bluuebunny/crossref_metadata_2025_split huggingface dataset:
PP289 Impact Of Regional Human Immunodeficiency Virus Therapeutic Pathway On Prescriptions: The Experience Of The Lazio Region In Italy
Authors: Bidino Rossella Di , Roberto Cauda , Massimo Andreoni , Andrea Antinori , Claudio Mastroianni , Vincenzo Vullo , Americo Cicchetti 
Published: December 2020

IntroductionIn 2017, the Lazio Region (Italy) published a care and therapeutic pathway (Percorso Diagnostico Terapeutico Assistenziale [PDTA]) to guide the choice of treatments for human immunodeficiency virus (HIV) patients. Recommendations were based on clinical and economic criteria to guarantee the most appropriate care and sustainability of the regional National Health Service. Our pilot study was conducted to assess how the PDTA impacts clinical decisions and expenditure. Organizational and economic analyses were based on four HIV treatment centers at the regional level.MethodsAn ad hoc data collection was conducted. Each center provided data on the volume of prescriptions for each treatment option for the first semester of 2017 and 2018. The period January-June 2017 (H1-2017) represents the scenario pre-PDTA, while January-June 2018 (H1-2018) provides evidence on the first impact of the PDTA. Expenditure was estimated considering prices reported in the PDTA document. For each center, a semi-structured survey collected evidence on which factors influence treatment decisions.ResultsBetween H1-2017 and H1-2018 the number of experienced patients increased 10.1 percent (6,580 versus 7,249, respectively), while that of naive patients decreased 3 percent (227 versus 220). More than 80 percent of naive patients were treated with regimes recommended by the PDTA versus 36 percent in H1-2017 and 62 percent in H1-2018 of experienced patients. Regimes with a monthly cost > EUR 700 were preferred. The survey showed that the PDTA is a useful tool for supporting clinical decisions.ConclusionsOur pilot study provides a snapshot on the impact of a regional HIV PDTA and identifies key aspects for its future update. Personalization of HIV therapies for an aging (5–29% of patients were >65 years in the four centers) and complex (>65% of patients had at least one comorbidity) population should be discussed for a PDTA update. Posology and treatment adherence should be further investigated.
PP309 Accuracy Of Automated Wrist Blood Pressure Monitors: Systematic Review
Authors: Albuquerque Nila , Araujo Thelma , Borges Samantha , Silva Liana Queren , da Silva Lais Vitoria , Rabelo Talita , Lino Maria Kecia , da Rocha Fabian Elery , de Freitas Luzia Sibele 
Published: December 2020

IntroductionThe use of automated blood pressure monitors is recommended by current guidelines; however, the accuracy of the device must be validated according to standardized protocols. Wrist blood pressure monitors have been undergoing technical improvements; nonetheless, their reliability is not unanimously recognized. No systematic review to date has analyzed the accuracy of wrist blood pressure monitors according to standardized protocols. This study aims to summarize the evidence on the accuracy of wrist blood pressure monitors in adults.MethodsThree databases (PubMed, Scopus and SciELO) were searched on 9 September 2019. The PICO (Patient, Intervention, Comparison and Outcome) strategy was used to outline the research question: Do automated wrist blood pressure monitors have accuracy equivalent to mercury sphygmomanometers in adults? Validation studies of wrist blood pressure monitors were included. Two reviewers independently screened abstracts and full texts. Summary data was extracted for each device, including mean difference of systolic blood pressure (SBP) and diastolic blood pressure (DBP) between the monitor and the mercury sphygmomanometer.ResultsThe review identified twenty-nine validation studies. Most of them were developed in China (44.82%), followed by Italy (20.68%). The most commonly used validation protocol was from the British Society of Hypertension. The mean difference between the devices and the mercury sphygmomanometers was 0.47 (±5.75) mmHg for SBP and 0.17 (±4.75) mmHg for DBP. The percentage of wrist blood pressure monitors that passed validation protocols was 93.1.ConclusionsMost automated wrist blood pressure monitors showed accuracy equivalent to the reference standard for blood pressure measurement, with mean differences less than 0.5 mmHg for SBP and 0.2 for DBP. This evidence supports the recommendation to adopt this technology for the measurement of blood pressure in adults. However, wrist blood pressure monitors have patient positioning specificities, which, if not followed, may lead to measurement errors. Therefore, the adoption of these monitors should consider not only their accuracy, but also aspects of patient use and preferences.
PP385 Using Common Data Models And Data Networks For Evidence Generation In Health Technology Assessment
Authors: Kent Seamus , Bouvy Jacoline 
Published: December 2020

IntroductionDifferences between healthcare datasets in structure, content, and coding systems are widely recognized as significant barriers to generating robust evidence for regulatory and medical decision making. As a result, there is a growing interest in using common data models embedded within large data networks. By standardizing the structure, contents, and semantics of disparate healthcare databases, common data models like the Observational and Medical Outcomes Partnerships common data model (OMOP-CDM) enable multidatabase studies to be undertaken at speed and in a transparent way. To date, little attention has been given to their potential role in health technology assessment (HTA).MethodsWe identify the uses of observational data in generating evidence in HTA, some common analytical challenges faced in their estimation, and the infrastructural, technical, and data reusability constraints that limit its wider use. We discuss where and how the OMOP-CDM could overcome these barriers in relation to different types of evidence requirements.ResultsThe OMOP-CDM increases the interoperability of otherwise disparate datasets, allowing reliable evidence to be generated from multidatabase studies at speed and transparently. The current analytical tools are best suited for clinical characterization and population-level effect estimation. Further developments to these tools are required to support analyses common in HTA like parametric survival modeling. Differences in costing methods as well as the structure of healthcare delivery between countries may limit the feasibility and value of standardization.ConclusionsThe OMOP-CDM has the potential to support reliable and timely evidence generation in HTA. The analytical tools should be further developed to support common HTA use cases.
PP469 From Theory To Practice: Which Value Framework Is Applied For Onco-Hematology Therapies In Italy? A 5-year Retrospective Analysis
Authors: Cicchetti Americo , Di Bidino Rossella , Xoxi Entela , Luccarini Irene , Brigido Alessia 
Published: December 2020

IntroductionDifferent value frameworks (VFs) have been proposed in order to translate available evidence on risk-benefit profiles of new treatments into Pricing & Reimbursement (P&R) decisions. However limited evidence is available on the impact of their implementation. It's relevant to distinguish among VFs proposed by scientific societies and providers, which usually are applicable to all treatments, and VFs elaborated by regulatory agencies and health technology assessment (HTA), which focused on specific therapeutic areas. Such heterogeneity in VFs has significant implications in terms of value dimension considered and criteria adopted to define or support a price decision.MethodsA literature research was conducted to identify already proposed or adopted VF for onco-hematology treatments. Both scientific and grey literature were investigated. Then, an ad hoc data collection was conducted for multiple myeloma; breast, prostate and urothelial cancer; and Non Small Cell Lung Cancer (NSCLC) therapies. Pharmaceutical products authorized by European Medicines Agency from January 2014 till December 2019 were identified. Primary sources of data were European Public Assessment Reports and P&R decision taken by the Italian Medicines Agency (AIFA) till September 2019.ResultsThe analysis allowed to define a taxonomy to distinguish categories of VF relevant to onco-hematological treatments. We identified the “real-world” VF that emerged given past P&R decisions taken at the Italian level. Data was collected both for clinical and economical outcomes/indicators, as well as decisions taken on innovativeness of therapies. Relevant differences emerge between the real world value framework and the one that should be applied given the normative framework of the Italian Health System.ConclusionsThe value framework that emerged from the analysis addressed issues of specific aspects of onco-hematological treatments which emerged during an ad hoc analysis conducted on treatment authorized in the last 5 years. The perspective adopted to elaborate the VF was the one of an HTA agency responsible for P&R decisions at a national level. Furthermore, comparing a real-world value framework with the one based on the general criteria defined by the national legislation, our analysis allowed identification of the most critical point of the current national P&R process in terms ofsustainability of current and future therapies as advance therapies and agnostic-tumor therapies.
PP553 Study On The Utilization Of Medical Resources In Patients With Malignant Tumors in China
Authors: Liu Yuehua , Du Tiantian , Zhang Fan , Zhao Kun 
Published: December 2020

IntroductionMalignant tumors have become a major public health problem and their treatment cost is increasing rapidly in China, but treatment aimed at healing diseases or extending patients’ life. There is little empirical research on utilization of healthcare resources of terminally ill cancer patients. In order to explore the optimal treatment decision for patients and provide information for relevant decision makers, this study analyzed the consumption status of medical resources in patients with cancer during the whole treatment period, and the current medical resource utilization efficiency in different levels of hospital for end-stage cancer patients.MethodsThis study was based on the clinical treatment and payment data of 2,536 cases of patients with lung cancer from the medical insurance database during the period of 2007 to 2014 in Hubei province. We retrospectively analyzed patients’ medical expenditure and utilization of different medical resources during their whole treatment period as well as at the end stage.ResultsThe per capita inpatient expenditures of patients under 50 years old was 193,000 CNY (27,451 USD), while that of the patients over 70 years were 80,000–90,000 CNY (11,379–12,802 USD). Secondly, the medical expenditures spent during the last 6 months of life accounted for 66.1 percent of the total expenditures. Lastly, the medical expenditure spent in tertiary hospitals accounted for 95.3 percent of the total expenditure, and the expenditure was 14,200 ± 17,030 CNY (2,019.82 ± 2,422.36 USD) per visit.ConclusionsPopulation aging is not the only factor causing the rise of medical expenditure. The unclear objectives of treatment and the reverse of medical resource allocation are also important factors to boost the growth of medical expenditure. It is necessary to improve the healthcare insurance payment system, strengthen the capacity of primary medical institutions, and develop the palliative care system in China.
PP554 Quality Assessment Of Clinical Practice Guidelines On Chronic Obstructive Pulmonary Disease Based On The Appraisal Of Guidelines For Research And Evaluation II (AGREE II) Instrument
Authors: Xu Qian , Zhao Kun , Xin Duan Cheng A , Ai Dandan , Sui Binyan 
Published: December 2020

IntroductionThe scientific application of clinical evidence-based guidelines can reduce the variability of clinical practice, and standardize clinical diagnosis and treatment pathways. At present, many evidence-based guidelines on Chronic Obstructive Pulmonary Disease (COPD) prevention have been issued in countries around the world, but the procedures and evaluation strategies developed by different guidelines are not the same. This study aimed to evaluate the quality of published clinical practice guidelines (CPGs) relating to COPD using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument.MethodsDatabases were systematically searched PubMed, EMBASE, Wan Fang, and CNKI as well as guidelines websites on COPD prevention and treatment. The search period was from inception of the database up to May 2019. The inclusion criteria for this study are as follows: (i) published and in accordance with the definition of the practice guidelines; (ii)the main target population is COPD patients with the diagnostic criteria of the 2019 edition of the global initiative for COPD (GOLD), and the content of the guideline is related to the prevention and treatment practice of COPD; (ii) the same guide is included in the latest updated version; (iv) the published language is English or Chinese. Guidelines that met these inclusion criteria were evaluated for the quality of the AGREE II guidelines. Then, a descriptive analysis was made of the consensus that exists in the guidelines.ResultsA total of fifteen guidelines/Consensuses Statements were included in the study. Two guidelines were assessed as recommended, eleven guidelines were assessed as recommended with modifications and two guidelines were not recommended. The mean scores of the included guidelines in the six domains (scope and purpose, personnel involved in guideline development, rigor of development, clarity, applicability, independence) were 90 percent, 72 percent, 49 percent, 96 percent, 60 percent, 69 percent, respectively. Thus, the study identified a consensus that disease risk factors and recommended interventions were mentioned in the guidelines, and that they comprehensively evaluated the quality of guideline reporting to provide reference for standardizing the development of practice guidelines for COPD in China.ConclusionsThe overall methodological quality of COPD CPGs should be improved. The key recommended areas for improvement include standardization of guideline report writing and synthesis of the latest and best evidence, to develop CPGs for COPD to improve the quality of clinical diagnosis and treatment for COPD.
PP585 A New Hope For Breast Cancer Survivors: Early Assessment Of A Breast Cancer Vaccine
Authors: Jamaluddin Norrina , Ghazali Izzuna Mudla Mohamed , Sabirin Junainah 
Published: December 2020

IntroductionBreast cancer is the most frequent cancer among women globally, impacting 2.1 million women each year, causing the greatest number of cancer-related deaths among women. In Malaysia, the new cases of breast cancer comprised of 32.7 percent of all new cancer cases in women as reported by The International Agency for Research on Cancer (IARC). The recurrence rate was about 16.4 percent post-mastectomy. This early assessment is to evaluate the effectiveness and safety of a breast cancer vaccine.MethodsA systematic review was conducted. Searches were done through PubMed, Medline and ClinicalTrial.gov. The articles were selected based on inclusion and exclusion criteria and appraised using Critical Appraisal Skills Programme (CASP) checklist. More than twenty cancer vaccines under development were identified.ResultsThe most advanced breast cancer vaccine is Nelipepimut-S (NPS). In a Phase 2b clinical trial, improvement disease-free survival (DFS) in the NPS group was 89.8 percent. The DFS rate in the NPS group was 92.6 percent for triple negative patients. Median DFS in the NPS group [hazard ratio (HR): 0.26 (95% confidence interval, Cl: 0.08–0.81)] showed a significant difference. A projection study showed the cost-effectiveness will be 90 percent success if the cost less than USD1,000 per patient. No safety issues were reported.ConclusionsEarly assessment showed potential benefit in patient with triple-negative breast cancer (TNBC). However, further research is required to ensure its efficacy, safety, and cost-effectiveness.
PP613 The Cost Analysis Of Subcutaneous And Intravenous Dosage Forms For Systemic Juvenile Idiopathic Arthritis Treatment In Ukraine
Authors: Masheiko Alona , Piniazhko Oresta , Romanenko Iryna , Leleka Mariya , Serediuk Valeriia 
Published: December 2020

IntroductionThe Health Technology Assessment (HTA) Department of the “State Expert Center of the Ministry of Health (MoH) of Ukraine” was established in 2019 for conducting assessments and development of recommendations for informing decisions for the Ministry of Health of Ukraine (MoH) regarding the financing of health technologies based on HTA. The study aimed to conduct cost analysis and compare the treatment costs of two available dosage forms of tocilizumab for subcutaneous and intravenous administration for systemic juvenile idiopathic arthritis in Ukraine. Currently there is a central procurement program financed by the state budget with pharmaceuticals provided to patients with juvenile idiopathic arthritis approved by the Cabinet of Ministers Decree of Ukraine №255 dated 13.03.2019.MethodsThe cost analysis was carried out for tocilizumab over a 1-year horizon per one patient. The analysis included drug manufacturers' prices from the registry of the MoH dated 19.09.2019. The annual number of tocilizumab vials for intravenous infusion for each weight category of patients is approved by the order MoH №334 from 14 February 2019. The direct medical costs were included in the analysis omitting cost of administration.ResultsThe direct medical costs of treatment with intravenous tocilizumab per one patient for one budgetary year ranged from between USD7,563.83 and USD30,255.30 depending on patient's weight that was in the range of 10–80 kg. The direct medical costs of treatment per one patient for one year with subcutaneous tocilizumab was USD7,782.40 for patients < 30 kg and USD15,564.80 for patients ≥ 30 kg.ConclusionsThe introduction of subcutaneous tocilizumab can potentially lead to cost savings on average USD 4,041.97 (34.2%) for patients < 30 kg and USD 5,245.82 (25.2%) for patients ≥ 30 kg per one patient for 1-year treatment compared to the intravenous route. Intravenous tocilizumab has an economic advantage over the subcutaneous route solely for the pediatric population of certain weight categories. The cost of intravenous tocilizumab was USD 218.58 lower (2.9%) for patients ≤ 13 kg and USD 2,320.25 lower (17.5%) for patients with weight 31–35 kg, compared to the cost of subcutaneous tocilizumab.
Legal Professionalism and the Ethical Challenge for Legal Education: Insights from a Comparative Study of Future Lawyers in Greater China
Authors: Wu Richard Wai-Sang , Lo Carlos Wing-Hung , Liu Ning 
Published: December 2020

AbstractThis article uses data gathered from a survey that probed the career orientations and values of more than 1,000 law students in Beijing, Hong Kong and Taipei to examine the legal professionalism of future lawyers being trained under different legal education systems in Greater China. Our findings suggest that these future lawyers have a “materialistic” career orientation, although those studying in a system whose legal education goal is to train professional lawyers are more inclined to pursue professional legal ideals, and those trained in a system that emphasizes legal ethics are more likely to pursue public interest issues. On the basis of the findings, we argue that legal education systems in Greater China, while different in their traditions, share the same need to strengthen legal professionalism by according greater emphasis to legal ethics in their respective law school curricula.
Cognitive appraisals of dissociation in psychosis: a new brief measure
Authors: Černis Emma , Bird Jessica C. , Molodynski Andrew , Ehlers Anke , Freeman Daniel 
Published: December 2020

AbstractBackground:Catastrophic cognitive appraisals, similar to those in anxiety disorders, are implicated in depersonalisation, a form of dissociation. No scales exist to measure appraisals of dissociative experiences. Dissociation is common in psychosis. Misinterpretations of dissociative experiences may maintain psychotic symptoms. Therefore, assessing appraisals in this context may be valuable.Aims:The primary aim was to develop a measure of key appraisals of dissociation in psychosis. Secondary aims were to test the relationship between appraisals and psychotic experiences (paranoia and hallucinations), and determine whether appraisals explain additional variance in psychotic symptoms above dissociative symptoms.Method:Fifty items were generated from transcripts of interviews with patients. The measure was developed and psychometrically validated via factor analysis of data from 9902 general population participants and 1026 patients with psychosis. Convergent validity, test–re-test reliability, and internal reliability were assessed. Regression analyses tested relationships with psychotic symptoms.Results:A 13-item single-factor measure was developed. Factor analysis indicated good model fit [χ2(65) = 247.173, comparative fit index (CFI) = 0.960, root mean square error of approximation (RMSEA) = 0.052]. The scale had good convergent validity with a rumination (non-clinical: r = 0.71; clinical: r = 0.73) and dissociation measure (r = 0.81; r = 0.80), high internal consistency (α = 0.93; α = 0.93), and excellent 1-week test–re-test reliability [intraclass correlation (ICC) = 0.90]. It explained variance in psychotic symptoms (paranoia: 36.4%; hallucinations: 35.0%), including additional variance compared with dissociation alone (paranoia: 5.3%; hallucinations: 2.3%).Conclusions:The Cognitive Appraisals of Dissociation in Psychosis (CAD-P) measure is a psychometrically robust scale identifying appraisals of dissociative experiences in psychosis and is associated with the presence of psychotic experiences. It is likely to prove useful for clinical assessment and research.
In the midst of theory and practice
Authors: Peltonen Hannes , Traisbach Knut 
Published: December 2020

AbstractThis cross-disciplinary symposium on Friedrich Kratochwil's The Status of Law in International Society engages with the interconnections between social knowledge (theory) and action (practice). Each contributor reflects critically on one of Kratochwil's nine meditations. These co-meditations cover not only Kratochwil's work, but they deepen discussions on the role of legal norms in international society, the practice turn, pragmatism, the production of knowledge, and human action. Kratochwil's reply to his co-meditators pushes the limits of prevailing thought on praxis. As a whole, the symposium exemplifies how we find ourselves always in the midst of theory and practice.
On concepts, conceptions, and conceptors: remarks ‘On the concept of law’
Authors: Traisbach Knut 
Published: December 2020

AbstractIn order to understand the concept of law, that is to understand what law is and does, Friedrich Kratochwil proposes to look at how we ‘use’ norms and relate them to actions. His approach promises less theoretical impasses and the ability ‘to go on’. These comments contend that a focus on ‘norm practice’ can only provide a particular understanding of how law functions. The article further suggests that the proposition and contestation of conceptions of law, including the uses of law these conceptions enable and legitimize, form part of the social practice of law. This calls for a comparative perspective.