Guidelines on COVID-19 vaccination in patients with immune-mediated rheumatic diseases: a Brazilian Society of Rheumatology task force.

OBJECTIVE: To provide guidelines on the coronavirus disease 2019 (COVID-19) vaccination in patients with immune-mediated rheumatic diseases (IMRD) to rheumatologists considering specific scenarios of the daily practice based on the shared-making decision (SMD) process. METHODS: A task force was constituted by 24 rheumatologists (panel members), with clinical and research expertise in immunizations and infectious diseases in immunocompromised patients, endorsed by the Brazilian Society of Rheumatology (BSR), to develop guidelines for COVID-19 vaccination in patients with IMRD. A consensus was built through the Delphi method and involved four rounds of anonymous voting, where five options were used to determine the level of agreement (LOA), based on the Likert Scale: (1) strongly disagree; (2) disagree, (3) neither agree nor disagree (neutral); (4) agree; and (5) strongly agree. Nineteen questions were addressed and discussed via teleconference to formulate the answers. In order to identify the relevant data on COVID-19 vaccines, a search with standardized descriptors and synonyms was performed on September 10th, 2021, of the MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and LILACS to identify studies of interest. We used the Newcastle-Ottawa Scale to assess the quality of nonrandomized studies. RESULTS: All the nineteen questions-answers (Q&A) were approved by the BSR Task Force with more than 80% of panelists voting options 4-agree-and 5-strongly agree-, and a consensus was reached. These Guidelines were focused in SMD on the most appropriate timing for IMRD patients to get vaccinated to reach the adequate covid-19 vaccination response. CONCLUSION: These guidelines were developed by a BSR Task Force with a high LOA among panelists, based on the literature review of published studies and expert opinion for COVID-19 vaccination in IMRD patients. Noteworthy, in the pandemic period, up to the time of the review and the consensus process for this document, high-quality evidence was scarce. Thus, it is not a substitute for clinical judgment.

Guidelines on COVID-19 vaccination in patients with immune-mediated rheumatic diseases: a Brazilian Society of Rheumatology task force

Abstract Objective: To provide guidelines on the coronavirus disease 2019 (COVID-19) vaccination in patients with immune-mediated rheumatic diseases (IMRD) to rheumatologists considering specific scenarios of the daily practice based on the shared-making decision (SMD) process. Methods: A task force was constituted by 24 rheumatologists (panel members), with clinical and research expertise in immunizations and infectious diseases in immunocompromised patients, endorsed by the Brazilian Society of Rheumatology (BSR), to develop guidelines for COVID-19 vaccination in patients with IMRD. A consensus was built through the Delphi method and involved four rounds of anonymous voting, where five options were used to determine the level of agreement (LOA), based on the Likert Scale: (1) strongly disagree; (2) disagree, (3) neither agree nor disagree (neutral); (4) agree; and (5) strongly agree. Nineteen questions were addressed and discussed via teleconference to formulate the answers. In order to identify the relevant data on COVID-19 vaccines, a search with standardized descriptors and synonyms was performed on September 10th, 2021, of the MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and LILACS to identify studies of interest. We used the Newcastle-Ottawa Scale to assess the quality of nonrandomized studies. Results: All the nineteen questions-answers (Q&A) were approved by the BSR Task Force with more than 80% of panelists voting options 4—agree—and 5—strongly agree—, and a consensus was reached. These Guidelines were focused in SMD on the most appropriate timing for IMRD patients to get vaccinated to reach the adequate covid-19 vaccination response. Conclusion: These guidelines were developed by a BSR Task Force with a high LOA among panelists, based on the literature review of published studies and expert opinion for COVID-19 vaccination in IMRD patients. Noteworthy, in the pandemic period, up to the time of the review and the consensus process for this document, high-quality evidence was scarce. Thus, it is not a substitute for clinical judgment.

Public Health Academic Alliance for COVID-19 Response: The Role of a National Medical Task Force in Puerto Rico.

Alliances between the government and academic communities can be a key component of the public health response to an emergency such as the coronavirus disease 2019 (COVID-19) pandemic. The Governor of Puerto Rico designated the Puerto Rico Medical Task Force (MTF) COVID-19 to provide direct guidance and evaluation of the government response to the epidemic in Puerto Rico. Several work groups were formed within the MTF to create protocols and provide evidence-based recommendations on different public health aspects. The collaboration between the academia and the government enhanced the Puerto Rican public health response and contributed to the reduction seen in the contagion curve. Healthcare services and hospitals have not reached their maximum patient care capacity and the death toll has been controlled. Incorporating a national MTF with members of the academia into the government structure was beneficial during the COVID-19 response in Puerto Rico. A similar strategy could serve as a model for other states or territories and countries in similar scenarios.

El apoyo a la innovación desde las agencias regulatorias. Experiencia internacional y nacional: el equipo multidisciplinario de apoyo a la innovación de la ANMAT / Innovation support from Regulatory Agencies. National and international experiences: The case of the multidisciplinary innovation support team of the ANMAT

En la actualidad existe un notable desarrollo de productos innovadores orientados a dar nuevas soluciones en materia de salud. En este marco, caracterizado por un escenario de conocimientos nuevos, multidisciplinario y, a su vez con pocos antecedentes a nivel regulatorio, las agencias sanitarias tienen el gran desafío de establecer el marco normativo para asegurar la seguridad y eficacia de estos productos. Por otro lado, dichos organismos se imponen el deber de propiciar el desarrollo de nuevas tecnologías de manera de impulsar, lo más pronto posible, su llegada a las personas que lo necesiten. Esta breve revisión se enfoca en analizar algunas de las iniciativas llevadas a cabo por algunas de las más importantes agencias regulatorias internacionales (EMA, FDA, Health Canada), organismos de referencia en salud (OMS, OPS) y espacios de convergencia regulatoria (IMDRF) en la evaluación e impulso a la innovación y, en particular, se hace hincapié en describir el trabajo del Equipo Multidisciplinario de Apoyo a la Innovación (EMAI) de la Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, orientado a brindar asistencia a proyectos y productos que revistan carácter de innovadores y resulten de interés para la salud pública.

Currently, there is a remarkable development of innovative products aimed at offering new solutions in matters of health. In this scenario, characterized by new multidisciplinary knowledge and little regulatory background, sanitary agencies address the great challenge of establishing the regulatory framework to ensure the safety and efficacy of these products. On the other hand, these organizations have the duty to encourage the development of innovative technologies in order to promote, as soon as possible, the arrival to people who need them. This brief review focuses on analyzing some of the initiatives carried out by some of the most important international regulatory agencies (EMA, FDA, Health Canada), health reference organizations (WHO, PAHO) and regulatory convergence spaces (IMDRF) on the evaluation and promotion of innovation and, in particular, it emphasizes describing the work of the Multidisciplinary Innovation Support Team of ANMAT (Argentinian regulatory agency), aimed at providing assistance to projects and products that are innovative and of interest to public health.

Highlights of key initiatives 2017-2018

This document highlights the major achievement of the Ministry of Health for the period 2017-2018. Contains information about compassionate care, the strengthening of the health system , treatment of non-communicable, combating communicable diseases, protecting the health of mothers and children and rehabilitation and new investment in critical health infrastructure.

General recommendations paper on the management of older patients with cancer: the SEOM geriatric oncology task force's position statement.

Population aging is associated with greater numbers of older people with cancer. Thanks to treatment advances, not only are more seniors diagnosed with cancer, but there are also more and more older cancer survivors. This upward trend will continue. Given the heterogeneity of aging, managing older patients with cancer poses a significant challenge for Medical Oncology. In Spain, a Geriatric Oncology Task Force has been set up within the framework of the Spanish Society for Medical Oncology (SEOM). With the aim of generating evidence and raising awareness, as well as helping medical oncologists in their training with respect to seniors with cancer, we have put together a series of basic management recommendations for this population. Many of the patients who are assessed in routine clinical practice in Oncology are older. CGA is the basic tool by means of which to evaluate older people with cancer and to understand their needs. Training and the correct use of recommendations regarding treatment for comorbidities and geriatric syndromes, support care, and drug-drug interactions and toxicities, including those of antineoplastic agents, as detailed in this article, will ensure that this population is properly managed.

Ministry of Health Annual report 2016-2017: Highlights of key initiatives

This document highlights the major achievement of the Ministry of Health for the period 2016-2017. Contains information about compassionate care, the strengthening of the health system , treatment of non-communicable diseases, combating communicable diseases, protecting the health of mothers and children, rehabilitation and new investment in critical health infrastructure.

Position statement on fetal myelomeningocele repair.

Following the promising multicenter randomized trial results of in utero fetal myelomeningocele repair; we anticipate that an increasing number of tertiary care centers may want to offer this therapy. It is essential to establish minimum criteria for centers providing open fetal myelomeningocele repair to ensure optimal maternal and fetal/pediatric outcomes, as well as patient safety both short- and long-term; and to advance our knowledge of the role and benefit of fetal surgery in the management of fetal myelomeningocele. The fetal myelomeningocele Maternal-Fetal Management Task Force was initially convened by the Eunice Kennedy Shriver National Institute of Child Health and Human Development to discuss the implementation of maternal fetal surgery for myelomeningocele. The decision was made to develop the optimal practice criteria presented in this document for the purpose of medical and surgical leadership. These criteria are not intended to be used for legal or regulatory purposes.