bluuebunny/crossref_metadata_2025_split huggingface dataset:
PP090 Reducing Low-Value Practices In Catalonia: Essencial Project
Authors: Almazan Cari , Caro Johanna 
Published: January 2018

INTRODUCTION:In 2013 the Essencial Project launched in Catalonia promotes the identification of low-value practices (LVP) by healthcare professionals and elaborates recommendations to avoid them. This project aims to reduce unnecessary care of health care services which harm outweighs the benefits, resulting in physical, psychological to the patients and wasteful healthcare services. The main objectives are to describe the implementation process at the primary care level and to evaluate the impact of recommendations on general practitioners (GPs) practice.METHODS:The implementation process consists in:(i) Nomination of clinical leaders to promote the project among their primary care teams (PCT) and to lead the implementation activities by identification of barriers and enablers for change in clinical practice towards avoiding LVP.(ii) Selection of recommendations to be implemented and definition of corresponding activities to be carried out by each PCT according to the specific characteristics of their organizations.(iii) Development of related indicators and comparison between baseline statusRESULTS:One hundred and sixteen PCT (covering 30 percent of the Catalan population) participated in the pilot experience of implementation. Twenty-one recommendations were selected such as: bisphosphonates in post-menopausal women with low risk of fracture, PSA screening and statins for primary prevention of cardiovascular disease, among others. At 12 month follow-up, use of bisphosphonates were reduced by 21 percent (p = .0005), PSA was reduced by 14 percent (p = .0009). The use of other treatments such as antidepressants, benzodiazepines for some specific clinical conditions decreases with no statistically significant changes.CONCLUSIONS:This is the first experience in Catalonia and Spain of implementation of the recommendations to avoid LVP with early involvement of target professionals. Follow-up results provide information about the early impact of recommendations at primary care level. Our challenge is to implement the recommendations at hospital level.
PP115 Patient And Public Involvement In Health Technology Assessment: Update Of A Systematic Review
Authors: Tantchou Mylène , Gagnon Marie-Pierre , Poder Thomas 
Published: January 2018

INTRODUCTION:There is a general consensus on the need to involve patients and the public in Health Technology Assessment (HTA) but questions remain about the best strategies for involving them into HTA structures and activities. The aim of this study was to update a systematic review (published in 2011) on patient and public engagement in HTA.METHODS:We searched papers published between January 2009 (end of the initial search) and November 2016 in eight databases and HTA journals using specific search strategies. We identified other publications through citation tracking, Internet search engines, HTA agencies websites, and discussion with experts in the field. Studies in English or French were included if they met the following criteria: (i) qualitative, quantitative or mixed-methods study; (ii) describing patients or public involvement; and (iii) in the HTA field. We extracted information using a pre-established grid including: characteristics of studies, type of activities for involving patients or public, effects on decisions, and factors facilitating or limiting involvement.RESULTS:We identified a total of 4,762 new publications from the main search strategy. Among them, twenty-eight articles (reporting on twenty-three studies) met the inclusion criteria, whereas seventeen articles were included in the previous systematic review. Research designs are qualitative (18/23), quantitative (3/23) or mixed (2/23). Two main strategies for involving patients and public are generally described. The first is when public representatives participate directly in decision-making processes (participation) and the second is when patient or public input is sought to inform decisions (consultation or indirect participation).CONCLUSIONS:The number of studies on patient and public involvement in HTA has increased in recent years. Findings from this update are mainly consistent with those of the previous systematic review. However, studies are still needed to assess the effectiveness of different strategies for involving patients and the public in HTA.
PP120 Health Technology Assessment Framework To Capture The Full Value Of Value Added Medicines
Authors: Toumi Mondher , Remuzat Cecile , Plich Adam 
Published: January 2018

INTRODUCTION:Value added medicines (VAM) are medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients, healthcare professionals and/or payers through drug repositioning, drug reformulation or drug combination (1-3). Recently, the European Commission, through the Safe and Timely Access to Medicines for Patients (STAMP) program, considered the issue of VAM development and regulatory process. Current Health Technology Assessment (HTA) tools may not fully capture the benefits of VAM, which could lead to obstacles for patient access to VAM in several European countries (1). The study objective was to identify how HTA frameworks should evolve to reflect VAM value.METHODS:HTA expert interviews were performed as a preparatory step to an advisory board meeting. The following topics were addressed: (i) Eligibility for HTA and early HTA dialogues; (ii) Attributes that should be considered in HTA; (iii) HTA methodology; and (iv) Involvement of stakeholders in HTA.RESULTS:VAMs bring additional benefit to patients and society. Therefore, the possibility for VAM assessment on a voluntary basis and within the appropriate assessment patterns/tools should be, in principle, included into HTA frameworks, as well as into early HTA dialogues. HTA should be patient-centric, and attributes such as patient preference, adherence, and patient reported outcomes should be considered where relevant. Unmet patient needs and disease burden should be used in a transparent and reproducible deliberative process. All these attributes should be used as explicitly and meaningfully weighted appraisal modifiers. HTA methodology should be comprehensive and should integrate societal perspectives. Patient representatives should take part in the decision-making process.CONCLUSIONS:Current HTA frameworks should evolve to enhance VAM value recognition and encourage industry investment in medicines with high potential value for society.
PP126 MEA In Italy: Correlation Between Time To Payment By Result And Time To Off Treatment Curve
Authors: Vittoria Gabriele , Fascì Antonio , Ferrario Matteo , Giuliani Giovanni 
Published: January 2018

INTRODUCTION:Payment by result agreements have been quite widely used in Italy to provide access for high costs oncologic drugs and minimize uncertainties of real life benefits (1). The aim of this analysis was to overview the Roche experience in terms of Payment by Result (Pbr) in oncology and investigate the relation between timing for the evaluation of treatment failures and observed Time to Off Treatment (TTOT) from Phase III clinical trials (2).METHODS:A retrospective analysis of the Roche payment by results schemes in place in Italy was conducted. For each drug included in the analysis it was collected: (i) the negotiated timing to assess the treatment failure for payment by result, (ii) the median time to off treatment curve observed in clinical trials for the experimental drug, (iii) the median time to off treatment observed in clinical trials for the control arm. The mean ratios between timing to assess the treatment failure for payment by result and the time to off treatment observed for the experimental drug or the median time to off treatment observed in the control arm were calculated to identify potential correlations. High level of correlation was expected if ratio was close to 1 (±.2).RESULTS:Roche products or different indications of the same product were identified as candidates for the analysis from 2008 to 2016. The timing for the evaluation of treatment failures for Pbr varies between 2 and 9 months, depending on the type of tumor and line of therapy. The mean Time to Payment By Result (TTPbr) / Control arm Time To Off Treatment (cTTOT) ratio was 1.16 (±.37) while the mean Time to Payment By Result (TTPbr) / Experimental arm Time To Off Treatment (eTTOT) ratio was .71 (±.13). Data analysis according to different time periods shows that the mean TTPbr/cTTOT and TTPbr/eTTOT for drugs negotiated from 2008 to 2015 were respectively 1.07 and 1.39 whereas for drugs negotiated in 2016 were respectively and .63 and 1.CONCLUSIONS:Good level of correlation between TTPbr and cTTOT was found. This finding is in line with the methodology used by Italian Medicines Agency so far, leveraging the cTTOT as the most appropriate proxy to assess any incremental effect of a new drug compared to the previous Standard of Care. The analysis over time of TTPbr shows that in the first years of payment by result negotiation TTPbr is more correlated to the cTTOT whereas in the last years is moving closer to the experimental one.
PP128 Regional Guidance On Spinal Cord Stimulation For Chronic Pain
Authors: Cavazzana Anna , Redomi Anna , Poerio Elena , Bassotto Francesca , Mottola Rita , Andretta Margherita , Scroccaro Giovanna 
Published: January 2018

INTRODUCTION:Chronic Pain (CP) is the uncontrolled pain that affects patients for a long time. CP can be caused by many conditions, sometimes still poorly understood, and its levels can vary from moderate to intense. The management of resistant CP requires a stepwise approach and spinal cord stimulation (SCS) could be considered an extreme strategy. With the aim of ensuring the economic sustainability, the Veneto Region usually establishes rigorous access criteria to high-cost medical devices through its Regional Technical Committee on Medical Devices (CTRDM) and a Health Technology Assessment (HTA) procedure.METHODS:The Regional Health Technology Assessment Unit (CRUF) conducted through Pubmed a literature review of randomized controlled trials, systematic reviews, meta-analysis on SCS published from March 2006 to February 2016. International and national clinical guidelines were included in the analysis as well. The regional multidisciplinary Working Group on CP, which involved local clinicians, pharmacists, clinical engineer and health economist, discussed the collected evidence by consensus. Final recommendations on the appropriate use were submitted to the CTRDM for final approval.RESULTS:The regional guidance describes the type of pain that can be treated with spinal neurostimulators and the criteria which determine the success of the test procedure. A comparative analysis of spinal neurostimulators available on the market and related patients eligibility criteria have been also included. Moreover, the guidelines stated a list of compulsory requirements in order to become a regional center authorized in performing spinal neurostimulation procedure. Finally, the document describes some indicators for appropriateness monitoring. The CTRDM approved the final version in October 2016.CONCLUSIONS:The regional guidance on SCS aims at ensuring the appropriate use of neurostimulators in patients affected by resistant CP. The strict monitoring of agreed indicators is essential for appropriateness and consequently the sustainability of medical devices expenditure throughout the Regional Health Service.
PP138 Italian Medicines Agency Registries Distribution By Managed Entry Agreements And By Anatomical Therapeutic Area
Authors: Vittoria Gabriele , Fascì Antonio , Ferrario Matteo , Giuliani Giovanni 
Published: January 2018

INTRODUCTION:In a budget constrained environment characterized by an increasing number of high-cost medicines, manufacturers need to demonstrate that their drugs can provide value-for-money. In this complex environment Managed Entry Agreements (MEAs) have been developed with the aim of sharing the risk between the National Health Service (NHS) and manufacturers (1). The objective of this analysis was to identify a correlation between Anatomical Therapeutic Chemical Classification (ATC) and different type of agreements assigned taking into consideration the distribution of Italian Medicines Agency registries by ATC and by kind of agreement negotiated (financial or performance based) (2).METHODS:This analysis takes into account all drugs under monitoring AIFA registries in place in Italy from 2006. For each registry included in the analysis it was collected the status of the registry (active, closed or incoming), the disease area that the registry covers and the monitored drugs with or without an associated Managed Entry Agreements. Considering the high weight of oncology drugs, a sub-analysis was done to investigate registries distribution for each specific form of cancer.RESULTS:The majority of drugs monitored are under a registry with no associated risk sharing agreement according to AIFA (60 percent). For what concerned monitored drugs with an associated agreement, performance-based agreement is the most diffused type of MEA. In terms of therapeutic area involved in the monitoring registries activity, oncology was the most common area. Financial based agreements characterize principally medicines used for Leukemia and Hepatitis C, whereas drugs administrated for Melanoma, Breast and Ovarian Cancer and Ophthalmology diseases follow performance based agreements.CONCLUSIONS:MEAs represent a way to guarantee a sustainable access for innovative medicines. It is proven that oncology products are most likely to have a MEA since they represent some of the most expensive drugs launched in recent years. From this study appear a correlation between the therapeutic disease area of the monitored drugs and MEA assigned by AIFA which is influenced also by other factors like budget impact, risk-benefit ratio and the presence of appropriate endpoints to evaluate the treatment response.
PP155 The Impact Of Lawsuits In The Brazilian Public Health System
Authors: Biella Carla , Pereira Viviane , Raynal Fabiana , Barreto Jorge , Canuto Vania , Petramale Clarice 
Published: January 2018

INTRODUCTION:The increase of litigation in Brazil on the right to health, and the Brazilian Public Health System (SUS) targets of litigation, are phenomena that generate discussions both in the judiciary, and among researchers and managers of health. The lawsuits are based on the integrality that includes the right to any health technology. Our aim was to gather information on the use of scientific evidence by judges and other law professionals to support their decisions in lawsuits involving health care in Brazil.METHODS:A narrative review by literature search using key terms of legalization in specific databases was conducted.RESULTS:Twenty-five studies showed litigation matters relating to health care which were focused on legal claims about drugs. In general, law operators used the scientific evidences in a limited way when making decisions, by considering the medical report and medication label indications and disregarding therapeutic alternatives contemplated in the SUS list. The access to health technologies, by litigation, reveals that the gap between scientific knowledge and legal practice are similar to those found between science and decision-making in the formulation and implementation of health policies. The Health Technology Assessment studies have high potential for use by the judiciary as a reference source to support technical and scientific decisions in lawsuits on health care.CONCLUSIONS:For the judiciary to ensure not only access to health technologies, but also the efficacy and safety of technologies to system users, their decisions must be substantiated by scientific evidence. The National Committee for Health Technology Incorporation (CONITEC) in SUS has established actions in conjunction with law operators and society, such as a communication using e-mail, aiding the decision for the injunction and elaboration of technical reports and a policy brief, with the intention that the decisions are taken with the greatest possible knowledge about technologies provided by SUS, and based on scientific evidence.
VP01 Effect Of Early Life Socioeconomic Status On Trajectories Of Chinese Elders Health
Authors: Hu Xiaoqian , Zhen Xuemei , Dong Hengjin 
Published: January 2018

INTRODUCTION:China, with the largest aging population which is fast increasing, faces great challenges. Increasingly, researchers are looking at the relationship between whole life conditions from birth to death and health status in old age using a life-course approach. Few researchers have paid attention to developing countries like China where early life conditions were worse than those in western countries in the early twentieth century. China has had a complex social and political history in the twentieth century. This study investigates trajectories of aging and the effects of childhood and adulthood Socioeconomic Status (SES) encompassing education, job and family condition, on oldest-elders physical health in China.METHODS:The data used in this study was from all seven waves (1998-2014) of the Chinese Longitudinal Healthy Longevity Survey and covered 6,483 respondents aged 80 to105 years in baseline. Measuring the limitation in activities of daily living represents physical health. Group-based trajectory modeling is used to identify groups of individuals with statistically similar developmental characteristics or trajectories. Multinomial logistic regression is used to compare the differences among trajectory groups.RESULTS:Three-group models best fit the data for males and females. Along with increasing age, there was an increase in the limitation in activities of daily living. Some groups changed gradually, while others rose rapidly. Some childhood and adulthood socioeconomic status characteristics influenced trajectory-group membership. For both genders, group one and two had similar childhood socioeconomic status, while higher adulthood socioeconomic status like jobs were associated with less favorable health status. For group three of males suffering the hardest childhood in regard to education, had stable health status instead.CONCLUSIONS:Diversity exists among aging procedure. Childhood and adulthood socioeconomic status influence health conditions of the oldest-elders in complex ways. Education is a remarkably positive factor significantly contributing to better health status.
VP13 Relation Between Magnetic Resonance Imaging Use And Hip Or Knee Replacements In The Organisation For Economic Co-operation And Development
Authors: Emprechtinger Robert 
Published: January 2018

INTRODUCTION:A high degree of geographic variation in the use of medical interventions is usually considered as a sign for inappropriate use. However, the plain geographic variation has the disadvantage that the variation might also be appropriate due to differences in the regions. Hence, we conducted a more comprehensive analysis on Magnetic Resonance Imaging (MRI) use and the relationship to hip or knee replacements. We evaluated whether there is evidence that guideline recommendations regarding hip replacements and total knee replacements are being followed. Additionally, we tried to assess whether the use of MRI is related to subsequent interventions.METHODS:We extracted recommendations of the American College of Radiology (ACR) on the use of MRI relevant to hip replacements and total knee replacements. Subsequently, we created three hypotheses on MRI for hip or total knee replacements on what to expect from the data when these recommendations are being followed.For each hypothesis we calculated a multiple linear regression to analyze Organisation for Economic Co-operation and Development (OECD) data. This was necessary to control for other important variables that might have had an influence on the number of interventions despite the MRI use (for example, healthcare spending, or Computed Tomography (CT) use).RESULTS:The initial results on (primary) hip replacement and secondary hip replacement were heavily influenced by outliers. After the exclusion of the outliers (Turkey and Belgium), (primary) hip replacements were related to MRI use but not secondary hip replacements. The results on MRI and (primary) hip replacement suggest that the relationship between MRI and hip replacement in Turkey is lower than in the other OECD nations.Regarding knee replacements, we detected a relationship between the MRI use and total knee replacement. An increase of 10 MRI examinations per 1,000 population would, according to our model, result in 9.8 additional total knee replacements per 100,000 population.CONCLUSIONS:The relationship of MRI and (primary) hip replacement hints to inappropriate use of MRI in Turkey since the data shows a substantial deviation in the relationship compared to the other OECD nations. Apart from this, we found no evidence for inappropriate use of MRI in connection with hip replacements.However, our results suggest that MRI is inappropriately used in relation to total knee replacements. This might contribute to potentially unnecessary total knee replacements.
VP14 Screening Recommendations For Socioeconomic Disadvantages In Pregnancy
Authors: Rosian Katharina 
Published: January 2018

INTRODUCTION:In 2015, 18.3 percent of the Austrian population were at risk of poverty and social exclusion - about 211,000 (20 percent) women aged 20–39 years were affected. International studies report that poverty may lead to an increased risk of complications and pathologies during pregnancy. Further, children who grow up in poverty often have poorer long-term health outcomes.METHODS:In order to identify recent guidelines (2011-2016) a comprehensive handsearch was conducted in the guideline databases National Guideline Clearinghouse (NGC) and Guidelines International Network (GIN). Moreover, a handsearch for systematic reviews and primary studies was conducted in PubMed.RESULTS:Two guidelines, the British National Institute for Health and Clinical Excellence (NICE) Guideline “Pregnancy and Complex Social Factors”, as well as the Australian Health Ministers' Advisory Council (AHMAC) Guideline “Antenatal Care”, address socioeconomic disadvantages of women during antenatal care. The recommendation of the AHMAC is that pregnancy care should be offered to all pregnant women. In addition, an individual approach will help to pay particular attention to socioeconomic factors and to incorporate them in routine examinations. NICE recommends in its guideline, affected women should be supported in order to ensure adequate prenatal care. NICE also defines criteria which are used to identify pregnant women who are in greater need of support. The only identified study developed and tested a tool for the identification of patients affected by poverty. The authors of this Canadian pilot study concluded that the defined questions helped to identify socioeconomically disadvantaged persons during anamnesis without stigmatizing.CONCLUSIONS:Due to the proven link between poverty and health risks, special attention must be paid to socioeconomically disadvantaged pregnant women. Research on non-stigmatizing instruments, which can identify vulnerable women, is of great importance. In addition to social policy measures, it is necessary to ensure that low-threshold services are available for socioeconomic disadvantaged women and their children.