From guidance to practice: Promoting risk communication and community engagement for prevention and control of coronavirus disease (COVID-19) outbreak in China.

Integrating risk communication and community engagement into the national public health emergency response is crucial. Considering the difficulties and challenges faced by China in the prevention and control of coronavirus disease (COVID-19) and based on interim guidelines from the World Health Organization, this article makes several recommendations addressing the outbreak in China. These include improvements in the internal governmental risk communication systems, enhancing the coordination between internal and partner governmental emergency management, and promoting public communication in response to societal concerns. Regarding these recommendations, we emphasize community engagement in joint prevention and control, confronting uncertainty and countering rumors effectively, and strengthening international cooperation and evidence-based decision making for prevention and control measures.

Regulatory perspectives on next-generation sequencing and complementary diagnostics in Japan.

INTRODUCTION: The 'one biomarker/one drug' scenario is unsustainable because cancer is a complex disorder that involves a number of molecular defects. In the past decade, major technological advances have lowered the overall cost and increased the efficiency of next-generation sequencing (NGS). AREAS COVERED: We review recent regulations on NGS and complementary diagnostics in Japan, mainly focusing on high-quality studies that utilized these new diagnostic modalities and were published within the last 5 years. We highlight significant changes in regulation, and explain the direction of efforts to translate the results of NGS and complementary diagnostics into clinical practice. EXPERT OPINION: NGS holds a number of advantages over conventional companion and complementary diagnostics that enable simultaneous analyzes of multiple cancer genes to detect actionable mutations. Parallel technological developments and regulatory changes have led to the rapid adoption of NGS into clinical practice. NGS-based genomic data have been leveraged to better understand the characteristics of a disease that affects its patient's response to a given therapy. As NGS-based tests become more widespread, however, Japanese authorities will face significant challenges particularly with respect to the complexity of genomic data, which will have to be managed if NGS is to benefit patients.

ACCELERATE and European Medicines Agency Paediatric Strategy Forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients.

The third multistakeholder Paediatric Strategy Forum organised by ACCELERATE and the European Medicines Agency focused on immune checkpoint inhibitors for use in combination therapy in children and adolescents. As immune checkpoint inhibitors, both as monotherapy and in combinations have shown impressive success in some adult malignancies and early phase trials in children of single agent checkpoint inhibitors have now been completed, it seemed an appropriate time to consider opportunities for paediatric studies of checkpoint inhibitors used in combination. Among paediatric patients, early clinical studies of checkpoint inhibitors used as monotherapy have demonstrated a high rate of activity, including complete responses, in Hodgkin lymphoma and hypermutant paediatric tumours. Activity has been very limited, however, in more common malignancies of childhood and adolescence. Furthermore, apart from tumour mutational burden, no other predictive biomarker for monotherapy activity in paediatric tumours has been identified. Based on these observations, there is collective agreement that there is no scientific rationale for children to be enrolled in new monotherapy trials of additional checkpoint inhibitors with the same mechanism of action of agents already studied (e.g. anti-PD1, anti-PDL1 anti-CTLA-4) unless additional scientific knowledge supporting a different approach becomes available. This shared perspective, based on scientific evidence and supported by paediatric oncology cooperative groups, should inform companies on whether a paediatric development plan is justified. This could then be proposed to regulators through the available regulatory tools. Generally, an academic-industry consensus on the scientific merits of a proposal before submission of a paediatric investigational plan would be of great benefit to determine which studies have the highest probability of generating new insights. There is already a rationale for the evaluation of combinations of checkpoint inhibitors with other agents in paediatric Hodgkin lymphoma and hypermutated tumours in view of the activity shown as single agents. In paediatric tumours where no single agent activity has been observed in multiple clinical trials of anti-PD1, anti-PDL1 and anti-CTLA-4 agents as monotherapy, combinations of checkpoint inhibitors with other treatment modalities should be explored when a scientific rationale indicates that they could be efficacious in paediatric cancers and not because these combinations are being evaluated in adults. Immunotherapy in the form of engineered proteins (e.g. monoclonal antibodies and T cell engaging agents) and cellular products (e.g. CAR T cells) has great therapeutic potential for benefit in paediatric cancer. The major challenge for developing checkpoint inhibitors for paediatric cancers is the lack of neoantigens (based on mutations) and corresponding antigen-specific T cells. Progress critically depends on understanding the immune macroenvironment and microenvironment and the ability of the adaptive immune system to recognise paediatric cancers in the absence of high neoantigen burden. Future clinical studies of checkpoint inhibitors in children need to build upon strong biological hypotheses that take into account the distinctive immunobiology of childhood cancers in comparison to that of checkpoint inhibitor responsive adult cancers.

Healthcare Supply Chain Network Coordination Through Medical Insurance Strategies with Reference Price Effect.

China has established the universal medical insurance system and individual out of pocket costs have decreased, however, the average healthcare expenditure of the Chinese population and the expenses of the whole society have increased substantially. One major challenge which impedes the progress of attaining sustainable development of the social healthcare system in China is that the number of hospital admissions is disproportionate. Superior hospitals are overcrowded, whereas subordinate hospitals are experiencing low admissions. In this paper, we apply the game theory model to coordinate the healthcare supply chain network, which is composed of the government, medical insurance fund, superior hospitals, subordinate hospitals and patients. Especially by taking the reference price effect into account, this paper analyzes different medical insurance reimbursement strategies and their influence on patient choice and the healthcare supply chain network. The result shows that the reference price effect increases the leverage of medical insurance, guides patients' choice, optimizes the allocation of medical resources and reduces the medical expends. In comparison to a decentralized decision- making strategy, a centralized decision- making strategy can stimulate both superior hospital and subordinate hospital's cooperative intentions which benefits the social healthcare system.

A neo-institutional analysis of the hidden interaction between the Israeli Supreme Court and the Ministry of Finance: the right to healthcare services.

BACKGROUND: Under structural conditions of non-governability, most players in the policy arena in Israel turn to two main channels that have proven effective in promoting the policies they seek: the submission of petitions to the High Court of Justice and making legislative amendments through the Economic Arrangements Law initiated by the Ministry of Finance. Nevertheless, an analysis of the principal trends emerging from the High Court of Justice rulings and legislative amendments through the Economic Arrangements Law indicates that these channels are open to influence, primarily by forces that are essentially neo-liberal. Little is known about the effects of these trends on the right to healthcare services, which in Israel has not been legislated as an independent constitutional law in Basic Laws. METHODS: We use four major legal cases decided by the Supreme Court of Israel in the past 10 years where the Court reviewed new legislative initiatives proposed by the Economic Arrangements Law in the area of healthcare. We utilize an institutional approach in our analysis. RESULTS: A neo-institutional analysis of the legal cases demonstrates that petitions against the Economic Arrangements Law in the area of healthcare services have been denied, even though the Court uses strong rhetoric against that law and the government more generally in addressing issues that concern access to healthcare services and reforms in the healthcare system. This move strengthens the trend toward a neo-liberal public policy and significantly weakens the legal protection of the right to healthcare services. CONCLUSION: In deciding petitions against the Economic Arrangements Law in the area of healthcare, the Supreme Court allows the Ministry of Finance to be a dominant player in the formation of public policy. In doing so, it may be promoting a goal of strengthening its position as a political institution that aspires to increase the public's trust in the judiciary and especially in the Supreme Court itself, in addition to exercising judicial restraint and allowing more leeway to the executive and legislative branches more generally.

Addiction disorders: a need for change. Proposal for a new management. Position paper of SIA, Italian Society on Alcohol.

Various epidemiological and biological evaluations and the recent publication of the DSM-V (diagnostic and statistical manual of mental disorders) has imposed on the scientific community a period of reflection on the diagnosis and treatment of what in the DSM-IV was defined as "addiction". To date, the term "addiction" has been replaced by the DSM-5, because there is no global scientific consensus that has unequivocally characterized its clinical characteristics. This, we will talk about substance/alcohol use disorders (SUDs/AUDs) and disorders related to behavioral alterations (DBA) that can generate organic diseases, mental disorders, and social problems. In the first psychotic episode 40-70% of subjects meet the criteria of a SUDs/AUDs, excluding tobacco dependence. Substances can not only be the cause of a psychotic onset, but they can also disrupt a psychotic picture or interfere with drug therapy. The pharmacodynamic profiles of many substances are able to provoke the phenomenology of the main psychotic symptoms in a way that can be superimposed onto those presented by psychotic subjects without a history of SUDs/AUDs. The Department of Addictions (DAs) must not be absorbed by or incorporated into the Departments of Mental Health (DMH), with which, however, precise operational cooperation protocols will have to be defined and maintained, but it will have to maintain its own autonomy and independent connotation. Addiction Medicine is a discipline that brings together elements of public health, prevention, internal medicine, clinical pharmacology, neurology, and even psychiatry. The inclusion of the DAs in those of DMH refers purely to a problem of pathology that has to do with lifestyle, choices, and behaviors. These, over time, show their dysfunctionality and only then do related problems emerge. Moreover, epidemiological, social, and clinical motivations impose the creation of alcohological teams dedicated to alcohol-related activities. The collaboration with self-help-groups (SHGs) is mandatory. The action of SHGs is accredited in numerous international recommendations both on the basis of consensus and evidence in the literature.

[Temporary approval for intranasal naloxone: Setting up in a French addiction center]. / Pratique de l'ATU de cohorte de la naloxone intranasale (Nalscue®) : mise en place dans un CSAPA parisien.

Intranasal naloxone aims at preventing opioid overdose related deaths in active drug users. In France, it has been available since July 2016 through a temporary approval which requires a hospital-based pharmacy and a nominative registration of each patient. We present the characteristics of the first patients who could receive this prescription in our hospital-based addiction center and how they used naloxone during follow-up. Results favor a larger dispensing of naloxone. Patients' as well as peers' and families' education is needed.

Number and type of guideline implementation tools varies by guideline, clinical condition, country of origin, and type of developer organization: content analysis of guidelines.

BACKGROUND: Guideline implementation tools (GI tools) can improve clinician behavior and patient outcomes. Analyses of guidelines published before 2010 found that many did not offer GI tools. Since 2010 standards, frameworks and instructions for GI tools have emerged. This study analyzed the number and types of GI tools offered by guidelines published in 2010 or later. METHODS: Content analysis and a published GI tool framework were used to categorize GI tools by condition, country, and type of organization. English-language guidelines on arthritis, asthma, colorectal cancer, depression, diabetes, heart failure, and stroke management were identified in the National Guideline Clearinghouse. Screening and data extraction were in triplicate. Findings were reported with summary statistics. RESULTS: Eighty-five (67.5%) of 126 eligible guidelines published between 2010 and 2017 offered one or more of a total of 464 GI tools. The mean number of GI tools per guideline was 5.5 (median 4.0, range 1 to 28) and increased over time. The majority of GI tools were for clinicians (239, 51.5%), few were for patients (113, 24.4%), and fewer still were to support implementation (66, 14.3%) or evaluation (46, 9.9%). Most clinician GI tools were guideline summaries (116, 48.5%), and most patient GI tools were condition-specific information (92, 81.4%). Government agencies (patient 23.5%, clinician 28.9%, implementation 24.1%, evaluation 23.5%) and developers in the UK (patient 18.5%, clinician 25.2%, implementation 27.2%, evaluation 29.1%) were more likely to generate guidelines that offered all four types of GI tools. Professional societies were more likely to generate guidelines that included clinician GI tools. CONCLUSIONS: Many guidelines do not include any GI tools, or a variety of GI tools for different stakeholders that may be more likely to prompt guideline uptake (point-of-care forms or checklists for clinicians, decision-making or self-management tools for patients, implementation and evaluation tools for managers and policy-makers). While this may vary by country and type of organization, and suggests that developers could improve the range of GI tools they develop, further research is needed to identify determinants and potential solutions. Research is also needed to examine the cost-effectiveness of various types of GI tools so that developers know where to direct their efforts and scarce resources.

Healthy people and healthy profits? Elaborating a conceptual framework for governing the commercial determinants of non-communicable diseases and identifying options for reducing risk exposure.

BACKGROUND: Non-communicable diseases (NCDs) represent a significant threat to human health and well-being, and carry significant implications for economic development and health care and other costs for governments and business, families and individuals. Risks for many of the major NCDs are associated with the production, marketing and consumption of commercially produced food and drink, particularly those containing sugar, salt and transfats (in ultra-processed products), alcohol and tobacco. The problems inherent in primary prevention of NCDs have received relatively little attention from international organizations, national governments and civil society, especially when compared to the attention paid to secondary and tertiary prevention regimes (i.e. those focused on provision of medical treatment and long-term clinical management). This may in part reflect that until recently the NCDs have not been deemed a priority on the overall global health agenda. Low political priority may also be due in part to the complexity inherent in implementing feasible and acceptable interventions, such as increased taxation or regulation of access, particularly given the need to coordinate action beyond the health sector. More fundamentally, governing determinants of risk frequently brings public health into conflict with the interests of profit-driven food, beverage, alcohol and tobacco industries. MATERIALS: We use a conceptual framework to review three models of governance of NCD risk: self-regulation by industry; hybrid models of public-private engagement; and public sector regulation. We analyse the challenges inherent in each model, and review what is known (or not) about their impact on NCD outcomes. CONCLUSION: While piecemeal efforts have been established, we argue that mechanisms to control the commercial determinants of NCDs are inadequate and efforts at remedial action too limited. Our paper sets out an agenda to strengthen each of the three governance models. We identify reforms that will be needed to the global health architecture to govern NCD risks, including to strengthen its ability to consolidate the collective power of diverse stakeholders, its authority to develop and enforce clear measures to address risks, as well as establish monitoring and rights-based accountability systems across all actors to drive measurable, equitable and sustainable progress in reducing the global burden of NCDs.

Posterior cranial fossa tumours in children at National Cancer Institute, Sudan: a single institution experience.

BACKGROUND: Posterior cranial fossa tumours (PCF) comprise 54-70% of childhood brain tumours. The clinical profile and outcomes of these tumours differ in area of the world. The aim of this study is to describe clinical characteristics, treatment and outcome of posterior cranial fossa tumours in Sudan. MATERIAL AND METHODS: A retrospective study of children diagnosed with posterior cranial fossa tumours and treated between January 1998 and December 2015 at National Cancer Institute, Sudan. RESULTS: A total of 31 paediatric patients with a posterior cranial fossa brain tumour were identified over the study period. The mean age was 7.9 years (standard deviation (SD) = 3.37). Females were slightly more affected (51%) than males (49%), and the majority of patients were from rural areas (71%). Brainstem tumours were the most frequent tumour type (48%) followed by medulloblastoma (36%). The mean pre-diagnostic symptomatic interval was 3.6 months (SD = 3.95). Overall survival rate of our total study population at 1, 2 and 5 years was 23, 19 and 13%, respectively. CONCLUSION: Overall, this study draws attention to the situation of paediatric brain tumours in Sudan. Late presentation, misdiagnosis and limited diagnostic and treatment resources are challenges that may contribute to poor outcome in these patients.

The Taiwan Tobacco and Liquor Corporation: To 'join the ranks of global companies'.

Until the late 1990s, the Taiwan Tobacco and Liquor Corporation (TTL) focused almost exclusively on serving the domestic market as a highly protected monopoly. This paper describes how the company has adopted a more outward looking strategy since 2000, with ambitions to become a regional, and eventually global, business by 2021. Drawing on company documents and industry sources, the paper argues that this shift in strategy was a direct reaction to the decline in domestic market share following liberalisation of the Taiwanese tobacco market and adoption of tougher domestic tobacco control measures. Market opening occurred as a result of pressure from the U.S. Trade Representative in the 1980s, as well as World Trade Organization membership in 2002. It is argued that TTL's efforts to globalise operations have been limited by bureaucratic company management and structures, and ongoing political tension between Taiwan and China. However, the relative success of TTL's alcohol branch, and potential détente as the Taiwanese government reaches out to improve relations with China, may provide TTL with new opportunities to achieve its goal of becoming a regional player with global ambitions. This article is part of the special issue 'The Emergence of Asian Tobacco Companies: Implications for Global Health Governance.'

The globalisation strategies of five Asian tobacco companies: An analytical framework.

With 30% of the world's smokers, two million deaths annually from tobacco use, and rising levels of tobacco consumption, the Asian region is recognised as central to the future of global tobacco control. There is less understanding, however, of how Asian tobacco companies with regional and global aspirations are contributing to the global burden of tobacco-related disease and death. This introductory article sets out the background and rationale for this special issue on 'The Emergence of Asian Tobacco Companies: Implications for Global Health Governance'. The article discusses the core questions to be addressed and presents an analytical framework for assessing the globalisation strategies of Asian tobacco firms. The article also discusses the selection of the five case studies, namely as independent companies in Asia which have demonstrated concerted ambitions to be a major player in the world market.

[Does a cancer moonshot make sense?]. / Cancer :faut-il viser la lune ? - Chroniques génomiques.

The recently announced "Cancer moonshot" may be greeted with scepticism: the previous "War on cancer" (1971) was not very successful. However the current plan seems well targeted, with emphasis not only on research investment but also on a strong effort to "break down silos" and ensure wide dissemination and use of clinical and molecular data. One big uncertainty, however, is what will happen to the programme after the 2016 presidential election… ‡.

Cancer patterns in Karachi (all districts), Pakistan: First results (2010-2015) from a Pathology based cancer registry of the largest government-run diagnostic and reference center of Karachi.

National level population-based cancer data have never been published from Pakistan in seven decades since independence (1947). Therefore, generation of high-quality regional data becomes highly relevant. Cancer data for the period of 2010-2015 representing the population from all districts of Karachi (14.6 million) are presented herein. After institutional approval (Ref no. IRB-459/DUHS/-14), a Pathology based cancer registry was established at the largest government-run diagnostic and reference center of Karachi. During 2010-2015, a total of 13,508 cancers (including 686 non-melanoma-skin-cancers (NMSC)) were diagnosed. Of these, 5665 (41.9%) were in males while 7843 (58.1%) were in females. Incidence rates for all cancers (excluding NMSC) were 66.7 per 100,000 (crude) and 105.1 per 100,000 (ASR) for males and 112.0 per 100,000 (crude) and 175.8 per 100,000 (ASR) for females. In males, cancer of lip and oral cavity was the most frequently diagnosed cancer (30.8%, ASR 33.1), followed by NMSC (7.7%, ASR 9.5) and colorectum (7%, ASR 7.3). In females, breast cancer was the most frequently recorded malignancy (49.5%, ASR 87.9), followed by lip and oral cavity (11.2%, ASR 22.0) and oesophagus (5.6%, ASR 10.7). We report that Karachi has the highest incidence of cancers of breast, lip and oral cavity, oesophagus and larynx in females and cancer of lip and oral cavity and larynx (2nd only to Turkey) in males compared to any of the Asian populations. Notably, incidence of tobacco associated cancers is very high in Karachi, demanding urgent attention by relevant authorities to address the un-controlled and drastically high consumption of various forms of tobacco in the city.