bluuebunny/crossref_metadata_2025 huggingface dataset:
PP03 Development Of A Medical Device Maintenance Management System
Authors: Rivas Ronald Alexis , Grossling Benicio , Galvan Pedro
Published: December 2019

Introduction

Health technologies are fundamental in an operational health system. Medical devices, in particular, are crucial for disease prevention, diagnosis, treatment and rehabilitation. Recognizing this important role of health technologies, the World Health Assembly adopted, in May 2007, resolution WHA60.29, which addresses issues arising from inadequate installation and use of health technologies, as well as the need to formulate national strategies for the implementation of evaluation, planning, procurement and management systems for health technologies, in collaboration with personnel dedicated to the evaluation of health technologies and biomedical engineering. Maintenance management computer systems and software have evolved to help maintain medical equipment and control associated costs. A Computerized Maintenance Management System contains a database about an organization's maintenance operations.

Methods

The pilot study of observational and descriptive design will include all the medical/laboratory equipment that the Research Institute of Health Sciences (IICS) has that meets the inclusion criteria. The work will be carried out at the IICS, which aims to develop a computerized system for the maintenance of equipment that allows the linking of Quick Response (QR) codes to an application (WebApp) by means of cameras in smartphones, able to relate each QR code (attached to a medical/laboratory equipment) to its corresponding URL, and thus able to access all the technical information of each IICS team and therefore monitor their maintenance (preventive, corrective, predictive), history, spare parts, budgets, and technical specifications.

Results

We have a database of all medical devices installed in the research center; we look forward to developing the program to include the data. The project focuses on the effective tool for decision making regarding the evaluation of the installed sanitary technology and those that will be installed.

Conclusions

The study proposes an effective solution for maintenance management, using data that supports administrative decisions regarding the acquisition of equipment in the future; that is, the system can contribute when it comes to evaluating installed and acquired sanitary technology.
PP09 Cost-Effectiveness Of Chronic Obstructive Pulmonary Disease Management
Authors: Plunkett Thomas , Carty Paul , O'Neill Michelle , Harrington Patricia , Smith Susan M , Ryan Mairin
Published: December 2019

Introduction

To inform the development of a national clinical guideline for Chronic Obstructive Pulmonary Disease (COPD), prioritized by the National Clinical Effectiveness Committee in Ireland, a systematic review was conducted to examine the cost-effectiveness of pulmonary rehabilitation programs (PRPs), outreach programs (OPs), and long-term oxygen therapy (LTOT), compared with usual care.

Methods

Medline, Embase, the Cochrane Library and grey literature sources were searched up to 19 June 2018. Studies evaluating cost-effectiveness published post-2008 in English were included. Screening, data extraction, and quality assessment using the Consensus Health Economic Criteria and International Society for Pharmacoeconomics questionnaires were conducted independently by two reviewers. Costs were converted to 2017 Irish Euro using consumer price indices for health and purchasing power parity.

Results

From 8,661 articles identified, seven studies (one comparing both PRPs and LTOT) were included (PRPs: five; OPs: one; LTOT: two). PRP cost-utility analyses (n = 4) reported conflicting results due to considerable heterogeneity in program and study design, with incremental cost-effectiveness ratios (ICERs) ranging between EUR 12,391 and EUR 509,122 per quality adjusted life-year (QALY) gained. The remaining study investigated hospitalizations avoided and found outpatient and community-based PRPs to be dominant, while home-based PRP produced an ICER of EUR 1,913. OPs were found to be less costly, but also less effective. However, the results of the underpinning trial were neither statistically nor clinically significant. LTOT was found to be cost-effective, with ICERs of EUR 17,603 and EUR 26,936 per QALY gained.

Conclusions

Applying a willingness-to-pay threshold of EUR 45,000 per QALY gained, this systematic review found that, compared with usual care, there is inconsistent but generally favorable evidence for PRPs, no clear evidence for the cost-effectiveness of OPs, and that LTOT is likely to be cost-effective. However, there was a lack of methodologically robust studies included in the review and most were not directly transferable to the Irish context.
PP32 Joint Early Dialogs Between Medical Device Regulation and Health Technology Assessment
Authors: Schnell-Inderst Petra , Wild Claudia
Published: December 2019

Introduction

In Europe, the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) that entered into force 2017 will have to be applied until 2020 and 2022, respectively. Under the old regulation, there was a large gap between evidence requirements for market approval and market access for high risk (class IIb and III) medical devices (MD). The MDR/IVDR will require appropriate clinical investigations for these MD classes. Despite the different purpose of market approval and surveillance and reimbursement decisions, there are possible synergies with regard to evidence generation, for example, design of pivotal trials and post-launch evidence generation with observational data. In the MDR, early scientific advice can be provided by expert panels of the European Commission if requested by MD developers. For medicinal products, the European network for Health Technology Assessment (EUnetHTA) has established joint early dialogs (JED) of HTA agencies with the European Medicines Agency and manufacturers. A similar approach might be possible with the Medical Device Coordination Group (MDCG). The objective was to explore possible synergies for JED with the MDCG and EUnetHTA.

Methods

In 2018, EUnetHTA established a task force for HTA and MDR/IVDR. A workshop, which will explore possible synergies and activities on JED as well as the viewpoints of stakeholders will be held in May 2019. Participants will be Directorate-Generals GROW (Internal Market, Industry, Entrepreneurship and SME) and SANTE (Health and Food Safety), EUnetHTA members assessing MD, representatives of national competent authorities, Team Notified Bodies, MedTech Europe, patient representatives and academia.

Results

A report on the presentations, the results of the discussion, and next steps in a possible collaboration will be presented.

Conclusions

Joint early scientific advice to manufacturers on the European level for evidence generation by HTA agencies and the MDCG has the potential to streamline evidence generation in the life cycle of high risk MD.
PP62 Cost-Effectiveness Of Cervical Cancer Screening In Estonia
Authors: Võrno Triin , Laisaar Kaja-Triin , Raud Terje , Jõers Kai , Meigas-Tohver Doris , Kiivet Raul-Allan , Lutsar Katrin
Published: December 2019

Introduction

In Estonia, organized cervical cancer screening program is targeted at women aged 30–55(59) years and Pap-tests are taken every five years. Since cervical cancer is associated with human papillomavirus (HPV), a number of countries have introduced the HPV-test as the primary method of screening. The objective of this study was to evaluate the cost-effectiveness of organized cervical cancer screening program in Estonia by comparing HPV- and Pap-test based strategies.

Methods

For the cost-effectiveness analysis, a Markov cohort model was developed. The model was used to estimate costs and quality-adjusted life-years (QALYs) of eight screening strategies, varying the primary screening test and triage scenarios, upper age limit of screening, and testing interval. Incremental cost-effectiveness ratios (ICERs) were calculated in comparison to current screening practice as well as to the next best option. Sensitivity analysis was performed by varying one or more similar parameter(s) at a time, while holding others at their base case value. The analysis was performed from the healthcare payer perspective adopting a five percent annual discount rate for both costs and utilities.

Results

In the base-case scenario, ICER for HPV-test based strategies in comparison to the current screening practice was estimated at EUR 8,596–9,786 per QALY. For alternative Pap-test based strategies ICER was estimated at EUR 2,332–2,425 per QALY. In comparison to the next best option, HPV-test based strategies were dominated by Pap-test based strategies. At the cost-effectiveness threshold of EUR 10,000 per QALY Pap-testing every three years would be the cost-effective strategy for women participating in the screening program from age 30 to 63 (ICER being EUR 3,112 per QALY).

Conclusions

Decreasing Pap-test based screening interval or changing to HPV-test based screening can both improve the effectiveness of cervical cancer screening program in Estonia, but based on the current cost-effectiveness study Pap-test based screening every three years should be preferred.
PP64 Economic Evaluation For Esophageal Cancer Screening In China
Authors: Li Yuanyuan , Du Lingbin , Hu Xiaoqian , Gu Shuyan , Zhen Xuemei , Gu Yuxuan , Dong Hengjin
Published: December 2019

Introduction

The aim of the study was to estimate the cost-effectiveness of esophageal cancer (EC) screening compared to non-screening in China.

Methods

A Markov model was conducted that followed the history of EC. Screening strategies targeted a population aged 40-69 years, classified into six age groups. Each age group had three cohorts: screening without follow-up, screening with yearly follow-up for low-grade intraepithelial neoplasia (LGIN), and non-screening. Life years (LYs) and quality-adjusted life years (QALYs) presented the effectiveness and utility. The incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR) were evaluating indicators. Eighteen cohorts from 100,000 hypothetical individuals were used to run the model, until aged 79 years or death. Costs were changed into USD using the purchasing power parity of 3.506 in 2017. The willingness-to-pay was set as three times the gross domestic product per capita (USD 51,340.6) in 2017. A sensitivity analysis was introduced to assess model robustness.

Results

Screening with follow-up compared to non-screening, ages 40-44, 45-49, and 50-54 years, showed cost-effectiveness, with one LY gained costing USD 6,875.0, USD 9,204.6, and USD 25,278.6, respectively. Ages 40-44 and 45-49 years explained cost-utility, with ICURs of USD 6,709.4/QALY and USD 13,991.4/QALY, respectively. Screening without follow-up compared to non-screening, ages 40-54 years, addressed cost-effectiveness, with one LY gained costing USD 6,934.8, USD 9,760.0, and USD 35,126.0 in ages 40-44, 45-49, and 50-54 years, respectively; the 40-44 years age group demonstrated cost-utility with an ICUR of USD 8,512.3/QALY. Screening with follow-up compared to screening without follow-up, all ages, explained cost-effectiveness and cost-utility. The probabilistic sensitivity analysis supported the outcome of the base cohort analysis.

Conclusions

Compared to non-screening, screening with follow-up targeting ages 40-54 years was highly recommended with the ICER as the evaluated indicator, whereas it targeting ages 40-49 years was suggested with the ICUR as indicator.
PP69 Potential Gains In Health-Adjusted Life Expectancy From Reducing Four Non-Communicable Diseases Among Chinese Elderly
Authors: Gu Shuyan , Zhen Xuemei , Sun Xueshan , Gu Yuxuan , Dong Hengjin , Hu Xiaoqian
Published: December 2019

Introduction

With the fast speed of aging, burden from non-communicable diseases (NCDs) is increasing in China, and will continue to increase to 2020 and beyond. This study aims to estimate the potential gains in health-adjusted life expectancy (HALE) after hypothetical elimination of four NCDs among Chinese elderly from 1990 to 2016, including cardiovascular diseases (CVD), cancers, chronic respiratory diseases (CRD) and diabetes mellitus (DM).

Methods

Based on data from Global Burden of Disease 2016, we generated life table by gender using Sullivan method to calculate HALE. Disease-deleted method was used to calculate cause-elimination HALE, after hypothetical elimination of specific diseases. This method could combine the impact of mortality and morbidity, which are particularly useful for estimating the impact of the disease and setting priorities for health planning to get ready for the new challenges in upcoming decade.

Results

From 1990 to 2016, HALE increased for all age groups. After hypothetically eliminating the four main NCDs, potential gain in HALE by CVD, DM and cancers increased, while CRD decreased from 1990 to 2016 for both genders. Among four main NCDs, potential gain in HALE after eliminating CVD was largest and increased most for both genders. Although elimination of DM led to the smallest gain in HALE, the increasing speed of gain in HALE by DM was faster than that by CVD and cancers from 1990 to 2016.

Conclusions

This study highlights the potential gains in HALE of NCDs among Chinese elderly from 1990 to 2016. HALE of Chinese elderly could further increase from the reduction of NCDs. Control measures and targeted prevention should be carried out to get ready for the new decade.
PP98 Educating Medical Students Toward Quality-Targeted Leadership
Authors: Tal Orna , Tal Inbal
Published: December 2019

Introduction

Classic health technology assessment (HTA) is based on safety, efficacy, and costs. However, in the dynamic world of medicine, “real-world” experience is used to improve HTA. Aggregating evidence is a constant challenge. Physicians are traditionally trained in professionalism (knowledge and skills) and compassion, concentrating on the patient and disease rather than the technology. Currently, medical education also emphasizes quality of care by promoting standardization, and reducing mistakes by root cause analysis. We aimed to integrate the key parameters of safety, effectiveness, quality measures, economic aspects, and assessment guidelines for real-world experience in medical education.

Methods

A group of medical students participated in a targeted HTA-orientated education program, which focused on the identification of challenges and barriers in the adoption of health technologies, and then completed a structured survey.

Results

The program included 243 students. They raised four major emerging challenges: (i) to initiate a culture of quality and HTA-targeted perception for individual physicians; (ii) to better understand the role of different stakeholders in the health system; (iii) to be exposed to considerations of budget allocation; and (iv) to incorporate patient preferences, expectations, and engagement so that patient-centered care becomes a critical part of HTA.

Conclusions

Incorporating values of HTA-targeted quality at an early stage of medical education, while future physicians are developing their professional identity, may create a professional, quality-focused leadership group in health care. The understanding and implementation of these “new” dimensions may serve as a platform for building smart capability to ensure better decision making processes among caregivers and medical managers.
PP99 Hospital-Based Health Technology Assessment Units In Brazil: Present And Future
Authors: Cohen Mírian , Lima Ana Flávia , Miguel Sandro , Aziz Marina , Cardoso Ricardo Bertoglio , Cruz Luciane
Published: December 2019

Introduction

Since 2007, 23 Núcleos de Avaliação de Tecnologias em Saúde or hospital-based health technology assessment (HB-HTA) units have been established in teaching hospitals across Brazil. These units aim to promote the development of health technology assessment in hospitals, assisting the decision-making process for implementing new technologies and evaluating and promoting the rational use of widespread technologies.

Methods

An online questionnaire was sent by e-mail to all HB-HTA units registered in the Brazilian Network for Evaluation of Health Technologies. Information was acquired to comprehensively assess the activity of the units.

Results

All 23 HB-HTA units answered the questionnaire. Of these, 65 percent had a technology prioritization process. The technologies assessed included drug therapies (73%), equipment (64%), medical devices (64%), clinical protocols (46%), and emerging technologies (27%). The dimensions of health technology assessment (HTA) evaluated by these organizations were: efficacy (76%); effectiveness (67%); safety (67%); costs (52%); cost effectiveness or cost utility (52%); and budget impact (43%). The hospital departments that required more HTA studies were: cardiology (50%); infectious diseases (45%); hospital management (45%); oncology (40%); surgery (40%); and endocrinology (20%). HTA studies supported: incorporation of new technologies (81%); protocol or guideline development (57%); new indications for already approved technologies (38%); and withdrawal of obsolete technologies (29%). Half of the institutions also conducted educational or training activities. The main difficulties reported were a lack of trained professionals (78%), funding (70%), and material resources (48%).

Conclusions

For low- and middle-income countries, the process of implementing HB-HTA units remains a challenge. Even though human resources and funding are scarce, HB-HTA units continue to develop. Given their importance in the decision-making process, it is imperative that every effort is made to ensure their activities continue.
PP103 A Comparative Study Of Catastrophic Health Expenditure In China
Authors: Zhen Xuemei , Zhang Hao , Hu Xiaoqian , Gu Shuyan , Li Yuanyuan , Gu Yuxuan , Huang Minzhuo , Sun Xueshan , Wei Jingming , Dong Hengjin
Published: December 2019

Introduction

China has made great achievements in health insurance coverage and healthcare financing. Nonetheless, the rate of catastrophic health expenditure (CHE) in China was 13 percent in 2008, which is higher than in some other countries. There are differences among the provinces in China in terms of the lifestyles, customs, prevalent medical conditions, and health consciousness of their populations. This study aimed to compare the proportion of households with CHE and the factors influencing this expenditure between the Zhejiang and Qinghai province in China.

Methods

Data were derived from household surveys conducted in Zhejiang and Qinghai. Sampling was based on a multi-stage, stratified random cluster method. Households with CHE were defined as those with an out-of-pocket payment for health care that was at least 40 percent of the household income. Univariate and multivariate logistic regression analyses were used to identify the factors associated with CHE.

Results

A total of 1,598 households were included: 995 in Zhejiang and 603 in Qinghai. The average rates of CHE in Zhejiang and Qinghai were 10 percent and 31 percent, respectively. The economic status of a household influenced the likelihood of experiencing CHE; households headed by an employed person were less likely to experience CHE. In contrast, households that included outpatients or individuals with chronic diseases had a higher risk of experiencing CHE across the two provinces. Poorer or uninsured households in Zhejiang were more likely to experience CHE, as were households in Qinghai that included outpatients or were headed by a person from a minority nationality.

Conclusions

This study highlighted the importance of promoting economic development, expanding employment, and adjusting policies to better protect individuals with chronic diseases and outpatients from the risk of CHE. The Chinese government should pay more attention to actual conditions in different provinces to ensure that policy decisions incorporate local knowledge.
PP133 Ensuring Secure Health Data Exchange Across Europe. The SHIELD Project
Authors: López-Moreno Borja , Martín-Barrios David , Revuelta-Antizar Ivan , Rodríguez-Tejedor Santiago , del Valle Ortega Mariluz , Arana-Arri Eunate
Published: December 2019

Introduction

Data exchange protection is one of the main challenges in e-health. Nowadays, many people move from one country to another for various reasons, even though they may have chronic diseases or multiple pathologies. The main objective of the SHIELD project is to create an open and extendable security architecture, with supported privacy mechanisms that citizens can trust, to provide systematic protection for the storage and exchange of health data across European borders.

Methods

epSOS is a European project that deals with the security and interoperability of e-health data, and has developed an Open National Contact Point (OpenNCP) architecture. For the initial validation of the framework, two OpenNCP virtual nodes were used to simulate the real nodes between Italy and Spain. For secure data exchange, different prototype tools were designed: end-to-end user interfaces (profiles for administrative staff, nurses, physicians, etc.); sensitivity and data hiding tools; consent management tools; report translation tools; and mobile device tampering detection tools.

Results

Validation scenarios (realistic use cases) were developed in Italy, Spain, and the United Kingdom. The first scenario was an Italian citizen traveling to Spain who has an acute emergency episode (e.g. stroke) and loses consciousness. The Spanish emergency department physician assisting the patient checks the patient's health record. The first round of SHIELD framework validations was successfully completed, and the results were presented to the European Commission.

Conclusions

Security challenges need to be addressed when assessing e-health solutions. The challenges include issues with interoperability, confidentiality, availability, integrity, privacy, ethics, regulations, and e-health data. In addition, decisions must be made as to which data will be shared and how. The results of the initial validations provide a basis for the in-depth requirements analysis and for setting the main pillars of the SHIELD architecture design.
PP166 A Mobile Clinical Decision Support System for Autism Spectrum Disorder
Authors: Robles Noemí , Carrion i Ribas Carme , Pàmias Montserrat , Parra Isabel , Conesa Jordi , Perez-Navarro Antoni , Alabert Marc , Aymerich Marta
Published: December 2019

Introduction

eHealth is a new approach for managing several health conditions, but up to now not so many interventions have shown their efficacy/effectiveness. The AUTAPP Project tries to add knowledge in eHealth interventions targeted to Mental Health disorders, specifically Autism Spectrum Disorder (ASD) management that requires complex interventions that integrate different psychosocial interventions. AUTAPP aims to develop an evidence based Clinical Decision Support System (CDSS) using mobile technology for improving the decision process on psychosocial therapies in ASD. This study aimed to identify recommendations on which the algorithm of the CDSS will be developed.

Methods

A systematic review (November 2009-November 2018) was carried out to identify the existing scientific evidence published in relation to the effectiveness of: (i) early detection protocols; (ii) assessment tools; (iii) existing non-pharmacological therapies. Main databases were consulted (PubMed, Cochrane Library, PsychoInfo). Articles were reviewed by two independent reviewers. The quality of included publications and recommendations were assessed according to SIGN criteria.

Results

A total number of 147 publications were included (477 identified): 96 for non-pharmacological therapies, 33 for assessment tools and eighteen for early detection. Regarding early detection and assessment, 12 recommendations were identified and six obtained the highest level (A), such as the convenience of multidisciplinary diagnosis teams and the usefulness of the Modified Checklist for Autism in Toddlers (M-CHAT) for ASD confirmation. For non-pharmacological therapies, 16 recommendations were collected. Those with higher levels of recommendations were family, environmental and educational (three As and one B). Interventions with lower levels of recommendation (C) were interventions which exercise, computers and neurological approaches.

Conclusions

This systematic review allows both to identify gaps and opportunities in psychosocial interventions research and be the base for the CDSS algorithm. In the future professionals, careers and people diagnosed with ASD will validate the mobile CDSS.
PP182 Natalizumab Therapy For Relapsing-Remitting Multiple Sclerosis
Authors: Fuchs Eva
Published: December 2019

Introduction

Multiple Sclerosis is a progressive, degenerating disease of the central nervous system (CNS), which affects more than 2.5 million people worldwide. The monoclonal antibody natalizumab (TysabriTM) has been approved by the European Medicines Agency in 2006. Yet, the treatment is associated with an increased risk of developing progressive multifocal encephalopathy (PML). The aim of the systematic review was to investigate whether natalizumab is more effective and safer than alternative pharmacological therapies or placebo over a prolonged period (≥ 36 months) with respect to annualised relapse rate (ARR), disability progression, quality of life and number of serious adverse events (SAEs).

Methods

A systematic literature search was conducted considering randomized controlled trials (no restriction in length) and prospective, non-randomized controlled trials. In terms of safety, prospective single arm studies were additionally included. The risk of bias (RoB) was assessed using the Cochrane RoB tool (RCT), the ROBINS-I tool (NRCT) and the Institute of Health Economics quality appraisal checklist (IHE-20) for case series (single-arm studies). The quality of evidence was determined using the GRADE-method (Grading of Recommendations, Assessment, Development and Evaluation).

Results

For the assessment of clinical effectiveness, three studies (one RCT and two NRCTs) met the inclusion criteria. No significant differences regarding the ARR and disability progression were detected, if natalizumab was compared to an alternative treatment with fingolimod. Yet, if compared to placebo or a group of natalizumab interrupters, a 70 percent reduction in the ARR was observed. For the assessment of safety, seven studies met the inclusion criteria. The proportion of patients suffering from SAEs ranged from 2.4 percent to 16.0 percent. In total, 35 cases of PML occurred. The results were supported by a very low quality of evidence.

Conclusions

Future research should provide more head-to-head RCTs comparing natalizumab with other disease modulating drugs along with a comprehensive documentation of adverse events.
PP238 Budget Impact Of Methionine-Free Amino Acid Formula For Homocystinuria
Authors: Mulinari Eduardo , Brito Nayara Castelano , Marra Lays Pires
Published: December 2019

Introduction

The National Committee for Health Technology Incorporation (CONITEC) evaluates health technologies to recommend their inclusion or exclusion within the Brazilian Public Health System (SUS), and uses the budget impact assessment to estimate costs to the system. This study estimated the budget impact of the supply of methionine-free amino acid formula (MFAAf) for patients with classical homocystinuria (HCU) in the SUS.

Methods

The incidence of one case per 250,000 live births in Brazil and the registration of a Brazilian association of patients with HCU was assumed to calculate the population. Mortality and responsiveness to pyridoxine rates were applied. The costs of treatment were estimated according to the recommended dosage in literature and public purchasing prices. For calculating the dose of MFAAf patients, a median age of 19 years and weight of 60 kg were assumed, according to Brazilian study data.

Results

The annual cost of treatment was estimated at BRL 77,000 (USD 21,084) per patient. The incorporation of MFAAf for HCU would generate a budget impact in SUS of around BRL 37 million (USD 10.1 million) in 2019 and BRL 188 million (USD 51.5 million) after five years which considers the epidemiological data, and a budget impact of around BRL 6.4 million (USD 1.75 million) in 2019 and BRL 33 million (USD 9 million) after five years which considers the information of a Brazilian association of patients with HCU. The wide range of values in the incremental budgetary impact is due to the lack of information on the epidemiology of the disease in Brazil.

Conclusions

The incorporation of the MFAAf in the SUS represents an important budgetary impact and covers a small number of patients. CONITEC recommended the incorporation of the MFAAf in the SUS, according to clinical protocol.
VP07 Cost-Effectiveness Of HTA Fees
Authors: Wang George , Macaulay Richard
Published: December 2019

Introduction

Health technology assessment (HTA) bodies evaluate the clinical and/or economic impact of new therapies to inform public reimbursement decision-making. This research evaluates the value for money of current or proposed fees for HTA in countries with mandatory cost-effectiveness HTA bodies relative to their respective public drug expenditure.

Methods

HTA appraisal fees were identified from publicly-available websites: National Institute for Health and Care Excellence (NICE), Canadian Agency for Drugs and Technologies in Health (CADTH), Institut National d'Excellence en Santé et Services Sociaux (INESSS), and Pharmaceutical Benefits Advisory Committee (PBAC). Annual national public drug expenditure (ANPDE) were sourced from the National Health Service England, Canadian Institute for Health Information, and the Pharmaceutical Benefit Scheme.

Results

NICE is proposing to charge GBP 126,000 (EUR 142,582) for a single technology or highly specialized technology appraisal, CADTH charges CAD 72,480 (EUR 48,576) for a Schedule A submission, INESSS charges CAD 38,921 (EUR 26,089) for the first evaluation of a new drug or new indication, and PBAC charges AUD 136,716 (EUR 87,576) for a Major Lodgment. The ANPDE in England: GBP 16 billion (EUR 18.1 billion), Canada: CAD 14.5 billion (EUR 9.7 billion), Quebec: CAD 4 billion (EUR 2.7 billion) and Australia: AUD 8.7 billion (EUR 5.6 billion). The appraisal cost to drug expenditure ratio for these countries/regions were: 126,984, 200,055, 102,772, and 63,636, respectively.

Conclusions

HTA submissions in the United Kingdom, Canada and Australia require financial contributions from manufacturers. These contributions bear little relation to the market size and cumulatively exceed EUR 300,000 (assuming no resubmissions). By adopting charging/cost recovery models, HTA bodies are aiming to reinvest the proceeds to increase the efficiency and capacity of appraisals, expediting patient access. However, these fees may be burdensome, especially for SMEs with promising therapies for orphan/rare diseases, and they may thus have the potential to deter/delay their submissions.
VP19 Cost-Effectiveness Of Combination Inhaled Long-Acting Bronchodilators
Authors: Plunkett Thomas , Carty Paul , O'Neill Michelle , Harrington Patricia , Smith Susan M , Ryan Mairin
Published: December 2019

Introduction

To inform the development of a national clinical guideline for Chronic Obstructive Pulmonary Disease (COPD), prioritised by the National Clinical Effectiveness Committee (NCEC) in Ireland, a systematic review was conducted to examine the cost-effectiveness of long-acting beta2-agonists (LABAs) in combination with long-acting muscarinic antagonists (LAMAs) compared with LAMA or LABA monotherapy.

Methods

Medline, Embase, the Cochrane Library and grey literature sources were searched up to 19 June 2018. Studies evaluating cost-effectiveness published post-2008 in English were included. Screening, data extraction, and quality assessment using the Consensus Health Economic Criteria (CHEC-list) and International Society for Pharmacoeconomics (ISPOR) questionnaires were conducted independently by two reviewers. Costs were adjusted to 2017 Irish Euro using consumer price indices and purchasing power parity as per national guidelines.

Results

From a total of 8,661 articles identified, nine studies (all cost-utility analyses) were included in the review. Studies ranged from low to high quality and compared LAMA/LABA combination therapy with LAMA monotherapy. The results reported were mixed, ranging from combination therapy being dominated by (that is, more costly and less effective than) LAMA monotherapy to being dominant (that is, less costly and more effective). However, when excluding low quality, less applicable studies, the remaining six studies reported incremental cost-effectiveness ratios (ICERs) of between EUR 2,770 and EUR 26,462 per quality-adjusted life year (QALY) gained. Only one study additionally compared LABA monotherapy as a comparator, reporting combination therapy to be even more cost-effective than in the LAMA monotherapy comparison.

Conclusions

Applying a cost-effectiveness willingness-to-pay threshold of EUR 45,000 per QALY gained, this systematic review found that LAMA/LABA combination therapy is cost-effective compared with LAMA or LABA monotherapy in COPD patients.
VP29 Designing A Mobile Clinical Decision Support System For Dementia
Authors: Robles Noemí , Carrion i Ribas Carme , Aymerich Marta
Published: December 2019

Introduction

E-health offers the opportunity of supporting the management of several diseases, but most of these tools are far from being based on scientific evidence and demonstrating their effectiveness and efficacy. The PSICODEM Project aims to develop a mobile personalized clinical decision support system (CDSS) based on evidence for contributing to e-health interventions addressed to the management of dementia that require not only a pharmacological approach but also psychosocial interventions for improving patients’ quality of life and reducing emotional, cognitive and behavioral symptoms. The present communication focuses on the identification of the evidence on which the CDSS algorithm will be developed.

Methods

Three systematic reviews were carried out in order to identify the existing scientific evidence published in relation to the effectiveness of behavioral, emotional and cognitive therapies addressing dementia (January 2009 to December 2017). The main databases were consulted (PubMed, Cochrane Library, PsychoInfo) and only randomized control trials (RCT) were considered. Articles were reviewed by two independent reviewers. The quality of the selected publications was assessed according to the SIGN criteria.

Results

Forty-seven RCTs were selected for cognitive therapies, thirty-two for emotional ones and fifteen for behavioral interventions. Those therapies with more support of evidence were skills training for cognitive therapies and reminiscence interventions for emotional interventions; however, in behavioral interventions a variety of therapeutically approaches were found. Wide differences were found between studies in terms of types and levels of dementia, forms of intervention (number, length and frequency of sessions) and outcome measures.

Conclusions

In-depth analysis of evidence will allow the identification of those interventions more appropriate for each patient according to their symptoms and level of dementia. According to this evidence, the mobile CDSS algorithm will be developed. Additionally, these findings point out the gaps in psychosocial intervention research.
VP30 Evaluation Of CINAHL In Six Systematic Reviews On Maternal Care
Authors: Overesch Inga , Sow Dorothea , Hausner Elke , Peterwerth Nina
Published: December 2019

Introduction

Information retrieval for systematic reviews (SRs) should include sensitive searches in several bibliographic databases. In addition to standard databases (i.e., MEDLINE, Embase and CENTRAL), researchers might consider subject-specific ones. In the fields of nursing and midwifery, a SR would typically include CINAHL as a subject-specific database. The aim of this study was to analyze the number and relevance of references retrieved from CINAHL in six SRs on maternal care.

Methods

We conducted a retrospective analysis of six SRs (e.g., benefit of intrapartum ultrasound or one-to-one care during labor). The study type was limited to randomized controlled trials (RCTs) in all but three SRs. In all cases, MEDLINE, Embase, CENTRAL and CINAHL were searched for primary studies. Further information sources (e.g., study registries and reference lists of SRs) were also considered. The proportion of the additional number of hits and studies included from CINAHL as well as the corresponding number of participants were calculated.

Results

Overall, the reviewers screened 12,013 references from bibliographic databases and identified forty relevant studies. CINAHL contained 2,643 (22 percent) of the references. In five out of six SRs, no additional studies were identified in CINAHL. In the remaining SR on birthing positions, the reviewers included thirteen RCTs of which one was a feasibility study with 68 participants indexed only in CINAHL. This corresponds to 0.9 percent of the women participating in all thirteen RCTs (n = 7,861). However, this study was cited in a journal article on a subsequent RCT that was identified and included via MEDLINE and ClinicalTrials.gov.

Conclusions

It is not necessary to search CINAHL in SRs on maternal care if standard databases and further information sources are considered. An additional study from CINAHL was included in one out of six SRs, a small feasibility study that could have been identified without CINAHL via a subsequent RCT.
VP41 NICE Interventional Procedures Advisory Committee Recommendations
Authors: Carroll Christopher , Dickson Rumona , Boland Angela , Houten Rachel , Walton Matthew
Published: December 2019

Introduction

This study explores the factors (principally evidential) that predict guidance recommendations by this NICE committee. There are three main types of recommendations: Standard/normal arrangements (can be done without restriction in the NHS); Special arrangements (can be done under certain conditions); and Research only.

Methods

The following data were extracted from all published pieces of Interventional Procedure Guidance (IPGs) produced by this committee: year, IPG number, recommendations, evidence base (numbers and types of included studies, numbers of included patients etc.). All data were extracted independently by two researchers, and any disagreements clarified by consensus. Data were tabulated and descriptive statistics produced. Regression analyses will be performed using these data to identify any statistically significant predictors of recommendations.

Results

IPG recommendations (n = 496); year range: 2003-2018. Proportion of IPGs by each recommendation: 50% Standard; 38% Special; 11% Research Only; 2% Do Not Do. Proportion of IPGs with highest level evidence (i.e. systematic review and/or RCT) by recommendation type: Standard = 64% (152/239); Special = 43% (77/180); Research Only = 48% (26/54); Do Not Do = 75% (6/8). Mean numbers of patients by recommendation type: Standard = 7,838; Special = 3,935; Research Only = 2,423. There is also a clear trend over time: Standard recommendations decrease for all IPGs from 63% in 2003-2009 to 40% in 2014-2018; and the evidence threshold for Standard recommendations increases over time from 56% based on systematic reviews and/or RCTs in 2003-2009 to 85% in 2014-2018; mean numbers of patients per Standard recommendation also increase from 2,002 to 6,098 over this period.

Conclusions

Higher levels evidence and numbers of patients increase the likelihood of the most positive recommendation. However, this evidence might still lack sufficient quality or certainty to answer a policy question. The evidence threshold to achieve a Standard recommendation has also increased markedly over time. As with other NICE committees, factors other than cost and perceived hierarchies of evidence clearly act as drivers of decisions.
VP59 The MedicineWise App: Extended Applications Beyond Medicine Management
Authors: Yu Kitty , Dartnell Jonathan
Published: December 2019

Introduction

The MedicineWise app is a free consumer health and medicine management app developed by NPS MedicineWise. With 107,000+ downloads and 78,000+ active sessions per month, the MedicineWise app's core functions include: keeping track current medicines lists, medicine dose reminders and recording health conditions, allergies, test results and other health information. Recent enhancements also enabled the app to deliver featured health- and medicine-related content to users based on their medicines and/or health conditions. The goal is to maximise the MedicineWise app's capabilities by personalizing to users’ needs and combining with health professional interventions when needed, to encourage better delivery of health and medicines information and improve medication adherence and health outcomes.

Methods

A number of personalized medicines management service offerings were created by combining a technology solution using the MedicineWise app (including the app's core functions as well as added targeted content delivery capability) with a humanistic solution (a health professional-mediated phone-based coaching service). MedicineWise app features were developed iteratively using a human-centred design approach. Consumers were involved in the design, prototyping and testing stages before the features moved to technical-build stage.

Results

Three use-cases will be presented to demonstrate how the MedicineWise app was used to provide personalized medicines management service offerings. These include: (1) curating relevant content and delivering push notifications to users for health conditions including asthma, rheumatoid arthritis and osteoporosis; (2) providing a triaged medication adherence support program with escalating levels of intervention for heart failure patients; and (3) collecting user-reported medication usage data and data monitoring by health professionals to provide support for heart failure patients.

Conclusions

The utility of MedicineWise app can be extended to provide personalized medicines management service offerings in the consumer health care space.
A Critique of the Decision in Conisbee that Vegetarianism Is Not ‘A Belief’
Authors: Cranmer Frank , Sandberg Russell
Published: December 2019

Mr G Conisbee v Crossley Farms Ltd & Ors [2019] ET 3335357/2018 was a preliminary hearing to determine whether or not vegetarianism was ‘capable of satisfying the requirement and definition of being a philosophical belief (protected characteristic) under the Equality Act 2010’. Employment Judge Postle held that vegetarianism did not amount to a philosophical belief, comparing it to veganism. The case is the latest in the confusing and contradictory case law on the meaning of the term ‘religion or belief’ under English law.
The Magnetic Structure of the Solar Wind: Ionic Composition and the Electron Strahl
Authors: Borovsky Joseph E.
Published: December 2019

To determine (1) whether there is an ion‐composition (helium abundance) structure of the solar wind plasma at 1 AU that corresponds to the magnetic structure of the solar wind and to determine (2) whether the changes in the intensity of the electron heat flux correspond to magnetic boundaries, times when the alpha‐to‐proton number density ratio clearly changes and times when the outward‐electron‐strahl intensity clearly changes are collected. Then whether those times correspond to the locations of strong current sheets (directional discontinuities and flux‐tube walls) in the solar wind was statistically determined. In both cases (ion composition and strahl), the changes correspond to current‐sheet crossings. This indicates that flux‐tube walls statistically correspond to boundaries in the ion composition and the heat‐flux intensity. The implications for a fossil‐flux‐tube picture of the magnetic structure and an MHD (magnetohydrodynamic) turbulence picture of the structure are discussed.
A Wave Model and Diffusion Coefficients for Plasmaspheric Hiss Parameterized by Plasmapause Location
Authors: Malaspina David M. , Zhu Hui , Drozdov Alexander Y.
Published: December 2019

The scattering of electrons via plasmaspheric hiss whistler‐mode plasma waves has profound consequences for the dynamics of electrons in the inner terrestrial magnetosphere, including the radiation belts. Consequently, simulations of inner magnetospheric electron dynamics incorporate hiss wave models, though these models are often parameterized by quantities convenient to describe particle populations (e.g., L shell). However, recent studies have revealed that the spatial distribution of plasmaspheric hiss wave power is only weakly dependent on L shell. Instead, it is dictated by the density structure of the plasmasphere (including radial extent and azimuthal structure). In this work, we create a plasmaspheric hiss wave model, and corresponding particle diffusion coefficients, parameterized by plasmapause location instead of L shell, in order to quantify the importance of including plasmapause organization of hiss waves for inner magnetosphere models. Noticeable differences in electron scattering lifetimes are found when comparing L shell parameterized hiss and plasmapause‐parameterized hiss wave models on the timescales of days for 1 MeV electrons. Comparison of the lifetimes calculated from diffusion around the loss cone also show differences between L shell‐ and plasmapause‐parameterized hiss models. This implies that plasmapause parameterization of hiss waves may be important for modeling specific geomagnetic events.
Composition, Diversity and Functional Analysis of the Modern Microbiome of the Middle Triassic Cava Superiore Beds (Monte San Giorgio, Switzerland)
Authors: Arif Sania , Reitner Joachim , Hoppert Michael
Published: December 2019

Organic-rich laminated shales and limestones from the Monte San Giorgio (Lugano Prealps, Switzerland) are known as famous fossil lagerstätten for excellently preserved fossils from the Middle Triassic Period. The various bituminous shales from Monte San Giorgio are thermally immature and rich in diverse organic compounds, which provide unique substrates for active soil microbial communities. We selected the Cava superior beds of the Acqua del Ghiffo site for this study. To investigate its microbial structure and diversity, contig assembly, Operational Taxonomic Units (OTUs) clustering, and rarefaction analysis were performed for bacterial 16S rDNA preparations from bituminous and non-bituminous limestone strata with the MetaAmp pipeline. Principal coordinates analysis shows that the microbial communities from the bituminous strata differ significantly from limestone samples (P < 0.05 Unifrac weighted). Moreover, metagenomic tools could also be used effectively to analyze the microbial communities shift during enrichment in specific growth media. In the nutrient-rich media, one or few taxa, mainly Proteobacteria and Firmicutes, were enriched which led to the drastic diversity loss while oligotrophic media could enrich many taxa simultaneously and sustain the richness and diversity of the inoculum. Piphillin, METAGENassist and MicrobiomeAnalyst pipeline also predicted that the Monte San Giorgio bituminous shales and oligotrophic enriched microbiomes degrade complex polycyclic aromatic hydrocarbons.