bluuebunny/crossref_metadata_2025 huggingface dataset:
Hierarchies of quantum chemical descriptors induced by statistical analyses of domain occupation number operators
Authors: Acke Guillaume , De Baerdemacker Stijn , Martín Pendás Ángel , Bultinck Patrick
Published: December 2019

As approximations to the wave functions governing quantum chemical systems become more and more complex, it is becoming increasingly important to devise descriptors that help understand the practical results of those approximations by condensing information in insightful ways. Quantum chemical descriptors that are able to capture the statistical signatures of quantum chemical interactions provide such conceptual building blocks. Central to an understanding of these descriptors is the concept of a “domain occupation number operator,” which allows the so‐called “real space” and Hilbert space partitionings to be treated on the same footing. Many of the existing descriptors can be expressed as the (central) densities and density cumulants associated with the domain operators. These densities can be obtained by successive differentiation of generating functions, effectively structuring domain associated densities into hierarchies. Not only do the resulting hierarchies indicate how many of the previously reported descriptors are related, they also show which areas have not yet been explored.

This article is categorized under:

Electronic Structure Theory > Ab Initio Electronic Structure Methods
Detection of spills related to natural gas production
Authors: Wickline Joseph , Hopkinson Leslie
Published: December 2019

Acute spills related to natural gas production are rare but pose a threat to water resources. This work evaluated the use of an event detection system (EDS) to identify spills related to Marcellus Shale development. An EDS was applied to water quality data from natural channels impacted by three known and one simulated spill of various oil and gas byproducts (spill volumes: 7.9–23.8 m3). Events were detected in the week following the spills for two of the known spills, but false alarms reduced confidence in detection. Events detected for the third spill were attributed to sensor malfunction. The simulated spill was not detected. Results highlight the difficulty in identifying acute events and support the need for the development of monitoring strategies.

Practitioner points

Event detection systems were utilized to identify spills related to natural gas production.

Spills of production fluid, drilling mud, and flowback fluid were considered.

Spills were not detected using the event detection system, supporting the need for the development of monitoring strategies.
Review of in situ X‐ray fluorescence analysis technology in China
Authors: Ge Liangquan , Li Fei
Published: December 2019

In the past two decades, the in situ X‐ray fluorescence (XRF) technology has been developed rapidly in China, which is mainly due to the rapid development of China's economy and the great demand for rapid qualitative and quantitative analysis of elements in geological exploration, environmental protection, and industrial process analysis. In this article, the development of in situ XRF analysis technology in China is reviewed from three aspects, namely in situ XRF analyzers, in situ XRF analysis technology, and applications of in situ XRF analysis technology. The in situ XRF analyzers are divided into four generations, and the technical characteristics of each generation of analyzers are discussed from the perspectives of X‐ray excitation source, detector, electronic circuit unit, and digital signal processing. The progress of X‐ray spectrum analysis, matrix effect correction, and correction of uneven effect and humidity effect is reviewed. The representative applications of XRF analysis technology in geological and mineral survey, environmental pollution investigation, cultural relic identification, and alloy analysis are introduced.
Let’s play on Facebook: using sentiment analysis and social media metrics to measure the success of YouTube gamers’ post types
Authors: Poecze Flora , Ebster Claus , Strauss Christine
Published: December 2019

This paper discusses the analysis results of successful self-marketing techniques on Facebook pages in the cases of three YouTube gamers: PewDiePie, Markiplier, and Kwebbelkop. The research focus was to identify significant differences in terms of the gamers’ user-generated Facebook metrics and commentary sentiments. Analysis of variance (ANOVA) andk-nearest neighbor sentiment analysis were employed as core research methods. ANOVA of the classified post categories revealed that photos tended to show significantly more user-generated interactions than other post types, while, on the other hand, re-posted YouTube videos gained significantly fewer numbers in the retrieved metrics than other content types.K-nearest neighbor sentiment analysis pointed out underlying follower negativity in cases where user-generated activity was relatively low, thereby improving the understanding of the opinion of the masses previously hidden behind metrics such as the number of likes, comments, and shares. The paper at hand highlights the methodological design of the study as well as a detailed discussion of key findings and their implications, and future work. The results per se indicate the need to utilize natural language processing techniques to optimize brand communication on social media and highlight the importance of considering machine learning sentiment analysis techniques for a better understanding of consumer feedback.
Efficacy and safety of migalastat in a Japanese population: a subgroup analysis of the ATTRACT study
Authors: Narita Ichiei , Ohashi Toya , Sakai Norio , Hamazaki Takashi , Skuban Nina , Castelli Jeffrey P. , Lagast Hjalmar , Barth Jay A.
Published: December 2019

Background

Fabry disease is a progressive X-linked lysosomal disorder. In this subgroup analysis of the global phase III ATTRACT study, the efficacy and safety of oral migalastat, a pharmacologic chaperone, were investigated in Japanese patients with Fabry disease.

Methods

Patients were randomly assigned to receive migalastat (150 mg every other day) or to continue biweekly enzyme replacement therapy infusions (ERT; agalsidase alfa 0.2 mg/kg or agalsidase beta 1.0 mg/kg) for 18 months followed by a 12-month open-label extension during which all patients received migalastat. End points included glomerular filtration rate (estimated and measured), left ventricular mass index (LVMi), composite clinical outcomes, leukocyte alpha-galactosidase A activity, plasma globotriaosylsphingosine (lyso-Gb3), and safety.

Results

Data from 7 Japanese patients (migalastat, 5; ERT, 2), mean age 55 years, with high disease burden, were analyzed. All patients in the migalastat group completed the open-label comparison and extension periods. At 18 months, efficacy in the Japanese patient population was similar to that in the overall ATTRACT population. Migalastat treatment increased leukocyte alpha-galactosidase A activity, stabilized renal function, and decreased LVMi. Plasma lyso-Gb3 levels remained low and stable. Additionally, the long-term extension study showed that efficacy of migalastat was maintained for up to 48 months. Migalastat was safe and well tolerated in the Japanese patients, as in the overall ATTRACT population.

Conclusion

Migalastat can be used to treat Japanese patients with Fabry disease with GLA mutations amenable to migalastat according to the dosage and administration approved in other countries.

Trial registration numbers

ClinicalTrials.gov, NCT01218659 and NCT02194985.
Clinical pharmacological study of dotinurad administered to male and female elderly or young subjects
Authors: Nakatani Hiroshi , Fushimi Masahiko , Sasaki Tomomitsu , Okui Daisuke , Ohashi Tetsuo
Published: December 2019

Background

Dotinurad is a novel selective urate reabsorption inhibitor (SURI) that selectively inhibits the reabsorption of uric acid in renal tubules and promotes the excretion of uric acid into urine. In this study, the effects of age and gender on the pharmacokinetics (PK), pharmacodynamics (PD), and safety of dotinurad were evaluated in healthy subjects.

Methods

An open-label study of a single oral administration of dotinurad 1 mg was conducted in elderly (≥ 65 years) Japanese males and females, and young (20–35 years) males and females (six patients each).

Results

Following a single-dose administration of dotinurad, the change in dotinurad plasma concentration showed a similar profile across groups. Regarding the PK parameters, there was no significant difference between elderly and young subjects. On comparing males and females, significant differences were observed in some parameters in elderly subjects. However, these differences in some parameters could not be detected by adjust for body weight. When PD parameters in elderly and young subjects were compared, significant differences were observed in some parameters in male subjects. On comparing males and females, significant differences were observed in some parameters in young subjects; however, the percent change in serum uric acid concentration decreased over time was relatively close for both groups. There were no clinically relevant safety problems.

Conclusion

Age and gender had no clinically meaningful effect on the PK, PD, and safety of dotinurad.

Clinical trials

ClinicalTrials.gov identifier: NCT02344875.
SEOM clinical guidelines in hereditary breast and ovarian cancer (2019)
Authors:   the SEOM Hereditary Cancer Working Group, González-Santiago S. , Ramón y Cajal T. , Aguirre E. , Alés-Martínez J. E. , Andrés R. , Balmaña J. , Graña B. , Herrero A. , Llort G. , González-del-Alba A.
Published: December 2019

Mutations inBRCA1andBRCA2high penetrance genes account for most hereditary breast and ovarian cancer, although other new high-moderate penetrance genes included in multigene panels have increased the genetic diagnosis of hereditary breast and ovarian cancer families by 50%. Multigene cancer panels provide new challenges related to increased frequency of variants of uncertain significance, new gene-specific cancer risk assessments, and clinical recommendations for carriers of mutations of new genes. Although clinical criteria for genetic testing continue to be largely based on personal and family history with around a 10% detection rate, broader criteria are being applied with a lower threshold for detecting mutations when there are therapeutic implications for patients with breast or ovarian cancer. In this regard, new models of genetic counselling and testing are being implemented following the registration of PARP inhibitors for individuals who display BRCA mutations. Massive sequencing techniques in tumor tissue is also driving a paradigm shift in genetic testing and potential identification of germline mutations. In this paper, we review the current clinical criteria for genetic testing, as well as surveillance recommendations in healthy carriers, risk reduction surgical options, and new treatment strategies in breast cancer gene-mutated carriers.
Managing large distributed dynamic graphs for smart city network applications
Authors: Voloch Nadav , Voloch - Bloch Noa , Zadok Yair
Published: December 2019

Smart cities and traffic applications can be modelled by dynamic graphs for which vertices or edges can be added, removed or change their properties. In the smart city or traffic monitoring problem, we wish to detect if a city dynamic graph maintains a certain local or global property. Monitoring city large dynamic graphs, is even more complicated. To treat the monitoring problem efficiently we divide a large city graph into sub-graphs. In the distributed monitoring problem we would like to define some local conditions for which the global city graph G maintains a certain property. Furthermore, we would like to detect if a local city change in a sub-graph affect a global graph property. Here we show that turning the graph into a non-trivial one by handling directed graphs, weighted graphs, graphs with nodes that contain different attributes or combinations of these aspects, can be integrated in known urban environment applications. These implementations are demonstrated here in two types of network applications: traffic network application and on-line social network smart city applications. We exemplify these two problems, show their experimental results and characterize efficient monitoring algorithms that can handle them.
The time varying network of urban space uses in Milan
Authors: Bernini Alba , Toure Amadou Lamine , Casagrandi Renato
Published: December 2019

In a metropolis, people movements design intricate patterns that change on very short temporal scales. Population mobility obviously is not random, but driven by the land uses of the city. Such an urban ecosystem can interestingly be explored by integrating the spatial analysis of land uses (through ecological indicators commonly used to characterize natural environments) with the temporal analysis of human mobility (reconstructed from anonymized mobile phone data). Considering the city of Milan (Italy) as a case study, here we aimed to identify the complex relations occurring between the land-use composition of its neighborhoods and the spatio-temporal patterns of occupation made by citizens. We generated two spatially explicit networks, one static and the other temporal, based on the analysis of land uses and mobile phone data, respectively. The comparison between the results of community detection performed on both networks revealed that neighborhoods that are similar in terms of land-use composition are not necessarily characterized by analogous temporal fluctuations of human activities. In particular, the historical concentric urban structure of Milan is still under play. Our big data driven approach to characterize urban diversity provides outcomes that could be important (i) to better understand how and when urban spaces are actually used, and (ii) to allow policy makers improving strategic development plans that account for the needs of metropolis-like permanently changing cities.
The UN Security Council and Non-state Actors
Authors: Boon Kristen
Published: December 2019

Since the end of the Cold War it has become clear that non-state actors (NSA)1 can have a substantial impact on situations affecting international peace and security.2 Although the authority of the Security Council to directly address NSA is not uncontroversial, it is clear that as a practical matter the Council does exercise this authority regularly.3 My remarks will address this practice and explain its legal significance.
Colonialism, Legal Borrowing, and Disruption in Africa
Authors: Arewa Olufunmilayo B.
Published: December 2019

Disruptive and other technologies have spread throughout Africa in recent years. Many see the digital economy as a potential new path that might enable leapfrogging that narrows economic and technological gaps between Africa and the rest of the world. Today, more than half a century after the end of colonialism, far too many remain poor in Africa. High rates of economic growth in the early years of the new millennium have decreased, while the population in many African countries is set to double between now and 2050. Unemployment and underemployment are pervasive in many African countries today.
The Law (and Politics) of Forced Displacement: Toward a History of the Present
Authors: Mann Itamar
Published: December 2019

It is a tremendous honor being here today and participating in this esteemed panel on the “Law (and Politics) of Displacement,” which Jill Goldenziel has organized. I would like to share some research Umut Özsu and I are working on. This is a work in progress, but I still think its outlines are worth discussion, by way of historical background. I hope the project also demonstrates quite well why several of us at the International Migration Law Interest Group at the American Society of International Law have been thinking that migration should become more central to the discipline of international law; as central, say, as international humanitarian law.
Law, Policy, and the Social Construction of Disaster
Authors: Cooper Michael D.
Published: December 2019

Emerging in the English language during the 1590s, the etymological origins of the word “disaster” are found in désastre from Middle French (1560s) and disastro from Italian, meaning “ill-starred,” with “dis-,” a pejorative and “astro” meaning “star” or “planet”—from the Latin astrum and from the Greek ástron. The notion was of “an unfavorable aspect of a star or planet,” a “malevolent astral influence,” or a “calamity blamed on an unfavorable position of a planet.”
Access to Information, Higher Education, and Reputational Risk: Insights from a Case Study
Authors: Lamoureux Patrick
Published: December 2019

Access to information and freedom of information (ATI/FOI) requests are an increasingly utilized means of generating data in the social sciences. An impressive multi-disciplinary and international literature has emerged which mobilizes ATI/FOI requests in research on policing, national security, and imprisonment. Absent from this growing literature is work which deploys ATI/FOI requests in research on higher education institutions (HEIs). In this article I examine the use of ATI/FOI requests as a methodological tool for producing data on HEIs. I highlight the data-generating opportunities that this tool offers higher education researchers and provide a first-hand account of how ATI/FOI requests can be mobilized in higher education research. I argue that despite the value of ATI/FOI requests for producing data on academic institutions, the information management practices of HEIs limit the effectiveness of ATI/FOI in ways that I detail drawing on my experience using information requests to scrutinize the quality assurance of undergraduate degree programs in Ontario. I suggest that in an age of rankings and league tables HEIs are likely to prioritize the protection of their reputation over the right of access. In conclusion I consider the implications of the article’s findings for higher education researchers and ATI/FOI users.
Scenes from the Global South: Women’s Bodies as Waste in Bolaño’s 2666
Authors: López Alfred J.
Published: December 2019

This essay reads the landscape of Roberto Bolaño’s fictional Santa Teresa through a new materialist lens. In the fourth section of Bolaño’s epic novel 2666, “The Part about the Crimes,” the bodies of 112 women, victims of a series of unsolved murders, accumulate as part of a postglobal dystopic narrative of material and existential waste. Critics have especially noted the text’s clinical narration of events, which effectively reduces the victims’ bodies to interchangeable parts of a larger assemblage that also includes the factories (maquiladoras) where the women work, the northern capital that funds them, the police force that repeatedly fails to solve the murders, and the trash heaps and landfills where many of the bodies appear. It is, however, the women’s inert, mutilated bodies that animate Bolaño’s novel. Dehumanized by the text, the bodies’ materiality paradoxically gives human heft to an otherwise mechanistic account of undifferentiated carnage.
Ecologies of Oil and Trauma of the Future inCurse of the Black Gold
Authors: Iheka Cajetan
Published: December 2019

Mineral extraction in Africa has exacerbated ecological degradation across the continent. This article focuses on the example of the Niger Delta scene of oil exploration depicted in Michael Watts and Ed Kashi’s multimedia project,Curse of the Black Gold: 50 Years of Oil in the Niger Delta.Analyzing the infringement on human and nonhuman bodies due to fossil fuel extraction, I read the Delta, inscribed in Watts and Kashi’s image-text, as an ecology of suffering and as a site of trauma. Although trauma studies tend to foreground the past and the present, I argue thatCurse of the Black Goldinvites serious consideration of trauma of the future, of-the-yet-to-come, in apprehending the problematic of suffering in the Delta. I conclude with a discussion of the ethics of representing postcolonial wounding, which on the one hand can create awareness of ecological degradation and generate affect, but which on the other hand, exploits the vulnerability of the depicted and leaves an ecological footprint.
The one text in the many: separate and composite readings of an Early Chinese historical manuscript
Authors: Krijgsman Rens , Vogt Paul Nicholas
Published: December 2019

The manuscript carrying the titleZhuangwang ji Cheng莊王既成, from the Shanghai Museum corpus of bamboo slips, bears two related anecdotes concerning the early Chinese monarch King Zhuang of Chu. In this article, we translate both stories and offer interpretations of them both as individual texts and as a composite narrative, situating both readings in a context of intertextual references based on shared cultural memory. Approaching the anecdotes together, we argue, generates an additional layer of meaning, yielding both a deep sense of dramatic irony and a critique of the value of foreknowledge – and, by extension, of the explanatory value of historiography. In detailing how this layer of meaning is generated, we explore the range of reading experiences and approaches to understanding the past enabled by combining separate but related textual units, a prevalent mode of composition and consumption in the manuscript culture of Warring States China.
OP28 Patient Involvement at AQuAS: Experiences And Reflections For Future
Authors: Masana Lina , Garcia Emmanuel Gimenez , Espallargues Mireia
Published: December 2019

Introduction

AQuAS is gradually incorporating patient involvement in health technology assessment (HTA). We present two experiences conducted during 2018 and the different methods and approaches used. The aim is to reflect on learnings from those experiences to improve ways for increasing patient involvement with HTA at AQuAS.

Methods

We conducted two experiences using different quantitative and qualitative techniques (mix-methods approach). The first, a focus group discussion regarding the use of 3D-technologies for maxillofacial reconstruction with a selection of hospital patients that received maxillofacial reconstruction, which included the use of a quality-of-life retrospective self-assessment tool. The second, a sequence of email correspondence regarding cataract surgery technology (femtosecond laser-assisted cataract surgery (FLACS), in the context of an EUnetHTA Joint Assessment) with a patients’ association representative, to learn their opinion regarding the use of laser technology.

Results

Main learnings were: (1) patients and associations have different levels of knowledge and expertise to consider when planning an HTA; (2) sharing experience and knowledge among peers (i.e. focus group) proved to have a positive impact on patients and worked as a resource for some to improve knowledge on their condition; (3) critiques were received regarding a specific Patient Reported Experience template for HTA patient involvement (iv) quality of life retrospective self-assessment tool provided unexpected positive and negative results.

Conclusions

Recent patient involvement in HTA at AQuAS proved to be useful to complement HTA reports. We believe that patients’ experiences and opinions can help decision-making regarding the use, disinvestment or incorporation of health technologies, contribute to the improvement of tools and survey accuracy and improve doctor-patient communication. Their involvement might be beneficial for them to gain more knowledge, share experiences, reflect on their health situation and improve communication with the professionals that treat them. Future patient-involvement in HTA is needed, e.g. considering the social perspective in economic evaluations or including patients in recommendation consensus panels.
OP38 Implementing Social Innovations: From Evidence-Based To Theory-Driven
Authors: Zechmeister-Koss Ingrid , Goodyear Melinda , Paul Jean , Bauer Annette
Published: December 2019

Introduction

For the last decades, health technology assessment has been strongly promoted in order to provide evidence-based rather than eminence-based healthcare. However, when it comes to implementing interventions that are based on processes and behavior rather than products, importing evidence-based interventions is likely to fail because it ignores the strong influence of contextual factors. In a recently started research project, an alternative approach is tested.

Methods

The project aims at improving identification and support of children who have parents with a mental illness in an Austrian region (Tyrol). A theory- and stakeholder-driven approach has been designed in order to co-develop, implement and evaluate practice approaches for improving the situation for children. The former addresses the questions whether, how and why suggested practices may work and the later brings together evidence and practice to develop interventions that are feasible and take the regional context and service settings into account.

Results

Based on evidence from various sources (literature, international and local stakeholder interviews), theories that describe the key mechanisms of action to influence outcomes for children have been developed. A regional and interdisciplinary group of practitioners and people with lived experience has been established to facilitate the development of the theory of change and practice approaches for the region and local service settings. The final practice model is then monitored in the respective organizations with implementation support from the research team.

Conclusions

Theory-driven and co-designed-based approaches are a feasible alternative to ‘off-the-shelf’ evidence-based practices for supporting decision makers in implementing complex interventions. However, they require a broad variety of skills within the research team as well as willingness to accept uncertainties of the final outcomes produced, which can also be of risk to funders. The ongoing project will demonstrate whether the developed practices will be implemented successfully and result in benefits for the affected children.
OP39 Adapting HTA To Suit Emerging Needs - An Australian Experience
Authors: Warner Mary
Published: December 2019

Introduction

Australia has a well-developed HTA system for approving, funding and disinvesting in medical services, but how does it cope when it assesses new or existing services when health system frameworks, policy and legislation do not keep pace? This presentation will present a number of case studies where HTA methods have adapted to suit emerging health needs of the Australian community.

Methods

Australia's HTA system has been adapted over recent years to allow it to perform HTA on novel services that do not fit into its standard HTA pathway to public funding. There has also been an increasing number of assessments where HTA has been unusually sponsored by the funder to assess priority health care needs.

Results

More Medicare funding for addiction and sexual health consultation services are an example of a novel HTA which led to more public funding for these services. Limited evidence for these services was available and there was difficulty in demonstrating that increased public funding would lead to better outcomes for patients. A range of techniques, such as examining real world data and stakeholder views were partnered with HTA to assess these services. Currently, HTA is being utilised to assess a novel medical treatment known as the anti-CD19 chimeric antigen receptor T cell (CAR-T) therapeutic process. This is a complex, non-standard HTA which encompasses aspects of the Australian hospital funding system, Medicare and the Pharmaceutical Benefits Scheme and requires an adapted HTA process to assess evidence across a range of funder systems.

Conclusions

Australia's well established HTA system has adapted to become more agile to suit emerging health care needs for a range of interest groups, the government, sponsors and consumers. Consultation with stakeholders and the community have assisted in developing and refining these new processes.
OP57 Threats And Opportunities To Digital Health In Primary Care
Authors: Gagnon Marie-Pierre , Rouleau Geneviève , Alami Hassane , Fortin Jean-Paul
Published: December 2019

Introduction

The use of digital technologies in healthcare systems (digital health)– such as electronic health records and telehealth – can improve primary care (PC). However, integration of digital health can be constrained/impaired and/or facilitated due to several factors. We propose an integrative framework for classifying the factors that could favour or limit digital health integration in PC in order to guide the identification of strategies that could be helpful for technology promoters, managers, clinicians and researchers.

Methods

Based on a systematic review, our framework includes seven categories to classify the main opportunities and threats to digital health integration in PC: technological; individual/interpersonal; professional; organisational/institutional; ethical/legal; sociopolitical; economical. We consulted a panel of researchers, managers, clinicians, and citizens/patients in a scientific meeting regarding the main opportunities and threats to the integration of digital health in PC. We performed a content analysis of the reported factors according to the framework.

Results

Technological factors such as maturity, interoperability and ease of use were often mentioned as key conditions for digital health integration. Individual and interpersonal factors such as depersonalisation and digital literacy were seen as threats. The impact on workload and shared responsibility were threats at the professional level, whereas silos and change management were noted as organisational threats. Current policies and social trends favored digital health. Threats regarding privacy and confidentiality were mentioned at the legal/ethical level. The possibility to reduce costs and sharing of benefits were noted as opportunities at the economic level.

Conclusions

Knowing these multidimensional conditions, perceived as either threats or opportunities depending on the context of each PC setting, is essential to inform decisions, from strategic planning to evaluation. Our integrative framework allows a simple classification of opportunities and threats that can guide the development and implementation of tailored strategies favouring the integration of digital health in PC.
OP63 Clinical Videoconferencing - Critical-realist Review As Evidence?
Authors: Ekeland Anne
Published: December 2019

Introduction

It is not clear yet whether new digital health interventions can and should be assessed by using ‘conventional’ health technology assessment (HTA) methodology. In response to the question about how much and which type of evidence is needed for decisions on new digital health interventions, this presentation discusses complimentary evidence as generated through a critical-realist review and a qualitative meta-synthesis. This work follows from earlier work by AG Ekeland, AH Hansen and TS Bergmo.

Methods

A realist review addresses complex social interventions investigated in real life settings. The review was conducted with the purpose of generating knowledge on what works, for whom and under which circumstances. The aim was to enable decision-makers to reach a deeper understanding of how the intervention can be made to work most effectively. A critical review goes beyond mere description of identified articles and includes analysis and conceptual innovation. An effective critical review synthesizes material from diverse sources, provides an opportunity to ‘take stock’ and evaluate what is of value related to a previous body of work.

Results

User patterns of clinical videoconferencing turned out to be dependent on contextual factors like clinical condition, motivation, technological skills, professional and organizational arrangements, trust and the perceived value they add compared with “services as usual”. The pattern of what works, for whom and under which circumstances was heterogeneous and dynamic. The review types helped identify and conceptualize new user categories, and understand the complex patterns of use.

Conclusions

The in-depth accounts of different clinical use resulting from such a review provide decision makers with a highly practical understanding of complex social interventions which is likely to be of use when planning and implementing programs at a national, regional or local level. A critical-realist review of digital services can complement controlled studies and evidence summaries in HTA.
OP83 Iterative Formative Research Informing Primary Care Education Design
Authors: Belcher Josephine , Alzaher Woroud , Naik-Panvelkar Pradnya , Granger Renee
Published: December 2019

Introduction

NPS MedicineWise delivers nationwide educational programs for Australian general practitioners and community pharmacists. Extensive searching and synthesis of published and grey literature is undertaken to inform program design and development. However, this formative research process is lengthy, labour intensive and attempts to pre-emptively answer questions that could arise during design and development, prompting a process re-evaluation.

Methods

A more targeted and iterative process was piloted entailing: (i) rapid collation (two weeks maximum) of basic contextual information into a pre-scoping briefing document including high-level statistics on medicines or test usage, key guidelines identification and collation of findings from relevant government and stakeholder reports, (ii) an internal advisory group reviewing the pre-scoping brief and identifying the highest priority research questions that must be answered to inform the design and development of the educational program, (iii) iterative work to answer the highest priority research questions with findings provided to the advisory group fortnightly, involving ad hoc search methods and snowballing techniques to identify pertinent literature quickly, (iv) iterative feedback from the advisory group as to whether the resulting work is adequate and development or whether further information is required, and reprioritisation of the work plan if necessary, and (v) completion of the formative research process within four or five iterations. The new approach was evaluated via surveys of the internal advisory group and staff involved in design and development. Administrative data on staffing and costs using the new approach were also compared with previous data.

Results

This approach was trialled for three different educational programs. The resulting reports are more targeted, answer specific advisory group questions and take half the time to produce.

Conclusions

This approach can rapidly provide appropriate information to inform program design. The iterative approach has allowed greater responsiveness to changing advisory group priorities and process improvements.
OP85 Persistence Leads To Ongoing Decreases In Primary Care Antibiotic Use
Authors: Dartnell Jonathan , Sterling Kirsten , Heaney Aine , Blogg Suzanne
Published: December 2019

Introduction

Australia has had high rates of antibiotic use in primary care. Consumer and health professional knowledge and practices in the community vary. In 2012, NPS MedicineWise implemented a five-year national educational program for consumers, general practitioners (GPs) and pharmacies to reduce antibiotic use in Australia.

Methods

For consumers, a social marketing approach was used focusing on the winter months. Strategies leveraged collectivism, nudge theory, celebrity endorsement and co-creation and used multiple communication channels. For health professionals, interventions were most intense in 2012 with additional activities implemented each year including face-to-face educational visiting, audits, comparative prescribing feedback, case studies and point-of-care materials. Surveys were conducted periodically to evaluate changes in knowledge and awareness. Pharmaceutical Benefits Scheme (PBS) claims data were analyzed. Organization for Economic Co-operation and Development data was used to compare Australian antibiotic per capita consumption to other countries. Time series analyses were used to estimate the cumulative program effect comparing observed and expected monthly dispensing volumes of antibiotics commonly prescribed for upper respiratory tract infections (URTIs), had interventions not occurred.

Results

Between 2012 and 2017, GP antibiotic PBS prescriptions reduced by 18.4 percent. Antibiotic defined daily doses per 1000 inhabitants reduced from 23.7 in 2012 to 18.4 in 2016, similar to Norway (18.6 in 2016) and the UK (18.7). Time series modelling estimated 24.8 percent fewer GP antibiotic URTI prescriptions by 2017 versus no program. Consumer survey results indicated increased awareness of antibiotic resistance (50 percent in 2011, 74 percent in 2017) and the minority expect/request antibiotics for URTIs (22 percent in 2017).

Conclusions

A five-year national educational program with multiple and repeated interventions for health professionals and consumers has resulted in ongoing reductions in antibiotic use in primary care.
OP129 Healthcare Utilization After Bariatric Surgery
Authors: Kelles Silvana Marcia Bruschi , Soares dos Santos Augusto Cesar , Horta Maria da Glória Cruvinel , Fernandes Mariana Ribeiro , Rodrigues Luíza de Oliveira , Avelar Sandra de Oliveira Sapori , Carvalho Lélia Maria de Almeida , Campos Nelson Otavio Beltrao , Scherrer Luciano Rios , Biscione Fernando Martin
Published: December 2019

Introduction

Bariatric surgery has become one of the fastest growing operative procedures due to its sustained results and the increasing prevalence of obesity worldwide. Despite this fact, bariatric surgery carries the usual risks and threats of surgical interventions and therefore its benefits might be undermined by its mid and long-term complications.

Methods

This retrospective study included obese patients requiring bariatric surgery from January 2004 to December 2017 provided by a private healthcare organization in Belo Horizonte, Brazil. Data regarding healthcare utilization were extracted from an administrative database (software Oracle Business Intelligence). Continuous variables were expressed as mean and standard deviation. Log-Rank test was used to adjust the survival curve (software STATA 13.1, Stata Corp, USA). This historical cohort resulted in no interventions, neither during the instituted treatment nor after the observed outcome. Privacy of subjects and the confidentiality of their personal information were handled in accordance with the ethical principles of the Declaration of Helsinki.

Results

In total, 16,786 patients were included in the study (mean age 37.2 ± 10.2 years; female 79.2 percent; mean body mass index 42.4 ± 5.5 kg/m2). Patients were followed for up to seven years before and after surgery (total of 78,113 patients/year). For this group, the hospitalization rate was 0.099 / patients-year before versus 0.151 / patients-year after the bariatric surgery (p < 0.001). There were 224 deaths (1.33 percent) identified during the follow-up period, 0.4 percent in the first 30 postoperative days. The average costs for hospitalization were USD 3,339.36 and USD 4,305.04 for open and laparoscopic surgery, respectively.

Conclusions

Bariatric surgery has been an increasingly popular choice in the management of obesity. In our sample, it did not reduce the overall mid-term healthcare utilization rate.
OP131 Rapid Review For Policy: Interchangeability Of Biological Medicines
Authors: Rego Daniela , Farinasso Cecilia , Silva Roberta Borges , Gomes Dalila Fernandes , de Aguiar Aurelina Aguiar , Leão Luciana Simões Camara , Sachetti Camile Giaretta , Gonçalves Lenilson Pereira , Leite Betânia
Published: December 2019

Introduction

Due 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.

Methods

We 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.

Results

We 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.

Conclusions

Evidence-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.
OP132 What Future For Drugs After An Early Dialogue Procedure?
Authors: Fernandez Judith , Thomassin Camille , Grande Mathilde , Bélorgey Chantal , Thuillez Christian , d'Andon Anne
Published: December 2019

Introduction

The French health technology assessment (HTA) body, Haute Autorité de la Santé (HAS), started to provide early advice on evidence generation plans to pharmaceutical manufacturers in 2010. It became an official mission in 2016. Requests are eligible when the product has a new mechanism of action, if there is an unmet or partially met medical need in the claimed indication and when the pivotal study has not yet started. This analysis aims to provide a first overview of clinical developments for which pharmaceutical companies sought an early dialogue with HAS.

Methods

For each product that went through an early dialogue procedure with HAS, information regarding the clinical development was collected on pharmaceuticals companies’ pipelines, clinicaltrials.gov, the website of the European Medicine Agency (EMA) and HAS's internal database.

Results

By the end of 2018, HAS has performed 84 early dialogues of which 53 were conducted in collaboration with the EMA and/or others European HTA bodies. They were mainly focused on phase III trials. Following early dialogue, the clinical study for which the company sought advice was not yet implemented in 25 cases. When the clinical trial was effectively launched, results were negative in 10 cases, positive in 11 cases and the study was still ongoing for 29 products. In nine cases, the clinical development was officially withdrawn or suspended before the initiation of the trial. Overall, only eight medicinal products were appraised by HAS, they all obtained a clinical added value score.

Conclusions

The success rate of clinical development for products that underwent an early dialogue procedure tends to be higher than data from literature, although it is likely to decrease in follow-up analysis. This could be partially explained by HAS's eligibility criteria that restrict early dialogues to promising products and by the scientific recommendations provided to pharmaceuticals companies.
OP142 Reviewing Methods For Early Assessment
Authors: Stome Linn Nathalie , Moger Tron , Kidholm Kristian , Kvaerner Kari
Published: December 2019

Introduction

The project DigiHelse aims to support the municipality health in Norway by offering a digital communication platform to users of the home care service nationally. In a concept stage of innovation, an early assessment of the potential socioeconomic value of the project was carried out by means of stakeholder insight and scenario drafting. As the assessment showed favorable potential in providing decision support and reducing risk, the project received funding to move into the pilot phase. The objective of this study is to reassess the effect of stakeholder insight and scenario drafting by validating the results using empirical data from the first pilot of DigiHelse.

Methods

Through collecting empirical data on resource consumption and inquiries to the service from four intervention districts and one control district in Oslo, the socioeconomic value of DigiHelse was reassessed. In addition to survey and register data collected before and after the pilot, behavioral data was introduced as a new data source.

Results

The effect of early assessment by means of stakeholder insight and scenario drafting was successfully studied adding empirical data from the projects first pilot. The real-time data on user behavior registered in the DigiHelse server contributed to verify the assumptions from the first assessment of the project. Although the results from the analysis were less optimistic than the first assessment, the study revealed important improvement measures necessary to improve the innovation process.

Conclusions

The usefulness of early assessment is questioned, due to lack of precision of estimates caused by scarce available data. The present study presents a first step in evaluating the precision of employing stakeholder insight and scenario drafting as additional information in early assessment of innovation. The studied approach to early assessment showed potential in enhancing decision support and reducing risk from a concept stage of innovation.
OP143 Assessment Of mHealth Apps: Is Current Regulation Policy Adequate?
Authors: Moshi Magdalena , Parsons Jacqueline , Tooher Rebecca , Merlin Tracy
Published: December 2019

Introduction

Australians are adjusting to mobile health (mHealth) applications (apps) being used in clinical care. The nature of apps presents unique challenges (e.g. rapid lifecycle) to mHealth regulation. The risks they pose are mainly through the information they provide and how it is used in clinical decision-making. This study explores the international regulation of mHealth apps. It assesses whether the approach used in Australia to regulate apps is consistent with international standards and suitable to address the unique challenges presented by the technology.

Methods

A policy analysis was conducted of all nine member jurisdictions of the International Medical Device Regulator's Forum (IMDRF), to determine if their regulatory agencies addressed the IMDRF recommendations relevant to the clinical evaluation of mHealth apps. Case-studies (submission to regulatory agencies) were also selected on varying types of regulated apps (standalone, active implantable, etc.) and assessed relative to the principles in the IMDRF's software as a medical device (SaMD): Clinical evaluation (2017) guidance document.

Results

All included jurisdictions evaluated the effectiveness of mHealth apps, assessing the majority of the key sub-categories recommended by SaMD: Clinical evaluation. The submissions and jurisdictional regulatory bodies did not address the IMDRF safety principles in terms of the apps’ information security (cybersecurity). Furthermore, by failing to use the method recommended by the IMDRF (risk-classification), none of the submissions or jurisdictions recognized the potential dangers of misinformation on patient safety.

Conclusions

None of the approaches used by global regulatory bodies adequately address the unique challenges posed by apps. Australia's approach is consistent with app regulatory procedures used internationally. We recommend that mHealth apps are evaluated for cybersecurity and are also classified using the IMDRF risk-categories so as to fully protect the public.