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1.
Soc Sci Med ; 278: 113937, 2021 Apr 20.
Artigo em Inglês | MEDLINE | ID: mdl-33932691

RESUMO

The study had a three-fold objective: (i) to estimate the amenable mortality rates and trends at a national and state level between 2000 and 2015 in Mexico; (ii) to estimate the contribution and trends of various causes of death to overall amenable mortality; and (iii) to determine the association between health system inputs and amenable mortality for the period 2000-2015. We used a panel dataset for the period 2000-2015. The following health care inputs were used in the analysis: density of general practitioners, specialists and nurses, as well as density of hospital beds. We find that amenable mortality fell from 136 per 100,000 in 2000, to 124.1 per 100,000 in 2015 nationally, with significant heterogeneity in the trends across states. Mortality due to infectious diseases, diseases of childhood, and cardiovascular diseases decreased, while deaths due to other non-communicable diseases, such as diabetes, increased. There was a significant negative association between the density of general practitioners and specialist physicians, and amenable mortality. Our results indicate that reducing the burden of non-communicable diseases must be a health system priority. Improvements in primary health care could lead to improved disease detection and earlier diagnosis which could further reduce amenable mortality in Mexico.

2.
Health Policy ; 125(5): 553-567, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33820678

RESUMO

Developing and distributing a safe and effective SARS-CoV-2 (COVID-19) vaccine has garnered immense global interest. Less than a year after COVID-19 was declared a pandemic, several vaccine candidates had received emergency use authorization across a range of countries. Despite this scientific breakthrough, the journey from vaccine discovery to global herd immunity against COVID-19 continues to present significant policy challenges that require a collaborative, global response. We offer a framework for understanding remaining and new policy challenges for successful global vaccine campaigns against COVID-19 as well as potential solutions to address them. Decision-makers must be aware of these challenges and strategize solutions that can be implemented at scale. These include challenges around maintaining R&D incentives, running clinical trials, authorizations, post-market surveillance, manufacturing and supply, global dissemination, allocation, uptake, and clinical system adaption. Alongside these challenges, financial and ethical concerns must also be addressed.

4.
JAMA Intern Med ; 181(4): 490-498, 2021 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-33616607

RESUMO

Importance: Numerous cancer drugs have received accelerated approval from the US Food and Drug Administration (FDA) based on clinical trial outcomes that are otherwise not acceptable for traditional FDA approval; the accelerated approval process allows outcomes based on surrogate measures that are only reasonably likely to estimate clinical benefits. In England, the National Institute for Health and Care Excellence (NICE) evaluates the clinical benefits and cost-effectiveness of drugs after they have received regulatory approval and issues recommendations regarding their coverage in the National Health Service (NHS). However, the level of concordance between European and FDA decision-making in the context of drugs qualifying for FDA accelerated approval is unknown. Objective: To compare FDA accelerated approval decisions for cancer drugs with NICE coverage decisions. Design, Setting, and Participants: This retrospective cohort study compared cancer drug indications that received FDA accelerated approval from December 11, 1992, to May 31, 2017, with the same set of drug indication pairs in England until August 31, 2019. Data from European Public Assessment Reports developed by the European Medicines Agency (EMA) and public appraisal documents from NICE were used to determine NHS coverage recommendations. National Institute for Health and Care Excellence (NICE) public appraisal documents were analyzed for drug indications, characteristics of clinical evidence, cost-effectiveness, and coverage decisions. Data were analyzed from September 1 to December 31, 2019. Main Outcomes and Measures: Cancer drug indication coverage decision by NICE. Results: From 1992 to 2017, 93 cancer drug indications received FDA accelerated approval, 6 of which were subsequently withdrawn, leaving 87 cancer drug indications on the market. As of August 2019, 5 of these indications had been withdrawn or denied market authorization for the European Union by the EMA. From the cohort of EMA-approved drugs, an additional 7 drug indications were not recommended by NICE and were not deemed to have sufficient clinical benefits or cost-effectiveness to warrant mandatory public coverage in England; 5 drugs were not recommended based on clinical benefit and cost-effectiveness criteria, and 2 drugs were not recommended based on cost-effectiveness criteria alone. In total, 12 drug indications were not recommended for public coverage in the NHS, and an additional 30 drug indications were not reviewed by either the EMA (14 drug indications) or NICE (16 drug indications) by the study end date. Most drug indications recommended by NICE were conditional on the negotiation of additional confidential discounts, the imposition of restricted indications that limited prescribing to specific patient subgroups, or the collection of additional data. Among the 9 drug indications with evidence of overall survival benefit at the time of NICE review, 2 were not recommended for public funding based on cost-effectiveness criteria. Conclusions and Relevance: In this cohort study, 30 cancer drug indications that were granted accelerated approval by the FDA were not subsequently reviewed by either European regulators or NICE, and 12 drugs were denied authorization or coverage owing to insufficient safety, clinical efficacy, or cost-effectiveness. National Health Service coverage of cancer drugs given FDA accelerated approval commonly required additional price concessions, restrictions to approved indications, or review of additional data.

7.
Health Syst Reform ; 6(1): e1846844, 2020 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-33314985

RESUMO

As China's health system is faced with challenges of overcrowded hospitals, there is a great need to better understand the recent patterns and determinants of people's choice between primary care facilities and hospitals for outpatient care. Based on recent individual-level data from the China Health and Retirement Longitudinal Survey (CHARLS) and official province-level data from China health statistical yearbooks, we examine the patterns of outpatient visits to primary care facilities versus hospitals among middle-aged and older individuals and explore both supply- and demand-side correlates that explain these patterns. We find that 53% of outpatient visits were paid to primary care facilities as opposed to hospitals in 2015, compared to 60% in 2011. Both supply and demand factors were associated with this decline. On the supply side, we find that the density of primary care facilities did not account for this decline, but higher densities of hospitals and licensed doctors were associated with lower use of primary care facilities. On the demand side, we find that individuals with higher socioeconomic status and greater health care needs were less likely to use primary health care facilities. Our findings suggest that a high concentration of health care professionals in hospitals diverts patients away from primary care facilities. Staffing the primary care facilities with a well-trained health care workforce is the key to a well-functioning primary care system. The findings also suggest a need to address demand-side inequality issues.

10.
Artigo em Inglês | MEDLINE | ID: mdl-33098422

RESUMO

AIMS: Pre-registration of study protocols in accessible databases is required for publication of study results in high-impact medical journals. Nonetheless, data on characteristics of clinical trials registered in these databases and their outcome, in terms of result reporting and publication are limited. METHODS AND RESULTS: We searched for interventional, late-phase cardiovascular disease (CVD) studies in adults registered in Clinicaltrials.gov. first posted after 1/1/2013 and completed up to 31/12/2018. Data on study design, result reporting and publication were collected, and potential associations with a pre-defined set of explanatory factors were examined.In total, 250 CVD trials were included in the analysis. Of these, 193 (77.2%) were randomized studies, 99 (39.6%) open label designs, and 126 (50.4%) had industry as main sponsor. 179 trials (71.6%) evaluated the effect of drugs and 27 (10.8%) evaluated devices. The most common primary outcomes were non-clinical endpoints (76.0%), with only 17% of studies evaluating clinical endpoints. Industry-funded trials focused on patent-protected drugs and devices more often than non-industry-funded trials (72.0% vs. 30.6%, P < 0.001 and 55.0% vs. 26.3%, P = 0.033, respectively). Sixty three studies (25.2%) had results posted on clinicaltrials.gov, and 116 (46.4%) had results published in the scientific literature. In multivariate analysis, industry sponsorship was statistically significantly associated with results posting (OR: 3.38; 95% CI: 1.56-7.30, P = 0.002) and publication (OR: 0.41; 95% CI: 0.23-0.75, P = 0.004). CONCLUSION: Among late-stage cardiovascular trials only 1/4 had results posted on clinicaltrials.gov and <50% had results published. Industry sponsors were more likely to invest in research on patent-protected drugs and devices than were non-industry sponsors. Industry-sponsored studies were more likely to have their results posted, but less likely to have their results published in the scientific literature.

11.
Int J Equity Health ; 19(1): 168, 2020 Oct 26.
Artigo em Inglês | MEDLINE | ID: mdl-33100214

RESUMO

BACKGROUND: Since the early 1990s, Colombia has made great strides in extending healthcare coverage to its population. In order to measure the impact of these efforts, it is important to assess whether the introduction of universal health coverage has translated into equitable access to healthcare in the country, particularly for the elderly. Thus, in this study we assessed the inequality in utilization of health services among elderly patients in Colombia. In addition, we identified the determinants of healthcare utilization. METHODS: We analyzed the 2015 Colombian health, well-being and aging study (SABE). To classify determinants of healthcare use into predisposing, enabling and need factors, we employed the Anderson framework of healthcare utilization. Use of outpatient, inpatient and preventive health services constituted the dependent variables. We performed multivariate logistic regressions, estimated concentration indexes (CI) and performed decomposition analyses of the CIs to determine the contribution of various determinants to inequality of healthcare utilization. RESULTS: The study sample included 23,694 adults over 60-years-old. Wealth quintile, urban dwelling, health insurance type and multimorbidity predicted the utilization of all types of healthcare services except for hospitalization. Aside from inpatient care, pro-rich inequality in utilization of healthcare services was present. Wealth quintile and type of health insurance were the largest contributors to pro-rich inequality in use of preventive services. CONCLUSIONS: While there has been progress in health insurance coverage for the elderly in Colombia, there are still equality challenges in the delivery of healthcare, especially for preventive and outpatient care. These inequalities are driven by individual characteristics such as wealth, urban residence, type of health insurance carried, and presence of multimorbidity. To address this issue, the Colombian health system should extend health insurance coverage to uninsured populations, as well as reduce barriers of access to healthcare services among poorest and the rural population receiving subsidized insurance.

13.
Int J Health Serv ; : 20731420966976, 2020 Oct 27.
Artigo em Inglês | MEDLINE | ID: mdl-33107779

RESUMO

For-profit hospitals' market share has increased in many nations over recent decades. Previous studies suggest that their growth is not attributable to superior performance on access, quality of care, or efficiency. We analyzed other factors that we hypothesized may contribute to the increasing role of for-profit hospitals. We studied the historical development of the for-profit hospital sector across 4 nations with contrasting trends in for-profit hospital market share: the United States, the United Kingdom, Germany, and the Netherlands. We focused on 3 factors that we believed might help explain why the role of for-profits grew in some nations but not in others: (1) the treatment of for-profits by public reimbursement plans, (2) physicians' financial interests, and (3) the effect of the political environment. We conclude that access to subsidies and reimbursement under favorable terms from public health care payors is an important factor in the rise of for-profit hospitals. Arrangements that aligned financial incentives of physicians with the interests of for-profit hospitals were important in stimulating for-profit growth in an earlier era, but they play little role at present. Remarkably, the environment for for-profit ownership seems to have been largely immune to political shifts.

14.
BMJ Open Qual ; 9(3)2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32988831

RESUMO

The COVID-19 pandemic has led to significant morbidity and mortality globally. As health systems grapple with caring for patients affected with COVID-19, cardiovascular procedures that are deemed 'elective' have been postponed. Guidelines concerning which cardiac procedures should be performed during the pandemic vary by specialty and geography in the USA. We propose a clinical heuristic to guide individual physicians and governing bodies in their decision making regarding which cardiac procedures should be performed during the COVID-19 pandemic using the behavioural economics concept of heuristics and ecological rationality.


Assuntos
Procedimentos Cirúrgicos Cardiovasculares/psicologia , Tomada de Decisão Clínica/métodos , Infecções por Coronavirus/prevenção & controle , Economia Comportamental , Procedimentos Cirúrgicos Eletivos/psicologia , Heurística , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Betacoronavirus , Contraindicações de Procedimentos , Humanos , Estados Unidos
15.
Soc Sci Med ; 263: 113247, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32799026

RESUMO

In the past decade, the Chinese central government has made sweeping reforms to national pharmaceutical policies. However, provincial authorities have retained control over most drug procurement procedures, potentially leading to cross-province differences in drug prices. The objectives of this study were to (i) examine drug price trends in 31 Chinese provinces and municipalities between 2010 and 2017; (ii) evaluate the association between provincial income levels and drug prices over this period; and (iii) compare the results for Chinese state-owned, Chinese private, and multinational pharmaceutical firms. Using publicly available data on procurement prices of the drugs manufactured by the top 30 pharmaceutical firms in China (in terms of revenues), we ran a generalized country-product-dummy regression to compare drug prices across provinces over the study period. We conducted subgroup analyses to test for differences between types of firms. Between 2010 and 2017, drug prices decreased by an average of 23% across the country. The prices of drugs sold by multinational firms dropped by 32% over this period, while the prices of drugs sold by Chinese private firms declined by 28%. By contrast, the drug prices of state-owned firms went up by 11%. There were statistically significant positive associations between drug prices and provincial income levels for the full sample in 2010, 2011, and 2013. There were no significant associations in other years. Several low-income provinces paid higher procurement prices than some high-income provinces for identical medicines, especially in later study years. The lack of association between income levels and prices poses equity concerns and may place a heavier cost burden on the poor. It also suggests that China's pharmaceutical policies may be failing to balance the dual aims of drug affordability and incentives for innovation.

18.
Int J Infect Dis ; 99: 263-265, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32781163

RESUMO

The COVID-19 pandemic has made the European Commission revaluate its role in member states health systems. In response, the European Union is planning to significantly increase investment to tackle cross-border health threats. The European Centre for Communicable Disease Prevention and Control is well positioned to capitalise upon this increased investment by designing and implementing a renewed European strategy for infection disease control. To secure meaningful and sustainable improvements, the European Centre for Communicable Disease Prevention and Control needs to be strengthened with more resources, an expanded geographical scope and legislative change.


Assuntos
Betacoronavirus , Controle de Doenças Transmissíveis/métodos , Controle de Doenças Transmissíveis/normas , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , União Europeia , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Europa (Continente)/epidemiologia , Humanos
19.
Nat Cancer ; : 1-3, 2020 May 20.
Artigo em Inglês | MEDLINE | ID: mdl-32838302

RESUMO

The COVID-19 pandemic has disrupted the spectrum of cancer care, including delaying diagnoses and treatment and halting clinical trials. In response, healthcare systems are rapidly reorganizing cancer services to ensure that patients continue to receive essential care while minimizing exposure to SARS-CoV-2 infection.

20.
Artigo em Inglês | MEDLINE | ID: mdl-32638664

RESUMO

OBJECTIVES: To investigate the impact of the uncertainty stemming from products with European conditional marketing authorization (CMA) or authorization in exceptional circumstances (AEC) on the National Institute for Health and Care Excellence's (NICE) recommendations. METHODS: Products which received CMA/AEC by European Medicines Agency (EMA) up to 1 December 2016 were identified and matched with corresponding NICE decisions issued by August 2017, the status of which was then traced to August 2019. We assessed whether the conversion of CMA to full marketing authorization triggered a review of a NICE decision. The odds of a recommendation carrying a commercial arrangement for products with and without CMA/AEC were calculated. RESULTS: Fifty-four products were granted CMA/AEC by EMA. NICE conducted thirty evaluations of products with CMA/AEC. Twelve products were recommended by NICE by August 2017 and fourteen by August 2019. All recommendations had an associated commercial arrangement. The odds of carrying a commercial arrangement were higher for products with CMA/AEC compared to those with full authorization. Conversions from conditional to full authorization among products not recommended by NICE did not trigger an appraisal review. CONCLUSIONS: Uncertainty, stemming from the lack of robust clinical data of products authorized with CMA/AEC, has a substantial impact on HTA recommendations, frequently requiring risk mitigation mechanisms such as commercial and data collection arrangements. Further analyses should be conducted to assess whether the benefits of early access strategies outweigh the risks for patients and the healthcare system.

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