scholarly journals Guidance for the Evaluation of Tuberculosis Diagnostics That Meet the World Health Organization (WHO) Target Product Profiles: An Introduction to WHO Process and Study Design Principles

2019 ◽  
Vol 220 (Supplement_3) ◽  
pp. S91-S98 ◽  
Author(s):  
Claudia M Denkinger ◽  
Samuel G Schumacher ◽  
Christopher Gilpin ◽  
Alexei Korobitsyn ◽  
William A Wells ◽  
...  

Abstract Existing high-priority target product profiles (TPPs) of the World Health Organization (WHO) establish important needs for tuberculosis (TB) diagnostic development. Building on this earlier work, this guidance series aims to provide study guidance for performing accuracy studies of novel diagnostic products that may meet the 4 high-priority WHO TPPs and thus enable adequate evidence generation to inform a WHO evidence review process. Diagnostic accuracy studies represent a fundamental step in the validation of all tests. Unfortunately, such studies often have limitations in design, execution, and reporting, leading to low certainty of the evidence about true test performance, which can delay or impede policy and scale-up decisions. This introductory paper outlines the following: (1) the purpose of this series of papers on study guidance; (2) WHO evidence needs and process for the development of policy guidelines for new TB diagnostic tests; and (3) study design considerations, ie, general diagnostic study considerations, intended use of test and role in the clinical pathway, choice of population and setting, index-test specific issues, suitable reference standard and comparators, study flow and specimen issues, and finally key issues beyond accuracy that should be considered. The other 4 papers in this series will provide more detailed guidance for each of the 4 WHO high-priority TPPs. By increasing the clarity around the clinical evaluation needs for tests that have the potential to meet the TPP specifications, we hope to support harmonized evidence generation and enable the WHO review process towards meeting the WHO End TB Strategy targets for reducing the incidence and mortality associated with TB.

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Getachew Seid ◽  
Tsegaye Tsedalu ◽  
Marta Ayele ◽  
Faham Khamesipour

Background. The World Health Organization recommends that all children below the age of five who have household contact with an infectious tuberculosis case should receive isoniazid preventive treatment for at least six months after the active tuberculosis disease has been ruled out. This research aims to determine the adherence of children, eligible for isoniazid preventive treatment, to the treatment who had contact with pulmonary tuberculosis patients. Methods. A mixed study design was used to prospectively assess the adherence to IPT among children under the age of 5 in contact with pulmonary TB patients through the quantitative study design and barriers of adherence in view of health care professionals and the family of children through a descriptive qualitative study. The study was conducted from July 2019 to December 2019 in Addis Ababa. Data were collected by a structured datasheet from the selected health center registration book. Data were entered into Epi Data software and analyzed by using SPSS version 20. Descriptive statistical methods were used to summarize the sociodemographic characteristics of the study participants. Result. The ratio of the total number of pulmonary tuberculosis index cases recruited into the study to the number of child contacts aged less than 5 years was 1 : 1.32. The total isoniazid preventive treatment uptake in this study was 75.2%; one-fifth (21.3%) of the children who started IPT did not complete the full course of six-month isoniazid preventive treatment. Except for HIV not to be tested ( P < 0.001 ), there was no significant association of the listed risk factors in default to complete the full six months of preventive treatment. Conclusion. Enrolment of eligible children for isoniazid preventive treatment in the urban city Addis Ababa was still below the target of the World Health Organization End tuberculosis strategy by 2030. The treatment adherence rate also needs a great deal of effort to achieve the strategy. Child default after the first visit indicates a lack of understanding about the benefit and safety of preventive therapy in young children among families of TB patients, and awareness-creating efforts by health extension workers will help to improve the outcomes.


2017 ◽  
Vol 79 (07) ◽  
pp. 526-527

Coenen M et al. [Recommendation for the collection and analysis of data on participation and disability from the perspective of the World Health Organization]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2016; 59: 1060–1067 Um eine gleichberechtigte Teilhabe an der Gesellschaft von Menschen mit Behinderung zu ermöglichen, werden zunächst Daten zu vorhandenen Einschränkungen gebraucht. Erst wenn diese detailliert erhoben wurden, können Konzepte zur Beseitigung von Problemen entwickelt werden. Ein standardisiertes Erhebungsinstrument für alle Aspekte der Funktionsfähigkeit fehlte jedoch bisher.


2020 ◽  
Vol 10 (31) ◽  
pp. 87-95
Author(s):  
Nicole Maria Miyamoto Bettini ◽  
Fabiana Tomé Ramos ◽  
Priscila Masquetto Vieira de Almeida

A Organização Mundial da Saúde - OMS confirmou a circulação internacional do novo Coronavírus em janeiro de 2020, nomeando-o como COVID-19 e, declarando uma pandemia. É de extrema importância que durante a pandemia, os profissionais de saúde tenham acesso e conhecimento sobre o uso correto dos Equipamentos de Proteção Individual (EPIs) e suas indicações, tomando assim, as devidas precauções na prevenção de infecções. O presente estudo buscou identificar a padronização mundial quanto ao uso dos EPIs utilizados no atendimento a pacientes suspeitos e/ou confirmados de COVID-19 no Brasil, EUA, China, Espanha, Itália e demais países europeus. Os guidelines apresentam a padronização quanto ao uso dos EPIs utilizados no atendimento a suspeitos e/ou confirmados de COVID-19, indo ao encontro das recomendações fornecidas pela OMS. Até o momento, o uso de EPIs é sem dúvida a estratégia mais importante e eficaz para proteger os profissionais de saúde durante a assistência ao paciente com COVID-19.Descritores: Infecções por Coronavírus, Equipamento de Proteção Individual, Pessoal de Saúde, Enfermagem. Recommendations for personal protective equipment to combat COVID-19Abstract: The World Health Organization - WHO confirmed the international circulation of the new Coronavirus in January 2020, naming it as COVID-19 and declaring a pandemic. It is extremely important that during the pandemic, health professionals have access and knowledge about the correct use of Personal Protective Equipment (PPE) and its indications, thus taking appropriate precautions to prevent infections. The present study sought to identify the worldwide standardization regarding the use of PPE utilized to take care of suspected and confirmed patients with COVID-19 in Brazil, USA, China, Spain, Italy and other European countries. The guidelines present a standardization regarding the use of PPE utilized to take care of suspected and confirmed with COVID-19, in line with the recommendations provided by WHO. To date, the use of PPE is undoubtedly the most important and effective strategy to protect healthcare professionals during care for patients with COVID-19.Descriptors: Coronavirus Infections, Personal Protective Equipment, Health Personnel, Nursing. Recomendaciones para el equipo de protección personal para combatir COVID-19Resumen: La Organización Mundial de la Salud - La OMS confirmó la circulación internacional del nuevo Coronavirus en enero de 2020, nombrándolo COVID-19 y declarando una pandemia. Es extremadamente importante que durante la pandemia, los profesionales de la salud tengan acceso y conocimiento sobre el uso correcto del Equipo de Protección Personal (EPP) y sus indicaciones, tomando así las precauciones adecuadas para prevenir infecciones. El presente estudio buscó identificar la estandarización mundial con respecto al uso de EPP utilizado para atender a pacientes sospechosos y/o confirmados con COVID-19 en Brasil, Estados Unidos, China, España, Italia y otros países europeos. Las pautas presentan la estandarización con respecto al uso de EPP utilizado para cuidar COVID-19 sospechoso y/o confirmado, de acuerdo con las recomendaciones proporcionadas por la OMS. Hasta la fecha, el uso de EPP es, sin duda, la estrategia más importante y efectiva para proteger a los profesionales de la salud durante la atención de pacientes con COVID-19.Descriptores: Infecciones por Coronavirus, Equipo de Protección Personal, Personal de Salud, Enfermería.


Author(s):  
Ghotekar D S ◽  
Vishal N Kushare ◽  
Sagar V Ghotekar

Coronaviruses are a family of viruses that cause illness such as respiratory diseases or gastrointestinal diseases. Respiratory diseases can range from the common cold to more severe diseases. A novel coronavirus outbreak was first documented in Wuhan, Hubei Province, China in December 2019. The World Health Organization (WHO) has declared the coronavirus disease 2019 (COVID-19) a pandemic. A global coordinated effort is needed to stop the further spread of the virus. A novel coronavirus (nCoV) is a new strain that has not been identified in humans previously. Once scientists determine exactly what coronavirus it is, they give it a name (as in the case of COVID-19, the virus causing it is SARS-CoV-2).


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