Exploring one aspect of family-centered practice: Readability of written documents to support parental understanding and decision-making regarding cochlear implants.

Informed consent forms (ICFs) for clinical trials are often written above the recommended eighth-grade level. We aimed to compare the readability of original ICFs used for National Institutes of Health-funded stroke-related clinical trials with ICFs edited for readability using artificial intelligence. Publicly available ICFs associated with National Institutes of Health-funded stroke-related clinical trials were accessed through ClinicalTrials.gov (search period: inception to August 12, 2025). Using ChatGPT-4o, we created a customized Generative Pre-Trained Transformer (GPT) designed to lower the reading level to eighth grade or below while maintaining ICF content. We processed each ICF using this GPT to create edited ICFs. Standard readability metrics, including the Flesch-Kincaid grade level (primary outcome), were compared between original and edited ICFs using paired t tests or the McNemar test (cross-sectional design). We also assessed semantic similarity using the MPNet language model, which produced continuous scores from 0 (no similarity) to 1 (perfect similarity). ICFs were available for 46 stroke trials, including behavioral (n=21), device (n=15), drug (n=5), and other (n=5) intervention types. Mean reading levels were 11.52 for the original and 9.47 for the GPT-edited ICFs using the Flesch-Kincaid grade level (P<0.001). Only 1 (2%) of the original ICFs and 18 (39%) of the GPT-edited ICFs had a Flesch-Kincaid reading level at or below eighth grade (P<0.001). Both the Simple Measure of Gobbledygook and Gunning Fog Index favored the GPT-edited ICFs by 1 to 2 grade levels. The Flesch Reading Ease score favored the GPT-edited ICFs by about 8 points. The mean similarity score was 0.85 (SD=0.04). GPT-edited ICFs achieved a readability reduction of approximately 2 grade levels compared with the original ICFs while preserving high semantic similarity. Customized GPTs may be a useful tool to improve the readability of clinical trial ICFs.

Recruitment for clinical trials in acute care settings, including intensive care units (ICUs), emergency departments, and peri-operative environments, presents distinctive ethical and practical challenges. These include time-sensitive decision-making, impaired patient capacity, complex consent processes, and reliance on surrogate decision-makers (SDMs). Despite growing attention to research ethics, there is a limited synthesis of how these challenges impact patient consent and trial recruitment. Following PRISMA-ScR guidance, a systematic search of PubMed/MEDLINE (2010-2025) was conducted, supplemented by a targeted ClinicalTrials.gov search to identify ongoing and completed trials. Data were extracted and classified into overarching domains to map the breadth of barriers and proposed solutions. Fifteen studies were included, spanning randomised controlled trials, qualitative studies, surveys, and reviews. Key barriers were: (1) timing and capacity constraints in high-pressure environments; (2) comprehension challenges with technical consent documents, especially in minority populations; (3) regulatory variability limiting harmonisation of alternative models (e.g., deferred and staged consent); and (4) under-representation of vulnerable groups, leading to selection bias. Nine additional randomised clinical trials identified in ClinicalTrials.gov explored innovative consent tools such as digital aids and AI chatbots; two had published results. Promising strategies included multimodal consent, culturally tailored materials, early SDM engagement, and patient and public involvement (PPI). Acute-care and anaesthetic trials require adaptive consent frameworks that balance ethical rigour with operational feasibility. Adoption of inclusive recruitment strategies and harmonised international standards may enhance both equity and efficiency in future critical-care research.

Radiotherapy for head and neck cancer (HNC) has significant physical and emotional effects. This study investigated the feasibility of delivering "Prep-4-Radiotherapy (RT)", a multi-modal, risk-stratified approach to prehabilitation for people with HNC. HNC patients planned for radiotherapy were screened for psychological distress, malnutrition, sarcopenia, dysphagia, and reduced physical function using self-report measures. Low-risk patients were provided access to self-management resources. High-risk patients were additionally referred to relevant allied health disciplines for specialist prehabilitation and provided access to self-management resources. The feasibility of Prep-4-RT was judged against a priori criteria. Primary feasibility outcomes included patient adoption (uptake: ≥ 70% of eligible patients consent to screening; intention to try: ≥ 60% of patients utilize self-management resources and ≥ 70% of high-risk patient participants verbally accept referrals to specialist prehabilitation) and fidelity (adherence to specialist pathway: ≥ 70% of high-risk patients receive specialist prehabilitation and attend ≥ 70% of scheduled prehabilitation appointments). Point estimates for four of five primary outcomes indicated acceptable feasibility. The point estimate for the fifth primary outcome, adherence as assessed by the percentage of high-risk patients assigned to specialist prehabilitation who received care from required clinicians before radiotherapy, indicated feasibility with further revision. Prep-4-RT appears to offer a feasible risk-stratified program to provide prehabilitation to HNC patients prior to radiotherapy, though results for some criteria were characterized by notable missing data. Further evaluation is required to determine its effect on clinical and health service outcomes. ANZCTA (Australian New Zealand Clinical Trials Registry) ACTRN12623000770662.

Minimally Invasive, Fertility-Sparing Surgical Management of Multiple Bilateral Ovarian Dermoid Cysts.

Visual impairment affects millions of reproductive-aged individuals worldwide, yet obstetric care for this population remains underrepresented in clinical guidelines and medical education. Patients with visual impairment face unique barriers throughout the reproductive continuum. This review provides a comprehensive, obstetrician-gynecologist-focused framework for the care of the visually impaired. Key topics include communication, optimization, screening for coercion and violence, prenatal care, labor and delivery, postpartum care, breast/chest feeding, and contraception. Emphasis is placed on patient autonomy, consent, trauma-informed care, and compliance with legal/ethical standards. Integrating disability-competent practices into obstetric care is essential to improving outcomes and advancing equity in reproductive health.

Informed consent and ethical considerations in AI for dentistry and medicine: a scoping review.

Background: Accessibility to healthcare is a fundamental human right aimed at facilitating better health outcomes for people with disabilities. However, the persistent gap between policy intents and actual implementation results in poorer health outcomes for people with disabilities, which is against universal health coverage. Objectives: This study explored policymakers’ perspectives on barriers to accessibility to healthcare services for people with disabilities. Method: Through purposive sampling, qualitative, descriptive, exploratory research was conducted among five policymakers in a rural constituency. Each participant signed an informed consent form. The face-to-face interview lasted 50–60 min and used validated semi-structured questions, audio recordings, and memos to capture data. Manual coding, employing an inductive approach and categorisation, was conducted, resulting in the formulation of themes. Results: Two main themes emerged: Systemic and structural challenges to inclusive healthcare, and training and attitudinal barriers to inclusive healthcare, highlighting transport and infrastructure barriers, as well as insufficient budget because of ineffective health policy implementation. A lack of training and discrimination were key issues reported. Conclusion: This study highlighted key obstacles related to weak policy enforcement, inadequate infrastructure, stigma, and funding issues, which impede accessibility to health services for people with disabilities in Namibia. Contribution: Understanding how policies are translated into practice is crucial for closing implementation gaps and enhancing healthcare access for people with disabilities.

Mental health is now recognised as a major global concern affecting people from diverse backgrounds. There is growing evidence that the gut microbiota plays a crucial role by producing metabolites that significantly influence a person's mood and behaviour. Despite its importance, there is a significant gap in the profiling and understanding of the gut microbiota's influence on mental health among Malaysians. Therefore, this study aims to determine gut microbiome profiles among patients with major depressive disorders (MDD) of different treatment groups attending psychiatric clinics in the state hospitals and compare them to healthy individuals in the community of Klang Valley, Malaysia. This cross-sectional study will be carried out in Klang Valley, Malaysia. Eligibility of the patients will be assessed by the psychiatrists prior to recruitment of patients. Patients with MDD will be categorised into monotherapy and polypharmacy while healthy individuals will be used as a comparison group. Demographic data will be recorded. Stool samples will be subjected to DNA extraction and 16S rRNA gene-sequencing analysis to determine the microbial compositions of the gut microbiome. This study will be conducted following the procedure set by the National Medical Research Register Malaysia. The Medical Research Ethics Committee (MREC), Ministry of Health Malaysia, has ratified this study and granted ethical approval to conduct this study (NMRR ID-22-00893-JVW). All the participants will be given an information sheet and will sign a consent form to participate. Participants have the right to withdraw from the study at any time without an explanation. All information gathered will be used for research purposes only and treated as confidential. The results will be submitted to peer-reviewed journals for publication as well as presented at national and international conferences. Informing policy makers at all levels is a crucial aspect of the dissemination and will be done from local to international levels. This study was registered under National Medical Research Register Malaysia (NMRR ID-22-00893-JVW), a mandatory procedure of the Ministry of Health Malaysia before the start of a research.

Polypharmacy, defined as the inappropriate use of multiple concomitant medications, represents a major concern in elderly care and is associated with drug-drug interactions, adverse effects, and poor medication adherence. Previous studies have emphasized the importance of proactive pharmacist involvement in addressing polypharmacy. However, evidence regarding patient outcomes following pharmaceutical interventions remains limited. This study aimed to evaluate whether community pharmacists could contribute to optimizing medication therapy among elderly patients living in the community. Pharmaceutical interventions targeting polypharmacy were implemented with consideration of patient characteristics and caregiver perspectives. Questionnaire surveys were conducted among elderly patients receiving six or more daily medications and among caregivers, including helpers and visiting nurses. Cases involving potentially inappropriate prescriptions were identified in elderly outpatients, and deprescribing proposals were communicated to the respective prescribing physicians with patient consent. Follow-up assessments were conducted at least four weeks after intervention in patients whose medications had been deprescribed. Among elderly respondents, 32.7% expressed a desire to reduce the number of oral medications. Caregivers frequently reported challenges associated with patients receiving multiple prescriptions. Following pharmacist-led interventions, the number of prescribed medications decreased, particularly within the gastrointestinal and pain medication categories. Most patients reported no worsening of symptoms, and some indicated that medication administration had become easier. These findings suggest that community pharmacists may contribute to improving the quality of medication therapy in elderly outpatients through community-based interventions targeting polypharmacy.

The Russia-Ukraine war has produced widespread lethal ballistic trauma with unusual injury patterns, including rare cases of projectile migration and arterial embolism. Prompt differential management near frontlines is crucial to improve outcomes and reduce evacuation risk. The aim of the study was to present clinical features, diagnostic workup, and management of a combat patient with a penetrating chest wound, cardiac involvement, and subsequent migration of a ballistic fragment into the superior mesenteric artery (SMA), and to contextualize this case within existing literature on ballistic emboli. A 41-year-old serviceman sustained a chest injury from FPV-drone munitions. Initial delayed evacuation and staged imaging (X-ray, FAST, whole-body CT) identified a ballistic channel from chest to abdomen and a metallic intraluminal fragment in the SMA. Clinical decision-making weighed endovascular versus open approaches amid tactical constraints and patient consent dynamics. Contrast-enhanced CT suggested transcardiac migration of the fragment into the SMA. With absent critical mesenteric ischemia and delayed consent, laparotomy on day 14 revealed an intraluminal metallic fragment that was removed via arteriotomy with primary repair. The patient recovered and was discharged after 21 days. The arterial ballistic emboli must be suspected in patients with isolated chest- or thoracoabdominal injuries. The whole-body contrast-enhanced CT scan is an important diagnostic tool for patients with gunshot injuries. In the absence of evidence of bowel necrosis, surgery can be postponed in patients with SMA emboli. An important role in visualization is played by contrast-enhanced MSCT. We recommend removing projectile fragments from the major blood vessels.

Aspiration thrombectomy is a widely adopted acute ischemic stroke treatment with low complication rates. Traditional aspiration catheter delivery relies on microcatheters and microwires. Their removal before active aspiration has been observed to incidentally promote clot engagement; however, the mechanical basis and clinical relevance of this interaction remain poorly understood. Recently developed internal delivery catheters (DCs), such as Tenzing (Route 92 Medical), closely match the aspiration catheter lumen and appear to accentuate this effect, enabling quantification of the underlying mechanism. A physiologic benchtop cerebrovascular model was used to measure vacuum pressures during DC withdrawal and assess their effect on clot interaction. Test configurations included 3 aspiration catheter sizes (0.054″, 0.070″, 0.088″) tested with and without a Tenzing DC using synthetic thrombi. Vacuum pressure data were synchronized with fluoroscopic imaging and correlated with clot engagement and ingestion outcomes. Institutional Review Board approval and patient consent were not required for this in vitro study. Tenzing DC withdrawal produced a brief but substantial negative pressure spike (0.45-1.81 seconds), reaching 52% to 97% of maximum syringe vacuum (-560 mm Hg). This transient vacuum coincided with clot motion before active aspiration. Overall rates of successful clot capture were similar with and without DC use; however, DC-assisted trials showed a higher incidence of corked and fully ingested clots (P < .05), whereas aspiration catheter-only trials more frequently resulted in full clot aspiration. Withdrawal of a closely size-matched DC generates a previously unquantified transient vacuum that initiates preaspiration clot engagement. This study identifies synthetic aperture aspiration as a mechanism creating a localized low-pressure field that may promote early clot mobilization and wall detachment before active suction. While DC withdrawal likely contributes to clot engagement, the primary value of a DC remains safe navigation and device delivery.

Introduction: This pilot study aimed to identify novel serum protein biomarkers distinguishing antepartum stillbirth from live birth cases using LC-MS-based proteomics. Methods: After obtaining ethical approval and the patient consent, serum from three stillbirth cases and three live birth controls was analyzed using liquid chromatography-mass spectrometry. Z-scores and t-tests identified significantly differentially expressed proteins (p &lt; 0.05), with the top candidate proteins being evaluated against validated against clinical profiles of cases and controls. Results: Of 3,076 detected proteins, 472 were unique to the stillbirth group, and 1,275 were unique to the control group. We identified 100 proteins that were significantly downregulated in stillbirth cases compared to controls, while 48 proteins were significantly upregulated. Subsequently, the top 14 proteins were evaluated in relation to the clinical complications of the subjects. Among these, Vacuolar protein sorting-associated protein 13D, immunoglobulin kappa variable 3–20, and Lysozyme C demonstrated markedly distinct expression patterns. Discussion: These novel proteins reflect vascular and placental dysfunction, cellular stress, and immune dysregulation that may contribute to stillbirth pathogenesis, acting as a multi-marker diagnostic panel. Conclusion: This study identifies three promising protein biomarker candidates for stillbirth prediction, paving the way for validation in larger cohorts and clinical assay development.

Informed consent and the patient's declaration of consent are of central importance in any medical treatment. They serve to protect the patient's right to self-determination. Properly provided informed consent is aprerequisite for the validity of the patient's consent; without it, amedical procedure is unlawful and may give rise to liability for damages. Pursuant to section 630e(1) of the German Civil Code (BGB), the treating physician is obligated to inform the patient of all circumstances essential to consent, in particular regarding the nature, scope, implementation, expected consequences, and risks of the procedure, as well as its necessity, urgency, suitability, and prospects of success. In addition, the patient must be informed of possible treatment alternatives. Information regarding treatment alternatives is always required when several equally indicated treatment methods with different risks and prospects of success are available. Informed consent must be provided verbally during aface-to-face consultation; simply handing over an informed consent form is not sufficient. It must also be provided in atimely manner and be understandable. In radiology, informed consent is also of central importance, as many radiological examinations carry potential risks, e.g., due to radiation exposure or contrast agents. Information about treatment alternatives is particularly relevant with regard to the varying levels of radiation exposure associated with different radiological procedures. Since the burden of proof for proper informed consent lies with the treating physician, careful documentation of the content of the informed consent discussion is recommended. When using informed consent forms, individualized notes are also recommended for evidentiary purposes.

Amyotrophic lateral sclerosis (ALS) is a rare, progressive neurodegenerative disorder, with a substantial proportion of cases attributed to genetic factors. Recent advances in gene discovery and genomic technologies have transformed ALS care by enabling genomic testing to inform prognosis, assess familial risk, and facilitate access to novel therapies. However, guidance on the delivery of genetic testing and counselling in ALS remains limited, leading to variability in clinical practice. In response, the Manchester Motor Neuron Disease (MND) Care Centre and the Manchester Centre for Genomic Medicine co-developed a structured genetic care pathway for ALS, drawing on real-world data, patient engagement, and multidisciplinary collaboration. A retrospective evaluation of 326 ALS patients at the Manchester MND Care Centre identified significant variability in genetic testing uptake, counselling practices, and record-keeping. Patient survey and engagement sessions revealed uncertainty regarding key genetic concepts and inconsistent recall of pre- and post-test discussions. Priorities for improvement included clearer communication, standardised discussions, and enhanced support for families following genetic findings. Consequently, the Greater Manchester ALS Genetic Testing Pathway was developed by a multidisciplinary team, incorporating consensus-based steps for patient identification, pre-test conversations, consent, testing, results disclosure, and post-test support. This pathway integrates genetic testing into routine ALS care, clarifies team responsibilities, and establishes a framework for ongoing evaluation using key performance indicators. Patient and staff feedback is used to support continuous improvement. The co-developed ALS genetic testing pathway provides a scalable model for standardising genomic care in mainstream clinical settings. By establishing clear processes for genetics discussions, consent, and follow-up, the pathway seeks to improve equity, transparency, and person-centred care. Ongoing evaluation and collaboration with patients, clinicians, and genetic services are essential to ensure the pathway remains responsive to scientific advances and evolving patient needs. Wider adoption of structured genetic pathways may facilitate the integration of genomics into care for rare diseases across healthcare systems.

Objective:Emotional intelligence plays an essential role in working nurses towards communication, decision-making on critical issues in high-stress environments, and collaborating with colleagues. Higher emotional intelligence nurses provide safe and high-quality care towards patient safety. This study was designed to be implemented on the premises of Jazan at King Fahad Hospital to examine the emotional intelligence in working nurses and how they deal with the patients.Methods:In this cross-sectional study, 132 individuals were recruited among working nurses based on the recommended sample size formula. Data were collected using the self-administered questionnaire from all the participated individuals after signing the consent form. This study was carried out between August 2024 and September 2024. Three scales, such as demographic data, the emotional intelligence questionnaire, and Patient Safety Scales, were used to measure the study variables with the help of a five-point Likert scale. Emotional intelligence levels were categorized as low, moderate, and high, while patient safety was assessed through adherence to safety practices.Results:The results of this study confirmed that emotional intelligence has a high mean value of 3.91 ± 0.57, and the Patient Safety Scale also showed 3.73 ± 0.48 levels. Correlation analysis confirmed the positive association between emotional intelligence and Patient Safety Scale (r = 0.68; p < 0.001). Bivariate analysis also showed the significant association between emotional intelligence and Patient Safety Scale in different variables studied (p < 0.05).Conclusion:This study validates that emotional intelligence is a significant determinant of patient safety among critical care nurses in Jazan. Nurses with high emotional intelligence are superior at handling stress, clear communication, and sounding clear in making clinical decisions, all of which contribute to safer patient care in high-stress environments. Health care organizations should focus on developing emotional intelligence through structured training programs, incorporate emotional competencies into nursing education, and tackle organizational obstacles that prevent the implementation of individual emotional skills to enhance system-level safety, as these measures can lead to improved patient outcomes and a more resilient healthcare workforce. These efforts aligned with the goals of Saudi Vision 2030, which aims to enhance the improvement of the quality of healthcare and patient safety in the Kingdom.

The digitization of medical data and advances in interoperability have opened opportunities for research studies to use more comprehensive, longitudinal patient data from multiple sources. As patients often interact with many providers and payers over time, collecting data across organizations may have critical implications for accuracy and bias in study results. US policy has promoted exchanging health information among providers, payers, and patients, but less attention has focused on facilitating data collection for research, which presents unique challenges. This study aimed to identify and evaluate existing and emerging approaches for collecting comprehensive provider and payer data for research in the United States, with the goals of informing researchers of possible methods and generating evidence to inform policy initiatives. Our focus was on electronic approaches to data aggregation for studies requiring patient consent. We conducted a landscape analysis through interviews with subject matter experts (SMEs). SMEs were selected based on expertise. We created a list of evaluation criteria, identified existing and emerging approaches, and described the benefits and limitations of each approach by applying the evaluation criteria. We interviewed SMEs until saturation was achieved. Data collection was limited to the United States. A total of 20 SMEs helped identify 8 distinct approaches: (1) general-purpose smartphone app, (2) commercial app, (3) research community app, (4) structured data export, (5) Trust Exchange Framework and Common Agreement Individual Access Service, (6) regional study query, (7) national study query, and (8) aggregated data source. Participant-mediated exchange approaches (1-5) leveraged patients' right of access. Three approaches leveraged existing data exchange services (5-7). To evaluate these approaches, we identified 12 criteria, including perspectives of participants, research teams, and broader stakeholders. Each approach had benefits and limitations; no single approach emerged as superior for all use cases. While currently available approaches for participant-mediated exchange bypass the need for complex governance arrangements, they are limited by participant burden, effort needed by research teams, and data gaps, especially from payers. Some regional health information exchanges and aggregated data sources address governance challenges and can provide services such as preparing analytic datasets but are restricted to specific locations and/or data-source coverage. National networks currently do not allow queries for research and confront challenges in establishing trust and enforcing compliance with data-sharing requirements among network sites. Collecting comprehensive health data from multiple providers and payers in the United States is a complex and evolving process. The suitability of an approach may vary based on the needs of a study. Given the numerous barriers and the lack of a clear dominant method, further exploration and benchmark comparisons of all identified approaches are necessary. Ongoing public policy efforts will likely play an important role in progress.

Cryotherapy for reducing the pain of sterile water injections: A three-arm multicentre randomised controlled trial.

PurposeInformed consent is a cornerstone of ethical practice. Eliciting patient questions during informed consent increases patient engagement and understanding, thus enhancing integrity of the consent process. However, a patient in visible pain can add an additional challenge to the informed consent process. The purpose of this research was to examine if and how anesthesiology residents ask for questions from a patient displaying severe pain during an informed consent simulation.MethodsAnesthesiology residents recruited from three anesthesia residency programs were video recorded performing an informed consent with a 52-year-old White male simulated patient awaiting urgent repair of a perforated gastric ulcer who was displaying verbal and nonverbal signs of pain. Two independent coders evaluated whether, when and how residents elicited patient questions during the informed consent process.ResultsAmong a sample of 65 first- and third-year anesthesiology residents, more than 20% of residents did not elicit questions during the informed consent encounter. Those who elicited questions typically did so late in the process, with approximately 10% inviting questions only after the consent form had been signed. Most questions were closed-ended (yes/no questions). Although residents did not typically incorporate the patient’s name when eliciting questions, most residents demonstrated eye contact. There were no differences in the number or characteristics of questions elicited based on resident gender or level of training.ConclusionOur findings suggest there is a need for increased education regarding the purpose and approach to eliciting patient questions during the informed consent process, especially for patients who are experiencing pain.

Little is known about the factors influencing patients' response and decision rates to requests for general consent, designed to cover the use of health-related personal data and biological samples, in tertiary university hospitals. As such, we first sought to evaluate different general consent administration modes implemented at Lausanne University Hospital between December 2012 and April 2022, based on the following indicators (i) information rates, (ii) response rates and (iii) consent rates. The second objective of the study was to assess patients' understanding, preferences, needs and expectations regarding the content, form and mode of administration of general consent. This mixed-methods study comprised two phases. First, we analysed retrospective administrative data and general consent-related information from 178,223 adult patients who had been informed about general consent. Second, we analysed 2445 anonymised questionnaires mailed to patients as well as 4737 patient communications, and conducted 32 semi-structured telephone interviews. The information-provision mode and clinical context influence patients' response to general consent.Oral information given by healthcare providers within medical departments is the most effective way of informing patients and making them reach a decision about granting general consent. However, 73.3% of questionnaire respondents considered that written information supported by a hotline is sufficient. Patients referred to the emergency room, following an accident for example, are less likely to respond to and grant general consent. Even though most respondents claim to fully grasp the information material, some topics seem less well understood and require additional explanations, such as the use of health-related personal data and biological samples in external institutions and the consequences of not replying to general consent. The study provides an accurate data-driven depiction of how general consent administration methods and clinical contexts impact patients' response and decision rates, as well as an assessment of patients' understanding and needs concerning general consent information. These data allow us to confirm the validity of several practices, draw lessons and propose pragmatic recommendations to optimise general consent administration in hospitals, specifically: 1) Promote general consent information provision before or during the hospital visit or stay, 2) If a patient has not replied to general consent, repeat the information in a more favourable clinical context, 3) Diversify information channels and explore digital options for more-personalised and adapted information, 4) Simplify, clarify and illustrate general consent documentation with concrete examples of research enabled by general consent.