OP131 Rapid Review For Policy: Interchangeability Of Biological Medicines

2019 ◽  
Vol 35 (S1) ◽  
pp. 30-30
Author(s):  
Daniela Rego ◽  
Cecilia Farinasso ◽  
Roberta Borges Silva ◽  
Dalila Fernandes Gomes ◽  
Aurelina Aguiar de Aguiar ◽  
...  
Keyword(s):  
Health System ◽  
Systematic Reviews ◽  
Evidence Synthesis ◽  
Scientific Evidence ◽  
National Policy ◽  
Primary Objective ◽  
Rapid Review ◽  
Pharmacovigilance System ◽  
Independent Manner ◽  
Unified Health System

IntroductionDue to the high judicialization rates which pressure the financing of biologic medicines by the Brazilian Unified Health System (Sistema Único de Saúde - SUS), it has been decided to formulate the National Policy for Biologic Medicines. After identification of problems and prioritization, interchangeability based only on economic criteria was the main problem to be confronted. The primary objective of this study was to identify political options to approach the problem of interchangeability in systematic reviews.MethodsWe conducted a rapid evidence synthesis for policy based on an adaptation of the SUPPORT tools, and searched in six literature databases. The selection of studies was performed in a systematic, transparent and independent manner. The International Network of Agencies in Health Technology Assessment (INAHTA) members were consulted to learn how this practice occurs worldwide.ResultsWe included seven systematic reviews and one policy brief, whose options to approach the problem were: production of robust scientific evidence on interchangeability; implementation of a pharmacovigilance system; appreciation of the clinical efficacy in the practice of interchangeability; and educational strategies for healthcare professionals in Brazil. Nine countries responded to our query.ConclusionsEvidence-informed policy has a central role for the Brazilian Ministry of Health. The present rapid evidence synthesis for policy will subsidize decision making regarding the interchangeability of biologic medicines within the Brazilian Unified Health System.

scholarly journals Regulation of herbal medicines in Brazil: advances and perspectives

2011 ◽  
Vol 47 (3) ◽  
pp. 467-473 ◽  
Author(s):  
Ana Cecília Bezerra Carvalho ◽  
João Paulo Silvério Perfeito ◽  
Leandro Viana Costa e Silva ◽  
Lívia Santos Ramalho ◽  
Robelma France de Oliveira Marques ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Medicinal Plants ◽  
Health System ◽  
National Policy ◽  
Herbal Medicines ◽  
Health Surveillance ◽  
Safety And Efficacy ◽  
Unified Health System

The National Policy of Integrative and Complementary Practices (PNPIC) in the Brazilian Unified Health System (SUS), and The National Policy of Medicinal Plants and Herbal Medicines (PNPMF) were launched in 2006. Based on these, the Brazilian Health Surveillance Agency (ANVISA) re-edited rules related to herbal medicines such as the Guideline to herbal medicine registration (RDC 14/10), the Good Manufacture Practices Guideline (RDC 17/10) and the List of references to assess the safety and efficacy of herbal medicines (IN 05/10). The requisites to prove herbal medicine's safety and efficacy were updated. Therefore, this review aims at presenting and commenting these new rules.

scholarly journals An evaluation matrix for self-instructional courses of Continuing and Online Education in Health

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
K C S Gasque ◽  
F L Guizardi ◽  
SMDBTC Coomans de Brachene ◽  
K Fernandes ◽  
E B Dutra ◽  
...  
Keyword(s):  
Online Education ◽  
Health System ◽  
Continuing Education ◽  
National Policy ◽  
Quality Criteria ◽  
Evaluation Tool ◽  
Good Tool ◽  
Unified Health System ◽  
The Matrix ◽  
Evaluation Matrix

Abstract Background In 2003, the National Policy for Continuing Education in Health (PNEPS) was created as a strategy to train and update workers of the Unified Health System. To be effectively instituted, the Open University of the Brazilian Unified Public Health System was conceived to offer free online courses. But, it was observed that the online educational modules developed were not structural and pedagogically homogeneous. Objective Propose a matrix of criteria and guidelines to support the improvement of the design of instructional modules, investigating three main areas: ergonomics, education and health. Methodology Anasynthesis was the approach to build the evaluation matrix. Results The matrix consists of 29 criteria (Accessibility, Progression Activities, Updating Practices, Self-Analysis and Self-Management, Assessment, Cognitive Load, Student-Centered, Collaboration, Compatibility and Interoperability, Consistency, Knowledge Building, Student Control, Documentation and Help, Aesthetics, Feedback, Flexibility, Error Management, Interactivity, Maintenance, Clear Instructional Goals and Objectives, Motivation, Personalization, Problem Practicing, Critical Reflection, Relevance, Renewable, Safety, Use of Different Paths, Valorization of Knowledge) with 132 guidelines that allows to check if the online self-instructional module meets minimum quality criteria. Five courses produced by the UNA-SUS system were tested and compared with the perception of users of these courses, obtained by the polls for opening and closing the courses. There was an approximation between the evaluations using the matrix and the responses of the surveys of the courses, answered by the users. Results from these surveys were transferred to a user matrix. The Interactivity and Collaboration criteria were considered non-mandatory for self-instructional courses without tutors. Conclusions The matrix is an adequate evaluation tool for self-instructional courses developed for Continuing Education. Key messages The evaluation matrix is adequate to evaluate online self-instructional courses developed for Health professionals qualification. Self-instructed courses could be a good tool for Continuing Education in health, according to students’ perceptions.

scholarly journals Taxonomic synopsis of medicinal Lamiales species used in Alta Floresta, Mato Grosso, Brazil: Potentialities for the Unified Health System

2021 ◽  
Vol 10 (11) ◽  
pp. e340101119686
Author(s):  
José Martins Fernandes
Keyword(s):  
Rural Communities ◽  
Medicinal Plants ◽  
Health System ◽  
Glandular Trichomes ◽  
National Policy ◽  
Plant Morphology ◽  
Medicinal Species ◽  
Mato Grosso ◽  
Unified Health System ◽  
The Status

This work presents the morphology of 16 medicinal species of Lamiales used in Alta Floresta, Mato Grosso, Brazil, as well comments about phytogeography, popular use in the municipality, the status of the species in the National Policy on Medicinal Plants and Phytotherapeutics, and examples of preclinical trials. The work was performed between March and September 2020, through botanical sample of the Lamiales species presented in the book " Plantas medicinais de Alta Floresta: com contribuição a etnobotânica", obtained in rural communities and urban neighborhoods in the municipality of Alta Floresta, State of Mato Grosso. The morphological study was carried out at the Laboratory of Plant Morphology, located at the University Campus of Alta Floresta, Universidade do Estado de Mato Grosso. In general, the species are native (56%) with wide distributions in Brazil. Most species have glandular trichomes (72%) on the leaves and/or flowers and have been shown to be efficient and/or promising (85.5%) in studies. However, only 37.5% of these studies were conducted by the Ministry of Health. None of the species are offered as a phytotherapeutic by the Unified Health System (SUS), although six are on the last National Report of Medicinal Plants of Interest published by SUS. Based on the information provided, it is evident that these species could be used in studies about new phytotherapeutics for SUS users.

scholarly journals Characteristics, quality and volume of the first 5 months of the COVID-19 evidence synthesis infodemic: a meta-research study

2021 ◽  
pp. bmjebm-2021-111710
Author(s):  
Rebecca Abbott ◽  
Alison Bethel ◽  
Morwenna Rogers ◽  
Rebecca Whear ◽  
Noreen Orr ◽  
...  
Keyword(s):  
Systematic Review ◽  
Systematic Reviews ◽  
Evidence Synthesis ◽  
Rapid Review ◽  
Cochrane Library ◽  
Measurement Tool ◽  
Qualitative Evidence Synthesis ◽  
High Quality ◽  
Definition Of

ObjectiveThe academic and scientific community has reacted at pace to gather evidence to help and inform about COVID-19. Concerns have been raised about the quality of this evidence. The aim of this review was to map the nature, scope and quality of evidence syntheses on COVID-19 and to explore the relationship between review quality and the extent of researcher, policy and media interest.Design and settingA meta-research: systematic review of reviews.Information sourcesPubMed, Epistemonikos COVID-19 evidence, the Cochrane Library of Systematic Reviews, the Cochrane COVID-19 Study Register, EMBASE, CINAHL, Web of Science Core Collection and the WHO COVID-19 database, searched between 10 June 2020 and 15 June 2020.Eligibility criteriaAny peer-reviewed article reported as a systematic review, rapid review, overview, meta-analysis or qualitative evidence synthesis in the title or abstract addressing a research question relating to COVID-19. Articles described as meta-analyses but not undertaken as part of a systematic or rapid review were excluded.Study selection and data extractionAbstract and full text screening were undertaken by two independent reviewers. Descriptive information on review type, purpose, population, size, citation and attention metrics were extracted along with whether the review met the definition of a systematic review according to six key methodological criteria. For those meeting all criteria, additional data on methods and publication metrics were extracted.Risk of biasFor articles meeting all six criteria required to meet the definition of a systematic review, AMSTAR-2 ((A MeaSurement Tool to Assess systematic Reviews, version 2.0) was used to assess the quality of the reported methods.Results2334 articles were screened, resulting in 280 reviews being included: 232 systematic reviews, 46 rapid reviews and 2 overviews. Less than half reported undertaking critical appraisal and a third had no reproducible search strategy. There was considerable overlap in topics, with discordant findings. Eighty-eight of the 280 reviews met all six systematic review criteria. Of these, just 3 were rated as of moderate or high quality on AMSTAR-2, with the majority having critical flaws: only a third reported registering a protocol, and less than one in five searched named COVID-19 databases. Review conduct and publication were rapid, with 52 of the 88 systematic reviews reported as being conducted within 3 weeks, and a half published within 3 weeks of submission. Researcher and media interest, as measured by altmetrics and citations, was high, and was not correlated with quality.DiscussionThis meta-research of early published COVID-19 evidence syntheses found low-quality reviews being published at pace, often with short publication turnarounds. Despite being of low quality and many lacking robust methods, the reviews received substantial attention across both academic and public platforms, and the attention was not related to the quality of review methods.InterpretationFlaws in systematic review methods limit the validity of a review and the generalisability of its findings. Yet, by being reported as ‘systematic reviews’, many readers may well regard them as high-quality evidence, irrespective of the actual methods undertaken. The challenge especially in times such as this pandemic is to provide indications of trustworthiness in evidence that is available in ‘real time’.PROSPERO registration numberCRD42020188822.

scholarly journals Health care for transgender people in Brazil: a systematic review protocol

2020 ◽  
Author(s):  
Rafael Rodolfo Tomaz de Lima ◽  
Taiana Brito Menezes Flor ◽  
Alexandre Bezerra Silva ◽  
Luiz Roberto Augusto Noro
Keyword(s):  
Systematic Review ◽  
Health Care ◽  
Health System ◽  
Scientific Evidence ◽  
Empirical Studies ◽  
Assessment Tools ◽  
Systematic Review Protocol ◽  
Transgender People ◽  
Unified Health System ◽  
Review Protocol

Abstract Background At the global level, transgender people (transvestites and transsexuals) live in worse health and living conditions due to the stigma and violence they face, including within health services. In Brazil, the Unified Health System must offer comprehensive care to the population, regardless of social class and gender. The aim of this article is to establish a systematic review protocol to analyze how health care occurs for the transgender population in the Unified Health System. Methods This protocol was guided by PRISMA-P and the bases SCIELO, LILACS, BVS and PUBMED will be consulted. Empirical studies, with a qualitative or quantitative approach, that deal with health care for the transgender population in the Unified Health System, where the respondents are transgender people, health professionals or health managers, will be included in the systematic review. For the definition of the final sample, the articles will undergo an assessment of methodological quality and risk of bias, with the help of the critical assessment tools of the Joanna Briggs Institute, using a specific checklist for each type of study. The synthesis of the findings will be carried out through the formal narrative and the presentation of tables with summarized data, with the final writing of the review guided by PRISMA. Discussion Based on scientific evidence, it is intended to present an overview of health care for the transgender population in the Unified Health System. In addition, to point out possible strategies to qualify the political, organizational and attitudinal aspects related to health care for that population. Systematic review registration: PROSPERO CRD42020188719.

scholarly journals 200 Years of Florence and the challenges of nursing practices management in the COVID-19 pandemic

2020 ◽  
Vol 28 ◽  
Author(s):  
Daniela Savi Geremia ◽  
Carine Vendruscolo ◽  
Ianka Cristina Celuppi ◽  
Edlamar Kátia Adamy ◽  
Beatriz Rosana Gonçalves de Oliveira Toso ◽  
...  
Keyword(s):  
Health System ◽  
Nurse Managers ◽  
Scientific Evidence ◽  
Public Health Practice ◽  
Knowledge Based ◽  
Florence Nightingale ◽  
Unified Health System ◽  
Analysis Technique ◽  
Main Ideas ◽  
Operational Capacity

Objective to analyze the main challenges of nursing in facing Coronavirus Disease-19 under the perspective of nurse managers in the west macro-region of Santa Catarina. Method it consists of a qualitative study, whose data collection was done through interviews with nurses who represent the management of health care network in the region. The analysis technique used was the Discourse of the Collective Subject (DCS). Results the legacy of Florence Nightingale to contemporary nursing practice; the weaknesses and the technical operational capacity with which nursing faces in the Unified Health System (Sistema Único de Saúde - SUS); the strategies for strengthening the Unified Health System and qualification of nursing practices; and the potentialities identified in the pandemic scenario were the main ideas that emerged. In the bicentennial year of Florence Nightingale, nurses recognize her legacy to public health practice and management. Several variables interfere in professional practice, such as epidemiological aspects, working conditions, and care management in a pandemic. Conclusion the pandemic scenario has taken nursing to a position of practical and scientific protagonism as a result of its proactivity and leadership in the search for knowledge based on scientific evidence.

scholarly journals Sigle-center, observational, prospective study describing same-day discharge implementation for uncomplicated elective percutaneous coronary intervention by radial approach: Study protocol

2021 ◽  
Vol 11 (3) ◽  
pp. 6-13
Author(s):  
Giovanna Silveira Lacerda de Mesquita Aquino ◽  
Júlia Braga Botelho ◽  
Camila Naomi Matsuda ◽  
Marcilene Aparecida da Silva ◽  
Bruno Laurenti Janella
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Prospective Study ◽  
Health System ◽  
Coronary Intervention ◽  
Early Discharge ◽  
Primary Objective ◽  
Unified Health System ◽  
Percutaneous Coronary ◽  
Same Day Discharge ◽  
The Impact

Objectives: The study's primary objective will be to evaluate the safety and describe the initial experience of implementing early discharge (on the same day) of coronary patients from the Unified Health System undergoing elective, uncomplicated, transradial percutaneous coronary intervention. The secondary objective will be to assess the impact on the direct cost per patient compared to previously known data from the classic hospital stay used (hospital overnight). Methods: Observational and prospective study of patients undergoing elective uncomplicated transradial percutaneous coronary intervention with early discharge, respecting the inclusion and exclusion criteria. Follow-up of patients will be carried out to prove the safety of the new strategy in the population of the Unified Health System and to compare the direct costs between overnight stays and discharge on the same day. This will be the first study dedicated to primarily evaluating the safety of early discharge after elective uncomplicated transradial coronary angioplasty, validating this protocol in the population of the Brazilian public health system.

scholarly journals What evidence is there on the effectiveness of different models of delivering urgent care? A rapid review

2015 ◽  
Vol 3 (43) ◽  
pp. 1-134 ◽  
Author(s):  
Janette Turner ◽  
Joanne Coster ◽  
Duncan Chambers ◽  
Anna Cantrell ◽  
Viet-Hai Phung ◽  
...  
Keyword(s):  
Empirical Evidence ◽  
Systematic Reviews ◽  
Evidence Synthesis ◽  
Evidence Base ◽  
Service Planning ◽  
Urgent Care ◽  
Rapid Review ◽  
Current Evidence ◽  
Primary Research ◽  
Current Evidence Base

BackgroundIn 2013 NHS England set out its strategy for the development of an emergency and urgent care system that is more responsive to patients’ needs, improves outcomes and delivers clinically excellent and safe care. Knowledge about the current evidence base on models for provision of safe and effective urgent care, and the gaps in evidence that need to be addressed, can support this process.ObjectiveThe purpose of the evidence synthesis is to assess the nature and quality of the existing evidence base on delivery of emergency and urgent care services and identify gaps that require further primary research or evidence synthesis.Data sourcesMEDLINE, EMBASE, The Cochrane Library, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and the Web of Science.MethodsWe have conducted a rapid, framework-based, evidence synthesis approach. Five separate reviews linked to themes in the NHS England review were conducted. One general and five theme-specific database searches were conducted for the years 1995–2014. Relevant systematic reviews and additional primary research papers were included and narrative assessment of evidence quality was conducted for each review.ResultsThe review was completed in 6 months. In total, 45 systematic reviews and 102 primary research studies have been included across all five reviews. The key findings for each review are as follows: (1) demand – there is little empirical evidence to explain increases in demand for urgent care; (2) telephone triage – overall, these services provide appropriate and safe decision-making with high patient satisfaction, but the required clinical skill mix and effectiveness in a system is unclear; (3) extended paramedic roles have been implemented in various health settings and appear to be successful at reducing the number of transports to hospital, making safe decisions about the need for transport and delivering acceptable, cost-effective care out of hospital; (4) emergency department (ED) – the evidence on co-location of general practitioner services with EDs indicates that there is potential to improve care. The attempt to summarise the evidence about wider ED operations proved to be too complex and further focused reviews are needed; and (5) there is no empirical evidence to support the design and development of urgent care networks.LimitationsAlthough there is a large body of evidence on relevant interventions, much of it is weak, with only very small numbers of randomised controlled trials identified. Evidence is dominated by single-site studies, many of which were uncontrolled.ConclusionsThe evidence gaps of most relevance to the delivery of services are (1) a requirement for more detailed understanding and mapping of the characteristics of demand to inform service planning; (2) assessment of the current state of urgent care network development and evaluation of the effectiveness of different models; and (3) expanding the current evidence base on existing interventions that are viewed as central to delivery of the NHS England plan by assessing the implications of increasing interventions at scale and measuring costs and system impact. It would be prudent to develop a national picture of existing pilot projects or interventions in development to support decisions about research commissioning.FundingThe National Institute for Health Research Health Services and Delivery Research Programme.

OP130 Evidence-Informed Policy For Biologic Medicines In Brazil

2019 ◽  
Vol 35 (S1) ◽  
pp. 29-30
Author(s):  
Cecilia Farinasso ◽  
Roberta Borges Silva ◽  
Daniela Rego ◽  
Dalila Gomes ◽  
Betânia Leite ◽  
...  
Keyword(s):  
Working Group ◽  
Evidence Synthesis ◽  
Research Question ◽  
National Policy ◽  
Vital Role ◽  
Rapid Review ◽  
Brazilian Government ◽  
Support Tools ◽  
Key Steps ◽  
Methodological Guidelines

IntroductionThe Department of Sciences and Technology (Decit) of the Brazilian Government has played a vital role in drafting of the National Policy for Biologic Medicines. Decit has provided methodological support to the working group, conducting a rapid review and a rapid evidence synthesis to subsidize decisions and recommendations.MethodsWe used the Methodological Guidelines for the Elaboration of Evidence Synthesis for Health Policies, which is a product of our own team, based on the SUPporting POlicy relevant Reviews and Trials (SUPPORT) Tools for evidence-informed health Policymaking.ResultsThe Decit team participated in the key steps to develop an evidence-informed policy. Our product, “Barriers to Access to Biologic Products: a Rapid Review” was used for the prioritization of health problems and the description of the problem. We then proceeded to the evidence synthesis planning and definition of the research question from an acronym. Together with the coordination of the working group, we decided to tackle the problem of interchangeability of biologic products motivated solely by economic factors in a synthesis of policy evidence. Our evidence synthesis went so far as to describe policy options. The working group used this product to inform a Policy Dialog.ConclusionsThis was the first time that the Decit team provided hands-on methodological assistance the development of a health policy. Not all steps recommended in the SUPPORT Tools were feasible due to time restraints. We observed that rapid evidence synthesis products were helpful to inform decision-making.

scholarly journals What are the most important unanswered research questions on rapid review methodology? A James Lind Alliance research methodology Priority Setting Partnership: the Priority III study protocol

2021 ◽  
Vol 4 ◽  
pp. 80
Author(s):  
Claire Beecher ◽  
Elaine Toomey ◽  
Beccy Maeso ◽  
Caroline Whiting ◽  
Derek C. Stewart ◽  
...  
Keyword(s):  
Health Care ◽  
Systematic Reviews ◽  
Priority Setting ◽  
Evidence Synthesis ◽  
Rapid Review ◽  
High Quality ◽  
Rapid Reviews ◽  
James Lind Alliance ◽  
Research Questions ◽  
Priority Setting Partnership

Background: The value of rapid reviews in informing health care decisions is more evident since the onset of the coronavirus disease 2019 (COVID-19) pandemic. While systematic reviews can be completed rapidly, rapid reviews are usually a type of evidence synthesis in which components of the systematic review process may be simplified or omitted to produce information more efficiently within constraints of time, expertise, funding or any combination thereof. There is an absence of high-quality evidence underpinning some decisions about how we plan, do and share rapid reviews. We will conduct a modified James Lind Alliance Priority Setting Partnership to determine the top 10 unanswered research questions about how we plan, do and share rapid reviews in collaboration with patients, public, reviewers, researchers, clinicians, policymakers and funders. Methods: An international steering group consisting of key stakeholder perspectives (patients, the public, reviewers, researchers, clinicians, policymakers and funders) will facilitate broad reach, recruitment and participation across stakeholder groups. An initial online survey will identify stakeholders’ perceptions of research uncertainties about how we plan, do and share rapid reviews. Responses will be categorised to generate a long list of questions. The list will be checked against systematic reviews published within the past three years to identify if the question is unanswered. A second online stakeholder survey will rank the long list in order of priority. Finally, a virtual consensus workshop of key stakeholders will agree on the top 10 unanswered questions. Discussion: Research prioritisation is an important means for minimising research waste and ensuring that research resources are targeted towards answering the most important questions. Identifying the top 10 rapid review methodology research priorities will help target research to improve how we plan, do and share rapid reviews and ultimately enhance the use of high-quality synthesised evidence to inform health care policy and practice.

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