BACKGROUND: Poor communication about serious injury in older adults can lead to treatment that is inconsistent with patient preferences, create conflict and strain healthcare resources. We developed a communication intervention called Best Case/Worst Case-intensive care unit (ICU) that uses daily scenario planning, that is, a narrative description of plausible futures, to support prognostication and facilitate dialogue among patients, their families and the trauma ICU team. This article describes a protocol for a multisite, randomised, stepped-wedge study to test the effectiveness of the intervention on the quality of communication (QOC) in the ICU.
METHODS: We will follow all patients aged 50 and older admitted to the trauma ICU for 3 or more days after a serious injury at eight high-volume level 1 trauma centres. We aim to survey one family or \'like family\' member per eligible patient 5-7 days following their loved ones\' admission and clinicians providing care in the trauma ICU. Using a stepped-wedge design, we will use permuted block randomisation to assign the timing for each site to begin implementation of the intervention and routine use of the Best Case/Worst Case-ICU tool. We will use a linear mixed-effects model to test the effect of the tool on family-reported QOC (using the QOC scale) as compared with usual care. Secondary outcomes include the effect of the tool on reducing clinician moral distress (using the Measure of Moral Distress for Healthcare Professionals scale) and patients\' length of stay in the ICU.
BACKGROUND: Institutional review board (IRB) approval was granted at the University of Wisconsin, and all study sites ceded review to the primary IRB. We plan to report results in peer-reviewed publications and national meetings.
BACKGROUND: NCT05780918.

Stroke is a leading cause of long-term disability in the United States that can lead to loss of function and consciousness. With the abrupt onset of the brain insult, end-of-life care discussions are an important attribute of respecting the patient\'s best wishes and upholding the ethical principles of autonomy, beneficence, nonmaleficence, fidelity, and justice. Furthermore, the topic of extending life support to individuals with poor prognostic factors of improvement in quality of life and functional recovery has been a continued topic of debate due to a multitude of factors, including the wishes of the patient, familial emotions, cultural beliefs, and religious influences. This case involves a patient who suffered from a left pontine stroke, necessitating multiple end-of-life care conversations. Despite no clinical improvement for several years, the patient required prolonged hospitalization and ongoing ventilator use.

OBJECTIVE: Participants\' comprehension of research process affects the quality of research output, which is the reason why translation of research instruments into local languages is standard practice. Literature has consistently reported that in Africa, knowledge about cervical cancer is low but paradoxically, expressed, and actual uptake of human papillomavirus vaccine for its prevention is high. This study explored the Yoruba names of cervical cancer among Yoruba people in Ibadan, Nigeria to guide the translation of cervical cancer research instruments to Yoruba language.
METHODS: Exploratory case study design was used and data were obtained with 10 in-depth interviews and four focused group discussions. Data were analysed using content analysis.
METHODS: The study took place in Ibadan North local government area, Southwest Nigeria.
METHODS: These were 4 traditional healers, 3 Yoruba linguists, 3 public health educators and 38 parents of adolescents.
METHODS: These were Yoruba names for cervical cancer and their meanings.
RESULTS: Participants were aware of cervical cancer but only the traditional healers and public health educators had names for it. These names were highly varied. The public health educators gave names that were linked with different parts of the female reproductive system and external genital which were actually different medical conditions. Each traditional healer also had different names for cervical cancer, which either described the female body parts, or symptoms of female genital infections. These various names can lead to unnecessary misconceptions and misinformation about cervical cancer, its prevention, management, and research.
CONCLUSIONS: There was no consensus Yoruba name for cervical cancer among the study participants. Efforts to educate the Yoruba speaking populace about cervical cancer, its prevention, management and participation in its research can be frustrated if a generally accepted Yoruba name is not provided for this cancer. Stakeholders\' collaboration is required to get an appropriate Yoruba name for cervical cancer.

Traumatic hemorrhagic shock is a common yet life-threatening occurrence across the United States and is typically managed with blood transfusions as the standard of care. However, providers caring for a Jehovah\'s Witness patient who refuses transfusions due to religious reasons face unique ethical challenges in upholding evidence-based shock resuscitation protocols while respecting the patient\'s autonomy and faith-based stance that strictly prohibits blood products. We present a complex clinical case of a 46-year-old Jehovah\'s Witness who developed severe hemorrhagic shock, partial amputation, and critical anemia after a traumatic 40-mile-per-hour motorcycle collision resulting in comminuted fractures and arterial disruption. Despite receiving emergent blood transfusions initially, further transfusions were declined once his identity as a practicing Jehovah\'s Witness was disclosed. His hemoglobin plunged to dangerously low levels of 4.6 g/dL before stabilizing to 5.3 g/dL with pharmaceutical alternatives including intravenous iron, high-dose erythropoietin, and phlebotomy minimization. Respecting patient convictions while delivering effective evidence-based shock management created significant ethical conflicts given the proven efficacy of blood transfusions. However, this complex case demonstrates that through meticulous medical and surgical care coordinated by a multi-disciplinary team applying customized non-transfusion techniques, traumatic hemorrhagic shock and life-threatening anemia can still achieve favorable outcomes without relying on transfusions when respecting faith-based refusal of blood products.

UNASSIGNED: Health technology assessment (HTA) is a conventional method for evaluating reasonable use of health technologies in many countries.
UNASSIGNED: To investigate the ethical soundness of HTA studies in Islamic Republic of Iran.
UNASSIGNED: All HTA reports published by the HTA office until 2020 were reviewed using the HTA Core Model and the Q-SEA questionnaires.
UNASSIGNED: We evaluated 91 reports for ethical soundness. The research question, literature search and inclusion/exclusion criteria were included in 91.2%, 83.5% and 82.4% of the HTA reports, respectively. Only 13.2% of the reports explicitly stated the objective of the analysis and 6.6% stated the ethics framework. Only 2.2%, 4.4%, 9.9%, 9.9%, 14.3%, and 2.2%, respectively, of the reports, complied with the completeness, bias, policy implications, other implications, conceptual clarification, and conflicting values.
UNASSIGNED: HTA reports in the Islamic Republic of Iran require coordinated and integrated framework acceptable to all stakeholders to ensure their compliance with sound ethical requirements.
السلامة الأخلاقية لتقارير تقييم التكنولوجيات الصحية في جمهورية إيران الإسلامية.
وحید یزدی- فیض آبادی، سلمان باش زر.
UNASSIGNED: يُعدُّ تقييم التكنولوجيات الصحية من الطرق التقليدية لتقييم الاستخدام المعقول للتكنولوجيات الصحية في العديد من البلدان.
UNASSIGNED: هدفت هذه الدراسة الى استقصاء السلامة الأخلاقية لدراسات تقييم التكنولوجيات الصحية في جمهورية إيران الإسلامية.
UNASSIGNED: استعرض المكتب المعني بتقييم التكنولوجيات الصحية جميع تقارير تقييم التكنولوجيات الصحية حتى عام 2020 باستخدام النموذج الأساسي لتقييم التكنولوجيات الصحية واستبيانات Q-SEA.
UNASSIGNED: قيِّمنا 91 تقريرًا عن السلامة الأخلاقية. وأُدرج سؤال البحث، والبحث في المؤلفات، ومعايير الإدراج/ الاستبعاد في 91.2٪، و83.5٪، و82.4٪ من تقارير تقييم التكنولوجيات الصحية، على التوالي. وأوضحت 13.2٪ فقط من التقارير صراحةً هدف التحليل، وذكرت 6.6٪ منها إطار الأخلاقيات. وقد امتثل فقط 2.2٪، و4.4٪، و9.9٪، و9.9٪، و14.3٪، و2.2٪ من التقارير، على التوالي، للاكتمال، والتحيز، والآثار المترتبة على السياسات، والآثار الأخرى، والإيضاحات المفاهيمية، والقيم المتضاربة.
UNASSIGNED: تتطلب تقارير تقييم التكنولوجيات الصحية في جمهورية إيران الإسلامية إطارًا منسقًا ومتكاملًًا، ويكون مقبولًًا من جميع أصحاب المصلحة لضمان امتثالهم للمتطلبات الأخلاقية السليمة.
Validité éthique des rapports d\'évaluation des technologies de la santé en République islamique d\'Iran.
UNASSIGNED: L\'évaluation des technologies de la santé (ETS) est une méthode conventionnelle permettant d\'évaluer l\'utilisation raisonnable des technologies de la santé dans de nombreux pays.
UNASSIGNED: Examiner la validité éthique des études ETS en République islamique d\'Iran.
UNASSIGNED: Tous les rapports d\'évaluation des technologies de la santé (ETS) publiés jusqu\'en 2020 par le bureau chargé de ces évaluations ont été examinés à l\'aide du modèle ETS principal et des questionnaires Q-SEA.
UNASSIGNED: Nous avons évalué la validité éthique de 91 rapports. La question de recherche, la recherche dans la littérature et les critères d\'inclusion et d\'exclusion étaient inclus dans 91,2 %, 83,5 % et 82,4 % des rapports ETS, respectivement. Seuls 13,2 % des rapports mentionnaient explicitement l\'objectif de l\'analyse et 6,6 % en indiquaient le cadre éthique. Parmi les rapports, seuls 2,2 %, 4,4 %, 9,9 %, 9,9 %, 14,3 % et 2,2 %, respectivement, étaient conformes aux exigences en matière d\'exhaustivité, d\'impartialité, d\'implications par rapport aux politiques ou autres, de clarification conceptuelle et de valeurs conflictuelles.
UNASSIGNED: Les rapports ETS en République islamique d\'Iran nécessitent un cadre coordonné et intégré qui soit acceptable pour toutes les parties prenantes, afin de garantir leur conformité avec des exigences éthiques bien fondées.

The Netherlands introduced an opt-out donor system in 2020. While the default in (presumed) consent cases is donation, family involvement adds a crucial layer of influence when applying this default in clinical practice. We explored how clinicians discuss patients\' donor registrations of (presumed) consent in donor conversations in the first years of the opt-out system.
A qualitative embedded multiple-case study in eight Dutch hospitals. We performed a thematic analysis based on audio recordings and direct observations of donor conversations (n = 15, 7 consent and 8 presumed consent) and interviews with the clinicians involved (n = 16).
Clinicians\' personal considerations, their prior experiences with the family and contextual factors in the clinicians\' profession defined their points of departure for the conversations. Four routes to discuss patients\' donor registrations were constructed. In the Consent route (A), clinicians followed patients\' explicit donation wishes. With presumed consent, increased uncertainty in interpreting the donation wish appeared and prompted clinicians to refer to \"the law\" as a conversation starter and verify patients\' wishes multiple times with the family. In the Presumed consent route (B), clinicians followed the law intending to effectuate donation, which was more easily achieved when families recognised and agreed with the registration. In the Consensus route (C), clinicians provided families some participation in decision-making, while in the Family consent route (D), families were given full decisional capacity to pursue optimal grief processing.
Donor conversations in an opt-out system are a complex interplay between seemingly straightforward donor registrations and clinician-family interactions. When clinicians are left with concerns regarding patients\' consent or families\' coping, families are given a larger role in the decision. A strict uniform application of the opt-out system is unfeasible. We suggest incorporating the four previously described routes in clinical training, stimulating discussions across cases, and encouraging public conversations about donation.

BACKGROUND: In healthcare practice, ethical challenges are inevitable and their optimal handling may potentialy improve patient care. Ethical development in medical education is critical for the transition from a medical and health sciences student to an ethical healthcare practitioner. Understanding the health professions students\' approaches towards practice-driven ethical dilemmas could harness i the effective ethical development in their medical education. This study attempts to identify the health professions students\' approaches towards practice-driven ethical dilemmas.
METHODS: An inductive qualitative evaluation was conducted on six recorded videos of health professions students\' case-based online group discussions, followed by a one-hour online ethics workshop. The online ethics workshop was organized with students from the College of Medicine, College of Dental Medicine and College of Pharmacy at the University of Sharjah, and the College of Medicine at the United Arab Emirates University. . The recorded videos were transcribed verbatim and imported to the qualitative data analysis software of MAXQDA 2022. Data were analyzed applying four stages of review, reflect, reduce and retrieve and two different coders triangulated the findings.
RESULTS: Six themes emerged from the qualitative analysis of the health professions students\' approaches to the practice-based ethical dilemmas; (1) emotions, (2) personal experiences, (3) law and legal system, (4) professional background, (5) knowledge of medical research and (6) inter-professional education. In addition, during the case-based group discussions in the ethics workshop, students efficiently applied the relevant ethical principles of autonomy, beneficence, non-maleficence and justice in their reasoning process to reach an ethical decision.
CONCLUSIONS: The findings of this study explained how health professions students resolve ethical dilemmas in their ethical reasoning process. This work sheds light on ethical development in medical education by gaining students\' perspectives in dealing with complex clinical scenarios. The findings from this qualitative evaluation will aid academic medical institutions in developing medical and research-based ethics curriculum to transform students to ethical leaders.

To describe the extent to which pragmatic trials underachieved or overachieved their target sample sizes, examine explanations and identify characteristics associated with under-recruitment and over-recruitment.
Secondary analysis of an existing database of primary trial reports published during 2014-2019, registered in ClinicalTrials.gov, self-labelled as pragmatic and with target and achieved sample sizes available.
Of 372 eligible trials, the prevalence of under-recruitment (achieving <90% of target sample size) was 71 (19.1%) and of over-recruitment (>110% of target) was 87 (23.4%). Under-recruiting trials commonly acknowledged that they did not achieve their targets (51, 71.8%), with the majority providing an explanation, but only 11 (12.6%) over-recruiting trials acknowledged recruitment excess. The prevalence of under-recruitment in individually randomised versus cluster randomised trials was 41 (17.0%) and 30 (22.9%), respectively; prevalence of over-recruitment was 39 (16.2%) vs 48 (36.7%), respectively. Overall, 101 025 participants were recruited to trials that did not achieve at least 90% of their target sample size. When considering trials with over-recruitment, the total number of participants recruited in excess of the target was a median (Q1-Q3) 319 (75-1478) per trial for an overall total of 555 309 more participants than targeted. In multinomial logistic regression, cluster randomisation and lower journal impact factor were significantly associated with both under-recruitment and over-recruitment, while using exclusively routinely collected data and educational/behavioural interventions were significantly associated with over-recruitment; we were unable to detect significant associations with obtaining consent, publication year, country of recruitment or public engagement.
A clear explanation for under-recruitment or over-recruitment in pragmatic trials should be provided to encourage transparency in research, and to inform recruitment to future trials with comparable designs. The issues and ethical implications of over-recruitment should be more widely recognised by trialists, particularly when designing cluster randomised trials.

Overdose-associated deaths and morbidity related to substance use is a global public health emergency with devastating social and economic costs. Complications of substance use are most pronounced among people who inject drugs (PWID), particularly infections, resulting in increased risk of hospitalization. PWID often require intravenous access for medical treatments such as antibiotics; however, vascular access may be limited due to the impacts of long-term self-venipuncture. While vascular access devices including peripherally inserted central catheters (PICCs) allow reliable and sustained routes of administration for indicated therapies, the use of PICCs among PWID presents unique challenges. The incidence and risks associated with self-injecting non-prescribed substances into vascular access devices (SIVAD) is one such concern for which there is limited evidence and absence of formal practice guidance.
We report the experience of a multidisciplinary team at a health organization in Vancouver, Canada, working to characterize the incidence, patient and healthcare provider perspectives, and overall impact of SIVAD. The case study of SIVAD begins with a patient\'s perspective, including patient rationale for SIVAD, understanding of risks and the varying responses given by healthcare providers following disclosure of SIVAD. Using the limited literature available on the subject, we summarize the intersection of SIVAD and substance use and outline known and anticipated health risks. The case study is further contextualized by experience from a Vancouver in-hospital Overdose Prevention Site (OPS), where 37% of all individual visits involve SIVAD. The case study concludes by describing the systematic process by which local clinical guidance for SIVAD harm reduction was developed with stakeholder engagement, medical ethics consultation, expert consensus guideline development and implementation with staff education and planned research evaluation.
SIVAD is encountered with enough frequency in an urban healthcare setting in Vancouver, Canada, to warrant an organizational approach. This case study aims to enhance appreciation of SIVAD as a common and complex clinical issue with anticipated health risks. The authors conclude that using a harm reduction lens for SIVAD policy and research can provide benefit to clinicians and patients by offering a clear and a consistent healthcare response to this common issue.

Given the burdens of treatment and poor prognosis, older adults with kidney failure would benefit from improved decision making and palliative care to clarify goals, address symptoms, and reduce unwanted procedures. Best Case/Worst Case (BC/WC) is a communication tool that uses scenario planning to support patients\' decision making. This article describes the protocol for a multisite, cluster randomised trial to test the effect of training nephrologists to use the BC/WC communication tool on patient receipt of palliative care, and quality of life and communication.
We are enrolling attending nephrologists, at 10 study sites in the USA, who see outpatients with advanced chronic kidney disease considering dialysis. We aim to enrol 320 patients with an estimated glomerular filtration rate of ≤24 mL/min/1.73 m2 who are age 60 and older and have a predicted survival of 18 months or less. Nephrologists will be randomised in a 1:1 ratio to receive training to use the communication tool (intervention) at study initiation or after study completion (wait-list control). Patients in the intervention group will receive care from a nephrologist trained to use the BC/WC communication tool. Patients in the control group will receive usual care. Using chart review and surveys of patients and caregivers, we will test the efficacy of the BC/WC intervention with receipt of palliative care as the primary outcome. Secondary outcomes include intensity of treatment at the end of life, the effect of the intervention on quality of communication (QOC) between nephrologists and patients (using the QOC scale), the change in quality of life (using the Functional Assessment of Chronic Illness Therapy-Palliative Care scale) and receipt of dialysis.
Approvals have been granted by the Institutional Review Board at the University of Wisconsin (ID: 2022-0193), with each study site ceding review to the primary IRB. All nephrologists will be consented and given a copy of the consent form. No patients or caregivers will be recruited or consented until their nephrology provider has chosen to participate in the study. Results will be disseminated via submission for publication in a peer-reviewed journal and at national meetings.
NCT04466865.