bluuebunny/crossref_metadata_2025_split huggingface dataset:
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

IntroductionChina 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.MethodsData 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.ResultsA 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.ConclusionsThis 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

IntroductionData 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.MethodsepSOS 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.ResultsValidation 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.ConclusionsSecurity 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

IntroductioneHealth 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.MethodsA 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.ResultsA 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.ConclusionsThis 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

IntroductionMultiple 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).MethodsA 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).ResultsFor 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.ConclusionsFuture 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

IntroductionThe 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.MethodsThe 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.ResultsThe 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.ConclusionsThe 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

IntroductionHealth 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.MethodsHTA 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.ResultsNICE 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.ConclusionsHTA 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

IntroductionTo 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.MethodsMedline, 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.ResultsFrom 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.ConclusionsApplying 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

IntroductionE-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.MethodsThree 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.ResultsForty-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.ConclusionsIn-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

IntroductionInformation 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.MethodsWe 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.ResultsOverall, 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.ConclusionsIt 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

IntroductionThis 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.MethodsThe 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.ResultsIPG 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.ConclusionsHigher 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.