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The transition from in-person to digital preoperative patient education requires effective methods for evaluating patients\' understanding of the perioperative process, risks, and instructions to ensure informed consent. A knowledge questionnaire covering different anaesthesia techniques and instructions could fulfil this need. We constructed a set of items covering common anaesthesia techniques requiring informed consent and developed the Rotterdam Anaesthesia Knowledge Questionnaire (RAKQ) using a structured approach and Item Response Theory. A team of anaesthetists and educational experts developed the initial set of 60 multiple-choice items, ensuring content and face validity. Next, based on exploratory factor analysis, we identified seven domains: General Anaesthesia-I (regarding what to expect), General Anaesthesia-II (regarding the risks), Spinal Anaesthesia, Epidural Anaesthesia, Regional Anaesthesia, Procedural sedation and analgesia, and Generic Items. This itemset was filled out by 577 patients in the Erasmus MC, Rotterdam, and Albert Schweitzer Hospital, Dordrecht, the Netherlands. Based on factor loadings (≥0.25) and considering clinical relevance this initial item set was reduced to 50 items, distributed over the seven domains. Each domain was processed to produce a separate questionnaire. Through an iterative process of item selection to ensure that the questionnaires met the criteria for Item Response Theory modelling, 40 items remained in the definitive set of seven questionnaires. Finally, we developed an Item Response Theory model for each questionnaire and evaluated its reliability. 1-PL and 2-PL models were chosen based on best model fit. No item misfit (S-χ2, p<0.001 = misfit) was detected in the final models. The newly developed RAKQ allows practitioners to assess their patients\' knowledge before consultation to better address knowledge gaps during consultation. Moreover, they can decide whether the level of knowledge is sufficient to obtain digital informed consent without face-to-face education. Researchers can use the RAKQ to compare new methods of patient education with traditional methods.

[This corrects the article DOI: 10.3389/frtra.2024.1346667.].

This report proposes a framework for evaluating the validity of informed consent and autonomy in face transplant candidates, taking into account the risk of depression and non-compliance. Traditional factors like decisional capacity, disclosure, comprehension, voluntariness, and agreement are insufficient for assessing valid informed consent in individuals whose self-worth relies on public perception, potentially leading to self-harm if societal worth is undermined. Reliance on self-esteem, rather than inherent personal value, poses risks of depression, poor treatment adherence, and deferential vulnerability. We suggest a qualitative analysis of self-worth, self-esteem, self-trust, and self-respect to better assess the autonomy of face transplant candidates in their decision-making process.

BACKGROUND: Communicating complex information about haemodialysis (HD) and ensuring it is well understood remains a challenge for clinicians. Informed consent is a high-impact checkpoint in augmenting patients\' decision awareness and engagement prior to HD. The aims of this study are to (1) develop a digital information interface to better equip patients in the decision-making process to undergo HD; (2) evaluate the effectiveness of the co-designed digital information interface to improve patient outcomes; and (3) evaluate an implementation strategy.
METHODS: First, a co-design process involving consumers and clinicians to develop audio-visual content for an innovative digital platform. Next a two-armed, open-label, multicentre, randomised controlled trial will compare the digital interface to the current informed consent practice among adult HD patients (n=244). Participants will be randomly assigned to either the intervention or control group. Intervention group: Participants will be coached to an online platform that delivers a simple-to-understand animation and knowledge test questions prior to signing an electronic consent form.
METHODS: Participants will be consented conventionally by a clinician and sign a paper consent form. Primary outcome is decision regret, with secondary outcomes including patient-reported experience, comprehension, anxiety, satisfaction, adherence to renal care, dialysis withdrawal, consent time and qualitative feedback. Implementation of eConsent for HD will be evaluated concurrently using the Consolidation Framework for Implementation Research (CFIR) methodology.
METHODS: For the randomised controlled trial, data will be analysed using intention-to-treat statistical methods. Descriptive statistics and CFIR-based analyses will inform implementation evaluation.
BACKGROUND: Human Research Ethics approval has been secured (Metro North Health Human Research Ethics Committee B, HREC/2022/MNHB/86890), and Dissemination will occur through partnerships with stakeholder and consumer groups, scientific meetings, publications and social media releases.
BACKGROUND: Australian and New Zealand Clinical Trials Registry (ACTRN12622001354774).

BACKGROUND: Electronic informed consent (eIC) is increasingly used in clinical research due to several benefits including increased enrollment and improved efficiency. Within a learning health care system, a pilot was conducted with an eIC for linking data from electronic health records with national registries, general practitioners, and other hospitals.
OBJECTIVE: We evaluated the eIC pilot by comparing the response to the eIC with the former traditional paper-based informed consent (IC). We assessed whether the use of eIC resulted in a different study population by comparing the clinical patient characteristics between the response categories of the eIC and former face-to-face IC procedure.
METHODS: All patients with increased cardiovascular risk visiting the University Medical Center Utrecht, the Netherlands, were eligible for the learning health care system. From November 2021 to August 2022, an eIC was piloted at the cardiology outpatient clinic. Prior to the pilot, a traditional face-to-face paper-based IC approach was used. Responses (ie, consent, no consent, or nonresponse) were assessed and compared between the eIC and face-to-face IC cohorts. Clinical characteristics of consenting and nonresponding patients were compared between and within the eIC and the face-to-face cohorts using multivariable regression analyses.
RESULTS: A total of 2254 patients were included in the face-to-face IC cohort and 885 patients in the eIC cohort. Full consent was more often obtained in the eIC than in the face-to-face cohort (415/885, 46.9% vs 876/2254, 38.9%, respectively). Apart from lower mean hemoglobin in the full consent group of the eIC cohort (8.5 vs 8.8; P=.0021), the characteristics of the full consenting patients did not differ between the eIC and face-to-face IC cohorts. In the eIC cohort, only age differed between the full consent and the nonresponse group (median 60 vs 56; P=.0002, respectively), whereas in the face-to-face IC cohort, the full consent group seemed healthier (ie, higher hemoglobin, lower glycated hemoglobin [HbA1c], lower C-reactive protein levels) than the nonresponse group.
CONCLUSIONS: More patients provided full consent using an eIC. In addition, the study population remained broadly similar. The face-to-face IC approach seemed to result in a healthier study population (ie, full consenting patients) than the patients without IC, while in the eIC cohort, the characteristics between consent groups were comparable. Thus, an eIC may lead to a better representation of the target population, increasing the generalizability of results.

The assessment of medical decision-making capacity as part of the process of clinical informed consent has been considered a bioethical housekeeping matter for decades. Yet in practice, the reality bears little resemblance to what is described in the medical literature and professed in medical education. Most literature on informed consent refers to medical decision-making capacity as a precondition to the consent process. That is, a clinician must first determine if a patient has capacity, and only then may the clinician engage with the patient for the rest of informed consent. The problem with this two-step approach is that it makes no sense in actual practice. We see the assessment of medical decision-making capacity within the process of informed consent as a spiral staircase, not just two steps, requiring clinicians to keep circling up and around, making progress, until they get to where they need to be: 1. Clinicians start with a general presumption of capacity for most adults, sometimes having a provisional appraisal of capacity based on prior patient contact. 2. Then, they begin performing informed consent for the current situation and intervention options. 3. Next, they must reassess capacity during this process. 4. After that, they continue with informed consent. 5. If capacity is not yet clear, they repeat 1-4.

BACKGROUND: Kidney living donation carries risks, yet standardized information provision regarding nephrectomy risks and psychological impacts for candidates remains lacking.
OBJECTIVE: This study assesses the benefit of interactive health technology in improving the informed consent process for kidney living donation.
METHODS: The Kidney Hub institutional open portal offers comprehensive information on kidney disease and donation. Individuals willing to start the kidney living donation process at Helsinki University Hospital (January 2019-January 2022) were invited to use the patient-tailored digital care path (Living Donor Digital Care Path) included in the Kidney Hub. This platform provides detailed donation process information and facilitates communication between health care professionals and patients. eHealth literacy was evaluated via the eHealth Literacy Scale (eHEALS), usability with the System Usability Scale (SUS), and system utility through Likert-scale surveys with scores of 1-5. Qualitative content analysis addressed an open-ended question.
RESULTS: The Kidney Hub portal received over 8000 monthly visits, including to its sections on donation benefits (n=1629 views) and impact on donors\' lives (n=4850 views). Of 127 living kidney donation candidates, 7 did not use Living Donor Digital Care Path. Users\' ages ranged from 20 to 79 years, and they exchanged over 3500 messages. A total of 74 living donor candidates participated in the survey. Female candidates more commonly searched the internet about kidney donation (n=79 female candidates vs n=48 male candidates; P=.04). The mean eHEALS score correlated with internet use for health decisions (r=0.45; P<.001) and its importance (r=0.40; P=.01). Participants found that the Living Donor Digital Care Path was technically satisfactory (mean SUS score 4.4, SD 0.54) and useful but not pivotal in donation decision-making. Concerns focused on postsurgery coping for donors and recipients.
CONCLUSIONS: Telemedicine effectively educates living kidney donor candidates on the donation process. The Living Donor Digital Care Path serves as a valuable eHealth tool, aiding clinicians in standardizing steps toward informed consent.
BACKGROUND: ClinicalTrials.gov NCT04791670; https://clinicaltrials.gov/study/NCT04791670.
UNASSIGNED: RR2-10.1136/bmjopen-2021-051166.

The establishment of clinical research resource platforms, including research databases and bio-sample library, is an important development in the field of clinical research. The international academic community proposes broad informed consent to regulate the ethical management of the issue. However, the broad informed consent fails to capture the main features of incomplete informed consent and authorization, misleads researchers and managers and leads to miss ethical management for clinical research projects. Therefore, the author proposes a named partial informed consent to improve ethical management for clinical research projects. Partial informed consent separates ethical management for establishing clinical research resource platforms and clinical research projects. After reviewing the legal and ethical foundation of clinical research ethics management, the author discussed the similarities and differences between project management and task management in the two informed consent solutions, the basis for approval of exempted informed consent signatures by the ethics committee, issues to be noted in the ethics management of multi-center research at the task level, and explained the substantive differences between broad informed consent and partial informed consent.
研究资源平台，包括研究数据库和生物样本库的建立，是临床研究领域的重要进展。国际学术界提出广泛知情同意签字（以下简称泛知情）以规范该类研究的伦理管理。但泛知情解决方案没有体现建立知情告知和同意授权不完整的主要特征，存在误导研究者和管理者，进而可能导致课题研究伦理管理缺位的问题。为此，本文提出部分知情同意授权解决方案，将资源平台建设与课题研究的伦理管理彻底分离，形成两个独立的伦理管理模块，分别纳入临床研究伦理管理框架。在回顾临床研究伦理管理法理基础和伦理基础的前提下，本文分析了项目管理与课题管理的异同、伦理委员会批准豁免知情同意签字的基础、课题层面的多中心研究伦理管理中需要注意的问题，解读了广泛知情同意签字和部分知情同意授权的背后实质内涵及操作层面的差异。.

BACKGROUND: Treatment pressures encompass communicative strategies that influence mental healthcare service users\' decision-making to increase their compliance with recommended treatment. Persuasion, interpersonal leverage, inducements, and threats have been described as examples of treatment pressures. Research indicates that treatment pressures are exerted not only by mental healthcare professionals but also by relatives. While relatives play a crucial role in their family member\'s pathway to care, research on the use of treatment pressures by relatives is still scarce. Likewise, little is known about other strategies relatives may use to promote the treatment compliance of their family member with a serious mental health condition. In particular, no study to date has investigated this from the perspective of relatives of people with a serious mental health condition.
OBJECTIVE: The aim of this study was to answer the following research questions: Which types of treatment pressures do relatives use? Which other strategies do relatives use to promote the treatment compliance of their family member with a serious mental health condition? How do treatment pressures relate to these other strategies?
METHODS: Eleven semi-structured interviews were conducted with relatives of people with a serious mental health condition in Germany. Participants were approached via relatives\' self-help groups and flyers in a local psychiatric hospital. Inclusion criteria were having a family member with a psychiatric diagnosis and the family member having experienced formal coercion. The data were analyzed using grounded theory methodology.
RESULTS: Relatives use a variety of strategies to promote the treatment compliance of their family member with a serious mental health condition. These strategies can be categorized into three general approaches: influencing the decision-making of the family member; not leaving the family member with a choice; and changing the social or legal context of the decision-making process. Our results show that the strategies that relatives use to promote their family member\'s treatment compliance go beyond the treatment pressures thus far described in the literature.
CONCLUSIONS: This qualitative study supports and conceptually expands prior findings that treatment pressures are not only frequently used within mental healthcare services but also by relatives in the home setting. Mental healthcare professionals should acknowledge the difficulties faced and efforts undertaken by relatives in seeking treatment for their family member. At the same time, they should recognize that a service user\'s consent to treatment may be affected and limited by strategies to promote treatment compliance employed by relatives.