bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP491 Beyond Horizon-Scanning And Early Identification Of Innovative Technologies – Development Of An Active Monitoring Framework
Authors: Aluko Patricia , Zanghelini Fernando , Ogunbayo Oladapo 
Published: December 2020

IntroductionWhile horizon-scanning systems aim to identify innovative and potentially disruptive health technologies in development, a key challenge is variation in information collation and tracking of the pace of change prior to regulatory approval. An active and efficient monitoring process is crucial for timely notification of health technology assessment (HTA) stakeholders to enhance faster market and patient access. The National Institute for Health Research Innovation Observatory (NIHRIO) identifies and notifies its key HTA stakeholders in England of technologies that are within three to five-year timeframe to regulatory approval. Regular review of each technology is required to meet this remit.MethodsA standardized monitoring framework was developed based on the knowledge and experience of the evidence synthesis specialists in NIHRIO, supplemented by literature to ensure consistency of setting review periods. This framework used predefined criteria that integrated the technology innovation (advanced therapies, orphan status, regulatory awards), trial data (phase, status, completion date, preliminary results) and estimated approval timelines obtained from the company or other sources (for example, press releases).ResultsThe framework has been piloted and early findings showed improved consistency in the monitoring process between different analysts. It ensures that each technology is reviewed at least once a year; review timelines are set at three, six, nine or twelve months based on the predefined criteria. Estimated timeframes obtained from the companies are used to triangulate and streamline review periods, improving efficiency of the monitoring process.ConclusionsFindings from the pilot work with the framework demonstrated improved consistency and efficiency of the technology monitoring process, which can be easily implemented to provide early awareness in an accurate and timely manner for HTA. This framework was designed using a systematic and transparent approach that integrated different data sources to set review periods. While most of the data used in defining the criteria are publicly available, commercially sensitive information provided by companies were also used which may not always be readily available. Implications for horizon-scanning organizations will be discussed.
OP615 Implementing EUnetHTA Products: The Implementation Experiences In Italy
Authors: Scalzo Alessandra Lo , Migliore Antonio , Paone Simona , Vicari Nicola 
Published: December 2020

IntroductionThe Italian National Agency for Regional Health Services (AGENAS) participation in the European network (EUnetHTA) allowed capacity building and the spread of knowledge, tools and methodologies built by the network. In the latest Joint Action, AGENAS is implementing both EUnetHTA tools/methdologies and assessments. This was done both by the “adaptation” of most relevant EunetHTA assessments to Italian context or by “traslation” of EUnetHTA assessments’ Summeries. Language barriers have been highlighted from local HTA partners who aknowledged that contents written in italian could have a higher potential for dissemination.MethodsTo adapt a EUnetHTA report we evaluate if the PICOD fits our context with clinicians and stakeholders. We thus update systematic review and/or add other context specific domains. The EUnetHTA report summaries were translated into Italian and reviwed by clinicians. The HTA Core Model® was incorporated into national processes (Procedure Manual, HTA report templates, assessment elements, the Planned and On going Projects (POP) database was also used.ResultsImplementation of EUnetHTA's tools and products consisted of i) Production of national assessment reports based on EUnetHTA assessments; ii) Dissemination of EUnetHTA assessment iii) Translation of EUnetHTA assessments summaries and publication on Agenas website iv) Use of EUnetHTA POP Database for the national HTA programme; v) Embedment Integration of the EUnetHTA HTA Core Model®ConclusionsThe use of the Core Model® allowed a better standardisation of AGENAS' outputs. The Assessement Element based structure assists authors with the choices of relevant research questions; and the Domain-based structure allowed an efficient division of work among the authors. The use of the Core Model® among European partners faciliated the adaptation of other national HTA reports to our context. The adaptation and translation of EUneHTA assessments provides more homogenous choices among Italian regions and European countries, and so does the use of the POP database as a source of information about technologies that are on other EU Countries agenda.
PP21 Use Of Real-World Evidence For Healthcare Decision Making: Infliximab Versus Etanercept And The Risk Of Tuberculosis
Authors: Rivera-Ramirez Paola Andrea , Fiestas-Saldarriaga Fabián Alejandro 
Published: December 2020

IntroductionIn the absence of direct evidence from randomized controlled trials (RCTs), real-world evidence (RWE) can play an important role in healthcare decision making. As part of a health technology assessment, we assessed the comparative risk of tuberculosis (TB) associated with using infliximab and etanercept in patients with rheumatoid arthritis.MethodsWe performed a systematic literature search using the PubMed database to identify relevant meta-analyses.ResultsWe located two relevant meta-analyses: one based on RCTs and one based on observational studies. Evidence from seven RCTs on infliximab (2,686 patients; 12 TB events) and two RCTs on etanercept (663 patients; 2 TB events) suggested no significant differences in the risk of TB between the two treatments, compared with placebo. In contrast, evidence from ten observational studies that directly compared the two treatments (443,941 patients; 253 TB events) indicated a significantly higher risk of TB with infliximab than with etanercept.ConclusionsAlthough RWE is prone to confounding and bias, in this case it had the advantage of providing direct comparisons with larger sample sizes and longer follow up than evidence from RCTs. As a result, RWE was used to inform decision making on the risk of TB with infliximab and etanercept in patients with rheumatoid arthritis.
PP159 Telemedicine In Paraguay: Contributions Of The Institute Of Health Sciences Research, National University Of Asunción
Authors: Rivas Ronald , Galván Pedro 
Published: December 2020

IntroductionThe modalities of telemedicine that have been developed and applied so far by the Department of Biomedical Engineering and Imaging at the National University of Asunción (IICS-UNA) are as follows: (i) telediagnosis: the remote sending of data, signals, and images for diagnostic purposes; (ii) general telediagnostic imaging; (iii) telemonitoring (including telemetry): remote monitoring of vital parameters to provide automatic or semi-automatic surveillance or alarm services in emergencies, epidemiology, or tele-public health; and (iv) tele-education: the use of telematic networks to provide virtual platforms for educating and training health professionals.MethodsWe conducted a comprehensive review of the scientific works developed by the IICS-UNA in order to evaluate the systematic implementation of Telemedicine in Paraguay. Documents, pilot projects (satellite telegraphy), telediagnostic research, telematics, tele-education, published articles, and statistical data (number of patients attending or studies performed, etcetera) relating to the implementation of the National Telemedicine System by the Ministry of Public Health and Social Welfare since 1999 were reviewed.ResultsImplementation of the telemedicine system has meant that 472,038 patients have attended referral centers nationwide, with 297,999 electrocardiographs, 165,323 computed tomography scans, and 8,697 electroencephalograms being conducted. Projects developed within the framework of the Telemedicine Research Line have included the following:
(i)Development and validation of a clinical telemicroscopy system based on cellular telephony;(ii)Implementation of a telemetry system for temperature monitoring of the collection of biological samples from a biomedical research center; and(iii)Production and development of a virtual campus at the National University of Asunción.ConclusionsGiven the current healthcare environment, developing a line of research based on telemedicine is a proactive step, since telemedicine provides an alternative solution to the problem of access to the health system. That is why the IICS-UNA Biomedical Engineering and Imaging Department has developed telemedicine as one of its main lines of research.
PP188 Prevalence And Severity Of Erectile Dysfunction In Patients With Benign Prostatic Hyperplasia In China: A Cross-Sectional Survey
Authors: Zhou Liqun , Pei Zhengcun , Wen Xingqiao , Zhang Yanlei , Li Peng , Zhan Siyan 
Published: December 2020

IntroductionErectile dysfunction (ED) and benign prostatic hyperplasia (BPH) are highly prevalent among aging men. However, the rate of coexistence of these two conditions in China is still unclear, especially among men aged 45 to 60 years. Instruments such as the abbreviated five-item version of the International Index of Erectile Function (IIEF-5) and the International Prostate Symptom Score (IPSS) can be used to determine the presence of ED and the symptoms and severity of BPH, respectively. This study aimed to estimate the prevalence of ED in men with BPH and to assess its impact on the quality of life (QoL) of these patients.MethodsBetween October 2018 and March 2019 we enrolled 650 patients aged 45 to 65 years who were diagnosed with BPH by a urologist in nine first- and second-tier cities in China. Information on patients’ demographics, lifestyle, comorbidities, and medication use was collected through an electronic clinical outcome assessment tool. Patients with an IIEF-5 score of less than twenty-two were considered to have ED. The IPSS and the five-level EuroQol questionnaire (EQ-5D-5L) were used to assess BPH severity and overall health-related QoL.ResultsWe enrolled 650 patients with BPH. Of these, only the 607 men who reported sexual intercourse attempts (mean age of 56.6 years, standard deviation 5.5) were included in the analysis because it was assumed that the other patients did not have ED. Signs of ED were present in ninety-seven percent of patients (IIEF-5 score < 22), and eighty-four percent had at least mild to moderate impairment (IIEF score < 17). Up to nineteen percent reported having physician-diagnosed ED previously, and twenty-eight percent had used medication for ED in the past six months. Compared to men without ED, those with ED and BPH had higher IPSS scores (13.2 versus 6.7, p < 0.05) and lower EQ-5D-5L scores (0.90 versus 0.97, p < 0.05).ConclusionsAlthough the prevalence of ED in men with BPH in China is high, it is still underdiagnosed and undertreated. Co-existing ED in patients with BPH is associated with more severe BPH symptoms and lower quality of life.
PP229 Surrogate Outcomes In Health Technology Assessments Of Oncology Drugs: The Osimertinib Case
Authors: Rodriguez-Zuniga Milton , Rivera-Ramirez Paola , Fiestas-Saldarriaga Fabian 
Published: December 2020

IntroductionDecision making in publicly funded healthcare systems must rely on patient-relevant outcomes that directly measure clinical benefit, such as overall survival and quality of life (QoL). However, studies that support market authorization of oncology drugs usually assess surrogate outcomes, without having previously demonstrated that these intermediate outcomes reliably predict clinical outcomes. As part of an HTA process, we evaluated the clinical benefit of osimertinib, compared with platinum-pemetrexed combination chemotherapy, in patients with epidermal growth factor receptor (EGFR) T790M mutation-positive advanced non-small cell lung cancer (NSCLC) that has progressed after first-line EGFR tyrosine kinase inhibitor (TKI) therapy.MethodsWe conducted a systematic search of the PubMed database for randomized controlled trials (RCT) published from inception to January 2019. The clinical outcomes of interest were overall survival and QoL. Where trials reported surrogate outcomes, we conducted additional PubMed searches for evidence of validity for predicting clinical outcomes and used guidance on surrogate outcome validation in oncology from the Institute for Quality and Efficiency in Health Care.ResultsEvidence on osimertinib, compared with chemotherapy, for patients with T790M-positive advanced NSCLC that has progressed after EGFR-TKI therapy was obtained from the AURA3 trial. In this study, overall survival data were immature and the results for QoL and symptom domains were not clinically meaningful. In addition, median progression-free survival (PFS) was six months longer for osimertinib than for chemotherapy. However, to date, no study has demonstrated that PFS reliably predicts longer survival or better QoL.ConclusionsOur HTA suggested that, unless proven, PFS should not be used as a valid surrogate outcome for decision making in public health. For example, the results of the AURA3 trial showed that osimertinib has an effect on the surrogate outcome of PFS in patients with EGFR T790M-positive advanced NSCLC that has progressed after first-line EGFR-TKI therapy, but not on the clinically relevant outcomes of overall survival and QoL. Furthermore, currently available evidence has failed to prove that PFS reliably predicts outcomes that are clinically relevant. Despite this, osimertinib has been given marketing authorization and is widely recommended in clinical guidelines.
PP262 PapSEEK: Liquid Biopsy For Endometrial And Ovarian Cancer Screening
Authors: Hijas-Gómez Ana Isabel , Polo-de-Santos Mª Mar , Luengo-Matos Setefilla , Sánchez-Gómez Luís María 
Published: December 2020

IntroductionEndometrial and ovarian cancer are the first and second leading causes of death from gynecological cancer in Spain. Survival is generally determined by stage at diagnosis, but there is no test currently used for early detection of both tumor types. PapSEEK is a test developed to diagnose endometrial and ovarian cancer by detecting aneuploidies and somatic mutations commonly associated with both tumor types through DNA next-generation sequencing (NGS) of liquid from Papanicolaou test (Pap smear) samples. The objective of this work was to assess the effectiveness and safety of PapSEEK.MethodsPapSEEK was identified by the Early Awareness and Alert System, “SINTESIS-new technologies”, of the Agencia de Evaluación de Tecnologías Sanitarias in Spain (AETS-ISCIII). An early assessment of the technology was conducted through a literature search of the following databases: PubMed, Embase, the Web of Science, the Trip database, the International Clinical Trials Registry Platform, ClinicalTrials.gov, and The Cochrane Library. Clinical studies on the effectiveness and safety of PapSEEK published up to February 2019 were reviewed.ResultsThe evidence comprised proof of concept and diagnostic accuracy studies, which showed good preliminary results regarding the accuracy of the test for diagnosing endometrial cancer (sensitivity ranged from 0.81 to 0.93), but not for ovarian cancer (sensitivity ranged from 0.33 to 0.45). The specificity for both tumor types ranged from 0.99 to 1.00. Since PapSEEK uses a sampling method that is routinely used in clinical practice (the Pap smear), no evidence was found in the literature on the safety of the test.ConclusionsPapSEEK is a novel technology developed to diagnose endometrial and ovarian cancer by means of DNA-NGS of Pap smear samples. The identified studies showed good preliminary results regarding the ability of the test to diagnose endometrial cancer, but not ovarian cancer. PapSEEK may be useful as a screening tool for endometrial cancer. However, further research on PapSEEK is needed to prospectively evaluate its diagnostic accuracy, compare it with current tests used in the early diagnosis of both cancer types, evaluate its effect on patient survival and disease progression, and measure its economic impact.
PP265 Application Of A Case-Mix Method For Medical Consumables Management In Anhui Province, China Using Healthcare Big Data
Authors: Tong Lin , Xu Qing-hua , Ye Hong , Zhang Shuang , Cao Chen 
Published: December 2020

IntroductionThe case-mix method involves combining cases with similar complexities and medical services. The process of treating one episode of the disease and receiving treatment is the research unit, thus achieving different medical units. The feasibility of the calculation method is verified by calculating the public hospital consumption ratio, medical income, health materials expenditure indicators, and the differences between the various types of surgical combinations. A decision-making basis can then be provided for the creation of government indicator standards.MethodsMedical records and data on the expenditure of medical consumables for the first and fourth quarters of 2017 were collected from seven third-class provincial hospitals. The medical consumption ratio for different diseases and surgical methods was calculated for the case-mix groups using a weighting method. Data were analyzed by descriptive statistics and the independent samples t-test.ResultsThere were significant differences in the proportions of combined use for different types of diseases. The same combination also had significant differences between different hospitals. In the fourth quarter of 2017, the operating group's consumption ratio was significantly lower than in the first quarter (p = 0.000).ConclusionsIt is reasonable to calculate the proportion of consumption by combined weighted analysis, which is also fairer for hospitals with better technical levels. This calculation method can be used by governments to manage the use and cost of medical consumables in hospitals.
PP268 Eliciting Meaningful Patient Preferences In Rare Diseases – Swing Weighting With Immunoglobulin A Nephropathy Patients In The United States And China
Authors: Marsh Kevin , Zaour Nancy , Ho Kerrie-Anne , Joshi Ankit , Lo Rachel , George Aneesh Thomas , Cook Nigel S. 
Published: December 2020

IntroductionReimbursement agencies are increasingly using patient preference data to evaluate health technologies. Discrete choice experiments (DCE) are commonly used to elicit patient preferences, but they require large sample sizes to obtain meaningful results. For this reason, it is often not possible to use DCE to elicit patient preferences in rare diseases. This study assessed a swing weighting method for eliciting preferences from a small sample: patients with immunoglobulin A nephropathy (IgAN) in the United States (US) and China.MethodsAttributes and levels were selected based on a review of clinical studies and qualitative research on patients. Computer-assisted, interview-based swing weighting exercises were piloted in a focus group with five participants each from the US and China. Preferences were then elicited in interviews with twenty-five patients in the US and fifteen patients in China. Consistency tests were used to assess internal validity. Qualitative data were collected on the reasons for patients’ preferences.ResultsPreference consistency: The weights for one attribute were elicited twice. The difference between initial and consistency test weights was not statistically significant (p < 0.1), although this may partly reflect the small sample sizes. Trade-offs: Qualitative data were used to demonstrate the validity of interpreting participants’ ratings as trade-offs. Using the partial value function for end-stage renal disease as an example, qualitative data demonstrated that patients were able to provide face-valid reasons for different shaped, non-linear preference functions. Robustness of treatment evaluation: Three hypothetical treatment profiles (using the attribute swings) were constructed. Preferences for these treatment profiles were robust to variations in patients’ preferences; all patients preferred one specific profile. This finding was not sensitive to changes in weights.ConclusionsThis study supports the feasibility of collecting valid and robust preference data from small groups of patients using swing weighting. Further work could be done to test the performance of swing weighting in larger sample sizes.
PP329 An Australian Cost-Effectiveness Analysis Of The EluviaTM Drug-Eluting Stent For Treatment Of Symptomatic Lower-Limb Peripheral Artery Disease
Authors: Gray William A. , Ariyaratne Thathya V. , Griffiths Robert I. , Elroy Peter W.M. , Amorosi Stacey L. , Akehurst Ronald L. , McGovern Alysha M. , Müller-Hülsbeck Stefan 
Published: December 2020

IntroductionDespite advances in endovascular interventions, including the introduction of drug-eluting stents (DES), high target lesion revascularization (TLR) rates still burden the treatment of symptomatic lower-limb peripheral arterial disease (PAD). EluviaTM, a novel, sustained-release, paclitaxel-eluting DES, was shown to further reduce TLRs when compared with the paclitaxel-coated Zilver® PTX® stent, in the IMPERIAL randomized controlled trial. This evaluation estimated the cost-effectiveness of Eluvia when compared with Zilver PTX in Australia, based on 12-month clinical outcomes from the IMPERIAL trial.MethodsA state-transition, decision-analytic model with a 12-month time horizon was developed from an Australian public healthcare system perspective. Cost parameters were obtained from the Australian National Hospital Cost Data Collection Cost Report (2016–17). All costs were captured in Australian dollars (AUD), where AUD 1 = USD 0.69 (June 2020). Complete sets of clinical parameters (primary patency loss, TLR, amputation, and death) and cost parameters from their respective distributions were bootstrapped in samples of 1,000 patients, for each intervention arm of the model. One-way and probabilistic sensitivity analyses were performed.ResultsAt 12 months, modeled TLR rates were 4.5 percent for Eluvia and 8.9 percent for Zilver PTX, and mean total direct costs were AUD 6,537 [USD 4,511] and AUD 6,908 [USD 4,767], respectively (Eluvia average per patient savings; overall cohort=AUD 371 [USD 256]; diabetic cohort=AUD 625 [USD 431]). In probabilistic sensitivity analyses, Eluvia was cost-effective relative to Zilver PTX in 92.0 percent of all simulations at a threshold of $10,000 per TLR avoided. Eluvia was more effective and less costly (dominant) than Zilver PTX in 76.0 percent of simulations.ConclusionsIn the first year after the intervention, Eluvia was more effective and less costly than Zilver PTX, making Eluvia the dominant treatment strategy for treatment of symptomatic lower-limb PAD, from an Australian public healthcare system perspective. These findings should be considered when formulating policy and practice guidelines in the context of priority setting and making evidence-based resource allocation decisions for treatment of PAD in Australia.