Quality by Design in Pulmonary Drug Delivery: A Review on Dry Powder Inhaler Development, Nanotherapy Approaches, and Regulatory Considerations.

Dry powder inhalers (DPIs) are state-of-the-art pulmonary drug delivery systems. This article explores the transformative impact of nanotechnology on DPIs, emphasizing the Quality Target Product Profile (QTPP) with a focus on aerodynamic performance and particle characteristics. It navigates global regulatory frameworks, underscoring the need for safety and efficacy standards. Additionally, it highlights the emerging field of nanoparticulate dry powder inhalers, showcasing their potential to enhance targeted drug delivery in respiratory medicine. This concise overview is a valuable resource for researchers, physicians, and pharmaceutical developers, providing insights into the development and commercialization of advanced inhalation systems.

Essential competencies of nurses for climate change response in Saudi Arabia: A rapid literature review.

AIM: Amidst the mounting challenges posed by climate change, the healthcare sector emerges as a vital frontliner, with nurses standing as its linchpins. This review delves into the pivotal role of nurses in combatting the health consequences of climatic alterations, particularly within the nuanced environment of Saudi Arabia. DESIGN: A rapid literature review. METHOD: Drawing from a rigorous analysis of 53 studies, our exploration revolves around the preparedness strategies formulated in response to Saudi Arabia's changing climate. The variables analysed included study design, sample size, focus area, geographical coverage and key findings related to nurse competencies. Data were collected using a structured data extraction form and analysed using thematic content analysis. Employing content analysis, we discerned essential domains: from grasping the health impacts of climate change to customizing care for the most susceptible populations and championing advocacy initiatives. FINDINGS: Salient findings highlight nurses' profound understanding of both direct and secondary health implications of climate shifts. Additionally, the results emphasize the tailored interventions needed for vulnerable groups, capacity building and disaster readiness. Crucially, our findings spotlight the significance of weaving cultural, ethical and regional threads into nursing strategies. By painting a comprehensive picture, we showcase the delicate balance of environmental evolution, healthcare dynamics and the unique socio-cultural tapestry of Saudi Arabia. CONCLUSION: The results of our analysis revealed key competencies required for nurses, including the ability to address immediate health impacts, provide tailored care for vulnerable populations and engage in advocacy and policy formulation. In summation, nurses' multifaceted roles-from immediate medical care to research, advocacy and strategizing-underscore their invaluable contribution to confronting the health adversities sparked by climate change. Our review accentuates the essential contributions of nurses in tackling climate-related health hurdles and calls for more nuanced research, policy adjustments and proactive measures attuned to Saudi Arabia's distinct backdrop.

Decompressive Craniectomy: From Ancient Practices to Modern Neurosurgery.

Decompressive craniectomy (DC) is a neurosurgical strategy that expels a parcel of the cranium to relieve pressure on a swollen or herniating brain. This review article explores the history of DC, from its ancient roots in trepanning to its contemporary applications. It then examines the mechanisms by which DC reduces intracranial pressure (ICP) and improves cerebral blood flow. The article highlights the efficacy of DC in treating patients with severe traumatic brain injury (TBI), stroke, and other conditions that cause increased ICP. However, it also acknowledges the potential complications of DC, such as infection and bleeding. The ethical considerations surrounding DC are explored in detail, particularly the challenging decision-making process for patients who are unable to give consent. A specific focus is given to the use of DC in pediatric patients, where the developing brain is especially vulnerable to pressure changes.

From care practices to speculative vignettes-design considerations for robots in good care.

The care sector has become one of the test beds for developing robotic technologies, which have been promised to mitigate problems with aging populations and labor shortages. Despite these promises, the practical application of such technologies have been met with limited success. Apart from technical limitations, other challenges exist in the way we approach designing these technologies. Critical to the development in the care sector is understanding the complexity of the contexts, the needs and goals of diverse actors, and how these are socio-materially scaffolded. This paper presents a study conducted at the intersection of a value sensitive design and speculative design to understand these sensitivities. Based on the data collected in interviews (n = 6) and card workshops (n = 6) from care workers and residents in mobile care and care home contexts in Austria, we developed five themes capturing situated practices and understandings of good care as built on trust-developing routines, negotiations between different actors, affective and reciprocal dimension of care, care worker self-care, and material mediations. Subsequently, we created six speculative vignettes which serve as rhetorical devices to emphasize the tensions that arise with any technological intervention entering and reshaping existing care practices and relations. We argue that our approach can support robot designers to develop a rich understanding of the values and tensions in the specific context under study from the before design and development begin.

Data sharing in cancer research: A qualitative study exploring community members' preferences.

BACKGROUND: Advancements in cancer treatment and survivorship rely on participation in research and access to health records. METHODS: This study explored preferences for data access and sharing in 14 workshops with 42 community members, most of whom were a cancer survivor or carer. Various scenarios for data access and sharing were presented and discussed, with participants' preferences summarized using descriptive statistics. Reasons underlying these preferences were identified through a thematic analysis of workshop transcripts. RESULTS: Most participants indicated a willingness for researchers to use their self-report data and current health records for a specific research project (86%). Many were also willing for their self-report data and current (62%) or all future (44%) health records to be shared with other researchers for use in other studies if made aware of this. Willingness to consent to data access and sharing data in cancer research was influenced by: (i) the potential for data sharing to advance medical discoveries and benefit people impacted by cancer in the future, (ii) transparency around researchers' credibility and their intentions for data sharing, (iii) level of ownership and control over data sharing, and (iv) protocols for privacy and confidentiality in data sharing. CONCLUSIONS: Based on these themes, we present practical strategies for optimizing data access and sharing in cancer research.

The invisible evidence: Digital forensics as key to solving crimes in the digital age.

Digital transformation rapidly changes how we live our lives in the post pandemic world. Unfortunately, digital technology is not limited to law abiding organisations and citizens. Criminal organisations and individuals are quick to identify new opportunities with new technologies, and digital transformation is dramatically changing the character of crimes, terror, and other threats. The fast emergence of new crimes is facilitated by possibilities brought by disruptive technologies such as AI, Internet of Things, drones, and cryptocurrencies that can be disastrous tools in the hands of criminals. Consequently, our society needs far better capacity to prevent and investigate criminal acts to protect organisations and citizens. This brings an urgent need to proactively reform digital forensics to significantly increase our capability to meet the strain on society brought by crimes evolving in the digital transformation era. The future of forensic science is already here, characterized by a mix of opportunities and challenges. It is essential to make it harder to effectively use digital technologies for criminal activities, while leveraging the possibilities of digital technologies by those affected, law enforcement agencies, business and organisations. As digital technologies continue to evolve, we need to stay up to date with the latest developments to effectively investigate and prosecute crimes in the digital age. There is an increased reliance on digital evidence, and the amount of heterogeneous digital evidence in criminal cases keep increasing. The forensic science techniques thus become more sophisticated and play an increasingly important role. However, the scientific area is extremely broad, and beyond the capability of most forensic science labs to keep up with the technology forefront development speed. Besides an urgent need to bring up the subject to the political arena, examples of how we can meet the challenges are discussed such as by extending our cooperation, encourage and facilitate cooperation for training and education to handle the extremely broad and rapid development, working out methods for explaining and visualising evidence for the treatment and legal values of digital evidence in prosecution, and cooperation between product developers and crime investigators for swift innovation of digital forensics tools and methodologies for quickly emerging threats. This paper will highlight specific examples where modern digital techniques are used to solve crimes in the physical world as well as crimes committed in the digital domain and discuss how "good AI" can be used to fight "evil AI" and finally touch on the sensitive balance between the increased power of the new digital forensic tools and private integrity.

Prescribing Complexities: A Patient Story Related to Seizure History and the Changing Therapeutic Landscape of Alzheimer's Disease.

The therapeutic landscape of Alzheimer's disease (AD) is rapidly changing. Disease-modifying medications for AD that target amyloid-beta (Aß) deposits in the brain have been approved by the Food and Drug Administration (FDA) in recent years. However, there remain many questions about which patients are most appropriate for these medications. One group in particular with unique considerations includes older adults with a prior history of seizures. AD and seizures represent an important, bidirectional relationship. This case report presents a patient story that highlights the importance of discussions around seizure history in consideration of anti-amyloid medications and the importance of risk-benefit assessments when considering anti-amyloid therapeutics for patients with AD.

Botulinum toxin treatment for hemifacial spasm: harmonising neurological and aesthetic outcomes.

Hemifacial spasm (HFS) represents a challenging cranial movement disorder primarily affecting the facial nerve innervated muscles, with significant prevalence among Asians. Botulinum toxin type A (BoNT/A) injections, established as a primary therapeutic intervention since FDA approval, offer considerable effectiveness in alleviating spasms, albeit accompanied by challenges such as temporary effects and potential adverse events including facial asymmetry. This comprehensive review underscores the crucial need for harmonising neurological benefits and aesthetic outcomes in HFS management. The discussion delves into the interplay between facial aesthetics and neurological objectives in BoNT/A injections, emphasising precise techniques, dosages, and site considerations. Distinct aspects in neurological and aesthetic domains are also examined, including detailing the targeted muscles and injection methodologies for optimal therapeutic and aesthetic results. Importantly, evidence regarding various BoNT/A formulations, recommendations, and reconstitution guidelines in both neurology and aesthetics contexts are provided, along with a schematic approach outlining the stepwise process for BoNT/A injection in HFS treatment, addressing critical areas such as orbicularis oculi muscle sites, eyebrow correction strategies, mid- and lower-face considerations, contralateral injection sites, and post-injection follow-up and complication management. By highlighting the culmination of neurological efficacy and facial esthetics in BoNT/A treatment for HFS patients, this review proposes a holistic paradigm to achieve balanced symptomatic relief and natural aesthetic expression, ultimately enhancing quality of life for individuals grappling with HFS.

Bulimia Nervosa and Binge-Eating Disorder Across the Lifespan.

This article aims to review the current evidence-based psychotherapy and psychopharmacological treatments for adults and youths with bulimia nervosa (BN) and binge-eating disorder (BED). Treatments for adults and for children and adolescents are discussed separately, including developmental considerations in the management of these disorders among youths. Although several evidence-based psychotherapy and psychopharmacological treatment options have been established for adults with BN or BED, there is much less empirical support for the management of these eating disorders among children and adolescents. This review concludes by discussing promising modalities and innovations, highlighting the potential utility of integrating technology into treatment approaches. Despite decades of treatment development and testing, a sizable proportion of individuals with BN or BED do not respond to the current evidence-based treatments, highlighting the need for continued research in these domains. Future research should focus on testing psychotherapy treatments among diverse samples in large, randomized controlled trials, as well as on treatments that can be easily scaled and implemented in community settings.

Deep brain stimulation and suicide attempts in treatment-resistant patients: a case report and neuroethical analysis.

This case presents the situation of a 66-year-old woman diagnosed with Multiple System Atrophy Parkinsonian Type who underwent deep brain stimulation (DBS) therapy and subsequently made two suicide attempts. Despite receiving treatment and extensive psychotherapy, her condition did not improve, leading to suicidal behavior over the course of a year. Notably, she held unrealistic beliefs about the effectiveness of DBS therapy, expressing dissatisfaction with its outcomes. Family dynamics were complex, with the patient concealing her psychological distress while coping with her worsening health condition. This severe distress culminated in two suicide attempts within a relatively short timeframe. Our psychiatric team promptly intervened, implementing a suicidality protocol and adjusting her medication regimen. Despite a documented prevalence of suicidal ideation and attempts post-DBS in the literature, the exact causes remain uncertain, with the suggested involvement of neuroimmune or neurological pathways. This case contributes to scientific understanding by shedding light on suicide attempts following ineffective DBS interventions, emphasizing the patient's right to be informed about potential suicide risks and the possibility of assisted suicide through a neuroethical analysis. Therefore, our case underlines the importance of psychiatric evaluation and intervention in DBS patients to prevent further suicidality, focusing on a multidisciplinary approach tailored to the patient's autonomy and neuroethical principles.

Leveraging AI and Machine Learning in Six-Sigma Documentation for Pharmaceutical Quality Assurance.

The pharmaceutical industry must maintain stringent quality assurance standards to ensure product safety and regulatory compliance. A key component of the well-known Six Sigma methodology for process improvement and quality control is precise and comprehensive documentation. However, there are a number of significant issues with traditional documentation procedures, including as slowness, human error, and difficulties with regulatory standards. This review research looks at innovative ways to employ machine learning (ML) and artificial intelligence (AI) to enhance Six Sigma documentation processes in the pharmaceutical sector. AI and ML provide cutting-edge technologies that have the potential to drastically alter documentation processes by automating data entry, collection, and analysis. Natural language processing (NLP) and computer vision technologies have the potential to significantly reduce human error rates and increase the efficacy of documentation processes. By applying machine learning algorithms to support real-time data analysis, predictive analytics, and proactive quality management, pharmaceutical organizations may be able to identify potential quality issues early on and take proactive efforts to address them. Combining AI and ML improves documentation accuracy and reliability while also strengthening compliance with stringent regulatory criteria. The primary barriers and limitations to the current state of Six Sigma documentation in the pharmaceutical industry are identified in this study. It examines the fundamentals of AI and ML with an emphasis on their specific applications in quality assurance and potential benefits for Six Sigma processes. The report includes extensive case studies that highlight notable developments and explain how AI/ML enhanced documentation is used in the real world.

Glucagon-Like Peptide Receptor-1 Agonists Used for Medically-Supervised Weight Loss in Patients With Hip and Knee Osteoarthritis: Critical Considerations for the Arthroplasty Surgeon.

Patients with morbid obesity and concomitant hip or knee osteoarthritis represent a challenging patient demographic to treat as these patients often present earlier in life, have more severe symptoms, and have worse surgical outcomes following total hip and total knee arthroplasty. Previously, bariatric and metabolic surgeries represented one of the few weight loss interventions that morbidly obese patients could undergo prior to total joint arthroplasty. However, data regarding the reduction in complications with preoperative bariatric surgery remain mixed. Glucagon-like peptide receptor-1 (GLP-1) agonists have emerged as an effective treatment option for obesity in patients with and without diabetes mellitus. Furthermore, recent data suggest these medications may serve as potential anti-inflammatory and disease-modifying agents for numerous chronic conditions, including osteoarthritis. This review will discuss the GLP-1 agonists and GLP-1/glucose-dependent insulinotropic polypeptide dual agonists currently available, along with GLP-1/glucose-dependent insulinotropic polypeptide/glucagon triple agonists presently being developed to address the obesity epidemic. Furthermore, this review will address the potential problem of GLP-1-related delayed gastric emptying and its impact on the timing of elective total joint arthroplasty. The review aims to provide arthroplasty surgeons with a primer for implementing this class of medication in their current and future practice, including perioperative instructions and perioperative safety considerations when treating patients taking these medications.

Chronic Facial Paralysis Treated With Non-absorbable APTOS Barbed Threads: A Case Report With Anatomic Considerations.

Chronic paralysis of the facial nerve leads to degenerative facial muscle and surrounding soft tissue alterations on the involved side, making the affected patients seem older than their actual age. Moreover, contralateral facial hypertrophy worsens facial asymmetry. Correction of the drooping or wrinkled face due to aging, trauma, or other pathology has been successfully treated with the thread-lifting technique. Here, we present the case report of a 23-year-old female patient suffering from oncologic post-surgery complications associated with chronic facial nerve paralysis. She also suffered from old and new cerebellar syndromes on the right side and lesions of the oculomotor, trochlear, and abducens nerves. Based on the patient history, the condition was treated under local anesthesia by the use of APTOS minimally invasive threads with barbs made from non-absorbable material. Correction and sculpting of the affected cheek area were performed by insertion of a light lift needle, and lifting of the superficial fat pads was secured by subdermal insertion of the light lift thread method. The jowl area was lifted by the superficial insertion of both types of threads. As a result, we significantly improved facial symmetry at rest, a more symmetric smile, a lifted corner of the mouth, and an anatomically sculpted cheek appearance.

Potentials of artificial intelligence in familial hypercholesterolemia: Advances in screening, diagnosis, and risk stratification for early intervention and treatment.

Familial hypercholesterolemia (FH) poses a global health challenge due to high incidence rates and underdiagnosis, leading to increased risks of early-onset atherosclerosis and cardiovascular diseases. Early detection and treatment of FH is critical in reducing the risk of cardiovascular events and improving the long-term outcomes and quality of life for affected individuals and their families. Traditional therapeutic approaches revolve around lipid-lowering interventions, yet challenges persist, particularly in accurate and timely diagnosis. The current diagnostic landscape heavily relies on genetic testing of specific LDL-C metabolism genes, often limited to specialized centers. This constraint has led to the adoption of alternative clinical scores for FH diagnosis. However, the rapid advancements in artificial intelligence (AI) and machine learning (ML) present promising solutions to these diagnostic challenges. This review explores the intricacies of FH, highlighting the challenges that are encountered in the diagnosis and management of the disorder. The revolutionary potential of ML, particularly in large-scale population screening, is highlighted. Applications of ML in FH screening, diagnosis, and risk stratification are discussed, showcasing its ability to outperform traditional criteria. However, challenges and ethical considerations, including algorithmic stability, data quality, privacy, and consent issues, are crucial areas that require attention. The review concludes by emphasizing the significant promise of AI and ML in FH management while underscoring the need for ethical and practical vigilance to ensure responsible and effective integration into healthcare practices.

The 2024 International Journal of Exercise Science Position Stand on Inclusion.

The International Journal of Exercise Science (IJES) Working Group for Opportunity, Representation, and Diverse Perspectives was tasked with developing a position stand to provide guidance in critical areas of inclusion. We present to authors, reviewers, and all readership IJES ideals to utilize in practice. Key points are presented, followed by a deeper look with greater explanation into the areas of inclusive language, diversity and inclusion in research, and accessibility. The same approach is presented for the areas of age, disability status, gender identity and sexual orientation, race, and ethnicity with attention to Indigenous Communities, religion, socioeconomic status, and neurodiversity. Person-first language is encouraged, with the acknowledgment that the preference of different community members may vary. IJES is committed to maintaining an environment that is welcoming to all identities so that they feel valued, respected, and included.

Stakeholder perspectives on ethical and trustworthy voice AI in health care.

Objective: Voice as a health biomarker using artificial intelligence (AI) is gaining momentum in research. The noninvasiveness of voice data collection through accessible technology (such as smartphones, telehealth, and ambient recordings) or within clinical contexts means voice AI may help address health disparities and promote the inclusion of marginalized communities. However, the development of AI-ready voice datasets free from bias and discrimination is a complex task. The objective of this study is to better understand the perspectives of engaged and interested stakeholders regarding ethical and trustworthy voice AI, to inform both further ethical inquiry and technology innovation. Methods: A questionnaire was administered to voice AI experts, clinicians, scholars, patients, trainees, and policy-makers who participated at the 2023 Voice AI Symposium organized by the Bridge2AI-Voice AI Consortium. The survey used a mix of Likert scale, ranking and open-ended questions. A total of 27 stakeholders participated in the study. Results: The main results of the study are the identification of priorities in terms of ethical issues, an initial definition of ethically sourced data for voice AI, insights into the use of synthetic voice data, and proposals for acting on the trustworthiness of voice AI. The study shows a diversity of perspectives and adds nuance to the planning and development of ethical and trustworthy voice AI. Conclusions: This study represents the first stakeholder survey related to voice as a biomarker of health published to date. This study sheds light on the critical importance of ethics and trustworthiness in the development of voice AI technologies for health applications.

Consideration of Sustainability When Approving Human Medical Research-A Scoping Review.

This article attempts to highlight the importance of including research sustainability as imperative when assessing human medical research in terms of ethical principles. Using a scoping review of recent literature, the complexity of research sustainability is highlighted with key themes and concepts surrounding this important topic being recognized and discussed. An overall paucity of guidance documents was identified and recommendations have been made to practically address this deficiency. An example of a research sustainability evaluation tool which is currently being piloted has been provided for possible adaptation and use by Ethics Committees and Institutional Review Boards to bolster the concept and inclusion of sustainability during the research approval process.

Physician-Modified Endografts for Repair of Complex Abdominal Aortic Aneurysms: Clinical Perspectives and Medico-Legal Profiles.

Standard endovascular aortic repair (EVAR) has become the standard of care for treating infrarenal abdominal aortic aneurysms (AAAs) in patients with favorable anatomies, while patients with challenging AAA anatomies, and those with suprarenal or thoraco-abdominal aneurysms, still need alternative, more complex, solutions, including custom-made branched or fenestrated grafts, which are constrained by production delay and costs. To address urgent needs and complex cases, physicians have proposed modifying standard endografts by manually creating graft fenestrations. This allows for effective aneurysm exclusion and satisfactory patency of visceral vessels. Although physician-modified grafts (PMEGs) have demonstrated high technical success, standardized creation processes and long-term safety data are still lacking, necessitating further study to validate their clinical and legal standing. The aim of this article is to illustrate the state of the art with regard to this surgical technique, summarizing its origin, evolution, and the main clinical evidence supporting its effectiveness. The paper also aims to discuss the main medico-legal issues related to the use of PMEGs, with particular reference to the issue of safety related to the standardization of the surgical technique, medical liability profiles, and informed consent.

Assessment of Suicide Risk and Cultural Considerations in Forcibly Displaced Migrant Youth.

Migrant youth who face forced displacement from their home countries have an emergent mental health burden, placing them at increased suicide risk. As such, it is crucial for pediatric providers to include suicide screening and assessment in their care for this population. Migrant families seek safety but, in many cases, encounter adverse events and psychosocial inequities in the migration journey and in the host community. Factors such as trauma, acculturative stress, and intersectionality influence suicide risk in migrants. Summative traumatic events contribute to the mental health load and worsen suicidal outcomes in migrant youth. Acculturative stress can lead to social marginalization in the host country, further adding to the existing mental health burden. Finally, intersectionality encompasses complex sociocultural influences, which shape the development of cultural identity in migrant youth and influence suicide risk. By examining these factors, the author advances cultural considerations in screening and assessment for suicide risk in migrant youth through evidence-based tools in pediatric clinical practice. Barriers to access to mental health services, stigma, and distrust of the health care system within the host community are also addressed. The author establishes recommendations for early suicide screening and prevention within this population through trauma-informed care, active advocacy, and cultural sensitivity.