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2.
Acta Anaesthesiol Scand ; 61(1): 23-30, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27808401

RESUMO

INTRODUCTION: supraglottic airway devices remain, despite advances in video laryngoscopy, important tools in the management of unexpected difficult airways. Intubation through a functioning supraglottic airway device with the aid of a fiberoptic bronchoscope is a well-known technique usually performed in apnoea. With a simple modification, the patient can be ventilated during this procedure. METHODS: In this observational study, Tracheal intubation Assisted by Bronchoscopy And Sad during Continuous Oxygenation (TABASCO) was performed as part of department training routine in 26 elective, fasted patients. A supraglottic airway device was used as a conduit for an endotracheal tube. RESULTS: All patients were easily intubated and ventilation was maintained during the procedure. The gap between the outer diameter of the fiberoptic bronchoscope and the inner diameter of the endotracheal tube was more than 2 mm in 25 of 26 patients. Effective ventilation was confirmed by clinical signs, capnography and pressure-volume curves. No signs of airtrapping occurred. DISCUSSION: No adverse events were observed during this form of airway management in this small series of elective and fasted patient when performed by an anaesthesiologist experienced in fiberoptic intubation. A gap between fiberoptic bronchoscope and endotracheal tube inner lumen seems to be prerequisite for easy ventilation through the supraglottic airway. In trained hands, this technique can be a means to secure an airway with an intubating bronchoscope without pausing ventilations. A prerequisite for this is a well-functioning supraglottic airway device.


Assuntos
Broncoscopia , Tecnologia de Fibra Óptica , Intubação Intratraqueal/instrumentação , Respiração Artificial , Adolescente , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Gravidez , Estudos Prospectivos
4.
Clin Pharmacol Ther ; 97(3): 234-46, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25669457

RESUMO

The concept of adaptive licensing (AL) has met with considerable interest. Yet some remain skeptical about its feasibility. Others argue that the focus and name of AL should be broadened. Against this background of ongoing debate, we examine the environmental changes that will likely make adaptive pathways the preferred approach in the future. The key drivers include: growing patient demand for timely access to promising therapies, emerging science leading to fragmentation of treatment populations, rising payer influence on product accessibility, and pressure on pharma/investors to ensure sustainability of drug development. We also discuss a number of environmental changes that will enable an adaptive paradigm. A life-span approach to bringing innovation to patients is expected to help address the perceived access vs. evidence trade-off, help de-risk drug development, and lead to better outcomes for patients.


Assuntos
Aprovação de Drogas/legislação & jurisprudência , Aprovação de Drogas/métodos , Descoberta de Drogas/legislação & jurisprudência , Licenciamento , Humanos
5.
Clin Pharmacol Ther ; 96(5): 559-71, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25006877

RESUMO

There is broad agreement among health-care stakeholders that more must be done to ensure that patients have timely access to new and innovative medicines. Assuming that industry will continue to develop such medicines at a sustainable rate, regulators and payers become the gatekeepers. Regulators, starting in the late 1980s/early 1990s, and, more recently, payers have implemented a variety of early-access pathways or initiatives, and this practice is continuing even today. This article describes the specific approaches that have been taken in four economically developed regions, reviews their success rates, and suggests possible new directions.


Assuntos
Acessibilidade aos Serviços de Saúde , Necessidades e Demandas de Serviços de Saúde , Preparações Farmacêuticas/provisão & distribuição , Tecnologia Biomédica , Canadá , Humanos , Mecanismo de Reembolso , Singapura , Estados Unidos , United States Food and Drug Administration
6.
Public Health Genomics ; 14(1): 43-52, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-20926845

RESUMO

The European Union has named genomics as one of the promising research fields for the development of new health technologies. Major concerns with regard to these fields are, on the one hand, the rather slow and limited translation of new knowledge and, on the other hand, missing insights into the impact on public health and health care practice of those technologies that are actually introduced. This paper aims to give an overview of the major assessment instruments in public health [health technology assessment (HTA), health needs assessment (HNA) and health impact assessment (HIA)] which could contribute to the systematic translation and assessment of genomic health applications by focussing at population level and on public health policy making. It is shown to what extent HTA, HNA and HIA contribute to translational research by using the continuum of translational research (T1-T4) in genomic medicine as an analytic framework. The selected assessment methodologies predominantly cover 2 to 4 phases within the T1-T4 system. HTA delivers the most complete set of methodologies when assessing health applications. HNA can be used to prioritize areas where genomic health applications are needed or to identify infrastructural needs. HIA delivers information on the impact of technologies in a wider scope and promotes informed decision making. HTA, HNA and HIA provide a partly overlapping and partly unique set of methodologies and infrastructure for the translation and assessment of genomic health applications. They are broad in scope and go beyond the continuum of T1-T4 translational research regarding policy translation.


Assuntos
Tecnologia Biomédica , Genômica , Necessidades e Demandas de Serviços de Saúde , Avaliação das Necessidades/organização & administração , Saúde Pública , Avaliação da Tecnologia Biomédica , Medicina Baseada em Evidências , Humanos
8.
Allergy ; 60(3): 338-42, 2005 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-15679719

RESUMO

BACKGROUND: Preliminary evidence suggests that inadequately controlled allergic rhinitis in asthmatic patients can contribute towards increased asthma exacerbations and poorer symptom control, which may increase medical resource use. The objective of this study was therefore to assess the effect of concomitant allergic rhinitis on asthma-related hospital resource utilization among children below 15 years of age with asthma in Norway. METHODS: A population-based retrospective cohort study of children (aged 0-14 years) with asthma was conducted using data from a patient-specific public national database of hospital admissions during a 2-year period, 1998-1999. Multivariate linear regression, adjusting for risk factors including age, gender, year of admission, urban/rural residence and severity of asthma episode, estimated the association between allergic rhinitis and total hospital days. A multivariate Cox proportional-hazards model estimated relative hazard of readmission according to concomitant allergic rhinitis status. RESULTS: Among 2961 asthmatic children under 15 years of age with at least one asthma-related hospital admission over a 2-year period, 795 (26.8%) had a recorded history of allergic rhinitis. Asthmatic children with allergic rhinitis had a 1.72-times greater hazard of asthma-related readmissions than asthmatic children without allergic rhinitis. Multivariate analysis revealed that history of concomitant allergic rhinitis was a significant predictor of increased number of hospital days per year (least-squares mean difference 0.23 days, P < 0.05). CONCLUSIONS: Concomitant allergic rhinitis in asthmatic children was associated with increased likelihood of asthma-related hospital readmissions and greater total hospital days.


Assuntos
Asma/complicações , Asma/terapia , Hospitalização/estatística & dados numéricos , Hipersensibilidade/complicações , Rinite/etiologia , Adolescente , Criança , Pré-Escolar , Estudos de Coortes , Feminino , Humanos , Lactente , Recém-Nascido , Análise dos Mínimos Quadrados , Masculino , Análise Multivariada , Noruega , Admissão do Paciente/estatística & dados numéricos , Prognóstico , Modelos de Riscos Proporcionais , Estudos Retrospectivos
9.
Eur J Health Econ ; 3(1): 54-8, 2002.
Artigo em Inglês | MEDLINE | ID: mdl-15609118

RESUMO

Health technology assessment (HTA) was introduced in Denmark 20 years ago. However, it only came into fashion a few years ago. This happened when politicians and health service decision-makers realized that due to the increasing pressure on resources prioritization was an inescapable fact. HTA was supposed to support this effort by providing a broad spectrum of information designed for decision-making. Events speeded up from that point on: a national HTA strategy, a national HTA institution, satellite institutions, and many HTA projects were set up - at national, regional, and local levels. The diversity and decentralization of decision-making combined with a broad and interdisciplinary approach to methodology guided the development of Danish HTA. Experiences with HTA were gained from successful applications and disappointing encounters with uncontrollable political processes. Politicians seem in general to be content with the development. An evaluation of the impact of HTA has not yet been undertaken, and a good deal of work lies ahead. The implementation of HTA results will be one of the greatest challenges of the years ahead.

11.
Vet Res Commun ; 26(8): 613-24, 2002 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-12507036

RESUMO

Compliance with the treatment protocol and the most significant reasons encountered in general practice for the discontinuation of treatment in hyposensitized dogs are examined. The data are based on (1) a review of order forms for the hyposenzitization mixture and information sheets for an ELISA test and (2) telephone interviews with dog owners. Most of the owners (81%) gave their dogs allergen injections at home. Non-compliance was defined as discontinuation of treatment in the induction period; 33.9% of the owners became non-compliant. A large proportion of non-compliant owners (51.2%) claimed to be unaware of the length of the induction period. Furthermore, 70.2% of the owners were not aware that treatment would most likely need to be lifelong if it was to remain effective. Although 67.5% of the owners perceived that their dogs had beneficial effects from hyposensitization, only 36.3% of the dogs were receiving maintenance injections at the time of the telephone interview, considerably reducing the long-term benefit from treatment. Canine atopy is a chronic disease characterized by remission and relapses. Since no control group was available in this study, the beneficial outcome of treatment reported by the owners could be partly due to the natural course of the disease. Nevertheless, the results indicated that the long-term effect of hyposensitization in canine atopy will be reduced by premature discontinuation of treatment in the maintenance period. The discontinuation of treatment could be a reflection of the treatment becoming less effective, owing to the development of new hypersensitivities or to a reduction in the placebo effect that may occur in 'new' treatments. However, poor client education and follow-up seem to be important reasons for both noncompliance and discontinuation of the treatment in the maintenance period.


Assuntos
Dermatite Atópica/veterinária , Dessensibilização Imunológica/veterinária , Doenças do Cão/imunologia , Alérgenos/análise , Animais , Dermatite Atópica/sangue , Dermatite Atópica/imunologia , Dermatite Atópica/prevenção & controle , Dessensibilização Imunológica/métodos , Cães , Ensaio de Imunoadsorção Enzimática , Feminino , Imunoglobulina E/sangue , Masculino , Estudos Retrospectivos , Testes Cutâneos/veterinária , Inquéritos e Questionários , Recusa do Paciente ao Tratamento
15.
Artigo em Alemão | MEDLINE | ID: mdl-27138147

RESUMO

Health technology assessment (HTA) has been established in Denmark 20 years ago. However, it only came into fashion a few years ago. This happened when politicians and health service decision-makers realised that due to the increasing limitation of resources prioritization was an inescapable fact. HTA was supposed to support this effort by providing a broad spectrum of information designed for decision-making. Events speeded up from that point on: a national HTA strategy, a national HTA institution, satellite institutions and many HTA-projects were set up · at national, regional and local levels. The diversity and decentralisation of decision-making combined with a broad and interdisciplinary approach to methodology guided the development of danish HTA. Experiences with HTA were gained from successful applications and disappointing encounters with uncontrollable political processes. Politicians seem, in general, to be satisfied with the achievements. An evaluation of the impact of HTA has not yet been undertaken and a good deal of work lies ahead. The implementation of HTA-results will be one of the greatest challenges of the years ahead.

16.
Int J Technol Assess Health Care ; 16(2): 347-81, 2000.
Artigo em Inglês | MEDLINE | ID: mdl-10932413

RESUMO

The Danish healthcare services are mainly provided by public sector institutions. The system is highly decentralized. The state has little direct influence on the provision of healthcare services. State influence is exercised through legislation and budget allocations. The main task of the state is to initiate, coordinate, and advise. Counties, which run the hospitals, also decide on the placement of services. The hospital sector is controlled within the framework of legislation and global budgets. General practitioners occupy a central position in the Danish healthcare sector, acting as gatekeepers to the rest of the system. The system works well, and its structure has resulted in steady costs of health care for a long period. There is no regulatory mechanism in the Danish health services requiring use of health technology assessment (HTA) as a basis for policy decisions, planning, or administrative procedures. However, since the late 1970s a number of comprehensive assessments of health technology have formed the basis for national health policy decisions. In 1997, after years of public criticism of the quality of hospital care and health technologies, and on the basis of a previously developed national HTA strategy, a national institute for HTA (DIHTA) was established. There seems to be a growing awareness of evidence-based healthcare among health professionals and a general acceptance of health economic analyses as a basis for health policy decision making. This progress is coupled with growing regional HTA activity in the health services. HTA seems to have a bright future in Denmark.


Assuntos
Atenção à Saúde/organização & administração , Avaliação da Tecnologia Biomédica/organização & administração , Adolescente , Adulto , Idoso , Atenção à Saúde/economia , Atenção à Saúde/legislação & jurisprudência , Dinamarca , Feminino , Pessoal de Saúde , Política de Saúde , Humanos , Recém-Nascido , Pessoa de Meia-Idade , Programas Nacionais de Saúde/organização & administração , Gravidez , Avaliação da Tecnologia Biomédica/legislação & jurisprudência
17.
Int J Technol Assess Health Care ; 16(4): 1201-9, 2000.
Artigo em Inglês | MEDLINE | ID: mdl-11155839

RESUMO

OBJECTIVE: The purpose of this study is to analyze the perception of the content of health technology assessment (HTA) among health professionals applying for a state grant of DKK 10 million. METHODS: A total of 113 applications were received and analyzed. When conducting the analysis, it was assumed that the applicants' maximum five-page project description would reflect: a) the applicants' perception of what an HTA is; b) how the assessment was to be conducted; and c) what the results were going to be used for. RESULTS: More than 40% of all applications focused on treatment; in 51% only one or two professional groups were to be involved (thus interdisciplinarity was questionable); only 22% of the HTA cases were intended to form the basis for political/administrative decisions; in general, the HTAs were planned far less comprehensively than was relevant; 76% of the projects did not include a formal synthesis phase; 41% intended to use diffusion as the only method for publication of the HTA result. CONCLUSIONS: The analysis reveals several areas where DIHTA has to make an effort in order to secure that HTA in fact constitutes a comprehensive and well-documented basis for decision making. These areas concern the following topics: multidisciplinarity, the objective of HTA, comprehensiveness, the synthesis phase, and publication and utilization of the HTA result.


Assuntos
Objetivos Organizacionais , Projetos de Pesquisa , Apoio à Pesquisa como Assunto , Avaliação da Tecnologia Biomédica , Dinamarca , Humanos
19.
Domest Anim Endocrinol ; 15(6): 525-36, 1998 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-9861543

RESUMO

An enzyme-linked immunosorbent assay to detect thyroglobulin autoantibodies (TGAB) in canine serum was developed and validated. The test result for each sample was derived from the optical density readings (OD) and expressed as an Ab-score(%) calculated from three in-house calibrators. The assay specifically detected TGAB as judged from lack of response in the assay after samples had been incubated with specific antigen. Intra- and interassay coefficients of variation ranged from 2.0-4.9% and 4.6-9.9%, respectively. The detection limit, an Ab-score of 5.6%, was close to the median Ab-score of 10% observed in healthy dogs (n = 132). The median Ab-score of dogs with primary hypothyroidism and lymphocytic thyroiditis (n = 11), skin diseases (n = 35), and non-thyroidal diseases (n = 63) was 340%, 12%, and 8%, respectively. The prevalence of TGAB in hypothyroid dogs with lymphocytic thyroiditis (sensitivity) was 91% (95% confidence limits: 59%-99%). In dogs with dermatological diseases without lymphocytic thyroiditis the prevalence of TGAB was 3% corresponding to a specificity of 97% (95% confidence limit: 85%-100%). In dogs with non-thyroidal diseases and healthy dogs the prevalence of TGAB was 5% and 6%, respectively. The diagnostic accuracy of serum TGAB was evaluated by subjecting the data from 11 dogs with lymphocytic thyroiditis and 35 control dogs without lymphocytic thyroiditis to receiver-operating characteristic curve analysis. The area under the receiver-operating characteristic curve (W = 0.966; 95% confidence limit 87%-100%) was significantly higher than that of a worthless test (0.5) (P < 0.0001), thereby indicating that serum TGAB measurements distinguished between dogs with and without lymphocytic thyroiditis.


Assuntos
Autoanticorpos/sangue , Cães/imunologia , Ensaio de Imunoadsorção Enzimática/métodos , Tireoglobulina/imunologia , Animais , Doenças do Cão/imunologia , Hipotireoidismo/imunologia , Hipotireoidismo/veterinária , Curva ROC , Sensibilidade e Especificidade , Dermatopatias/imunologia , Dermatopatias/veterinária , Tireoidite Autoimune/imunologia , Tireoidite Autoimune/veterinária
20.
Vet Rec ; 143(1): 16-20, 1998 Jul 04.
Artigo em Inglês | MEDLINE | ID: mdl-9698628

RESUMO

The protein fractions in urine from proteinuric dogs with and without pyoderma were estimated. Fifteen dogs with pyoderma (five with superficial and 10 with deep pyoderma) were compared with 10 dogs with glomerulopathy and 27 dogs with diseases other than pyoderma or urinary tract problems. Agarose gel electrophoresis was used to fractionate the proteins. Three types of electrophoretogram were obtained with albuminuria, globulinuria and serum-like profiles. An albuminuria profile was found in eight of the 27 dogs with other diseases, in three of the five dogs with superficial pyoderma, in eight of the 10 dogs with deep pyoderma and in all 10 dogs with glomerulopathy. The albuminuria profile (mean [sem] albumin/globulin ratio 1.98 [0.10]) was also characterised by alpha 1b, alpha 2a and beta 2 globulin peaks in all 29 dogs with this profile, which was therefore thought to indicate that albuminuria (glomerular proteinuria) was a result of glomerular damage and inflammation because alpha 1b, alpha 2a, and beta 2 globulins are considered to be acute phase proteins. The serum-like profile (mean [sem] albumin/globulin ratio 0.72 [0.01]) was observed in 13 per cent of the proteinuric dogs examined and contained all the protein fractions normally detected by electrophoresis of serum. The profile was considered to be a variant from of the albuminuria profile, probably indicating advanced glomerular lesions and inflammation. The globulinuria profile (mean [sem] albumin/globulin ratio 0.33 [0.08]) was significantly different from the other two in that it was characterised by a low albumin peak and the presence of globulin fractions not clearly distinguishable from each other because of their confluency and absence of individual peaks. This profile could indicate severe glomerulotubular lesions and degradation of certain protein fractions. It could also be a result of increased secretion of tissue and other proteins by damaged tubules. It was concluded that glomerular damage leads to glomerular proteinuria characterised by high proportions of albumin together with alpha 1b, alpha 2a and beta 2 globulins in lower but significantly diagnostic proportions.


Assuntos
Doenças do Cão/patologia , Proteinúria/veterinária , Pioderma/veterinária , Albuminúria/veterinária , Animais , Cães , Globulinas/urina , Proteinúria/classificação , Proteinúria/etiologia , Pioderma/patologia
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