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.

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 Study protocol of a systematic review and qualitative evidence synthesis using two different approaches: Healthcare related needs and desires of older people with post-stroke aphasia

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e039348
Author(s):  
Nadine Janis Pohontsch ◽  
Thorsten Meyer ◽  
Yvonne Eisenmann ◽  
Maria-Inti Metzendorf ◽  
Verena Leve ◽  
...  
Keyword(s):  
Systematic Review ◽  
Older People ◽  
Evidence Synthesis ◽  
Meta Analysis ◽  
Research Question ◽  
Treatment Success ◽  
Qualitative Studies ◽  
Qualitative Evidence Synthesis ◽  
Healthcare Needs ◽  
Qualitative Evidence

IntroductionStroke is a frequent disease in the older population of Western Europe with aphasia as a common consequence. Aphasia is known to impede targeting treatment to individual patients’ needs and therefore may reduce treatment success. In Germany, the postacute care of patients who had stroke is provided by different healthcare institutions of different sectors (rehabilitation, nursing and primary care) with substantial difficulties to coordinate services. We will conduct two qualitative evidence syntheses (QESs) aiming at exploring distinct healthcare needs and desires of older people living with poststroke aphasia. We thereby hope to support the development of integrated care models based on needs of patients who are very restricted to communicate them. Since various methods of QESs exist, the aim of the study embedding the two QESs was to determine if findings differ according to the approach used.Methods and analysisWe will conduct two QESs by using metaethnography (ME) and thematic synthesis (ThS) independently to synthesise the findings of primary qualitative studies. The main differences between these two methods are the underlying epistemologies (idealism (ME) vs realism (ThS)) and the type of research question (emerging (ME) vs fixed (ThS)).We will search seven bibliographical databases. Inclusion criteria comprise: patients with poststroke aphasia, aged 65 years and older, studies in German/English, all types of qualitative studies concerning needs and desires related to healthcare or the healthcare system. The protocol was registered in the International Prospective Register of Systematic Reviews, follows Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines and includes three items from the Enhancing Transparency in Reporting the synthesis of Qualitative Research checklist.Ethics and disseminationEthical approval is not required. Findings will be published in a peer-reviewed journal and presented on national conferences.

scholarly journals Impact of COVID-19 on management of urogynaecology patients: a rapid review of the literature

2021 ◽  
Author(s):  
Jemina Loganathan ◽  
◽  
Stergios K. Doumouchtsis
Keyword(s):  
Evidence Synthesis ◽  
Horizontal Transmission ◽  
Rapid Review ◽  
Review Of The Literature ◽  
First Line ◽  
Face To Face ◽  
Manual Search ◽  
Guidance Documents ◽  
Management Recommendations

Abstract Introduction and hypothesis The coronavirus (COVID-19) pandemic has impacted health systems worldwide. There is a continuing need for clinicians to adapt practice to facilitate timely provision of medical care, whilst minimising horizontal transmission. Guidance and recommendations are increasingly available, and this rapid review aimed to provide a timely evidence synthesis on the current recommendations surrounding urogynaecological care. Methods We performed a literature review using PubMed/Medline, Embase and Cochrane and a manual search of national and international societies for management recommendations for urogynaecological patients during the COVID-19 pandemic. Results Nine guidance documents and 17 articles, including 10 reviews, were included. Virtual clinics are recommended for new and follow-up patients, to assess and initiate treatment, as well as triage patients who require face-to-face appointments. Outpatient investigations such as urodynamics and cystoscopy for benign indications can be deferred. Prolapse and continence surgery should be suspended, except in specific circumstances such as procidentia with upper tract complications and failed pessaries. There is no evidence to support a particular route of surgery, but recommendations are made to minimise COVID-19 transmission. Conclusions Urogynaecological patients face particular challenges owing to inherent vulnerabilities of these populations. Behavioural and medical therapies should be recommended as first line options and initiated via virtual or remote clinics, which are integral to management during the COVID-19 pandemic. Expanding the availability and accessibility of technology will be increasingly required. The majority of outpatient and inpatient procedures can be deferred, but the longer-term effects of such practices are unclear.

Policy as Assemblage

2011 ◽  
Vol 10 (4) ◽  
pp. 611-622 ◽  
Author(s):  
Radhika Gorur
Keyword(s):  
International Student ◽  
Research Question ◽  
Student Assessment ◽  
Research Work ◽  
National Policy ◽  
International Student Assessment ◽  
Documentary Analysis ◽  
Policy Work ◽  
The Relationship ◽  
Research World

In this article, the author tells the story of her search for appropriate tools to conceptualise policy work. She had set out to explore the relationship between the Programme for International Student Assessment (PISA) of the Organisation for Economic Co-operation and Development (OECD) and Australia's education policy, but early interview data forced her to reconsider her research question. The plethora of available models of policy did not satisfactorily accommodate her growing understanding of the messiness and complexity of policy work. On the basis of interviews with 18 policy actors, including former OECD officials, PISA analysts and bureaucrats, as well as documentary analysis of government reports and ministerial media releases, she suggests that the concept of ‘assemblage’ provides the tools to better understand the messy processes of policy work. The relationship between PISA and national policy is of interest to many scholars in Europe, making this study widely relevant. An article that argues for the unsettling of tidy accounts of knowledge making in policy can hardly afford to obscure the untidiness of its own assemblage. Accordingly, this article is somewhat unconventional in its presentation, and attempts to take the reader into the messiness of the research world as well as the policy world. Implicit in this presentation is the suggestion that both policy work and research work are ongoing attempts to find order and coherence through the cobbling together of a variety of resources.

scholarly journals Flexible and innovative learning spaces: An exploration of parental perspectives on change, consultation and participation

2021 ◽  
pp. 147490412110412
Author(s):  
Leon Benade
Keyword(s):  
Research Question ◽  
National Policy ◽  
Ministry Of Education ◽  
Learning Spaces ◽  
Parent Questionnaire ◽  
Educational Environments ◽  
Innovative Learning ◽  
Open Plan ◽  
Role Of Parents ◽  
Education Delivery

The role played by innovative educational environments to support learning for the 21st century has attracted the interest of the Organisation for Economic Cooperation and Development at the global governance level and at the national policy level internationally. This article draws on global, European and Australasian research and data from a qualitative study of consultation and participation in the development of innovative and flexible learning spaces in the New Zealand context. It focuses specifically on the role of parents, drawing data from relevant policies and documents, a parent questionnaire and interviews of parents, architects and Ministry of Education Delivery Managers, responsible for delivering large capital works projects. While the architect participants believe their bold designs are inspirational and promote new pedagogical styles, and positive relationships, some parents view these open-plan learning areas (and associated pedagogies) as needlessly experimental, placing the needs and education of their children at risk. Delivery Managers are focussed on seeing the projects to conclusion, on time and on budget. The critical analysis considers the findings in relation to the research question and reflects on the dual themes of innovation and risk. Further questions for research are suggested.

scholarly journals Adequação da MOSE® Competence para a Implementação do Capítulo VII da LGPD: Um Mapeamento dos Ativos de Segurança e Boas Práticas

2021 ◽  
Author(s):  
Maykon Araújo de Souza ◽  
Sandro Ronaldo Bezerra Oliveira
Keyword(s):  
Research Question ◽  
Personal Data ◽  
Private Companies ◽  
Public And Private ◽  
Good Practices ◽  
Goods And Services ◽  
Brazilian Government ◽  
General Data ◽  
Definition Of ◽  
Specific Section

This study presents a mapping of the assets present in the Guiding Model for the Success of Public and Private Companies (MOSE) and the articles included in the General Data Protection Law (LGPD) of the Brazilian Government, with regard to Security and Good Practices in Chapter VII of this law. The theme becomes relevant, as more and more companies from different contexts need to implement the articles contained in this law in order to adhere to the standard of regulation of personal data processing activities defined by the Brazilian Federal Government. However, this law still needs guidelines for its proper implementation based on the adoption of good practices in models, methods and/or techniques available in the specialized literature. One of these instruments refers to the MOSE, which helps public and private companies to achieve levels of excellence in performance, governance and quality, in the production of goods and services, based on the use of practices and indicators specific to the area of knowledge or specialty. Thus, the research question guiding this work is: how to correspond/map the practices included in the MOSE to guide the implementation of the articles of the LGPD law? The methodology adopted was the asset mapping, described in a specific section of the paper, which included the following steps: definition of the LGPD chapter that focuses on data security management; definition of the model and law structures, and their inputs to be analyzed; identification of the description of each asset; analysis of correspondence between assets; evaluation of the mapping using the peer review technique with expert in the two target standards of this research. The result was the perception that 33% of the MOSE’s competences goals, with the appropriate adjustments, have total adherence with 100% of the security and good pratices assets of LGPD. This mapping is intended to provide assistance in defining a roadmap containing activities, work products, tools, indicators and expected results to achieve the goals defined in the LGPD.

scholarly journals What causes prescribing errors in children? Scoping review

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e028680 ◽  
Author(s):  
Richard L Conn ◽  
Orla Kearney ◽  
Mary P Tully ◽  
Michael D Shields ◽  
Tim Dornan
Keyword(s):  
Scoping Review ◽  
Evidence Synthesis ◽  
Research Question ◽  
Grey Literature ◽  
Qualitative Evidence Synthesis ◽  
Prescribing Errors ◽  
Prescribing Error ◽  
Stakeholder Consultation ◽  
Published Evidence ◽  
Included Review

Objectives(1) Systematically assemble, analyse and synthesise published evidence on causes of prescribing error in children. (2) Present results to a multidisciplinary group of paediatric prescribing stakeholders to validate findings and establish how causative factors lead to errors in practice.DesignScoping review using Arksey and O’Malley’s framework, including stakeholder consultation; qualitative evidence synthesis.MethodsWe followed the six scoping review stages. (1) Research question—the research question was ‘What is known about causes of prescribing error in children?’ (2) Search strategy—we searched MEDLINE, EMBASE, CINAHL (from inception to February 2018), grey literature and reference lists of included studies. (3) Article selection—all published evidence contributing information on the causes of prescribing error in children was eligible for inclusion. We included review articles as secondary evidence to broaden understanding. (4) Charting data—results were collated in a custom data charting form. (5) Reporting results—we summarised article characteristics, extracted causal evidence and thematically synthesised findings. (6) Stakeholder consultation—results were presented to a multidisciplinary focus group of six prescribing stakeholders to establish validity, relevance and mechanisms by which causes lead to errors in practice.Results68 articles were included. We identified six main causes of prescribing errors: children’s fundamental differences led to individualised dosing and calculations; off-licence prescribing; medication formulations; communication with children; and experience working with children. Primary evidence clarifying causes was lacking.ConclusionsSpecific factors complicate prescribing for children and increase risk of errors. Primary research is needed to confirm and elaborate these causes of error. In the meantime, this review uses existing evidence to make provisional paediatric-specific recommendations for policy, practice and education.

Education for sustainable development in humanitarian logistics

2020 ◽  
Vol 10 (4) ◽  
pp. 573-602
Author(s):  
Muhammad Khan ◽  
Muhammad Sarmad ◽  
Sami Ullah ◽  
Junghan Bae
Keyword(s):  
Sustainable Development ◽  
Formal Education ◽  
Research Question ◽  
Education For Sustainable Development ◽  
Vital Role ◽  
Humanitarian Logistics ◽  
Equation Modeling ◽  
Content Type ◽  
Explanatory Variables ◽  
Structure Equation Modeling

PurposeAs humanitarian logistics (HL) functions in complicated, changing and ambiguous situations, all people, particularly the educated youth, have to know how to control the situation and assist victims, which are best achieved through formal education and training. Teaching at university has been extensively used in the context of business logistics. However, education in HL is a poorly researched field and, consequently, this article explores education for sustainable development in HL. The study addresses the following research question: How the teaching of HL at university can help to increase HL performance (HLP) and to reduce suffering.Design/methodology/approachA covariance-based structure equation modeling (CB-SEM) is implemented on the basis of confirmatory factor analysis.FindingsThe results show that the association between the explanatory variables and the dependent variable (HLP) is mediated by sustainability, and that the teaching of HL at university plays a vital role in enhancing HLP and is therefore a very suitable approach for sustainable development in HL. This direct approach is creative, informative and productive practice for both students and teachers.Originality/valueIn spite of the growing number of activities and courses in supply chain and logistics education, no study, to the best of our knowledge, has empirically analyzed the critical topic of whether or not education can bring sustainable development in HL. In order to save lives and reduce the suffering of victims, this study attempts to fill this gap.

ENDPOINTS FOR RELATIVE EFFECTIVENESS ASSESSMENT (REA) OF PHARMACEUTICALS

2014 ◽  
Vol 30 (5) ◽  
pp. 508-513 ◽  
Author(s):  
Mira Pavlovic ◽  
Conor Teljeur ◽  
Beate Wieseler ◽  
Marianne Klemp ◽  
Irina Cleemput ◽  
...  
Keyword(s):  
Guideline Development ◽  
Research Question ◽  
Relative Effectiveness ◽  
Clinical Endpoints ◽  
Related Quality ◽  
Health Related ◽  
Effectiveness Assessment ◽  
The Impact ◽  
Methodological Guidelines

Objectives: Clinical endpoints are defined as valid measures of clinical benefit or harm due to treatment, that describe the impact of treatment on how a patient feels, functions, and survives. The choice of endpoints and the manner in which they are reported have a major impact on the relative effectiveness assessment (REA) of pharmaceuticals. The aim of this article is to describe the guideline development process and the key findings that set a framework for appropriate use of endpoints in REAs in Europe.Methods: A multi-health technology assessment (HTA)-agency collaborative process in EUnetHTA JA1 was used to scope, draft, and finalize methodological guidelines for REA in Europe.Results: Patient-relevant clinical endpoints can be broadly categorized into: mortality, morbidity and health-related quality of life. A clinical endpoint is a main symptom or sign of a disease that is clinically relevant, valid, reproducible and responsive to change. Preference is for long-term or final endpoints whenever possible. Surrogate endpoints may be used when there is compelling evidence of a clear and consistent correlation of treatment effects on the surrogate and final outcome of interest.Conclusions: The relevance and hierarchy of the different types of clinical endpoints depend on the research question, disease, and the treatment investigated. Not only the primary endpoint, but also other relevant endpoints are assessed in comparison to adequate comparator(s). This simultaneous assessment of all relevant endpoints is a hallmark of REA.

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