plueme/wizJson huggingface dataset:
location: nan, 'Global 
year: 2017 source: BMC 
title: Why European and United States drug regulators are not speaking with one voice on anti-influenza drugs: regulatory review methodologies and the importance of ‘deep’ product reviews 
abstract:BackgroundRelenza represents the first neuraminidase inhibitor (NI), a class of drugs that also includes the drug Tamiflu. Although heralded as breakthrough treatments in influenza, NI efficacy has remained highly controversial. A key unsettled question is why the United States Food and Drug Administration (FDA) has approved more cautious efficacy statements in labelling than European regulators for both drugs.MethodsWe conducted a qualitative analysis of United States and European Union regulatory appraisals for Relenza to investigate the reasons for divergent regulatory interpretations, pertaining to Relenza’s capacity to alleviate symptoms and reduce frequency of complications of influenza.ResultsIn Europe, Relenza was evaluated via the so-called national procedure with Sweden as the reference country. We show that FDA reviewers, unlike their European (i.e. Swedish) counterpart, (1) rejected the manufacturer’s insistence on pooling efficacy data, (2) remained wary of subgroup analyses, and (3) insisted on stringent statistical analyses. These differences meant that the FDA was less likely to depart from prevailing regulatory and scientific standards in interpreting trial results. We argue that the differences are explained largely by divergent institutionalised review methodologies, i.e. the European regulator’s reliance on manufacturer-compiled summaries compared to the FDA’s examination of original data and documentation from trials.ConclusionsThe FDA’s more probing and meticulous evaluative methodology allowed its reviewers to develop ‘deep’ knowledge concerning the clinical and statistical facets of trials, and more informed opinions regarding suitable methods for analysing trial results. These findings challenge the current emphasis on evaluating regulatory performance mainly in terms of speed of review. We propose that persistent uncertainty and knowledge deficits regarding NIs could have been ameliorated had regulators engaged in the public debates over the drugs’ efficacy and explained their contrasting methodologies and judgments. Regulators use major resources to evaluate drugs, but if regulators’ assessments are not effectively disseminated and used, resources are used inefficiently.
location: nan, 'Global 
year: 2017 source: BMC 
title: A ‘Grantathon’ model to mentor new investigators in mental health research 
abstract:BackgroundThere is a critical gap between needs and available resources for mental health treatment across the world, particularly in low- and middle-income countries (LMICs). In countries committed to increasing resources to address these needs it is important to conduct research, not only to assess the depth of mental health needs and the current provision of public and private mental health services, but also to examine implementation methods and evaluate mental health approaches to determine which methods are most effective in local contexts. However, research resources in many LMICs are inadequate, largely because conventional research training is time-consuming and expensive. Adapting a hackathon model may be a feasible method of increasing capacity for mental health services research in resource-poor countries.MethodsTo explore the feasibility of this approach, we developed a ‘grantathon’, i.e. a research training workshop, to build capacity among new investigators on implementation research of Indian government-funded mental health programmes, which was based on a need expressed by government agencies. The workshop was conducted in Delhi, India, and brought together junior faculty members working in mental health services settings throughout the country, experienced international behavioural health researchers and representatives of the Indian Council for Medical Research (ICMR), the prime Indian medical research funding agency. Pre- and post-assessments were used to capture changes in participants’ perceived abilities to develop proposals, design research studies, evaluate outcomes and develop collaborations with ICMR and other researchers. Process measures were used to track the number of single-or multi-site proposals that were generated and funded.ResultsParticipants (n = 24) generated 12 single- or multi-site research grant applications that will be funded by ICMR.ConclusionThe grantathon model described herein can be modified to build mental health services research capacity in other contexts. Given that this workshop not only was conceptualised and delivered but also returned results in less than 1 year, this model has the potential to quickly build research capacity and ultimately reduce the mental health treatment gap in resource-limited settings.
location: nan, 'Global 
year: 2017 source: BMC 
title: Building capacity for medical education research in family medicine: the Program for Innovation in Medical Education (PIME) 
abstract:BackgroundDespite the apparent benefits to teaching, many faculty members are reluctant to participate in medical education research (MER) for a variety of reasons. In addition to the further demand on their time, physicians often lack the confidence to initiate MER projects and require more support in the form of funding, structure and guidance. These obstacles have contributed to a decline in physician participation in MER as well as to a perceived decay in its quality. As a countermeasure to encourage physicians to undertake research, the Department of Family Medicine at the University of Ottawa implemented a programme in which physicians receive the funding, coaching and support staff necessary to complete a 2-year research project. The programme is intended primarily for first-time researchers and is meant to serve as a gateway to a research career funded by external grants. Since its inception in 2010, the Program for Innovation in Medical Education (PIME) has supported 16 new clinician investigators across 14 projects.MethodsWe performed a programme evaluation 3 years after the programme launched to assess its utility to participants. This evaluation employed semi-structured interviews with physicians who performed a research project within the programme.ResultsProgramme participants stated that their confidence in conducting research had improved and that they felt well supported throughout their project. They appreciated the collaborative nature of the programme and remarked that it had improved their willingness to solicit the expertise of others. Finally, the programme allowed participants to develop in the scholarly role expected by family physicians in Canada.ConclusionThe PIME may serve as a helpful model for institutions seeking to engage faculty physicians in Medical Education Research and to thereby enhance the teaching received by their medical learners.
location: nan, 'Global 
year: 2017 source: BMC 
title: A critical appraisal of guidelines used for management of severe acute malnutrition in South Africa’s referral system 
abstract:BackgroundFocusing on healthcare referral processes for children with severe acute malnutrition (SAM) in South Africa, this paper discusses the comprehensiveness of documents (global and national) that guide the country’s SAM healthcare. This research is relevant because South African studies on SAM mostly examine the implementation of WHO guidelines in hospitals, making their technical relevance to the country’s lower level and referral healthcare system under-explored.MethodsTo add to both literature and methods for studying SAM healthcare, we critically appraised four child healthcare guidelines (global and national) and conducted complementary expert interviews (n = 5). Combining both methods enabled us to examine the comprehensiveness of the documents as related to guiding SAM healthcare within the country’s referral system as well as the credibility (rigour and stakeholder representation) of the guideline documents’ development process.ResultsNone of the guidelines appraised covered all steps of SAM referrals; however, each addressed certain steps thoroughly, apart from transit care. Our study also revealed that national documents were mostly modelled after WHO guidelines but were not explicitly adapted to local context. Furthermore, we found most guidelines’ formulation processes to be unclear and stakeholder involvement in the process to be minimal.ConclusionIn adapting guidelines for management of SAM in South Africa, it is important that local context applicability is taken into consideration. In doing this, wider stakeholder involvement is essential; this is important because factors that affect SAM management go beyond in-hospital care. Community, civil society, medical and administrative involvement during guideline formulation processes will enhance acceptability and adherence to the guidelines.
location: nan, 'Global 
year: 2017 source: BMC 
title: Evidence-based decision-making for diagnostic and therapeutic methods: the changing landscape of assessment approaches in Germany 
abstract:This article examines the current status and most important changes over time to the legislative framework on the health technology assessment-informed decision-making process on diagnostic and therapeutic ‘methods’ in Germany. The relevant information was obtained through documentary analysis covering the period 1990 to 2017. The findings show that, even if the outpatient care sector appears to be much more regulated than the inpatient sector (based on a strict separation of the two care settings), developments in Germany have led to a more tightened assessment framework, making the use of evidence a firm component in the decision-making process. Nevertheless, a comprehensive approach for a systematic assessment of diagnostic and therapeutic ‘methods’ still does not exist. Readjustments of current regulations in Germany, such as the existing ‘Verbotsvorbehalt’ (i.e. provision of a diagnostic and therapeutic ‘method’ possible unless actively delisted) in the inpatient care setting, as well as further developments at the European level are needed in order to create a system that ensures early access to innovation under controlled study conditions.
location: nan, 'Global 
year: 2017 source: BMC 
title: Building a bright, evidence-informed future: a conversation starter from the incoming editors 
abstract:Health Research and Policy Systems (HARPS) has gone from strength to strength since it was established in 2003. As new Editors-in-Chief, we look forward to a bright future for HARPS, and we would like to start a conversation with you, HARPS readers, authors, editors and others, about how HARPS can best support ongoing progress and debate on evidence-informed health research policy and systems, particularly in developing countries. As a starting point for discussion, we would like to highlight three areas that we are passionate about, namely supporting an integrated community of researchers and policy-makers; building a focus on how health research and policy systems can support achievement of the Sustainable Development Goals; and strengthening our commitment to communicating and disseminating the work published in HARPS. We invite you to contribute your thoughts, ideas and suggestions on the future of HARPS, as we work together towards an evidence-informed future.
location: nan, 'Global 
year: 2017 source: BMC 
title: Identifying research priorities for public health research to address health inequalities: use of Delphi-like survey methods 
abstract:BackgroundIn the funding of health research and public health research it is vital that research questions posed are important and that funded research meets a research need or a gap in evidence. Many methods are used in the identification of research priorities, however, these can be resource intensive, costly and logistically challenging. Identifying such research priorities can be particularly challenging for complex public health problems as there is a need to consult a number of experts across disciplines and with a range of expertise. This study investigated the use of Delphi-like survey methods in identifying important research priorities relating to health inequalities and framing tractable research questions for topic areas identified.MethodsThe study was conducted in two phases, both using Delphi-like survey methods. Firstly, public health professionals with an interest in health inequalities were asked to identify research priorities. Secondly academic researchers were asked to frame tractable research questions relating to the priorities identified. These research priorities identified using Delphi-like survey methods were subsequently compared to those identified using different methods.ResultsA total of 52 public health professionals and 21 academics across the United Kingdom agreed to take part. The response rates were high, from public health professionals across three survey rounds (69%, 50% and 40%) and from academics across one round (52%), indicating that participants were receptive to the method and motivated to respond. The themes identified as encompassing the most important research priorities were mental health, healthy environment and health behaviours. Within these themes, the topic areas that emerged most strongly included community interventions for prevention of mental health problems and the food and alcohol environment. Some responses received from academic researchers were (as requested) in the form of tractable research questions, whereas others contributed further potential topic areas instead.ConclusionsDelphi-like survey methods are practical and productive as a means of obtaining opinions from a wide number of relevant experts identifying potential priority topic areas for research; however, this method is less appropriate for framing tractable research questions.
location: nan, 'Global 
year: 2017 source: BMC 
title: Generating demand for and use of evaluation evidence in government health ministries: lessons from a pilot programme in Uganda and Zambia 
abstract:BackgroundThe Demand-Driven Evaluations for Decisions (3DE) programme was piloted in Zambia and Uganda in 2012–2015. It aimed to answer evaluative questions raised by policymakers in Ministries of Health, rapidly and with limited resources. The aim of our evaluation was to assess whether the 3DE model was successful in supporting and increasing evidence-based policymaking, building capacity and changing behaviour of Ministry staff.MethodsUsing mixed methods, we compared the ex-ante theory of change with what had happened in practice, why and with what results (intended and unintended), including a qualitative assessment of 3DE’s contribution. Data sources included a structured quality assessment of the five impact evaluations produced, 46 key informant interviews at national and international levels, structured extraction from 170 programme documents, a wider literature review of relevant topics, and a political economy analysis conducted in Zambia.ResultsWe found that 3DE had a very limited contribution to changing evidence-based policymaking, capacity and behaviour in both countries as a result of having a number of aspirations not all compatible with one another. Co-developing evaluation questions was more time-consuming than anticipated, Ministry evidence needs did not fit neatly into questions suitable for impact evaluations and constricted timeframes for undertaking trials did not necessarily produce the most effective results and value for money. The evaluation recommended a focusing of objectives and a more strategic approach to strengthening evaluative demand and capacity.ConclusionsLessons emerge that are likely to apply in other low- and middle-income settings, such as the importance of supporting evaluative thinking and capacity within wider institutions, of understanding the political economy of evidence use and its uptake, and of allowing for some flexibility in terms of programme targets. Fixating on one type of evidence is unhelpful in the context of institutions like ministries of health, which require a wide range of evidence to plan and deliver programmes. In addition, having success tied to indicators, such as number of ‘policy decisions made’, provides potentially perverse incentives and neglects arguably more important aspects such as incremental programmatic adjustments and improved implementation.
location: nan, 'Global 
year: 2017 source: BMC 
title: Non-communicable diseases: mapping research funding organisations, funding mechanisms and research practices in Italy and Germany 
abstract:BackgroundEvidence shows that territorial borders continue to have an impact on research collaboration in Europe. Knowledge of national research structural contexts is therefore crucial to the promotion of Europe-wide policies for research funding. Nevertheless, studies assessing and comparing research systems remain scarce. This paper aims to further the knowledge on national research landscapes in Europe, focusing on non-communicable disease (NCD) research in Italy and Germany.MethodsTo capture the architecture of country-specific research funding systems, a three-fold strategy was adopted. First, a literature review was conducted to determine a list of key public, voluntary/private non-profit and commercial research funding organisations (RFOs). Second, an electronic survey was administered qualifying RFOs. Finally, survey results were integrated with semi-structured interviews with key opinion leaders in NCD research. Three major dimensions of interest were investigated – funding mechanisms, funding patterns and expectations regarding outputs.ResultsThe number of RFOs in Italy is four times larger than that in Germany and the Italian research system has more project funding instruments than the German system. Regarding the funding patterns towards NCD areas, in both countries, respiratory disease research resulted as the lowest funded, whereas cancer research was the target of most funding streams. The most reported expected outputs of funded research activity were scholarly publication of articles and reports.ConclusionsThis cross-country comparison on the Italian and German research funding structures revealed substantial differences between the two systems. The current system is prone to duplicated research efforts, popular funding for some diseases and intransparency of research results. Future research will require addressing the need for better coordination of research funding efforts, even more so if European research efforts are to play a greater role.
location: nan, 'Global 
year: 2017 source: BMC 
title: How do we define the policy impact of public health research? A systematic review 
abstract:BackgroundIn order to understand and measure the policy impact of research we need a definition of research impact that is suited to the task. This article systematically reviewed both peer-reviewed and grey literature for definitions of research impact to develop a definition of research impact that can be used to investigate how public health research influences policy.MethodKeyword searches of the electronic databases Web of Science, ProQuest, PubMed, EMBASE, CINAHL, Informit, PsycINFO, The Cochrane Database of Systematic Reviews and Google Scholar were conducted between August 2015 and April 2016. Keywords included ‘definition’ and ‘policy’ and ‘research impact’ or ‘research evidence’. The search terms ‘health’, public health’ or ‘mental health’ and ‘knowledge transfer’ or ‘research translation’ were used to focus the search on relevant health discipline approaches. Studies included in the review described processes, theories or frameworks associated with public health, health services or mental health policy.ResultsWe identified 108 definitions in 83 publications. The key findings were that literature on research impact is growing, but only 23% of peer-reviewed publications on the topic explicitly defined the term and that the majority (76%) of definitions were derived from research organisations and funding institutions. We identified four main types of definition, namely (1) definitions that conceptualise research impacts in terms of positive changes or effects that evidence can bring about when transferred into policies (example Research Excellence Framework definition), (2) definitions that interpret research impacts as measurable outcomes (Research Councils UK), and (3) bibliometric and (4) use-based definitions. We identified four constructs underpinning these definitions that related to concepts of contribution, change, avenues and levels of impact.ConclusionThe dominance of bureaucratic definitions, the tendency to discuss but not define the concept of research impact, and the heterogeneity of definitions confirm the need for conceptual clarity in this area. We propose a working definition of research impact that can be used in a range of health policy contexts.
location: nan, 'Global 
year: 2017 source: BMC 
title: Knowledge mobilisation for policy development: implementing systems approaches through participatory dynamic simulation modelling 
abstract:BackgroundEvidence-based decision-making is an important foundation for health policy and service planning decisions, yet there remain challenges in ensuring that the many forms of available evidence are considered when decisions are being made. Mobilising knowledge for policy and practice is an emergent process, and one that is highly relational, often messy and profoundly context dependent. Systems approaches, such as dynamic simulation modelling can be used to examine both complex health issues and the context in which they are embedded, and to develop decision support tools.ObjectiveThis paper reports on the novel use of participatory simulation modelling as a knowledge mobilisation tool in Australian real-world policy settings. We describe how this approach combined systems science methodology and some of the core elements of knowledge mobilisation best practice. We describe the strategies adopted in three case studies to address both technical and socio-political issues, and compile the experiential lessons derived. Finally, we consider the implications of these knowledge mobilisation case studies and provide evidence for the feasibility of this approach in policy development settings.ConclusionParticipatory dynamic simulation modelling builds on contemporary knowledge mobilisation approaches for health stakeholders to collaborate and explore policy and health service scenarios for priority public health topics. The participatory methods place the decision-maker at the centre of the process and embed deliberative methods and co-production of knowledge. The simulation models function as health policy and programme dynamic decision support tools that integrate diverse forms of evidence, including research evidence, expert knowledge and localised contextual information. Further research is underway to determine the impact of these methods on health service decision-making.