bluuebunny/crossref_metadata_2025_split huggingface dataset:
VP35 Economic Consequences Of A Restricted Dutch Sexually Transmitted Infection-Testing Policy
Authors: Suijkerbuijk Anita , Over Eelco , Aar Fleur , Götz Hannelore , Benthem Birgit , Lugnér Anna 
Published: January 2018

INTRODUCTION:Due to the rising costs caused by an increasing demand for Sexually Transmitted Infection (STI) care, the Dutch government changed the funding of STI-clinics (1). A more restrictive testing policy introduced in 2015 no longer required syphilis and human immunodeficiency virus (HIV) tests for younger, heterosexual clients. A less extensive testing policy could be detrimental to the aim of finding and treating STIs (2,3). Infections that remain undetected could possibly lead to an increase in both the total and individual burden of disease, due to transmission and the need for more intensive treatment resulting in higher healthcare costs in the long term. In this study, we evaluated the new Dutch testing policy with respect to intended savings and missed syphilis and/or HIV infections. Moreover, we explored the efficiency of alternative test policies.METHODS:Using national surveillance data from 2011 to 2013 with still comprehensive testing for all, we estimated the effects of restrictive testing on test costs, number of infections missed, costs per missed infection, costs per Quality Adjusted Life Year (QALY) lost, and calculated the net monetary benefit.RESULTS:The 2015-policy led to estimated savings of EUR1.1 million, while missing approximately three of ten HIV infections and seven of twenty syphilis infections among all younger heterosexual clients (in total 143,612 consultations) per year. Savings were EUR435,000 per QALY lost. Standard testing second-generation immigrants for syphilis and HIV saved EUR525,000/QALY lost. Offering an HIV test when diagnosed with chlamydia or gonorrhoea resulted in savings of EUR568,000/ QALY lost.CONCLUSIONS:The 2015-testing policy resulted in substantial savings as few missed HIV and syphilis infections caused QALY losses. Additional standard syphilis and HIV tests for second-generation immigrants and an additional HIV test in case of positive chlamydia or gonorrhoea diagnosis could reduce missed infections in a cost-effective way.
VP90 Uniform Assessment Methods To Assess New Genomic Tests
Authors: Scheibler Fueloep , Fleer Daniel , Angelescu Konstanze , Rodenhäuser Lina , Markes Martina , Rutjes Anne 
Published: January 2018

INTRODUCTION:With the possibility to analyze gene expression a plethora of new genomic tests are surging into the medical market. The assessment of these new technologies in Health Technology Assessment (HTA) reports is challenging and we need international consensus on uniform criteria to support HTA, but also to establish clear and standardized requirements for clinical studies.METHODS:The German Institute for Quality and Efficiency in Health Care (IQWiG) has been commissioned to assess the benefits and harms of biomarkers to predict which women would benefit from chemotherapy treatment after surgery of primary breast cancer. The final report was published in October, 2016 (1).RESULTS:Only eight studies complied with the inclusion criteria of the systematic review. No prognostic study fulfilled the inclusion criteria. Only two randomized controlled trials (RCTs) delivered information utilizable for benefit assessment. Based mainly on 5-year results from the MINDACT trial, the report concluded that there currently is not enough information to support a positive decision on biomarkers in this specific indication. Ongoing randomized controlled trials like TailorX, PlanB, RxPONDER, ADAPT or OPTIMA are expected to provide some additional evidence in the near future. After publication of the IQWiG report an extensive debate on several methodological characteristics of this report was fuelled. In addition, some other HTA agencies, such as the National Institute for Health and Care Excellence (NICE) made slightly different conclusions.CONCLUSIONS:The presentation will give a résumé of the main arguments and focus on differences between the IQWiG report and other HTA reports. Questions, like the required study type, study characteristics (for example, attrition rate, follow up, outcomes), data quality, cut-offs or patient preferences in diagnostic information will be provided. The aim of the presentation and discussion is to get a step forward in defining key characteristics and elements of benefit assessment and primary studies for these new technologies. A consensus among HTA reviewers in these approaches seems to be essential in the near future.
VP94 Framework Of High-Quality Value Assessment Criteria In Health Care
Authors: Raycheva Ralitsa , Stefanov Rumen 
Published: January 2018

INTRODUCTION:No single assessment can evaluate the wide spectrum of health technologies pending access to healthcare systems. It is important to envision a complex systematic framework, in which different instruments are used for different purposes - all criteria should be used to ensure the transparency of the process, and should model good assessment and implementation practices (1,2).METHODS:A cross-sectional web-based survey was conducted from September 2013 to May 2015 which was designed to gain information about the present status of Health Technology Assessment (HTA) activities; to examine its institutional contexts and the kind of application of its principles, logic, assessment methods, tools and best practices.RESULTS:A total number of 161 questionnaires from 39 countries on 6 continents were received representing a 41.7 percent response rate. Based on analysis of the results, a complex systematic framework for value assessment was designed. Five major features define the framework that can fully measure the common and support the evaluation of more complex health technologies: (i) implementation of higher-order evaluation approaches that support complex multi-criteria assessment, rather than emphasizing only the use of basic evaluation procedures; (ii) precise evaluation of critical criteria, that measure technologies directly as they will be used in actual practical settings; (iii) assessment approaches, based on international best HTA practices that are accurate, in terms of the content and context of the evaluated technology, as well as the expected performance; (iv) high-fidelity priority-setting elements that are evaluation sensitive; and (v) assessments that are sound, unbiased, and transparent – in order to be truly valid for a wide range of technologies, assessments should evaluate them accurately and do so reliably across technology content and context. They should be unbiased and accessible and used in ways that support superior outcomes and higher quality for healthcare systems.CONCLUSIONS:The healthcare systems that decide to use this framework should evaluate the set of assessments they select and develop them against the standards required, and should use them in ways for which they have been appropriately validated and in contexts that ensure a transparent evaluation process (3).
VP110 Building Capacity In Health Technology Assessment Through Plain Language
Authors: Globerman Kinneret 
Published: January 2018

INTRODUCTION:Health Technology Assessments (HTAs) and policy papers are generally written in academic style using industry jargon — pharmaceutical, medical, or scientific terminology — with a generous use of abbreviations. Transforming technical or biomedical data into easily understandable text is a necessity and a challenge for all of us if our goal is to facilitate HTA collaboration beyond borders and integrate HTA into healthcare practice. Many countries have legislated for plain language (PL), and organizations globally are beginning to recognize how it helps in the uptake of information, whether geared to healthcare professionals and all those interested in HTA, or the lay public.METHODS:A preliminary, informal online search for legislative and supporting guidance on PL was conducted, and a query sent out to forty-eight International Network of Agencies for Health Technology Assessment (INAHTA) members.RESULTS:•The United States Plain Writing Act of 2010 has legislated that federal agencies use “clear Government communication that the public can understand and use” (1). Of the twenty-one respondents from INAHTA Listserv, seven use plain language in either their knowledge transfer tools (such as executive and research summaries, booklets and fact sheets, and patient or lay material).•The Government of Canada promotes plain language in all of its communications (2).•McMaster University's 2014 Health Forum on strengthening public and patient engagement in HTA in Ontario supported “clarity and consistency in the use of public- and patient-engagement terminology” in HTAs.•A growing number of international health-related and HTA organizations promote PL in their reports and HTAs to help with their health literacy.•Many pharmaceutical companies encourage PL communication in their writing (3).•Of the eighteen INAHTA responses received, eight reported that they use PL in their report summaries, knowledge transfer materials, and/or patient education tools.CONCLUSIONS:Adopting the practice of clear, straightforward writing and editing in all biomedical communication — including HTAs and journal articles — encourages interaction and engagement among patient, public, and healthcare stakeholders invested in HTAs, and their desire to have measured decision making based on comprehensive, informed, and easily understandable information. However, it remains to be seen if PL will be embraced by organizations worldwide. This preliminary, informal inquiry as to its use suggests that the adoption of PL by governments, HTA organizations, and the scientific community worldwide has not yet been fully embraced.
VP124 The End Of A French Medical Dogma For Hepatitis B And C Diagnosis
Authors: Lafarge Jean-Charles , David Denis-Jean , Morin-Surroca Michèle 
Published: January 2018

INTRODUCTION:Since the 1990s in France, based on contemporary French consensus conferences, for Hepatitis B (HBV) or Hepatitis C (HCV), diagnosis is acknowledged when detection of Hepatitis B surface antigen or anti-HCV antibody is positive on a 1st test line and further replicated on an independent blood sample.The replication was introduced to alleviate the low performance of immunoassay and avoid false positive results.Currently, the Haute Autorité de santé (HAS) is managing an update of diagnostic tests reimbursed for HBV and HCV to fully cover diagnostic needs.Our aim is to assess the clinical relevance of this repetition.METHODS:The assessment involves a critical analysis of national and international guidelines identified by a systematic literature search, and stakeholders’ views (professionals and public authorities).RESULTS:Since the 1990s, new tools were introduced (that is, polymerase chain reaction (PCR) for diagnosis and follow-up), and performances were improved for both enzyme immunoassay tests and PCR. Despite those change, replications are still performed nowadays in France.Neither guidelines nor stakeholders’ contributions mentioned any replication tests’ clinical relevance.The Ministry of Health confirms that replications have not any legal basis contrary to HIV diagnosis procedures. Also the French National agency for health products safety confirms there are neither technological pitfalls nor reagent vigilance signals involving HBV or HCV in vitro diagnostic tests. Furthermore, after 1st line positive results, a second blood sample is always collected to test other markers such as HBV DNA or HCV RNA which represent the best 2nd proof of infection.CONCLUSIONS:This work has enlightened a lack of clinical relevance for the replication of the same serological makers’ detection. It may obliterate soon this French medical dogma. This work has illustrated that short assessment based on critical guideline analysis linked with stakeholders’ views allows a rapid answer without assessment quality reduction. This HAS work will contribute to medical practice rationalization and cost reduction.
VP157 What Is The Response To Immuno-Oncology By Health Technology Assessment Agencies?
Authors: Rubinstein Judith , Adler Boaz , Blumenthal Jake , Chang Ruth , Ho S. Yin , Jaksa Ashley , Lurie Briana , Pontynen Anson , Rubinstein Emily , Sliman Rachel 
Published: January 2018

INTRODUCTION:Immunotherapies are a relatively new innovative class of drug that have garnered excitement in the fight against cancer. In 2011, the immunotherapy drug, ipilimumab, was approved. Since then, four additional drugs have gained approval. This analysis evaluates the initial reception of immunotherapies by Health Technology Assessment (HTA) agencies.METHODS:The Context Matters Data Model was used to evaluate the regulatory and HTA agency decisions surrounding the five approved immunotherapies through November 2016: atezolizumab, elotuzumab, ipilimumab, nivolumab, and pembrolizumab. Thirty-three labels from Australia, Canada, Europe, and the United States, and ninety-two assessments from Agenzia Italiana del Farmaco (AIFA), Gemeinsamer Bundesausschuss (Federal Joint Committee; G-BA), Haute Autorité de Santé (French National Authority for Health; HAS), Institute for Clinical and Economic Review (ICER), Institute for Quality and Efficiency in Health Care (IQWiG), National Institute for Health and Care Excellence (NICE), Pharmaceutical Benefits Advisory Committee (PBAC), pan-Canadian Oncology Drug Review (pCODR), and Scottish Medicines Consortium (SMC) were found. Using a sample t-test and a chi-squared test, reimbursement agencies’ decisions were evaluated, and the clinical and economic factors that went into these decisions were examined.RESULTS:Of the evaluated reviews: sixty-four were for melanoma indications, fourteen were for non-small-cell lung cancer (NSCLC) indications, and seven were for kidney cancer indications. Many of the reviews did not reach any decision, but 75 percent of HTA decisions (n = 72; p = .0000) reached were positive. Elotuzumab, approved for multiple myeloma, received a positive decision from G-BA and a negative one from SMC. There was an association between different disease conditions or drugs and the rate of positive decisions.For reviews that had clinical reasons for their decisions, 72.9 percent (n = 59; p = .0000) had positive clinical rationales that were associated with positive decisions (p = .000). Economic rationales for decisions were more mixed, with only 48.4 percent (n = 31; p = .0000) receiving positive decisions. Positive economic evaluations were also associated with positive decisions (p = .000). Atezolizumab, approved only in the United States at the time of this writing, has yet to be reviewed by any of the HTA agencies.CONCLUSIONS:Immunotherapies are promising new options for the treatment of cancer. Thus far, reception by HTA agencies has generally been positive.
VP161 Identification Of Needs Of Pigmented Villonodular Synovitis Patients Using Online Bulletin Board
Authors: Cook Nigel , Landskroner Kyle , Walda Susann , Weiss Olivia , Pallapotu Vikrant 
Published: January 2018

INTRODUCTION:Pigmented villonodular synovitis (PVNS) is a very rare, benign proliferative tumor affecting the inner lining of synovial joints and tendon sheets. Information on treatment needs of PVNS patients to inform drug development is currently scarce, hence we conducted qualitative research with patients using an online bulletin board (OBB) methodology to generate insights on objective and emotional aspects related to the medical journey and living with this disease.METHODS:OBB is an asynchronous, online qualitative market research tool that allows participants to comprehensively answer pre-defined questions in a comprehensive manner. Patients were recruited via physician referral and underwent screening questions to ensure eligibility for the study and willingness to participate. The discussion was moderated, structured, and allowed open answers and in response to other participants posts. Analysis was conducted using a combination of different qualitative analytical tools.RESULTS:The patient OBB ran for 4 days with eleven participants (n = 3 Canada, n = 4 United Kingdom, n = 4 United States of America) aged 28–57 years, suffering from PVNS for 2–27 years. The key patient insights were: (i) pain is the primary factor, constituting a significant emotional and psychological burden; (ii) surgery (arthroscopy) does not get rid of PVNS, relapse rate was high in these patients; and (iii) PVNS has a big financial impact on patients, their families, and the healthcare system, due in particular to time off work/lost wages (patient & caretaker), for healthcare system it is repeat costs for surgeries/hospital stays plus other medical expenses. We also identified orthopedic specialists/surgeons are the physicians who predominantly manage PVNS at this point, as surgery is the only option.CONCLUSIONS:This study shows the suitability of the OBB for uncovering qualitative patient insights to inform decision making and strategy in early pharmaceutical drug development. OBB lends itself very well to uncovering patient insights which might not be revealed in focus group or telephone interviews, particularly in a rare disease like this. PVNS patients are in need of a medical drug treatment which can reduce pain, relapses and provide an alternative to surgery, the current standard of care.
VP180 Effect Of Two-Invoice System On Drug Distribution And Price In China
Authors: Ye Yingfeng , Ying XiaoHua 
Published: January 2018

INTRODUCTION:Drug prices are mainly determined by production costs, commercial circulation and use in medical institutions. In 2015, total sales of the Chinese drug distribution industry was CNY1,613.3 billion (USD248.6 billion at 31 December 2015 exchange rate), with CNY28.3 billion (USD4.4 billion) profit and an average cost rate of 5.4 percent due to high logistics costs (1). Under Multi-invoice Systems in China, drugs are delivered through national, provincial, local agents, with invoiced and prices going up each time (2). The Two-invoice System, which comes up in April 2016, is China's first drug distribution policy aiming to compress circulation, and reduce unrealistically high prices. There will be only two invoices, one from production enterprises to distributors, the other from distributors to medical institutions. The objective of this study is to evaluate the effect of the Two-invoice System on drug distribution and price in China.METHODS:We conducted a literature review of relevant articles and policies in five provinces on China National Knowledge Infrastructure (CNKI), Wanfang, PubMed and government websites. We conducted in-depth individual interviews for qualitative research on policy mechanisms with two government officials and four drug production and distribution enterprise managers. The quantitative study on policy effect measured indicators, namely, number of distributors, concentration ratio index (CR), net sales ratio, and ex-factory price. We compared the pilot province before and after the policy, with national level and other provinces. We considered related drug policies to eliminate confounding. Focus group discussion on conclusions and suggestions will be conducted.RESULTS:There are no peer review articles, only news media on this topic. In Fujian Province, the number of distributors droped from 246 to 62. In 2015, the Top 3 drug wholesalers reached a market share of 36 percent (CR3), and Top 10 for 86 percent (CR10). Compared to the whole country, CR3 is 26 percent and CR100 is 86 percent. Net sales in the drug wholesale market in Fujian accounted for 75.6 percent, with an increase of 4.3 percent. While at the national level, it is only 57.2 percent with an increase of 0.3 percent (3).CONCLUSIONS:The Two-invoice System in China reduces intermediate circulation, and increases industrial concentration. Net sales directly to hospitals are encouraged, whichaffects distribution and production areas. Production enterprises tend to invoice with higher prices instead of offering reserve prices to agents.
Evaluation of ELISA and haemagglutination inhibition as screening tests in serosurveillance for H5/H7 avian influenza in commercial chicken flocks
Authors: Arnold M. E. , Slomka M. J. , Breed A. C. , Hjulsager C. K. , Pritz-Verschuren S. , Venema-Kemper S. , Bouwstra R. J. , Trebbien R. , Zohari S. , Ceeraz V. , Larsen L. E. , Manvell R. J. , Koch G. , Brown I. H. 
Published: January 2018

AbstractAvian influenza virus (AIV) subtypes H5 and H7 can infect poultry causing low pathogenicity (LP) AI, but these LPAIVs may mutate to highly pathogenic AIV in chickens or turkeys causing high mortality, hence H5/H7 subtypes demand statutory intervention. Serological surveillance in the European Union provides evidence of H5/H7 AIV exposure in apparently healthy poultry. To identify the most sensitive screening method as the first step in an algorithm to provide evidence of H5/H7 AIV infection, the standard approach of H5/H7 antibody testing by haemagglutination inhibition (HI) was compared with an ELISA, which detects antibodies to all subtypes. Sera (n = 1055) from 74 commercial chicken flocks were tested by both methods. A Bayesian approach served to estimate diagnostic test sensitivities and specificities, without assuming any ‘gold standard’. Sensitivity and specificity of the ELISA was 97% and 99.8%, and for H5/H7 HI 43% and 99.8%, respectively, although H5/H7 HI sensitivity varied considerably between infected flocks. ELISA therefore provides superior sensitivity for the screening of chicken flocks as part of an algorithm, which subsequently utilises H5/H7 HI to identify infection by these two subtypes. With the calculated sensitivity and specificity, testing nine sera per flock is sufficient to detect a flock seroprevalence of 30% with 95% probability.
Immune loss as a driver of coexistence during host-phage coevolution
Authors: Weissman J L , Holmes Rayshawn , Barrangou Rodolphe , Moineau Sylvain , Fagan William F , Levin Bruce , Johnson Philip L F 
Published: January 2018

Abstract
Bacteria and their viral pathogens face constant pressure for augmented immune and infective capabilities, respectively. Under this reciprocally imposed selective regime, we expect to see a runaway evolutionary arms race, ultimately leading to the extinction of one species. Despite this prediction, in many systems host and pathogen coexist with minimal coevolution even when well-mixed. Previous work explained this puzzling phenomenon by invoking fitness tradeoffs, which can diminish an arms race dynamic. Here we propose that the regular loss of immunity by the bacterial host can also produce host-phage coexistence. We pair a general model of immunity with an experimental and theoretical case study of the CRISPR-Cas immune system to contrast the behavior of tradeoff and loss mechanisms in well-mixed systems. We find that, while both mechanisms can produce stable coexistence, only immune loss does so robustly within realistic parameter ranges.