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1.
J Virol ; 98(1): e0179123, 2024 Jan 23.
Artículo en Inglés | MEDLINE | ID: mdl-38168672

RESUMEN

In the United States (US), biosafety and biosecurity oversight of research on viruses is being reappraised. Safety in virology research is paramount and oversight frameworks should be reviewed periodically. Changes should be made with care, however, to avoid impeding science that is essential for rapidly reducing and responding to pandemic threats as well as addressing more common challenges caused by infectious diseases. Decades of research uniquely positioned the US to be able to respond to the COVID-19 crisis with astounding speed, delivering life-saving vaccines within a year of identifying the virus. We should embolden and empower this strength, which is a vital part of protecting the health, economy, and security of US citizens. Herein, we offer our perspectives on priorities for revised rules governing virology research in the US.


Asunto(s)
Investigación Biomédica , Contención de Riesgos Biológicos , Virología , Humanos , COVID-19 , Estados Unidos , Virus , Investigación Biomédica/normas
2.
BMC Public Health ; 24(1): 2059, 2024 Jul 31.
Artículo en Inglés | MEDLINE | ID: mdl-39085794

RESUMEN

BACKGROUND: The Coronavirus Disease 2019 (COVID-19) pandemic precipitated an urgent need for clinical trials to discover safe and efficacious treatments. We examined how COVID-19 experiences, clinical trial awareness, and trust in the vaccine safety process were associated with willingness to participate in COVID-19 clinical trials. The objective was to investigate the relationship between trust in federal oversight of vaccine safety and willingness to participate in clinical trials for COVID-19 treatment across four distinct time points over an 18-month period during the COVID-19 pandemic. METHODS: We used four waves of data collected from September 2021 to March 2023 among 582 Philadelphia residents (with a missing data rate of 0.9%). Generalized estimating equations estimated the association between willingness to participate in COVID-19 clinical trials and participants' trust in the federal government's oversight of COVID-19 vaccine safety, COVID-19-related variables (COVID-19 related health challenges, history of COVID-19 infection), awareness of clinical trials and how to enroll in them, and sociodemographic characteristics (age, race/ethnicity, sexual orientation, gender, parental status, education, and insurance). RESULTS: On average, willingness to participate in a COVID-19 clinical trial was positively associated with greater trust in the federal government's oversight of vaccine safety [ß = 0.34, 95% confidence interval (CI): 0.15-0.53], having COVID-19 (ß = 0.40, 95% CI: 0.08-0.73), awareness of clinical trials (ß = 0.38, 95% CI: 0.04-0.73), and knowledge of how to enroll (ß = 0.83, 95% CI: 0.44-1.23). Among sociodemographic characteristics, race/ethnicity (p = 0.001) and gender (p = 0.018) were identified as predictors for COVID-19 trial willingness. CONCLUSION: Willingness to participate in clinical trials may be bolstered by strengthening the public's trust in the federal government's role within vaccine safety oversight, increasing the perceived relevance of clinical trials to individuals' health and well-being, and offering tailored information to educate diverse communities about ongoing trials and how to enroll in them.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Ensayos Clínicos como Asunto , Confianza , Humanos , Masculino , COVID-19/prevención & control , Philadelphia , Femenino , Persona de Mediana Edad , Adulto , Anciano , Gobierno Federal , Adulto Joven , Estados Unidos , SARS-CoV-2
3.
BMC Public Health ; 24(1): 830, 2024 Mar 16.
Artículo en Inglés | MEDLINE | ID: mdl-38493101

RESUMEN

BACKGROUND: Over half of the youth population in the United States, aged 6 months to 17 years, have not received the Coronavirus Disease 2019 (COVID-19) vaccine. Given parents' central role in vaccinating their children, we examined associations between parents' trust of the federal oversight of COVID-19 vaccine safety and their willingness to vaccinate their children against COVID-19. METHODS: This cross-sectional study included 975 parents of minor children residing in Philadelphia who completed the online survey between September 2021 and February 2022. Trust was measured using a four-point Likert scale ranging from 'do not trust' to 'fully trust' for two variables: (1) trust in federal oversight of COVID-19 vaccine safety for children and (2) trust in federal oversight of COVID-19 vaccine safety for the general public. A multiple logistic regression evaluated associations between trust and parents' willingness to vaccinate their children, which was measured on a five-point Likert scale ranging from 'strongly disagree' to 'strongly agree.' The analysis was adjusted for race/ethnicity, age, sexual orientation, gender, education, insurance, and parents' vaccination status. RESULTS: Analyses included 975 parents whose children had not previously been vaccinated against COVID-19 (mean age 36.79, standard deviation 6.4; 42.1% racial/ethnic minorities; 93.2% heterosexual; and 73.7% with a college degree). Greater trust regarding federal oversight of COVID-19 vaccine safety for children [adjusted odds ratio (aOR) = 1.52, 95% confidence interval (CI): 1.13-2.04] and for the public (aOR = 1.58, 95% CI: 1.17-2.14) were each associated with increased willingness to have their child vaccinated against COVID-19. Unvaccinated parents had decreased willingness compared to parents who had received at least one dose of the vaccine (aOR = 0.14, 95% CI: 0.04-0.41). College-graduate parents exhibited increased willingness compared to those without a college degree (aOR = 2.07, 95% CI: 1.52-2.81). Non-heterosexual parents showed increased willingness compared to heterosexual parents (aOR = 2.30, 95% CI: 1.20-4.76). CONCLUSIONS: Trust in federal COVID-19 vaccine oversight was associated with parental willingness to vaccinate their children against COVID-19 among parents whose children have not yet been vaccinated. Identifying and addressing causes of mistrust are crucial next steps to promote child vaccination. Intervention efforts to address trust gaps should remain a public health priority.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Adolescente , Adulto , Niño , Femenino , Humanos , Masculino , COVID-19/epidemiología , COVID-19/prevención & control , Estudios Transversales , Escolaridad , Padres , Confianza , Vacunación , Lactante , Preescolar
4.
J Environ Manage ; 359: 121039, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38710150

RESUMEN

Enterprise digital transformation (EDT) is a strategic initiative that provides robust support for optimising resource allocation, fosters business innovation, and significantly impacts ecological environment to increase financial performance. This study re-examines the substantial contributions of EDT to climate change mitigation. Drawing on data from Chinese A-share listed companies from 2010 to 2021, we investigated the changes and mechanisms influencing carbon emissions reduction performance (CERP) of enterprises undergoing digital transformation. The empirical results indicate that EDT actively contributes to enhancing the CERP of enterprises, with a more pronounced effect observed in non-polluting industries, state-owned enterprises, and manufacturing companies. Furthermore, empirical findings from mechanism tests reveal that EDT effectively improves the CERP by driving green technological innovation, strengthening industry chain connections, and enhancing capacity utilisation. Finally, within external oversight groups, particularly in government and investor supervision, the enhancement of enterprise CERP is more significant, highlighting the crucial role of external oversight in the EDT process.


Asunto(s)
Cambio Climático , Carbono , China
5.
Cancer Control ; 30: 10732748221131652, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36592477

RESUMEN

OBJECTIVE: In this article on adenoid cystic carcinoma (ACC) of salivary gland, we intend to summarize the causes of misdiagnosis and oversight of ACC hoping to improve cytological diagnostic accuracy, clinical management and patient treatment. METHODS: The study retrospectively reviewed 32 patients with ACC of salivary gland, registered at the Affiliated Hospital of Southwest Medical University from July 2014 to June 2021. These cases were diagnosed by FNA and surgical excision biopsy. All cytopathological results were retrospectively categorized according to Milan system for reporting salivary gland cytopathology (MSRSGC). The accuracy of FNA was verified by surgical excision biopsy. RESULTS: Of these 32 patients, 16 (50.0%) cases were male, and 16 (50.0%) were female. Their age ranged from 21 to 79 years, with an average age of 50.32 years. The highest incidence (15/32, 46.9%) of ACC was observed in patients between 41 and 50 years of age. 10 cases (31.3%) occurred in the parotid gland, 9 cases (28.1%) in the submandibular gland, 9 cases (28.1%) in the sublingual gland, 3 cases (9.4%) in the palate, and 1 case (3.1%) in the lip. Among the 32 cases of ACC, 23 cases (71.9%) were classified to VI, 4 cases (12.5%) to IVa, and 5 cases (15.6%) to II by MSRSGC. A comparison of the FNA results with biopsy showed that the accuracy of FNA in ACC of salivary gland is 71.9%. Being able to identify the cytomorphological features is the key factor for accurate diagnosis of ACC of the salivary gland. CONCLUSION: Our results confirm that FNA is an important initial screening in the diagnosis of ACC of salivary gland. Increased study of the cytomorphology of ACC is beneficial for more accurate diagnosis of ACC, to reduce misdiagnosis and oversight.


Asunto(s)
Carcinoma Adenoide Quístico , Neoplasias de las Glándulas Salivales , Humanos , Masculino , Femenino , Persona de Mediana Edad , Adulto Joven , Adulto , Anciano , Carcinoma Adenoide Quístico/diagnóstico , Carcinoma Adenoide Quístico/patología , Neoplasias de las Glándulas Salivales/diagnóstico , Neoplasias de las Glándulas Salivales/epidemiología , Neoplasias de las Glándulas Salivales/patología , Estudios Retrospectivos , Biopsia con Aguja Fina/métodos , Glándulas Salivales/cirugía , Glándulas Salivales/patología , Errores Diagnósticos
6.
Eur J Clin Pharmacol ; 79(7): 989-1002, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-37249640

RESUMEN

INTRODUCTION: This study documents imprecision in Japanese reports of adverse events following immunization (AEFI). In doing so, it presents methods to analyze this imprecision. METHODS: These methods include use of unique Japanese data on the validity of certain AEFIs. They also include ways to estimate AEFI rates, which allow comparison of AEFI data between countries. Using US AEFI data for comparison, we show how differences in AEFI reporting systems likely influence AEFI statistics. RESULTS: Although our comparisons of AEFI rates are not precise, many of the difference we detected between Japanese and US statistics make sense and reflect differences in the societal and medical perspectives on various vaccines or can be explained by differences in the reporting systems including reporting sources. For example, differences in societal and medical perspective probably underly the extraordinarily high Japanese rates of anaphylaxis and other AEs following HPV immunizations from 2010 to 2016 compared to US rates and to Japanese rates for other vaccines. High US rates of reported Guillain-Barré syndrome following influenza vaccination relative to Japanese rates and to rates for other US vaccines are consistent with data suggesting that the index of suspicion for such reactions could affect AEFI rates. The findings that over half of Japanese anaphylaxis reports for every vaccine are erroneous, and that close to half of "serious" Japanese AEFI cases probably are not serious may be due in part not only to explanations unique to Japan, but also to factors that apply to the USA and other countries. Differences in reporting systems account for a much higher rate of non-serious AEFI reports in the USA compared to Japan. Japanese marketing authorization holders are probably at least as assiduous and timely in their reporting of AEFIs as health care providers, though granular level differences are apparent in reporting by various sources. CONCLUSION: The methods we used to analyze the validity of Japanese statistics can be used to analyze the validity of AEFI reports from other countries and aid the harmonization of adverse event reporting systems. Eventually, similar reporting systems might be adapted for drugs and medical devices.


Asunto(s)
Anafilaxia , Vacunas , Humanos , Farmacovigilancia , Anafilaxia/inducido químicamente , Anafilaxia/epidemiología , Salud Pública , Sistemas de Registro de Reacción Adversa a Medicamentos , Vacunación/efectos adversos , Vacunas/efectos adversos
7.
Global Health ; 19(1): 70, 2023 09 14.
Artículo en Inglés | MEDLINE | ID: mdl-37710336

RESUMEN

Meta-regulation - the rules that govern how individual policies are developed and reviewed - has not received much attention in the study of health policy. We argue that these rules, far from value-free and objective, have significant potential to shape policy outputs and, as such, health outcomes. Channelling and operationalising wider paradigms like neoliberalism, they determine, for instance, what is considered 'good' policy, how decisions are made, based on which evidence, and whose voices matter. Exploring an archetypal example of meta-regulation, the European Union's Better Regulation agenda, we illustrate why meta-regulatory tools such as impact assessment, stakeholder consultation, and evaluation - and the norms that underlie their application - matter for health. In so doing, we concentrate especially on the ways in which Better Regulation may affect interest groups' ability to exert influence and, conversely, how actors have sought to shape Better Regulation. We argue that attention to meta-regulation contributes to counter-balancing the focus on agency within debates at the intersection of globalisation and health, and notably those on regulatory practices and coordination. Whilst research has noted, for instance, the origins of frameworks like Better Regulation and the increasing inclusion of 'good regulatory practice' provisions within trade and investment agreements, less attention is directed to the role that these frameworks play once institutionalised. Yet, as we illustrate, there is considerable scope for meta-regulation to enhance our understanding of the forces shaping health policy via, for instance, conceptualisations of the (social, economic, political, commercial) determinants of health. As such, we call for increased attention to the role of meta-regulation in research and practice aimed at improving human and planetary health.


Asunto(s)
Formación de Concepto , Salud Pública , Humanos , Política de Salud , Inversiones en Salud , Derivación y Consulta
8.
BMC Med Ethics ; 24(1): 37, 2023 06 03.
Artículo en Inglés | MEDLINE | ID: mdl-37270597

RESUMEN

PURPOSE: We explored the views of Botswana stakeholders involved in developing, implementing and applying ethical standards for return of individual study results from genomic research. This allowed for mapping opportunities and challenges regarding actionability requirements that determine whether individual genomic research results should be fed back. METHODS: Using in-depth interviews, this study explored the views of sixteen (16) stakeholders about the extent, nature and timing of feedback of individual genomic research findings, including incidental findings that arise in the context of African genomics research. Coded data was analyzed through an iterative process of analytic induction to document and interpret themes. RESULTS: Overall, respondents were of the view that feedback of actionable individual genomic results was an important outcome that could benefit participants. However, a number of themes surfaced that pointed to opportunities and challenges that exist in Botswana that could help in planning for feeding back of individual genomic results that were mapped. Some of the opportunities cited by the respondents included the existence of good governance; democracy and humanitarianism; universal healthcare system; national commitment to science; research and innovation to transform Botswana into a knowledge-based economy; and applicable standard of care which could promote actionability. On the other hand, contextual issues like the requirement for validation of genomic research results in accredited laboratories, high cost of validation of genomic results, and linkage to care, as well as lack of experts like genomic scientists and counselors were considered as challenges for return of individual results. CONCLUSION: We propose that decisions whether and which genomic results to return take into consideration contextual opportunities and challenges for actionability for return of results in a research setting. This is likely to avoid or minimize ethical issues of justice, equity and harm regarding actionability decisions.


Asunto(s)
Genoma Humano , Genómica , Humanos , Botswana , Hallazgos Incidentales
9.
BMC Med Educ ; 23(1): 952, 2023 Dec 12.
Artículo en Inglés | MEDLINE | ID: mdl-38087252

RESUMEN

BACKGROUND: In Ireland, there are currently three educational institutions (recognised institutions- RIs) providing paramedic programmes, accredited by the regulator, the Pre-Hospital Emergency Care Council (PHECC). Each RI assesses their students in-house, and in order to acquire a licence to practice, students must also pass summative assessments provided by PHECC. These assessments comprise multiple choice questions, short answer questions and skills assessments. The objective of this study was to explore the perceptions and experiences of paramedic educators of assessments used within their institution and by the regulator to provide insights that could inform the future design of paramedic assessments. METHODS: A qualitative study with an interpretivist approach and purposive sampling strategy was performed. Semi-structured interviews were conducted with educators from one RI, across their three sites. Data were analysed using an inductive approach to thematic analysis. RESULTS: Four major themes were identified in the data: improving assessments by enhancing authenticity, modifying the current process of assessment, aligning the PHECC and RI examinations and opportunities to use assessment as learning. CONCLUSIONS: This study identifies perceived deficits and opportunities in the assessments currently used for paramedic students and ways in which these assessments could be improved. While participants were relatively content with their own RI assessments, they identified ways to improve both the RI and PHECC assessments. Modifying some of the current methods could be a useful first step. In particular, assessments used by PHECC could be improved by reflecting 'real-world' practice. The inclusion of additional assessment methods by PHECC, a continuous assessment process or devolvement of the entire assessment suite, to the RI/University has the potential to enhance assessments, particularly summative assessments, for paramedic students.


Asunto(s)
Auxiliares de Urgencia , Paramédico , Humanos , Auxiliares de Urgencia/educación , Aprendizaje , Investigación Cualitativa , Estudiantes
10.
Camb Q Healthc Ethics ; : 1-10, 2023 Jan 10.
Artículo en Inglés | MEDLINE | ID: mdl-36624620

RESUMEN

Human decisions are increasingly supported by decision support systems (DSS). Humans are required to remain "on the loop," by monitoring and approving/rejecting machine recommendations. However, use of DSS can lead to overreliance on machines, reducing human oversight. This paper proposes "reflection machines" (RM) to increase meaningful human control. An RM provides a medical expert not with suggestions for a decision, but with questions that stimulate reflection about decisions. It can refer to data points or suggest counterarguments that are less compatible with the planned decision. RMs think against the proposed decision in order to increase human resistance against automation complacency. Building on preliminary research, this paper will (1) make a case for deriving a set of design requirements for RMs from EU regulations, (2) suggest a way how RMs could support decision-making, (3) describe the possibility of how a prototype of an RM could apply to the medical domain of chronic low back pain, and (4) highlight the importance of exploring an RM's functionality and the experiences of users working with it.

11.
J Law Med ; 30(1): 23-47, 2023 May.
Artículo en Inglés | MEDLINE | ID: mdl-37271949

RESUMEN

Victoria is the first Australian jurisdiction to enact legislation establishing a regulatory framework specifically to guide government management of the COVID-19 pandemic and future pandemics. The Public Health and Wellbeing Amendment (Pandemic Management) Act 2021 (Vic) inserts Pt 8A into the Public Health and Wellbeing Act 2008 (Vic). The worthwhile stated objective of Pt 8A is to ensure that decision-making in response to an existing or emergent pandemic is "proactive and responsive", "informed by public health advice and other relevant information", and transparent and accountable. This column analyses sections of Pt 8A related to this aim, which grant decision-making powers, require various matters to inform this decision-making, and provide measures for oversight of decision-making. The column argues that Pt 8A constitutes a useful model on which Victoria and other jurisdictions could build and recommends further legislative amendments to help achieve its objective.


Asunto(s)
COVID-19 , Salud Pública , Humanos , Pandemias/prevención & control , Australia , COVID-19/epidemiología
12.
J Surg Res ; 269: 36-43, 2022 01.
Artículo en Inglés | MEDLINE | ID: mdl-34517187

RESUMEN

BACKGROUND: Children's hospitals within larger hospitals (CH/LH) have the specific clinical advantage of easily facilitated collaboration between adult and children's surgeons. These collaborations, which we have termed hybrid surgical offerings (HSOs) are often required for disease processes requiring interventions that fall outside the customary practice of children's surgeons. Formal models to describe or evaluate these practices are lacking. METHODS: HSOs within a CH/LH were identified. Principles of systems-engineering were used to develop a standardized model (Children's Hybrid Enhanced Surgical Services [CHESS]) to describe and evaluate HSOs. Face validity was established via unstructured interviews of CH leaders and HSO surgeons. Areas for improved system-wide standardization and programmatic development were identified. RESULTS: HSOs were identified in collaboration with adult bariatric, minimally invasive, advanced endoscopic, endocrine, thoracic, and orthopedic trauma surgical services. The CHESS framework encompassed: 1) quality improvement metrics, 2) credentialing and oversight, 3) transitions of care, 4) pediatric family-centered care, 5) maintenance of the cycle of expertise, 6) continuing medical education, 7) scholarship. While HSOs fulfilled the majority of aforementioned programmatic domains across all six HSO-providing services, areas for improvement included maintaining a cycle of expertise (33%), quality improvement metrics (50%), and pediatric family-centered care (66%).  Additional noted advantages included faster translation of adult innovation to pediatric care and facilitation of emergency interdisciplinary care. CONCLUSION: Formal evaluation of HSOs is necessary to standardize and improve the quality of children's surgical care. Development of a structured framework such as CHESS addresses gaps in quality oversight and provides a basis for performance improvement, patient safety, and programmatic development.


Asunto(s)
Especialidades Quirúrgicas , Cirujanos , Adulto , Niño , Hospitales Pediátricos , Humanos , Mejoramiento de la Calidad
13.
Clin Trials ; 19(1): 112-115, 2022 02.
Artículo en Inglés | MEDLINE | ID: mdl-34727786

RESUMEN

Recent guidance documents from international regulators emphasize the importance of thoughtful trial design and risk-based oversight in delivering reliable results. In practice, these recommendations are often implemented in a fragmented manner, reducing their effectiveness. We argue that collaborative, cross-stakeholder engagement that prioritizes both optimal trial design and tailored oversight are a necessary and effective approach to modernize quality management. This practice is at the core of Quality by Design, an approach that involves identifying important errors that could undermine trial credibility or participant safety and addressing them proactively. While Quality by Design is well suited for clinical trials supporting regulatory approval of a new medicinal product, we describe how the approach is equally relevant for pragmatic trials, including those conducted in the context of a pandemic.

14.
Global Health ; 18(1): 63, 2022 06 20.
Artículo en Inglés | MEDLINE | ID: mdl-35725614

RESUMEN

BACKGROUND: A stable, well-functioning and integrated national medicines regulatory system is a core component of health systems resilient against infectious disease outbreaks. In many low- and middle-income countries, however, sizable gaps exist in the emergency preparedness framework of national regulatory authorities (NRAs). RegTrain-VaccTrain is a project of Germany Ministry of Health's Global Health Protection Programme that contributes to global efforts aimed at strengthening such regulatory systems by providing technical support and advice to partner NRAs. In this study, we probed the outputs of our capacity-strengthening activities for clinical trials oversight (CTO) to take stock of progress made and examine remaining priorities in order to provide specialized technical assistance in addressing them to improve operational readiness for emergencies. METHOD: Data validated from NRA self-benchmarking results in 2017 and worksheet records of November 2021 were utilized to assess the emergency preparedness capacity for CTO in three VaccTrain partner NRAs (Liberia, Sierra Leone, The Gambia) before and after interventional capacity-strengthening partnership, using specific public health emergency-related (sub-)indicators of the WHO Global Benchmarking Tool. RESULTS: A generally weak and vulnerable structural framework for CTO characterized the emergency preparedness capacity in all three partner NRAs at baseline, thus putting their operational readiness for public health emergencies at risk. VaccTrain's collaborative work was successful at supporting individual NRAs to develop the full spectrum of operational structures (including (draft) regulations, guidelines, and standard operating procedures) required to improve regulatory preparedness. A gap in the formal approval and implementation of developed legal documents in two of three NRAs still remains. Notwithstanding, a robust emergency framework now exists and the NRAs stand better prepared to respond to (future) locally-concerning health emergencies, during which time clinical trials activity was observed to heighten. CONCLUSIONS: These results exemplify a north-south capacity-strengthening partnership model that effectively contributes in developing structures to enhance regulatory oversight and support expeditious product development in response to crises. They further underscore the equally critical role local/national processes play in facilitating the full implementation of developed structures.


Asunto(s)
Planificación en Desastres , Salud Pública , Benchmarking , Urgencias Médicas , Salud Global , Humanos , Organización Mundial de la Salud
15.
Can J Microbiol ; 68(11): 655-660, 2022 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-36041228

RESUMEN

Life science research was analyzed for potential misuse in the 2004 report "Biotechnology Research in an Age of Bioterrorism". However, it was not until 2015 that the United States Government (USG) Institutional Dual Use Research of Concern (DURC) policy went into effect. Institutions receiving USG funding for life science research are required to scan their research portfolios for research involving one of 15 agents and subsequent 7 experimental effects described in the policy. In practice, this policy was implemented in a variety of ways with varying outcomes and lessons learned. First and foremost, reviewing research for potential DURC is a highly subjective process that differs depending on the risk tolerance, experience, and training of the individuals charged with reviewing research for an institution as well as the review process itself. The information being reviewed also lends to the subjectivity of the process, that is, the experimental data provided. It is difficult to determine whether research is potential DURC without experimental data. Any review process is hypothetical until there is data. Lastly, reviewers of the research should look beyond the research proposals, like how compounding existing research information can create new risks, potential use in other organisms or systems, or the creation of a roadmap that, for example, shows how to create a concerning organism or could be used in a pathogen.


Asunto(s)
Investigación Biomédica , Investigación de Doble Uso , Estados Unidos , Humanos , Bioterrorismo/prevención & control , Gobierno , Políticas
16.
Clin Oral Investig ; 26(12): 6871-6879, 2022 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-36153437

RESUMEN

OBJECTIVES: This review aims to share the current developments of artificial intelligence (AI) solutions in the field of medico-dental diagnostics of the face. The primary focus of this review is to present the applicability of artificial neural networks (ANN) to interpret medical images, together with the associated opportunities, obstacles, and ethico-legal concerns. MATERIAL AND METHODS: Narrative literature review. RESULTS: Narrative literature review. CONCLUSION: Curated facial images are widely available and easily accessible and are as such particularly suitable big data for ANN training. New AI solutions have the potential to change contemporary dentistry by optimizing existing processes and enriching dental care with the introduction of new tools for assessment or treatment planning. The analyses of health-related big data may also contribute to revolutionize personalized medicine through the detection of previously unknown associations. In regard to facial images, advances in medico-dental AI-based diagnostics include software solutions for the detection and classification of pathologies, for rating attractiveness and for the prediction of age or gender. In order for an ANN to be suitable for medical diagnostics of the face, the arising challenges regarding computation and management of the software are discussed, with special emphasis on the use of non-medical big data for ANN training. The legal and ethical ramifications of feeding patients' facial images to a neural network for diagnostic purposes are related to patient consent, data privacy, data security, liability, and intellectual property. Current ethico-legal regulation practices seem incapable of addressing all concerns and ensuring accountability. CLINICAL SIGNIFICANCE: While this review confirms the many benefits derived from AI solutions used for the diagnosis of medical images, it highlights the evident lack of regulatory oversight, the urgent need to establish licensing protocols, and the imperative to investigate the moral quality of new norms set with the implementation of AI applications in medico-dental diagnostics.


Asunto(s)
Inteligencia Artificial , Humanos
17.
Prehosp Emerg Care ; 25(4): 593-595, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33886431

RESUMEN

The National Association of Emergency Medicine Services (EMS) Physicians (NAEMSP) recognizes the continued growth and complexity of mass gathering events and the integral role of the medical director in their planning and management. There is a growing body of literature that provides additional insight into patient presentations as well as preparation, staffing, and planning for these events. The clinical practice of EMS medicine encompasses the provision of care in a variety of out-of-hospital environments, including those defined as mass gathering events. This updated guidance is intended for use by EMS personnel, EMS medical directors, emergency physicians, and other members of the multidisciplinary care team as they strive to provide the best care for patients in a variety of out-of-hospital environments. This document is not meant to be a complete review of all the issues on this topic, but rather a consensus statement based on the combination of available peer-reviewed, published evidence and expert opinion.


Asunto(s)
Planificación en Desastres , Servicios Médicos de Urgencia , Incidentes con Víctimas en Masa , Consenso , Humanos , Atención al Paciente
18.
Adv Health Sci Educ Theory Pract ; 26(1): 297-311, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-32833138

RESUMEN

Australian general practice trainees typically consult with patients from their first week of training, seeking in-consultation supervisory assistance only when not sufficiently confident to complete patient consultations independently. Trainee help-seeking plays a key role in supervisor oversight of trainee consultations. This study used focus groups and interviews with general practice supervisors to explore their approaches to trainee help-seeking and in-consultation supervision. Supervisor approaches are discussed under three themes: establishing a help-seeking culture; perceptions of in-consultation assistance required; and scripts for help provision. Within these themes, three interwoven entrustment processes were identified: supervisor entrustment; trainee self-entrustment; and 'patient entrustment' (patient confidence in the trainee's clinical management). Entrustment appears to develop rapidly, holistically and informally in general practice training, partly in response to workflow pressure and time constraints. Typical supervisor scripts and etiquette for help-provision involve indirect, soft correction strategies to build trainee self-entrustment. These scripts appear to be difficult to adapt appropriately to under-performing trainees. Importantly, supervisor scripts also promote patient entrustment, increasing the likelihood of patients returning to the trainee and training practice for subsequent review, which is a major mechanism for ensuring patient safety in general practice. Theories of entrustment in general practice training must account for the interplay between supervisor, trainee and patient entrustment processes, and work-related constraints. Gaps between entrustment as espoused in theory, and entrustment as enacted, may suggest limitations of entrustment theory when extended to the general practice context, and/or room for improvement in the oversight of trainee consultations in general practice training.


Asunto(s)
Docentes Médicos/organización & administración , Medicina General/educación , Internado y Residencia/organización & administración , Aprendizaje , Confianza , Adulto , Anciano , Australia , Docentes Médicos/psicología , Femenino , Humanos , Internado y Residencia/normas , Entrevistas como Asunto , Masculino , Persona de Mediana Edad , Cultura Organizacional , Seguridad del Paciente/normas , Investigación Cualitativa
19.
J Appl Clin Med Phys ; 22(6): 4-10, 2021 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-33938120

RESUMEN

The American Association of Physicists in Medicine (AAPM) is a nonprofit professional society whose primary purposes are to advance the science, education and professional practice of medical physics. The AAPM has more than 8000 members and is the principal organization of medical physicists in the United States. The AAPM will periodically define new practice guidelines for medical physics practice to help advance the science of medical physics and to improve the quality of service to patients throughout the United States. Existing medical physics practice guidelines will be reviewed for the purpose of revision or renewal, as appropriate, on their fifth anniversary or sooner. Each medical physics practice guideline represents a policy statement by the AAPM, has undergone a thorough consensus process in which it has been subjected to extensive review, and requires the approval of the Professional Council. The medical physics practice guidelines recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific training, skills, and techniques, as described in each document. Reproduction or modification of the published practice guidelines and technical standards by those entities not providing these services is not authorized. The following terms are used in the AAPM practice guidelines: (a) Must and Must Not: Used to indicate that adherence to the recommendation is considered necessary to conform to this practice guideline. (b) Should and Should Not: Used to indicate a prudent practice to which exceptions may occasionally be made in appropriate circumstances.


Asunto(s)
Física Sanitaria , Oncología por Radiación , Citarabina , Humanos , Sociedades , Tomografía Computarizada por Rayos X , Estados Unidos
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