To define standardised outcomes, the Core Outcome Set (COS) for reporting in studies of Intrahepatic Cholestasis of Pregnancy (ICP). e-Delphi survey and consensus process. International. 155 individuals from Asia, Europe, Oceania, North and South America: 31 patients (20%), 121 clinicians (78%), and 3 researchers (2%). Maternal and perinatal outcomes reported in studies of ICP were collated. Stakeholders in ICP research and clinical care scored the importance of each outcome using a 9-point Likert scale over three rounds; short-listed outcomes were ranked during face-to-face consensus meetings. The final COS was agreed by the Study Steering Committee. The study was registered prospectively with Core Outcome Measures in Effectiveness Trials. Ethical approval was granted by the King's College London Research Ethics Committee (KCL MRA-23/24-39574). From 54 manuscripts, 97 individual clinical outcomes were attributed to ICP. Twenty three outcomes were shortlisted by the e-Delphi surveys, the ranking of which enabled selection of 10 core outcomes. Maternal core outcomes comprise: total maternal bile acid (BA) concentration (maximum), gestational age at peak BA concentration, and itch impact on maternal wellbeing. Birth core outcomes comprise: stillbirth, gestational age at birth, and spontaneous preterm birth versus induced preterm birth. Neonatal core outcomes comprise: perinatal death within 7 days of birth, perinatal asphyxia, neonatal unit admission, and mechanical ventilation. Given the heterogeneity of reported outcomes, we have confirmed the need for a COS in ICP, standardising the minimum reported outcomes to reduce outcome reporting bias and research wastage.

To strategically optimize diagnostic capacity in a low-resource, rural hospital setting, we developed a systematic evaluation of diagnostic tool needs and associated costs. This local data-driven method, accounting for patient characteristics and disease prevalence, can be adapted to other contexts. A retrospective patient record analysis was conducted at San Miguel Hospital (SMH) in Sucumbíos, Ecuador, which provides outpatient and emergency care to inhabitants of the Ecuadorian and Colombian Amazon basin. Ethics approval was granted retrospectively by the Research Ethics Committee on Human Beings of the Universidad San Francisco de Quito.Data was retrieved from electronic medical records (EMRs) of the first 796 patients seen after hospital opening. For each of the 1975 diagnoses made, patient characteristics and the presence or absence of appropriate diagnostic tools were recorded. Unavailable tools were further evaluated for accessibility within the local context. Serving a population primarily of mixed and indigenous ethnicities, SMH confirmed 66% of diagnoses using existing resources, with potassium hydroxide (KOH) fungal microscopy, chikungunya and influenza rapid tests, and access to anatomical pathology identified as the diagnostic tools offering the highest return on investment. Data from SMH's EMRs suggest which diagnostic tools would offer the greatest return on investment through increased diagnostic confirmation. This evaluation tool supports improved health care delivery at SMH and, with adaptation, can be applied in comparable health care settings. N/A.

Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used for postoperative pain management after hip and knee arthroplasties but have been associated with renal adverse effects. The risk may increase when NSAIDs are combined with diuretics and angiotensin converting enzyme (ACE) inhibitors or Angiotensin-II-receptor antagonists. The aim of this substudy is to assess potential renal adverse effects of an eight-day postoperative treatment with ibuprofen in patients undergoing hip or knee arthroplasty during 90-days follow-up. This substudy is part of the PERISAFE trial-a randomized, placebo-controlled, blinded multicenter trial including 2904 patients undergoing hip or knee arthroplasty. Patients are randomized to receive either ibuprofen 400 mg three times daily or identical placebo three times daily for 8 days postoperatively. The primary outcome is the number of patients with renal dysfunction according to RIFLE criteria Level 1-5, at any point during the 90-day follow-up. The substudy is powered at 86.3% to detect or discard a 40% relative risk reduction in the placebo group, assuming an incidence of acute renal injury of 6.2%. The ethical approval for this substudy is included in the main PERISAFE trial, which has been approved by the Danish Medicine Agency, the National Committee on Health Research Ethics (EU CT no. 2022-502502-32-00), and the Danish Data Protection Agency (REG-149-2022).

Drought is a prolonged period of abnormally low precipitation, leading to a significant water deficit that adversely affects the environment, agriculture, and various socio-economic activities. Severe weather phenomena, including droughts, floods, wildfires and hurricanes inflict rapid and significant economic losses among businessmen and women. They interrupt commercial activities, harm critical infrastructure, wipe out agricultural production, and force many communities to relocate. The aim of this study was to assess the economic effects of drought and identify strategic adaptation mechanisms employed by Small and Medium Enterprises (SMEs) in Lusaka District, Zambia. A cross-sectional research design was used in this study. This study used a stratified random sampling method to select 384 participants (owners and managers of SMEs) from SMEs within such targeted sites as Town Centers, Soweto market, City Market, and Buseko Market. Approval was obtained from the University of Zambia Biomedical Research Ethics Committee (UNZABREC) REF. No. 5913-2024 and the Lusaka City Council to ensure ethical compliance for the study. Respondents were informed that participating in this study was completely voluntary and that, they were free to withdraw from the study at any time without any consequence. The participants were informed that taking part in the study would not put them at risk of harm and that they would not gain any immediate personal benefits from their involvement. Respondents were also assured that the collected data would not be disclosed to anyone and that confidentiality and anonymity would be maintained throughout the study. After all aspects of the study had been clearly explained and the participants had demonstrated understanding, written informed consent was obtained from each respondent prior to the commencement of data collection. Primary data was collected using a structured questionnaire with closed-ended questions. The collected primary data was analysed using SPSS version 28, and the analysed data were presented using pie charts and tables. The results from this study demonstrated that, most of the respondents (63.2%) reported that drought lead to reduced operational costs and increased profitability among Small and Medium Enterprises (SMEs) in Lusaka District. The study also found that, few study participants (20%) indicated that, drought decreased revenue, increased operational costs, and caused challenges to the continuity of businesses. The findings from this study found that, most of the respondents (52.1%) diversified their products and services to meet changing demands of their customers during droughts. In contrast, increasing staff wages emerged as the second most significant strategy adopted by 27.1% (104) of SMEs. The study further disclosed that, the majority of respondents (82.1%) reported that limited access to financial resources and credit facilities emerged as a major challenge faced by small and medium enterprises in implementing effective drought adaptation strategies in Lusaka District of Zambia. While the majority of SMEs reported increased profitability and reduced operational costs due to strategic adaptations, a notable minority highlighted challenges such as revenue loss, increased expenses, and operational disruptions. The author recommends that, to enhance resilience, SMEs in Lusaka District should build on adaptive strategies such as product diversification and wage adjustments, while policymakers and financial institutions should work to overcome the critical barriers of limited access to credit and financial resources.

Introduction: Emergency contraception (EC) is a method used to prevent pregnancy after unprotected sexual intercourse, following incorrect use or failure of regular contraceptive methods, including cases of sexual assault where no contraceptive protection was used. The widespread availability of emergency contraception in middle‑income nations like Zambia offers an effective means of preventing a large proportion of unintended pregnancies. The aim of this study was to establish the level of knowledge, attitude and perception of female students (18-49) towards emergency contraceptive pill utilization at Lusaka Apex Medical University. Methods: A cross-sectional study design was employed to assess the level of knowledge, attitude and perception of female students (18-49) towards emergency contraceptive pill utilization at Lusaka Apex Medical University. Simple random sampling technique was used to select 230 respondents to participate in the study. The ethical approval was obtained from The University of Zambia Biomedical Research Ethics Committee (REF. No. 5593-2024), and Lusaka Apex Medical University respectively. Primary data was collected from 230 study participants using structured questionnaire with closed ended questions. The collected data was analyzed using SPSS version 29 and MS excel and was presented using tables and pie charts. Multivariate logistic regression analysis was used to examine the relationships between socio-demographic characteristics and knowledge, attitude and perception parameters. Results: The study found that, the largest age group among the participants was 41-49 years, comprising 30% of the sample, while the smallest age group was 21-30 years, accounting for 22.17%. In addition, the study disclosed that, most of the respondents (70%) at Lusaka Apex Medical University possessed an adequate level of knowledge regarding the utilization of emergency contraceptive pills, whereas 30% exhibited inadequate knowledge on the subject. Age (p < 0.003), marital status (p < 0.004), religion (p < 0.001), level of education (p < 0.000), occupation (p < 0.000) and number of children (p < 0.000) were found to have significant association with level of knowledge on emergency contraceptive pill utilization among female students at Lusaka Apex Medical University. Apart from that, the study also revealed that most of the respondents (71.8%) had positive attitudes towards emergency contraceptive pills utilization at Lusaka Apex Medical University in Zambia. In addition, 28.2% of study participants had negative attitudes towards emergency contraceptive pills utilization. The study further exposed that, a good proportion of study participants (65%) had a positive perception of emergency contraceptive pills utilization, in contrast to 35% who held negative perceptions. Conclusion: The study concludes that female students at Lusaka Apex Medical University generally demonstrate adequate knowledge, positive attitudes, and favorable perceptions toward the utilization of emergency contraceptive pills. However, notable proportions of participants still exhibited inadequate knowledge, negative attitudes, and unfavorable perceptions, indicating existing gaps. Therefore, the researcher recommends that Lusaka Apex Medical University, in collaboration with the Ministry of Health, the Ministry of Higher Education, and international partners such as WHO and UNESCO, strengthens and institutionalizes targeted reproductive health promotion programs on emergency contraceptive pill (ECP) utilization. These programs should integrate comprehensive health education, social mobilization, health communication, peer education, and counseling to enhance knowledge, promote informed decision-making, and foster positive perceptions of ECP use among female students in institutions of higher learning. Additionally, the introduction of community discussions and campus-based health forums is recommended to address misconceptions and shift negative perceptions toward ECP utilization.

Introduction: Cervical cancer is a malignancy that originates in the cervix, the lower part of the uterus that connects to the vagina, and is caused primarily by high-risk types of human papillomavirus (HPV). Globally, cervical cancer is the fourth most common cancer among women, with approximately 660,000 new cases and about 350,000 deaths reported in 2022. This study aimed to assess the facilitators and barriers influencing the utilization of cervical cancer health services among childbearing women aged 15-49 in Lusaka District of Zambia. Methods: A cross-sectional study design was utilized to investigate the facilitators and barriers that influence the utilization of cervical cancer health services among women of reproductive age. Ethical approval was sought and obtained from Lusaka Apex Medical University Biomedical Research Ethics Committee IRB number 00799-24. Results: The study disclosed that a large proportion of respondents were Christians (83.8%) and were not employed (45.8%). Research revealed that while 51.4% of respondents have heard about cervical cancer, a significant majority of them (67.6%) are still unaware of risk factors, endorsed frequency (73.2%) and acceptable methods (64.8%) of cervical cancer screening and the importance of early cervical cancer detection and management (73.2%). The study further disclosed that, while 64.8% of women have been encouraged by healthcare professionals, and the convenience of multiple healthcare facilities (64.8%) across the district, a significant proportion of respondents (84.5%) do not attend educational awareness campaigns on cervical cancer. Not only that, the study also disclosed that, many study participants (67.6%) are still unaware of government initiatives about cervical cancer. The study also revealed that, 64.8% of study participants have never received information about cervical cancer health services through community awareness campaigns in Lusaka District. Age, marital status, social class, religion, level of education, occupation and number of children were found to have statistically significant association with respondents’ level of awareness of cervical cancer (P < 0.05). The study also found that, most of the study participants’ significant challenges faced when accessing and utilizing cervical cancer health services include transportation issues and lack of privacy, each affecting 90.3% of study participants, and financial constraints impacting 67.9% of respondents. The study further uncovered that, 67.6% of women feel that the distance to healthcare facilities is another major obstacle to cervical cancer services accessibility and utilization. The study also disclosed that 64.8% of respondents are still unaware of available free cervical cancer health services due to lack of availability of health information and education among women of reproductive age. The study further disclosed that, most of the respondents (73.2%) do not perceive fear or anxiety about cervical cancer screening procedures to affect their willingness to utilize cervical cancer health services in the district. Conclusion: The study found that utilization of cervical cancer health services among women of childbearing age in Lusaka District remains suboptimal, largely due to low levels of awareness, limited access to health information, and persistent structural barriers such as transportation challenges, financial constraints, distance to health facilities, and concerns regarding privacy. Socio-demographic factors, including age, marital status, education, occupation, religion, and parity, were significantly associated with awareness of cervical cancer services. In response, the study recommends that the Lusaka District Health Office, in collaboration with the Ministry of Health and the World Health Organization (WHO), strengthen community engagement, social mobilization, and health education campaigns to improve awareness of cervical cancer risk factors, screening services, and HPV vaccination. Additionally, capacity building for healthcare providers in culturally sensitive communication, patient confidentiality, stigma-free care, and the expansion of mobile outreach services is essential to address existing access-related barriers.

This study aimed to determine the level of teachers’ awareness of the utilization of special education funds in the first-class municipality in the central Philippines. Specifically, it examined teachers’ awareness in four areas of SEF utilization: operation and maintenance of school facilities and equipment, construction and repair of school buildings, educational research, and the purchase of books and periodicals. The data needed for this descriptive study were collected from 166 respondents using a 32-item self-made data gathering instrument that had undergone stringent tests of validity and reliability. Throughout the entire research process, this study adhered to research ethics protocol. The ensuing analysis showed that teachers demonstrated a high level of awareness across all SEF utilization areas. Findings further indicated that awareness levels did not significantly differ when grouped according to the aforementioned demographic variables, thus failing to reject the null hypothesis. While teachers exhibited strong awareness of documentation and reporting processes, gaps were observed in their understanding of acquisition, disbursement, and research funding mechanisms. The study concludes that although teachers possess substantial general awareness of SEF utilization, technical awareness related to procurement and research remains limited. These findings provide a basis for proposing information, education, communication, and action plan to promote a deeper understanding and more effective utilization of SEF in public schools. Keywords: Teachers’ awareness; utilization of special education fund; Negros Occidental, Philippines.

Purpose Artificial intelligence (AI) has redefined what it means to perform, achieve and succeed. Algorithms now surpass human capability in processing speed, pattern recognition and data-driven decision-making. However, as machines become increasingly intelligent, the question of what constitutes success in the human sense becomes increasingly important. The purpose of this paper is to provide a framework for evaluation of these intersecting concepts. Design/methodology/approach Drawing on leadership theory, emotional intelligence research and AI ethics, “Deconstructing success” involves dismantling productivity-based definitions and reconstructing a framework centered on adaptability and purpose. In an age of automation, being human is not a disadvantage; it is a defining strategic advantage. Findings This paper argues that the future of success will not depend on outpacing machines but on cultivating distinctly human capacities: empathy, discernment, imagination and moral reasoning. Originality/value This conceptual essay proposes the Human Excellence 2.0 model, positioning human consciousness and ethical awareness as the new frontier of achievement.

Industry relationships are common in plastic surgery but can introduce bias through conflicts of interest (COI). In 2010, the Physician Payment Sunshine Act mandated biomedical companies to disclose and publish physician payment records on the Open Payments database. Inconsistent author disclosures have been identified in peer-reviewed plastic surgery literature, but opinion-based plastic surgery literature (i.e., letters, commentaries, editorials) remain overlooked, despite a greater risk for bias and subjectivity. This study aimed to compare author disclosures in opinion-based plastic surgery articles with Open Payments records. COI disclosures amongst plastic surgeon authorships in all opinion-based articles published in Aesthetic Surgery Journal and Plastic and Reconstructive Surgery from 2021 to 2023 were systematically reviewed and cross-referenced with Open Payments. The primary outcome was discrepancies of COIs with Open Payments records and vice versa. Secondary outcomes included proportion of discrepancies over $250 and predictive factors for discrepancies. 1,108 authorship disclosures were compared with Open Payments data. 62% (n=689) of authorships had at least one discrepancy; 61% (n=678) received undisclosed payments, while 12% (n=128) disclosed relationships without corresponding Open Payments record. Authorships with payments over $250 were more likely to have a discrepancy (99.6% vs 62%, p <0.0001). Publication year and author position were predictive of discrepancies, but there was no significant difference between journals. COI is under-reported in opinion-based plastic surgery literature, leaving readers unaware of potential biases. Accurate COI disclosure is essential to maintain ethical and high-quality research, therefore collaboration between authors, editors, and regulatory bodies is needed to improve reporting standards.

Clinical research in persons with a terminal illness (PTI) can offer valuable scientific opportunities but raises the challenge of ensuring adequate protections for participants. Existing ethical frameworks provide limited, and sometimes conflicting guidance for navigating this tension. Given that enrolling only PTI (e.g., palliative care research) or PTI alongside participants without a terminal illness (many studies in geriatrics and other disciplines) is somewhat common, establishing the right balance is important. This paper-grounded in general research ethics requirements-thus proposes a framework based on the defining feature of PTI, namely, limited life expectancy. We explore how limited life expectancy and characteristics common (but not unique to) PTI (e.g., decisional impairment) can make it difficult for studies to meet one or more commonly recognized ethical requirements (e.g., social value, favorable risk-benefit ratio, fair participant selection, informed consent, and respect for participants and third parties). We suggest ways to address these challenges and offer considerations for IRBs when evaluating studies with adults with a terminal illness. This approach aims to balance protecting PTI and ensuring they can contribute to important research without undue restrictions.

Polycystic ovary syndrome (PCOS) is one of the most prevalent endocrine disorders globally, affecting 11-13% of women during reproductive age. PCOS is associated with an elevated risk of reproductive, metabolic, endocrine and mental health features. While lifestyle changes are first-line treatment for managing PCOS, metformin is often recommended for individuals with a body mass index (BMI) ≥25 kg/m2. The aim of the metformin use in polycystic ovary syndrome (MET-PCOS) trial is to determine whether a metformin dose of 1500 mg per day or 2250 mg per day is superior in managing biochemical and clinical outcomes in PCOS. MET-PCOS is a double-blind randomised controlled trial with two arms. It will be carried out at the Reproductive Medicine Unit at Helsinki University Hospital, starting from November 2025. Participants aged 18-37 years with a BMI≥25 kg/m2 meeting the updated 2023 Rotterdam criteria for a PCOS diagnosis will be included. The participants (n=184) will be allocated (1:1) to a metformin dose of 1500 mg or 2250 mg per day. Outcomes include anthropometry, metabolic outcomes, hyperandrogenism, polycystic ovary morphology, menstrual cyclicity, mental health and gastrointestinal adverse effects. Measurements for study endpoints will be undertaken at baseline, 14 and 26 weeks. The Finnish Medicines Agency has authorised the clinical trial (FIMEA/2025/00755) and the Regional Committee Medical Research Ethics, Finland (T7323/2024) has approved the trial protocol. This study will guide care providers in selecting the ideal metformin dose for individuals with PCOS. NCT07120815, EU trial number: 2023-509259-15-01.

Undocumented migrants in Germany face significant challenges in accessing healthcare. Although they are entitled to limited health services under the Asylum Seekers' Benefits Act, they cannot utilize these services without risking detection and deportation due to reporting obligations of social authorities. This study systematically reviews the existing research on healthcare access in this population in Germany for the first time. The literature research was conducted following the PRISMA-ScR standard in the databases Medline, CINAHL, PSYNDEX, SocINDEX, and Juris, with additional information gathered through supplementary email inquiries and manual searches. Studies from the years 2005-2024 were included. The data were analyzed regarding legal, structural, and practical access barriers and treatment gaps as well as recommended measures. Atotal of 88studies were included, most of which are based on quantitative data collection. The studies reveal that access to healthcare for people without valid residence permits is usually limited to emergency care and is characterized by treatment interruptions and alack of continuity in care. Humanitarian healthcare provision and anonymous healthcare vouchers partially compensate for existing gaps, but do not offer an adequate alternative to regular care. Despite civil society initiatives, undocumented migrants are underserved, and the right to health is not implemented. Future research should be aligned with the research ethics principles of care, harm minimization, and the self-determination of those affected.

The institutionalisation of older adults has become increasingly common in Sri Lanka due to recent socioeconomic changes. Tai Chi is a traditional Chinese martial art that provides numerous physical and psychological health benefits. Despite its proven effectiveness, Tai Chi is a relatively new intervention in Sri Lanka, with no local research on its feasibility and efficacy among older adults. This study aims to evaluate the feasibility and effectiveness of Tai Chi on physical function and fall risk, lung function, depression, pain and health-related quality of life (HRQOL) in older adults residing in aged care homes in Sri Lanka. A single-arm pretest-posttest feasibility study will be conducted among older adults aged 60 and over (n=40) living in aged care homes in Kandy District, Sri Lanka. A certified Tai Chi instructor will deliver two 60 min sessions of the Tai Chi for Arthritis and Fall Prevention programme per week over a 12-week period in aged care home settings. Acceptability, demand, implementation, practicality, adaptation, integration, expansion and study limitations will be assessed to determine feasibility. Baseline and post-12-week Tai Chi programme outcomes will be assessed, focusing on physical function and fall risk, lung function, pain, depression and HRQOL. Additionally, field notes will be taken during the intervention, and a post-intervention follow-up group discussion will be conducted. Paired t-tests will be used to assess the effectiveness of the Tai Chi programme. A narrative synthesis will be used to analyse qualitative data. The Research Ethics Committee of the Faculty of Medicine, University of Peradeniya, Sri Lanka, approved this study (No.: 2024/EC/34). Written informed consent will be obtained from each participant before data collection. The findings will be presented at national and international research conferences and published in a reputed journal. This study was registered with the Sri Lanka Trial Registration (SLCTR/2025/025) at https://slctr.lk/trials/slctr-2025-025 (date: 26 June 2025).

Psychedelic-assisted therapy shows promise for treating various mental health conditions; however, its reliance on intensive psychological preparation limits its broader application. Digital health interventions have the potential to address this limitation by providing structured, accessible and scalable preparation solutions. This randomised controlled feasibility trial aims to evaluate the feasibility and preliminary efficacy of the Digital Intervention for Psychedelic Preparation (DIPP), a 21-day mobile-accessible programme designed to prepare individuals for psychedelic experiences. The study will recruit 40 non-treatment-seeking adults without a clinical diagnosis, randomly assigning them to one of two conditions: (1) DIPP-MEDITATE, which combines daily guided meditation with background music or (2) DIPP-MUSIC, which provides the same background music without guided meditation. Both groups will complete the 21-day digital intervention remotely. Following the intervention, participants will attend an in-person supervised psilocybin session, receiving a standardised 25 mg dose. Primary outcomes focus on feasibility metrics including recruitment efficiency, participant retention and adherence to the intervention protocol. Secondary outcomes assess subjective feasibility, acceptability and preliminary efficacy, specifically evaluating psychedelic preparedness, the quality of the psychedelic experience and changes in wellbeing, with follow-up assessments at 2 weeks, and at 3, 6 and 9 months post-session. Exploratory measures include neuroimaging, physiological, cognitive and psychological assessments, as well as voice note experience sampling through a chatbot (referred to as 'DIPP-bot') to monitor inner speech, thought and emotional states during the intervention and follow-up periods. Approved by UCL Research Ethics Committee (ID: 19113/003), this study follows the Declaration of Helsinki. Results will be published in peer-reviewed journals and presented at conferences. Confidentiality will be maintained throughout. NCT06815653.

ABSTRACT Due to the social experiment characteristics of reality television (RTV) series, our paper proposes a code of ethics for RTV grounded in research and media industry ethics to ensure the ethical treatment of participants. This code should extend from pre-production through one-year post-production and include transparent contractual provisions that attend to: (1) participants’ mental and physical well-being; (2) informed consent and right to withdraw; (3) limitations on production manipulation; and (4) accountability for anyone with power over participants. Given its centrality in current RTV controversies and its framing as an “experiment,” Love is Blind serves as an exemplar through which we argue that applying industry-specific ethical research standards can improve the treatment of participants and still allow for meaningful and entertaining insights into human behavior.

Primary open-angle glaucoma (POAG) is a common type of glaucoma in clinical practice and an important irreversible blinding eye disease. Basic and clinical research related to optic nerve protection has been conducted in related fields for many years, but there is still a lack of methods that can truly exert optic nerve protection in POAG clinical practice. This article analyzes and summarizes the challenges and difficulties encountered in clinical research on optic nerve protection in POAG from four perspectives: disease and pathophysiology, research design and ethics, drugs and their mechanisms of action, and translational medicine. In addition, this article actively explores possible coping strategies and future development directions for the aforementioned issues, aiming to provide guidance and reference for clinical research on optic neuroprotection in POAG.

Obtaining informed consent can be challenging in emergency and critical care research due to the acute and severe nature of the patient's condition. However, such research is urgently needed to inform practice and optimise patient outcomes. While alternative consent approaches have been commonly used, opinions may vary, particularly among diverse and underserved patient groups and in the context of the recent COVID-19 pandemic. The objective of this review was to assess views of alternative consent methods in emergency and critical care research. We conducted a rapid systematic review to understand diverse opinions of alternative consent models used in emergency and critical care research with searches of MEDLINE, EMBASE, PsycINFO, Web of Science and CENTRAL carried out to July 31, 2024. We included quantitative and qualitative studies and summarised findings using narrative synthesis. We specifically investigated underserved groups and consent in the pandemic setting. From 9974 citations, we screened 289 full-text articles, and included 145 eligible studies from 26 countries. Consent methods included prospective informed consent, deferred consent, surrogate decision maker consent, healthcare professional consent and waived consent. Groups represented included previous trial participants, relatives of trial participants, patients, members of the general public, healthcare providers, researchers, site staff, and research ethics committees. It was recognised that prospective informed consent from the patient is not possible in all scenarios. In general, alternative consent models were acceptable, with emphasis on the inclusion of the patient and relatives in the decision-making process whenever possible. Acceptability of alternative consent models was influenced by previous research participation, experience of critical or emergency illness, perceived risk of participation, and invasiveness of the intervention. Study staff highlighted potential limitations of some alternative consent models, such as unavailability of relatives. Pandemic studies showed an increased need for alternative consent methods, and greater preparedness and engagement with ethics committees to facilitate implementation. Sub-analysis evaluating the views of underserved groups did not show consensus, and accommodations were largely not reported. Alternative consent models used for emergency, critical care and pandemic research including deferred consent, relative/surrogate decision maker consent, and physician consent were generally acceptable. PROSPERO CRD42023408305(April 19, 2023).

Newborn bloodspot screening (NBS) is freely and universally available to babies born in Australia, with nearly 300 000 newborns screened each year. The NBS programme screens for approximately 30 conditions; however, there are hundreds of childhood conditions that could be treated if identified earlier and asymptomatically. Contemporary screening platforms have relied on mass spectrometry-based technologies, limiting surveillance to conditions with validated biomarkers detectable within the neonatal period. Advancements in metabolic techniques and genomics have expanded the range of conditions that could be detected. The NewbornsInSA research study will develop, validate and evaluate a novel multi-omic model of newborn screening, integrating metabolomic and genomic newborn screening as complementary methodologies. Parents can opt in to additional NBS through NewbornsInSA during pregnancy or shortly after birth. One thousand prospectively recruited families will be offered genomic NBS by whole-genome sequencing, including analysis of a virtual gene panel of over 600 genes, and concurrent metabolomic screening. Clinically actionable pathogenic or likely pathogenic genetic variants will be reported to parents and whole genome sequencing data will be available on request for diagnostic reanalysis, if required later in life.Acceptability of the NewbornsInSA programme will be evaluated through stakeholder engagement activities with healthcare professionals, members of the public and patient advocacy groups. Family experiences will be assessed using online surveys. The diagnostic yield, accuracy and the costs and consequences of the multi-omic NBS model will be assessed by comparison to standard-of-care NBS.NewbornsInSA will investigate the acceptability, feasibility and cost-effectiveness of a multi-omic newborn screening model in a prospectively recruited South Australian population. We hypothesise that this approach will increase the number of conditions identified, reduce the time to diagnosis and facilitate earlier care with better outcomes for newborns with genetic conditions. This research study has been ethically approved by the Women's and Children's Health Network Human Research Ethics Committee (2022/HRE00258 and 2023/HRE00236). Findings will be disseminated through peer-reviewed publication and conferences.

Food retail outlets in sports and recreation facilities often fail to support healthy eating, despite aligning with healthy lifestyles and goals of local governments (LGs) that often own or manage them. LGs face barriers to implementing facility changes including inadequate staffing, training and incentives. The Promoting CHANGE initiative was co-designed to support LGs in improving and sustaining healthier food and drink offerings in these settings. A 3-year, type 2 effectiveness-implementation hybrid cluster randomised controlled trial will evaluate the Promoting CHANGE capacity-building and support package in three Intervention and four Control LGs in Victoria, Australia (August 2023-July 2026). The co-designed initiative includes human resource support, training, tools, technical assistance, community-of-practice groups, feedback based on food outlet audit and sales data and small grant incentives. Using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) evaluation framework, the trial's co-primary outcomes are the percentage of least healthiest food and drinks (1) displayed (implementation) and (2) sold weekly (effectiveness). Key secondary outcomes are effectiveness (sales and revenue); facility-level adoption, implementation, maintenance of healthy changes; cost-effectiveness (within-trial modelled economic evaluation). Findings will provide evidence of the initiative's effectiveness and scalability, informing recommendations for advancing healthier food environments in over 6000 community-based food outlets across 500 Australian LGs, with implications globally. This study has received approval from the Deakin University Human Research Ethics Committee (reference number HEAG-H 92_2023). The results will be published in scientific peer-reviewed journals along with plain language summaries for participants. ACTRN12621001120864.

The advent of technology, particularly the rapid advancement of Artificial Intelligence (AI), is posing significant challenges to traditional models of postgraduate student supervision, ranging from affective mentorship relationships to automated interactions. AI-powered tools such as ChatGPT, Grammarly, DeepSeek, and automated data analysis software provide unprecedented data support to students, thereby enhancing and automating routine tasks. Consequently, the role of supervisors in upholding the fundamental principles of mentoring—such as fostering critical thinking, creativity, and ethical inquiry—is being scrutinised in light of this technological shift. This chapter examines the challenges associated with the incorporation of AI into postgraduate supervision, investigating its impact on intellectual independence, academic integrity, and mentor-mentee dynamics. Through a comprehensive Systematic Literature Review, this conceptual paper identifies strategies for balancing AI-driven efficiencies with human-centred mentoring practices. Additionally, we address ethical considerations, power dynamics, and equity issues that arise within AI-mediated supervision. Our contributions suggest that while AI offers transformative potential, it is essential to preserve the human elements of supervision, empathy, intuition, and the capacity to inspire original thought. This chapter contributes to the ongoing conversation on redefining postgraduate supervision in the digital age, providing actionable insights for supervisors navigating the challenges and opportunities presented by AI.