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      INFLUENCE OF HUMAN ROTAVIRUS VACCINE IN HOSPITALIZATIONS FOR GASTROENTERITIS IN CHILDREN IN BRAZIL Translated title: INFLUENCIA DE LA VACUNA CONTRA EL ROTAVIRUS HUMANO EN LAS HOSPITALIZACIONES POR GASTROENTERITIS EN NIÑOS EN BRASIL Translated title: INFLUÊNCIA DA VACINA CONTRA O ROTAVÍRUS HUMANO EM HOSPITALIZAÇÕES POR GASTROENTERITE EM CRIANÇAS NO BRASIL

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          Abstract

          ABSTRACT Objectives: to describe and analyze the influence of human rotavirus vaccine on hospitalizations for gastroenteritis in children under 5 years of age, in Brazil, 2001 to 2018 (pre- and post-vaccination period). Method: this is a retrospective, descriptive ecological study, combining the description of a time series from 2001 to 2018 and collected in the months August 2019 to Janaury 2020. The data were obtained from a secondary source. To analyze the effect of different variables, multiple models of mathematical evaluations were used (accumulated growth rate, geometric growth rate; standard deviation, mean, variance and simple linear regression). The level of significance was set at 5% (p <0.05). Results: there was a reduction in hospitalizations related to gastroenteritis in children under 5 years old, when comparing the pre- and post-vaccination periods. This reduction occurred in all Brazilian regions. Conclusion: after the implementation of human rotavirus vaccine, there was a significant reduction in hospitalizations of children under 5 years.

          Translated abstract

          RESUMEN Objetivos: describir y analizar la influencia de la vacuna contra el rotavirus humano en las hospitalizaciones por gastroenteritis en niños menores de 5 años, en Brasil, 2001 a 2018 (período pre y posvacunación). Método: se trata de un estudio ecológico descriptivo, retrospectivo, que combina la descripción de la serie temporal de 2001 a 2018 y recogidos en los meses de 2019 a enero de 2020. Los datos se obtuvieron de una fuente secundaria. Para analizar el efecto de diferentes variables se utilizaron múltiples modelos de evaluaciones matemáticas (tasa de crecimiento acumulada, tasa de crecimiento geométrico; desviación estándar, media, varianza y regresión lineal simple). Se consideró el nivel de significancia del 5% (p<0,05). Resultados: hubo una reducción de las hospitalizaciones por gastroenteritis en menores de 5 años, al comparar los periodos pre y posvacunación. Esta reducción ocurrió en todas las regiones brasileñas. Conclusión: luego de la implementación de la vacuna contra el rotavirus humano, hubo una reducción significativa en las hospitalizaciones de niños menores de 5 años.

          Translated abstract

          RESUMO Objetivos: descrever e analisar a influência da vacina contra o rotavírus humano nas hospitalizações por gastroenterite em crianças menores de 5 anos, no Brasil, 2001 a 2018 (período pré e pós-vacinal). Método: trata-se de um estudo ecológico retrospectivo, descritivo, combinando a descrição das séries temporais do período de 2001 a 2018. Os dados foram obtidos de fonte secundária e coletados nos meses de agosto de 2019 a janeiro de 2020. Para análise do efeito de diferentes variáveis, utilizaram-se múltiplos modelos de avaliações matemáticas (taxa de crescimento acumulado, taxa de crescimento geométrico; desvio padrão, média, variância e regressão linear simples). Considerou-se o nível de significância de 5% (p<0,05). Resultados: houve redução das hospitalizações relacionadas à gastroenterites em crianças menores de 5 anos, quando comparados os períodos pré e pós-vacinal. Essa redução ocorreu em todas as regiões brasileiras. Conclusão: após a implementação da vacina contra o rotavírus humano, houve expressiva redução das hospitalizações de crianças menores de 5 anos.

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          The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies

          Introduction Many questions in medical research are investigated in observational studies [1]. Much of the research into the cause of diseases relies on cohort, case-control, or cross-sectional studies. Observational studies also have a role in research into the benefits and harms of medical interventions [2]. Randomised trials cannot answer all important questions about a given intervention. For example, observational studies are more suitable to detect rare or late adverse effects of treatments, and are more likely to provide an indication of what is achieved in daily medical practice [3]. Research should be reported transparently so that readers can follow what was planned, what was done, what was found, and what conclusions were drawn. The credibility of research depends on a critical assessment by others of the strengths and weaknesses in study design, conduct, and analysis. Transparent reporting is also needed to judge whether and how results can be included in systematic reviews [4,5]. However, in published observational research important information is often missing or unclear. An analysis of epidemiological studies published in general medical and specialist journals found that the rationale behind the choice of potential confounding variables was often not reported [6]. Only few reports of case-control studies in psychiatry explained the methods used to identify cases and controls [7]. In a survey of longitudinal studies in stroke research, 17 of 49 articles (35%) did not specify the eligibility criteria [8]. Others have argued that without sufficient clarity of reporting, the benefits of research might be achieved more slowly [9], and that there is a need for guidance in reporting observational studies [10,11]. Recommendations on the reporting of research can improve reporting quality. The Consolidated Standards of Reporting Trials (CONSORT) Statement was developed in 1996 and revised 5 years later [12]. Many medical journals supported this initiative [13], which has helped to improve the quality of reports of randomised trials [14,15]. Similar initiatives have followed for other research areas—e.g., for the reporting of meta-analyses of randomised trials [16] or diagnostic studies [17]. We established a network of methodologists, researchers, and journal editors to develop recommendations for the reporting of observational research: the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement. Aims and Use of the STROBE Statement The STROBE Statement is a checklist of items that should be addressed in articles reporting on the 3 main study designs of analytical epidemiology: cohort, case-control, and cross-sectional studies. The intention is solely to provide guidance on how to report observational research well: these recommendations are not prescriptions for designing or conducting studies. Also, while clarity of reporting is a prerequisite to evaluation, the checklist is not an instrument to evaluate the quality of observational research. Here we present the STROBE Statement and explain how it was developed. In a detailed companion paper, the Explanation and Elaboration article [18–20], we justify the inclusion of the different checklist items and give methodological background and published examples of what we consider transparent reporting. We strongly recommend using the STROBE checklist in conjunction with the explanatory article, which is available freely on the Web sites of PLoS Medicine (http://www.plosmedicine.org/), Annals of Internal Medicine (http://www.annals.org/), and Epidemiology (http://www.epidem.com/). Development of the STROBE Statement We established the STROBE Initiative in 2004, obtained funding for a workshop and set up a Web site (http://www.strobe-statement.org/). We searched textbooks, bibliographic databases, reference lists, and personal files for relevant material, including previous recommendations, empirical studies of reporting and articles describing relevant methodological research. Because observational research makes use of many different study designs, we felt that the scope of STROBE had to be clearly defined early on. We decided to focus on the 3 study designs that are used most widely in analytical observational research: cohort, case-control, and cross-sectional studies. We organised a 2-day workshop in Bristol, UK, in September 2004. 23 individuals attended this meeting, including editorial staff from Annals of Internal Medicine, BMJ, Bulletin of the World Health Organization, International Journal of Epidemiology, JAMA, Preventive Medicine, and The Lancet, as well as epidemiologists, methodologists, statisticians, and practitioners from Europe and North America. Written contributions were sought from 10 other individuals who declared an interest in contributing to STROBE, but could not attend. Three working groups identified items deemed to be important to include in checklists for each type of study. A provisional list of items prepared in advance (available from our Web site) was used to facilitate discussions. The 3 draft checklists were then discussed by all participants and, where possible, items were revised to make them applicable to all three study designs. In a final plenary session, the group decided on the strategy for finalizing and disseminating the STROBE Statement. After the workshop we drafted a combined checklist including all three designs and made it available on our Web site. We invited participants and additional scientists and editors to comment on this draft checklist. We subsequently published 3 revisions on the Web site, and 2 summaries of comments received and changes made. During this process the coordinating group (i.e., the authors of the present paper) met on eight occasions for 1 or 2 days and held several telephone conferences to revise the checklist and to prepare the present paper and the Explanation and Elaboration paper [18–20]. The coordinating group invited 3 additional co-authors with methodological and editorial expertise to help write the Explanation and Elaboration paper, and sought feedback from more than 30 people, who are listed at the end of this paper. We allowed several weeks for comments on subsequent drafts of the paper and reminded collaborators about deadlines by e-mail. STROBE Components The STROBE Statement is a checklist of 22 items that we consider essential for good reporting of observational studies (Table 1). These items relate to the article's title and abstract (item 1), the introduction (items 2 and 3), methods (items 4–12), results (items 13–17) and discussion sections (items 18–21), and other information (item 22 on funding). 18 items are common to all three designs, while four (items 6, 12, 14, and 15) are design-specific, with different versions for all or part of the item. For some items (indicated by asterisks), information should be given separately for cases and controls in case-control studies, or exposed and unexposed groups in cohort and cross-sectional studies. Although presented here as a single checklist, separate checklists are available for each of the 3 study designs on the STROBE Web site. Table 1 The STROBE Statement—Checklist of Items That Should Be Addressed in Reports of Observational Studies Implications and Limitations The STROBE Statement was developed to assist authors when writing up analytical observational studies, to support editors and reviewers when considering such articles for publication, and to help readers when critically appraising published articles. We developed the checklist through an open process, taking into account the experience gained with previous initiatives, in particular CONSORT. We reviewed the relevant empirical evidence as well as methodological work, and subjected consecutive drafts to an extensive iterative process of consultation. The checklist presented here is thus based on input from a large number of individuals with diverse backgrounds and perspectives. The comprehensive explanatory article [18–20], which is intended for use alongside the checklist, also benefited greatly from this consultation process. Observational studies serve a wide range of purposes, on a continuum from the discovery of new findings to the confirmation or refutation of previous findings [18–20]. Some studies are essentially exploratory and raise interesting hypotheses. Others pursue clearly defined hypotheses in available data. In yet another type of studies, the collection of new data is planned carefully on the basis of an existing hypothesis. We believe the present checklist can be useful for all these studies, since the readers always need to know what was planned (and what was not), what was done, what was found, and what the results mean. We acknowledge that STROBE is currently limited to three main observational study designs. We would welcome extensions that adapt the checklist to other designs—e.g., case-crossover studies or ecological studies—and also to specific topic areas. Four extensions are now available for the CONSORT statement [21–24]. A first extension to STROBE is underway for gene-disease association studies: the STROBE Extension to Genetic Association studies (STREGA) initiative [25]. We ask those who aim to develop extensions of the STROBE Statement to contact the coordinating group first to avoid duplication of effort. The STROBE Statement should not be interpreted as an attempt to prescribe the reporting of observational research in a rigid format. The checklist items should be addressed in sufficient detail and with clarity somewhere in an article, but the order and format for presenting information depends on author preferences, journal style, and the traditions of the research field. For instance, we discuss the reporting of results under a number of separate items, while recognizing that authors might address several items within a single section of text or in a table. Also, item 22, on the source of funding and the role of funders, could be addressed in an appendix or in the methods section of the article. We do not aim at standardising reporting. Authors of randomised clinical trials were asked by an editor of a specialist medical journal to “CONSORT” their manuscripts on submission [26]. We believe that manuscripts should not be “STROBEd”, in the sense of regulating style or terminology. We encourage authors to use narrative elements, including the description of illustrative cases, to complement the essential information about their study, and to make their articles an interesting read [27]. We emphasise that the STROBE Statement was not developed as a tool for assessing the quality of published observational research. Such instruments have been developed by other groups and were the subject of a recent systematic review [28]. In the Explanation and Elaboration paper, we used several examples of good reporting from studies whose results were not confirmed in further research – the important feature was the good reporting, not whether the research was of good quality. However, if STROBE is adopted by authors and journals, issues such as confounding, bias, and generalisability could become more transparent, which might help temper the over-enthusiastic reporting of new findings in the scientific community and popular media [29], and improve the methodology of studies in the long term. Better reporting may also help to have more informed decisions about when new studies are needed, and what they should address. We did not undertake a comprehensive systematic review for each of the checklist items and sub-items, or do our own research to fill gaps in the evidence base. Further, although no one was excluded from the process, the composition of the group of contributors was influenced by existing networks and was not representative in terms of geography (it was dominated by contributors from Europe and North America) and probably was not representative in terms of research interests and disciplines. We stress that STROBE and other recommendations on the reporting of research should be seen as evolving documents that require continual assessment, refinement, and, if necessary, change. We welcome suggestions for the further dissemination of STROBE—e.g., by re-publication of the present article in specialist journals and in journals published in other languages. Groups or individuals who intend to translate the checklist to other languages should consult the coordinating group beforehand. We will revise the checklist in the future, taking into account comments, criticism, new evidence, and experience from its use. We invite readers to submit their comments via the STROBE Web site (http://www.strobe-statement.org/).
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            Effectiveness of Rotavirus Vaccination: A systematic review of the first decade of global post-licensure data, 2006-2016.

            Two rotavirus vaccines, Rotarix (RV1) and RotaTeq (RV5), were licensed for global use in 2006. A systematic review of 48 peer-reviewed articles with post-licensure data from 24 countries showed a median RV1 vaccine effectiveness (VE) of 84%, 75%, and 57% in low, medium, and high child mortality countries, respectively, and RV5 VE of 90% in low and 45% in high child mortality countries. A partial vaccine series provided considerable protection, but not to the same level as a full series. VE tended to decline in the second year of life, particularly in medium and high mortality settings, and tended to be greater against more severe rotavirus disease. Post-licensure data from countries across geographic regions and with different child mortality levels demonstrate that under routine use, both RV1 and RV5 are effective against rotavirus disease, supporting the WHO recommendation that all countries introduce rotavirus vaccine into their national immunization program.
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              Política Nacional de Atenção Básica 2017: retrocessos e riscos para o Sistema Único de Saúde

              RESUMO O artigo discute os significados e as implicações das mudanças introduzidas pela Política Nacional de Atenção Básica 2017, que promovem a relativização da cobertura universal, a segmentação do acesso, a recomposição das equipes, a reorganização do processo de trabalho e a fragilização da coordenação nacional da política. Argumenta-se que sua revisão indica sérios riscos para as conquistas obtidas com o fortalecimento da Atenção Primária à Saúde no Brasil. Na conjuntura atual de fortalecimento da ideologia neoliberal, tais modificações reforçam a subtração de direitos e o processo de desconstrução do Sistema Único de Saúde em curso no País.
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                Author and article information

                Journal
                tce
                Texto & Contexto - Enfermagem
                Texto contexto - enferm.
                Universidade Federal de Santa Catarina, Programa de Pós Graduação em Enfermagem (, SC, Brazil )
                0104-0707
                1980-265X
                2021
                : 30
                Affiliations
                Gurupi Tocantins orgnameUniversidade de Gurupi orgdiv1Departamento de Medicina Brasil
                Balsas Maranhão orgnameUniversidade Estadual do Maranhão orgdiv1Centro de Estudos Superiores de Balsas Brazil
                Rio de Janeiro Rio de Janeiro orgnameUniversidade Federal do Rio de Janeiro orgdiv1Centro de Ciências da Saúde orgdiv2Escola de Enfermagem Anna Nery Brazil
                Article
                S0104-07072021000100339 S0104-0707(21)03000000339
                10.1590/1980-265x-tce-2020-0354

                This work is licensed under a Creative Commons Attribution 4.0 International License.

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