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Integrating Clinical Research into Epidemic Response: The Ebola Experience
Gerald Keusch, Keith McAdam, Patricia Cuff, Michelle Mancher, and Emily R. Busta
National Academies of Sciences, Engineering, and Medicine
(2017)
C1
The 2014–2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia,
...
and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Republic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014–2015 were relatively isolated and of short duration, little was known about how to best manage patients to improve survival, and there were no approved therapeutics or vaccines. When the World Heath Organization declared the 2014-2015 epidemic a public health emergency of international concern in August 2014, several teams began conducting formal clinical trials in the Ebola affected countries during the outbreak.
more
Although Kenyans enjoy comparatively good health, the prevalence of
chronic disease is increasing and our ageing population is placing evergrowing pressures on the finite resources of our
...
health system.
more
Q7. SCOPING QUESTION: In adults with moderate-severe depressive disorder, what is the effectiveness and safety of antidepressant medication (ADM) in comparison with psychological treatment?
The WHO mhGAP programme’s existing guidelines recommen
...
d that either structured brief psychological treatments (e.g., interpersonal psychotherapy or cognitive behavioural therapy, including behavioural activation) or antidepressant medication (e.g., SSRIsi and tricyclic antidepressants) be considered in adults with moderate-severe depression. Health care workers need to know whether these treatments have different effects, including side-effects, in treating depressive disorder in the short and long term, in order to improve clinical decision-making.
more
Using the WHO model list of essential medicines to update a national essential medicines list
Since 1977, WHO has been working with countries to design the package of essential medicines as an integral component of treatment within the continuum of care, developing
...
and disseminating the Model List of Essential Medicines (Model List). WHO is committed to supporting Member States in sharing best practices in selecting
essential medicines, and in developing processes for the selection of medicines for national essential medicines lists (national EMLs, or NEMLs) consistent with the evidence-based methods used for updating the WHO Model List.
more
The World Health Organization’s comprehensive antenatal care (ANC) guideline WHO recommendations on antenatal care for a positive pregnancy experience was published in 2016 with the objective of improving the quality of routine
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health care that all women and adolescent girls receive during pregnancy. The overarching principle – to provide pregnant service users with a positive pregnancy experience – aims to encourage countries to expand their health-care agendas beyond survival, with a view to maximizing health, human rights and the potential of their populations. Recognizing that ANC provides a strategic platform for important health-care functions, including health promotion and disease prevention, 14 out of the 49 recommendations in the WHO 2016 ANC guideline relate to nutrition in pregnancy.
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This Pharmaceutical Country Profile for Kenya (2010) has been developed by the Ministry of Medical Services with support of the World Health Organization. The Profile contains information on existing socio-economic
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and health-related conditions, resources, regulatory structures and processes and outcomes relating to the pharmaceutical sector in Kenya.
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Irresponsible pharmaceutical companies fuel the proliferation of superbugs through supply chain pollution, the European Public Health Alliance (EPHA) reports. The advocacy group uncovered lapses such as dirty production
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and inadequate waste disposal in the production of antimicrobials in China and India, which supplies most of the antimicrobials consumed in Europe. In a briefing detailing the pollution, the EPHA urges major purchasers of antibiotics to blacklist irresponsible pharmaceutical companies, demand that the industry clean up its supply chain, introduce greater transparency on the origin of antibiotics, and review and revise procurement policies from an ethics perspective.
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This report, published in conjunction with a summary overview of results of rounds 1–8, is the eighth and final report in a series of laboratory-based evaluations of rapid diagnostic tests (RDTs) for malaria. It provides a comparative measure of
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their performance in a standardized way to distinguish between well and poorly performing tests.
These results constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs and inform the current WHO procurement recommendations. In round 8, 35 RDTs from 17 manufacturers were assessed. For the first time the evaluation included an assessment of product performance against a panel of P. falciparum parasites with pfhrp2/3 gene deletions and therefore not expressing HRP2.
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Antibiotics have been a critical public health tool since the discovery of Penicillin in 1928, saving the lives of millions of people around the world. In developing country like ours, where the burden of treatable disease is very high
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and access to health facilities and laboratories is difficult, antibiotics have long acted as miracle drugs. Today, however, the emergence of drug
resistance in bacteria is reversing the miracles of the past eighty years, with drug choices for the treatment of many bacterial infections becoming increasingly limited, expensive, and in some cases, nonexistent. Diseases previously regarded as relatively easy to manage are much harder to treat as doctors must use “last-resort” drugs that are more costly, take longer to work
and are often unavailable or unaffordable in developing countries. Moreover, regular prescription of antibiotics, random treatment, over the counter sales, inadequate dosage, inclusion of antibiotics in animal feeds and agriculture has contributed equally to emergence of antibiotics resistance as silent epidemic within the country.
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WHO Pharmacovigilance indicators: a practical manual for the assessment of pharmacovigilance systems
This manual provides a practical method for determining the pharmacovigilance indices. It is designed to be simple and can be understood by any worker in pharmacovigilance without formal training in monitoring
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and evaluation. Pharmacovigilance as a medical discipline is crucial in preventing medicine-related adverse effects in humans, promoting patient safety, and the rational use of medicines. The indicators proposed in this manual are based on the expected functions of pharmacovigilance centres as described in the WHO Mimimum Requirements for a Functional Pharmacovigilance System (1) (see Annex 1 of the manual).
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This is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antiretrovirals. It is intended to be a source of practical advice for Pharmacovigilance Centres and health
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professionals involved in HIV/AIDS prevention and treatment programmes. A number of WHO publications are available that provide a background to pharmacovigilance and, as far as possible, that material will not be repeated here. Health officials, planners, the staff of Pharmacovigilance Centres, public health teams and all health workers should become familiar with these publications, which are: • Safety of Medicines: A guide to detecting and reporting adverse drug reactions
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Household transmission investigation protocol for 2019-novel coronavirus (2019-nCoV) infection
recommended
The household transmission investigation is a case-ascertained prospective study of all identified household contacts of a laboratory confirmed 2019-nCoV infection (see 2.2 Study population). It is intended to provide rapid and early information on
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the clinical, epidemiological and virological characteristics of 2019-nCoV.
There are three primary objectives of this household transmission study:
To better understand the extent of transmission within a household by estimating the secondary infection rate for household contacts at an individual level, and factors associated with any variation in the secondary infection risk.
To characterize secondary cases including the range of clinical presentation, risk factors for infection, and the extent and fraction of asymptomatic infections.
To characterize serologic response following confirmed 2019-nCoV infection (highly encouraged, but optional depending on laboratory capacity and resources)
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The WHO COVID-19 Clinical management: living guidance contains the Organization’s most up-to-date recommendations for the clinical management of people with COVID-19. Providing guidance that is comprehensive and holistic for the optimal care of CO
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VID-19 patients throughout their entire illness is important. The latest version of this living guideline is available in pdf format (via the ‘Download’ button) and via an online platform, and is updated regularly as new evidence emerges. No further updates to the previous existing recommendations were made in this latest version.
This updated (fifth) version contains 16 new recommendations for the rehabilitation of adults with post COVID-19 condition (see Chapter 24)
This updated (fourth) version contains three new recommendations regarding hospitalized patients with severe or critical COVID-19
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The World Health Organization’s comprehensive antenatal care (ANC) guideline WHO recommendations on antenatal care for a positive pregnancy experience was first published in 2016 with the objective of improving the quality of routine
...
health care that all women and adolescent girls receive during pregnancy. The overarching principle – to provide pregnant service users with a positive pregnancy experience – aims to encourage countries to expand their health-care agendas beyond survival, with a view to maximizing health, human rights and the potential of their populations. Recognizing that ANC provides a strategic platform for important health-care functions, including health promotion and disease prevention, 14 out of the 49 recommendations in the WHO 2016 ANC guideline relate to nutritional interventions in pregnancy.
more
The Committee discussed the implications for preparedness for smallpox-like events reflected by the ongoing COVID-19 pandemic. The Committee noted how quickly diagnostics and vaccines could be developed an
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d deployed when resources and political will were abundant. This rapidity was also due to the fact that the genetic sequence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had been shared worldwide. It was noted that in one country SARS-CoV-2 had been reconstructed in a laboratory from the viral genome sequence before the first case of COVID-19 had been reported, highlighting the benefits of synthetic biology technologies for accelerated development of diagnostics as well as the oft-described potential risks. Lessons learned about clinical care during the COVID-19 pandemic were also discussed.
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The WHO COVID-19 Clinical management: living guidance contains the most up-to-date recommendations for the clinical management of people with COVID-19. Providing guidance that is comprehensive and holistic for the optimal care of COVID-19 patients t
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hroughout their entire illness is important.
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This update of the Guidelines for poison control, entitled Guidelines for establishing a poison centre, reflects the development of the role of poison centres in public health and the sound manageme
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nt of chemicals, described in section 1, and the opportunities provided by new technology. Assessments carried out under the IHR show
continuing gaps in capacity for managing chemicals (2). In particular, many countries still lack access to poison
centre services (3). There is therefore demand for updated guidance.
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Long-lasting insecticidal nets (LNs) constitute a core vector control intervention against malaria. A number of new LN products are under development and will require assessment of risks to humans. This document provides an updated generic model tha
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t can be used for the risk assessment of exposure to insecticides of individuals sleeping under LNs and during the washing of nets.
In an Annex, exposures and health risks are described for the conventional treatment or retreatment of nets (ITNs) with an insecticide considering that such practices may still be used in evaluation of ITNs and their use. The generic model does not include the risks associated with the manufacturing of LNs in a factory environment. more
In an Annex, exposures and health risks are described for the conventional treatment or retreatment of nets (ITNs) with an insecticide considering that such practices may still be used in evaluation of ITNs and their use. The generic model does not include the risks associated with the manufacturing of LNs in a factory environment. more
This field workbook supports the implementation of the interagency (FAO, UNICEF, WHO) “Communication for Behavioural Impact (COMBI): A toolkit for behavioural and social communication in outbreak response”. It is a handheld guide
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and notebook for applying the WHO COMBI methodology in 7-steps, during an outbreak. It is primarily intended for risk communication, developmental communication and health promotion/education personnel working in multidisciplinary teams to investigate and respond to disease outbreaks. It contains essential tools, checklists, and information needed to design effective behavioural and communication interventions in support of outbreak prevention and control objectives - to limit loss of life and minimize disruption to families, communities and societies
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Based on WHO South-East Asia Regional Strategy on Autism Spectrum Disorder
The collaborative framework for implementation of the “WHO South-East Asia Regional Strategy on Autism Spectrum Disorders” articulates to Member States: the nature of autism spectrum disorder ... and the issues faced by PwASD and their caregivers; the foundation on which the Regional Strategy and the collaborative framework is based; desired outcomes against each objective of the ASD Regional Strategy; recommended actions to fulfill each objective; requisite parameters that should govern the recommended actions; and suggested guidelines for monitoring, evaluating and reporting a Member State’s progress towards fulfilling the objectives. It encourages Member States to share best practices and information for promoting cooperation and partnerships for development of effective and sustainable programmes. more
The collaborative framework for implementation of the “WHO South-East Asia Regional Strategy on Autism Spectrum Disorders” articulates to Member States: the nature of autism spectrum disorder ... and the issues faced by PwASD and their caregivers; the foundation on which the Regional Strategy and the collaborative framework is based; desired outcomes against each objective of the ASD Regional Strategy; recommended actions to fulfill each objective; requisite parameters that should govern the recommended actions; and suggested guidelines for monitoring, evaluating and reporting a Member State’s progress towards fulfilling the objectives. It encourages Member States to share best practices and information for promoting cooperation and partnerships for development of effective and sustainable programmes. more
