bluuebunny/crossref_metadata_2025 huggingface dataset:
PD34 São Paulo Congenital Heart Corrections: Three-Years' Assist Registry
Authors: Trindade Evelinda , Caneo Luiz Fernando , Turquetto Aida Luiza , Amato Luciana , Carmona Fabio , Preto Ribeirão , Vincente Walter , Arrieta Santiago Raul , Miura Nana , Manso Paulo Henrique , Furlanetto Beatriz Helena , Jatene Marcelo , Jatene Fabio , Silveira Joao Bruno , Ritchmann Marcella
Published: January 2019

Introduction:

Death from congenital heart disease (CHD) can be avoided, contributing to reduced infant mortality. The objective of this study was to identify the profile of patients undergoing surgical correction for CHD in three São Paulo State hospitals, and to determine factors that contribute to morbidity and mortality.

Methods:

The Voluntary Pediatric Cardiovascular Surgery Multicenter Registry (ASSIST) was created in 2014 through a Research Grant Program for the Public Healthcare System (Pesquisas para o Sistema Único de Saúde, PPSUS)* project, a federal-state joint strategic public policies research grant, coordinated by the Hospital das Clínicas of Faculdade de Medicina of Universidade de São Paulo (InCor-HCFMUSP-SP) and Ribeirão Preto's Hospital das Clínicas, both linked to the São Paulo University Medical School.

Results:

We analyzed 1,842 patients, with an average age of 1.2 (range 0.4–8.6) years, 50.9 percent were male. Procedural complexity was classified as “Risk Adjustment in Congenital Heart Surgery” version 1 score, RACHS-1: 18.2 percent RACHS1, 25.5 percent RACHS2, 41.2 percent RACHS3, 9.6 percent RACHS4 and 5.4 percent RACHS5–6. Overall hospital mortality was 12.2 percent, and preoperative risk factors included: age <30 days (Odds Ratio, OR = 1.7 p = 0.012), prolonged ICU admission (OR = 3.3 p = 0.001). Other significant factors were RACHS score >4 (OR = 5.3 p < 0.001), heart dysfunction (OR = 3.4 p = 0.001), sepsis (OR = 3 p = 0.001), hemodynamic or surgical re-intervention required (OR = 6.2 p < 0.001), cardiorespiratory arrest (CPR, OR = 24.9 p < 0.001) and renal failure (OR = 5.4 p<0.001). The frequency of related morbidity was 16.2 heart failure, 7.1 percent arrythmia, 5.9 percent pneumonia, 5.9 percent pneumotórax, 4.2 percent pleural and pericardial effusion, 10 percent mechanical ventiation > 7 days, 13.2 percent late sternal closure, 2.8 percent had wound infection, 3.7 percent neurological alterations, 2.3 percent diaphragmatic dysfunction, 11.5 percent CPR, 3.2 percent renal failure, 4.5 percent sepsis, 55.1 percent length of hospital stay longer than 5 days with 45.8 percent postoperative hospital admission longer than 15 days and 6.1 percent needed surgical or hemodynamic re-intervention.

Conclusions:

The information collected in the ASSIST registry was of great importance in the São Paulo State CHD surgical practice evaluation. Morbi-mortality related factors elicited critical points and allowed improvement actions. Excluding age and intrinsic procedure complexity, identified outcome modifier factors can be manageable, aiming to increase patient safety and program resolubility or performance.
PD41 Use Of High-Sensitivity Cardiac Troponin Assays In Real-Practice Within Emergency Departments
Authors: Marchetti Marco , Camoni Laura , Urbina Luz Irene , Biondi Alessia , Grassi Tiziana , Rolli Marianna , Sacco Adriano , Montemagno Mirko
Published: January 2019

Introduction:

Acute myocardial infarction (AMI) is one of the leading causes of death and disability worldwide. The European Society of Cardiology Guidelines have established a new definition of myocardial infarction and have strengthened the central role of cardiac troponins in cardiology diagnostics for rule-in and rule-out of non ST-elevation myocardial infarction (NSTEMI). High-sensitivity cardiac troponin I assays (hsTnI) should increase diagnostic sensitivity, and a shorter interval for ruling-in and ruling-out AMI. This analysis aims to provide an overview of the clinical, economic, organizational and ethical impact of the use of hsTnI in clinical practice of Emergency Departments (ED) in Italy.

Methods:

HsTnl for rule-in and rule-out of AMI in the ED is being evaluated using the EUnetHTA Core Model® framework for health technology assessment. The hsTnI HTA assessment will be completed with real-world evidence derived from a multicenter observational study which has been designed to be conducted in 12 Italian EDs, enrolling 6000 patients with chest pain of suspected cardiac origin, aiming to provide data from the Italian context on clinical, organizational and economic aspects of the use of the test in the ED. Endpoints of the study include: time lapses related to diagnosis, admission, treatment and discharge of patients; number of tests performed; and number of patients diagnosed with AMI.

Results:

Initial results from a literature review confirm the usefulness of the hsTnI assay in diagnosing AMI. Generated real-world data will be collected, analyzed and integrated to existing evidence to assess the utility of the test in real contexts, providing details relevant for organizational aspects of the use of the test in the ED.

Conclusions:

The use of hsTnl could improve diagnosis of AMI by allowing a faster ruling-in or ruling-out, and reducing inappropriate hospitalizations. Furthermore, this technology could represent an opportunity to reduce overall costs for the healthcare system.
PD43 Value-Based Procedure For Updating The Italian Health Benefit Package
Authors: Marchetti Marco , Iannone Primiano , Urbina Luz Irene , Camoni Laura , Biondi Alessia , Brino Eugenio Di , Rolli Marianna , Montemagno Mirko , Sacco Adriano
Published: January 2019

Introduction:

In Italy, the central government sets the health benefit package (denominated “Livelli Essenziali di Assistenza” - LEAs) of the National Health System (NHS), which must be provided to all residents. In 2004, the Italian Ministry of Health established a new technical body, the National LEA Commission, responsible for updating LEAs.

Methods:

Recently, the Ministry has commissioned to the National Institute of Health (NIH) the development of a new value-based procedure for updating the health benefit package for the Italian NHS, supporting the National LEA Commission. A review and comparison of value frameworks and decisional models was performed in order to select a framework and a model that can be applied to the Italian context, design an administrative process for the update procedure, and propose approaches for: (i) the assessment of services currently included in the health benefit basket and of those planned to be incorporated, (ii) the process of appraisal and decision-making to be adopted by the Commission.

Results:

The NIH outlined an evidence and value-based three-step (i.e. priority setting, assessment and appraisal) administrative process that integrates roles and responsibilities of the different Italian healthcare institutions involved in LEA updating and HTA.

Conclusions:

The NIH is proposing to the Ministry of Health and to the National LEA Commission a new evidence and value-based procedure for updating the health benefit package for the Italian NHS. This procedure is entering a pilot phase in which potential gaps can be identified and minimized for its subsequent implementation.
PD58 Cost-Effectiveness Of Quinolone For Acute External Otitis In Brazil
Authors: de Oliveira Gustavo , Chacarolli Camila , Silva Sarah , de Brito Artur Felipe
Published: January 2019

Introduction:

In Brazil, the medicines marketed for acute external otitis are ciprofloxacin and the combination polymyxin B, neomycin, and fluocinolone. The aim of this study was to evaluate the proportion of cure and cost-effectiveness of quinolone versus polymyxin B, neomycin, and steroid combined (PNS) for acute external otitis from the perspective of the Brazilian Public health system.

Methods:

A systematic review was conducted using Medline, Cochrane Library, CRD and Lilacs databases. Studies evaluating quinolones versus PNS in the treatment of acute external otitis were included. A cost-effectiveness model was made using a decision tree, considering the direct cost of treatment. Univariate sensitivity analysis was conducted, considering the confidence interval of clinical outcomes and a 15 percent variation in cost.

Results:

The proportion of cure in up to 10 days was 70.1 percent with quinolone and 60.4 percent with PNS (p = 0.004). The treatment costs were BRL 16.22 (USD 5.02) with quinolone and BRL 3.04 (USD 0.94) with PNS. The incremental cost-effectiveness ratio was BRL 136.25 (USD 42.15) per cure in up to 10 days for quinolone in relation to PNS. This value was more sensitive to clinical outcomes, ranging from BRL 95.48 (USD 29.54) to BRL 254.25 (USD 78.65) for cure with quinolone and from BRL 90.77 (USD 28.08) to BRL 262.57 (USD 81.23) for cure with PNS. These values should be considered with caution because acute external otitis is resolved within a few days and treatment effectiveness is not measured by life years.

Conclusions:

There are few studies on therapeutic alternatives available in Brazil. Through the available evidence, there is a lack of results on the effects attributed to each drug. Considering the higher effectiveness, low cost and rational use of antibiotics, quinolone is considered a cost-effective alternative for acute external otitis in Brazil.
PD59 Formulation and Disclosure Of Information On Technologies In Health
Authors: Marra Lays , Silva Sarah , Rabelo Roberta , Chacarolli Camila , Brito Nayara , Catanheide Izamara , de Brito Artur Felipe
Published: January 2019

Introduction:

The Brazilian public health system (SUS) provides technologies based on the best available scientific evidence. However, there is a large number of lawsuits against the government for access to non-standard technologies, a phenomenon called “judicialization of the right to health”, which disrupts the system's operating logic. The aspect of judicialization that most impacts the health system involves unregistered technologies without scientific evidence of superiority being comparing to the alternatives already offered in the country. The aim of this study is to report experience of the National Committee for Health Technology Incorporation in the Brazilian Health System (CONITEC) to mitigate the effects of the judiciary, with the elaboration of informative documents about technologies directed towards policy-makers, patient, users of system health, professional health and other stakeholders.

Methods:

The main judicialized technologies in the country were identified and then a meeting with experts was realized to discuss a more appropriate format for these documents. After defining the format, a review of the literature was carried out to identify the best available evidence of those health technologies.

Results:

A question-and-answer (QA) format document was drawn. The QA addressed information on the use of the technology for a specific clinical condition. Health registry and price in Brazil, if it has already been evaluated by CONITEC and its respective recommendation, as well as strategies of care and therapeutic alternatives available in the SUS were included. Their content has been adapted to a lay language and all of the documents were made available on the CONITEC website in the “Law and Health Section”.

Conclusions:

The availability of QA represents a strong link between evidence and actions in health. For, they enable broad access to quality information by the lay public and stakeholders who seek information to support evidence-based decision-making.
PD61 HTA Regional Network In The Central Region Of Brazil: Survey In 2016
Authors: Elias Flavia Tavares Silva , da Motta Girardi Juliana , Moraes Rafael , Amorim Fabio , Pereira Ana Carolina , Almeida Karlo Josefo , Silva Erica , Pereira Daniella
Published: January 2019

Introduction:

The Federal District in Brazil has about 2.9 million inhabitants and the public health system is focused on medical specialties, with one university hospital and twenty regional hospitals. This ecosystem is favorable for fostering health technology assessment (HTA) to improve the efficiency and effectiveness of health care. The objective was to identify institutions that could form a HTA network to support decision-oriented evidence in the public health system.

Methods:

Stakeholders from the hospitals and training/research institutions in the Federal District were surveyed. An online questionnaire (Google Docs) was developed to identify the potential and capacity of institutions to analyze or produce clinical and economic evidence. Two HTA seminars were held to spread knowledge about HTA and to encourage stakeholders to complete the survey.

Results:

The questionnaire response rate was thirty-five percent (25/70). Fifteen institutions were cited by the respondents as having the potential to build a HTA network. Twelve of the institutions produced rapid reviews and clinical guidelines, but only three of these had an organized priority setting process or produced assessments at the request of the hospital manager. The challenges identified were training and willingness of decision makers to organize HTA units in the hospitals.

Conclusions:

An executive group was created which defined a strategy to support the implementation of HTA units as part of the HTA National Network (REBRATS). A regulation proposal was also created to encourage decision makers to activate a HTA network in the Federal District.
PD65 The Acquisition Of Eculizumab By Judicial Proceeding In Brazil
Authors: Salomon Flavia , Simabuku Eliete , Beutel Jose , Oliveira Eduardo De , Rabelo Roberta , Petramale Clarice , de Brito Artur Felipe , Souza Kathiaja Miranda
Published: January 2019

Introduction:

Eculizumab is a monoclonal antibody indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) or with atypical hemolytic uremic syndrome (aHUS). In Brazil in recent years eculizumab was the most expensive drug requested through court orders, obliging public health managers to import it from the USA. From 2012 to 2016, approximately BRL 424 million (USD 112 million) was spent on eculizumab. The purpose of this study was to assess the regulatory situation and the scientific evidence on the safety and efficacy of eculizumab.

Methods:

A literature search was conducted in PubMed, The Cochrane Library, and the Centre for Reviews and Dissemination databases on September 2017. The websites of regulatory agencies were also searched.

Results:

In 2007, the use of eculizumab was approved by the United States Food and Drug Administration and the European Medicines Agency. In Brazil, despite the provision of eculizumab through judicial proceedings since 2009, the manufacturer of eculizumab only requested a licence for it in 2017, after several meetings with the government when the company agreed to provide the drug at approximately half the price of the imported product. The efficacy of eculizumab in PNH patients was assessed in one randomized, placebo controlled study, one single arm study, and one long-term extension study. The drug reduced hemolysis and the need for transfusion, although the studies had methodological problems. The efficacy of eculizumab in the treatment of aHUS was assessed in four prospective, controlled open-label studies, two long-term extension studies, and one retrospective study. Eculizumab normalized platelet counts and reduced the need for plasmapheresis, although the studies had no control group. Eculizumab was well tolerated, with no meningococcal infections occurring after patients were immunized.

Conclusions:

Some companies have no interest in licensing their products in Brazil because their provision by judicial proceedings is more lucrative. This situation promotes litigation and irrational prescription of drugs, and also obligates the Brazilian government to import expensive health products.
PD70 Cost-Effectiveness Of Deep Brain Stimulation For Epilepsy In Australia
Authors: Joglekar Rashmi , Pietzsch Jan , Garner Abigail , Ramirez Belinda , Gillespie John
Published: January 2019

Introduction:

Deep brain stimulation (DBS), which uses an implantable device to modulate brain activity, is an adjunctive treatment for partial-onset seizures in patients with medically refractory epilepsy. Our objective was to perform an exploratory cost-utility analysis of DBS in conjunction with medical therapy, compared with medical therapy alone, using the latest clinical data and costs for the Australian healthcare system.

Methods:

A deterministic five-state Markov model was used to project treatment response and outcomes over the patients’ lifetimes, based on 5-year data from the recent Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy (SANTE) DBS trial and drug outcome data identified through a literature search. Costs were based on 2017 data for the Australian healthcare system, and response-specific utilities were derived from published literature. We estimated the lifetime discounted incremental cost-effectiveness ratio (ICER) in Australian dollars per quality-adjusted life-year (QALY) for patients 36 years of age, fifty-five percent of whom were men. Costs and effects were discounted at five percent per annum. The robustness of projections was evaluated through scenario and sensitivity analyses.

Results:

Under assumed continued treatment benefit, DBS was projected to add 3.48 QALYs over the patients’ lifetimes, at an increased cost of AUD 142,304 (USD 105,960), resulting in an ICER of AUD 40,951 (USD 30,492) per QALY gained. Reducing the analysis horizon to 20 years increased the ICER to AUD 49,803 (USD 37,083). Increasing the DBS generator life from 3 to 6 years decreased the ICER to AUD 23,956 (USD 17,838) per QALY. Longer follow-up periods and younger age at treatment were associated with greater cost effectiveness. Results were sensitive to assumptions about health state-specific utility estimates and long-term treatment effects.

Conclusions:

Our exploratory findings suggest that DBS is a cost-effective treatment strategy in the Australian healthcare system for patients with medically refractory epilepsy. DBS therapy might meaningfully improve patient outcome at a health economic profile that compares favorably to other well accepted therapies. Consideration of indirect costs would further add to this value proposition.
PD76 The Value Of Continuous Lateral Rotation Therapy In The ICU
Authors: Kang So Yeon , DiStefano Michael , Yehia Farah , Koszalka Maria , Padula William
Published: January 2019

Introduction:

Mechanical ventilation in the intensive care unit (ICU) increases the risk of hospital-acquired conditions (HACs) such as ventilator-associated pneumonia (VAP) and pressure injuries (PrI). Continuous lateral rotation therapy (CLRT) has been shown to reduce VAP and PrI incidence, but the value of switching to CLRT over standard care is presently unknown. We evaluate the cost-effectiveness of CLRT beds compared to standard care in ICUs and determine the return on investment (ROI) associated with its implementation.

Methods:

A Markov model was constructed to predict health state transitions from the time of ventilation through 28 days using the healthcare sector perspective. Daily transition probabilities were extrapolated from prospective clinical studies comparing CLRT with standard care. Costs were estimated in 2014 USD. Utility scores were extracted from the published literature. Cost per quality-adjusted life-years (QALYs) was calculated and sensitivity analyses were conducted. A secondary analysis from a societal perspective with a one-year time horizon included the costs of patient and caregiver lost productivity. ROI analysis was performed to estimate the net benefit and breakeven point of the investment. Value of Information analysis was performed to determine whether further research is warranted.

Results:

From both perspectives, CLRT was dominant. From the healthcare sector perspective, the expected cost for CLRT per patient was USD 47,165 compared to standard care at USD 49,258 per patient, showing that CLRT saves cost per patient. The expected effectiveness of CLRT per patient was 0.0418 QALYs compared to 0.0416 QALYs for standard care. CLRT was dominant in 99.94 percent of Monte Carlo simulations. CLRT also reached the break-even point after 5 months. Expected Value of Perfect Information was equal to 0.019, indicating little value of additional evidence at the current level of parameter uncertainty.

Conclusions:

CLRT is highly cost-effective compared to standard care by preventing ventilator-associated infections and PrIs in an ICU setting.
PD78 Minimally Invasive Capsulorhexis In Children's Cataracts
Authors: Sánchez-Gómez Luis María , Luengo-Matos Setefilla , Pablo Juan , Orrego Chalco , Polo-Desantos Mar
Published: January 2019

Introduction:

Minimally invasive capsulorhexis is an incision in the anterior capsule in the peripheral zone for cataract extraction. It allows reduction of the size of the lesion, ensuring a better transparency of the visual axis, preserving the capsule almost intact and a layer of lenticular epithelial cells. The procedure could have a potential regenerative effect of the lens in a natural way. The objective of this study is to assess the efficacy and safety of minimally invasive capsulorhexis to promote lens regeneration in children's cataracts.

Methods:

This technology was identified by the early Awareness and Alert System, “SINTESIS-new technologies” of Agencia de Evaluación de Tecnologías Sanitarias (AETS) Instituto de Salud Carlos III (ISCIII). An early assessment was conducted. The searched databases were: PubMed, Centre for Reviews and Dissemination (CRD), and Cochrane Library. Clinical studies using the procedure published in any language until 29 September 2017 were reviewed.

Results:

An open-label, randomized trial in pediatric cataract patients (age: 0–2 years) was retrieved. Twelve patients underwent minimally invasive capsulorhexis, while twenty-five patients received the standard treatment. Regarding efficacy, a transparent regenerated biconvex lens was found in 100 percent of eyes three months after surgery, but wasn't found in the control group. 100 percent of capsular openings healed within one month after surgery in the experimental group, but not in the control group. Both groups increased their visual acuity parameters without significant differences. Regarding safety, children receiving the standard technique had a higher incidence of corneal edema (eight percent in the intervention vs thirty percent in the control group), anterior chamber inflammation (seventeen percent vs seventy-four percent), additional laser capsulotomy (zero percent vs eighty-four percent) and increased visual axis opacification (four percent vs eighty-four percent).

Conclusions:

Minimally invasive capsulorhexis in children's cataracts seems to be a promising new procedure. Preliminary efficacy results were good and safety profile was better than standard treatment. However, it would be necessary to continue further studies to confirm these results.
PD79 Poor Design And Reporting Impacts The Value Of Systematic Reviews
Authors: Vreugdenburg Thomas , Cameron Alun , Wild Claudia
Published: January 2019

Introduction:

Systematic reviews are useful for identifying gaps in research, setting priorities for future research, and informing clinical practice and public policy decisions. However, appropriate methods are needed to ensure that systematic reviews are of suitable quality in order to maximize their potential to achieve impact. The aim of this study was to evaluate the quality and transparency of systematic reviews conducted on prostate artery embolization (PAE), a topic of considerable interest in urology.

Methods:

We conducted a cross-case analysis. Existing reviews were identified through a systematic search of four biomedical databases (Cochrane Library, York Centre for Reviews and Dissemination, Embase, Medline) from inception up to 8 December 2016. Systematic reviews that evaluated the safety and effectiveness of PAE to treat benign prostatic hyperplasia were included. Included reviews were critically appraised using the AMSTAR (A MeaSurement Tool to Assess systematic Reviews) tool, and were scored against the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) criteria.

Results:

From 536 search results, nine relevant systematic reviews were identified, of which eight were published in 2016. None of the included reviews were prospectively registered on the PROSPERO database. The median AMSTAR score was four of 11 (range 0–7). The most common methodological concerns were related to comprehensive searches (33 percent), inclusion of grey literature (0 percent), and evaluation of publication bias (0 percent). Reviews adequately reported a median of 17 of 21 items (range 6–19) against the PRISMA checklist.

Conclusions:

Despite the availability of robust guidelines for conducting systematic reviews, methodological limitations in reviews of PAE are prolific, leading to considerable heterogeneity. There is also a significant duplication of effort, which can be prevented by prospectively registering systematic reviews on PROSPERO. Reducing duplication and increasing methodological quality are imperative to reducing waste in urological research.
VP23 The New Cancer Drugs Fund: The Future Model Of Oncology Reimbursement
Authors: Walsh Sean , Macaulay Richard , Turkstra Erika , Tsang Ricky
Published: January 2019

Introduction:

The Cancer Drugs Fund (CDF) was set up in 2011 in England to enable patients to access oncology therapies that are not routinely publicly funded. In April 2016, the CDF became a temporary reimbursement fund under the remit of the National Institute for Health and Care Excellence (NICE) with the aim of collecting observational data to inform subsequent technology appraisals. This study aims to evaluate how the reformed CDF has been utilized in the 18 months since this reform.

Methods:

NICE Final Appraisal Determinations for Single Technology Appraisals of oncology drugs from (29 July 2016 to 24 November 2017) were identified and key data extracted.

Results:

Seventy-four oncology drug:indication appraisals were identified, 54 (73 percent) were recommended/optimized, 10 (14 percent) were not recommended and 10 drug:indication pairings (14 percent: osimertinib, brentuximab vedotin, pembrolizumab, olaratumab, obinutuzumab, venetoclax, nivolumab [3 indications], and ibrutinib) were referred to the CDF. For most, the greatest uncertainty in their cost-effectiveness analyses related to their survival benefits, intended to primarily be resolved through subsequent clinical trial readouts. However, for venetoclax, ibrutinib and brentuximab, the main areas of uncertainty (relating to comparative survival benefit, pre-progression mortality, and rate of subsequent stem cell transplants, respectively) are expected to be resolved primarily through observational data collected under the CDF.

Conclusions:

The newly reformed CDF has been utilized in a minority of cases. Typically, the CDF acts as a temporary access mechanism for treatments that receive market authorization based on early/single-arm trial data until longer-term and/or Phase III data are available. However, venetoclax, brentuximab, and ibrutinib demonstrate how the CDF may address significant areas of uncertainty through the collection of uncontrolled observational data. For venetoclax, with only single-arm supportive clinical trial data, observational data of this intervention and appropriate comparator are to be collected, providing a potential case study of how to appropriately manage reimbursement in the face of significant clinical uncertainty.
VP24 HTA To Assess Esthetic Procedures In France: Haute Autorité de Santé (HAS) Seven Year Experience
Authors: Lhuillier-Nkandjeu Huguette , Guzina Irena , Daurat Veronique , Squalli Nadia , Merle Nathalie , David Denis-Jean , Carbonneil Cedric
Published: January 2019

Introduction:

The Health Technology Assessment (HTA) of esthetic procedures was performed by the French National Authority for Health (HAS), at the request of the French Ministry of Health (MoH), and under a new regulatory framework enabling the government to ban esthetic procedures considered harmful or potentially harmful to patients and consumers by HAS. Objectives: Describe HAS’ seven year experience with the safety assessment of four esthetic procedures.

Methods:

This is an HAS review of its methods used in four HTAs for the following evaluated techniques: lipolysis; cryolipolysis; esthetic mesotherapy; and, ultraviolet (UV) radiation in tanning devices. The review aimed to describe how these assessments have been undertaken and information sources used, from 2010 to 2017, to appreciate the safety profile of these procedures.

Results:

A systematic literature review (SRL) and analysis was performed for all four HTAs. Since findings did not allow for thorough appreciation of safety, additional sources of information were consulted to address evidence gaps. Sources may have included any combination of the following: i) National and international health care authority data and alerts ii) Legal and ethical frameworks iii) Public consultation iv) Expert opinion v) Patient-consumer association opinion vi) Economic analysis

Conclusions:

An adaptation of the HTA methodology was necessary to meet the specific requirements of these assessments. Despite sources accumulated and consulted within the seven year period, quantitative data were found insufficient to fully appreciate the safety profile for any one of the studied esthetic procedures. National regulatory reinforcement on the reporting of adverse events, with implementation of a centralized online tool, is expected to generate and capture reliable data on the frequency and severity of adverse events associated with esthetic procedures. Recent European Union (EU) regulatory requirements on the safety and performance of medical devices include equipment used for esthetic procedures, indicating agreement and alignment on national and EU-level monitoring efforts.
VP30 The Use Of Artificial Intelligence In Health Technology Assessment
Authors: Jonsson Egon
Published: January 2019

Introduction:

To make itself more relevant in a longer perspective health technology assessment (HTA) will have to make use of novel ways to improve its services; in particular in terms of rapid response, cost savings and reduction of risk of bias. The use of artificial intelligence (AI) offers significant assistance at essentially all stages of any HTA. It can search, retrieve, read and organize relevant literature, not only from traditional databases but from numerous data sources related to specific issues (e.g. clinical trials, health outcomes, payment of services), and from databases in other areas such as in social, justice, and educational services, and public health.

Methods:

This presentation will explain the use and feasibility of AI in HTAs based on the findings from a currently ongoing project in the province of Alberta Canada. It will (i) provide an overview of AI in healthcare, (ii) outline selected international efforts of using AI in systematic reviews, such as the Robotreviewer, (iii) describe the information needed, and the development of the algorithms for using AI in HTAs, and (iv) report on the findings from a comparative study of human versus AI resources in performing an HTA.

Results:

This project has just started, however preliminary findings from the comparative analysis of AI versus human performance on a specific topic for HTA will be presented.

Conclusions:

It is expected that the comparative study will demonstrate that artificial intelligence will become a useful tool in HTA in that it will significantly speed up systematic reviews, and decrease the risk of bias in syntheses of findings from research.
Making Modern Social Science: The Global Imagination in East Central and Southeastern Europe after Versailles
Authors: Lebow Katherine , Mazurek Małgorzata , Wawrzyniak Joanna
Published: January 2019

The events of 1914 initiated the redrawing of many boundaries, both geopolitical and intellectual. At the outbreak of the war the London-based anthropologist Bronisław Malinowski was at a professional meeting in Australia. Technically an ‘enemy alien’ (a Pole of Austro-Hungarian citizenship), he was barred from returning to Britain; stranded in Australia, under surveillance by authorities and with insecure finances, Malinowski began fieldwork in the Trobriand Islands that would result in his groundbreakingArgonauts of the Western Pacific(1922).1Argonauts’ influence rested on its compelling portrait of the anthropologist as ‘participant-observer’, the insider/outsider uniquely poised to decode and recode cultures and meanings.2Malinowski thus adeptly retooled his own ambiguous status into a paradigm of the ethnographer’s optimal subject-position – quipping that he himself was particularly suited to this role, as ‘the Slavonic nature is more plastic and more naturally savage than that of Western Europeans’.3
Stock markets, banks and economic growth in the UK, 1850–1913
Authors: Jansson Walter
Published: January 2019

This article shows that neither stock markets nor commercial banks had a significant impact on the UK's economic growth from 1850 to 1913. These results are based on a new dataset on paid-in capital of securities listed on the UK's stock exchanges, which is analysed using a vector autoregression with time-varying parameters. Econometric results also indicate that the growth of the banking sector and the capital markets was, to a significant extent, driven by factors other than domestic economic growth.
Observed Spatiotemporal Changes in the Mechanisms of Extreme Water Available for Runoff in the Western United States
Authors: Yan Hongxiang , Sun Ning , Wigmosta Mark , Skaggs Richard , Leung L. Ruby , Coleman Andre , Hou Zhangshuan
Published: January 2019

This paper presents the first study to identity, in historical records, regional changes in the mechanisms of extreme water available for runoff (W). We used a quality‐controlled Snowpack Telemetry data set (1979–2017) combined with the nonparametric regional Kendall test to examine changes in annual maximum W under four hydrometeorological conditions (melt only/rain‐on‐snow/all melt/all melt plus rainfall) over the mountainous regions of the western United States. Under a warming climate, our analyses indicated significant declining trends in annual maximum W at regional scale under all four conditions. The annual maximum of all melt plus rainfall decreased significantly by 15% in the southwestern United States, while the frequency of rain‐on‐snow events increased significantly by 32% in the northwestern United States. The annual maximum snowmelt only decreased significantly by 21% across the entire western United States. Our results confirmed that interaction between regional humidity and solar radiation with warming temperature helps drive these changes.
Role of Arctic Sea Ice in the 2014–2015 Eurasian Warm Winter
Authors: Xie Jinbo , Zhang Minghua , Liu Hailong
Published: January 2019

Because of large internal variabilities, the role of Arctic sea ice concentration (SIC) on regional climate cannot be easily separated. This study uses two groups of large ensemble atmospheric model simulations under climatological and observed SIC boundary conditions to investigate the role of SIC in the 2014–2015 December to February Eurasian warm winter (DJF15). It is shown that the SIC has large impact on the probability distribution function of the DJF15 temperature and pressure fields. The anomalous high Barents Sea ice during the 2014–2015 autumn and winter leads to significant shift in the probability distribution function skewness of the DJF15 surface temperature (from −0.13 to −0.48) and the related sea level pressure (from −0.18 to 0.32) that favor more occurrences of warm temperature anomaly and positive North Atlantic Oscillation‐like pattern. This asymmetry is consistent with anomalous forcing in phase with the anomalies of the sea level pressure field.
The South American Low‐Level Jet: A New Climatology, Variability, and Changes
Authors: Montini Tessa L. , Jones Charles , Carvalho Leila M. V.
Published: January 2019

The South American low‐level jet (SALLJ) east of the Andes plays an important role in regional weather and hydrology by transporting large amounts of moisture from the Amazon to the subtropics. A new methodology is introduced for detecting SALLJ events based on seasonal‐percentile thresholds of wind speed and wind shear. Direct comparisons are made between new and conventional fixed‐threshold methods. Identification of SALLJ events is compared between five different reanalysis products and validated against available radiosonde observations. A new climatology of the SALLJ is presented for one particular reanalysis during a 38‐year period (1979–2016). Based on this new definition, the present study analyzes the spatiotemporal variability of the SALLJ on seasonal and interannual timescales, as well as trends in the jet over recent decades. Results show that the interannual variability of the jet's strength and frequency is significantly modulated by the El Niño Southern Oscillation, especially during spring. Trends in the vertically integrated moisture transport during SALLJ days reveal significant increases in the northwesterly moisture flux associated with the jet toward southern Brazil in spring, summer, and fall. These changes likely contribute to the increase in precipitation and extreme precipitation events observed over southeastern South America in recent decades.
Seasonal Bias in Soil Carbonate Formation and Its Implications for Interpreting High‐Resolution Paleoarchives: Evidence From Southern Utah
Authors: Huth T. E. , Cerling T. E. , Marchetti D. W. , Bowling D. R. , Ellwein A. L. , Passey B. H.
Published: January 2019

Pedogenic carbonate is commonly used as a paleoarchive, but its interpretation is limited by our understanding of its formation conditions. We investigated laminated soil carbonate rinds as a high‐resolution paleoarchive in Torrey, Utah, USA, by characterizing and modeling their formation conditions. We compared late Holocene (<5 ka) soil carbonate conventional (C and O) and “clumped” isotopes to modern soil environment and isotope measurements: soil CO2 partial pressure, soil temperature, soil moisture, δ13C‐soil CO2, δ18O precipitation, and δ18O‐soil water. Data unambiguously identified a strong summer seasonality bias, but modeling suggested soil carbonate formed several times throughout the year during infiltration events causing dissolution‐formation reactions. This apparent discrepancy resulted from preferential preservation of calcite formed from the largest annual infiltration events (summer) overprinting previously formed calcite. Soil carbonate therefore formed predominantly due to changes in soil water content. As soil CO2 was at its annual maximum during soil carbonate formation, assuming uniformly low soil CO2 formation conditions for soil carbonate in estimating paleoatmospheric CO2 is likely not viable. Additionally, we showed modern summer δ13C‐soil CO2 and soil CO2 measurements could not produce a modeled δ13C‐soil carbonate consistent with late Holocene observations. We suggest using multiple lines of evidence to identify nonanalogous modern conditions. Finally, a nearly linear radiocarbon age model from a laminated rind showed that rinds can be used as a high‐resolution paleoarchive if samples are from a single depth and the timing and conditions of soil carbonate formation can be constrained through time.
Soil Chemistry Aspects of Predicting Future Phosphorus Requirements in Sub‐Saharan Africa
Authors: Magnone Daniel , Niasar Vahid J. , Bouwman Alexander F. , Beusen Arthur H. W. , van der Zee Sjoerd E. A. T. M. , Sattari Sheida Z.
Published: January 2019

Phosphorus (P) is a finite resource and critical to plant growth and therefore food security. Regional‐ and continental‐scale studies propose how much P would be required to feed the world by 2050. These indicate that Sub‐Saharan Africa soils have the highest soil P deficit globally. However, the spatial heterogeneity of the P deficit caused by heterogeneous soil chemistry in the continental scale has never been addressed. We provide a combination of a broadly adopted P‐sorption model that is integrated into a highly influential, large‐scale soil phosphorus cycling model. As a result, we show significant differences between the model outputs in both the soil‐P concentrations and total P required to produce future crops for the same predicted scenarios. These results indicate the importance of soil chemistry for soil‐nutrient modeling and highlight that previous influential studies may have overestimated P required. This is particularly the case in Somalia where conventional modeling predicts twice as much P required to 2050 as our new proposed model.
Alkenone Paleothermometry in Coastal Settings: Evaluating the Potential for Highly Resolved Time Series of Sea Surface Temperature
Authors: Salacup J. M. , Farmer J. R. , Herbert T. D. , Prell W. L.
Published: January 2019

The unsaturation ratios of alkenones have been applied widely to reconstruct pelagic sea surface temperatures (SSTs). However, applications to costal settings have been hampered by the effects of salinity and nutrient dynamics. Here we present a 4.5‐year‐long record of alkenones in water column particulate organic matter from sites in Narragansett Bay (RI, USA) spanning wide ranges in salinity and nutrients, and a 300‐year alkenone record from two Narragansett Bay sediment cores. Particulate organic matter results suggest that there are two distinct alkenone producing populations. One is a widespread population that blooms in summer (July–September) and displays alkenones typical of Group III producers—the basis for the widely applied marine Uk’37 temperature index. The other population is confined to brackish waters in the Providence River during spring salinity minima and displays alkenone profiles consistent with Group I production—the first detection of Group I in a brackish nonlacustrine environment. The sedimentary alkenone profiles consist of only Group III alkenone distributions, allowing for the reconstruction of a 300‐year‐long record of Narragansett Bay SST. Comparison of the most recent 100 years of this reconstruction with local and regional instrumental SST records shows excellent agreement, confirming a regional pattern of SST rise in the coastal northeastern United States that exceeds global or hemispheric rates. Group III alkenone production in coastal settings may be common and may open the way to high resolution local and regional SST reconstruction.
Scientists Invited to Collaborate in Satellite Mission’s Debut
Authors: Morrow Rosemary , Fu Lee-Lueng , D’Ovidio Francesco , Farrar J.
Published: January 2019

The Surface Water and Ocean Topography mission will begin by scanning Earth’s surface once a day. We invite ocean scientists to contribute ground-based measurements to compare with the satellite data.
Can Earthquakes Trigger Volcanic Eruptions?
Authors: Flaherty Brittany
Published: January 2019

A new study supports the idea that earthquakes may be associated with increased volcanic eruptions, but over longer time spans than prior research indicated.
“Plasmonics” in free space: observation of giant wavevectors, vortices, and energy backflow in superoscillatory optical fields
Authors: Yuan Guanghui , Rogers Edward T. F. , Zheludev Nikolay I.
Published: January 2019

Evanescent light can be localized at the nanoscale by resonant absorption in a plasmonic nanoparticle or taper or by transmission through a nanohole. However, a conventional lens cannot focus free-space light beyond half of the wavelength λ. Nevertheless, precisely tailored interference of multiple waves can form a hotspot in free space of an arbitrarily small size, which is known as superoscillation. Here, we report a new type of integrated metasurface interferometry that allows for the first time mapping of fields with a deep subwavelength resolution ~λ/100. The findings reveal that an electromagnetic field near the superoscillatory hotspot has many features similar to those found near resonant plasmonic nanoparticles or nanoholes: the hotspots are surrounded by nanoscale phase singularities and zones where the phase of the superoscillatory field changes more than tenfold faster than a free-propagating plane wave. Areas with high local wavevectors are pinned to phase vortices and zones of energy backflow (~λ/20 in size) that contribute to tightening of the main focal spot size beyond the Abbe–Rayleigh limit. Our observations reveal some analogy between plasmonic nanofocusing of evanescent waves and superoscillatory nanofocusing of free-space waves and prove the fundamental link between superoscillations and superfocusing, offering new opportunities for nanoscale metrology and imaging.
The CSN3 subunit of the COP9 signalosome interacts with the HD region of Sos1 regulating stability of this GEF protein
Authors: Zarich Natasha , Anta Begoña , Fernández-Medarde Alberto , Ballester Alicia , de Lucas María Pilar , Cámara Ana Belén , Anta Berta , Oliva José Luís , Rojas-Cabañeros José M. , Santos Eugenio
Published: January 2019

Sos1 is an universal, widely expressed Ras guanine nucleotide-exchange factor (RasGEF) in eukaryotic cells. Its N-terminal HD motif is known to be involved in allosteric regulation of Sos1 GEF activity through intramolecular interaction with the neighboring PH domain. Here, we searched for other cellular proteins also able to interact productively with the Sos1 HD domain. Using a yeast two-hybrid system, we identified the interaction between the Sos1 HD region and CSN3, the third component of the COP9 signalosome, a conserved, multi-subunit protein complex that functions in the ubiquitin–proteasome pathway to control degradation of many cellular proteins. The interaction of CSN3 with the HD of Sos1 was confirmed in vitro by GST pull-down assays using truncated mutants and reproduced in vivo by co-immunoprecipitation with the endogenous, full-length cellular Sos1 protein. In vitro kinase assays showed that PKD, a COP9 signalosome-associated-kinase, is able to phosphorylate Sos1. The intracellular levels of Sos1 protein were clearly diminished following CSN3 or PKD knockdown. A sizable fraction of the endogenous Sos1 protein was found ubiquitinated in different mammalian cell types. A significant reduction of RasGTP formation upon growth factor stimulation was also observed in CSN3-silenced as compared with control cells. Our data suggest that the interaction of Sos1 with the COP9 signalosome and PKD plays a significant role in maintenance of cellular Sos1 protein stability and homeostasis under physiological conditions and raises the possibility of considering the CSN/PKD complex as a potential target for design of novel therapeutic drugs.
Size differences predict niche and relative fitness differences between phytoplankton species but not their coexistence
Authors: Gallego Irene , Venail Patrick , Ibelings Bas W
Published: January 2019

Here we aim to incorporate trait-based information into the modern coexistence framework that comprises a balance between stabilizing (niche-based) and equalizing (fitness) mechanisms among interacting species. Taking the modern coexistence framework as our basis, we experimentally tested the effect of size differences among species on coexistence by using fifteen unique pairs of resident vs. invading cyanobacteria, resulting in thirty unique invasibility tests. The cyanobacteria covered two orders of magnitude differences in size. We found that both niche and fitness differences increased with size differences. Niche differences increased faster with size differences than relative fitness differences and whereas coexisting pairs showed larger size differences than non-coexisting pairs, ultimately species coexistence could not be predicted on basis of size differences only. Our findings suggest that size is more than a key trait controlling physiological and population-level aspects of phytoplankton, it is also relevant for community-level phenomena such as niche and fitness differences which influence coexistence and biodiversity.