bluuebunny/crossref_metadata_2025 huggingface dataset:
Mercury in Cobia from Estuarine and Offshore Waters of the Southeastern United States: Fisheries Implications
Authors: Adams Douglas H.
Published: January 2018

In marine ecosystems, upper‐trophic‐level pelagic fish often contain high concentrations of mercury. Individuals of several frequently landed marine fish species bioaccumulate mercury at concentrations linked directly to effects on fish physiology and human health risks. Knowledge of mercury in Cobias Rachycentron canadum has been limited. With this study, I addressed that problem by providing a comprehensive assessment of mercury in muscle taken from Cobia specimens within a range of size‐ and age‐classes representative of those targeted by the recreational and commercial fisheries operating in the southeastern United States (Atlantic Ocean and eastern Gulf of Mexico). Total mercury concentration (THg) in muscle ranged from 0.025 to 3.9 mg/kg (wet weight), with a mean of 0.743 mg/kg (SD = 0.609). In approximately 95% of all legal‐size Cobias (≥838.2 mm FL), THg exceeded 0.3 mg/kg (i.e., the U.S. Environmental Protection Agency's human health screening value for mercury). Proposed and recent increases in size limits for Cobias in some waters of the southeastern United States would further increase this percentage. The present results for Cobias from the western Atlantic and Gulf of Mexico further substantiate current fish consumption advisories and provide guidance for new or revised advisories in other regions.
Layered Double Hydroxide‐Based Functional Nanohybrids as Controlled Release Carriers of Pharmaceutically Active Ingredients
Authors: Ray Suprakas Sinha , Mosangi Damodar , Pillai Sreejarani
Published: January 2018

The chemical stability, degradation and penetration ability of pharmaceutically active ingredients in topical formulations are the greatest challenges because of problems with the protection of actives for long times and with delivery. Therefore, the development of unique and efficient substrate material is vital for their protection and controlled drug release. Layered double hydroxides (LDHs) known as hydrotalcite like compounds possess positive charges due to isomorphic substitutions, which are counterbalanced by hydrated exchangeable anions located in the interlayer region. Some of the active ingredient molecules can be intercalated into the inner region of the LDHs through ionic bonding, hydrogen bonding or van der Waals interaction to form nanohybrids, which are more potent for their protection and controlled‐release. This account focuses on our recent research efforts and key scientific and technical challenges in the development of LDH based nanohybrids for commercial use in advanced controlled release carriers of active ingredients in topical formulations.
Unexpected ecological advances made possible by long‐term data: A Coweeta example
Authors: Jackson C. Rhett , Webster Jackson R. , Knoepp Jennifer D. , Elliott Katherine J. , Emanuel Ryan E. , Caldwell Peter V. , Miniat Chelcy F.
Published: January 2018

In the 1970s, Forest Service and academic researchers clearcut the forest in Watershed 7 in the Coweeta Basin to observe how far the perturbation would move the ecosystem and how quickly the ecosystem would return to its predisturbance state. Our long‐term observations demonstrated that this view of resistance and resilience was too simplistic. Forest disturbance triggered a chain of ecological dynamics that are still evolving after 40 years. Short‐term pulses in dissolved inorganic nitrogen (DIN) (3 years) and streamflows (4 years) were followed by several years in which the system appeared to be returning to predisturbance conditions. Then however, changes in forest composition triggered a regime change in DIN dynamics from biological to hydrological control as well as persistent high stream DIN levels mediated by climatic conditions. These forest composition changes also led to later reductions in streamflow. These long‐term observations of streamflows, stream DIN concentrations, stream DIN exports, and stand composition have substantially advanced our understanding of forest ecosystem dynamics; and they demonstrate the value of long‐term observational data in revealing ecosystem complexities and surprises, generating new hypotheses, and motivating mechanistic research. Shorter observational records from this experiment would have produced incomplete or erroneous inference. WIREs Water 2018, 5:e1273. doi: 10.1002/wat2.1273

This article is categorized under:

Science of Water > Hydrological Processes

Science of Water > Water Quality

Water and Life > Nature of Freshwater Ecosystems
Impact of sirtuin-1 expression on H3K56 acetylation and oxidative stress: a double-blind randomized controlled trial with resveratrol supplementation
Authors: Bo Simona , Togliatto Gabriele , Gambino Roberto , Ponzo Valentina , Lombardo Giusy , Rosato Rosalba , Cassader Maurizio , Brizzi Maria Felice
Published: January 2018

Aims

Sirtuin-1 (SIRT-1) down-regulation in type 2 diabetes mellitus (T2DM) has been associated with epigenetic markers of oxidative stress. We herein aim to evaluate whether an increase in SIRT-1 expression affects histone 3 acetylation at the 56 lysine residue (H3K56ac) in T2DM patients randomly selected to receive either resveratrol (40 mg or 500 mg) or a placebo for 6 months. The primary outcome is changes in the H3K56ac level by variation in SIRT-1 expression and the secondary outcome is the evidence of association between SIRT-1 level, antioxidant markers (TAS), and metabolic variables.

Methods and results

At baseline, peripheral blood mononuclear cell H3K56ac values among the SIRT-1 tertiles did not differ. At trial end, SIRT-1 levels were significantly higher in patients receiving 500 mg resveratrol. At follow-up, patients were divided into tertiles of delta (trial end minus baseline) SIRT-1 value. Significant reductions in H3K56ac and body fat percentage were found in the highest tertile as were increased TAS levels. A multiple logistic regression model showed that the highest delta SIRT-1 tertile was inversely associated with variations in H3K56ac (OR = 0.66; 95% CI 0.44–0.99), TAS (OR = 1.01; 95% CI 1.00–1.02), and body fat percentage (OR = 0.75; 95% CI 0.58–0.96).

Conclusions

We provide new knowledge on H3K56ac and SIRT-1 association in T2DM. These data suggest that boosting SIRT-1 expression/activation may impact redox homeostasis in these patients.

ClinicalTrials.gov Identifier NCT02244879.
Laser ion source for heavy ion inertial fusion
Authors: Okamura Masahiro
Published: January 2018

The proposed heavy ion inertial fusion (HIF) scenarios require ampere class low charge state ion beams of heavy species. The laser ion source (LIS) is recognized as one of the promising candidates of ion beam providers, since it can deliver high brightness heavy ion beams to accelerators. The design of LIS for the HIF depends on the accelerator structure and accelerator complex following the source. In this article, we discuss the specifications and design of an appropriate LIS assuming two major types of the accelerators: radio frequency (RF) high quality factor cavity type and non-resonant induction core type. We believe that a properly designed LIS would satisfy the requirements of both types, while some issues need to be verified experimentally.
UNPACKING THE DIFFERENTIAL IMPACT OF FAMILY PLANNING POLICIES IN CHINA: ANALYSIS OF PARITY PROGRESSION RATIOS FROM RETROSPECTIVE BIRTH HISTORY DATA, 1971–2005
Authors: Qin Min , Falkingham Jane , Padmadas Sabu S.
Published: January 2018

Although China’s family planning programme is often referred to in the singular, most notably the One-Child policy, in reality there have been a number of different policies in place simultaneously, targeted at different sub-populations characterized by region and socioeconomic conditions. This study attempted to systematically assess the differential impact of China’s family planning programmes over the past 40 years. The contribution of Parity Progression Ratios to fertility change among different sub-populations exposed to various family planning policies over time was assessed. Cross-sectional birth history data from six consecutive rounds of nationally representative population and family planning surveys from the early 1970s until the mid-2000s were used, covering all geographical regions of China. Four sub-populations exposed to differential family planning regimes were identified. The analyses provide compelling evidence of the influential role of family planning policies in reducing higher Parity Progression Ratios across different sub-populations, particularly in urban China where fertility dropped to replacement level even before the implementation of the One-Child policy. The prevailing socioeconomic conditions in turn have been instrumental in adapting and accelerating family planning policy responses to reducing fertility levels across China.
Wartime Globalization in Asia, 1937–1945, Conflicted Connections, and Convergences
Authors: FROST MARK RAVINDER , SCHUMACHER DANIEL
Published: January 2018

Given war's propensity for trampling over and demolishing borders—its literal, one might even say primordial, function as a motor of deterritorialization and reterritorialization—the scant scholarly attention paid to it as a globalizing force remains surprising. An extensive body of literature has responded to the complex role of globalization in the making, as well as the supposed unmaking, of conflict. Liberal economists and political theorists, in an intellectual lineage that dates back to the writings of the European Enlightenment, have made bold claims about global economic integration and the emergence of a ‘capitalist peace’. Critics of their arguments have pointed to the Western imperial violence which, from the mid-eighteenth century on, cleared the ground (and perhaps, more importantly, the seas) to make way for the so-called ‘free’ market world economy, a process which established several of those fundamental worldwide inequalities that have been perpetuated to this day. The hard evidence of a more recent past makes a mockery of the presumption that global capitalist enterprises such as Starbucks and McDonalds might bring about some kind of Big Mac and Frappuccino-mediated universal fraternity. Critical observers of globalization during the ‘Noughties’ (2000–2010) now recognize it as both one of the most interconnected decades in world history, and also one of the bloodiest.
OP02 A Managed Access Approach To Appraising New Cancer Drugs In England
Authors: Landells Linda , Burke Martyn , Boysen Meindert
Published: January 2018

INTRODUCTION:

The changing regulatory landscape brings new challenges to Health Technology Assessment (HTA). Marketing authorizations are being granted as the evidence base evolves to facilitate timely patient access to promising health technologies. Consequently, some products come to HTA bodies sooner in their development cycles with less evidence, which ultimately leads to greater uncertainty in decision making. A key challenge for payer and HTA bodies is providing access to promising medicines while the evidence is still emerging, in a financially sustainable way.

METHODS:

Changes to the Cancer Drugs Fund (CDF) have resulted in a managed access fund for cancer medicines in England. The National Institute for Health and Care Excellence (NICE) can now recommend a treatment for use within the CDF if there is plausible potential to satisfy the criteria for routine use in the National Health Service (NHS) at its current price, but the evidence is not robust enough and associated with significant uncertainty. Further evidence is then generated in clinical trials, through observational data collection, or a combination of the two, while the drug's price reflects the decision uncertainty. At the end of the managed access period, NICE reviews the guidance to determine if the treatment can be recommended for routine commissioning.

RESULTS:

The first treatment recommended for use within the new CDF was osimertinib for non-small cell lung cancer (1). At the time of NICE appraisal, there was considerable uncertainty in osimertinib's clinical and cost effectiveness because only short-term phase II trial results were available. NICE's independent appraisal committee considered there was plausible potential for osimertinib to be cost effective and identified that an ongoing phase III trial would provide longer-term data addressing the key uncertainties.

CONCLUSIONS:

An integrated approach between payer and HTA decision-maker has significantly changed how cancer treatments in England are appraised. This collaborative way of working heralds a more sustainable approach to introducing promising cancer treatments.
OP04 Lessons Learnt When Implementing A Health Technology Assessment Institution In Costa Rica
Authors: Gutiérrez-Ibarluzea Iñaki , Cercone James , Bronstein Daniel , Tacsan Luis , Morales Pablo , Sancho Ana Eduviges , Benguria-Arrate Gaizka , Llorca Fernando
Published: January 2018

INTRODUCTION:

Faced with increasing financial challenges to the single-payer social security system and constitutional challenges supporting all citizen's right to health, Costa Rica has endeavored to introduce Health Technology Assessment (HTA) to ensure sustainability and promote the timely introduction of technology innovations in the health system. The Ministry of Health initiated a process to establish an independent, external institution providing leadership in the process of HTA.

METHODS:

Based on a survey developed by REDETSA/PAHO (HTA Network of the Americas/Pan American Health Organization), an inclusive method of stakeholders participation was used to analyze the strengths, weaknesses, opportunities and threats regarding the implementation of an HTA entity. This was combined with qualitative research methods, market access situation analysis and the review of coverage and provision processes to define the elements for the new HTA institution. The “in-depth” interviews extended to manufacturers, ministry representatives, services providers, purchasers, patients and citizens representatives, judiciary court, professional colleges, academia and non-governmental organizations (NGOs). Analysis of the professional competencies required for the HTA institution was carried out based on best practice analysis of international HTA institutions.

RESULTS:

The implementation of an HTA unit in Costa Rica was identified by all the actors as crucial to ensuring the health system's sustainability. Costa Rica's health system is based on all citizens right to health and all inputs required delivering health services, judicialization and access to health care have become a big issue. Two main issues were identified as essential to implement an HTA institution: the establishment of a clear framework to provide legal and financial support and the need to have sufficient independence from the Ministry and the Social Security, including maximum transparency and methodological robustness.

CONCLUSIONS:

The business model for the new HTA institution should consider the participation of all the interested actors. The HTA institution should bridge the gap between technology regulation and health technology management and aim to improve both processes. It should also provide third party independent evidence to inform the constitutional court around health care claims.
OP28 Health Apps: A Proposed Framework To Guide Clinical Risk Assessment
Authors: van Velthoven Michelle Helena , Powell John , Wyatt Jeremy
Published: January 2018

INTRODUCTION:

Globally, health systems are struggling with reliably appraising the safety and efficacy of rapidly changing digital health interventions whilst allowing useful innovations to be rapidly adopted. Assessment and regulation of the large number of health apps should be proportional to their clinical risk, but there is large uncertainty about suitable criteria to assess risk (1). We aimed to identify criteria for assessing clinical risks associated with different types of health apps.

METHODS:

Our work builds on previous studies that identified some of the risks that health apps can pose and contextual factors that can moderate these risks (2,3). This work is grounded in a review of existing literature; wide consultation of stakeholders; participation in multi-agency policy discussion; and sense-checking successive versions of the framework that evolved over time. We combined different risk domains for apps (technical safety, usability, intervention quality, and engagement) with their functions (learning, behaviour and cognition change, communication, record keeping, and clinical decision support).

RESULTS:

We developed a comprehensive generic risk framework that app users, developers, commissioners, regulators and other stakeholders worldwide can use to guide assessment of the likely risks posed by a specified health app in a specific context. We also propose questions that should help determine whether these risks have been addressed.

CONCLUSIONS:

Apps are very promising in health care but are very numerous, complex, rapidly evolving and with overlapping functions. A rigorous risk framework should help stakeholders to deal with the large quantity of health apps, classify and manage clinical risks, and improve patient safety by applying generic risk assessment criteria. Further work is needed to test and develop the criteria we propose, especially as apps that integrate different functions are emerging, which will make risk assessment more complex.
OP37 Can Local Ultra-Orphan Patient Evidence Shape Global Understanding?
Authors: Livingstone Heidi , Upadhyaya Sheela , Thomas Lizzie , Leng Gillian
Published: January 2018

INTRODUCTION:

Written patient evidence is submitted to the National Institute for Health and Care Excellence (NICE) by patient organizations and their nominated patient experts. We reviewed the impact that patient evidence had on the committee's decision making. This local learning can help generate global opportunities for Health Technology Assessment (HTA) bodies and patient groups to further develop their understanding and methodology about how patient evidence can support HTA decision making for ultra-orphan conditions.

METHODS:

There were two phases.

Phase one was an online questionnaire about the impact of patient evidence on the committee's decision making for ultra-orphan HTA evaluations. It was sent to the committee chair, lay committee members and selected other committee members.

Phase 2 developed the initial questionnaire findings using in-depth interviews with the committee chair and the lay members. These gained further understanding of the impact of patient evidence and the themes raised.

RESULTS:

Key findings showed patient evidence was helpful to understand the:

•

Burden of disease

•

Patient population

•

Likely uptake of new medicines

•

Impact on carers.

For ultra-orphan conditions, where other forms of evidence are scarcer, patient evidence is fundamental to understanding patient needs, the impact of the disease, patient population and preferences.

CONCLUSIONS:

Patient evidence was useful for the committee in different ways; it provided the committee with new evidence and it helped the committee understand and interpret the evidence submitted by others. Both are key to committee decision making. It was clear that due to the very small patient population, patient groups knew the patient population, their stage of disease, and their preferences in detail.

The findings will be used to inform an updated patient submission template for ultra-orphan HTAs, and supporting guide. These will be available on the NICE website and offered to the HTAi Interest Group on Patient and Citizen Involvement so they can be shared globally.
OP38 Improving The Patient Centricity Of Value Assessments: A Rubric
Authors: Perfetto Eleanor , Oehrlein Elisabeth , Boutin Marc , Reid Sarah , Gascho Eric
Published: January 2018

INTRODUCTION:

Value frameworks, analogous to Health Technology Assessment (HTA) internationally, have emerged in the United States to aid stakeholders in assessing the value of new treatments. Since patient perspectives on value may differ significantly from other stakeholders, formalized procedures to involve patients in their work have been created. Despite these efforts, concerns persist that patient involvement is insufficient or “rhetoric.” To assist in this effort, the National Health Council (NHC) created a rubric to aid decision makers in improving the patient centricity of their value assessments.

METHODS:

A convenience sample of twenty-eight organizations was invited to participate in a roundtable discussion. Participants discussed experiences with value frameworks; debated and thematically grouped hallmark patient-centeredness characteristics; and developed illustrative examples of the characteristics. These materials were organized into the rubric, and subsequently vetted via multi-stakeholder peer review.

RESULTS:

Participants agreed upon six key domains of patient centeredness: partnership (patients are involved in every step of development/dissemination processes), transparency (assumptions/inputs are disclosed in an understandable, timely way), inclusiveness (perspectives drawn from broad range of stakeholders), diversity (differences in subpopulations, trajectory of disease, and stage of a life should be accounted for), outcomes (includes those that patients have identified as important), and data (variety of credible data sources are used allowing for timely incorporation of new information and account for the diversity of patient populations and patient-centered outcomes). The Rubric describes each domain and includes illustrative examples of how patient engagement/centeredness can be operationalized through direct and indirect pathways.

CONCLUSIONS:

The NHC Rubric is a first step toward creating patient-centered value assessments that patients and their families can rely on. It is intended to assist all stakeholders, especially the patient community, in assessing the level of patient centeredness and engagement in a given framework or model. It can be a guide to support developers in conceptualizing plans for meaningfully engaging patients.
OP43 Unconventional Health Technology Assessment Use: Diagnosis Of Likely Emerging Tropical Diseases
Authors: Lafarge Jean-Charles , David Denis-Jean , Morin-Surroca Michèle
Published: January 2018

INTRODUCTION:

The increase in travelers and refugees combined with global warming may soon lead to the development of tropical diseases such as Schistosoma or Strongyloides infections in some European countries.

Those intestinal parasites may persist for decades with subclinical infections or low-grade disease with nonspecific manifestations. In the presence of immunosuppression, strongyloidiasis can rapidly evolve into life-threatening disseminated disease, whereas chronic schistosomiasis can lead to complications causing future morbidity and death.

Currently in France, an update of diagnostic tests reimbursed for those tropical diseases is ongoing to fully cover diagnostic needs.

Our aim was to assess the clinical relevance of tests used in schistosomiasis’ or strongyloidiasis’ diagnosis and include the most relevant in the national list of reimbursed tests.

METHODS:

The assessment involves a critical analysis of national and international guidelines identified by a systematic literature search, and stakeholders’ views.

RESULTS:

This work identifies several autochthonous outbreaks of those diseases in France; such as urogenital schistosomiasis that occurred in Corsica, in summer 2013. Also it enlightens the increase of strongyloides serological tests performed in the past years. Those facts prove the potential development of those infections in Europe.

It underlines that, serology is the first diagnostic test line for most cases and is more sensitive than stool microscopy which represents however the final diagnostic investigation to confirm the intestinal infection.

It confirms the main indications of those two diagnostic tools.

It relies on a tropical infectious disease expert network including the French army health service. They have brought further clarification of diagnostic tests clinical relevance for travelers or autochthonous cases.

CONCLUSIONS:

This new use of Health Technology Assessment has allowed updating and listing the relevant diagnostic tools which might be crucial to better follow those diseases and it may help the health system to face the increase of tropical infections.
OP44 Cost-Effectiveness Of Hepatitis C Virus Screening In Swiss Prisons Using Rapid Tests
Authors: Girardin François , Hearmon Natalie , Castro Erika , Negro Francesco , Perard Rodolphe , Schnyder Anita , Eddowes Lucy , Gétaz Laurent , Wolff Hans
Published: January 2018

INTRODUCTION:

This study explored the cost-effectiveness of expanding Hepatitis C Virus (HCV) screening and subsequent treatment in Swiss custodial settings, given the availability of rapid antibody saliva tests (Oraquick®) and dried blood spot tests (semi-quantitative viremia and viral genotype), and recent therapeutic advances which have higher cure rates and shorter treatment courses (1).

METHODS:

A comprehensive strategy offering screening to all detainees was compared to the current setup of screening high-risk individuals (for example, from endemic countries, active or former injecting drug users). A decision tree simulated the diagnosis pathway, and results from a Markov model were included to predict treatment effects and natural progression over a lifetime time-horizon. Input data were derived from clinical studies, literature reviews, custodial health services and expert opinion (2). The net monetary benefit (NMB) and incremental cost-effectiveness ratio (ICER) of comprehensive compared to current screening were calculated. Deterministic and probabilistic sensitivity analyses were performed to explore parameter uncertainty and whether variations informed by expert opinion changed the cost-effectiveness of comprehensive screening.

RESULTS:

At a willingness-to-pay threshold of CHF100,000 (USD99,500) per Quality-Adjusted Life-Year (QALY), comprehensive screening had an 83 percent probability of being cost-effective, with a corresponding NMB of CHF33,451,972 (USD33,284,712) and ICER of CHF7,168/QALY (USD7,132/QALY). Results were most sensitive to the QALYs gained from the treatment model (both treatment and no treatment arms), respective HCV prevalence in the current and comprehensive screening populations, treatment initiation rates, and screening offer acceptance rates. Compared to the current practice of screening high-risk individuals, comprehensive screening is likely to be cost-effective due to the increase in testing rates, which were conservatively estimated in this study. Furthermore, comprehensive HCV screening of prisoners may prove more cost-effective in countries where prisoners are not routinely screened.

CONCLUSIONS:

Comprehensive screening programs could be considered in prison units with a large proportion of high-risk individuals and where detainees are incarcerated for enough time to complete a treatment course during their sentence.
OP46 Addressing National Health Service (NHS) Priorities: Medtech Innovation Briefings
Authors: Herz Naomi , Macmillan Thomas , Goddard Kate , Chalkidou Anastasia
Published: January 2018

INTRODUCTION:

Medtech innovation briefings (MIBs) are intended to support National Health Service (NHS) decision makers and staff who are considering using new innovative medical devices and in-vitro diagnostics. MIBs are produced in support of the NHS 5-Year Forward View, specifically to accelerate innovation in new treatments and diagnostics. This project aimed to evaluate the extent to which published MIBs address national priorities set by NHS England, including in six clinical areas: cancer, mental health, dementia, diabetes, learning disabilities, and maternity.

METHODS:

Data was extracted from eighty-seven MIBs downloaded from the National Institute for Health and Care Excellence (NICE) website including: study design, amount of evidence, date of CE mark, population, cost, manufacturer, device class, publication date, and category of conditions and disease (as prescribed by NICE). Descriptive analysis was done for each variable and frequency tables were produced for MIBs by disease category.

RESULTS:

Cardiovascular disease (n = 19) and cancer (n = 12) were the two most common conditions addressed by MIB-evaluated devices. The four medical conditions with the fewest MIBs (n = 1 each) were: diabetes, liver conditions, neurological conditions, and fertility, pregnancy and childbirth. Of the eighty-five MIBs with stated device classifications, just over half were Class IIa and IIb devices and 18 percent were in-vitro diagnostics. The earliest original CE mark was 1997, and approximately half of the devices obtained or updated their CE mark after 2010.

CONCLUSIONS:

Chronic conditions such as cancer, cardiovascular disease, and diabetes accounted for 89 percent of total deaths in the UK in 2014, thus, the most commonly published MIBs aptly address these issues. However, MIBs are lacking in five out of six NHS priority areas. There is opportunity for innovative technologies to be reviewed via MIBs and alternative NICE pathways in the areas of diabetes, maternity, mental health, and learning disabilities and dementia.
OP55 Health Technology Assessment In Children And Adolescents: Adolescent Preferences For Child Health Utility 9D Health States
Authors: Ratcliffe Julie , Chen Gang , Huynh Elisabeth , Xu Frank , Stevens Katherine , Brazier John , Swait Joffre
Published: January 2018

INTRODUCTION:

Preference-based measures of health-related quality of life play a key role in the calculation of Quality-Adjusted Life Years (QALYs) for Health Technology Assessment (HTA). The Child Health Utility 9D (CHU9D) is a new preference-based instrument designed specifically for application in children and adolescents (aged 7 to 17 years). This study aimed to compare Chinese and Australian adolescent population preferences for CHU9D health states using profile case best worst scaling (BWS) methods.

METHODS:

Fifty CHU9D health states (blocked into five survey versions) were generated for valuation using a fractional factorial design. Study participants were recruited through an online panel company in Australia, and through primary and secondary schools in China. A latent class modelling framework was adopted for econometric analysis.

RESULTS:

A total of 1,982 respondents (51 percent female) in Australia and 902 respondents (43 percent female) in China provided useable survey responses. Latent class analysis indicated the existence of preference heterogeneity for both population groups. In the Australian sample, respondents in Class I placed the most importance on the mental health dimensions of the CHU9D (for example, Worried and Annoyed) and the least importance on daily activities (for example, Activities, Daily routine, Sleep), whilst respondents in Class II placed equal weights on all attributes. In the Chinese sample, respondents in Class I placed the most importance on the Activities dimension of the CHU9D and the least importance on the Annoyed dimension, whist Class II placed the most importance on the Schoolwork dimension and the least importance on Pain.

CONCLUSIONS:

This study has provided important cross-country insights into the use of profile case BWS methods to elicit health state preferences with young people for application in HTA in children and adolescents. The differential latent classes identified between Australia and China highlights the necessity to derive country-specific adolescent scoring algorithms for the CHU9D instrument for application in HTA.
OP69 Hospital-based Health Technology Assessment Is Applicable To Investment Decision-Making Process
Authors: Ikonen Tuija , Lähteenmäki Heli
Published: January 2018

INTRODUCTION:

Hospital mangers need information for decision making (1). Hospital-based health technology assessment (HTA) methods were tested out to support the budget planning of investments for a new building to be constructed for diagnostic and teaching units at a publicly funded tertiary care university hospital. The hospital board nominated an ad hoc working group to reassess all investment proposals for devices, equipment and furniture for the diagnostic or teaching units that intended to move into the new building. The need for assessment was obliged when the submitted proposals of the units exceeded two-fold the initially allocated investment budget.

METHODS:

Depending on the level of expenditure, all proposals were assessed by one of the following processes: (i) Proposals over EUR250,000 were evaluated by three to five person expert groups using multi-domain assessment adapting Hospital-based HTA-principles; (ii) Proposals between EUR50,000 and EUR250,000 were returned to the units for miniHTA-assessments by clinicians who submitted the initial proposals and (iii) All proposals below EUR50,000 were prioritized by the units to cut the expenditure by at least 25 percent, with a special emphasis on synergistic use of devices and equipment among the units.

RESULTS:

The expert groups suggested significant reductions to the proposals, including the withdrawal of a Magnetic Resonance Imaging (MRI)-unit considered to be suboptimally located. Furthermore, the need for a new scanner was declined by promoting adherence to evidence-based diagnostic guidelines and more efficient utilization of existing scanners. Self-assessed MiniHTAs revealed proposals that were unnecessary or the specifications for devices needed re-adjustments. Prioritization revealed excess numbers of devices, for instance the number of cold storage appliances could be reduced. Altogether, the investment proposals were cut by over EUR3.8 million to reach the initial budgetary allocation.

CONCLUSIONS:

Innovative and flexible usage of hospital-based HTA methodology can be applied to budget planning and evaluation of investment proposals to support decision making. Based on encouraging results, hospital-based HTA was accepted to become a part of hospital strategy as a tool for the annual investment planning.
OP93 Conditional Financing In Health Technology Assessment Practice: The Dutch Experience
Authors: Makady Amr , Nijmeijer Hugo , van Veelen Ard , de Boer Anthonius , Hillege Hans , Klunger Olaf , Goettsch Wim
Published: January 2018

INTRODUCTION:

In 2007, the National Healthcare Institute (ZIN) initiated conditional financing (CF) of expensive hospital drugs as an example of conditional reimbursement schemes (CRS). CF is a 4-year procedure encompassing initial HTA assessment (T = 0) followed by additional data collection via outcomes research (separately assessing appropriate use & cost-effectiveness in routine practice) and re-assessment (T = 4). This study aims to review performance and experiences with CF in the Netherlands to date.

METHODS:

All dossiers for drugs that underwent the full CF procedure were reviewed. Using a standardized data abstraction form, two researchers independently extracted information on procedural, methodological and decision-making aspects (that is, related to implemented outcomes research, evidence assessment and appraisal). A scoring algorithm was used to assess all three aspects.

RESULTS:

Fourty-seven candidates were nominated for CF; fourty-four underwent T = 0 assessments and eleven T = 4 assessments. The procedure extended beyond 4 years for 10/11 candidates. For the eleven candidates, applicants clearly defined study designs and data collection methods for outcomes research proposals addressing 16/22 research questions posed in T = 0 reports. ZIN provided discussion points and recommendations regarding research proposals for 18/22 research questions. Applicants implemented recommendations fully in 8/22 cases and partially in 12/22. Sufficient data was available at T = 4 to answer 15/22 research questions posed at T = 0. However, discussion points remained regarding implemented outcomes research for all eleven candidates at T = 4. ZIN advised to continue reimbursement for nine candidates and to stop reimbursement for two. For six of the nine candidates, reimbursement was continued on the basis of conditions relating to additional evidence generation beyond T = 4.

CONCLUSIONS:

Theoretically, CF provides a valuable option for enabling quick but conditional access to medicines in the Netherlands. However, procedural, methodological and decision-making considerations related to scheme design and implementation may affect its value in decision-making practice.
OP95 An Update On The Economic Value Of A Statistical Life Year In Europe
Authors: Schlander Michael , Schaefer Ramon , Schwarz Oliver
Published: January 2018

INTRODUCTION:

Evaluation of “value for money” is an important component of Health Technology Assessments (HTAs). It is often conceptualized as “cost effectiveness” or cost per (quality-adjusted) life year gained. Whether used in isolation or alongside further drivers of social value (such as priority for younger or more severely impaired patient groups, or for access to effective treatment, even if costly), for example within a multi-criteria decision analysis framework, any reference “value of a statistical life year” (VSLY) should be supported by empirical data capturing the preferences of the population(s) in question. Here we report results based on a systematic review of relevant European economic studies, which were published during the last two decades, that is, from 1995 to 2015.

METHODS:

Our literature search (using the EconBiz and EconLit databases, supplemented by an analysis of relevant reviews) identified fourty-one European studies providing original data, yielding a total of fourty-eight average estimates for the value of a statistical life (VSL, or fatality prevented). We classified studies by methodology, for example, revealed preference (RP) or stated preference (contingent valuation, CV; discrete choice experiment, DCE) approach. We transformed VSL estimates into VSLY expressed in year 2014 Euros, using the life expectancy of the populations studied, a real discount rate of 3 percent, the national Consumer Price Index (CPI) for inflating, and purchasing power parities for currency conversion. We calculated confidence intervals by means of nonparametric bootstrapping.

RESULTS:

The median VSLY was EUR158,000 (for RP studies, EUR218,000; DCE, EUR188,000; CV, EUR143,000); we did not identify studies using the human capital approach. Our VSLY estimates showed large heterogeneity, both by methodology and regional origin; thus the differences that we observed did not reach statistical significance.

CONCLUSIONS:

Our results suggest that the empirical willingness-to-pay for a statistical life year might be substantially higher than benchmarks currently used by the international HTA community.
OP124 Can Registry Failures Be Compensated By Medico-Administrative Database
Authors: Lesquelen Anne , Ghazouani Aziza , Galmiche Hubert , Emery Gregory , Belorgey Chantal , Belghiti Jacques
Published: January 2018

INTRODUCTION:

Post-approval studies (PAS) constitute an important tool in medical devices (MD) assessment usually supported by registries. However, registries are often poorly designed or incomplete. The French health insurance databases are organized since 2003 into a digital data warehouse, the Système national d'information inter-régime de l'assurance maladie (SNIIR-AM), and is the main source of information on patients, hospital activity and associated expenditure. The aim of the study was to determine if these medico-administrative data can be sufficiently relevant to guide a renewal of MD reimbursement in the context of registry failure.

METHODS:

The initial PAS aimed to assess the impact of the guidelines on practice (characteristics of patients, type of stenosis, indications, use of cerebral protection system, surgical procedure) and to determine the 30-day cumulative morbidity and mortality rate of endovascular procedure associated with stenting. Medico-administrative databases provide information on age, sex, symptomatic or asymptomatic stenosis in-hospital mortality and long-term mortality (with a linkage to epidemiological data) and morbidity estimated by ischemic stroke.

RESULTS:

The database allowed selection of a cohort of 2,071 patients in whom carotid stenting was performed in 161 centers (40 percent of stents were implanted in 14 centers) with a follow-up of 1 year. Carotid stents were mainly implanted in asymptomatic patients (81.6 percent). Morbi-mortality in symptomatic patients at 30 days (9.2 percent: 5.7 percent stroke and 3.4 percent mortality) was similar with results observed in a French comparative study EVA-3S (9.6 percent: 2.8 percent stroke and 8.8 percent mortality). These data allow the concerned HAS (French Health Authority) committee to renew the reimbursement proposal of these stents.

CONCLUSIONS:

Medico-administrative database collecting robust criteria can be used to support reimbursement renewal of high risk implantable medical devices. The implementation of other criteria including the disease etiology and the complications imputability may allow to consider the use of these data for non-invasive MD.
OP141 Patient Relevant Outcome Measures As Predictors Of Healthcare Use In Multiple Sclerosis
Authors: Tinelli Michela , Efthymiadou Olina , Mossman Jean , Kanavos Panos
Published: January 2018

INTRODUCTION:

Multiple-sclerosis (MS) is a highly disabling chronic disorder affecting young adults with long term economic consequences on society that escalate as MS disability increases (1,2). In the long-term, progression of MS results in increased level of disability and most patients will eventually experience some degree of functional impairment of the nervous system that impacts on mobility as well as sensory and coordination issues, bladder and sexual functioning, and mood and cognitionon (2). This is usually accompanied by a deterioration of their quality of life. Patient relevant outcome measures (PROMS) are largely used to measure individual disability, and quality of life in MS (2). International evidence from the International Multiple Sclerosis Study (IMPrESS) (2) was used to quantify the relationship between healthcare resources utilisation and disability, quality of life in individuals with MS.

METHODS:

Multivariable logistic regression was performed in order to identify patient-related variables reporting disability (Barthel) and utility (EQ-5D) that predict use of healthcare services (visits to GP, specialists, nurses, hospitalisation and treatment) and work limitation within the participants of the IMPrESS.

RESULTS:

Reponses were collected from 1,152 individuals across 21 countries of which 74.3 percent (856) were useful for analysis. Preliminary findings indicated that for the pooled data sets both EQ-5D and Barthel scores were predictors of healthcare resource use, across different categories (p<.05), except for nurse visits (Barthel only; p<.09). Overall the association between PROM data and use of healthcare resources appeared to be stronger with EQ-5D compared to Barthel. EQ-5D appeared to also predict the impact of MS on loss of productivity (in terms of work limitation; p<.05).

CONCLUSIONS:

PROMs can be used to predict the economic consequences of MS on healthcare providers and society, but more research is needed to confirm the robustness of the evidence and its validity across individual healthcare system settings.
PP006 Ebola In The Netherlands: Costs Of Preparedness And Response
Authors: Suijkerbuijk Anita , Swaan Corien , Mangen Marie-Josee J. , Polder Johan , Timen Aura , Ruijs Helma
Published: January 2018

INTRODUCTION:

Between December 2013 and April 2016, an unprecedented epidemic of Ebola Virus Disease (EVD) took place. This epidemic urged countries all over the world to be prepared for the possibility of having an EVD patient (1). Besides morbidity and mortality of the disease, containment efforts also have economic consequences for society. In this study, costs of preparedness for and response to EVD made by the Dutch health system were estimated.

METHODS:

We used an activity-based costing method in which cost of personnel time targeted at preparedness, and response activities was based on a time recording system and interviews with key professionals of the organizations involved. In addition, patient days of hospitalizations, laboratory tests, personal protective equipment (PPE), as well as costs for additional cleaning and disinfection were acquired via the organizations. All costs are expressed at the 2015-euro price level.

RESULTS:

The estimated total costs of EVD preparedness and response in the Netherlands were averaged at EUR14.1 million, ranging from EUR7.6 to EUR24.9 million. There were thirteen possible cases clinically evaluated and one confirmed case, admitted through an international evacuation request, corresponding to approximately EUR1 million per case (2). Preparedness activities of personnel, especially of all ambulance care services and hospitals that could possibly receive a case, and expenditures on PPE, were the main cost drivers.

CONCLUSIONS:

The estimated total cost of EVD preparedness and response in the Netherlands was substantial. Costs made by healthcare organizations were higher than among public health organizations (3). Designating one ambulance care service and fewer hospitals for the assessment of possible patients with viral hemorrhagic fever or other highly infectious disease of high consequence might improve efficiency and reduce future costs. The experiences and collaboration of healthcare organizations that managed patients with possible EVD can serve as a valuable resource for future outbreaks of other highly infectious diseases.
PP009 Quality Assessment In A Clinical Setting: A Look Upstream From Health Technology Assessment
Authors: Fattal Julie , Goyer Caroline
Published: January 2018

INTRODUCTION:

Health Technology Assessment (HTA) has various areas of application, one of which is quality improvement activities in clinical settings. Using patients' satisfaction as indicator of quality of care can inform the ‘needs assessment’ of a clinical deparment.

The principal aim of this study is to quantify patients’ satisfaction with the anesthesia services received perioperatively at our hospital, including physical discomfort and anesthesia care. To this end, we asked the following question: “In adult patients who undergo day surgery at our hospital, what is the level of satisfaction with the anesthesia services received perioperatively?" A second aim is to discuss how quality assessment and HTA can intertwine.

METHODS:

This is a quality assessment study, using a patient self-administered survey method.

We included all patients who had a day-surgery at our hospital and we excluded those who cannot understand English or French, who present cognitive barriers, and those who were admitted the same day.

Patients were recruited postoperatively in phase II of recovery, using a nonprobability convenience sampling method. We used a validated questionnaire which addresses the two dimensions of anesthesia care related our research question: (i) physical discomfort and (ii) satisfaction with anesthesia care. We added to this questionnaire, a supplemental question to measure satisfaction with preoperative anesthetic care. Parallel to this, we also gathered the data routinely collected by the recovery nurses during a 24 hour postoperative patient follow-up.

RESULTS:

We collected data from November 2015 to February 2016. A total of 156 questionnaires was completed. Two respondents (1.3 percent) said they were ‘unsatisfied’ or ‘very unsatisfied’ with the anesthesia care they received in general and thirty-six (23 percent) said they were ‘satisfied’. The most frequently reported physical discomfort symptoms were: thirst (78 percent), pain (72 percent), drowsiness (68 percent), cold (58 percent), and sore throat (54 percent).

CONCLUSIONS:

Our study suggests that, while reporting patients' level of satisfaction regarding various aspects of the anesthesia care they received, such quality assessment study can identify gaps in the use of existing methods and technologies and help in acquisition prioritizing.