented here with the goal of elevating patient privacy and physician transparency, while also offering support and resources for infrequent SoMe users to increase their engagement with each other in new, virtual formats.

Surgical Residents' Perspective on Informed Consent-How Does It Compare With Attending Surgeons?

BACKGROUND: The informed consent discussion (ICD) is a compulsory element of clinical practice. Surgical residents are often tasked with obtaining informed consent, but formal instruction is not included in standard curricula. This study aims to examine attitudes of surgeons and residents concerning ICD. MATERIALS AND METHODS: A survey regarding ICD was administered to residents and attending surgeons at an academic medical center with an Accreditation Council for Graduate Medical Education-accredited general surgery residency. RESULTS: In total, 44 of 64 (68.75%) residents and 37 of 50 (72%) attending surgeons participated. Most residents felt comfortable consenting for elective (93%) and emergent (82%) cases, but attending surgeons were less comfortable with resident-led ICD (51% elective, 73% emergent). Resident comfort increased with postgraduate year (PGY) (PGY1 = 39%, PGY5 = 85%). A majority of participants (80% attending surgeons, 73% residents) believed resident ICD skills should be formally evaluated, and most residents in PGY1 (61%) requested formal instruction. High percentages of residents (86%) and attendings (100%) believed that ICD skills were best learned from direct observation of attending surgeons. CONCLUSIONS: Resident comfort with ICD increases as residents advance through training. Residents acknowledge the importance of their participation in this process, and in particular, junior residents believe formal instruction is important. Attending surgeons are not universally comfortable with resident-led ICDs, particularly for elective surgeries. Efforts for improving ICD education including direct observation between attending surgeons and residents and formal evaluation may benefit the residency curriculum.

Start me up: ways to encourage sharing of genomic information with research participants.

Personalized and precision medicine initiatives explicitly call for researchers to treat research participants as partners. One way to realize that goal is by returning individual research results to participants. I propose a number of concrete steps that could facilitate that process.

A literature review of consent declines and consent withdrawals in randomized controlled trials conducted during the COVID-19 pandemic.

Objectives: We evaluated the extent of consent declines and consent withdrawals during the COVID-19 pandemic as seen in published randomized controlled trials (RCTs) and compared it with non-COVID-19 RCTs published at the same time and two historical controls. Methods: PubMed/Medline only was searched using key-word "COVID-19" and "RCTs" separately, and filtered for COVID-19 RCTs and non-COVID-19 RCTs respectively, published during a nine-month period (1 Feb - 1 Nov 2020). Exclusions were study protocols, observational studies, interim analysis of RCT data and RCTs with missing data. Primary outcome measures were the proportion of consent declines and consent withdrawals as percentage of total participants screened and randomized respectively in COVID-19 RCTs. We compared consent declines and consent withdrawals of COVID-19 RCTs with non-COVID-19 RCTs and two earlier studies on the same topic that served as historical controls (non-pandemic setting). Results: The search yielded a total of 111 COVID-19 RCTs and 49 non-COVID-19 RCTs. Of these, 39 (35.13%) COVID-19 RCTs and 11 (22.45%) non-COVID-19 RCTs were finally analysed. A total of 770/17759 (4.3%) consent declines and 100/7607 (1.31%) consent withdrawals were seen in 39 COVID-19 RCTs. A significant difference was observed in consent declines between COVID-19 vs non-COVID-19 RCTs [4.3% vs 11.9%, p < 0.0001] and between COVID-19 RCTs vs two historical controls [(4.3% vs 8.6%, p < 0.0001) and (4.3% vs 21.1%, p < 0.0001), respectively]. Conclusion: RCTs conducted during the COVID-19 pandemic appear to have significantly lower consent declines relative to non-COVID-19 RCTs during pandemic and RCTs conducted in non-pandemic settings.

Conducting clinical trials in heart failure during (and after) the COVID-19 pandemic: an Expert Consensus Position Paper from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC).

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has important implications for the safety of participants in clinical trials and the research staff caring for them and, consequently, for the trials themselves. Patients with heart failure may be at greater risk of infection with COVID-19 and the consequences might also be more serious, but they are also at risk of adverse outcomes if their clinical care is compromised. As physicians and clinical trialists, it is our responsibility to ensure safe and effective care is delivered to trial participants without affecting the integrity of the trial. The social contract with our patients demands no less. Many regulatory authorities from different world regions have issued guidance statements regarding the conduct of clinical trials during this COVID-19 crisis. However, international trials may benefit from expert guidance from a global panel of experts to supplement local advice and regulations, thereby enhancing the safety of participants and the integrity of the trial. Accordingly, the Heart Failure Association of the European Society of Cardiology on 21 and 22 March 2020 conducted web-based meetings with expert clinical trialists in Europe, North America, South America, Australia, and Asia. The main objectives of this Expert Position Paper are to highlight the challenges that this pandemic poses for the conduct of clinical trials in heart failure and to offer advice on how they might be overcome, with some practical examples. While this panel of experts are focused on heart failure clinical trials, these discussions and recommendations may apply to clinical trials in other therapeutic areas.

Thinking about the idea of consent in data science genomics: How 'informed' is it?

In this paper we argue that 'informed' consent in Big Data genomic biobanking is frequently less than optimally informative. This is due to the particular features of genomic biobanking research which render it ethically problematic. We discuss these features together with details of consent models aimed to address them. Using insights from consent theory, we provide a detailed analysis of the essential components of informed consent which includes recommendations to improve consent performance. In addition, and using insights from philosophy of mind and language and psycholinguistics we support our analyses by identifying the nature and function of concepts (ideas) operational in human cognition and language together with an implicit coding/decoding model of human communication. We identify this model as the source of patients/participants poor understanding. We suggest an alternative, explicit model of human communication, namely, that of relevance-theoretic inference which obviates the limitations of the code model. We suggest practical strategies to assist health service professionals to ensure that the specific information they provide concerning the proposed treatment or research is used to inform participants' decision to consent. We do not prescribe a standard, formal approach to decision-making where boxes are ticked; rather, we aim to focus attention towards the sorts of considerations and questions that might usefully be borne in mind in any consent situation. We hope that our theorising will be of real practical benefit to nurses and midwives working on the clinical and research front-line of genomic science.

Errors and omissions in deprivation of liberty authorisation forms.

Richard Griffith, Senior Lecturer in Health Law at Swansea University, considers the impact of errors and omissions in the forms required to lawfully authorise a deprivation of liberty under the Mental Health Act 2005.