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1.
Front Public Health ; 9: 698995, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34490183

RESUMO

Objective: The first wave of the coronavirus SARS-COV-2 pandemic has revealed a fragmented governance within the European Union (EU) to tackle public health emergencies. This qualitative study aims: 1) to understand the current EU position within the field of public health emergencies taking the case of the COVID-19 as an example by comparing and contrasting experiences from EU institutions and experts from various EU Member States at the beginning of the pandemic; and, 2) to identify and to formulate future EU pandemic strategies and actions based on experts' opinions. Methods: Eighteen semi-structured interviews were conducted with public health experts from various European Member States and European Commission officials from May 2020 until August 2020. The transcripts were analyzed by Thematic Content Analysis (TCA), mainly a manifest content analysis. Results: This study demonstrated that the limited EU mandate in health hinders proper actions to prevent and tackle infectious disease outbreaks, such as the COVID-19 pandemic. The results showed that this limitation significantly impacted the ECDC, as the Member States' competence did not allow the agency to have more capacity. The European Commission has fulfilled its role of coordinating and supporting the Member States by facilitating networks and information exchange. However, EU intra- and inter-communication need further improvement. Although diverse EU instruments and mechanisms were found valid, their implementation needed to be faster and more efficient. The results pointed out that underlying political challenges in EU decision-making regarding health emergencies hinder the aligned response. It was stated that the Member States were not prepared, and due to the restriction of their mandate, EU institutions could not enforce binding guidelines. Additionally, the study explored future EU pandemic strategies and actions. Both, EU institutions and national experts suggested similar and clear recommendations regarding the ECDC, the investment, and future harmonized preparedness tools. Conclusion: The complex politics of public health at the EU level have led to the fragmentation of its governance for effective pandemic responses. This ongoing pandemic has shed light on the fragility of the political and structural systems in Europe in public health emergencies. Health should be of high importance in the political agenda, and robust health reforms at the local, regional, national, and EU levels are highly recommended.


Assuntos
COVID-19 , Saúde Pública , Emergências , União Europeia , Prova Pericial , Humanos , Pandemias/prevenção & controle , SARS-CoV-2
3.
Law Hum Behav ; 45(3): 229-242, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-34351205

RESUMO

OBJECTIVE: The present research examined whether concurrent expert testimony ("hot tubbing") and court-appointed testimony reduced adversarial allegiance in clinical experts' judgments compared with traditional adversarial expert testimony. HYPOTHESES: We predicted Hypothesis 1: Defense experts would render more not responsible judgments and lower ratings of criminal responsibility than would prosecution experts; Hypothesis 2: Adversarial allegiance effects on experts' judgments would be heightened for adversarial experts and attenuated for concurrent experts over time; Hypothesis 3: Adversarial and concurrent experts would report higher dissonance than would court-appointed experts and adversarial experts' ratings would increase over time, concurrent experts' ratings would decrease, and court-appointed experts' ratings would remain unchanged. METHOD: Clinicians and advanced clinical doctoral students conducted simulated criminal responsibility evaluations for the prosecution, defense, or court. We categorized participants as favoring the prosecution or defense based on their preexisting attitudes and randomly assigned them to the adversarial, concurrent, or court-appointed expert testimony conditions. Participants completed a dichotomous responsibility judgment, strength of responsibility ratings, and cognitive dissonance measure after initial evidence review (n = 93), report completion (n = 52), and testimony (n = 48). Concurrent experts generated a joint report outlining areas of agreement and disagreement before providing testimony. RESULTS: Concurrent testimony did not eliminate adversarial allegiance. Adversarial and concurrent experts' perceptions of responsibility did not significantly differ (d = .04, 95% CI [-.64, .71]) or change over time (ηp2 = .03); however, prosecution experts-across testimony types-rated the defendant as significantly more responsible than did defense experts (d = 1.87, 95% CI [1.06, 2.67]). Concurrent and adversarial experts did not differ in their reports and minimally differed in testimony content. CONCLUSIONS: Experts who initially favored the prosecution or defense showed adversarial allegiance regardless of expert testimony method, and we observed no attenuation of this bias over the course of their case involvement. (PsycInfo Database Record (c) 2021 APA, all rights reserved).


Assuntos
Viés , Prova Pericial/métodos , Defesa por Insanidade , Julgamento , Adulto , Dissonância Cognitiva , Dissidências e Disputas/legislação & jurisprudência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
4.
Stomatologiia (Mosk) ; 100(4): 49-54, 2021.
Artigo em Russo | MEDLINE | ID: mdl-34357728

RESUMO

OBJECTIVE: The aim of the study is to identify the consistency of expert opinions when manually identifying the reference points positions for studying the soft-tissue face profile in digital teleradiological images of the skull lateral projection. MATERIAL AND METHODS: The study involved 11 orthodontists having a 1 to 8 year experience. They localized the reference points manually, using the software with image enhancement options. Each doctor processed 100 X-ray images of the skull lateral projection. Totally, 1100 positions were identified (11 parameters in 100 images). The average position of 11 manual localizations was taken as the baseline. Then, manually identified positions were automatically compared with the basic localization. RESULTS: We have a good consistency of expert opinions when determining the reference points of the soft-tissue face profile. Herewith, the highest consistency of expert opinions is observed for soft-tissue reference points of the upper and lower lips (LL and EN points) with the average variation coefficients equal to 0.557726 and 0.566349 respectively; and the lowest consistency is observed for the hard tissue point Po with the average variation coefficient of 0.819904. Despite rather serious shortcomings in determining separate points (such as Or, DT, Po) in teleradiological images of the lateral skull projection, the method for determining soft-tissue profilometric reference points gives satisfactory results for more than 85.87% cases. In general, the method can be considered clinically reliable. However, the means and methods for identifying reference points require improving.


Assuntos
Prova Pericial , Crânio , Cefalometria , Humanos , Crânio/diagnóstico por imagem , Software
5.
Anaesth Intensive Care ; 49(4): 268-274, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34344162

RESUMO

The use of high flow nasal oxygen in the care of COVID-19-positive adult patients remains an area of contention. Early guidelines have discouraged the use of high flow nasal oxygen therapy in this setting due to the risk of viral spread to healthcare workers. However, there is the need to balance the relative risks of increased aerosol generation and virus transmission to healthcare workers against the role high flow nasal oxygen has in reducing hypoxaemia when managing the airway in high-risk patients during intubation or sedation procedures. The authors of this article undertook a narrative review to present results from several recent papers. Surrogate outcome studies suggest that the risk of high flow nasal oxygen in dispersing aerosol-sized particles is probably not as great as first perceived. Smoke laser-visualisation experiments and particle counter studies suggest that the generation and dispersion of bio-aerosols via high flow nasal oxygen with flow rates up to 60 l/min is similar to standard oxygen therapies. The risk appears to be similar to oxygen supplementation via a Hudson mask at 15 l/min and significantly less than low flow nasal prong oxygen 1-5 l/min, nasal continuous positive airway pressure with ill-fitting masks, bilevel positive airway pressure, or from a coughing patient. However, given the limited safety data, we recommend a cautious approach. For intubation in the COVID-positive or suspected COVID-positive patient we support the use of high flow nasal oxygen to extend time to desaturation in the at-risk groups, which include the morbidly obese, those with predicted difficult airways and patients with significant hypoxaemia, ensuring well-fitted high flow nasal oxygen prongs with staff wearing full personal protective equipment. For sedation cases, we support the use of high flow nasal oxygen when there is an elevated risk of hypoxaemia (e.g. bariatric endoscopy or prone-positioned procedures), but recommend securing the airway with a cuffed endotracheal tube for the longer duration procedures when theatre staff remain in close proximity to the upper airway, or considering the use of a surgical mask to reduce the risk of exhaled particle dispersion.


Assuntos
COVID-19 , Obesidade Mórbida , Adulto , Pressão Positiva Contínua nas Vias Aéreas , Prova Pericial , Humanos , Oxigênio , SARS-CoV-2
6.
Ann R Coll Surg Engl ; 103(8): 553-560, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34464555

RESUMO

INTRODUCTION: Our study investigated how the standard of surgical care is assessed within the English and Welsh litigation process. The 'shadowline' represents the dividing line between acceptable and unacceptable standards of care. Our hypothesis was that different assessors risk adopting materially different interpretations regarding the acceptable standard of care. Any variation in the interpretation of where the shadowline falls will create uncertainty and unfairness to surgeons and patients alike. METHODS: We summarised the legal literature and suggested the factors affecting the assessment of surgical standards. We illustrated our findings on distribution curves. RESULTS: There was a risk that the shape of the curve and the location of the shadowline may vary according to the assessor. Importantly, a gap may have developed between the legal and clinical shadowlines in respect of the consenting process. DISCUSSION AND CONCLUSION: We suggested how a gap between the surgical and legal shadow lines could be narrowed. Clinical governance, balanced literature and realistic expert assessments were all part of the solution.


Assuntos
Padrão de Cuidado/legislação & jurisprudência , Procedimentos Cirúrgicos Operatórios/normas , Prática Clínica Baseada em Evidências/legislação & jurisprudência , Prova Pericial/legislação & jurisprudência , Humanos , Procedimentos Cirúrgicos Operatórios/legislação & jurisprudência
7.
Ann R Coll Surg Engl ; 103(8): 544-545, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34464566

RESUMO

At the outset of an alleged medical negligence case, it is common for medical expert witnesses to be asked to write a brief report, sometimes called a short report or a screening report. Such requests may come from solicitors acting for a claimant or for the defence. Reassurances may be offered that the opinion given will not be disclosed. However, this is very often not the case. Doctors and the instructing solicitors need to be aware of the legal and ethical implications of providing such instructions. The medical expert must be aware that their duty to the court begins from the time of receipt of a letter from a solicitor requesting such a report.


Assuntos
Ética Médica , Imperícia/legislação & jurisprudência , Documentação , Prova Pericial/legislação & jurisprudência , Juramento Hipocrático , Humanos , Reino Unido
8.
Eur J Endocrinol ; 185(4): G35-G42, 2021 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-34292875

RESUMO

COVID-19 has changed the nature of medical consultations, emphasizing virtual patient counselling, with relevance for patients with diabetes insipidus (DI) or hyponatraemia. The main complication of desmopressin treatment in DI is dilutional hyponatraemia. Since plasma sodium monitoring is not always possible in times of COVID-19, we recommend to delay the desmopressin dose once a week until aquaresis occurs allowing excess retained water to be excreted. Patients should measure their body weight daily. Patients with DI admitted to the hospital with COVID-19 have a high risk for mortality due to volume depletion. Specialists must supervise fluid replacement and dosing of desmopressin. Patients after pituitary surgery should drink to thirst and measure their body weight daily to early recognize the development of postoperative SIAD. They should know hyponatraemia symptoms. Hyponatraemia in COVID-19 is common with a prevalence of 20-30% and is mostly due to SIAD or hypovolaemia. It mirrors disease severity and is an early predictor of mortality. Hypernatraemia may also develop in COVID-19 patients, with a prevalence of 3-5%, especially in ICU, and derives from different multifactorial reasons, for example, due to insensible water losses from pyrexia, increased respiration rate and use of diuretics. Hypernatraemic dehydration may contribute to the high risk of acute kidney injury in COVID-19. IV fluid replacement should be administered with caution in severe cases of COVID-19 because of the risk of pulmonary oedema.


Assuntos
COVID-19/epidemiologia , Diabetes Insípido/terapia , Endocrinologia/normas , Hiponatremia/terapia , Assistência Ambulatorial/métodos , Assistência Ambulatorial/normas , Consenso , Diabetes Insípido/epidemiologia , Diabetes Insípido/patologia , Aconselhamento à Distância/métodos , Aconselhamento à Distância/normas , Endocrinologia/história , Endocrinologia/tendências , Prova Pericial , História do Século XXI , Hospitalização/estatística & dados numéricos , Humanos , Hiponatremia/epidemiologia , Hiponatremia/patologia , Pandemias , Padrões de Prática Médica/história , Padrões de Prática Médica/normas , Padrões de Prática Médica/tendências , SARS-CoV-2 , Índice de Gravidade de Doença , Telemedicina/história , Telemedicina/métodos , Telemedicina/normas
9.
Neuropsychologia ; 159: 107951, 2021 08 20.
Artigo em Inglês | MEDLINE | ID: mdl-34246663

RESUMO

Individual attitudes and preferences are easily affected by social information. In a world where information sharing and dissemination are extremely convenient, social influence has played a greater role than in any previous era. Previous studies have suggested that the medial prefrontal cortex (mPFC) participates in mediating the tendency towards social conformity. However, the specific role of this brain area is still unknown, and it is not clear whether various types of external information influences share a mechanism. In this research, we aimed to use transcranial direct current stimulation (tDCS) to further explore the role of the mPFC in human conformity behaviour. In our experiment, the subjects received the majority opinion/expert opinion, and conformity behaviour was measured by the subject's tendency to follow this information after receiving the social information. Our research found that when social information conveys the majority opinion, cathodal stimulation of the mPFC significantly enhances the subject's consistency tendency. When social information conveys an expert opinion, stimulation of the mPFC has no significant effect on the conformity tendency of subjects. The results suggest that the mPFC plays an inhibitory role in regulating the social conformity tendency and that the activated neural circuits may vary with source when dealing with social influences.


Assuntos
Estimulação Transcraniana por Corrente Contínua , Eletrodos , Prova Pericial , Humanos , Córtex Pré-Frontal
10.
J Glob Health ; 11: 15001, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34327002

RESUMO

Background: The reasons why episodes of illness can lead to fatal outcomes in affected persons in low resource settings are numerous and complex. A tool that allows policy makers to better understand those complexities could be useful to improve success of programmes that are implemented globally to reduce mortality. Methods: We developed a "Pathways to Survival" (PATHS) tool: an epidemiological model using decision trees, available evidence and expert opinion. PATHS visualises the "architecture" of mortality in the population by following the entire population cohort over a certain period of time. It explains how initially healthy persons progress through health systems to lethal outcomes at the end of the specified time period. We developed an illustrative example based on the 136 million newborns and an estimated 907 000 deaths from newborn sepsis in the year 2008. This allowed us to develop an epidemiological model that described pathways to deaths from neonatal sepsis globally in 2010. Results: The model described the "status quo' situation in 2010 with 907 000 deaths to allow an assessment of the potential impact and feasibility of different interventions and programmes at various level of health systems in reducing this cause of mortality. A useful model should incorporate both a 'horizontal' and a 'vertical' component. The 'horizontal' would track the progress of all neonates globally through time, ie, their first 28 days of life, and separate them into different 'pathways' every time a change in their risk of dying from neonatal infection occurs because of their specific contextual circumstances. The 'vertical' would track their position within the health systems of their countries and separate them into different categories based on the ability of health system to intervene and reduce their risk of dying. Based on those requirements, PATHS tool was developed which is based on decision trees where different "branches" of the trees are associated with varying case-fatality rates. Conclusions: The application of the PATHS tool on the example of newborn sepsis revealed that novel diagnostic tests could save many lives, so we should continue to invest in them to improve their validity, deliverability and affordability. However, PATHS showed that investments in better diagnostics have limited impact unless they are coupled with improvements of the context. Programs for parental education improve compliance and care seeking. Promoting legislation change to empower community health workers (CHWs) to actively engage in prevention, diagnosis and care also makes a difference, as well as programs for training CHWs to use diagnostic tests and administer treatments correctly. Care-seeking behaviour can also be improved through programs of conditional cash transfers. Finally, PATHS demonstrated that improving access to primary and secondary health care for everyone is the most powerful contextual change.


Assuntos
Mortalidade Infantil , Modelos Biológicos , Análise de Sobrevida , Prática Clínica Baseada em Evidências , Prova Pericial , Humanos , Lactente , Mortalidade Infantil/tendências , Recém-Nascido
12.
Forensic Sci Int ; 325: 110856, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34116402

RESUMO

Although the analysis of bloodstain pattern evidence left at crime scenes relies on the expert opinions of bloodstain pattern analysts, the accuracy and reproducibility of these conclusions have never been rigorously evaluated at a large scale. We investigated conclusions made by 75 practicing bloodstain pattern analysts on 192 bloodstain patterns selected to be broadly representative of operational casework, resulting in 33,005 responses to prompts and 1760 short text responses. Our results show that conclusions were often erroneous and often contradicted other analysts. On samples with known causes, 11.2% of responses were erroneous. The results show limited reproducibility of conclusions: 7.8% of responses contradicted other analysts. The disagreements with respect to the meaning and usage of BPA terminology and classifications suggest a need for improved standards. Both semantic differences and contradictory interpretations contributed to errors and disagreements, which could have serious implications if they occurred in casework.


Assuntos
Manchas de Sangue , Prova Pericial , Variações Dependentes do Observador , Medicina Legal , Humanos , Reprodutibilidade dos Testes
13.
Postgrad Med ; 133(6): 592-598, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34171981

RESUMO

OBJECTIVES: COVID19 pandemic has forced physicians from different specialties to assist cases overload. Our aim is to assess gastroenterologist's assistance in COVID-19 by assessing mortality, ICU admission, and length of stay, and seek for risk factors for in-hospital mortality and longer hospital stay. METHODS: A total of 41 COVID-19 patients assisted by gastroenterologist (GI cohort) and 137 assisted by pulmonologist, internal medicine practitioners, and infectious disease specialists (COVID expert cohort) during October-November 2020 were prospectively collected. Clinical, demographic, imaging, and laboratory markers were collected and compared between both cohorts. Bivariate analysis and logistic regression were performed to search for risk factors of mortality and longer hospital stays. RESULTS: A total of 27 patients died (15.1%), 11 were admitted to ICU (6.1%). There were no differences between cohorts in mortality (14.6% vs 15.4%;p = 0.90), ICU admission (12.1% vs 4%;p = 0.13), and length of stay (6.67 ± 4 vs 7.15 ± 4.5 days; p = 0.58). PaO2/FiO2 on admission (OR 0.991;CI95% 0.984-0.998) and age > 70 (OR 17.54;CI95% 3.93-78.22) were independently related to mortality. Age > 70, history of malignancy, diabetes, and cardiovascular disease were related to longer hospital stays (p < 0.001, p = 0.03, p = 0.04, p = 0.02 respectively). CONCLUSIONS: COVID-19 assistance was similar between gastroenterologist and COVID experts when assessing mortality, ICU admission, and length of stay. Age>70 and decreased PaO2/FiO2 on admission were independent risk factors of mortality. Age and several comorbidities were related to longer hospital stay.


Assuntos
COVID-19 , Prova Pericial , Gastroenterologistas/estatística & dados numéricos , Tempo de Internação/estatística & dados numéricos , Fatores Etários , Idoso , COVID-19/diagnóstico , COVID-19/mortalidade , COVID-19/fisiopatologia , Comorbidade , Prova Pericial/métodos , Prova Pericial/estatística & dados numéricos , Feminino , Mortalidade Hospitalar , Hospitalização/estatística & dados numéricos , Humanos , Comunicação Interdisciplinar , Masculino , Prognóstico , Medição de Risco/métodos , Medição de Risco/estatística & dados numéricos , Fatores de Risco , SARS-CoV-2/isolamento & purificação , Espanha/epidemiologia
14.
Intern Emerg Med ; 16(5): 1113-1119, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34191218

RESUMO

The amazing effort of vaccination against COVID-19, with more than 2 billion vaccine doses administered all around the world as of 16 June 2021, has changed the history of this pandemic, drastically reducing the number of severe cases or deaths in countries were mass vaccination campaign have been carried out. However, the people's rising enthusiasm has been blunted in late February 2021 by the report of several cases of unusual thrombotic events in combination with thrombocytopenia after vaccination with ChAdOx1 nCov-19 (Vaxzevria), and a few months later also after Ad26.COV2. S vaccines. Of note, both products used an Adenovirus-based (AdV) platform to deliver the mRNA molecule - coding for the spike protein of SARS-CoV-2. A clinical entity characterized by cerebral and/or splanchnic vein thrombosis, often associated with multiple thromboses, with thrombocytopenia and bleeding, and sometimes disseminated intravascular coagulation (DIC), was soon recognized as a new syndrome, named vaccine-induced immune thrombotic thrombocytopenia (VITT) or thrombosis with thrombocytopenia syndrome (TTS). VITT was mainly observed in females under 55 years of age, between 4 and 16 days after receiving only Adenovirus-based vaccine and displayed a seriously high fatality rate. This prompted the Medicine Regulatory Agencies of various countries to enforce the pharmacovigilance programs, and to provide some advices to restrict the use of AdV-based vaccines to some age groups. This point-of view is aimed at providing a comprehensive review of epidemiological issues, pathogenetic hypothesis and treatment strategies of this rare but compelling syndrome, thus helping physicians to offer an up-to dated and evidence-based counseling to their often alarmed patients.


Assuntos
Vacinas contra COVID-19/efeitos adversos , Trombocitopenia/etiologia , Vacinação/estatística & dados numéricos , Biomarcadores/análise , Vacinas contra COVID-19/farmacocinética , Vacinas contra COVID-19/uso terapêutico , Correlação de Dados , Prova Pericial , Humanos , Trombocitopenia/fisiopatologia , Vacinação/efeitos adversos , Vacinação/métodos
16.
Adv Ther ; 38(7): 3589-3621, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-34086265

RESUMO

The prescribing and use of opioid analgesics is increasing in Italy owing to a profusion in the number and types of opioid analgesic products available, and the increasing prevalence of conditions associated with severe pain, the latter being related to population aging. Herein we provide the expert opinion of an Italian multidisciplinary panel on the management of opioid-induced constipation (OIC) and bowel dysfunction. OIC and opioid-induced bowel dysfunction are well-recognised unwanted effects of treatment with opioid analgesics that can profoundly affect quality of life. OIC can be due to additional factors such as reduced mobility, a low-fibre diet, comorbidities, and concomitant medications. Fixed-dose combinations of opioids with mu (µ) opioid receptor antagonists, such as oxycodone/naloxone, have become available, but have limited utility in clinical practice because the individual components cannot be independently titrated, creating a risk of breakthrough pain as the dose is increased. A comprehensive prevention and management strategy for OIC should include interventions that aim to improve fibre and fluid intake, increase mobility or exercise, and restore bowel function without compromising pain control. Recommended first-line pharmacological treatment of OIC is with an osmotic laxative (preferably polyethylene glycol [macrogol]), or a stimulant laxative such as an anthraquinone. A second laxative with a complementary mechanism of action should be added in the event of an inadequate response. Second-line treatment with a peripherally acting µ opioid receptor antagonist (PAMORA), such as methylnaltrexone, naloxegol or naldemedine, should be considered in patients with OIC that has not responded to combination laxative treatment. Prokinetics or intestinal secretagogues, such as lubiprostone, may be appropriate in the third-line setting, but their use in OIC is off-label in Italy, and should therefore be restricted to settings such as specialist centres and clinical trials.


Assuntos
Analgésicos Opioides , Constipação Induzida por Opioides , Analgésicos Opioides/efeitos adversos , Constipação Intestinal/induzido quimicamente , Constipação Intestinal/tratamento farmacológico , Prova Pericial , Humanos , Itália/epidemiologia , Antagonistas de Entorpecentes/uso terapêutico , Qualidade de Vida , Receptores Opioides mu
17.
Anesth Analg ; 133(1): 274-283, 2021 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-34127591

RESUMO

The perioperative care of adult patients undergoing free tissue transfer during head and neck surgical (microvascular) reconstruction is inconsistent across practitioners and institutions. The executive board of the Society for Head and Neck Anesthesia (SHANA) nominated specialized anesthesiologists and head and neck surgeons to an expert group, to develop expert consensus statements. The group conducted an extensive review of the literature to identify evidence and gaps and to prioritize quality improvement opportunities. This report of expert consensus statements aims to improve and standardize perioperative care in this setting. The Modified Delphi method was used to evaluate the degree of agreement with draft consensus statements. Additional discussion and collaboration was performed via video conference and electronic communication to refine expert opinions and to achieve consensus on key statements. Thirty-one statements were initially formulated, 14 statements met criteria for consensus, 9 were near consensus, and 8 did not reach criteria for consensus. The expert statements reaching consensus described considerations for preoperative assessment and optimization, airway management, perioperative monitoring, fluid management, blood management, tracheal extubation, and postoperative care. This group also examined the role for vasopressors, communication, and other quality improvement efforts. This report provides the priorities and perspectives of a group of clinical experts to help guide perioperative care and provides actionable guidance for and opportunities for improvement in the care of patients undergoing free tissue transfer for head and neck reconstruction. The lack of consensus for some areas likely reflects differing clinical experiences and a limited available evidence base.


Assuntos
Anestesia/normas , Anestesiologistas/normas , Consenso , Assistência Perioperatória/normas , Procedimentos Cirúrgicos Reconstrutivos/normas , Sociedades Médicas/normas , Anestesia/métodos , Prova Pericial , Cabeça/cirurgia , Humanos , Pescoço/cirurgia , Assistência Perioperatória/métodos , Procedimentos Cirúrgicos Reconstrutivos/métodos
18.
Paediatr Drugs ; 23(4): 381-394, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34173206

RESUMO

Regulatory changes have been enacted in the United States (US) and European Union (EU) to encourage the development of new treatments for pediatric cancer. Here, we review some of the factors that have hampered the development of pediatric cancer treatments and provide a comparison of the US and EU regulations implemented to address this clinical need. We then provide some recommendations for each stage of the oncology drug development pathway to help researchers maximize their chance of successful drug development while complying with regulations. A key recommendation is the engagement of key stakeholders such as regulatory authorities, pediatric oncologists, academic researchers, patient advocacy groups, and a Pediatric Expert Group early in the drug development process. During drug target selection, sponsors are encouraged to consult the Food and Drug Administration (FDA), European Medicines Agency (EMA), and the FDA target list, in addition to relevant US and European consortia that have been established to characterize and prioritize oncology drug targets. Sponsors also need to carefully consider the resourcing requirements for preclinical testing, which include ensuring appropriate access to the most relevant databases, clinical samples, and preclinical models (cell lines and animal models). During clinical development, sponsors can account for the pharmacodynamic (PD)/pharmacokinetic (PK) considerations specific to a pediatric population by developing pediatric formulations, selecting suitable PD endpoints, and employing sparse PK sampling or modeling/simulation of drug exposures where appropriate. Additional clinical considerations include the specific design of the clinical trial, the potential inclusion of children in adult trials, and the value of cooperative group trials.


Assuntos
Antineoplásicos/uso terapêutico , Desenvolvimento de Medicamentos/legislação & jurisprudência , Prova Pericial/legislação & jurisprudência , Oncologia/legislação & jurisprudência , Neoplasias/tratamento farmacológico , Antineoplásicos/síntese química , Criança , Ensaios Clínicos como Assunto/legislação & jurisprudência , Ensaios Clínicos como Assunto/métodos , Sistemas de Liberação de Medicamentos/métodos , Desenvolvimento de Medicamentos/métodos , União Europeia , Prova Pericial/métodos , Humanos , Oncologia/métodos , Neoplasias/epidemiologia , Estados Unidos , United States Food and Drug Administration/legislação & jurisprudência
19.
Kardiol Pol ; 79(5): 595-603, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34125943

RESUMO

The coronavirus disease 2019 (COVID-19) pandemic resulted in an urgent need to reorganize the work of echocardiography laboratories in order to ensure the safety of patients and the protection of physicians, technicians, and other staff members. In the previous Expert Opinion of the Working Group on Echocardiography of Polish Cardiac Society we provided recommendations for the echocardiographic services, in order to ensure maximum possible safety and efficiency of imagers facing epidemic threat. Now, with much better knowledge and larger experience in treating COVID-19 patients and with introduction of vaccination programs, we present updated recommendations for performing transthoracic and transesophageal examinations, including information on the potential impact of personnel and the patient vaccination program, and growing numbers of convalescents on performance of echocardiographic laboratories, with the goal of their ultimate reopening.


Assuntos
COVID-19 , Pandemias , Ecocardiografia , Prova Pericial , Humanos , Polônia , SARS-CoV-2 , Vacinação
20.
Kardiologiia ; 61(5): 71-78, 2021 May 31.
Artigo em Russo, Inglês | MEDLINE | ID: mdl-34112078

RESUMO

Senile asthenia syndrome (SAS) is a geriatric syndrome characterized by age-associated decline of the physiological reserve and function in multiple systems, which results in higher vulnerability to effects of endo- and exogenous factors and a high risk of unfavorable outcomes, loss of self-sufficiency, and death. Generally, SAS is observed in elderly patients with comorbidities. In cardiovascular diseases, SAS is associated with a poor prognosis, including a higher incidence of exacerbation and death both during acute events and in chronic disease. However, SAS is often not taken into account in developing diagnostic and therapeutic programs for managing elderly patients with cardiovascular diseases (CVD). This article analyzes available scientific information about SAS, algorithms for SAS diagnosis, and the scales that may be useful in developing individual plans for management of elderly patients with CVD.


Assuntos
Doenças Cardiovasculares , Geriatras , Idoso , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Prova Pericial , Avaliação Geriátrica , Humanos , Federação Russa/epidemiologia
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