Surfactants and the importance of informed consent: Nurturing culturally competent care in healthcare settings.

BACKGROUND: Culturally competent healthcare improves patient satisfaction and clinical outcomes. Many drugs, dressings and implants have human or animal-derived content which may conflict with patients' religious beliefs, and may even have medicolegal implications. METHODS: This cross-sectional study (anonymous web-based survey) was done to understand the informed consent process followed by paediatricians and neonatologists in India, their views regarding disclosure pertaining to the animal origin of exogenous surfactants to patients' families, and their willingness and ability to provide alternative surfactants based on parental preferences. RESULTS: A total of 114 neonatologists/paediatricians involved in neonatal care and using surfactants in their practice responded to the survey. Although 61(53.5%) neonatal care units stocked two or more brands of surfactant in their inventory, only 38(33.3%) units had both bovine and porcine preparations. Most (104, 91.2%) of the doctors always take parental consent before administering surfactants; but only a few (12,10.5%) said they always inform parents about its animal origin. None of the respondents offer parents a choice between bovine or porcine-origin surfactants, most (73, 64%) presuming that it would be irrelevant for the parents. However, many respondents (27, 23.7%) mentioned that they want to offer the choice to parents but are unable to do so because they do not stock both bovine and porcine preparations. CONCLUSION: Although most parents might agree to a life-saving medicine in emergency situations, this does not mean they do not want to be informed. Healthcare professionals should not have a dismissive attitude to parental belief systems. They must use the antenatal period to take the cultural/spiritual history and the necessary consent.

Ethical issues and proposed solutions in conducting practical assessment of medical students involving patients.

Practical assessment involving patients plays a vital role in medical education, allowing students to demonstrate their clinical competencies. However, there are significant ethical concerns associated with these assessments that require careful consideration and resolution. The primary ethical concerns include violation of patient autonomy, lack of written informed consent, power dynamics, cultural differences, potential harm to patients, breach of privacy and confidentiality, discomfort to admitted patients, financial loss to patients, impact on other patients' care, and delays in workup/procedures. To address these concerns, measures such as respecting patient autonomy, obtaining written informed consent, ensuring patient safety, exploring alternative methods, providing reimbursement, resource planning, creating a supportive environment, developing cultural competency, putting in place a feedback system, prioritising patient care, and implementing ethical oversight and monitoring are recommended. The formulation of a guideline could be a crucial starting point, and it should be integrated into a broader ethical framework that encompasses education and training, ethical oversight, ongoing monitoring, and a culture that prioritises ethical conduct.

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.

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.

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.

#consented - A semantic consent code to facilitate consistent documentation and implementation of consent in collaborative medical research.

INTRODUCTION: In German and international research networks different approaches concerning patient consent are applied. So far it is time-consuming to find out to what extent data from these networks can be used for a specific research project. To make the contents of the consents queryable, we aimed for a permission-based approach (Opt-In) that can map both the permission and the withdrawal of consent contents as well as make it queryable beyond project boundaries. MATERIALS AND METHODS: The current state of research was analysed in terms of approach and reusability. Selected process models for defining consent policies were abstracted in a next step. On this basis, a standardised semantic terminology for the description of consent policies was developed and initially agreed with experts. In a final step, the resulting code was evaluated with regards to different aspects of applicability. RESULTS: A first and extendable version for a Semantic Consent Code (SCC) based on 3-axis (CLASS, ACTION, PURPOSE) was developed, consolidated und published. The added value achieved by the SCC was illustrated using the example of real consents from large national research associations (Medical Informatics Initiative and NUM NAPKON/NUKLEUS). The applicability of the SCC was successfully evaluated in terms of the manual semantic mapping of consents by briefly trained personnel and the automated interpretability of consent policies according to the SCC (and vice versa). In addition, a concept for the use of the SCC to simplify consent queries in heterogeneous research scenarios was presented. CONCLUSIONS: The Semantic Consent Code has already successfully undergone initial evaluations. As the published 3-axis code SCC is an essential preliminary work to standardising initially diverse consent texts and contents and can iteratively be extended in multiple ways in terms of content and technical additions. It should be extended in cooperation with the potential user community.

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.

Normative challenges in data governance: insights from global health research.

Many important questions in health professions education require datasets that are built from several sources, in some cases using data collected for a different purpose. In building and maintaining these datasets, project leaders will need to make decisions about the data. While such decisions are often construed as technical, there are several normative concerns, such as who should have access, how the data will be used, how products resulting from the data will be shared, and how to ensure privacy of the individuals the data is about is respected, etc. Establishing a framework for data governance can help project leaders in avoiding problems, related to such matters, that could limit what can be learned from the data or that might put the project (or future projects) at risk. In this paper, we highlight several normative challenges to be addressed when determining a data governance framework. Drawing from lessons in global health, we illustrate three kinds of normative challenges for projects that rely on data from multiple sources or involved partnerships across institutions or jurisdictions: (1) legal and regulatory requirements, (2) consent, and (3) equitable sharing and fair distribution.

[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.

Patient information leaflets for placebo-controlled surgical trials: a review of current practice and recommendations for developers.

INTRODUCTION: Informed consent for participation in an RCT is an important ethical and legal requirement. In placebo surgical trials, further issues are raised, and to date, this has not been explored. Patient information leaflets (PILs) are a core component of the informed consent process. This study aimed to investigate the key content of PILs for recently completed placebo-controlled trials of invasive procedures, including surgery, to highlight areas of good practice, identify gaps in information provision for trials of this type and provide recommendations for practice. METHODS: PILs were sought from trials included in a recent systematic review of placebo-controlled trials of invasive procedures, including surgery. Trial characteristics and data on surgical and placebo interventions under evaluation were extracted. Directed content analysis was applied, informed by published regulatory and good practice guidance on PIL content and existing research on placebo-controlled surgical trials. Results were analysed using descriptive statistics and presented as a narrative summary. RESULTS: Of the 62 eligible RCTs, authors of 59 trials were contactable and 14 PILs were received for analysis. At least 50% of all PILs included content on general trial design. Explanations of how the placebo differs or is similar to the surgical intervention (i.e. fidelity) were reported in 6 (43%) of the included PILs. Over half (57%) of the PILs included information on the potential therapeutic benefits of the surgical intervention. One (7%) included information on potential indirect therapeutic benefits from invasive components of the placebo. Five (36%) presented the known risks of the placebo intervention, whilst 8 (57%) presented information on the known risks of the surgical intervention. A range of terms was used across the PILs to describe the placebo component, including 'control', 'mock' and 'sham'. CONCLUSION: Developers of PILs for placebo-controlled surgical trials should carefully consider the use of language (e.g. sham, mock), be explicit about how the placebo differs (or is similar) to the surgical intervention and provide balanced presentations of potential benefits and risks of the surgical intervention separately from the placebo. Further research is required to determine optimal approaches to design and deliver this information for these trials.

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.

[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.

The Impact of Using Electronic Consents on Documentation of Language-Concordant Surgical Consent for Patients with Limited English Proficiency.

BACKGROUND: Although access to a professional medical interpreter is federally mandated, surgeons report underutilization during informed consent. Improvement requires understanding the extent of the lapses. Adoption of electronic consent (eConsent) has been associated with improvements in documentation and identification of practice improvement opportunities. The authors evaluated the impact of the transition from paper to eConsent on language-concordant surgical consent delivery for patients with limited English proficiency (LEP). METHODS: The study period (February 8, 2023, to June 14, 2023) corresponds to the period immediately following the institutional adoption of eConsents. Inclusion criteria included age > 18 years, documented preferred language other than English, and self-signed eConsent form. The authors assessed documentation of language-concordant interpreter-mediated verbal consent discussion and delivery of the written surgical consent form in a language-concordant template. Performance was compared to a preimplementation baseline derived from monthly random audits of paper consents between January and December 2022. RESULTS: A total of 1,016 eConsent encounters for patients with LEP were included, with patients speaking 49 different languages, most commonly Spanish (46.5%), Chinese (22.1%), and Russian (6.8%). After the implementation of eConsent, overall documentation of language-concordant interpreter-mediated consents increased from 56.9% to 83.9% (p < 0.001), although there was variation between surgical services and between languages, suggesting that there is still likely room for improvement. Most patients (94.1%) whose preferred language had an associated translated written consent template (Spanish, Chinese, Russian, Arabic), received a language-concordant written consent. CONCLUSION: The transition to eConsent was associated with improved documentation of language-concordant informed consent in surgery, both in terms of providing written materials in the patient's preferred language and in the documentation of interpreter use, and allowed for the identification of areas to target for practice improvement with interpreter use.

Surgical informed consent practices and influencing factors in sub-Saharan Africa: a scoping review of the literature.

INTRODUCTION: Current international standards in consent to surgery practices are usually derived from health systems in Western countries, while little attention has been given to other contexts such as sub-Saharan Africa (SSA), despite this region facing the highest burdens of disease amenable to surgery globally. The aim of this study was to examine how the concept of informed consent for surgery is interpreted and applied in the context of SSA, and factors affecting current practices. METHODS: A systematic search of Medline, Embase and African Journal OnLine databases as well as grey sources was executed in May 2023 to retrieve relevant literature published since 2010 in English language against a set of given criteria. The socioecological framework for health was used for organising and summarising the identified evidence. RESULTS: A total of 27 papers were included in the review. Findings revealed that consent to surgery practices is generally substandard across SSA and the process is not adequate. Patients' understanding of informed consent is limited, likewise awareness of their rights to decision-making. A range of factors at the individual, interpersonal, institutional and system/societal levels affect the informed consent process. CONCLUSION: There is a need to find more culturally acceptable and ethical ways to include the participation of patients in the decision-making process for surgical treatment in the SSA and define standards more closely aligned with the local context.

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.

Should Obtaining Informed Consent Be Considered an Entrustable Professional Activity? Insights From Whether and How Attendings Entrust Surgical Trainees.

PURPOSE: Because residents are frequently delegated the task of obtaining consent early in their training, the American Association of Medical Colleges describes "obtaining informed consent" as a core entrustable professional activity (EPA) for medical school graduates. However, prior studies demonstrated that residents frequently perform this task without receiving formal instruction or assessment of competency. This study sought to understand how attending physicians decide to delegate obtaining informed consent for surgical procedures to trainees. METHOD: The authors conducted a survey of attending surgeons at a university-based health care system of 6 affiliated teaching hospitals (October-December 2020) to collect data about current entrustment practices and attendings' knowledge, experience, and attitudes surrounding the informed consent process. Summary statistics and bivariate analyses were applied. RESULTS: Eighty-five attending surgeons participated (response rate, 49.4%) from diverse specialties, practice types, and years in practice. Fifty-eight of 85 (68.2%) stated they "never" granted responsibility for the consent conversation to a trainee, and 74/81 (91.4%) reported they typically repeated their own consent conversation whenever a trainee already obtained consent. The most common reasons they retained responsibility for consent were ethical duty (69/82, 84.1%) and the patient relationship (65/82, 79.3%), while less than half (40/82, 48.8%) described concerns about trainee competency. Reflecting on hypothetical clinical scenarios, increased resident competency did not correspond with increased entrustment ( P = .27-.62). Nearly all respondents (83/85, 97.7%) believed residents should receive formal training; however, only 41/85 (48.2%) felt additional training and assessment of residents might change their current entrustment practices. CONCLUSIONS: Attendings view informed consent as an ethical and professional obligation that typically cannot be entrusted to trainees. This practice is discordant with previous literature studying residents' perspectives. Furthermore, resident competency does not play a predominant role in this decision, calling into question whether informed consent can be considered an EPA.

Algunos interrogantes a la no presencialidad y la mediación tecnológica en el proceso de consentimiento informado / Some questions regarding non-presence and mediation technology in the informed consent process

Frente a los grandes desafíos que se nos presenta con los avances tecnológicos nos interrogamos sobre la posibilidad del uso de las nuevas tecnologías para la obtención del consentimiento informado. Sin perder de vista la necesidad de agilizar estos procedimientos pero puesta la mirada en el sujeto, parte de la investigación, ¿se protege su dignidad y su autonomía con el uso de estas nuevas formas? O pensarlo de modo contrario, ¿con el tradicional procedimiento de consentimiento informado, se protege al sujeto que participa en el proyecto de investigación? (AU)

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.