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This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic tests (RDTs) for symptomatic patients. It summarises the minimum performance requirements, includin
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g analytical and clinical performance standards, and emphasises considerations relating to diverse specimen types, testing environments and user populations in low- and middle-income countries. The guidance is aligned with the criteria and prequalification processes of the WHO Global Malaria Programme, while clarifying that demonstration of clinical utility is outside the scope of prequalification.
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This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic tests (RDTs) for symptomatic patients. It summarises the minimum performance requirements, includin
...
g analytical and clinical performance standards, and emphasises considerations relating to diverse specimen types, testing environments and user populations in low- and middle-income countries. The guidance is aligned with the criteria and prequalification processes of the WHO Global Malaria Programme, while clarifying that demonstration of clinical utility is outside the scope of prequalification.
more
Non-Communicable Diseases (NCDs) have emerged as conditions of great public health concern in Kenya accounting for 39% of deaths annually. The Ministry of Health through the Department of Non-Communicable Diseases has adopted the vision of achieving a nation free from preventable burden of NCDs. Fur
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ther, the mission of this strategy is to halt and reverse the rising burden of NCDs through effective multisectoral collaboration and partnerships by ensuring Kenyans receive the highest attainable standard of NCD continuum of care that is accessible, affordable, quality, equitable and sustainable thus alleviating suffering, disease and death for their well-being and socio-economic development.
The scope of NCDs covered by this strategy include; cardiovascular diseases, cancer, diabetes, chronic respiratory diseases, mental health conditions, violence and injuries, hemoglobinopathies, haemophilia and other bleeding disorders, auto immune diseases, chronic renal diseases, epilepsy and other neurological disorders, chronic skin conditions and oral diseases and conditions. It equally addresses seven risk factors; tobacco use, harmful use of alcohol, unhealthy diets and toxins, physical inactivity, indoor air pollution, environmental pollutants and toxins and stress.
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Health in All Policies (HiAP) promotes health and equity. It is based on the recognition that our greatest health challenges for example, non-communicable diseases, health inequities and inequalities, climate change, and spiraling health care costs are highly complex and often linked through the soc
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ial determinants of health (SDH). In this context, promoting healthy communities, and in particular health equity across different population groups, requires that we address the social determinants of health, such as public transportation, education access, access to healthy food, economic opportunities, and more. While many public policies work to achieve this, conflicts of interest may arise. Alternatively, unintended impacts of policies are not measured and addressed. This requires innovative solutions, and structures that build channels for dialogue and decision-making that work across traditional government policy siloes. Hence, HiAP could be adopted to ensure commitment from the highest decision makers within government to address the social determinants of health.
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To guide the provision of quality palliative care services across the African region, the African Palliative Care Association (APCA) has developed a framework of core palliative care competencies that can be used by service providers, educators and other stakeholders to guide programmes development.
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These guidelines have been developed in simple, user-friendly language and they explain the procedures for patients’ access to and the safe management of Schedule I and II drugs that are necessary for the treatment and relief of moderate to severe pain. They provide both procedures for acquisition
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and information on records or documents that are necessary to ensure that these medicines are made available and accessible to patients across the entire health care delivery system (i.e. from tertiary institutions to primary level) and ensuring prevention of illicit non-medical use.
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The African Palliative Care Association is pleased to publish the first edition of Palliative Care Standards for Africa. The development of these standards was achieved through wide consultation with service beneficiaries and providers, and they have been developed to suit different levels of
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service delivery, from primary to tertiary. These standards are underpinned by the World Health Organization’s definition of palliative care, and recognise that scaling up palliative care requires a public health approach with four pillars: policy, education, drug availability and implementation. In addition, the increasing need to establish specific indicators of quality and effectiveness for palliative care has been a big driving force behind these comprehensive standards. It is APCA’s wish that they will provide a framework for the development of evaluation
and performance indicators that can facilitate programme improvement and development. The standards are designed to allow the development or improvement of palliative care across the different services levels, within the organisational capacity of various service providers. They describe a relationship between primary, intermediary and tertiary level service providers, with expectations for all providers articulated through detailed criteria for each standard. It is therefore expected that these standards will influence the planning and delivery of palliative care services at all levels of health care service delivery.
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The Guidelines for the Use of the APCA African Palliative Outcome Scale (POS) has been developed by the APCA, in collaboration with
stakeholders, to help appropriately trained health practitioners and researchers across the region to utilise the APCA African POS in their work place (Powell et
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al, 2007; Warria et al, 2007). Not only do the guidelines provide a clear rationale for measuring palliative care outcomes, but they also outline practical information on how to use the tool to collect data and analyse its results. So why is there a need for these guidelines?
Palliative care as a concept and discipline is not well understood across Africa, and its development is still embryonic in many countries. While there are many obstacles that hinder palliative care development on the continent, a key challenge is the lack of accurate information about the palliative care being provided and its outcomes. The APCA African POS is a useful tool to help us measure these outcomes and, given that
measuring palliative care outcomes remains a relatively new concept, it is important to guide people on how to use the tool. Of course, these guidelines are not intended to address everything related to the measurement of palliative care outcomes; they contain only essential information for providers. More detailed information on the use of outcome tools, and in particular within the research setting, can be gained from contacting relevantly trained professionals.
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In the absence of a such a measure, and building on the success of developing the APCA African
Palliative Outcome Scale (POS) for adults, the African Palliative Care Association has developed the
APCA African Children’s POS. The tool has been validated across diseases, countries, settings and
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languages and used in both quality improvement and research studies. Moreover, feedback on the
tool from doctors and nurses who have used it has been very supportive, with providers perceiving
it as an easy-to-use instrument that helps them undertake holistic assessments that in part entail
discussing difficult issues.
This booklet is a practical guide intended to help users employ the APCA African POS correctly.
Following a discussion of the origins and background to the APCA African PPOS, the guide discusses
the measurement of outcomes, the development of the tool and its use (including the analysis of
collected data), before finishing with illustrative examples of the use of the questionnaire.
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