Universal screening of colorectal tumors for lynch syndrome: a survey of patient experiences and opinions.

BACKGROUND: Lynch syndrome represents the most common hereditary cause of both colorectal and endometrial cancer. It is caused by defects in mismatch repair genes, as well as EPCAM. Universal screening of colon tumors for Lynch syndrome via microsatellite instability (MSI) and/or immunohistochemistry (IHC) can identify patients and families at risk to develop further cancers and potentially impact surveillance and treatment options. The approach to implementation of universal screening, taking ethical considerations into account, is critical to its effectiveness, with patient perspectives providing valuable insight. METHODS: Patients whose colon tumors underwent universal screening at Penn State Hershey Medical Center over a period of 2.5 years were mailed a survey on universal screening in 2017. Along with the survey, they received a recruitment letter and a summary explanation of research. The survey included both multiple choice and free-response questions that covered topics including respondent knowledge of Lynch syndrome, attitudes toward universal screening and experiences with the screening protocol as implemented. RESULTS: Sixty-six of 297 possible patients (22.2%) responded to the survey, including 13 whose screening results raised concern for Lynch syndrome. 75.8% of respondents supported universal tumor screening without informed consent. 92.4% preferred receiving screening results regardless of outcome. Respondents described benefits to screening for themselves and their families. CONCLUSIONS: While broadly supporting universal tumor screening without informed consent, respondents also wanted more information shared about the screening policy, as well as their results. These patient preferences should be one of many factors considered when implementing universal screening and can also inform practices regarding both tumor profiling and universal genetic testing, which is becoming more prevalent.

Enhancing informed consent through multimedia tools in pediatric spinal surgery: a comprehensive review.

Pediatric spine surgery is a high complexity procedure that can carry risks ranging from pain to neurological damage, and even death. This comprehensive mini review explores current best practice obtaining valid and meaningful informed consent (IC) prior to pediatric spinal surgery, including modalities that support effective comprehension and understanding. An evaluation of the literature was performed to explore understanding of surgical IC by patients or their guardians and the role of multimedia tools as a possible facilitator. The evidence discussed throughout this review, based on legal and ethical perspectives, reveals challenges faced by patients and guardians in achieving comprehension and understanding, especially when facing stressful medical situations. In this context, the introduction of multimedia tools emerges as a patient-centered strategy to help improve comprehension and decrease pre-operative uncertainty. This review highlights the need for a tailored approach in obtaining IC for pediatric patients and suggests a potential role of shared decision-making (SDM) in the surgical discussion process.

Informed consent in neurosurgery - Evaluation of current practice and implementation of future strategies.

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.

Understanding the Appropriate and Beneficial Use of Before and After Photos in Breast Surgery: A North American Survey.

Introduction: Before and after photographs (BAPs) in breast surgery have been identified as important components of the informed consent process. Currently, there is limited consensus on the contents and presentation of BAPs. This study collected the opinions of prior and prospective patients on this topic. Methods: A survey, based on criteria identified by our previous nominal group technique (NGT) study, was designed to obtain patient perspectives on BAPs in breast surgery. Amazon Mechanical Turk, a validated crowd-sourcing tool, was used to identify and survey a group of 72 participants who indicated that they had undergone or were planning to undergo breast surgery. Likert items were analyzed using either chi-squared or Fisher's exact test. Results: Most respondents were cis-gendered-women (89%), Caucasian (83%), and between 31 and 41 years old (38%). Respondents agreed that BAPs are important to the consent process, for enabling patient-centered care, and should be presented in standardized sets. BAPs should be more accessible through different platforms, display multiple time points to show the healing process, and have multiple views including close-ups of scars. Photos should be unaltered except for de-identification, and have more diversity with regard to patient gender, age, skin color, and body mass index. These results align with results from our NGT study. Conclusion: Through this study we have identified many criteria that BAPs should meet according to prior and prospective breast surgery patients. Surgeons should think critically about how they present BAPs during the consent process to ensure effective patient-centered care.

Introduction : En chirurgie mammaire, les photos avant-après (PAP) font partie des aspects importants du processus de consentement éclairé. À l'heure actuelle, le consensus sur le contenu et la présentation des PAP est limité. La présente étude visait à recueillir l'avis de patientes passées et prospectives sur le sujet. Méthodologie : Les chercheurs ont préparé un sondage reposant sur les critères qu'ils avaient établis lors de leur étude antérieure sur la technique du groupe nominal (TGN) pour obtenir les points de vue des patients sur les PAP en chirurgie mammaire. Ils ont utilisé l'outil de production participative validé MechanicalTurk d'Amazon pour repérer et sonder un groupe de 72 participants qui ont indiqué avoir subi ou planifié de subir une chirurgie mammaire. Ils ont analysé les énoncés de l'échelle de Likert au moyen du test du chi carré ou de la méthode exacte de Fisher. Résultats : La plupart des répondants étaient des femme cisgenres (89%), blanches (83%), âgées de 31 à 41 ans (38%). Ces répondants ont convenu que les PAP constituent un aspect important du processus de consentement, qu'elles favorisent des soins axés sur les patients et qu'elles doivent être présentées sous forme d'ensembles standardisés. Les PAP devraient être plus accessibles sur diverses plateformes, présenter divers moments du processus de guérison et de multiples points de vue, y compris des gros plans des cicatrices. Les photos devraient être inaltérées, à part pour la désidentification, et refléter une plus grande diversité de genres, d'âges, de couleurs de peau et d'indices de masse corporelle. Ces résultats concordent avec ceux de l'étude antérieure par la TGN. Conclusion : Grâce à la présente étude, les chercheurs ont relevé de nombreux critères que doivent respecter les PAP selon les patients passés et prospectifs en chirurgie mammaire. Les chirurgiens devraient recourir à la réflexion critique quant à la manière de présenter les PAP pendant le processus de consentement pour s'assurer de prodiguer des soins efficaces axés sur les patients.

Evaluation of a group-based online informed consent conversation (eConsent) in participants from a low-risk vaccination clinical trial.

BACKGROUND: Electronic informed consent (eConsent) usage has expanded in recent years in Europe, especially during the pandemic. Slow recruitment rate and limitations in participant outreach are the challenges often faced in clinical research. Given the benefits of eConsent and group counselling reported in the literature, group eConsent was implemented in recruitment for the SWITCH-ON study. We aim to explore the experience of participants who attended group eConsent for the SWITCH-ON study and evaluate its potential for future use. METHODS: SWITCH-ON study aims to analyse the immunogenicity of a healthy population following bivalent COVID-19 booster vaccination. Four hundred thirty-four healthcare workers aged 18-65 were successfully recruited and sent a questionnaire about their experience with group eConsent. Out of 399 completed questionnaires (response rate 92%), 39 participants did not join group eConsent. The remaining 360 responses were included in the final analysis. Quantitative and qualitative data were reported using descriptive statistical analysis and thematic analysis respectively. RESULTS: Participants found that group eConsent was an efficient method that it allowed them to hear each other's questions and concerns and created a sense of togetherness. However, limited privacy, barriers to asking questions in a group, and peer pressure can limit the use of group eConsent. One hundred sixty-five (46%) participants thought that group eConsent was suitable to recruit participants with diseases or conditions, while 87 (24%) reported limitations with this method. The remaining participants suggested that applicability of group eConsent depended on the diseases or conditions of the study population, and one-to-one conversation should always be available. Participants who had experienced both one-to-one and group eConsent shared different preferred consent formats for future studies. CONCLUSION: Group eConsent was positively evaluated by the participants of a low-risk vaccination study. Participants advised using webinars to provide general information about the study, followed by an individual session for each participant, would retain the benefits of group eConsent and minimise the limitations it posed. This proposed setting addresses privacy questions and makes group eConsent easier to implement. TRIAL REGISTRATION: ClinicalTrials.gov NCT05471440 (registered on 22nd of July, 2022).

The use and ethics of dental photography and social media at an oral healthcare training centre in South Africa.

Background: The ethics surrounding the use and sharing of photographs on social media has come under the spotlight as the Protection of Personal Information Act (POPI Act) has come into play. Aim: The aim is to determine the use, ethical practice and sharing of dental photography on social media among qualified and undergraduate oral health practitioners at a dental school in South Africa. Methods: A cross-sectional study design was used on staff and students at the University of the Western Cape's Dental Faculty in 2022. Chi-squared and Fisher's exact tests were used to determine associations between the different graduation statuses and various demographic factors. Results: From the 80 undergraduate students and 46 qualified oral healthcare practitioners, the majority were aware that photography could be used in dentistry, and 87.3% (n = 110) took photographs of the dental treatments performed on their patients. Only 60.3% of the participants attended an ethical course that addressed issues with social media and digital photography. Almost 80% (n = 100) of the participants did not feel that they needed to mention all the social media platforms that they would use with their patients' photographs before sharing. Conclusion: Dental photography is being used and sometimes shared on social media platforms by some students and staff at university level. Not all participants have attended an ethical course on clinical photography. Dental training needs to include an ethical course on dental photography and the use of sharing photographs on social media. Contribution: Good ethical practice regarding clinical photographs in all undergraduate and postgraduate curriculums, to eliminate any uncertainty.

Are clinicians ethically obligated to disclose their use of medical machine learning systems to patients?

It is commonly accepted that clinicians are ethically obligated to disclose their use of medical machine learning systems to patients, and that failure to do so would amount to a moral fault for which clinicians ought to be held accountable. Call this 'the disclosure thesis.' Four main arguments have been, or could be, given to support the disclosure thesis in the ethics literature: the risk-based argument, the rights-based argument, the materiality argument and the autonomy argument. In this article, I argue that each of these four arguments are unconvincing, and therefore, that the disclosure thesis ought to be rejected. I suggest that mandating disclosure may also even risk harming patients by providing stakeholders with a way to avoid accountability for harm that results from improper applications or uses of these systems.

Willingness to participate in a personalized health cohort - insights from the swiss health study pilot phase.

BACKGROUND: This paper explores the feasibility of establishing a large-scale population-based cohort and biobank in Switzerland by assessing potential participants' needs, expectations, and concerns about such an infrastructure providing information on health, lifestyle, and exposure trajectories, the development of disease, and risk factors over time. METHODS: We utilized a scenario-based questionnaire in the Swiss Health Study pilot phase (2020-2021), involving 1349 adults aged 20-69 from the cantons Vaud and Bern. We conducted descriptive statistics supported by R and qualitative content analysis of n = 374 open responses related to attitudes towards research. RESULTS: We highlight the benefits and challenges of the scenario-based approach, discuss the sample represented in the pilot phase, and present implications for building a full cohort. We also report on participants' attitudes towards and previous experience with health research. We analyze references regarding informed consent and feedback, attitudes towards the Swiss Health Study, and recommendations on improving its scope, design, and instruments. Results indicate a high interest (90%) in participating in a national health study, with 85% of a random population sample willing to join a long-term cohort. Only 43% were familiar with biobanks, and 44% preferred general consent. Trust was high for Swiss-based public research but lower for researchers from other countries or private sector. Over 95% expressed willingness to complete online questionnaires, undergo physical examination, and donate biosamples. Almost all participants wanted to know the outcomes of the medical tests (99.5%) and the exposure to environmental stressors (95%) from their study center visit. Preferred tools for monitoring sleep, physical activity, and diet were known smartphone apps with automatic data management. CONCLUSION: Overall, the study reveals a positive attitude towards personalized health research, with a strong willingness to share data and samples. Key insights focus the meaning of informed consent for participation, the relevance of sampling and representativeness, as well as the significance and challenges of personalized feedback, especially regarding environmental health concerns. Findings emphasize participants' supportive yet reflexive stances, underscoring the importance of aligning research values with individual values in personalized health research. These insights contribute valuable considerations for refining the scope, design, and instruments of future cohort studies.

Consent for interventions during childbirth: A national population-based study.

OBJECTIVE: To assess the frequency and determinants of medical interventions during childbirth without women's consent at the population level. METHODS: The nationwide cross-sectional Enquête Nationale Périnatale 2021 provided a representative sample of women who delivered in metropolitan France with a 2-month postpartum follow-up (n = 7394). Rates and 95% confidence intervals (CI) of interventions during childbirth (oxytocin administration, episiotomy or emergency cesarean section) without consent were calculated. Associations with maternal, obstetric, and organizational characteristics were assessed using robust variance Poisson regressions, after multiple imputation for missing covariates, and weighted to account for 2-month attrition. RESULTS: Women reporting failure to seek consent were 44.7% (CI: 42.6-47.0) for oxytocin administration, 60.2% (CI: 55.4-65.0) for episiotomy, and 36.6% (CI: 33.3-40.0) for emergency cesarean birth. Lack of consent for oxytocin was associated with maternal birth abroad (adjusted prevalence ratio [aPR] 1.20; 95% CI: 1.06-1.36), low education level, and increased cervical dilation at oxytocin initiation, whereas women with a birth plan reported less frequently lack of consent (aPR 0.79; 95% CI: 0.68-0.92). Delivery assisted by an obstetrician was more often associated with lack of consent for episiotomy (aPR 1.46; 95% CI: 1.11-1.94 for spontaneous delivery and aPR 1.39; 95% CI: 1.13-1.72 for instrumental delivery, reference: spontaneous delivery with a midwife). Cesarean for fetal distress was associated with failure to ask for consent for emergency cesarean delivery (aPR 1.58; 95% CI: 1.28-1.96). CONCLUSION: Women frequently reported that perinatal professionals failed to seek consent for interventions during childbirth. Reorganization of care, particularly in emergency contexts, training focusing on adequate communication and promotion of birth plans are necessary to improve women's involvement in decision making during childbirth.

Designing e-consent protocols for pragmatic clinical trials: case studies from a UKCRC clinical trials unit.

BACKGROUND: Interest in and use of electronic consent (e-consent) in the conduct of academic clinical trials has increased since the COVID-19 pandemic. E-consent offers advantages including increased efficiency and accessibility, and reduced burden on site staff, which can be appealing to academic trialists anticipating challenges in recruitment to complex trial designs or with limited funding. However, there are many options to consider when using e-consent in a study protocol. This paper presents five case studies from Norwich Clinical Trials Unit, demonstrating how e-consent models can be effectively tailored to the needs of different trials. These examples illustrate the options around and benefits of e-consent, the acceptability of e-consent by participants, and the design considerations that were made during the development of the trial protocols. CASE STUDIES: Five randomised trials are presented, selected from a range of different trial designs, disease areas, interventions, and patient populations. E-consent was either offered as an alternative to paper consent, according to participant preference, or as the sole method of consent. E-consent was generally used to facilitate remote consent in decentralised trials but was also chosen to increase efficiency and reduce burden in an emergency department setting. The technical implementation of e-consent and detailed participant procedures were tailored to the needs of the trial settings and patient populations. For example, accompanying participant information sheets were provided in paper or electronic form, and electronic signatures could be typed or drawn. Administrative data on uptake of e-consent is presented where available. CONCLUSION: This paper demonstrates that the operational and technical aspects of implementing e-consent in clinical trials can be influenced by the trial design, the needs and characteristics of the trial population, financial/efficiency considerations, and level of risk. E-consent is not a one-size-fits-all tool for trials, and its use should be carefully considered during the development of the trial protocol, in conjunction with patient and public involvement contributors, site staff and other trial stakeholders.

Ethics of Wearable-Based Out-of-Hospital Cardiac Arrest Detection.

Out-of-hospital cardiac arrest is a major health problem, and immediate treatment is essential for improving the chances of survival. The development of technological solutions to detect out-of-hospital cardiac arrest and alert emergency responders is gaining momentum; multiple research consortia are currently developing wearable technology for this purpose. For the responsible design and implementation of this technology, it is necessary to attend to the ethical implications. This review identifies relevant ethical aspects of wearable-based out-of-hospital cardiac arrest detection according to 4 key principles of medical ethics. First, aspects related to beneficence are related to the effectiveness of the technology. Second, nonmaleficence requires preventing psychological distress associated with wearing the device and raises questions about the desirability of screening. Third, grounded in autonomy are empowerment, the potential reidentification from continuously collected data, issues of data access, bystander privacy, and informed consent. Finally, justice concerns include the risks of algorithmic bias and unequal technology access. Based on this overview and relevant legislation, we formulate design recommendations. We suggest that key elements are device accuracy and reliability, dynamic consent, purpose limitation, and personalization. Further empirical research is needed into the perspectives of stakeholders, including people at risk of out-of-hospital cardiac arrest and their next-of-kin, to achieve a successful and ethically balanced integration of this technology in society.

Use of E-Consent in Healthcare Settings: A Scoping Review.

Electronic consent is a technology-driven approach that remains challenging in various healthcare settings. Transitioning from paper-based to electronic consent (e-consent) has streamlined the consent process. This scoping review explores patients' electronic consent in different healthcare settings. We searched four databases and selected 14 studies that met our inclusion criteria. Our results show that E-consent is associated with key measures such as sufficient information, accuracy, enhanced shared decision-making, and efficiency. The majority of studies used a comparative design model to contrast paper-based consent with E-consent. Our findings provide an overview of the current state of E-consent use in healthcare settings.

Parental views on prospective consent: Experience from a pilot randomised trial recruiting extremely preterm infants during the perinatal period.

AIM: To explore parental perceptions of the consenting process and understanding of the study in a pilot randomised controlled trial wherein extremely premature infants (<29 weeks' gestation) were recruited either antenatally or by 4 h of life. METHODS: We prospectively surveyed parents who had consented, declined consent or were eligible infants in the Positioning Preterm Infants for Neuroprotection study, a low-risk intervention study in the first 72 h of life. Structured interview questions explored the process and acceptability of the consenting approach by the parents and their knowledge of the study. Additional comments made by the parents were transcribed verbatim. RESULTS: Sixty-two parents participated in the surveys; of those, 41 had provided their consent, 8 declined consent and 13 were parents of missed eligible infants. Overall, most parents reported they understood the study well before providing their consent and approaching them for consenting did not create a burden for them. A verbal explanation of the study by the study team, especially by the medical practitioners, was viewed as beneficial. Where consent was obtained in the birthing unit (imminent births and within 4 h of birthing), it was suggested that the 4-h period for obtaining post-natal consent may be too short. A deferred consent with a follow-up opportunity for obtaining informed consent could be a suitable alternative. CONCLUSION: Parents found the consenting process acceptable and indicated they had sufficient understanding of the study to provide an informed consent. Deferred consent should be explored for future, low-risk intervention studies as an alternative to prospective consent where extremely preterm infants need to be recruited in the immediate neonatal period.

Examining Introduction of E-consent in The Neurosurgical Caseload: Understanding The Barriers to Implementation.

OBJECTIVE: To evaluate current usage and barriers of e-consent implementation in neurosurgical practice. Electronic consent (e-consent) forms provide an alternative method for conducting the informed consent (IC) procedure. IC requires an ability to understand, retain, weigh up and communicate decisions regarding the proposed procedure. Currently, e-consent has shown promise as a method of improving IC, yet barriers to implementation exist. METHODS: A comparative analysis regarding procedural and consent data was collected over six months in two neurosurgical centres with elective and emergency caseloads. These were evaluated for changes over time following e-consent introduction. Clinicians were surveyed for their experience using of e-consenting to understand the barriers to implementation. RESULTS: Over half (55.6%) of neurosurgical procedures made use of e-consent for IC. Lower rates of e-consent were used in trauma related procedures (38.38%) as compared to elective procedures. This did not increase significantly over the study period. Positive clinician survey feedback indicated e-consenting reduces the time required to perform IC, with 50% of respondents strongly agreeing. Barriers to implementation were reported on free-text entry pertaining largely to difficulties in emergency situations due to form complexity. The inability to create and edit templates for personalised e-consent delivery was a further limitation. CONCLUSION: Despite the advantages conferred by e-consent for the administration of IC in neurosurgical procedures, reflected in our survey data, there remains limited use of the technology. Limitations remain relating to ease of access and complexity of use in trauma scenarios.

Enhancing patient informed consent in elective skin cancer surgeries: a comparative study of traditional and digital approaches in a German public hospital.

BACKGROUND: This study aims to investigate the integration of modern sources of patient information, such as videos, internet-based resources, and scientific abstracts, into the traditional patient informed consent process in outpatient elective surgeries. The goal is to optimize the informed consent experience, enhance patient satisfaction, and promote shared decision making (SDM) between patients and surgeons. By exploring different patient informed consent formats and their impact on patient satisfaction, this research seeks to improve healthcare practices and ultimately enhance patient outcomes. The findings of this study will contribute to the ongoing efforts to improve the informed consent process in public hospitals and advance patient-centred care. METHODS: Data collection occurred at the day care clinic of a prominent German public hospital, forming an integral component of a prospective clinical investigation. The study exclusively focused on individuals who had undergone surgical intervention for skin cancer. For the purpose of meticulous data examination, the statistical software SPSS version 21 was harnessed. In the course of this study, a chi-square test was aptly employed. Its purpose was to scrutinize the nuances in patient experiences pertaining to informed consent across four distinct categories, viz., oral informed consent discussion (Oral ICD), written informed consent discussion (Written ICD), video-assisted informed consent discussion (video-assisted ICD), and digitally assisted informed consent discussion (digital-assisted ICD). The primary dataset of this inquiry was diligently gathered via a structured questionnaire administered to a targeted cohort of 160 patients. Within this sample, a balanced representation of genders was observed, encompassing 82 males and 78 females. Their collective age span ranged from 18 to 92 years, with an average age of 71 years. A randomized selection methodology was employed to include participants in this study during the period spanning from July 2017 to August 2018. RESULTS: Significant differences were observed across the groups for all research questions, highlighting variations in patient responses. Video-assisted and digital-assisted IC were rated as superior in patient satisfaction with information compared to written and oral IC. Demographic profiles of the four study groups were found to be comparable. CONCLUSION: The findings of this study indicate that the incorporation of digital technologies in the informed consent process can enhance patient understanding during outpatient elective skin cancer surgeries. These results have important implications for increasing patient satisfaction and improving the SDM process within the hospital environment.

The Collaborative Biobank (CoBi): Donor and recipient samples & data to facilitate future research on hematopoietic cell transplantation.

Biobanking provides benefit for future generations by facilitating medical research and subsequent translation and application of research findings. Long-term storage and research involving biological material and associated data necessitate the proper implementation of ethical and legal standards. A key principle includes recognizing informed consent as a crucial element for legitimizing the collection of biological material and data. Furthermore, any collected material and data must be employed exclusively for the research framework that aligns with the explicit consent provided by the participants. Last but not least, data privacy and security are essential in biobanking. This review elucidates chances and limitations of biobanking in the field of allogeneic hematopoietic cell transplantation. We discuss the practical implementation of the requirements, illustrated by the Collaborative Biobank, a collaborative research platform for research in blood cancer.

Compromised informed consent due to functional health literacy challenges in Chinese hospitals.

BACKGROUND: Medical informed consent stands as an ethical and legal requisite preceding any medical intervention. Hospitalized patients face functional health literacy (FHL) challenges when dealing with informed consent forms (ICFs). The legitimacy of ICFs and informed consent procedures in China remains substantially undisclosed. The study's aim was to investigate if Chinese patients have adequate FHL to be truly informed before providing medical consent. METHODS: In this cross-sectional, structured interview-based study, FHL was assessed within the context of the informed consent scenarios in two teaching hospitals (a 1500-bed general tertiary hospital and a 700-bed cancer hospital) affiliated with Shantou University Medical College. Twenty-seven patients admitted across clinical departments, along with their relatives (n = 59), were enrolled in the study after obtaining informed consent. The participants underwent a three-step assessment with two selected ICFs -teach-back skills, perceived understanding (perception), and informed knowledge (cognizance), with each component carrying a maximum score of 10. Data were analyzed with SPSS (version 22.0) for descriptive and inferential statistics, with consideration of significant P values as < 0.05. RESULTS: The median age (IQR and range) of participants was 35.5 (28 - 49 and 13 - 74) years. Most participants had only high school education (24.4%, 21/86) or below high school education (47.7%, 41/86). The median score (IQR) of FHL assessments-teach-back, perception, and cognizance-was 4.0 (2.5, 5.8), 8.0 (6.8, 8.8), and 6.5 (5.5, 8.0) out of 10, respectively. A moderate correlation was observed between the scores of cognizance and teach-back (r = 0.359, P = 0.002) or perception (r = 0.437, P < 0.001). Multivariate linear regression analysis predicted being a patient and having lower education levels as independent risk factors of inadequate FHL (Ps = 0.001). Lack of patient-centeredness in ICFs, time constraints, and poor clinical communication were identified as barriers impeding informed consent. CONCLUSIONS: This study demonstrates inadequacy in personal FHL and impaired organizational HL, resulting in compromised informed consent in Chinese teaching hospitals. As a remedy, we propose improving the quality of ICFs and institutionally mandated outcome-focused training on informed consent for all concerned clinicians to enhance medical ethics, ensure quality health care, address patient values, and mitigate potential medical conflicts.

Ethical, Legal, and Practical Concerns Surrounding the Implemention of New Forms of Consent for Health Data Research: Qualitative Interview Study.

BACKGROUND: In Europe, within the scope of the General Data Protection Regulation, more and more digital infrastructures are created to allow for large-scale access to patients' health data and their use for research. When the research is performed on the basis of patient consent, traditional study-specific consent appears too cumbersome for many researchers. Alternative models of consent are currently being discussed and introduced in different contexts. OBJECTIVE: This study explores stakeholder perspectives on ethical, legal, and practical concerns regarding models of consent for health data research at German university medical centers. METHODS: Semistructured focus group interviews were conducted with medical researchers at German university medical centers, health IT specialists, data protection officers, and patient representatives. The interviews were analyzed using a software-supported structuring qualitative content analysis. RESULTS: Stakeholders regarded broad consent to be only marginally less laborious to implement and manage than tiered consent. Patient representatives favored specific consent, with tiered consent as a possible alternative. All stakeholders lamented that information material was difficult to understand. Oral information and videos were mentioned as a means of improvement. Patient representatives doubted that researchers had a sufficient degree of data security expertise to act as sole information providers. They were afraid of undue pressure if obtaining health data research consent were part of medical appointments. IT specialists and other stakeholders regarded the withdrawal of consent to be a major challenge and called for digital consent management solutions. On the one hand, the transfer of health data to non-European countries and for-profit organizations is seen as a necessity for research. On the other hand, there are data security concerns with regard to these actors. Research without consent is legally possible under certain conditions but deemed problematic by all stakeholder groups, albeit for differing reasons and to different degrees. CONCLUSIONS: More efforts should be made to determine which options of choice should be included in health data research consent. Digital tools could improve patient information and facilitate consent management. A unified and strict regulation for research without consent is required at the national and European Union level. Obtaining consent for health data research should be independent of medical appointments, and additional personnel should be trained in data security to provide information on health data research.

Impact of nitrous oxide use on parturient recall of neuraxial analgesia risks.

STUDY OBJECTIVE: Nitrous oxide affects memory and recall. We aimed to determine if using nitrous oxide during labor affected patients' ability to learn and recall the risks and benefits of neuraxial analgesia. DESIGN: Single-center, prospective cohort study. SETTING: Labor and delivery unit in a large academic medical center. PATIENTS: Nulliparous patients with spontaneous or planned induction of labor. INTERVENTIONS: Parturients chose whether to use nitrous oxide during labor. At the discussion for epidural consent, 4 risks were described: headache, infection, nerve damage, bleeding. MEASUREMENTS: Labor pain score, time from nitrous oxide discontinuation, and cervical dilation were documented at the discussion of epidural risks. Patients were assessed for unprompted recall and prompted recall of epidural risks on postpartum day 1 and unprompted recall at postpartum week 6. The number and proportion of patients who indicated each true risk (unprompted and prompted recall) or distractor (prompted recall only) were summarized by treatment group and results compared using Pearson χ2 tests. MAIN RESULTS: Of the 403 enrolled patients, 294 (73%) did not use nitrous oxide, and 109 (27%) did. The 2 groups were similar except women who used nitrous oxide were more likely to be cared for by midwives and had higher pain scores at their epidural request. Scores for unprompted or prompted recall of epidural risks were not different between women who received or did not receive nitrous oxide. All 4 risks were recalled unprompted by only 3% in the nitrous oxide group and by 6% in the group not receiving nitrous oxide (P = .18). CONCLUSIONS: The use of nitrous oxide for labor analgesia does not adversely influence a parturient's ability to recall the risks of epidural placement. Patients who receive nitrous oxide for labor analgesia should be considered eligible to provide consent for subsequent procedures.

Ethical framework for FACILITATE: a foundation for the return of clinical trial data to participants.

This paper discusses the importance of return of clinical trial data to patients in the context of the FACILITATE project that aims to develop a participant-centric approach for the systematic return of individual clinical trial data. It reflects on the need for an ethical framework to support the return of clinical trial data. The discussion revolves around the developing FACILITATE ethical framework, specifically focusing on the ethical principles that form the foundation of the framework and guidance on how to implement those principles into practice.