bluuebunny/crossref_metadata_2025 huggingface dataset:
eHealth and mHealth Interventions for Ethnic Minority and Historically Underserved Populations in Developed Countries: an Umbrella Review
Authors: Armaou Maria , Araviaki Evangelia , Musikanski Laura
Published: December 2019

Health disparities among historically disadvantaged populations can undermine the effectiveness of eHealth and mHealth interventions and limit their acceptability among diverse community members. The twin aims of this umbrella review of systematic reviews (SRs) are to summarise the evidence on the characteristics and effectiveness of eHealth and mHealth interventions among underserved populations in developed counties and provide recommendations to community organizers, policy makers and researchers. Comprehensive searches were conducted in bibliographic databases, Google Scholar and references lists for SRs published in English between 2000 and 2019. SRs were selected following a protocol registered with PROSPERO. Two independent reviewers were involved in the selection appraisal process, quality assessment and data extraction process. Six SRs met the inclusion criteria for this umbrella review. The six SRs concerned interventions delivered by computer programmes, cell-phones or other electronic devices. The studies in the SRs reported improvements to physiological well-being, health knowledge and self-management, as well as improvements in psychosocial outcomes. This umbrella review concludes with recommendations for community organizers, policy makers and researches for the formation of guidelines, inclusion of target community members in the development of eHealth interventions and directions for future research.
Special Issue: Advances in the Economic Analysis of Food System Drivers and Effects
Authors: Goetz Stephan J. , Jaenicke Edward C.
Published: December 2019

National interest in the effects of the U.S. food system has risen to such a level that the Institute of Medicine (IOM) and National Research Council (NRC) of the National Academies was compelled recently to publishA Framework for Assessing Effects of the Food System(IOM/NRC 2015), focusing on health, environmental, and economic and social variables. While providing a useful framework, the volume stopped short of actually carrying out studies to validate or test the assumptions of the framework. In addition to having measurable societal effects, food systems are also being affected by powerful secular forces that range from rising income inequality, consolidation and rationalization in retailing, consumer preferences for local and regional foods, to changes in climate and competition for land associated with urbanization. In parallel, an expanding “food movement” has emerged that, with little formal or rigorous analysis, has become highly critical of the food system and its consequent health, environmental, and economic and social effects.
Introduction Remarks by Callista Harris
Authors: Harris Callista
Published: December 2019

This year's Annual Meeting theme, “International Law as an Instrument,” invites us to reflect on, among other things, the ways in which actors use international law to resolve their disputes. Are obligations to negotiate a tool that states have at their disposal to help them resolve disputes? Does the claim by one state of a legal obligation to negotiate bring other states to the negotiating table? Or does it have the opposite effect?
In the Shadow of Empires—Latin American Perceptions of Development and International Law
Authors: Backer Larry Catá
Published: December 2019

Contemporary Latin American approaches to international law, development, and regional integration were forged in the shadow of two imperial systems. The Spanish colonial system produced a cultural and structural narrative of vertically arranged and centrally planned organization. The American commercial system embedded a strong ideology of markets and privatization of control bound together by regulatory effects of markets and organized according to relative market power. In their contemporary and embedded forms, Latin American states oscillate between Western liberalism, indigeneity, and variations of Caribbean Marxism. They swing between rigid hierarchies of centrally planned control and technocratic managerialism of markets.
Introductory Remarks by Jill Goldenziel
Authors: Goldenziel Jill
Published: December 2019

Welcome to what promises to be a great panel. My name is Jill Goldenziel and I am associate professor of international law and international relations at Marine Corps University – Command and Staff College. My views today are my own and do not represent those of my University or any arm of the U.S. government. We are fortunate to have such esteemed panelists here today to discuss this important topic in one of the meeting's premier rooms.
A Tribute To Robert H. Jackson – Recalling America's Contributions To International Criminal Justice
Authors: Eboe-Osuji Chile
Published: December 2019

It is an immense honor to be here. But the honor is special indeed; because it was around this time seventy-four years ago—more precisely on April 13, 1945—that Robert H. Jackson (as an associate justice of the U.S. Supreme Court) addressed this same gathering, in a classic speech titled “Rule of Law Among Nations.”
Remarks by Pamela Bookman
Authors: Bookman Pamela
Published: December 2019

I am here to represent the corporate perspective. In my remarks, I would like to discuss three questions. First, how are companies reacting to this litigation in Europe? Second, what are the implications for jurisdiction and notions of judicial imperialism? And third, what effects might Brexit have on this litigation?
Conflicts of Interests and International Adjudication: Trust at Stake
Authors: Fabri Hélène Ruiz
Published: December 2019

A complex society like ours favors multipositionality of actors, in that they are affiliated with multiple social and professional spheres each having its own networks, interests and governing principles, and generating special bonds of interest. This is especially true for international adjudication as being an international judge or arbitrator is not a career. There is always a before, often an after, and sometimes other professional activities in parallel. Moreover, to have the necessary competences is not enough to be appointed and appointment is more likely for people affiliated to multiple networks.
Building the RCEP: Legal and Political Implications
Authors: Hsieh Pasha L.
Published: December 2019

The Trump administration declared the “Free and Open Indo-Pacific” (FOIP) strategy as the new U.S. policy on Asia in 2017. This new strategy will have far-reaching implications for U.S.-Asia relations and global governance. The FOIP is conventionally perceived to focus on security dimensions. By “free,” the United States expects all countries “to exercise their sovereignty free from coercion by other countries.”1 The qualifier, “open,” is meant to refer to regional connectivity, in particular including freedom of navigation.2 Notably, the economic dimensions of this component also envision “fair and reciprocal trade” and “transparent agreements.”
Indo-Pacific Legal Infrastructure: A China Perspective
Authors: Erie Matthew S.
Published: December 2019

The Indo-Pacific, given its economic and geopolitical significance as exemplified by the growing multilateralism in the region, is an incubatory space for innovative legal infrastructure. Against the backdrop of growing tension between the United States and China in the region, I emphasize China's expanding footprint through the “Belt and Road Initiative” (BRI) and its capacity to shape institutions, practices, and norms of international economic law. I begin by providing context and then suggest six ways in which the BRI may offer a novel approach to international economic law, with particular salience for the Indo-Pacific region.
Introductory Remarks by Scott Anderson
Authors: Anderson Scott
Published: December 2019

Over the past two years, we have really seen the Trump administration make treaty withdrawal something of a signature move, from the Treaty of Amity with Iran to the Intermediate-Range Nuclear Forces Treaty, to the Optional Protocol for the Vienna Convention on Diplomatic Relations. The administration has taken steps to remove the United States, rightly or wrongly, from a wide array of longstanding international legal obligations. And while it is far from unprecedented, the administration has done so at a little bit of a faster pace than certain prior administrations have—and has embedded a lot of these moves within a consistent critique of international institutions and international commitments that promises further change on the horizon.
State Representative: The Thucydides Trap and the Future of Global Governance
Authors: Helal Mohamed S.
Published: December 2019

Imagining an alternative institutional and normative architecture for global governance must proceed on the bases of an identification and understanding of the principal challenges facing the international system. In my view, the gravest challenge facing the international system, and perhaps the greatest political drama of the twenty-first century, is the ongoing shift in the global balance of power. As we move from a U.S.-led unipolar system to a world in which non-Western powers, particularly China, exercise greater influence in international affairs, the foremost priority for global governance is to ensure that this transition proceeds peacefully and to minimize the potential for Great Power conflict, especially between the United States and China.
L’effacement du droit au consentement préalable, libre et éclairé des peuples autochtones dans le discours des juges interaméricains
Authors: Farget Doris
Published: December 2019

En se basant sur les travaux de Sally Engle Merry, cet article étudie le parcours du droit au consentement préalable, libre et éclairé des peuples autochtones en droit interaméricain, et met en lumière les dynamiques de glissement, d’effacement et de confusion qui opèrent entre cette norme et le droit à la consultation active. En prenant en considération le contexte d’intervention des instances interaméricaines, l’article met en lumière la vulnérabilité des juges interaméricains dans leur rôle de « traducteurs » et identifie des pistes de réflexion quant aux répercussions de ces glissements discursifs sur les relations entre les peuples autochtones et les États.
Leçons tirées de dix pays sur la réglementation des antimicrobiens pour les animaux d’élevage
Authors: Baral Prativa , Danik Marie E. , Hoffman Steven J.
Published: December 2019

Cette étude examine les approches réglementaires de dix pays : la France, le Danemark, l’Australie, le Canada, les États-Unis, la Russie, le Japon, le Brésil, la Chine et l’Inde, relativement à la réglementation des antimicrobiens aux trois points d’entrée principaux dans le processus agricole, soit dans le cadre de la médecine vétérinaire, de la production agricole et de la vente des produits agricoles. Pour être efficace, la réglementation doit tenir compte du contexte dans lequel elle s’inscrit. Cette étude tente donc de tirer des leçons des dix juridictions ci-haut à la lumière des réalités qui entourent l’utilisation d’antimicrobiens dans les processus agricoles.
A framework to develop semiautomated surveillance of surgical site infections: An international multicenter study
Authors: van Rooden Stephanie M. , Tacconelli Evelina , Pujol Miquel , Gomila Aina , Kluytmans Jan A. J. W. , Romme Jannie , Moen Gonny , Couvé-Deacon Elodie , Bataille Camille , Rodríguez Baño Jesús , Lanz Joaquín , van Mourik Maaike S.M.
Published: December 2019

Objective:

Automated surveillance of healthcare-associated infections reduces workload and improves standardization, but it has not yet been adopted widely. In this study, we assessed the performance and feasibility of an easy implementable framework to develop algorithms for semiautomated surveillance of deep incisional and organ-space surgical site infections (SSIs) after orthopedic, cardiac, and colon surgeries.

Design:

Retrospective cohort study in multiple countries.

Methods:

European hospitals were recruited and selected based on the availability of manual SSI surveillance data from 2012 onward (reference standard) and on the ability to extract relevant data from electronic health records. A questionnaire on local manual surveillance and clinical practices was administered to participating hospitals, and the information collected was used to pre-emptively design semiautomated surveillance algorithms standardized for multiple hospitals and for center-specific application. Algorithm sensitivity, positive predictive value, and reduction of manual charts requiring review were calculated. Reasons for misclassification were explored using discrepancy analyses.

Results:

The study included 3 hospitals, in the Netherlands, France, and Spain. Classification algorithms were developed to indicate procedures with a high probability of SSI. Components concerned microbiology, prolonged length of stay or readmission, and reinterventions. Antibiotics and radiology ordering were optional. In total, 4,770 orthopedic procedures, 5,047 cardiac procedures, and 3,906 colon procedures were analyzed. Across hospitals, standardized algorithm sensitivity ranged between 82% and 100% for orthopedic surgery, between 67% and 100% for cardiac surgery, and between 84% and 100% for colon surgery, with 72%–98% workload reduction. Center-specific algorithms had lower sensitivity.

Conclusions:

Using this framework, algorithms for semiautomated surveillance of SSI can be successfully developed. The high performance of standardized algorithms holds promise for large-scale standardization.
Cut-stem treatments using graminicides for burmareed (Neyraudia reynaudiana) invasions in Pine Rocklands, South Florida, USA
Authors: Prince Candice M. , Quincy Kaitlyn H. , Enloe Stephen F. , Possley Jennifer , Leary James
Published: December 2019

Burmareed [Neyraudia reynaudiana (Kunth) Keng ex Hitchc.] is an aggressive invader of pine rockland communities in south Florida. Currently, it is managed by clipping the stems and later returning, when plants have regrown to approximately 50 cm in height, to administer applications of glyphosate to new foliar growth (a “cut–return–treat,” or CRT, strategy). This multi-visit strategy is time-consuming and may result in off-target effects due to the broad-spectrum nature of glyphosate. With this study we evaluated a cut-stem (CS) approach, in which stems are cut and immediately treated with herbicide. Further, we tested the efficacy of the selective graminicides sethoxydim and fluazifop-P-butyl. In a pot study, CS treatments included: glyphosate (239.7 g ae L−1) in water, sethoxydim (9.0 g ai L−1) or fluazifop-P-butyl (12.1 g ai L−1) in either basal oil or water, and triclopyr (47.9 g ae L−1) in basal oil. All CS treatments provided mortality and growth reduction comparable to the best CRT treatments (glyphosate, sethoxydim, and fluazifop-P-butyl) and were therefore evaluated under field conditions using the same application rates. Mortality was low in the field (≤30%) regardless of herbicide treatment. Overall, fluazifop-P-butyl provided greater control than sethoxydim, resulting in 71% and 94% relative growth reduction in total shoot length with oil and water carriers, respectively, compared with 50% and 43% reduction for sethoxydim. Fluazifop also provided control similar to triclopyr and glyphosate (≥65% reduction in total shoot length). Results suggest that CS treatments may be a viable strategy for managing N. reynaudiana and reducing management costs. However, more research is needed to optimize rates. Further, fluazifop-P-butyl allows for a more selective option than glyphosate that may decrease off-target effects on native understory vegetation in pine rocklands.
Nostalgia for Otiose Leisure: Laying Claim to an Indian Tradition ofOtium
Authors: Fludernik Monika
Published: December 2019

Focusing on the representation of leisure or otium, the article discusses recent South Asian fiction and its idealization of states of otiose leisure that existed in the past and are now nostalgically dwelled on in contrast to current conditions of stress exacerbated by global capitalism. After explaining the origin of this approach to South Asian fiction in an interdisciplinary research cluster on otium, the main thesis of the article is laid out. An example text, Sunetra Gupta’sA Sin of Colour, is used to illustrate the various aspects of nostalgic leisure. The article also discusses narrative strategies that enhance a readerly experience of retardation and concentration.
Voyage to the Marvelous: A Traveler’s Guide to The Kingdom of This World
Authors: Tal-mason Ali
Published: December 2019

Following a legacy of four and a half centuries of literature written by foreign travelers landing on Haiti’s shores, Alejo Carpentier’s seminal novel about the Haitian Revolution is predicated upon Carpentier’s voyage to Haiti six years earlier. This article attends to the role of voyage in Carpentier’s The Kingdom of This World, revealing the ways in which Carpentier’s storytelling and rendering of Haiti in both the novel and its prologue, and his accompanying theory of the marvelous real, adhere to Eurocentric conceptions of time that reinscribe this neocolonial space as anachronistic space. Because Carpentier can only perceive Haiti in the past, he replicates the role of the imperial travel writer in fashioning metropolitan conceptions of colonial spaces and reproduces the imbalance of power between visitor/visited. This perspective reinforces a dominant Euro-American image of Haiti as a strange and magical object of consumption and fails to imagine it as an independent, post-revolution state.
Paradosis and monotheism: a late antique approach to the meaning ofislāmin the Quran
Authors: Cole Juan
Published: December 2019

Both the Muslim exegetical tradition and most Western scholarship have posited that the termislāmin the Quran means “submission”, i.e. to God, and that it refers to the religion brought by the prophet Muhammad. This paper argues that neither of these assertions is correct. Rather, the abstract nounislāmas used in the Quran means “tradition”. It is underlain by the Aramaicmashlmānūtā, which in turn was the term generally used to translate the Greekparadosis. That the Greek usage had a direct impact on Arabic is also considered. The wide range of meanings givenparadosisby Greek and Syriac authors is surveyed. A close reading of Quran verses in which the wordislāmappears shows that it refers to the prophetic tradition of monotheism rather than the surrender of an individual to God. It is synonymous with the Logos of Abraham, in which all the monotheistic religions participate.
OP23 Smart Searches For Context-Sensitive Topics: Geographic Search Filters
Authors: Ayiku Lynda , Finnegan Amy
Published: December 2019

Introduction

Some systematic review topics are context-sensitive and informed by evidence about a specific geographic setting. Smart information retrieval methods are required to identify such evidence in an efficient manner. This presentation will discuss how validated geographic search filters enable smart literature searching for context-sensitive reviews using the National Institute for Health and Care Excellence (NICE) United Kingdom (UK) filters for MEDLINE and Embase (OVID) as examples. The NICE UK filters were developed in 2016. The filters demonstrated high recall and high precision, however, further research was required to confirm these results.

Methods

In 2018, the filters’ recall of references from 100 UK-based multidisciplinary reviews was calculated. Reproducible search strategies were identified from twenty-six of the 100 reviews in MEDLINE and from nine reviews in Embase. From this, the precision and number-needed-to-read (NNR) were calculated.

Results

The MEDLINE filter achieved 96 percent recall (1401 out of 1454 UK references), 2.1 percent precision and a NNR of forty-seven. The Embase filter achieved 97 percent recall (1520 out of 1560 UK references), 0.7 percent precision and a NNR of 146. Compared to not using a filter, the MEDLINE and Embase filters reduced the number of search results by an average of 87 percent and 80 percent, respectively.

Conclusions

The filters retrieve the majority of evidence for UK topics while reducing search result volumes and so enable smart literature searching for context-sensitive topics. Large literature search result volumes can increase development time-frames for systematic reviews. Using the filters can therefore save time for reviews with a UK focus. There are currently two other validated geographic search filters for Africa and Spain. It is hoped that the NICE UK filters’ successful retrieval performance will encourage the development of validated search filters for more geographic regions.
OP52 Use Of Intention To Treat And Magnitude Of Treatment Effects
Authors: Armijo-Olivo Susan , Da costa Bruno , Arienti Chiara , Stefano Negrini
Published: December 2019

Introduction

Intention to treat (ITT) is a gold standard strategy to analyze the results of randomized controlled trials (RCTs). ITT analysis has been considered a methodological indicator of the quality of clinical trials. The extent to which the use of ITT is related to the treatment effects observed in RCTs has not been rigorously explored. Therefore, the main objective of this study was to determine the association between biases related to attrition and missing data and the use of intention to treat principle, and changes in effect size estimates in RCTs.

Methods

This was a meta-epidemiological study. A random sample of RCTs included in meta-analyses was identified. Data extraction including assessments of the use of intention to treat principle, missing data and drop-outs was conducted independently by two reviewers. To determine the association between biases related to attrition, missing data, and the use of intention to treat and effect sizes, a two-level analysis was conducted using a meta-meta-analytic approach.

Results

Three-hundred and ninety-three trials included in 43 meta-analyses, analyzing 44,622 patients contributed to this study. From these, 134 trials (34.1%) used ITT and 218 (55.5%) did not use ITT. Trials which did not use the ITT principle, or which were assessed as having an inappropriate control of incomplete outcome data (based on the Cochrane risk of bias tool) tended to underestimate the treatment effect when compared with trials with adequate use of ITT (ES= -0.13; 95%CI -0.26, -0.01) or trials which were assessed as having an appropriate control of incomplete outcome (ES= -0.18; 95%CI -0.29, -0.08).

Conclusions

Our results suggest that when evaluating risk of bias of primary RCTs, systematic reviewers should pay attention to these biases since they could underestimate treatment effects. Systematic reviewers should perform sensitivity analysis including trials with low risk of bias in these domains.
OP53 Health Technology Assessment Acceptability Of Innovative Survival Metrics In Oncology
Authors: Macaulay Richard
Published: December 2019

Introduction

Most new oncology therapies are studied in the advanced/metastatic setting. However, there is an increasing focus on earlier stage disease. Nevertheless, measuring Overall Survival (OS) in neo-/adjuvant therapy trials can be very challenging due to the increased life expectancy and the confounding effects of subsequent treatments. Thus, their primary endpoints tend to be surrogate survival metrics (e.g. metastases-free survival). This research aims evaluates the health technology assessment (HTA) acceptability of such endpoints through recent neo-/adjuvant HTA assessments.

Methods

The European Medicines Agency (EMA) website was screened for any neo-/adjuvant oncology therapies approved (1 January 2013-22 October 2018) and any corresponding publicly-available assessments by HTA bodies (NICE, SMC, IQWiG, G-BA, CADTH, PBAC, HAS) were identified and key data extracted.

Results

Six neo-/adjuvant therapies have received marketing authorization by the European Commission (EC). These six have been on the market for an average of 8.9 months (range: 0.9-39.3 months, median: 3.3 months). In four of the six, the pivotal trial primary endpoints were measures of relapse-/disease-free survival, (others: pathological complete response and PFS/OS co-primary). Only one had mature OS data available at EC-approval. Four of the six therapies had received at least draft guidance by an HTA body, encompassing 11 HTA assessments in total (4: NICE, 2: IQWiG, HAS; 1: SMC, CADTH, G-BA). Only two of 11 (18%) were positive outcomes (both NICE), the remaining nine were negative.

Conclusions

Oncology therapies are increasingly receiving regulatory approval in the neo-/adjuvant setting. However, their pivotal trials are frequently powered to show benefits in disease-/metastases-free survival. Whilst sufficient for regulatory approval, translating this to favorable HTA decisions has been more challenging. Clearly establishing linkages between surrogate survival metrics and OS alongside measuring metrics that clearly portray patient benefits (e.g. time to symptomatic progression) could improve HTA-acceptability. Further, some payers allow for temporary reimbursement whilst additional evidence is generated (e.g. Cancer Drugs Fund in England).
OP60 Challenges In Evaluating Smart Medical Devices
Authors: Mähs Mareike
Published: December 2019

Introduction

Smart medical devices can empower elderly to live independently in their familiar surroundings. To enhance their dissemination, they have to be shown to be cost-effective. Economic studies evaluating such technologies are missing or are criticized for their low quality. There are several challenges in the evaluation of smart medical devices, including their complex nature and innovative character. The question arises: how can evaluations elicit the benefits and cost-effectiveness of smart medical devices. This research has the aim of outlining challenges and demands on the evaluation of smart medical devices.

Methods

The embedding of the technology in existing structures can influence the effectiveness of the technology. By comparing such a technology with a regular intervention, learning effects have to be considered. Regular modifications and further developments of these technologies can complicate the traceability of the effects. Complex cause-effect relationships with possible interactions arise that are difficult to quantify and express in standardized endpoints, utilities or monetary values. Demands on the evaluation of smart medical devices have been explored with literature reviews and scenario techniques using the example of intelligent rollators.

Results

It is important to apply mixed-method approaches not only in the clinical but also practical setting and conduct observational as well as qualitative studies. Potential users, their relatives and care personnel should be involved in the evaluation of intelligent rollators and attention should be payed to subjects with disabilities. Prospective studies should be conducted at different stages along the lifecycle of the technology. A conceptual model should be developed and evaluated as well as adapted on a regular basis.

Conclusions

The research shows the need to adapt common methods used in economic evaluation to the characteristics of smart medical devices. As a next step, a framework for the economic evaluation of such technologies within the scope of Health Technology Assessment is developed based on these demands.
OP80 Impact Of Patient Group Participation At Scottish Medicines Consortium Committee Meetings
Authors: Dickson Jennifer , Lockhart Lindsay , Taylor Louise , McCormack Jackie , Walker Laura
Published: December 2019

Introduction

The Scottish Medicines Consortium (SMC) encourages patient group (PG) representatives to participate in the decision-making committee meetings, answering questions from committee members and providing points of clarity throughout discussions if required. In a continuous improvement approach the process and the participant experience is continually evaluated to monitor impact and emerging themes.

Methods

The interactions between committee members and PG representatives are recorded in writing by the public involvement team to monitor the questions or points of clarity raised. These interactions were analyzed using thematic analysis to look for emerging themes. Following the meeting, PG representatives are invited to complete an online survey on their experience of working with SMC.

Results

From July 2017 to October 2018, 36 PG representatives have attended committee meetings for the discussion of their submission. Committee members asked 17 PG representatives to contribute. Key themes that have emerged to date include insight into the impact of living with the condition on quality of life and how a new medicine may affect this. Survey feedback has been positive with participants reporting that patient engagement has been strengthened, and that the patient voice is heard, valued and supports committee members in making fully informed decisions. PG representatives expressed a willingness to participate again. Feedback also highlighted that the preparatory support offered to PG representatives by the public involvement team is highly valued.

Conclusions

Patient group participation in committee meetings has been received positively by PG representatives. They report that discussions relating to quality of life impact of medicines on patients and carers better reflect the lived experience, enriching committee's deliberations. This demonstrates SMCs commitment to openness and transparency and has strengthened patient engagement in our processes.
OP84 Collaborative Program To Improve Early Management Rheumatoid Arthritis
Authors: Dartnell Jonathan , London Jane , Elliott Jeffrey , Hill Catherine , Buchbinder Rachelle
Published: December 2019

Introduction

Optimal rheumatoid arthritis (RA) management requires coordinated management and consistent communication by health practitioners with patients. Suboptimal methotrexate use is a factor leading to increased use of biological disease modifying antirheumatic drugs (bDMARDs), which account for significant government drug expenditure. A multidisciplinary co-design approach was used to develop and implement a program aiming to improve early management and quality use of medicines (QUM) for people with RA in Australia.

Methods

Literature review and key informant interviews identified broad potential QUM issues in RA management. An initial exploratory multidisciplinary meeting prioritized QUM issues, identified audiences and perspectives, and scoped focus areas to address with education. Iteratively through co-design meetings and activities, program objectives were agreed, barriers and enablers for change explored, characteristics of intervention activities considered and rated, and program products developed and reviewed. Program evaluation included participation and distribution data, surveys and interviews, and analyses of general practice and Pharmaceutical Benefits Scheme (PBS) data.

Results

QUM issues addressed include: (i) timely initiation of conventional synthetic (cs) DMARDs; (ii) appropriate use and persistence with csDMARD therapy, especially methotrexate; and (iii) clarity around professional roles and best practice for prescribing, dispensing, and monitoring DMARDs, and managing lifestyle factors and other risks associated with RA. The educational program (October 2017 to June 2018) included: an article promoting key messages (email to ~115,000 health practitioners), prescriber feedback report based on PBS data (to all Australian rheumatologists), an RA action plan (completed by health practitioners for consumers), an interactive case study (553 participants), visits to 1200 pharmacies promoting key messages, a multidisciplinary webinar (431 live and 366 on-demand), fact sheets for consumers available through MedicineWise app (medicine management app for consumers), and social media activity.

Conclusions

A multidisciplinary co-design process has provided a model for developing a multifaceted QUM program incorporating and addressing multiple perspectives.
OP93 Collaboration Between Health Technology Assessment And Procurement: A Rapid Mixed-Methods Study
Authors: Harkin Kathleen
Published: December 2019

Introduction

The Irish Health Service (HSE) Health Technology Assessment Group (HTAG) aims to maximise the impact of its work by collaborating with HSE Procurement, formalised through an evidence-based Memorandum of Understanding (MOU). This study aims to inform the MOU.

Methods

A sequential mixed-methods study design was used. A rapid review of the literature identified no substantive body of evidence on collaboration between independent national health technology assessment (HTA) and procurement bodies. Personnel involved in HTA or procurement were invited by email to complete a survey, take part in an interview, or both. The quantitative and qualitative data were analysed using descriptive statistics and thematic analysis, respectively. Findings were integrated using a conceptual framework that examined the complementarity of HTA and procurement processes relevant to an MOU.

Results

Thirteen surveys were completed (response rate was 13 percent). Eleven interviews (five Ireland, two Canada, three UK, one New Zealand) were conducted between August and November, 2017. No formalised collaboration between independent national HTA and procurement bodies was identified. However in New Zealand, HTA and procurement are an integrated function of the Pharmaceutical Management Agency (PHARMAC). In other jurisdictions, successful ad hoc collaborations occurred where there was a clear need expressed by Procurement for additional evidence required for decision-making, and where HTA personnel tailored their research approaches accordingly. Key themes to successful collaboration were relationships, communication, clear roles, rigorous research and ‘system support’. Good individual relationships and ready access/communication promoted successful outcomes. Successful outcomes included improved clinical practice, and major cost savings. Collaboration may be focussed on: innovative or established devices; specific types of HTA/research products; specific categories/specialties; or specific procurement departments.

Conclusions

All participants considered collaboration to be beneficial but requiring good relationships and ‘system support’. Furthermore, successful collaboration requires clarity regarding the purpose, parties involved, their roles, responsibilities, modes of communication, information to be shared, and the expected outcomes.
OP98 Limitations In Health-Economic Guidance For Medical Devices
Authors: Blüher Maximilian , Mittard Virginie , Torres Rafael , Saunders Rhodri
Published: December 2019

Introduction

Health technology assessment (HTA) includes consideration of health and economic factors, playing a key role in optimizing healthcare provision in Europe. Medical devices are an important contributor to both health outcomes and the cost of healthcare provision, yet they are rarely addressed in current guidance for health-economic evaluation. Our aim is to help improve assessment of medical devices via review of European health-economic guidelines and recent research.

Methods

Searches for European HTA guidelines were performed and where available were reviewed by two researchers working independently. Additionally, a systematic review of published literature focused on assessment of medical devices was conducted. English, German, or French literature published between 2000 and 2017 was analyzed. The status of HTA guidance to date was subsequently reviewed in light of current research findings and suggestions made to help improve standardization.

Results

Of the 41 investigated European countries, 22 had official HTA guidance. Only four of 22 (18 percent) dedicated documentation to guidance specific to medical devices. Where differences between pharmaceuticals and medical devices were highlighted, specifics for health-economic assessment of medical devices were generally absent. The systematic review yielded 472 unique articles, 28 of which underwent full-text review. Issues surrounding medical device value assessment that commonly emerged were: limited evidence base, learning curve effects, organizational impact, incremental innovation, diversity of devices, dynamic pricing, and transferability. While identification of issues was ubiquitous, actionable suggestions on how to overcome them were less common. The most frequent recommendations were use of Bayesian methods, inclusion of real-world data, and modelling the learning curve. Key to implementation is determination of the medical device type and its impact duration.

Conclusions

Current guidelines rarely address the needs of medical devices. Practical recommendations for improvements exist and provide opportunity to start discussion on how best to serve the medical devices field and improve the HTA process.
OP137 Translating Results From Clinical Audit Studies To Local Context
Authors: Moga Carmen , Chojecki Dagmara , Guo Bing
Published: December 2019

Introduction

Despite widespread use of oxygen (O2) therapy, there is relatively little available information on routine O2 administration and monitoring; this is an issue particularly when considering the potential risks associated with inappropriate O2 utilization. A rapid health technology assessment (HTA) was conducted to inform the Respiratory Health Strategic Clinical Network Oxygen Summit in Alberta on aspects related to current practice in the use of O2 therapy in acute care, including administration, safety and quality, and inappropriate practice. Clinical audit is a tool used to determine deviations in practice and to identify opportunities for improvement. The objective of this presentation is to describe the experience and lessons learned from including clinical audit studies in the rapid HTA.

Methods

A standardized rapid review approach was used to identify, select, and synthesize evidence from studies published in English from 2005 to 2016. A supplementary literature search conducted in 2018 provided additional background information on the value, applicability, and limitation of using results from clinical audit studies to inform questions of good practice.

Results

Twenty-four clinical audit studies on O2 therapy were identified; the majority were conducted in the United Kingdom. The studies varied in design, methodology, and data and outcomes reporting. Ten studies investigated the appropriateness of O2 therapy prescription pre- and post-implementation of local initiatives and interventions, which helped pinpoint major gaps in current practice, and identified general recommendations for improvement of practice. A list of reporting criteria is proposed for improving the reporting of clinical audit studies results.

Conclusions

Conducting clinical audit studies is resource-intensive. In the absence of other research evidence and local practice data, translating results from clinical audit studies conducted in other jurisdictions, while challenging, can help address appropriateness questions. However, inferences from these studies may be suitable only for certain topics or an operating context.
OP138 Stakeholders’ Involvement When Developing A mHealth Assessment Tool
Authors: Puig Elisa Puigdomenech , Ferrer Elisa Poses , Masana Lina , Espallargues Mireia
Published: December 2019

Introduction

Due to the specific characteristics and challenges of mobile health (mHealth) technologies there is a need to have assessment tools based on their particularities to be used by health technology assessment (HTA) agencies and evaluation experts. In the development of a comprehensive and practical evaluation tool for the evaluation of mHealth solutions we aimed to include the views and opinions of key stakeholders: health professionals, developers, hospital managers, HTA agencies, patients and general public.

Methods

Focus groups and an online modification of the Delphi technique are being used to discuss and agree on domains and criteria to be included in the mHealth assessment tool. Domains and criteria used for health apps evaluation were drawn from a literature review on the topic. The initial list includes 95 criteria grouped into the following domains: purpose of the app, privacy and security, clinical effectiveness, content of the intervention, user experience and usability, interoperability, expenses, impact on the organization, and legal and ethical aspects. Data coming from focus groups is currently being analyzed from a thematic and content analysis perspective.

Results

Focus groups with professionals have showed that the most important domains to be considered when evaluating health apps are those related with security, user experience, and clinical effectiveness. Some criteria were considered to be mandatory (mainly regarding safety issues), on which a first step assessment should indicate whether the app ‘pass or fails’ for the subsequent throughout assessment. Focus groups with patients will provide insight on critical aspects related to the choice, use and adherence to a health app.

Conclusions

Insights from main stakeholders on the design of the tool for mHealth assessment are relevant and complementary between them. Next steps include (i) the agreement of criteria by using an online modification of the Delphi Technique and (ii) piloting of the tool.
OP157 Carbon Ion Radiotherapy: A Systematic Review
Authors: Goetz Gregor , Mitić Marija , Mittermayr Tarquin , Wild Claudia
Published: December 2019

Introduction

Due to the promising physical dose distribution of carbon ion radiation therapy (CIRT), CIRT can be regarded as a novel tumor irradiation technique and is sometimes considered as a breakthrough therapy for various tumor types. However, it is unclear whether superiority or inferiority can be claimed when compared to standard irradiation. This study aimed to assess the scientific evidence regarding the effectiveness and safety of CIRT.

Methods

A systematic literature review was conducted using the European Network for Health Technology Assessment (EUnetHTA) Core Model® for rapid relative effectiveness assessment. The literature search for clinical outcome studies on CIRT was performed in four databases [Cochrane (Central), Centre for Research and Dissemination (CRD), Embase and OVID MEDLINE]. The risk of bias was assessed using the Cochrane Risk of Bias Tool (for randomized controlled trials) and the Institute of Health Economics (IHE) Checklist (for observational studies). The evidence synthesis was restricted to 12 tumor regions (and 54 indications) and studies with a low or moderate risk of bias, published between 2005 and 2017.

Results

In total 27 studies were eligible for the qualitative synthesis of the evidence regarding the effectiveness and safety of CIRT; one randomized controlled trial that primarily focused on the feasibility of CIRT, three case-control studies, three before-after studies focusing on quality of life, and 20 further case series studies. Overall, insufficient scientific evidence was found for 13 (out of 54) indications in seven tumor regions and no scientific evidence was found for 41 (out of 54) indications.

Conclusions

Theoretically, CIRT is undoubtedly a promising cancer treatment. To date, however, 54 oncologic indications in 12 tumor regions under investigation lack randomized controlled trials assessing the long-term effectiveness and harms associated with its use. CIRT must be considered as an experimental treatment due to the lack of high-quality clinical research.
PP14 Budget Impact Of Sapropterin Dihydrochloride For Phenylketonuria
Authors: Mulinari Eduardo , Brito Nayara Castelano , Marra Lays Pires
Published: December 2019

Introduction

The National Committee for Health Technology Incorporation (CONITEC) evaluates health technologies to recommend their inclusion or exclusion within the Brazilian Public Health System (SUS), and uses the budget impact assessment to estimate costs to the system. The Ministry of Health (MS) guideline recommends treatment of phenylketonuria (PKU) with restricted phenylalanine diet and phenylalanine-free amino acid formula (PFAAf) supplementation. CONITEC evaluated the inclusion of sapropterin dihydrochloride for PKU in the SUS.

Methods

The population eligible for treatment was evaluated by the number of patients receiving PFAAf between 2014 and 2017 registered in the SUS. Patients were stratified by age/weight and a simple linear regression was performed to estimate the future population. The costs of treatment and testing the responsiveness of sapropterin dihydrochloride were estimated according to the recommended dosage guideline of the MS, leaflet and public purchasing prices. A univariate deterministic sensitivity analysis was performed to evaluate different prices, responsiveness test methods and variations in the reduction of formula use.

Results

The incorporation of sapropterin dihydrochloride would generate an incremental budget impact in the SUS of around BRL 79 million (USD 21.7 million) in 2019 and BRL 300 million (USD 82.1 million) in five years (2019-2023). The univariate sensitivity analysis estimated that the incremental budget impact could be between BRL 66 and BRL 103 million (USD 18 and USD 28 million) in the first year and between BRL 251 and BRL 388 million (USD 69 and USD 106 million) in five years. Sensitivity analysis showed that the price of sapropterin dihydrochloride was the most sensitive variable in the model.

Conclusions

The incorporation of sapropterin dihydrochloride in the SUS represents a significant budgetary impact and covers a small number of patients. Sapropterin dihydrochloride was recommended by CONITEC for the treatment of women with PKU, with a positive drug responsiveness test, and who are in the preconception period or in the gestational period.
PP43 Decision-Making Tool In Case Of Beta-Lactam Allergy: How To Help Clinicians?
Authors: Bouchard Sylvie , Robitaille Geneviève , Karam Fatiha , Daigle Jean-Marc , Tardif Mélanie
Published: December 2019

Introduction

Beta-lactams (BLs), especially penicillins, are the most commonly used antibiotics, particularly in primary care, and one of the most reported drug allergies. Fearing cross-reactivity, clinicians refrain from prescribing another BL (e.g., cephalosporin or carbapenem) to penicillin-allergic patients. This can have significant consequences for the patients and the health-care system (e.g., exposure to broad-spectrum antibiotics, increased risk adverse effects, and increased healthcare costs).

Methods

To assess the absolute cross-reactivity risk, two systematic reviews with meta-analysis were conducted. Then, an approach based on a knowledge mobilization framework considering scientific, contextual and experiential evidences was used. Focus groups with stakeholders, including primary care clinicians, pediatricians, infectious disease specialists and allergists/immunologists, were also held to meet the needs of all actors concerned.

Results

Following this work, it appears that true allergies to penicillin are very rare. Indeed, in patients with a history of penicillin allergy, very few are truly allergic and thus the risk of cross-reaction with another BL is even lower, varying according to structural and physicochemical similarities with alleged-penicillin. Moreover, the risk of having an anaphylactic reaction after penicillin exposure is very low, especially among children. As well, in patients with confirmed penicillin allergy, the observed reactions are usually delayed non-severe skin reactions. However, with a confirmed penicillin allergy, it is important to remain cautious when administering a new BL, especially if the initial reaction was serious or severe. Based on these key messages, a decision aid including an algorithm was developed. Likewise, individualized algorithms for common infections met in primary care were produced.

Conclusions

From this work, health professionals non-specialized in allergology should be able to better manage the risks attributed to penicillin allergies. Therefore, patients should receive the most effective and safe antibiotics to treat their clinical conditions in primary care.