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Iron deficiency has been associated with heart failure severity and mortality in children and adults. Intravenous iron therapy has been associated with improved outcomes for adults with heart failure. However, little is known about its impact and safety in children. We performed a single-centre review of all intravenous iron sucrose infusions prescribed to hospitalised patients ≤ 21 years of age with a primary cardiac diagnosis from 2020 to 2022. Ninety-one children (median age 6 years, weight 18 kg) received 339 iron sucrose infusions with a median dose of 6.5 mg/kg [5.1 mg/kg, 7.0 mg/kg]. At initial infusion, the majority (n = 63, 69%) had CHD, 70 patients (77%) were being managed by the advanced cardiac therapy team for heart failure, 13 (14%) were listed for heart transplant, 32 (35%) were on at least one vasoactive infusion, and 5 (6%) were supported with a ventricular assist device. Twenty infusions (6%) were associated with 27 possible infusion-related adverse events in 15 patients. There were no episodes of anaphylaxis or life-threatening adverse events. The most common adverse events were hypotension (n = 12), fever (n = 5), tachycardia (n = 3), and nausea/vomiting (n = 3). Eight of 20 infusion-related adverse events required intervention, and two infusions were associated with escalation in a patient’s level of care. Following intravenous iron repletion, patients’ serum iron, serum ferritin, transferrin saturation, and haemoglobin increased (p < 0.05 for all). In children hospitalised with cardiac disease, intravenous iron sucrose repletion is safe and may improve haemoglobin and iron parameters, including transferrin saturation and ferritin levels.
Technological developments and affordable price structures have increased the usage of unmanned aerial vehicles (UAVs) across almost all sectors, hence increasing demand. Since UAVs can fly and perform various tasks without requiring a human operator, the most dangerous and time-consuming tasks previously performed by humans in many sectors are now accomplished by using UAVs. The increased use of UAVs has also introduced critical safety and security risks, including airspace congestion, collisions and malicious use, and therefore, identifying and assessing the risks associated with UAVs and finding ways to mitigate them is of great importance. This qualitative study investigates the safety and security risks posed by the increased use of UAVs and discusses ways to mitigate these risks. Semi-structured interviews with aviation professionals, including pilots, air traffic controllers and academicians, were conducted, and the collected data were analysed by using MAXQDA 24 qualitative analysis software. The results indicate that 86% of participants emphasised air traffic density as a major safety concern, while 71% underlined the need for dedicated air corridors and robust legal frameworks to reduce collision risks. These insights suggest that the safe integration of UAVs into current aviation systems demands a multifaceted strategy involving regulatory interventions, such as clearly defined UAV flight zones and essential technological enhancements. Overall, the study underscores the urgent need for coordinated efforts–legal, technological, and inter-institutional–to ensure the secure incorporation of UAVs into national airspace.
Edited by
Rebecca Leslie, Royal United Hospitals NHS Foundation Trust, Bath,Emily Johnson, Worcester Acute Hospitals NHS Trust, Worcester,Alex Goodwin, Royal United Hospitals NHS Foundation Trust, Bath,Samuel Nava, Severn Deanery, Bristol
Chapter 3.8 introduces the basic principles of electricity, from current and flow in Ohm’s law, to resistance and impedance within electrical circuits. We discuss the danger of electricity within medical equipment, of the different types of electrical shock and measures in place to reduce the risk of electrical injury. We cover classification of electrical equipment according to safety measures.
Transcranial direct current stimulation (tDCS) has emerged as a promising neuromodulation technique for managing obsessive-compulsive disorder (OCD). Early intervention with tDCS may lead to improved treatment outcomes for individuals with OCD, offering hope for more effective and timely intervention strategies. This study aimed to evaluate the safety and efficacy of tDCS as an early augmentation strategy in adults with OCD.
Methods
Drug-free adult patients with OCD were randomized into active and sham groups and received fluoxetine 20 mg (up to 60 mg). The protocol involved placing the cathode over the left supplementary motor area and the anode over the left dorsolateral prefrontal cortex, using a 2-mA current for 20 minutes, with a ramp time of 10 seconds. A total of 10 sessions were given over 2 weeks. Following the baseline assessment, both illness severity and side effects were measured periodically at 2, 4, and 6 weeks.
Results
A total of 40 patients completed this study (20 in each group). The active group demonstrated a significant reduction in Yale-Brown Obsessive-Compulsive Scale scores at 2, 4, and 6 weeks compared with the sham group, with a number needed to treat of 2.5. Additionally, the effect size of the intervention at 2 weeks was calculated to be 0.58, indicating a moderate effect according to Cohen’s d. Side effects were milder, tolerable, and uncommon.
Conclusion
Early augmentation with tDCS is a safe and effective method for rapidly reducing symptom severity in adult patients with OCD.
The literature on persistent antidepressant withdrawal symptoms is sparse. This systematic review is the first to examine the prevalence, duration, severity, risk/protective factors and treatment strategies for post-acute withdrawal syndrome (PAWS) following the discontinuation of antidepressant medications.
Methods
We searched PubMed, Web of Science and PsycInfo, focusing on newer-generation antidepressants. The electronic database search was complemented with handsearching reference lists of pivotal studies. We included original studies in adults reporting on PAWS and providing data about epidemiology and clinical management of withdrawal symptoms persisting for at least 6 weeks.
Results
The literature search yielded 1286 results, with 26 records assessed for eligibility, and seven studies fulfilled our selection criteria. Prevalence data were sparse, with one small cohort study reporting a 15% prevalence rate for PAWS in patients with panic disorder and agoraphobia. The duration of PAWS varied considerably across studies, ranging from 1.5 to 166 months. Long-term paroxetine use emerged as a potential risk factor for the development of PAWS. There was no reliable evidence to support the effectiveness of various treatment strategies, including the reinstatement of antidepressant medication, the use of benzodiazepines and the provision of cognitive-behavioral therapy.
Conclusions
The current evidence on PAWS is sparse and predominantly of low certainty. The presence of withdrawal symptoms, lasting several months and possibly even years in some patients, underscores the need for further research with rigorous methodology. Large prospective cohort studies are needed to assess the epidemiology of PAWS, while randomized controlled trials are quired to test the efficacy of clinical interventions to treat PAWS.
Over the past two decades, digital mental health interventions (DMHIs) have seen a surge in studies with people experiencing mental ill-health, whether this be via web-based platforms, smartphone applications, text messages or other digital devices. Although DMHIs already demonstrate evidence of their acceptability and some of their effectiveness among different populations, the information about their safety is less clear. This Editorial reflects on a Delphi study by Taher and colleagues that explored the regulation of DMHIs and generated ten safety recommendations. We discuss these recommendations in the context of existing relevant literature and provide suggestions for further steps to advance research and policy on DMHIs in the UK and globally. Further dialog is needed, including the views and experiences of all key stakeholders, and particularly of people with lived experience, to ensure DMHIs are not only an acceptable and potentially effective treatment approach, but also safe for those that use them.
Safety accounts of knowledge intend to explain why certain true and intuitively justified beliefs fail to be knowledge in terms of such beliefs falling prey to a modal veritic type of luck. In particular, they explain why true and intuitively justified beliefs in “lottery propositions” (highly likely propositions reporting that a particular statistical outcome obtains) are not knowledge. In this paper, I argue that there is a type of case involving lottery propositions that inevitably lies beyond the scope of any reasonable safety account of epistemic luck. I offer counterexamples to accounts of epistemic luck in terms of safety conditions that involve both “locally” and “globally” reliable ways of forming beliefs in nearby worlds. All such counterexamples present a lottery case illustrating the next possibility: the process of selecting the lottery winner might be such that any world in which it delivers a different outcome is extremely far away from the actual world. In addition to being a case of safe ignorance, this type of lottery case shows that, ultimately, either veritic epistemic luck is not unsafe true belief or beliefs in lottery propositions are not epistemically luckily true.
New developments in neuro-navigation and machine learning have allowed for personalised approaches to repetitive transcranial magnetic stimulation (rTMS) to treat various neuropsychiatric disorders. One specific approach, known as the cingulum framework, identifies individualised brain parcellations from resting state fMRI based on a machine-learning algorithm. Theta burst stimulation, a more rapid form of rTMS, is then delivered for 25 sessions, 5 per day, over 5 days consecutively or spaced out over 10 days. Preliminary studies have documented this approach for various neurological and psychiatric ailments. However, the safety and tolerability of this approach are unclear.
Methods:
We performed a retrospective study on 165 unique patients (202 target sets) treated with this personalised approach between January 2020 and December 2023.
Results:
Common side effects included fatigue (102/202, 50%), local muscle twitching (89/202, 43%), headaches (49/202, 23%), and discomfort (31/202, 17%), all transient. The top 10 unique parcellations commonly found in the target sets included L8av (52%), LPGs (28%), LTe1m (21%), RTe1m (18%), LPFM (17%), Ls6–8 (13%), Rs6–8 (9%), L46 (7%), L1 (6%), and L6v (6%). Fatigue was most common in target sets that contained R6v (6/6, 100%) and L8c (5/5, 100%). Muscle twitches were most common in target sets that contained RTGv (5/5, 100%) and LTGv (4/4, 100%).
Conclusion:
These side effects were all transient and well-tolerated. No serious side effects were recorded. Results suggested that individualised, connectome-guided rTMS is safe and contain side-effect profiles similar to other TMS approaches reported in the literature.
Edited by
Dharti Patel, Mount Sinai West and Morningside Hospitals, New York,Sang J. Kim, Hospital for Special Surgery, New York,Himani V. Bhatt, Mount Sinai West and Morningside Hospitals, New York,Alopi M. Patel, Rutgers Robert Wood Johnson Medical School, New Jersey
There are many important principles related to ventilators, alarms, and safety features in the operating room and intensive care unit that are relevant to preparation for the American Board of Anesthesiology BASIX exam and anesthesiology training in general. The first part of this chapter is focused on ventilator management and begins with an overview of phase variables (trigger, limit, cycle). An introduction to non-invasive, controlled mechanical, and assisted mechanical modes of ventilation follows, along with relevant high-yield principles. The final section of the chapter provides an overview of alarm design and commonly tested safety features.
Chapter 3 explores safety and ethics in online and offline environments, particularly focused on research with adolescents. The chapter emphasises the need for a more rapid response to a very rapidly evolving field. Ethics is understood from a dynamic perspective, adapting to the individual, contextual, social and cultural contexts and needs of individuals and studies. Getting the balance right between enabling adolescent voice and safety is challenging.
This study explores how we can improve the government’s research and technology for disasters and safety.
Methods
This study employs the Structural Equation Model (SEM) based on 268 experts’ perspectives.
Results
R&D performance exerts a directly significant impact on R&D achievement with the coefficient of 0.429. Second, while professionality and environment of R&D do not show a direct effect on achievement, they exhibit an indirect effect on it with the coefficient of 1.124 and 0.354, respectively. Third, R&D professionality exerts a significant impact on the R&D environment (0.964), and R&D environment has a positive effect on R&D performance (0.827).
Conclusion
Governments and policymakers should develop disaster and safety policies by understanding direct and indirect effects and the relationship of factors related to R&D for improving R&D achievement.
It is a well-worn platitude that knowledge excludes luck. According to anti-luck virtue epistemology, making good on the anti-luck platitude requires an explicit anti-luck condition along the lines of safety: S knows that p only if S’s true belief that p could not have easily been mistaken. This paper offers an independent, virtue epistemological argument against the claim that safety is a necessary condition of knowledge, one that adequately captures the anti-luck platitude. The argument proceeds by way of analogy. I focus on two paradigmatic kinds of normative achievements that also exclude luck: (i) – having a doxastically justified belief and (ii) – performing a morally worthy action. I then show that while (i) and (ii) exclude luck, they are nevertheless susceptible to what I call “modal luck.” I then move on to show that knowledge, or at least some instance of knowledge, is a normative achievement, which I claim provides strong reasons to expect that knowledge is also susceptible to modal luck. Since safety entails that knowledge is incompatible with modal luck, the argument provides strong reasons to reject safety as a necessary condition of knowledge.
Chapter 3 focuses on massively multiplayer online game and chat software Club Penguin that was popular with children until the desktop version was closed down in 2018. The chapter reveals unique aspects of Club Penguin chat environments, including evanescent posts which constrain interaction due to users’ lack of access to review of their conversation. The analysis of Club Penguin chat interaction distinguishes between open conversation, which is similar to ordinary conversation but in written form, role-play and more structured play-oriented social interaction, which is constrained by game rules. The chapter identifies available linguistic resources to ascertain their potential to create naturalistic conversational sequences and routines. The analysis of real life chats reveals that children use the restricted language creatively and effectively in social interaction and virtual play with other users, with greater variety of linguistic devices and negotiations evident in small group exchanges. Some of these exchanges include negotiations related to inclusion of other children, which suggest that this environment may provide opportunities for children’s social development, ideally under adult supervision. Linguistic analysis in fact indicates that despite the software’s linguistic restrictions, which are intended to promote safety, children’s safety can be elusive when users deploy ambiguous polysemic vocabulary.
This chapter contains a broad overview of the technical and environmental issues to be addressed in the contruction of onshore wind energy projects. The former include ecological considerations, including birds and mammals; the requirements of typical pre-construction ornithological surveys are described with an example. Public safety and acceptance is discussed in the context of catastrophic damage to wind turbines, visual impact, shadow flicker, and noise nuisance. In the last case equations and simple rules for noise assessment are given in the context of typical planning guidelines. Sound power levels for a range of commercial wind turbines are compared, and empirical relationships given relating noise to rated output, and rotor size and tip speed. Risks to aviation are discussed, covering aircraft collision and interference to radar systems, including both primary and secondary surveillance radars. The concept of ‘stealthy’ wind turbine blades is discussed, and described in outline. Other siting criteria include avoidance of RF and microwave communications beams and television interference. Rules are given to avoid interference, while minimising required separation distances.
This position paper focuses on healthy ageing for the frailest and institutionalized older adults in the context of the recent pandemic. The paper aims to identify and discuss hindering and promoting factors for healthy ageing in this context, taking both health safety and a meaningful social life into account, in a pandemic situation and beyond.
Background:
The recent COVID-19 pandemic has highlighted the vulnerability of frail older adults residing in long-term care institutions. This is a segment of the older population that does not seem to align well with the recent policy trend of healthy and active ageing. The need for healthy ageing in this population has been voiced by professionals and interest organizations alike, alluding to inadequate support systems during the pandemic, conditioned by both previous and newly emerging contextual factors. Supporting healthy ageing in older adults in nursing homes and other residential care settings calls for attending to meaningful social life as well as to disease control.
Methods:
Findings and early conclusions leading up to the position paper were presented with peer discussions involving healthcare professionals and researchers at two joint EFPC PRIMORE workshops 2021 and 2022, as well as other international research seminars on long-term care. The following aspects of long-term care and COVID-19 were systematically discussed in those events, with reference to relevant research literature: 1. Long-term care policies, 2. pre-COVID state of long-term care facilities and vulnerability to the pandemic, 3. factors influencing the extent of spread of infection in long-term care facilities, and 4. the challenge of balancing between strict measures for infection control and maintaining a meaningful social life for residents and their significant others.
Findings:
A policy shift towards ageing at home and supporting the healthiest of older adults seems to have had unwarranted effects both for frail older adults, their significant others, and professional care staff attending to their needs. Resulting insufficient investment in primary health care staff and in the built environment for frail older adults in nursing homes were detrimental both for the older adults living in nursing homes, their significant others, and staff. More investment in staff and in physical surroundings might improve the quality of care and the social life of older adults in nursing homes in a non-pandemic situation and be a resource for primary health care staff ensuring both protection from health hazards and a meaningful social life for frail older adults in a pandemic or epidemic situation. As for investing in the physical surroundings, smaller nursing homes are advantageous, with singular resident rooms and for developing out-and indoor spaces for socializing and for meeting with families and other visitors. Regarding investment in staff, there is a documented need for educated staff in full-time positions. Use of part-time or temporary staff should be limited.
The European legislator has included the fulfilment service provider (FSP) in European product safety legislation as a new responsible economic operator (EO) in e-commerce for instances where no other EO is based in the European Union. As a matter of coherency, this adjusted personal scope of product safety law will likely be mirrored in a revised product liability directive. This article explores to what extent the aims and expectations of European legislator with respect to these legal changes (law in the books) align with the perceptions of FSPs and legal advisors in the field (law in action). This is done by means of a legal analysis of the goals and envisioned effects of these changes as well as a semi-structured interview study on how FSPs and legal advisors in the field perceive this new role, responsibility, and liability. The findings provide indications that product safety law currently in force might not (yet) lead to the desired effects. The findings also make us question the extent to which victim compensation is actually improved by the proposed adjustment of the personal scope of the product liability directive.
The robots of tomorrow should be endowed with the ability to adapt to drastic and unpredicted changes in their environment and interactions with humans. Such adaptations, however, cannot be boundless: the robot must stay trustworthy. So, the adaptations should not be just a recovery into a degraded functionality. Instead, they must be true adaptations: the robot must change its behaviour while maintaining or even increasing its expected performance and staying at least as safe and robust as before. The RoboSAPIENS project will focus on autonomous robotic software adaptations and will lay the foundations for ensuring that they are carried out in an intrinsically trustworthy, safe and efficient manner, thereby reconciling open-ended self-adaptation with safety by design. RoboSAPIENS will transform these foundations into ‘first time right’-design tools and platforms and will validate and demonstrate them.
Half of all mental health problems start by the age of 15 and the teenage and young adult years are particularly difficult for girls with high and increasing rates of anxiety, depression and self-harm. Many different factors contribute, including social media, peer pressures, focus on appearance, friends, relationships, schoolwork and, as Everyone’s Invited has recently highlighted, personal safety. There is tremendous pressure to conform with the expectations of others. Attitudes to women and girls seem to have gone into reverse during the author’s lifetime. It is too simplistic to view the problems of young women as a simply a ‘lack of self-esteem’. The difficulties they face in society are consistently underestimated and not taken seriously. Fast access to therapy is crucial. Bullying must be addressed effectively. Sexist and mysogynistic attitudes in school must be challenged and, given the easy access now to pornography, the issues of consent should addressed head on by both parents and schools. Using the example of Everyone’s Invited, women and girls need to reach out and support each other. The personal is still political.
Access to psychedelic drugs is liberalizing, yet responses are highly unpredictable. It is therefore imperative that we improve our ability to predict the nature of the acute psychedelic experience to improve safety and optimize potential therapeutic outcomes. This study sought to validate the ‘Imperial Psychedelic Predictor Scale’ (IPPS), a short, widely applicable, prospective measure intended to be predictive of salient dimensions of the psychedelic experience.
Methods
Using four independent datasets in which the IPPS was completed prospectively – two online surveys of ‘naturalistic’ use (N = 741, N = 836) and two controlled administration datasets (N = 30, N = 28) – we conducted factor analysis, regression, and correlation analyses to assess the construct, predictive, and convergent validity of the IPPS.
Results
Our approach produced a 9-item scale with good internal consistency (Cronbach's α = 0.8) containing three factors: set, rapport, and intention. The IPPS was significantly predictive of ‘mystical’, ‘challenging’, and ‘emotional breakthrough’ experiences. In a controlled administration dataset (N = 28), multiple regression found set and rapport explaining 40% of variance in mystical experience, and simple regression found set explained 16% of variance in challenging experience. In another (N = 30), rapport was related to emotional breakthrough explaining 9% of variance.
Conclusions
Together, these data suggest that the IPPS is predictive of relevant acute features of the psychedelic experience in a broad range of contexts. We hope that this brief 9-item scale will be widely adopted for improved knowledge of psychedelic preparedness in controlled settings and beyond.
While clozapine has risks, relative risk of fatality is overestimated. The UK pharmacovigilance programme is efficient, but comparisons with other drugs can mislead because of reporting variations. Clozapine actually lowers mortality, partly by reducing schizophrenia-related suicides, but preventable deaths still occur. Clozapine should be used earlier and more widely, but there should be better monitoring and better management of toxicity.