bluuebunny/crossref_metadata_2025_split huggingface dataset:
PP050 Analysis Of Pharmacoeconomic Studies Published In The Scientific Electronic Library “eLIBRARY.RU” (RSCI)
Authors: Yagudina Roza , Kulikov Andrey , Zubarev Pavel , Protsenko Marina , Ugrekhelidze Dzhumber 
Published: January 2018

INTRODUCTION:During the information search revealed that there is no published analysis reflecting the actual status of pharmacoeconomic and clinical-economic research, but there are databases that allow you to do so. The platform for searching research data was scientific electronic library “eLIBRARY.RU”. This portal is Russia's largest internet library of scientific publications, with rich search capabilities and the timely receipt of necessary information.METHODS:A search was carried out during the period from 2005 to 2015 of research papers on Russian and foreign pharmacoeconomic and clinical-economic research was carried out as at 1 September 2016 on the words “pharmacoeconomic*”, “clinical and econom*” with the appropriate endings. The criteria for inclusion in this analysis were general accessibility and availability of full text scientific material on the portal.RESULTS:Over the last ten years the number of publications increased by 4 times. The leading destinations included cardiovascular, pulmonary, oncological and endocrinological diseases. According to published reports pharmacoeconomic and clinical-economic studies carried out in fifty-two subjects of the Russian Federation on the basis of sixty-three Universities. In addition to researchers from the Russian Federation, has placed the representatives from eleven countries. Only one third of the published studies are generally cited. Among the methods of pharmacoeconomic analysis of the most popular in published studies is the analysis of “cost–effectiveness”, which is used in about 45 percent of the available studies.CONCLUSIONS:As a result, 1,425 articles were identified and analyzed. With the aim of providing concrete data that clearly illustrate the situation with the Russian scientific, pharmacoeconomic and clinical-economic writings to date all studies were classified according to the following parameters: geographical, temporary, local and nosological. In the framework of the analysis highlighted the authors whose works are most RISC (Russian Science Citation Index) with leading positions in the number of publications.
PP071 Health Technology Assessment In Bulgaria: A Review Of The First Fifteen Reports Assessed
Authors: Raycheva Ralitsa , Iskrov Georgi , Stefanov Rumen 
Published: January 2018

INTRODUCTION:In Bulgaria, the regulatory body sets for the first time legal requirements for Health Technology Assessment (HTA) in Law on Medicinal Products in Human Medicine (LMPHM) on 27 June 2015. The next essential step for HTA capacity building was the promulgation of Ordinance 9 / December 1, 2015 on the conditions and procedures for conducting health technology assessment by the Ministry of Health (1). In the beginning of 2016, the Main Price and Reimbursement Committee was set and launched a process for establishing the small working groups with the task of reviewing the first applicants reports of pharmaceuticals for inclusion in the Positive Drug List (PDL).METHODS:The objective of this study is to summarize the recommendations of the newly established HTA Committee in Bulgaria and to examine the characteristics of the technologies and the key considerations that led to those decisions. We systematically read all published by the Committee recommendations for 2016 and analyzed them under: type of recommendations (positive or negative for inclusion in PDL), population, specialization, type of service, type of justification and the impact on final conclusions.RESULTS:For the first year of its work the HTA Committee was able to assess fifteen technologies (pharmaceuticals) and only one received a negative recommendation (6 percent) from the working group. All the rest (n = 14; 94 percent) were recommended for funding. The final recommendation from the Main Price and Reimbursement Committee is available for four (27 percent) technologies – all positive for inclusion in PDL. All recommendations were connected with adults and in oncology (n = 4; 27 percent); heart diseases (n = 4; 27 percent); Chronic Obstructive Pulmonary Disease, COPD (n = 2; 13 percent); diabetes (n = 2; 13 percent); psoriasis (n = 2; 13 percent); Hepatitis C (n = 1; 7 percent). The only negative recommendation was justified due to lack of robust evidence, safety issues and credibility of HTA analysis (2).CONCLUSIONS:The information about the number of applications received from the Committee is not available and correct conclusions about the capability is not possible, but indirect circumstances, as the lack of well-trained HTA experts, certainly impede establishment of the small working groups and slow the assessment process (3). At this point it is clear that additional efforts are need to overcome the barriers and smooth adoption and implementation of HTA methods in Bulgaria.
PP100 Economic Evaluation Of A New Non-Antibiotic First-line Treatment Of Recurrent Urinary Tract Infections
Authors: Guglielmo Annamaria , Damiano Rocco , Ciani Oriana , Tarricone Rosanna , Cicione Antonio , Giancotti Monica , Mauro Marianna 
Published: January 2018

INTRODUCTION:Urinary tract infections (UTIs) are common in female patients in general practice. These bacterial infections affect half of all women at least once in their life. Antibiotics are usually prescribed for UTIs, and continuous low antimicrobial prophylaxis is administered to patients at high risk of recurrent UTI (rUTIs) (1). However, a major concern arises due to the increased rates of severe treatment-related side effects and emergence of antimicrobial resistance, which makes rUTIs management more challenging while seeking the use of more expensive alternatives. On this basis, clinical evaluations of rUTI interventions should be accompanied by economic evaluations in order to guide healthcare policy and decision processes about healthcare resources allocation. The aim of this work was to perform a cost-effectiveness analysis of a novel effective non-antibiotic treatment option for prophylaxis of female patients with a history of rUTIs, based on intravesical administration of hyaluronic acid (HA) plus chondroitin sulfate (CS), as compared to recommended 1st-line antibiotic therapy (2).METHODS:A cost-utility analysis was performed in order to estimate the effectiveness of each treatment, according to the number of UTIs annual episodes, and the incremental cost-effectiveness (ICER) for patients with UTI, starting from data collected during a multicentric observational case-cross-over clinical trial involving seven European centers (2). The economic model includes the costs of HA treatment and the costs associated with each UTI, such as costs of UTI diagnostics and antibiotic treatment, additional care by the elderly-care physician, additional nursing care, and hospitalizations, as well as the expected QALY, measured through the Short Form Health Survey (SF-36) questionnaires administered to patients, for both groups (3).RESULTS:At this stage, preliminary findings suggest that HA plus CS is a cost-effective alternative to antibiotics for the treatment of recurrent UTIs, that could reduce UTIs events in female patients with a history of recurrent UTI at an acceptable cost.CONCLUSIONS:The results of this study support the use of HA plus CS against antimicrobials as 1st-line therapy in the management of rUTIs.
PP142 A Mental Health Hospital-based Health Technology Assessment In Quebec, Canada: Structure And Products
Authors: Gheorghiu Ionela , Lesage Alain , Mongodin Adam , Galdin Marlène 
Published: January 2018

INTRODUCTION:Our Hospital-based Health Technology Assessment unit (HB-HTA) was founded in 2011 following the nomination of Louis-H. Lafontaine hospital as the Montreal University Mental Health Institute (IUSMM). From the beginning, the HB-HTA has been supporting and advising the Chief Executive Officer of IUSMM in the decision-making process concerning the implementation of new technologies and practices in mental health. Since 2015, the HB-HTA is part of the East of Montreal Regional Integrated Health and Social Services Centre (CIUSSS de l'Est-de-l’Île de Montréal), continuing to support decisions in mental health. Currently, the HB-HTA unit is nested in the Quality, Performance and Ethics department.METHODS:Formed by a coordinator, a scientific advisor and a manager, the HB-HTA team plans, organizes and sets up the evaluation activities. The unit benefits from the support of a Steering Committee which consists of representatives of clinical, administrative and research directions, as well as of health users and families. This committee determine the strategic orientation of the HB-HTA unit, prioritize the projects, approves the evaluation products and gives indications on the knowledge transfer process.RESULTS:To answer the decision questions, our HB-HTA unit employs two types of products: evaluation reports and informative notes. Based on an exhaustive literature search and consultations with stakeholders, the evaluation reports offer recommendations to support the decision-making process. The informative notes are rapid responses based on a partial literature search. The nature of this type of analysis does not allow the formulation of recommendations, however, a conclusion of the consulted literature is offered.CONCLUSIONS:Based on the work of our HB-HTA unit, some important decisions were made by the IUSMM. As an example, the systematic screening of psychiatric patients for drug and alcohol was not favored by our institution; rather than this, priority was given to staff training, in order to better identify and treat psychiatric patients with substance abuse comorbidity.
VP08 Real-World Data Use In Health Technology Assessments: A Comparison Of Five Health Technology Assessment Agencies
Authors: Makady Amr , van Veelen Ard , de Boer Anthonius , Hillege Hans , Klunger Olaf , Goettsch Wim 
Published: January 2018

INTRODUCTION:Reimbursement decisions are usually based on evidence from randomized controlled trials (RCT) with high internal validity but lower external validity. Real-World Data (RWD) may provide complimentary evidence for relative effectiveness assessments (REA's) and cost-effectiveness assessments (CEA's) of treatments. This study explores to which extent RWD is incorporated in REA's and CEA's of drugs used to treat metastatic melanoma (MM) by five Health Technology Assessment (HTA) agencies.METHODS:Dossiers for MM drugs published between 1 January 2011 and 31 December 2016 were retrieved for HTA agencies in five countries: the United Kingdom (NICE), Scotland (SMC), France (HAS), Germany (IQWiG) and the Netherlands (ZIN). A standardized data-extraction form was used to extract data on RWD mentioned in the assessment and its impact on appraisal (for example, positive, negative, neutral or unknown) for both REA and CEA.RESULTS:In total, fourty-nine dossiers were retrieved: NICE = 10, SMC = 13, IQWiG = 16, HAS = 8 and ZIN = 2. Nine dossiers (18.4 percent) included RWD in REA's for several parameters: to describe effectiveness (n = 5) and/or the safety (n = 2) of the drug, and/or the prevalence of MM (n = 4). CEA's were included in 25/49 dossiers (IQWiG and HAS did not perform CEA's). Of the twenty-five CEA's, twenty (80 percent) included RWD to extrapolate long-term effectiveness (n = 19), and/or identify costs associated with treatments (n = 7). When RWD was included in REA's (n = 9), its impact on the appraisal was negative (n = 4), neutral (n = 2), unknown (n = 1) or was not discussed in the appraisal (n = 2). When RWD was included in CEA's (n = 11), its impact on the appraisal varied between positive (n = 2), negative (n = 5) and unknown (n = 4).CONCLUSIONS:Generally, RWD is more often included in CEA's than REA's (80 percent versus 18.4 percent, respectively). When included, RWD was mostly used to describe the effectiveness of the drug (REA) or to predict long-term effectiveness (CEA). The impact of RWD on the appraisal varied greatly within both REA's and CEA's.
VP15 A Comparison Of Reporting In United Kingdom Health Technology Assessment And Other Systematic Reviews
Authors: Carroll Christopher , Kaltenthaler Eva 
Published: January 2018

INTRODUCTION:A recent study claimed that increasing numbers of reviews are being published and many are poorly conducted and reported (1). The aim of the present study was to assess how well reporting standards in systematic reviews published in 2014 in the United Kingdom Health Technology Assessment (UK HTA) monograph series compared with the reporting in Cochrane and other “non-Cochrane” systematic reviews from the same year, as reported by Page et al. (1).METHODS:All relevant UK HTA programme systematic reviews published in 2014 were identified. After piloting of the form, two reviewers each extracted relevant data on conduct and reporting from these reviews. These data were compared with data for Cochrane and “non-Cochrane" systematic reviews from 2014, as published by Page et al. (1). All data were tabulated and summarized.RESULTS:There were 30 UK HTA programme systematic reviews and 300 other systematic reviews, including Cochrane reviews (n = 45). Fewer UK HTA reviews covered therapeutic and pharmaceutical topics (53 percent and 20 percent respectively) than Cochrane (100 percent and 51 percent). The percentage of HTA reviews with required elements of conduct and reporting was frequently very similar to Cochrane and much higher than all other systematic reviews: for example, availability of protocols (90 percent, 98 percent and 16 percent respectively); the specification of study design criteria (100 percent, 100 percent, 79 percent); the reporting of outcomes (100 percent, 100 percent, 78 percent), quality assessment (100 percent, 100 percent, 70 percent) and other processes; the searching of trial registries for unpublished data (70 percent, 62 percent, 19 percent); reporting of reasons for excluding studies (91 percent, 91 percent and 70 percent) and reporting of authors' conflicts of interest (100 percent, 100 percent, 87 percent). However, HTA reviews compare less favourably with Cochrane and other reviews in the assessment of publication bias and reporting overall numbers of patients in the review.CONCLUSIONS:UK HTA systematic reviews are often produced within a specific policy-making context and cover a greater variety of topics than Cochrane reviews. This has implications for timelines, tools and resources. However, they still tend to present standards of conduct and reporting equivalent to “gold standard” Cochrane reviews and are superior to systematic reviews more generally.
VP26 Comparing Statistical Methods For Meta-Analysis Of Rare Event Data
Authors: Sharma Tarang , Gøtzsche Peter , Kuss Oliver 
Published: January 2018

INTRODUCTION:We aimed to identify the validity and robustness of effect estimates for serious rare adverse events in clinical study reports of antidepressant trials, across different meta-analysis methods for rare binary events data (1,2).METHODS:Four serious rare adverse events (all-cause mortality, suicidality, aggressive behaviour and akathisia) were meta-analyzed using different methods (3). The Yusuf-Peto odds ratio (OR), which ignores studies with no events in the treatment arms, was compared with the alternative approaches of generalized linear mixed models (GLMM), conditional logistic regression, a Bayesian approach using Markov Chain Monte Carlo (MCMC) and a beta-binomial regression model.RESULTS:Though the estimates for the four outcomes did not change substantially across the different analysis methods, the Yusuf-Peto method underestimated the treatment harm and overstimated its precision, especially when the estimated odds ratio (OR) deviated greatly from 1. For example the OR for suicidality for children and adolescents was 2.39 (95 percent Confidence Interval, CI 1.32 to 4.33, using the Yusuf-Peto method), but increased to 2.64 (95 percent CI 1.33 to 5.26) using conditional logistic regression, to 2.69 (95 percent CI 1.19 to 6.09) using beta-binomial, to 2.73 (95 percent CI 1.37 to 5.42) using the GLMM and finally to 2.87 (95 percent CI 1.42 to 5.98) using the MCMC approach.CONCLUSIONS:The method used for meta-analysis of rare events data influences the estimates obtained and the exclusion of double zero-event studies can give misleading results. To ensure reduction of bias and erroneous inferences, sensitivity analyses should be performed using different methods and we recommend that the Yusuf-Peto approach should no longer be used. Other methods, in particular the beta-binomial method that was shown to be superior, should be considered instead.
VP28 The Use Of Ethnographic Fieldwork In Health Technology Assessment
Authors: Hansen Helle , Thomsen Tine 
Published: January 2018

INTRODUCTION:The aim of the study was to introduce ethnographic fieldwork (1), including participant-observation and ethnographic interviews. Ethnographic fieldwork is a robust research methodology to study patients experiences and perspectives and, therefore, particularly valuable for Health Technology Assessment (HTA). Conducting ethnographic fieldwork requires that the researcher joins the people under study where they live or work for a period of time to observe and experience their everyday life and grasp their point of view in relation to the assessment of a health technology.METHODS:The presentation focuses on ethnographic fieldwork with participant-observation and ethnographic interviews. In relation to HTA, fieldwork can be highly relevant in order to understand the social world of the patients, for instance how they perceive and act in relation to a health technology. Furthermore fieldnotes, considerations on the analytic process and the production of knowledge will be a focus in the presentation.RESULTS:We argue, that a small fieldwork study based on participant-observation can do much more than just act as supplements to differents forms of interviews. We demonstrate that in the production of an HTA, patient knowledge should not depend on or prioritize one method like interviews or recorded talks. We show the importance of good fieldnotes in the process of analysis together with a discussion of the production of knowledge.CONCLUSIONS:To explore patients perspectives is thus not to identify one ’true’ perspective through an individual interview. Patients perspectives and experiences are emerging, relational and shifting. Therefore, there is a need for enhancing methodological and epistemological reflections and discussions about future development of ethnographic fieldwork in relation to HTA and patient involvement. The potential use of ethnographic fieldwork including participant-observation and ethnographic interviews will be highly relevant in relation to the assessment of new screening procedures, tele-health solutions, and collaboration between different sectors such as hospitals, municipalities and general practice. Furthermore, ethnographic fieldwork would be of importance for exploring how technology is working in local settings.
VP34 Economic Impact Of Influenza-Like-Illness In Vietnam
Authors: Vo Trung 
Published: January 2018

INTRODUCTION:Influenza is a disease related to the human respiratory system, with economic and social burden a common cause of Influenza-Like-Illness (ILI) among children and the elderly. This study was conducted to estimate cost of illness based on social perspectives of ILI cases.METHODS:A prospective study was conducted between February and March 2016 in pharmacies and private clinics at Khanh Hoa, Lam Dong, Tay Ninh, Dong Nai province, Ho Chi Minh City and Hospital of Tropical Diseases. Demographic and clinical information was collected by face-to-face interview. Treatment costs included direct costs (for example, diagnosis, therapeutics) and indirect cost (cost of days lost).RESULTS:Average costs associated with the ILI were USD88.09 per case among all age groups, direct non-medical costs were more dominant than direct medical costs accounting for 39.5 percent in pharmacies, 71.1 percent in clinics and 64.2 percent in hospitals. Total average cost was estimated to be EUR105 in children, and EUR514 in adults in Germany (1); and in South China, direct medical cost of ILI would be USD22.69 (2).CONCLUSIONS:The cost of ILI was the reason for the economic burden of patients and their families. This study provides the data for the future research, programs and policies which can be applied for influenza or ILI in Vietnam.
VP55 Health Technology Assessment Of Orphan Drugs: The Case Of Hereditary Angioedema In Italy
Authors: Federici Carlo , Cicardi Marco , Perego Francesca , Tarricone Rosanna 
Published: January 2018

INTRODUCTION:The evaluation of orphan drugs raises both positive and normative issues. Due to the rarity of the disease, higher drug costs and greater uncertainty on effectiveness often result in incremental cost-effectiveness ratios (ICER) far beyond the usually accepted thresholds for reimbursement. However, decision makers may need to consider other criteria to assess the social value of orphan drugs such as equity, the rule of rescue, and the perceived need in the community. Hereditary Angioedema (HAE) is a rare congenital deficiency resulting in recurrent attacks of angioedema in affected patients. These episodes cause extreme pain and distress, and may even be fatal when air pathways are involved. In Italy, icantibant or C1-Esterase-Inhibitors (C1-INH) are the indicated treatments for acute attacks. Although more expensive, icantibant may reduce time to symptom-relief and the need for further treatments. Nonetheless, evidence on its social value is missing. The present study aims at evaluating the cost-effectiveness of icantibant and providing new insights on other potentially relevant criteria for decision making on HAE treatments.METHODS:A cost-effectiveness model of icantibant versus C1-INH (Berinert) was developed. Using a two-part bayesian model, costs were estimated from real-world data of an unpublished national registry. Efficacy data were synthesized from both the registry and an indirect comparison of existing trials, whereas utilities were derived from the literature.RESULTS:In our Italian registry, respectively 98 percent and 60 percent of patients self-administered icatibant or Berinert at home in absence of medical personnel. On average, per treatment costs were 60 percent higher and attack duration 25 percent shorter with icantibant compared to Berinert. The resulting ICER greatly exceeded the considered threshold of EUR30,000.CONCLUSIONS:On cost-effectiveness grounds icantibant did not demonstrate good value for money compared to Berinert. However, further considerations are needed on whether standard health-related quality of life measures are able to truly reflect societal preferences for HAE treatments.The use of real-world data for the economic evaluation of orphan drugs can support decision making when evidence from clinical studies is too sparse.