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Costs and benefits of early access to new cancer drugs through the US Food and Drug Administration's accelerated approval pathway: retrospective observational study and economic evaluation.

OBJECTIVE: To evaluate the survival gains and additional Medicare spending associated with early access to new cancer drugs granted accelerated approval by the US Food and Drug Administration (FDA), compared with access to cancer drugs following completion of confirmatory trials. DESIGN: Retrospective observational study and economic evaluation. SETTING: US Medicare programme, which provides health insurance for adults aged 65 years and older. PARTICIPANTS: Medicare beneficiaries who received new cancer drug indications from the time of FDA accelerated approval to conversion to regular appr

Ten years of AMNOG from an oncological perspective: new horizons and continuing expansion.

Purpose2021 marks the tenth anniversary of the AMNOG process and brought with it a new German administration-two good reasons to take stock of where we stand today, what has been achieved so far, and how the path of early benefit assessments in Germany should continue.ResultsFrom the perspective of manufacturers of cancer drugs, the AMNOG process, as a constantly evolving system, has for the most part proved itself-which does not mean that there is no longer room for improvement. Significant improvements have been achieved in the area of early consultation of medical societies regarding the se

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… From the outset it was a political aspiration in Germany—especially with regard to cancer patients—to ensure that benefit evaluations would not lead to the availability of drugs being delayed for months or even years after approval. … Early on, oncology associations within the Association of Scientific Medical Societies in Germany (AWMF) as well as representatives from politics, medicine, science and business promoted the AMNOG process as a system that must evolve over the years. …

Более широкие соображения в отношении интеграции медицинских и стоматологических данных

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Insights into the Impact of Hesitancy on Cancer Care and COVID-19.

World Health Organization findings indicate that the COVID-19 pandemic adversely affected cancer diagnosis and management. The COVID-19 pandemic disrupted the optimal management of outpatient appointments, scheduled treatments, and hospitalizations for cancer patients because of hesitancy among patients and health-care providers. Travel restrictions and other factors likely affected medical, surgical, and radiation treatments during the COVID-19 pandemic. Cancer patients were more likely to be affected by severe illness and complications if they contracted COVID-19. A compromised immune system

A rare coincidence of different types of driver mutations among uterine leiomyomas (UL).

BACKGROUND: Alcohol is a major risk factor for preventable illness, with huge cost to healthcare economies. There is a role for alcohol-specific digital health interventions (DHI), but there have been few randomised controlled trials (RCT) comparing DHI with face-to-face treatment. Such trials are complex and face obstacles in recruitment and retention. METHODS: Mixed-methods feasibility RCT of an alcohol DHI, testing recruitment, online data-collection and randomisation processes, with an embedded process evaluation. Recruitment ran from October 2014 for 9 months. Participants were adults dr

Factors that influence caregivers' and adolescents' views and practices regarding human papillomavirus (HPV) vaccination for adolescents: a qualitative evidence synthesis.

BACKGROUND: Human papillomavirus (HPV) vaccination in adolescents provides a powerful tool for preventing cervical cancer in women and other HPV-associated diseases in people of all genders. HPV vaccines have been progressively introduced in many countries. However, worldwide, many adolescents do not receive HPV vaccination, for various reasons. The HPV vaccine might be costly or unavailable, healthcare systems might lack capacity for its delivery, or adolescent health might not be prioritised. Some caregivers and adolescents may not accept available HPV vaccines and vaccination services. We c

Factors that influence parents' and informal caregivers' views and practices regarding routine childhood vaccination: a qualitative evidence synthesis.

BACKGROUND: Childhood vaccination is one of the most effective ways to prevent serious illnesses and deaths in children. However, worldwide, many children do not receive all recommended vaccinations, for several potential reasons. Vaccines might be unavailable, or parents may experience difficulties in accessing vaccination services; for instance, because of poor quality health services, distance from a health facility, or lack of money. Some parents may not accept available vaccines and vaccination services. Our understanding of what influences parents' views and practices around childhood va

[Lysenkoism in Polish botany].

Lysenkoism in Poland was never an autonomous phenomenon. The whole array of reasons for which it appeared in Polish science would require a separate study--here it only needs to be pointed out that the major reasons included terror on the part of the security service, lawlessness, the ubiquitous atmosphere of intimidation and terror, censorship, the diminishing sphere of civil liberties, political show trials, propaganda and denunciations. An important role in facilitating the introduction of Lysenkoism was played also by the reorganization of science after World War Two, the isolation of Poli

Does childhood obesity foreshadow a future time-bomb of early and more aggressive cancers?

There has been a global explosion in the prevalence of childhood obesity with 20% of children worldwide now growing up with excess weight and, despite many calls for interventions to redress the costs to health and society, rates continue to rise. It has also recently been observed that there is a global trend with the incidence of early-onset cancers, diagnoses prior to age 50, increasing. We outline the different lines of evidence implicating that these two trends may be linked. Conclusive proof will only be obtained when longitudinal studies, initiated after the current surge in childhood o

The pathological anatomical collection of the Natural History Museum Vienna.

The pathological anatomical collection Vienna (Pathologisch-Anatomische Sammlung Wien; PASW) is a living and still growing research collection. It was established as early as 1796 as part of the Medical University of Vienna, acquired the status of an independent federal museum in 1971, and was assigned to the Natural History Museum Vienna in 2012. It houses a wide range of human wet and dry specimens and further objects, such as moulages, medical devices, microbiological and histological specimens, and a photo archive (approximately 50,000 objects), which, as a meaningful source, may contribut

On the occurrence of mirror modes at Mercury and their comparison with magnetic holes and ion cyclotron waves.

In the context of this review, civil unrest is defined as disharmony, expressive dissatisfaction and/or disagreement between members of a community, which leads to a situation of competitive aggression that may find expression as disruption of organisation, conflicts, damage to property and injuries. Such a breakdown of harmonious relationships, which may result in property damage and human injuries that may be threatening to life, varies in magnitude from participation of a very few individuals up to the involvement of large crowds of people, which may evolve into a full-scale riot. It is the

Regulatory policy and pharmaceutical innovation in the United Kingdom after Brexit: Initial insights.

Brexit was presented as an opportunity to promote innovation by breaking free from the European Union regulatory framework. Since the beginning of 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) has operated as the independent regulatory agency for the United Kingdom. The MHRA's regulatory activity in 2021 was analyzed and compared to that of other international regulatory bodies. The MHRA remained reliant on EU regulatory decision-making for novel medicines and there were significant regulatory delays for a small number of novel medicines in the UK, the reasons being so fa

Can the sustainable development goals for cancer be met in Brazil? A population-based study.

BackgroundA one-third reduction in premature mortality (30-69 years) from chronic noncommunicable diseases is goal 3.4 of the United Nations Sustainable Development Goals (UN SDG). The burden of NCDs is expected to continue to increase in low- and middle-income countries, including Brazil.ObjectivesThe aim of this study was to assess geographical and temporal patterns in premature cancer mortality in Brazil between 2001 and 2015 and to predict this to 2030 in order to benchmark against the 3.4 SDG target.MethodsWe used data on deaths from cancer in those aged 30-69, by age group, sex and cance

Racial and ethnic variations in caregiving-related physical, emotional, and financial strain during COVID-19 among those caring for adult cancer patients.

PurposeCancer caregiving is shown to be a burdensome experience in typical times. The purpose of this study was to describe cancer caregivers' emotional, physical, and financial strain during the COVID-19 pandemic and compared to preCOVID-19, and explore racial and ethnic variations in caregiver strain.MethodsWe conducted a cross-sectional online survey using Lucid, LLC, incorporating quotas for race, ethnicity, gender and age. Caregivers had to be adults living in the USA and currently providing unpaid care to an adult cancer patient (i.e., during COVID-19) and prior to the pandemic. We asses

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… Coppock A, McClellan OA (2019) Validating the demographic, political, psychological, and experimental results obtained from a new source of online survey respondents. Research and Politics 16. Higginson IJ, et al. Short-form Zarit caregiver burden interviews were valid in advanced conditions. …

Myeloma bone disease.

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A call for the United States to continue investing in science.

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An Experimental Investigation of Moral Self-Violation and Mental Contamination.

This paper describes the Data Domotopia a 2300 + respondent self-administered web-based survey. It includes 100 + multi-purpose items about home-making and stillness in a moving world. We suppose that home-making can reveal coping strategies and resilience practices to make everyday life work - as home is a central location in people's activity-travel patterns. To describe this phenomenon, the concept of Domotopia is introduced, defining how people arrange, use, and experience their homes to cope with the pathologies of accelerated and liquid modernity (Bauman 2005). While the Data Domotopia i

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… Inhabiting also implies cohabitation, which raises various forms of political issues, inequalities, and domination (Barthes 2012 ). … Among his last publications is Politics of Urban Planning : Making and Unmaking of the Mumbai Development Plan 2014–2034 (ed. with Amita Bihde and Christing Lütringer), Springer, 2022 . …

Cancer burden across the South Asian Association for Regional Cooperation in 2022.

ObjectiveThe objective of this study is to present a cross-sectional analysis of cancer burden in the South Asian Association for Regional Cooperation (SAARC) region and explain unique characteristics of its cancer burden as compared with the rest of the world.Methods and analysisUsing publicly available data from the Global Cancer Observatory (GCO) and the World Bank, we collected cancer statistics and population statistics for Afghanistan, Bangladesh, Bhutan, India, the Maldives, Nepal, Pakistan, and Sri Lanka from 2017 to 2022.ResultsThe number of newly diagnosed cases in the region was 1 8

Management of Myeloma Bone Lesions.

Multiple myeloma (MM) is a B-cell neoplasm characterized by clonal plasma-cell proliferation. The survival and prognosis of this condition have been significantly improved by treatment with active anti-MM drugs such as bortezomib or lenalidomide. Further, the discovery of novel agents has recently paved the way for new areas of investigation. However, MM, including myeloma-related bone diseases, remains fatal. Bone disease or bone destruction in MM is a consequence of skeletal involvement with bone pain, spinal cord compression, and bone fracture resulting from osteolytic lesions. These conseq

A call for the United States to continue investing in science.

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