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1.
BMJ Open ; 8(11): e024006, 2018 11 18.
Artigo em Inglês | MEDLINE | ID: mdl-30455390

RESUMO

OBJECTIVES: To assess the quality of sleep of employees in the German offshore wind industry and to explore factors associated with poor sleep quality. DESIGN: Web-based cross-sectional survey. SETTING: Offshore companies operating in wind farms within the German exclusive economic zone. PARTICIPANTS: Workers with regular offshore commitments and at least 28 days spent offshore in the past year (n=268). OUTCOME MEASURES: Sleep quality in the past 4 weeks, troubles falling asleep or sleeping through in the past 4 weeks, differences in sleep quality between offshore deployments and onshore leaves. RESULTS: Having problems with sleep onset was reported by 9.5% of the respondents. 16.5% reported troubles with maintaining sleep three or more times per week. The overall quality of sleep was rated as very bad by only 1.7% of the participants. 47.9% of the workers reported their quality of sleep to be worse during offshore commitments than when being onshore. Higher levels of exposition to noise, vibrations and poor air quality were associated with sleeping troubles and poorer sleep quality. Sharing the sleep cabin with colleagues was associated with troubles sleeping through. No association was found for working in rotating shifts and for regularity of the offshore commitments. CONCLUSIONS: Workers in our study showed frequent sleep problems and poorer sleep quality offshore than onshore. Our results indicate that higher degrees of exposure to noise, vibrations and artificial ventilation are associated with poor sleep quality rather than organisational factors such as shift-work and type of working schedule. In view of the high demands of the offshore workplace and the workers' particular recovery needs, addressing sleep disorders should be part of any health and safety management strategy for this workplace.


Assuntos
Poluição do Ar em Ambientes Fechados , Indústrias , Ruído Ocupacional , Distúrbios do Início e da Manutenção do Sono/epidemiologia , Sono , Ventilação , Vibração , Vento , Adulto , Estudos Transversais , Alemanha/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Ruído , Mar do Norte , Saúde Ocupacional , Energia Renovável , Inquéritos e Questionários , Adulto Jovem
2.
BMJ Open ; 8(8): e020493, 2018 08 05.
Artigo em Inglês | MEDLINE | ID: mdl-30082344

RESUMO

OBJECTIVES: To investigate the awareness and use of health promotion offers among offshore wind workers and to study associations with demographic and workplace characteristics. To examine employees' reasons for (non-)participation and their wishes for health promotion activities offshore. DESIGN: Mixed-methods study presenting the results from semistructured telephone interviews and a web-based cross-sectional survey. SETTING: Offshore wind parks in the German exclusive economic zone in the North and Baltic Seas. PARTICIPANTS: 21 offshore workers in the qualitative study (19 male/2 female; all German). 303 offshore workers in the quantitative study (287 male/13 female; 275 German/24 other nationalities). OUTCOME MEASURES: Awareness and use of workplace health promotion offers and associations with demographic and workplace characteristics (age, work schedule and wind park phase); reasons for (non-)participation; needs and wishes for health promotion offers. RESULTS: Few workers indicated being aware of health promotion programmes at their workplace. Single offers were reported, with fitness facilities being the most common offer employees recognised and had used (n=168, 55.6%). Employees with a regular work schedule were more likely to have used fitness facilities offshore (adjusted OR (AOR)=3.22, 95% CI 1.53 to 6.80). Workers in the construction phase were more likely to have used massages (AOR=8.19, 95% CI 2.82 to 23.77). Younger workers were less likely to belong to the group of those who were aware of fitness facilities but had not used them (AOR=0.43, 95% CI 0.19 to 0.98). Employees expressed various needs and wishes for behavioural and environmental preventive measures offshore. CONCLUSIONS: The results demonstrate a perceived need among the workers for the development of health promotion programmes offshore. Since the awareness and use of offers may partly depend on personal and organisational characteristics, this should be taken into account in the planning of health promotion activities.


Assuntos
Promoção da Saúde , Saúde Ocupacional , Local de Trabalho , Adulto , Estudos Transversais , Feminino , Academias de Ginástica/estatística & dados numéricos , Alemanha , Humanos , Entrevistas como Assunto , Masculino , Massagem/estatística & dados numéricos , Energia Renovável , Inquéritos e Questionários , Vento , Adulto Jovem
3.
BMJ Open ; 8(3): e020157, 2018 03 30.
Artigo em Inglês | MEDLINE | ID: mdl-29602849

RESUMO

OBJECTIVES: To assess the physical strains of employees in the German offshore wind industry, according to job type and phase of the wind farm (under construction or operation). DESIGN: Web-based cross-sectional survey. SETTING: Offshore wind farm companies operating within the German exclusive economic zone. PARTICIPANTS: Male workers with regular offshore commitments and at least 28 days spent offshore in the past year (n=268). OUTCOME MEASURES: Physical strains (eg, climbing, noise, working overhead, with twisted upper body or in confined spaces, vibration, heavy lifting, humidity, odours). RESULTS: The most frequently mentioned physical strain was 'climbing' with 63.8% of the respondents reporting to be always or frequently confronted with climbing and ascending stairs during offshore work. Work as a technician was associated with a greater exposition to noise, vibrations, humidity, cold, heat, chemical substances, lifting/carrying heavy loads, transport of equipment, working in non-ergonomic positions and in cramped spaces, as well as climbing.Indeed, statistical analyses showed that, after adjusting for phase of the wind farm, age, nationality, offshore experience, work schedule and type of shift, compared with non-technicians, working as a technician was associated with more frequently lifting/carrying of heavy loads (OR 2.58, 95% CI 1.58 to 4.23), transport of equipment (OR 2.06 95% CI 1.27 to 3.33), working with a twisted upper body (OR 2.85 95% CI 1.74 to 4.69), working overhead (OR 2.77 95% CI 1.67 to 4.58) and climbing (OR 2.30 95% CI 1.40 to 3.77). Working in wind farms under construction was strongly associated with increased and decreased exposure to humidity (OR 2.32 95% CI 1.38 to 3.92) and poor air quality (OR 0.58 95% CI 0.35 to 0.95), respectively. CONCLUSIONS: Workers on offshore wind farms constitute a heterogeneous group, including a wide variety of occupations. The degree of exposure to detrimental physical strains varies depending on the type of job. Technicians are more exposed to ergonomic challenges than other offshore workers.


Assuntos
Exposição Ocupacional , Saúde Ocupacional , Estresse Fisiológico , Vento , Estudos Transversais , Humanos , Masculino , Ruído , Inquéritos e Questionários
4.
BMC Fam Pract ; 17: 6, 2016 Jan 27.
Artigo em Inglês | MEDLINE | ID: mdl-26818052

RESUMO

BACKGROUND: Patient safety gained widespread public attention in the last 20 years. However, most patient safety research relied upon professionals' exceptions and was realised especially in the hospital sector. Gradually patients' attention has been focused on safety campaigns in inpatient care. We aimed to better assess patients' perceptions in primary and ambulatory care. METHODS: A systematic review was conducted by use of database searches with additional reference and hand searching. The search strategy implied MeSH-terms relating to adverse events, incident reporting and outpatient care. Relevant articles were selected by applying defined eligibility criteria. Studies exclusively based on hospital data as well as the professionals' point of view were excluded. RESULTS: We included 19 studies. Patients were able to identify events that were traditionally recognised by the medical community as technical medical aspects (e.g. errors in diagnosis). An important field of patient participation in prevention of adverse events was proposed in the medication process. Most reported events however could be described as service quality incidents. Communication problems were shown to have implications on the occurrence of technical medical aspects and patients' satisfaction of their care. Further, unsatisfied patients were more likely to recognize adverse events. CONCLUSION: Patients' perception of patient safety in primary and ambulatorycare broadened the previous focus on technical medical aspects. Especially communication factors played an important role in the occurrence and consequence of adverse events and patients' satisfaction. Future research should concentrate on developing possible ways to integrate patients' views and participation in ensuring safety in outpatient care.


Assuntos
Assistência Ambulatorial , Atitude Frente a Saúde , Comunicação , Erros Médicos , Segurança do Paciente , Satisfação do Paciente , Atenção Primária à Saúde , Humanos , Gestão de Riscos
5.
J Health Serv Res Policy ; 16 Suppl 2: 27-37, 2011 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-21737527

RESUMO

OBJECTIVE: Europe's health care decision-makers are facing an increasingly complex and rapidly changing landscape. It is crucial that health care problems are addressed with evidence-informed policy and that evidence finding is aimed at those topics most urgent on policy agendas. Research on health systems addresses the macro-level of health care delivery and aims at generating evidence for policy-making. Our aim was to assess the field of health systems research in Europe, primarily based on an analysis of the published literature. METHODS: Starting from current definitions of health systems, during 2004-09 we identified four thematic areas for research and defined keywords to construct a sensitive literature search limited to European research. RESULTS: The database search resulted in 26,945 hits between 2004-09. Until 2008, the annual number of publications on health systems research increased at an average rate of 5.2%. Most (88%) were in English. The largest producer of research on health systems has been the UK (nearly 10,000 in six years; 37% of the total for Europe), which is also the country most frequently the object of research. In contrast, seven countries had produced no publications. There were modest correlations between a country's research production and its gross domestic product (r = 0.62) but less so with its population size (0.33). The most frequent keywords were 'patients' (49% of all references), 'patient satisfaction' (27%), 'organization and administration' (23%), 'education' (19%) and 'attitude of health personnel' (13%). Closer inspection of a sub-sample of 1000 abstracts revealed that only 24% met our definition of 'health systems research' rather than other fields of health services research. CONCLUSION: There is a wide-spread need to develop health systems research capacity, in particular in eastern European countries, and to address the effects of health care reform, particularly the effects of privatization and commercialization of health services.


Assuntos
Atenção à Saúde/estatística & dados numéricos , Administração de Serviços de Saúde/estatística & dados numéricos , Pesquisa sobre Serviços de Saúde/estatística & dados numéricos , Europa (Continente) , Produto Interno Bruto , Reforma dos Serviços de Saúde , Política de Saúde , Humanos
6.
Scand J Prim Health Care ; 29(1): 28-38, 2011 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-21192758

RESUMO

OBJECTIVE: To assess the effects of physician-centred gatekeeping on health, health care utilization, and costs by conducting a systematic review of the literature. METHODS: Systematic search in PubMed (MEDLINE and Pre-MEDLINE), EMBASE, and the Cochrane Library, from the databases' respective inception dates up to January 2010, using the search words "gatekeeping", "gatekeeper*", "first contact", and "self-referral". We included RCTs, CCTs, cohort studies, CBAs, and interrupted time-series. We included only studies in which the gatekeeper function was exercised by a physician and that reported health and patient-related outcomes including quality of life and satisfaction, quality of care, health care utilization, and/or economic outcomes (e.g. expenditures or efficiency). Selection was made independently by two reviewers and discrepancies were solved by consensus after discussion. Data on target population, intervention, additional interventions, study results, and methodological quality were extracted. Methodological quality was assessed independently by two reviewers following the previously defined criteria. Discrepancies were solved by consensus after discussion. RESULTS: This review includes 26 studies in 32 publications. The majority of studies (62%) reported data from the United States and in most gatekeeping was associated with lower utilization of health services (up to -78%) and lower expenditures (up to -80%). However, there was great variability in the magnitude and direction of the differences. CONCLUSION: Overall, the evidence regarding the effects of gatekeeping is of limited quality. Many studies are available regarding the effects on health care utilisation and expenditures, whereas effects on health and patient-related outcomes have been studied only exceptionally and are inconclusive.


Assuntos
Controle de Acesso , Serviços de Saúde , Medicina Baseada em Evidências , Custos de Cuidados de Saúde , Gastos em Saúde , Serviços de Saúde/economia , Serviços de Saúde/normas , Serviços de Saúde/estatística & dados numéricos , Humanos , Avaliação de Processos e Resultados em Cuidados de Saúde , Autorreferência Médica , Atenção Primária à Saúde/economia , Atenção Primária à Saúde/normas , Atenção Primária à Saúde/estatística & dados numéricos , Qualidade da Assistência à Saúde
7.
Health Policy ; 94(3): 196-202, 2010 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-19889471

RESUMO

This article discusses the development of Heath Technology Assessment methods and HTA institutions, in regards to meeting the information needs of all levels and fields of health policy-making. On the one hand, HTA needs to expand and develop its methods. Although health products and health care services have been its preponderant focus to date, HTA should develop to increase its focus on the "technologies applied to health care" (i.e. the regulatory and policy measures for managing and organizing health care systems) and on policies in non-health care sectors. Such a knowledge synthesis for health policy should not necessarily be called HTA or conducted by narrowly defined HTA agencies. However, the trends observed in several European HTA agencies indicate the recognition of these development needs. Countries embarking on HTA should not consider establishing separate agencies for HTA, quality development, performance measurement, and health services development, but should rather combine these functions and goals into a common knowledge strategy for evidence-informed decision-making on health care and the health system.


Assuntos
Necessidades e Demandas de Serviços de Saúde , Avaliação da Tecnologia Biomédica , Necessidades e Demandas de Serviços de Saúde/organização & administração , Modelos Organizacionais , Avaliação das Necessidades/organização & administração , Formulação de Políticas , Avaliação da Tecnologia Biomédica/métodos , Avaliação da Tecnologia Biomédica/organização & administração
8.
Копенгаген; Всемирная организация здравоохранения. Европейское региональное бюро; 2010.
Monografia em Russo | WHO IRIS | ID: who-276988

RESUMO

Постоянно предлагаются все новые технологические достижения, потенциально способствующие улучшению здоровья людей. Однако не все из них автоматически приводят к желаемому результату. Процедуры оценки технологий здравоохранения обеспечивают получение фактической информации о масштабах и характере использования конкретных вмешательств и методик, что позволяет оптимальным образом осуществить отбор наиболее эффективных, принимая в то же время во внимание весь комплекс сопутствующих организационных, социальных и этических факторов. В настоящей публикации проанализированы взаимоотношения между проводимой оценкой технологий здравоохранения и формированием политики и исследуется вопрос о том, как использовать результаты таких оценок для оптимизации процессов развития политики и принятия стратегических решений. Популяризируя как среди руководителей и организаторов здравоохранения, так и в более широкой аудитории, идеи ценности и потенциала методов оценки технологий здравоохранения, книга в конечном счете направлена на улучшение показателей здоровья населения за счет предоставления оптимальных медико-санитарных услуг.


Assuntos
Avaliação da Tecnologia Biomédica , Avaliação de Processos e Resultados em Cuidados de Saúde , Formulação de Políticas , Política de Saúde , Atenção à Saúde , Europa (Continente)
9.
Int J Technol Assess Health Care ; 25(3): 315-22, 2009 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-19619350

RESUMO

OBJECTIVES: Our aim was to review the recommendations given by health technology assessment (HTA) institutions in their methodological guidelines concerning the use of surrogate outcomes in their assessments. In a second step, we aimed at quantifying the role surrogate parameters take in assessment reports. METHODS: We analyzed methodological papers and guidelines from HTA agencies with International Network of Agencies for Health Technology Assessment membership as well as from institutions related to pharmaceutical regulation (i.e., reimbursement, pricing). We analyzed the use of surrogate outcomes in a sample of HTA reports randomly drawn from the HTA database. We checked methods, results (including evidence tables), and conclusions sections and extracted the outcomes reported. We report descriptive statistics on the presence of surrogate outcomes in the reports. RESULTS: We identified thirty-four methodological guidelines, twenty of them addressing the issue of outcome parameter choice and the problematic of surrogate outcomes. Overall HTA agencies call on caution regarding the reliance on surrogate outcomes. None of the agencies has provided a list or catalog of acceptable and validated surrogate outcomes. We extracted the outcome parameter of 140 HTA reports. Only around half of the reports determined the outcomes for the assessment prospectively. Surrogate outcomes had been used in 62 percent of the reports. However, only 3.6 percent were based upon surrogate outcomes exclusively. All of them assessed diagnostic or screening technologies and the surrogate outcomes were predominantly test characteristics. CONCLUSIONS: HTA institutions seem to agree on a cautious approach to the use of surrogate outcomes in technology assessment. Thorough assessment of health technologies should not rely exclusively on surrogate outcomes.


Assuntos
Biomarcadores , Avaliação da Tecnologia Biomédica , Guias como Assunto , Internacionalidade
10.
GMS Health Technol Assess ; 5: Doc12, 2009 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-21289899

RESUMO

The different actors involved in health system decision-making and regulation have to deal with the question which are valid parameters to assess the health value of health technologies.So called surrogate endpoints represent in the best case preliminary steps in the casual chain leading to the relevant outcome (e. g. mortality, morbidity) and are not usually directly perceptible by patients. Surrogate endpoints are not only used in trials of pharmaceuticals but also in studies of other technologies. Their use in the assessment of the benefit of a health technology is however problematic.IN THIS REPORT WE INTEND TO ANSWER THE FOLLOWING RESEARCH QUESTIONS: Which criteria need to be fulfilled for a surrogate parameter to be considered a valid endpoint? Which methods have been described in the literature for the assessment of the validity of surrogate endpoints? Which methodological recommendations concerning the use of surrogate endpoints have been made by international HTA agencies? Which place has been given to surrogate endpoints in international and German HTA reports?For this purpose, we choose three different approaches. Firstly, we conduct a review of the methodological literature dealing with the issue of surrogate endpoints and their validation. Secondly, we analyse current methodological guidelines of HTA agencies members of the International network of agencies for Health Technology Assessment (INAHTA) as well as of agencies concerned with assessments for reimbursement purposes. Finally, we analyse the outcome parameter used in a sample of HTA reports available for the public.The analysis of methodological guidelines shows a very cautious position of HTA institutions regarding the use of surrogate endpoints in technology assessment. Surrogate endpoints have not been prominently used in HTA reports. None of the analysed reports based its conclusions solely on the results of surrogate endpoints. The analysis of German HTA reports shows a similar pattern.The validation of a surrogate endpoint requires extensive research, including randomized controlled trials (RCT) assessing clinical relevant endpoints. The validity of a surrogate parameter is rather technology-specific than disease-specific. Thus - even in the case of apparently similar technologies - it is necessary to validate the surrogate for every single technology (i. e. for every single active agent).The use of surrogate endpoints in the assessment of the benefit of health technologies is still to be seen very critically.

11.
Bull World Health Organ ; 86(8): 617-23, 2008 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-18797620

RESUMO

Health technology assessment (HTA) is the multidisciplinary study of the implications of the development, diffusion and use of health technologies. It supports health-policy decisions by providing a joint knowledge base for decision-makers. To increase its policy relevance, HTA tries to extend beyond effectiveness and costs to also considering the social, organizational and ethical implications of technologies. However, a commonly accepted method for analysing the ethical aspects of health technologies is lacking. This paper describes a model for ethical analysis of health technology that is easy and flexible to use in different organizational settings and cultures. The model is part of the EUnetHTA project, which focuses on the transferability of HTAs between countries. The EUnetHTA ethics model is based on the insight that the whole HTA process is value laden. It is not sufficient to only analyse the ethical consequences of a technology, but also the ethical issues of the whole HTA process must be considered. Selection of assessment topics, methods and outcomes is essentially a value-laden decision. Health technologies may challenge moral or cultural values and beliefs, and their implementation may also have significant impact on people other than the patient. These are essential considerations for health policy. The ethics model is structured around key ethical questions rather than philosophical theories, to be applicable to different cultures and usable by non-philosophers. Integrating ethical considerations into HTA can improve the relevance of technology assessments for health care and health policy in both developed and developing countries.


Assuntos
Tomada de Decisões Gerenciais , Política de Saúde , Internacionalidade , Modelos Organizacionais , Avaliação da Tecnologia Biomédica/ética , Atitude Frente a Saúde , Análise Custo-Benefício , Cultura , Difusão de Inovações , Análise Ética , Humanos , Comunicação Interdisciplinar , Princípios Morais , Projetos Piloto , Avaliação de Programas e Projetos de Saúde , Responsabilidade Social , Valores Sociais/etnologia , Avaliação da Tecnologia Biomédica/organização & administração
12.
GMS Health Technol Assess ; 4: Doc09, 2008 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-21289915

RESUMO

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system which is accompanied by considerable disability and high costs. This report summarises the evidence on effectiveness and costs of beta-interferons and natalizumab in the treatment of multiple sclerosis.The review included systematic reviews and randomised controlled trials (with an observation time of at least one year) in patients with MS which assessed outcome parameters such as progression, exacerbations and adverse effects. An extensive literature search included databases such as MEDLINE, EMBASE, the Cochrane Library and various HTA-databases. Studies were selected according to predefined criteria, their quality was assessed according to criteria defined prospectively, and data were summarised systematically in tables. Cost-effectiveness evaluations were also included.Two systematic reviews and 24 randomised controlled trials of beta-interferon therapy were included, as well as three trials on the effectiveness of natalizumab. A total of 22 cost-effectiveness analyses for interferons were included, whereas no economic evaluations for natalizumab were identified.Use of interferon beta-1a or interferon beta-1b after a first demyelinating event led to a reduction of the conversion to definite MS during an observation time of two to three years. In relapsing remitting MS, interferon beta-1a reduced progression. The effects of interferon beta-1b on progression are unclear. Interferon beta-1a and interferon beta-1b reduced in some but not all studies outcomes relating to exacerbations. In direct comparison trials, interferon beta-1b (Betaferon(®) or Betaseron(®)) and interferon beta-1a (Rebif(®), higher dosage of 44 µg three subcutaneous injections per week) proved superior to interferon beta-1a (Avonex(®), 30 µg per week intramuscular) with respect to exacerbation outcomes. For secondary progressive MS, only one of five studies found a reduced progression with interferon beta-1a and only a part of the studies found an improvement with respect to outcomes relating to exacerbations. For primary progressive MS no advantage of therapy with beta-interferons was found with respect to patient-related outcomes. Beta-interferons showed characteristic and frequently occurring adverse effects, including reactions at the injection site and flu-like symptoms. A large proportion of patients stop interferon therapy because of adverse events. The other main reason for stopping therapy is the felt ineffectiveness of the treatment when patients experience a new exacerbation while on treatment. Many patients produce interferon-neutralising antibodies during therapy. The ultimate effect of neutralising antibodies on the efficacy of interferon treatment is unclear.In patients with relapsing remitting (and partially with secondary progressive) MS, treatment with natalizumab led to a reduction of progression and of exacerbation rates. However, a number of cases of progressive multifocal leucoencephalopathy have been reported after natalizumab therapy. These raise serious concerns about patient safety. Reliable data on the long term effectiveness of beta-interferons or natalizumab are not yet available.The absolute cost of interferon therapy is high and the available, international cost-effectiveness analyses indicate a high cost for achieving moderate benefits in quality of life. Further research is needed to provide specific cost-effectiveness estimates for Germany.

13.
Copenhagen; World Health Organization. Regional Office for Europe; 2008.
Monografia em Inglês | WHO IRIS | ID: who-107911

RESUMO

New technologies with the potential to improve the health of populations are continuously being introduced. But not every technological development results in clear health gains. Health technology assessment provides evidence-based information on the coverage and usage of health technologies, enabling them to be evaluated properly and applied to health care efficaciously, promoting the most effective ones while also taking into account organizational, societal and ethical issues. This book reviews the relationship between health technology assessment and policy-making, and examines how to increase the contribution such research makes to policy- and decision-making processes. By communicating the value and potential of health technology assessment to a wider audience, both within and beyond decision-making and health care management, it aims ultimately to contribute to improving the health status of the population through the delivery of optimum health services.


Assuntos
Avaliação da Tecnologia Biomédica , Avaliação de Resultados em Cuidados de Saúde , Formulação de Políticas , Política de Saúde , Atenção à Saúde , Europa (Continente)
14.
GMS Health Technol Assess ; 1: Doc09, 2005 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-21289930

RESUMO

POLITICAL BACKGROUND: As a German novelty, the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen; IGWiG) was established in 2004 to, among other tasks, evaluate the benefit of pharmaceuticals. In this context it is of importance that patented pharmaceuticals are only excluded from the reference pricing system if they offer a therapeutic improvement. The institute is commissioned by the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) or by the Ministry of Health and Social Security. The German policy objective expressed by the latest health care reform (Gesetz zur Modernisierung der Gesetzlichen Krankenversicherung, GMG) is to base decisions on a scientific assessment of pharmaceuticals in comparison to already available treatments. However, procedures and methods are still to be established. RESEARCH QUESTIONS AND METHODS: This health technology assessment (HTA) report was commissioned by the German Agency for HTA at the Institute for Medical Documentation and Information (DAHTA@DIMDI). It analysed criteria, procedures, and methods of comparative drug assessment in other EU-/OECD-countries. The research question was the following: How do national public institutions compare medicines in connection with pharmaceutical regulation, i.e. licensing, reimbursement and pricing of drugs? Institutions as well as documents concerning comparative drug evaluation (e.g. regulations, guidelines) were identified through internet, systematic literature, and hand searches. Publications were selected according to pre-defined inclusion and exclusion criteria. Documents were analysed in a qualitative matter following an analytic framework that had been developed in advance. Results were summarised narratively and presented in evidence tables. RESULTS AND DISCUSSION: Currently licensing agencies do not systematically assess a new drug's added value for patients and society. This is why many countries made post-licensing evaluation of pharmaceuticals a requirement for reimbursement or pricing decisions. Typically an explicitly designated drug review body is involved. In all eleven countries included (Austria, Australia, Canada, Switzerland, Finland, France, the Netherlands, Norway, New Zealand, Sweden, and the United Kingdom) a drug's therapeutic benefit in comparison to treatment alternatives is leading the evaluation. A medicine is classified as a therapeutic improvement if it demonstrates an improved benefit-/risk-profile compared to treatment alternatives. However, evidence of superiority to a relevant degree is requested. Health related quality of life is considered as the most appropriate criterion for a drug's added value from patients' perspective. Review bodies in Australia, New Zealand, and the United Kingdom have committed themselves to include this outcome measure whenever possible. Pharmacological or innovative characteristics (e.g. administration route, dosage regime, new acting principle) and other advantages (e.g. taste, appearance) are considered in about half of the countries. However, in most cases these aspects rank as second line criteria for a drug's added value. All countries except France and Switzerland perform a comparative pharmacoeconomic evaluation to analyse costs caused by a drug intervention in relation to its benefit (preferably by cost utility analysis). However, the question if a medicine is cost effective in relation to treatment alternatives is answered in a political and social context. A range of remarkably varying criteria are considered. Countries agree that randomised controlled head-to-head trials (head-to-head RCT) with a high degree of internal and external validity provide the most reliable and least biased evidence of a drug's relative treatment effects (as do systematic reviews and meta-analyses of these RCT). Final outcome parameters reflecting long-term treatment objectives (mortality, morbidity, quality of life) are preferred to surrogate parameters. Following the concept of community effectiveness, drug review institutions also explicitly favour RCT in a "natural" design, i.e. in daily routine and country specific care settings. The countries' requirements for pharmacoeconomic studies are similar despite some methodological inconsistencies, e.g. concerning cost calculation. Outcomes of clinical and pharmacoeconomic analyses are largely determined by the choice of comparator. Selecting an appropriate comparative treatment is therefore crucial. In theory, the best or most cost effective therapy is regarded as appropriate comparator for clinical and economic studies. Pragmatically however, institutions accept that the drug is compared to the treatment of daily routine or to the least expensive therapy. If a pharmaceutical offers several approved indications, in some countries all of them are assessed. Others only evaluate a drug's main indication. Canada is the only country which also considers a medicine's off-label use. It is well known that clinical trials and pharmacoeconomic studies directly comparing a drug with adequate competitors are lacking - in quantitative as well as in qualitative terms. This is specifically the case before or shortly after marketing authorisation. Yet there is the need to support reimbursement or pricing decisions by scientific evidence. In this situation review bodies are often forced to rely on observational studies or on other internally less valid data (including expert and consensus opinions). As a second option they use statistical approaches like indirect adjusted comparisons (in Australia and the United Kingdom) and, commonly, economic modelling. However, there is consensus that results provided by these techniques need to be verified by valid head-to-head comparisons as soon as possible. CONCLUSIONS: In the majority of countries reimbursement and pricing decisions are based on systematic and evidence-based evaluation comparing a drug's clinical and economic characteristics to daily treatment routine. However, further evaluation criteria, requirements and specific methodological issues still lack internationally consented standards.

15.
Copenhagen; World Health Organization. Regional Office for Europe; 2005. (WHO/EURO:2005-611-40346-54035).
Monografia em Inglês | WHO IRIS | ID: who-332207

RESUMO

This policy brief introduces the concept of health technology assessment (HTA), which is concerned with the medical, organizational, economic and societal consequences of implementing health technologies or interventions within the health system. It reviews the structures and institutions involved in HTA at the European level.


Assuntos
Avaliação da Tecnologia Biomédica , Avaliação de Resultados em Cuidados de Saúde , Medicina Baseada em Evidências , Europa (Continente)
16.
Copenhagen; World Health Organization. Regional Office for Europe; 2003-08.
Monografia em Inglês | WHO IRIS | ID: who-363760

RESUMO

Chronic diseases account for most of the burden of disease in the European Region. Although there are effective interventions for the management of various chronic conditions, there are also wide practice variations in the delivery of care. Disease management programmes (DMPs) are one of the measures intended to address this situation. DMPs organize care in multidisciplinary, multicomponent programmes, in a proactive approach focusing on the whole course of a chronic disease, using evidence-based standards of care. This report is Health Evidence Network’s (HEN’s) response to a question from a decision-maker. It provides a synthesis of the best available evidence, including a summary of the main findings and policy options related to the issue. HEN, initiated and coordinated by the WHO Regional Office for Europe, is an information service for public health and health care decision-makers in the WHO European Region. Other interested parties might also benefit from HEN.


Assuntos
Qualidade da Assistência à Saúde , Doença Crônica , Atenção à Saúde , Estudo de Avaliação , Programas Nacionais de Saúde , Técnicas de Apoio para a Decisão , Europa (Continente)
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