Potential Harm Research Articles

Ethical implications of artificial intelligence in skin cancer diagnostics: use-case analyses.

Skin cancer is the most common cancer worldwide. Early diagnosis is crucial for improving patient survival and morbidity. Artificial intelligence (AI)-assisted smartphone applications (apps) for skin cancer potentially offer accessible, early risk assessment of suspicious skin lesions. However, the integration of novel technologies into dermatology pathways raises ethical concerns. Although ethical principles for AI governance are well known, how these principles should be applied to real-life AI apps readily available for public use is less well understood. We conducted an ethical use-case analysis of commercially available skin cancer apps to better understand the ethical issues arising from their development and use in a real-world context. Established methods for ethical analysis of clinical AI applications were applied to two popular skin cancer apps in the UK: SkinVision and Scanoma. Systematic searches of published literature, regulatory documents, and websites were conducted to review the evidence regarding app development, effectiveness, and use. Screening for inclusion was undertaken by two researchers independently. Ethical concerns were identified with reference to previously described ethical concerns and principles for AI-assisted healthcare. By conceptualising ethical principles within the use-context of skin cancer apps, we identified specific ethical issues arising throughout the AI lifecycle of both apps. One company provided extensive detail regarding algorithm development and decision-making, this information was insufficiently reported for the other app. Other concerns identified related to number, quality, and consistency of studies assessing algorithm efficacy. Limited efforts to address potential skin tone biases and exclusion of individuals with darker skin tones as target users by one app risks perpetuating existing inequalities. Inadequate regulatory oversight was identified. Findings from our ethical use-case analysis of two patient-facing AI-assisted skin cancer apps suggest inadequate incorporation of bioethical norms such as justice, responsibility and transparency into the development and deployment of both apps. Improved regulation should increase accountability. Ensuring ethics by design through integration between technology developers, dermatologists, ethicists, and the public is urgently needed to prevent the potential benefits of AI-assisted skin cancer apps being overshadowed by potential ethical harms.

Screening for Adverse Childhood Experiences: A Critical Appraisal.

Adverse childhood experiences (ACEs) are common and can impact health across the life course. Thus, it is essential for professionals in child- and family-serving roles, including pediatric and adult primary care clinicians, to understand the health implications of childhood adversity and trauma and respond appropriately. Screening for ACEs in health care settings has received attention as a potential approach to ACEs identification and response. Careful examination of the existing evidence on ACEs screening and consideration, from a clinical and ethical perspective, of the potential benefits, challenges, and harms is critical to ensuring evidence-informed practice. In this critical appraisal, we synthesize existing systematic and scoping reviews on ACEs screening, summarize recent studies on the ability of ACEs to predict health outcomes at the individual level, and provide a comprehensive overview of potential benefits, challenges, and harms of ACEs screening. We identify gaps in the existing evidence base and specify directions for future research. We also describe trauma-informed, relational care as an orientation and perspective that can help pediatric and primary care clinicians to sensitively assess for and respond to ACEs and other potentially traumatic experiences. Overall, we do not yet have sufficient evidence regarding the potential benefits, challenges, and harms of ACEs screening in health care and other settings. In the absence of this evidence, we cannot assume that screening will not cause harm and that potential benefits outweigh potential harms.

Exploring the Feasibility and Acceptability of Technological Interventions to Prevent Adolescents' Exposure to Online Pornography: Qualitative Research.

Amid growing concern over children's access to online pornography, policy makers are looking toward new and emerging technological concepts for unexplored solutions including artificial intelligence and facial recognition. This study sought to explore and ideate emerging technological interventions that are feasible, acceptable, and effective in preventing and controlling the exposure of young people to online pornographic material. We conducted a series of qualitative co-design workshops with both adult (n=8; aged 32-53 years) and adolescent participants (n=4; aged 15-17 years) to ideate potential technological interventions that are feasible, acceptable, and effective at preventing and controlling the exposure of young people to online pornographic material. A story stem methodology was used to explore participants' attitudes toward two unique technological prototypes. Participants expressed a generally favorable view of the proposed technological concepts but remained unconvinced of their overall utility and effectiveness in preventing the intentional viewing of pornography by young people. Age-appropriate parent-child conversations remained participants' preferred approach to mitigating potential harms from pornographic material, with parents also expressing a desire for more educational resources to help them better navigate these discussions. User privacy and data security were a primary concern for participants, particularly surrounding the use and collection of biometric data. Internationally, policy makers are taking action to use age assurance technologies to prevent children's access to online pornography. It is important to consider the needs and opinions of parents and young people in the use and implementation of these technologies. Participants in this study were generally supportive of new and emerging technologies as useful tools in preventing the accidental exposure of young people to online pornographic material. However, participants remained less convinced of their ability to avert intentional viewing, with substantial concerns regarding technological efficacy, adaptability, and user privacy. Further, co-design and prototype refinement are needed to better understand user acceptability and comfortability of these new technological interventions, alongside additional research exploring sociocultural differences in information needs and user experiences.

NOVEL AGENTS IN THE MANAGEMENT OF DIABETES AND RISK OF WORSENING DIABETIC RETINOPATHY.

Novel therapies for diabetes have potent effects on glycemic control, obesity, and cardiovascular risk reduction, but some, including the popular drug semaglutide, have also been implicated in worsening of diabetic retinopathy (DR). Given the ubiquity of these new agents, understanding the risks to vision is important. Here, we review the data for several newly available agents in terms of systemic efficacy and retinal safety. Literature review. Novel antihyperglycemic treatments include incretin mimetics and enhancers, sodium-glucose cotransporter inhibitors, long-acting insulins, and insulin delivery systems. All improve glycemic control, and some have been shown to reduce major cardiovascular outcomes. In a pivotal trial, semaglutide was associated with approximately 75% increased risk of DR worsening. The novel long-acting insulin icodec, formulated for once weekly dosing, showed increased risk of DR worsening over a once daily insulin. No other recent antihyperglycemic agent was associated with DR worsening, although following the semaglutide trials, nearly all studies excluded patients with preexisting DR. Cases of DR worsening were rare in all instances. Dedicated safety studies for semaglutide in DR are currently underway. For most patients being considered for treatment with a novel antihyperglycemic agent, benefits on systemic metabolic and cardiovascular health are very likely to outweigh potential retinal harms. Although the true risks of the new agents on DR are unclear because their safety data come from secondary end points, the most vulnerable patients are those with preexisting high-risk DR, poor baseline glycemic control, and using insulin.

MiRNA-driven sensitization of breast cancer cells to Doxorubicin treatment following exposure to low dose of Zinc Oxide nanoparticles.

The impact of Engineered nanomaterials (ENMs) (i.e., Zinc Oxide nanoparticles (ZnO NPs)) on human health has been investigated at high and unrealistic exposure levels, overlooking the potential indirect harm of subtoxic and long exposures. Therefore, this study aimed to investigate the impacts of subtoxic concentrations of zinc oxide (ZnO NPs) on breast cancer cells' response to Doxorubicin. Zinc oxide nanoparticles caused a concentration-dependent reduction of cell viability in multiple breast cancer cell lines. A subtoxic concentration of 1.56µg/mL (i.e., no observed adverse effect level) was used in subsequent mechanistic studies. Molecularly, miRNA profiling revealed significant downregulation of 13 oncogenic miRNAs (OncomiRs) in cells exposed to the sub-toxic dose of ZnO NPs followed by doxorubicin treatment. Our comprehensive bioinformatic analysis has identified 617 target genes enriched in ten pathways, mainly regulating gene expression and transcription, cell cycle, and apoptotic cell death. Several tumor suppressor genes emerged as validated direct targets of the 13 OncomiRs, including TFDP2, YWHAG, SMAD2, SMAD4, CDKN1A, CDKN1B, BCL2L11, and TGIF2. This study insinuates the importance of miRNAs in regulating the responsiveness of cancer cells to chemotherapy. Our findings further indicate that being exposed to environmental ENMs, even at levels below toxicity, might still modulate cancer cells' response to chemotherapy, which highlights the need to reestablish endpoints of ENM exposure and toxicity in cancer patients receiving chemotherapeutics.

OA08 Ocrelizumab in pregnancy in a patient with juvenile onset systemic lupus erythematosus

Abstract Introduction Juvenile-onset systemic lupus erythematosus (jSLE) is a multisystem autoimmune disease that results in increased disease activity compared to adult-onset SLE. jSLE in pregnancy results in a greater incidence of disease flares as well as adverse pregnancy outcomes. Management of SLE in pregnancy is particularly difficult due to lack of safety data for immunosuppressant medications and is therefore limited. Ocrelizumab is a humanised monoclonal antibody that selectively targets CD20 B cells and is approved for the treatment of multiple sclerosis. Despite never being trialled in a patient with active SLE in pregnancy, this case demonstrates its use with a successful outcome. Case description An 18-year-old female was diagnosed at age 14 with juvenile onset systemic lupus erythematosus with the presence of a photosensitive malar rash, arthralgia, alopecia, aphthous ulcers and headache. At the time of diagnosis her investigations revealed ANA 1:5120 with homogenous pattern, high dsDNA, low C3 and C4, thrombocytopenia, antibodies to Smith, Ro, RNP, anti-Rib-P, strongly positive lupus anticoagulant antibodies and low titre anti-cardiolipin IgG and IgM. Previous treatment included methotrexate, mycophenolate mofetil and cyclosporin which were discontinued either due to patient choice, inefficacy or adverse reaction. Azathioprine was contraindicated due to low TMPT. Rituximab was trialled and although effective had to be stopped due to adverse reaction. Unfortunately, she experienced a primigravida pregnancy loss at 15-20 weeks secondary to active SLE and pre-eclampsia. Shortly after this, she developed a rare case of anti-fascin antibody neuropathy and was treated with ocrelizumab. Six months later during her second pregnancy, she was treated with hydroxychloroquine 400 mg, aspirin 150 mg, folic acid 5 mg and low molecular weight heparin prophylaxis which were continued throughout the pregnancy. Due to concerns of active lupus at 13 weeks due to facial rash and fatigue, prednisolone was commenced at 10 mg daily and continued. After careful consideration, Ocrelizumab was given in the second trimester at 17 and 19 weeks’ gestation. Following this, symptoms remained under control and disease activity was low with normal C3/C4 and dsDNA levels without significant proteinuria. A newborn baby was delivered at 38 weeks by caesarean section without complication or foetal abnormalities. Both the mother and baby remain under close follow- up but have not demonstrated adverse outcomes at 3 months postpartum. Discussion This case demonstrates the use of Ocrelizumab in the second trimester of a high-risk pregnancy complicated by active jSLE. At present, there is no license for use of Ocrelizumab in SLE and no safety data on its use in pregnancy. However, there was a good outcome for this patient which resulted in no antenatal or postpartum complications and the successful birth of a healthy newborn without foetal abnormalities. Ocrelizumab is used for the treatment of early relapsing-remitting multiple sclerosis (RRMS) and is increasingly used by neurologists in women of childbearing age despite being unlicensed for use in pregnancy. Concerns of its use in pregnancy surround B cell depletion in the neonate which while tends to be transient, causes significant concern regarding long term immunological development and response to vaccination. B cell depleting therapies are widely used in the context of active and refractory SLE and therefore use of Ocrelizumab has been evaluated in cases of SLE in two phase III clinical trials. The first study examined the efficacy of Ocrelizumab in SLE without renal involvement (BEGIN) and the second recruited patients with lupus nephritis (BELONG). The BEGIN study was terminated early due to lack of response and the BELONG study was terminated due to a significant increase in serious infections (in the Ocrelizumab plus mycophenolate treatment group). However, results on disease activity were positive with complete renal response being achieved non-statistically more frequently in the Ocrelizumab treated patients versus placebo. Real world evidence shows the importance of achieving disease control in SLE around pregnancy to prevent adverse outcomes. The decision for the use of Ocrelizumab therefore needs to be balanced carefully against potential harm to the baby either from direct foetal exposure to the drug, or from gestation in an immunocompromised mother. Key learning points • Pre-pregnancy counselling is of paramount importance in severe cases of active SLE and when possible, pregnancy should be postponed in these instances until disease activity is stabilised with contraception counselling offered to those on teratogenic immunosuppressive agents. • A multidisciplinary approach to the management of complex SLE in pregnancy in essential with obstetrician, midwife, maternal medicine physician and rheumatologist input. • The benefit of potentially life-saving immunosuppressive treatment should be carefully balanced against the poor outcomes of active SLE in pregnancy and decisions should be made on a case-by-case basis.

Healthcare Provider Burnout: Red Flag for a Rising Epidemic.

This article aims to broaden the understanding of burnout in healthcare providers, its causes, and its reduction strategies. The objectives are to raise awareness, facilitate early intervention, and, ultimately, improve the overall well-being of healthcare providers and the quality of patient care. The study investigated healthcare-provision-associated burnout, an often-unrecognized syndrome affecting professionals worldwide, and its prevalence. It also examined the impact of burnout on patient outcomes, safety, and provider health and well-being. Here, we delve into the triad of burnout attributes: emotional exhaustion, depersonalization, and decreased personal accomplishment. Specific causes, such as work-life balance, workplace environment, and communication/teamwork, are investigated. The existing literature and studies we report explore the pathophysiological effects of burnout, including its impact on health, sleep patterns, and the alarming correlation with suicide. The prevalence of burnout among healthcare providers is between 30% and 50%. Burnout is a significant factor contributing to poor patient outcomes and threatening patient safety. Furthermore, burnout can induce physical symptoms, including psychological, cardiovascular, and gastrointestinal disorders. We emphasize the importance of identifying and preventing burnout to maintain the overall integrity of healthcare providers and eliminate vulnerabilities for harm to their patients. Burnout awareness should be a priority from the early stages of healthcare providers' careers because it is crucial for maintaining their well-being, preventing medical errors, and sustaining high-quality patient care. The identification and prevention of burnout are deemed vital not only for the well-being of healthcare providers but also to safeguard against potential harm to patients. This article calls for increased awareness of burnout, its underlying causes, and the implementation of effective reduction strategies in the healthcare profession.

Reduce Speed Limits to Minimize Potential Harm and Maximize the Health Benefits of Street Trees

Urban greening is threatened by the concern that street trees increase traffic-related injury/death. Associations between all serious and fatal traffic crashes and street tree percentages were examined in Sydney, Australia. Associations were adjusted for confounding factors relating to driver behavior (speeding, fatigue, and use of alcohol) and road infrastructure, including alignment (e.g., straight, curved), surface condition (e.g., dry, wet, ice), type (e.g., freeway, roundabout), and speed limit. Models indicated that 10% more street trees were associated with 3% and 20% higher odds of serious or fatal injuries and 20% tree collisions on roads of any speed, respectively. However, further analysis stratified by speed limit revealed contrasting results. Along roads of 70 km/h or greater, 10% more street trees were associated with 8% higher odds of serious or fatal injury and 25% higher odds of death. Comparable associations were not found between street trees and serious or fatal injuries along roads below 70 km/h. Reducing speed limits below 70 km/h saves lives and may mitigate risks of serious or fatal traffic accidents associated with street trees, enabling greener, cooler, healthier cities.

How Should Clinicians Share Decision Making With Patients Interested in Using Psychedelics to Feel Psychologically Safe?

This commentary on a case of a transgender patient interested in using psychedelics to feel more at peace and achieve a sense of psychological safety argues that health care practitioners can help their patients minimize potential harms of psychedelics by providing psychoeducation and resources to identify clinical trials or skilled and knowledgeable psychedelic practitioners. This approach can support patients' agency in their mental health care and ability to foster moments of peace in their lives.

Towards automated phenotype definition extraction using large language models

Electronic phenotyping involves a detailed analysis of both structured and unstructured data, employing rule-based methods, machine learning, natural language processing, and hybrid approaches. Currently, the development of accurate phenotype definitions demands extensive literature reviews and clinical experts, rendering the process time-consuming and inherently unscalable. Large language models offer a promising avenue for automating phenotype definition extraction but come with significant drawbacks, including reliability issues, the tendency to generate non-factual data (“hallucinations”), misleading results, and potential harm. To address these challenges, our study embarked on two key objectives: (1) defining a standard evaluation set to ensure large language models outputs are both useful and reliable and (2) evaluating various prompting approaches to extract phenotype definitions from large language models, assessing them with our established evaluation task. Our findings reveal promising results that still require human evaluation and validation for this task. However, enhanced phenotype extraction is possible, reducing the amount of time spent in literature review and evaluation.

Moments of Silence: Ethics and Harm in Autoethnography

This paper explores ethical pitfalls and potential harms that arise in autoethnography. I use evocative autoethnographic writing to reflect upon my experiences undertaking a research project on social and natural isolation in Orkney and Svalbard (2001-2002). This project involved a commitment for me to remain silent and not speak for six months. On the basis of these reflections, I discuss problems concerning the impossibility of acquiring free consent and the potential for autoethnography to produce and reproduce harms. I analyse these problems as deriving from the fact that in autoethnography, the researcher and the research subject are the same person. I give suggestions for ways of mitigating harm and conclude by advancing the need for better appreciation of ethical treatment of the autoethnographic subject.

‘Vaping is a break from all of that’: Exploring attitudes, harm perceptions, cessation barriers and social dynamics among people who vape

Objective: Vaping, initially a smoking cessation aid, is now a widespread recreational activity sometimes associated with perceived health concerns. This study explored attitudes, harm perceptions and cessation barriers in the context of participants’ vaping behaviours, guided by the theoretical lens of fundamental social causes. Design and Setting: The study focused on a subset of 571 current adult vapers from a larger survey investigating vaping attitudes. It analysed open-text survey responses relating to vaping behaviours. To analyse the responses, we employed layered analyses, using deductive conceptual mapping to inform an inductive thematic content analysis. Results: Participants mentioned nuanced vaping risks, citing cancer and respiratory concerns, often comparing them to tobacco’s well-known harmful effects. Despite acknowledging vaping’s potential harms, participants perceived the practice to be less harmful than smoking, emphasising relative safety. Some viewed vaping positively for former smokers, contingent on regulated products. This complex attitude balance reflected the intricate interplay between health concerns and social dynamics. Recurrent vaping symbolised consistent engagement, with cravings and widespread availability associated with quitting challenges. Conclusions: Participants’ nuanced perceptions of health risks reflect a harm duopoly, resembling illicit drug harm tiering. There is a complex interplay between health knowledge and social influences in the context of vaping behaviours. Study findings underscore the need for messaging interventions discouraging vaping among those who do not smoke tobacco to consider these health and social dynamics, leveraging collaborative design.

The Hidden Toll: Exploring the Impact of Challenging Patron Behaviors on Australian Public Library Staff

ABSTRACT As a public-facing profession, public library workers are often exposed to challenging behaviors that raise concern for their safety. To understand these concerns, this study explores these staff safety issues in Australian public libraries through semi-structured interviews with 59 staff members from six library services. Findings reveal that library workers frequently encounter challenging and sometimes violent behaviors from patrons. These incidents impact staff wellbeing, causing stress, anxiety, and potential long-term psychological effects. Many workers receive insufficient workplace support following traumatic incidents, leading to internalization of the trauma the experiences cause. The study highlights the need for improved institutional support and better safety measures. It also recognizes the tension created by libraries’ open-door policies, which may expose workers to potential harm.

Development of a framework of potential adverse effects of interventions to improve critical thinking about health choices: A mixed methods study.

Background People need critical thinking skills to make well-informed health choices and avoid waste and unnecessary suffering. However, educational interventions can have adverse effects, which is often overlooked. We created a framework of potential harms of interventions to improve critical thinking about health choices. The objective was to identify potential effects and articulate potential mechanisms. We intended to use the framework to inform the development and evaluation of an intervention in Kenya, Rwanda, and Uganda. Methods We created an initial framework drawing on two earlier frameworks. We surveyed external experts using Likert-scale and open-ended items, including researchers, educators, and others, in a variety of relevant fields. We emailed the survey to an international advisory network, and all other experts recommended by respondents. We analyzed the quantitative data using descriptive statistics. We conducted a thematic analysis of the qualitative data. We revised the framework based on those results. To identify any effects missing from the revised framework, we individually interviewed a convenience sample of one teacher from each of Kenya, Rwanda, and Uganda. Results We received responses from 38 of 70 external experts (54%). The quantitative survey data suggested respondents agreed with the initial framework overall. However, the qualitative data led to substantial revisions. The revised framework consists of categories of adverse outcomes; outcomes within each category; sub-outcomes; individuals, groups, and populations that might experience each adverse outcome; beneficial outcomes corresponding with adverse outcomes; and potential mechanisms of adverse effects. There are six categories: decision-making harms, psychological harms, equity harms, group and social harms, waste, and other harms. In the interviews with teachers, we did not identify any effects missing from the revised framework. Conclusions As far as we know, the framework is the first tool of its kind for education research. It can be improved upon and adapted.

Probing clarity: AI-generated simplified breast imaging reports for enhanced patient comprehension powered by ChatGPT-4o

BackgroundTo assess the reliability and comprehensibility of breast radiology reports simplified by artificial intelligence using the large language model (LLM) ChatGPT-4o.MethodsA radiologist with 20 years’ experience selected 21 anonymized breast radiology reports, 7 mammography, 7 breast ultrasound, and 7 breast magnetic resonance imaging (MRI), categorized according to breast imaging reporting and data system (BI-RADS). These reports underwent simplification by prompting ChatGPT-4o with “Explain this medical report to a patient using simple language”. Five breast radiologists assessed the quality of these simplified reports for factual accuracy, completeness, and potential harm with a 5-point Likert scale from 1 (strongly agree) to 5 (strongly disagree). Another breast radiologist evaluated the text comprehension of five non-healthcare personnel readers using a 5-point Likert scale from 1 (excellent) to 5 (poor). Descriptive statistics, Cronbach’s α, and the Kruskal–Wallis test were used.ResultsMammography, ultrasound, and MRI showed high factual accuracy (median 2) and completeness (median 2) across radiologists, with low potential harm scores (median 5); no significant group differences (p ≥ 0.780), and high internal consistency (α > 0.80) were observed. Non-healthcare readers showed high comprehension (median 2 for mammography and MRI and 1 for ultrasound); no significant group differences across modalities (p = 0.368), and high internal consistency (α > 0.85) were observed. BI-RADS 0, 1, and 2 reports were accurately explained, while BI-RADS 3–6 reports were challenging.ConclusionThe model demonstrated reliability and clarity, offering promise for patients with diverse backgrounds. LLMs like ChatGPT-4o could simplify breast radiology reports, aid in communication, and enhance patient care.Relevance statementSimplified breast radiology reports generated by ChatGPT-4o show potential in enhancing communication with patients, improving comprehension across varying educational backgrounds, and contributing to patient-centered care in radiology practice.Key PointsAI simplifies complex breast imaging reports, enhancing patient understanding.Simplified reports from AI maintain accuracy, improving patient comprehension significantly.Implementing AI reports enhances patient engagement and communication in breast imaging.Graphical

Use and perceptions of involuntary civil commitment among post-overdose outreach staff in Massachusetts, United States: A mixed-methods study.

Involuntary civil commitment (ICC) is a legal process by which people are compulsorily admitted to substance use treatment. This study explored views about and promotion of ICC procedures for substance use disorders among public health-public safety post-overdose outreach programs and their outreach team members in Massachusetts, USA. In this mixed-methods study, survey data were collected from post-overdose outreach programs in 2019, and semi-structured interviews were conducted with outreach team members in 2019 and 2020. Massachusetts, USA. We received 138 survey responses and conducted 38 interviews with post-overdose outreach team members (law enforcement officers, recovery coaches, social workers and harm reductionists) who were majority male (57%) and white (66%). We used the survey instrument to categorize programs as more (discussed ICC at 50% or more of outreach encounters) or less ICC focused (discussed ICC at less than 50% of outreach encounters) and to identify program characteristics that corresponded with each categorization. Semi-structured interviews explored staff perceptions of ICC effectiveness. Among 138 programs, 36% (n = 50) discussed ICC at 50% or more of outreach encounters. Discussing ICC at a majority of visits was positively associated with abstinence-only program philosophies (36% v. 6%, P < 0.001) and collaborating with drug courts (60% v. 30%, P < 0.001), but negatively associated with naloxone distribution (48% v. 75%, P < 0.001) and referring to syringe service programs (26% v. 65%, P < 0.001). Qualitative interviews identified three themes: 1) some programs viewed ICC as a first line tool to engage overdose survivors in treatment; 2) other programs considered ICC a last resort, skeptical of its benefits and concerned about potential harms; 3) families commonly initiated discussions about ICC, reportedly out of desperation. Promotion of involuntary civil commitment (ICC) appears to vary widely across post-overdose outreach programs in Massachusetts, USA, with approaches ranging from seeing it as a first step to treatment to being a tool of last resort. Demand for ICC among family members may relate to inadequate access to voluntary treatment. Family interest in ICC appears to be driven by inadequate availability of treatment and other services. ICC at post-overdose outreach visits should be limited, if used at all.

Real-time exposure to negative news media and suicidal ideation intensity among LGBTQ young adults in a high-stigma US state

Abstract Background With a recent surge in anti-LGBTQ policies and associated news/media coverage worldwide, there is a crucial need to study the role of LGBTQ negative news/media on proximal risk for suicide among LGBTQ youth, especially in high-stigma contexts. Methods Using a smartphone-based protocol, participants responded to brief self-report surveys 3x per day for 28 consecutive days. LGBTQ young adults (ages 18-24 years old) residing in Tennessee with recent suicidal ideation were recruited. At each assessment, participants reported real-time exposure to negative news/media, whether the news/media was related to LGBTQ topics, expectations of anti-LGBTQ rejection, and current intensity of passive suicidal ideation, active suicidal ideation, and self-harm ideation. Statistical analyses employed multilevel path analyses with restricted maximum likelihood estimation. Results 31 participants completed 2189 assessments (90.5% median compliance). Within-person effects showed that real-time exposure to LGBTQ - but not general - negative news/media was positively associated with suicidal ideation intensity. Significant indirect effects were present from exposure to LGBTQ negative news/media to higher suicidal ideation intensity through expectations of rejection. Mediation through expectations of rejection accounted for 25% and 39% of the total effect for active and passive suicidal ideation, respectively. Conclusions Findings have important public health implications related to media reporting, policy, and clinical intervention. Interventions targeting media organizations should promote responsible reporting practices and increase awareness of the potential suicidogenic impact of negative LGBTQ news coverage. This study joins numerous others in documenting the potential mental health harms of policies that restrict LGBTQ visibility and rights. Mental health professionals play a vital role in promoting coping in the face of exposure to LGBTQ negative news/media content.

Statistical methods leveraging the hierarchical structure of adverse events for signal detection in clinical trials: a scoping review of the methodological literature

BackgroundIn randomised controlled trials with efficacy-related primary outcomes, adverse events are collected to monitor potential intervention harms. The analysis of adverse event data is challenging, due to the complex nature of the data and the large number of unprespecified outcomes. This is compounded by a lack of guidance on best analysis approaches, resulting in widespread inadequate practices and the use of overly simplistic methods; leading to sub-optimal exploitation of these rich datasets. To address the complexities of adverse events analysis, statistical methods are proposed that leverage existing structures within the data, for instance by considering groupings of adverse events based on biological or clinical relationships.MethodsWe conducted a methodological scoping review of the literature to identify all existing methods using structures within the data to detect signals for adverse reactions in a trial. Embase, MEDLINE, Scopus and Web of Science databases were systematically searched. We reviewed the analysis approaches of each method, extracted methodological characteristics and constructed a narrative summary of the findings.ResultsWe identified 18 different methods from 14 sources. These were categorised as either Bayesian approaches (n=11), which flagged events based on posterior estimates of treatment effects, or error controlling procedures (n=7), which flagged events based on adjusted p-values while controlling for some type of error rate. We identified 5 defining methodological characteristics: the type of outcomes considered (e.g. binary outcomes), the nature of the data (e.g. summary data), the timing of the analysis (e.g. final analysis), the restrictions on the events considered (e.g. rare events) and the grouping systems used.ConclusionsWe found a large number of analysis methods that use the group structures of adverse events. Continuous methodological developments in this area highlight the growing awareness that better practices are needed. The use of more adequate analysis methods could help trialists obtain a better picture of the safety-risk profile of an intervention. The results of this review can be used by statisticians to better understand the current methodological landscape and identify suitable methods for data analysis - although further research is needed to determine which methods are best suited and create adequate recommendations.

Co-use of psychedelics with other substances: Findings from the global psychedelic survey.

While most psychedelic substances are considered to carry a relatively low risk of acute or long-term harm, co-use with other psychoactive substances may increase health and social harm. Using a large international survey of adults who use psychedelics, we sought to comprehensively characterize psychedelic co-use. We used data from the 2023 Global Psychedelic Survey, a web-based survey of adults ⩾21 with lifetime use of psychedelics. We explored patterns of co-use (prevalence, secondary substances used, timing, and motives of co-use) and examined sociodemographic and psychedelic use-related characteristics associated with co-use overall and by specific psychedelics. In total, 5370 respondents were included in this analysis, of whom 3228 (56.3%) reported typically co-using at least one of the 11 psychedelic substances of interest, with co-use lowest for ayahuasca (14.8%) and highest for nitrous oxide (54.5%). Cannabis and alcohol were the most common secondary substances. Depressants were the only secondary substance class that increased in use following psychedelic experiences. Greater experience with psychedelics was significantly associated with co-use, as was using for recreational purposes or to reduce/substitute the use of other substances. Personal exploration and therapeutic purposes for psychedelic use were negatively associated with co-use. In this detailed analysis of psychedelic co-use, we observed high rates of co-use with certain psychedelics, specifically when used recreationally. Our findings highlight psychedelic-specific consumers for whom harm reduction messaging around co-use practices may be best tailored. Further research is justified to assess whether specific patterns of co-use might reduce or increase potential harms.

Unlocking equity: assessing for gaps in cardiovascular guidelines for pregnant women

Abstract Introduction Cardiovascular disease is the primary contributor to pregnancy-related fatalities in the United States, displaying a gradual rise over the years. Pregnancy introduces unique physiological changes that can impact pre-existing cardiovascular conditions and trigger new complications. Considerable inequalities in pregnancy-related mortality built on race and ethnicity are unmistakable, with the highest rates observed in black non-Hispanic women. Purpose This study aims to evaluate current gaps in racial/ethnic minority participation in randomized control trials (RCTs) cited in major cardiology guidelines. Methods Citations in the 2018 ESC Guidelines for the Management of Cardiovascular Diseases During Pregnancy were evaluated for RCTs. The American Heart Association and American College of Cardiology guidelines were also examined. Manuscripts and supplementary data were examined for participant-level racial or ethnic data, including age, race, and ethnicity. Results Thirteen RCTs, representing 20,665 participants, spanning the period from 2002 to 2017, were reviewed. European guidelines referenced thirteen of the RCTS, while American guidelines referenced two RCTs. The average age of participants was 31 years old. Most of the trials were conducted in Europe (46%). Forty-six percent of RCTs reported race/ethnicity breakdowns, with pooled participation showing a majority of non-Hispanic white participants (76.7%), with limited representation from other racial groups (table). Eight trials focused on hypertension, two on venous thromboembolism, and one on heart failure. Conclusion Pregnant women are frequently excluded from RCTs due to concerns about potential harm to the developing fetus. Consequently, current guidelines lack robust RCTs tailored to pregnant women with various cardiovascular diseases. The underrepresentation of ethnic minorities in cardiovascular disease trials contributes to a scarcity of evidence-based recommendations for managing these conditions during pregnancy and postpartum. Future clinical practice guidelines should advocate for a more personalized and evidence-based approach to managing cardiovascular diseases in pregnancy.