Open Data governance at the Canadian Open Neuroscience Platform (CONP): From the Walled Garden to the Arboretum.

Scientific research communities pursue dual imperatives in implementing strategies to share their data. These communities attempt to maximize the accessibility of biomedical data for downstream research use, in furtherance of open science objectives. Simultaneously, such communities safeguard the interests of research participants through data stewardship measures and the integration of suitable risk disclosures to the informed consent process. The Canadian Open Neuroscience Platform (CONP) convened an Ethics and Governance Committee composed of experts in bioethics, neuroethics, and law to develop holistic policy tools, organizational approaches, and technological supports to align the open governance of data with ethical and legal norms. The CONP has adopted novel platform governance methods that favor full data openness, legitimated through the use of robust deidentification processes and informed consent practices. The experience of the CONP is articulated as a potential template for other open science efforts to further build upon. This experience highlights informed consent guidance, deidentification practices, ethicolegal metadata, platform-level norms, and commercialization and publication policies as the principal pillars of a practicable approach to the governance of open data. The governance approach adopted by the CONP stands as a viable model for the broader neuroscience and open science communities to adopt for sharing data in full open access.

Consent practices in midwifery: A survey of UK midwives.

OBJECTIVE: To explore midwives' knowledge and understanding of the law and practice of consent in the post-Montgomery world. DESIGN: Cross-sectional online survey. Descriptive statistical analysis of midwives' survey responses. SETTINGS: Social media: Instagram, Facebook and Twitter. Survey distribution was via the UCL Opinio survey platform. PARTICIPANTS: A total of 402 midwives, surveyed over a four month period between 2nd March and 2nd July 2021. MEASUREMENTS: Knowledge of legal consent, 'sureness' of meeting current legal requirements and competence to gain consent. FINDINGS: 91% of participants acknowledged correctly that consent must be voluntary. 91% reported that women must be informed of all the risks associated with their care, although 26% reported that women should be informed of some of the risks associated with their care. Most participants were 'sure' that their discussions of consent meet current legal requirements (91%). 21% rated their competence to gain consent as 'excellent', 71% rated themselves as 'very good', whilst 1% rated their competence as 'poor'. Deficiencies in fundamental knowledge of consent were noted in some participants rating themselves highest in 'sureness' of meeting legal requirements and competence to consent. KEY CONCLUSIONS: Fundamental gaps in midwives' knowledge of legal consent were identified. Participants demonstrated uncertainty regarding the extent of risk disclosure and discussion of alternative care options. Participants generally rated themselves highly in their consenting practices, despite lacking in basic knowledge of legal consent, revealing a discrepancy between midwives' self-perceptions and their actual knowledge. IMPLICATIONS FOR PRACTICE: The overconfidence displayed by some participants is concerning for clinical midwifery practice. Professional education and guidance for midwives on legal consent in keeping with Montgomery is urgently required to ensure that midwives are legally compliant in their consenting practices.

Opinions and practices of midwives working in the delivery rooms on informed consent in vaginal deliveries.

Obtaining informed consent from women for vaginal birth both safeguards their autonomy and establishes a legal foundation for midwives. This study aimed to determine the opinions and practices of midwives on obtaining valid informed consent for vaginal deliveries. This descriptive study was conducted between November 2021 and December 2022 in two different cities of Turkey, Bursa and Kocaeli. Data were analyzed with Chi-square test. In the study all midwives who had not received ethics training had a common perception that informed consent merely involved obtaining a signature and was a standard practice for vaginal birth (p=0.002). In the study, 92.9% of the midwives reported that they found it necessary to obtain informed consent in vaginal deliveries, 97.6% reported that they provided verbal information. However, information provided by midwives for valid informed consent was mostly not comprehensive (range 44.4%-80.2%). Most midwives (80.2%) focused on highlighting the benefits of vaginal birth for mothers, with comparatively less emphasis on communicating information regarding the potential risks and complications associated with vaginal birth for newborns. The high percentage of midwives who considered it necessary to obtain informed consent in vaginal deliveries in our study suggests that these midwives are well aware of the significance of informed consent.

L'obtention du consentement éclairé des femmes pour un accouchement vaginal garantit à la fois leur autonomie et leur établit une base juridique pour les sages-femmes. Cette étude visait à déterminer les opinions et les pratiques des sages-femmes concernant l'obtention d'un consentement éclairé valide pour les accouchements par voie vaginale. Cette étude descriptive a été menée entre novembre 2021 et décembre 2022 dans deux villes différentes de Turquie, Bursa et Kocaeli. Les données ont été analysées avec le test du Chi carré. Dans l'étude, toutes les sages-femmes qui n'avaient pas reçu de formation en éthique avaient la perception commune que le consentement éclairé impliquait simplement l'obtention d'une signature et constituait une pratique standard pour l'accouchement vaginal (p = 0,002). Dans l'étude, 92,9 % des sages-femmes ont déclaré qu'elles jugeaient nécessaire d'obtenir un consentement éclairé lors d'un accouchement vaginal, 97,6 % ont déclaré avoir fourni des informations verbales. Cependant, les informations fournies par les sages-femmes pour obtenir un consentement éclairé valide n'étaient pour la plupart pas complètes (plage de 44,4 % à 80,2 %). La plupart des sages-femmes (80,2 %) se sont attachées à souligner les avantages de l'accouchement vaginal pour les mères, en mettant comparativement moins l'accent sur la communication d'informations concernant les risques et les complications potentiels associés à l'accouchement vaginal pour les nouveau-nés. Le pourcentage élevé de sages-femmes qui ont jugé nécessaire d'obtenir un consentement éclairé lors d'un accouchement vaginal dans notre étude suggère que ces sagesfemmes sont bien conscientes de l'importance du consentement éclairé.

What Is Wellbeing, and What Is Important for Wellbeing? Indigenous Voices from across Canada.

Indigenous peoples' perceptions of wellbeing differ from non-Indigenous constructs. Thus, it is imperative to recognize that Indigenous peoples will conceptualize wellbeing from their perspectives and set their own wellbeing priorities. In keeping with this viewpoint, the aims of the present study were to conceptualize wellbeing and determine what was (and is) important for wellbeing from Canadian Indigenous peoples' perspectives. In this paper, we take a partnership approach based on the elements of respect, equity, and empowerment. One primary data source and two existing data sources were examined and analyzed thematically utilizing a combination approach of deductive and inductive coding. Indigenous leadership and organizations viewed wellbeing holistically and conceptualized wellbeing multidimensionally. From across Canada, wellbeing was communicated as physical, economic, political, social, and cultural. The scaling of wellbeing represented a collectivist perspective, and land was the connecting thread between all types of wellbeing, being a place to practice cultural traditions, reassert one's Indigenous identity, find solace, and pass on Indigenous knowledge and languages. Although wellbeing was discussed in the context of the individual, family, community, and nation, wellbeing was most often discussed at the cultural level by regional and national Indigenous leadership and organizations. Even in acknowledging the great cultural diversity among Canadian Indigenous nations, four concordant themes were identified regionally and nationally, with respect to what was important for cultural wellbeing: land and water, sustainability, and inherent obligations; being on the land, and indigenous languages and knowledge systems; sustainable development; and meaningful involvement in decision-making, and free, prior, and informed consent. Taking into account these themes is foundational for any interaction with Indigenous peoples, especially in the context of land, culture, and development. There needs to be a new beginning on the journey to reconciliation with land and cultural wellbeing at the forefront.

Prioritizing women's choices, consent, and bodily autonomy: From a continuum of violence to women-centric reproductive care.

Obstetric violence is a product of medical institutions' failure to prioritize women-centric reproductive care. Through interviews with local activists and leaders in Oaxaca, Mexico, as well as analysis of primary and secondary sources, we find that women-centric reproductive care is hindered by three barriers that are a part of a continuum of violence. These barriers include the cultural and religious norms surrounding reproductive care, the medical community and medical profiteers' opposition to combatting obstetric violence, and the state's resistance to women's human rights policy changes. Shifting to a women-centric reproductive care model requires: the life of the woman to be prioritized in reproductive care, the criminalization of obstetric violence, improved training for the medical community, reduced monetary incentives for unnecessary cesarean sections, and the respectful inclusion of indigenous and midwife knowledge and practices. Our study's theoretical and empirical contributions add to the scholarly research regarding the systemic causes of obstetric violence and the care ethic required for transformative change. Our recommendations can be applied across contexts with locally developed and culturally inclusive models of women-centric reproductive care.

Physician-Investigator, Research Coordinator, and Patient Perspectives on Dual-Role Consent in Oncology: A Qualitative Study.

Importance: Classic statements of research ethics generally advise against dual-role consent in which physician-investigators seek consent for research participation from patients with whom they have preexisting treatment relationships. Yet dual-role consent is common in clinical oncology research, as studies are often conducted in close relationship with clinical care. Objective: To explore key stakeholders' perspectives on dual-role consent in clinical oncology trials. Design, Setting, and Participants: This qualitative study with 43 participants was conducted at a National Cancer Institute-designated comprehensive cancer center from 2018 to 2022. Semistructured qualitative interviews of physician-investigators, research coordinators, and patients were performed. Respondents were recruited from 3 populations: (1) physician-investigators engaged in clinical oncology research; (2) research coordinators engaged in clinical oncology research; and (3) patients, with and without prior clinical trial experience, who had received a new cancer diagnosis at least 2 months prior to enrollment in this study. Main Outcomes and Measures: Interviews were audio recorded and professionally transcribed. A thematic analysis approach was used to develop a codebook that included both theory-driven, a priori codes and emergent, inductive codes. Two authors double-coded all transcripts and met regularly to compare coding, discuss discrepancies, refine the codebook, and draft memos describing relevant themes and their frequency. Results: Among the 43 respondents, 28 (65.1%) were female; 9 (20.9%) were African American, 8 (18.6%) were Asian, 6 (14.0%) were Hispanic, and 21 (48.8%) were White; 15 were physician-investigators (6 [40.0%] with 6-10 years of experience, 4 [26.7%] with at least 20 years of experience), 13 were research coordinators (5 [38.5%] with 0-5 years of experience, 5 [38.5%] with 6-10 years of experience), and 15 were patients (9 [60.0%] aged 46-64 years). Four main themes were found: interviewees (1) perceived greater potential for role synergy than for role conflict; (2) reported dual-role consent as having mixed effects on the consent process, increasing prospective participants' understanding and likelihood of agreement while also challenging voluntariness; (3) preferred a team-based approach to the consent process in which physician-investigators and research coordinators share responsibility for communicating with prospective participants and safeguarding voluntariness; and (4) offered strategies for managing tensions in dual-role consent. Conclusions and Relevance: This qualitative study found that concerns about dual-role consent in clinical oncology, while valid, may be outweighed by corresponding advantages, particularly if appropriate mitigation strategies are in place. These findings support a team-based approach to informed consent, in which physician-investigators and research coordinators promote both the understanding and voluntariness of prospective participants.

Creation of a risk of harms informed consent form for dry needling: A nominal group technique.

BACKGROUND: When consenting patients to dry needling treatment, it is necessary to inform patients of potential risks of harms. OBJECTIVES: The aim of this study was to identify elements and framework for an Informed Consent (IC) risk of harm statement to improve patient decision-making. DESIGN: A virtual Nominal Group Technique (vNGT) methodology was used to achieve consensus among participants to identify what needs to be on a consent form, how it should be framed, and what it should state so patients understand the true risks. METHODS: Eligible participants were identified as one of four groups: legal expert, policy expert, dry needling expert, or patient. The vNGT session consisted of 5 rounds of idea generation and final consensus voting which lasted for 2 h. RESULTS: Five individuals consented to participate. Of the 27 original ideas, 22 reached consensus including ones specifically related to a risk of harms statement: identifying risks and discomforts, identify different sensations, and using a classification to order risks by severity. Consensus was achieved with percent agreement of ≥ 80%. The constructed risk of harm statement had a reading level of grade 7 and provided a list of stratified risks associated with dry needling. CONCLUSION: The generated risk of harm statement can be incorporated on IC forms that require disclosure of risks in both the clinical and research setting. Additionally, further elements were identified by panel participants about defining the framework for an IC form outside of the risk of harm statement. GOV REGISTRATION: NCT05560100 (29/09/22).

Traditional Health Care Practitioners' Perspectives on Applying Informed Consent During African Traditional Medical Practice in Akwa Ibom State, Nigeria: A Cross-Sectional Qualitative Study.

Introduction: This study explored the perspectives of traditional health care practitioners (THPs) practicing in the areas of herbalism, bone setting, and traditional birth attendance, from Akwa Ibom state, Nigeria, on the possibility and implications of applying informed consent (IC) during African traditional medicine (ATM) practice. Methods: Semistructured interviews were conducted with 11 THPs, consisting of 5 herbalists, 3 traditional bone setters (TBS), and 3 traditional birth attendants (TBAs), who represented the diverse groups that the study intended to cover. In-depth interviews were conducted using a semistructured guide and were recorded, transcribed, and analyzed using thematic analysis with the assistance of NVivo® qualitative analysis software. Results: Participants were seven males (64%) and four females (36%), 35-67 years of age, with 5-25 years of experience as THPs. Forty-six percent of participants were herbalists (27%), TBS, and TBAs (27%). Most participants (82%) were Annang, and (18%) were Ibibio first-language speakers. Three major themes emerged from the data analysis: (i) Existing ethical framework related to IC, (ii) knowledge of consent, and (iii) application of IC during traditional medical practice. These themes and relevant subthemes were explored. All (100%) THPs agreed that it was essential to communicate risks and benefits while allowing patients to ask questions before treatment. All participants (100%) stated that risk communication is essential in ATM, whereas 36% said they communicated all therapy benefits to their patients. Respondents believed patients could make an informed choice if they had complete information disclosure. However, THPs in this study had limited knowledge of formal IC rules and regulations. Conclusions: This study revealed that THPs in this setting disclose a diagnosis, risks, some benefits, and treatment options to patients. Consent/agreement was obtained verbally and voluntarily during ATM practice, consistent with IC doctrine. THPs had limited knowledge of the critical elements of IC. However, they suggested that a form of IC that does not conflict with traditional African norms could be applicable in ATM. IC could facilitate documentation and help reduce risks in ATM practice.

The study protocol for the randomized controlled trial of the effects of a theory-based intervention on resilience, social capital, psychological wellbeing, and health-promoting lifestyle in healthcare workers.

BACKGROUND: The workplace has been identified as a key determinant of health status. There is evidence of innumerable health problems among employees, particularly healthcare workers. Against this background, a holistic-systemic approach together with a good theoretical framework is required to reflect on this issue, and to support the design of effective interventions to promote the health and wellbeing of the given population. The present study aims to evaluate the effectiveness of an educational intervention in improving resilience, social capital, psychological wellbeing, and health-promoting lifestyle in healthcare workers, utilizing the Social Cognitive Theory integrated into the PRECEDE-PROCEED model. METHODS: This randomized controlled trial will be performed on a large sample of the employees working in two healthcare centers in the city of Shiraz, Iran. The study will proceed with the healthcare workers of one city being given the educational intervention and the healthcare workers of the other city serving as a control group. Using a census method, all healthcare workers in the two cities will be informed of the trial and its purpose, and then invitations to join the study will be issued. The minimum sample size required has been calculated as 66 individuals in each healthcare centers. Recruitment to the trial will by systematic random sampling of eligible employees who submit an expression of interest in joining the trial, and subsequently give informed consent. Data will be collected through a self-administered survey instrument at three stages: at baseline, and both immediately and three months after the intervention. The experimental group members should participate in at least eight of the ten weekly educational sessions of the intervention and complete the surveys in the three stages. There is no educational intervention for the control group, and they simply experience some routine programs, and complete the surveys at the same three timepoints. DISCUSSION: The findings will provide evidence for the possible effectiveness of a theory-based educational intervention to improve resilience, social capital, psychological wellbeing, and health-promoting lifestyle among healthcare workers. If the educational intervention is found to be effective, then its protocol will be exploited in other organizations to boost resilience. Trial registration IRCT20220509054790N1.

Informed consent in episiotomy: Co-analysis with midwives and distillation of best practice.

BACKGROUND: Performing an episiotomy where clinically indicated is a key intervention in the Obstetric Anal Sphincter Injury Care Bundle (OASI-CB) implemented across England and Wales to reduce the risk and increase the detection of severe perineal trauma after birth. Standards of consent provided to people in maternity care generally and for episiotomy specifically have been reported as suboptimal. Compromising birthing people's personal autonomy or sense of control has been linked to a dissatisfying birth experience, negative psychological sequelae, and litigation. METHODS: This study explored experienced midwives' practice of informed consent for episiotomy during a midwife-led birth. We sampled 43 midwives across eight NHS Trusts in England and Wales using online focus groups and telephone interviews about their experience of consent in episiotomy. Using qualitative content analysis and art-based co-analysis methods with eight midwives from across the research sites, we co-analyzed and co-constructed three themes and four practice recommendations from the data. RESULTS: Three themes were constructed from the data: Assent rather than consent, Change in culture to support best practice, and Standardized information. These themes informed the shaping of four recommendations for best practice in episiotomy informed consent. CONCLUSION: This study has shown how variations in midwifery practice and culture may impact birthing people's experience of informed consent in episiotomy. Midwives may not have the knowledge or skills to conduct a detailed consent conversation, leading to variation in practice and messages for birthing people. The use of antenatal discussion aids can offer women the opportunity to become informed and fully participate in the decision-making process.

Electronic Consent at US Cancer Centers: A Survey of Practices, Challenges, and Opportunities.

PURPOSE: Digital technologies create opportunities for improving consenting processes in cancer care and research. Yet, little is known about the prevalence of electronic consenting, or e-consent, at US cancer care institutions. METHODS: We surveyed institutions in the National Comprehensive Cancer Network about their capabilities for clinical, research, and administrative e-consents; technologies used; telemedicine consents; multilingual support; evaluations; and opportunities and challenges in moving from paper-based to electronic processes. Responses were summarized across responding institutions. RESULTS: Twenty-five institutions completed the survey (81% response rate). Respondents were from all census regions and included freestanding and matrix cancer centers. Twenty (80%) had e-consent capabilities, with variability in the extent of adoption: One (5%) had implemented e-consent for all clinical, research, and administrative needs while 19 (95%) had a mix of paper and electronic consenting. Among those with e-consent capabilities, the majority (14 of 20, 70%) were using features embedded in their electronic health record. Most had a combination of paper and e-consenting for clinical purposes (18, 72%). About two-thirds relied entirely on paper for research consents (16, 64%) but had at least some electronic processes for administrative consents (15, 60%). Obstacles to e-consenting included challenges with procuring or maintaining hardware, content management, workflow integration, and digital literacy of patients. Successes included positive user experiences, workflow improvements, and better record-keeping. Only two of 20 (10%) respondents with e-consent capabilities had evaluated the impact of automating consent processes. CONCLUSION: E-consent was prevalent in our sample, with 80% of institutions reporting at least some capabilities. Further progress is needed for the benefits of e-consenting to be realized broadly.

Information et consentement sur l'épisiotomie : Comment améliorer les pratiques ?

Intro Context and subject of the study: While women are increasingly demanding to be actors of their birth and to participate in the choices concerning their care, a study showed in 2013 that the information they received concerning episiotomy had improved, but that consent was very rarely sought. The interest of our study was therefore to explore the practices of midwives a few years later, and to highlight the factors that may encourage or hinder them in the delivery room to inform women and obtain their consent. METHOD: We conducted 12 semi-structured interviews with midwives working in the delivery room in several maternity hospitals in the Ile-de-France region. A manual content analysis was carried out independently by two researchers who then compared their results. A complementary analysis using NVivo software confirmed the validity of the manual analysis. RESULTS: Information on episiotomy and collection of consent in the delivery room were respectively limited by the anxiety-inducing nature of the information and its temporality (labour and delivery are not appropriate times for information according to the professionals), and by the fear of refusal. Information given beforehand during pregnancy and the drafting of a birth plan would facilitate the collection of consent in the delivery room. CONCLUSION: A time dedicated to information and the distribution of an information leaflet on episiotomy to patients could help improve the practices of health professionals.

Struggling with extensive informed consent procedures for cancer trials-is there even a benefit for the patients?

PURPOSE: Informed consent procedures in clinical trials often differ in length and complexity to those in clinical routine care. Little is known about the benefit of extensive procedures as intended in clinical trials compared to procedures in routine cancer treatment. METHODS: In two different clinical studies performed at a comprehensive cancer center, we compared patients' comprehension and satisfaction of current informed consent procedures in routine clinical care with the level of comprehension and satisfaction of patients treated within clinical trials. Patients with a new cancer diagnosis and recent informed consent received a questionnaire about satisfaction, comprehension, time management, and physician-patient relationship of the informed consent process. Patients in cohort 1 consented to cancer treatment within a clinical trial and were additionally interviewed in a structured way; patients in cohort 2 consented to "standard" chemotherapy and received a follow-up questionnaire after 6 months. RESULTS: In cohort 1, 82 patients completed the questionnaire and had an additional structured interview. They were treated in 41 different trials, receiving up to 40 pages of educational material. In cohort 2, 89 patients completed the first and 52 completed the follow-up questionnaire after receiving a standard informed consent form of 6 pages. Subjective understanding and satisfaction with the information provided was equally very high. However, deficits in objective understanding were observed in both cohorts. CONCLUSION: Extensive informed consent procedures for clinical cancer trials have not been associated with a higher level of satisfaction or measurable objective understanding; therefore, the benefit seems to be limited.

Autonomy and the folk concept of valid consent.

Consent governs innumerable everyday social interactions, including sex, medical exams, the use of property, and economic transactions. Yet little is known about how ordinary people reason about the validity of consent. Across the domains of sex, medicine, and police entry, Study 1 showed that when agents lack autonomous decision-making capacities, participants are less likely to view their consent as valid; however, failing to exercise this capacity and deciding in a nonautonomous way did not reduce consent judgments. Study 2 found that specific and concrete incapacities reduced judgments of valid consent, but failing to exercise these specific capacities did not, even when the consenter makes an irrational and inauthentic decision. Finally, Study 3 showed that the effect of autonomy on judgments of valid consent carries important downstream consequences for moral reasoning about the rights and obligations of third parties, even when the consented-to action is morally wrong. Overall, these findings suggest that laypeople embrace a normative, domain-general concept of valid consent that depends consistently on the possession of autonomous capacities, but not on the exercise of these capacities. Autonomous decisions and autonomous capacities thus play divergent roles in moral reasoning about consent interactions: while the former appears relevant for assessing the wrongfulness of consented-to acts, the latter plays a role in whether consent is regarded as authoritative and therefore as transforming moral rights.

Data privacy concerns and use of telehealth in the aged care context: An integrative review and research agenda.

OBJECTIVE: Effective use of telehealth offers substantial benefits to older persons and aged care providers. However, data privacy concerns challenge the effective use of telehealth and subsequent business value. Through developing a theoretical model, we explain how privacy concerns can influence the adoption ad use of telehealth in this complex context. METHOD: An integrative review of empirical investigations was conducted by linking privacy concerns, telehealth use, and aged care. We searched three major databases (PubMed, Web of Science, and Scopus) for articles published until December 2020. Articles were analyzed and presented using an integrative theoretical model that we labeled CPCPO (Context-Privacy Concerns-Practice-Outcomes). RESULTS: Our review revealed that privacy concerns are a contextual concept, i.e., different contexts (users, telehealth systems, aged care services, data) produce different privacy concerns. We found that privacy concerns were more voiced in home telecare and were associated with the degree of telemonitoring and surveillance. Contextual privacy concerns were related to video recording, behavioral data (e.g., sleep patterns and eating behavior), location data, and future use of data. These concerns can influence the adoption and use of telehealth. However, privacy protection practices (e.g., informed consent) can help in reducing the concerns and improving the acceptance of telehealth for older persons. CONCLUSION: CPCPO offers contextual explanations of telehealth privacy concerns and systems use. For improving telehealth acceptance, privacy concerns of data processing (e.g., recording, collection, storage, and secondary use) must be addressed by performing data protection practices. Based on the review results, we suggest avenues for future research.

Tailored Messages About Research Participation: Using an Interactive Information Aid to Improve Study Recruitment.

After a diagnosis of cancer (or other serious disease), patients may be asked to consider joining a clinical trial. Because most people are unfamiliar with the scientific concepts that are necessary to the provision of meaningful informed consent, patient education is necessary. Increasing knowledge alone is not sufficient; understanding how clinical trial participation aligns with personal circumstances and knowledge is central to the decision-making process. In this study, 302 cancer patients and survivors evaluated an interactive information aid (IA) designed to inform their decision to join a research study or clinical trial by providing tailored information to patients' responses to questions pertaining to seven key barriers or facilitators of clinical trial participation. The development of the IA was done with input from the authors' Clinical Translational Science Institute; linked components of the IA were vetted by members and leaders of the institution's NCI-designated comprehensive cancer center. Results of the study indicated that the information aid was successful in significantly reducing fears and increasing knowledge, attitudes, perceived behavioral control, and behavioral intentions about research participation relative to a control condition. Thus, an interactive information aid that provides information that is responsive to patients' values, knowledge, and personal circumstances can help patients to be better prepared to consider a decision about research participation.

Borderline personality disorder, therapeutic privilege, integrated care: is it ethical to withhold a psychiatric diagnosis?

Once common, therapeutic privilege-the practice whereby a physician withholds diagnostic or prognostic information from a patient intending to protect the patient-is now generally seen as unethical. However, instances of therapeutic privilege are common in some areas of clinical psychiatry. We describe therapeutic privilege in the context of borderline personality disorder, discuss the implications of diagnostic non-disclosure on integrated care and offer recommendations to promote diagnostic disclosure for this patient population.

Using hyperrealistic simulations to improve digital informed consent for endourological procedures.

OBJECTIVES: To show that digital informed consent (DIC) improves the subjective understanding of information and, therefore, informed consent. PATIENTS AND METHODS: A nonblinded randomized controlled trial was performed in 84 patients who had undergone transurethral resection of bladder, transurethral resection of prostate, or ureterorenoscopy between July 2017 and March 2018. The DIC group watched a hyperrealistic simulation on a tablet device before surgery. After surgery and again 30 days later, both groups completed a validated questionnaire that measured subjective understanding, anxiety, and utility of and need for information. RESULTS: The mean ± SD age of the participants was 68.7 ± 11.1 years. Nine of 84 patients (10.7%) did not complete the questionnaire. A total of 42 patients were allocated to the DIC group and 42 to the control group. The mean ± SD score for immediate subjective understanding in the DIC group was 14.5% higher than in the control group (72% ± 17.5% vs 57.5% ± 23.5%, respectively; P = 0.006). There was no statistical difference in anxiety, utility of and need for information relative to delayed subjective understanding. In subgroup analysis, subjective understanding scores were higher, but not significantly so, among patients with low and higher education levels in the DIC group than in the control group (68% ± 18.1% vs 54% ± 22.5% [P = 0.06] and 76% ± 18.3% vs and 66% ± 21.9%, respectively [P = 0.89]). CONCLUSION: Hyperrealistic simulations improved subjective understanding of information and, therefore, informed consent for endourological procedures.

Enhancing Cancer care of rural dwellers through telehealth and engagement (ENCORE): protocol to evaluate effectiveness of a multi-level telehealth-based intervention to improve rural cancer care delivery.

BACKGROUND: Despite lower cancer incidence rates, cancer mortality is higher among rural compared to urban dwellers. Patient, provider, and institutional level factors contribute to these disparities. The overarching objective of this study is to leverage the multidisciplinary, multispecialty oncology team from an academic cancer center in order to provide comprehensive cancer care at both the patient and provider levels in rural healthcare centers. Our specific aims are to: 1) evaluate the clinical effectiveness of a multi-level telehealth-based intervention consisting of provider access to molecular tumor board expertise along with patient access to a supportive care intervention to improve cancer care delivery; and 2) identify the facilitators and barriers to future larger scale dissemination and implementation of the multi-level intervention. METHODS: Coordinated by a National Cancer Institute-designated comprehensive cancer center, this study will include providers and patients across several clinics in two large healthcare systems serving rural communities. Using a telehealth-based molecular tumor board, sequencing results are reviewed, predictive and prognostic markers are discussed, and treatment plans are formulated between expert oncologists and rural providers. Simultaneously, the rural patients will be randomized to receive an evidence-based 6-week self-management supportive care program, Cancer Thriving and Surviving, versus an education attention control. Primary outcomes will be provider uptake of the molecular tumor board recommendation and patient treatment adherence. A mixed methods approach guided by the Consolidated Framework for Implementation Research that combines qualitative key informant interviews and quantitative surveys will be collected from both the patient and provider in order to identify facilitators and barriers to implementing the multi-level intervention. DISCUSSION: The proposed study will leverage information technology-enabled, team-based care delivery models in order to deliver comprehensive, coordinated, and high-quality cancer care to rural and/or underserved populations. Simultaneous attention to institutional, provider, and patient level barriers to quality care will afford the opportunity for us to broadly share oncology expertise and develop dissemination and implementation strategies that will enhance the cancer care delivered to patients residing within underserved rural communities. TRIAL REGISTRATION: Clinicaltrials.gov , NCT04758338 . Registered 17 February 2021 - Retrospectively registered, http://www.clinicaltrials.gov/.