EFFECTIVENESS AND SAFETY OF MACITENTAN IN THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION

EFFECTIVENESS AND SAFETY OF MACITENTAN IN THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION

A83 VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8 blocking method was able to retain 99.5% of possible matches, while maintaining at mos...

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VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8

blocking method was able to retain 99.5% of possible matches, while maintaining at most 50 comparisons per batch record, representing a reduction of 99.995% in the number of comparisons compared to a naïve search strategy. As more errors were introduced into the dataset, the rate of retention decreased, while the 50 comparisons per batch record remained constant.  Conclusions: Our algorithm significantly reduced the number of comparisons while retaining almost all matches. The string distance measures were significantly more effective at identifying matching records than deterministic decision rules. To efficiently match error prone records, a record blocking stage is required. PRM66 INSIGHTS FOR CARE: BUILDING A PSEUDONYMISED, LINKED, CROSS-SETTING REAL-WORLD EVIDENCE LAB IN BIRMINGHAM, UNITED KINGDOM Foxcroft R 1, Chapman D 1, Yassa L 1, Bidgoli F 2, Cooke M 3, Bellary S 3, Ronte H 1 Deloitte, London, UK, 2Merck Sharp & Dohme Limited, Hoddesdon, UK, 3Heart of England NHS Foundation Trust, Birmingham, UK .

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1Monitor

Objectives: Heart of England NHS Foundation Trust (HEFT) (Birmingham, UK), Merck Sharp & Dohme Limited and Monitor Deloitte have collaborated to establish the Insights for Care (IfC) Partnership to build the largest Real-World Evidence Lab in the UK, initially focusing on diabetes mellitus and non-small cell lung cancer (NSCLC). IfC works with primary, secondary, tertiary and community pharmacy providers within a Birmingham urban local health economy (LHE) to link pseudonymised (non-identifiable) patient-level clinical and administrative data. The Partnership is anticipated to operate until November 2018, with quarterly data refresh to permit retrospective and prospective studies.  Methods: The dataset covers all LHE patients diagnosed with diabetes or NSCLC since 2008, and captures preand post-diagnosis interactions with the NHS. Records include healthcare activities (e.g., dates and procedures), clinical information (e.g., diagnoses and pathology) and prescribing data. In addition to a SQL-based technological architecture, IfC incorporates a rigorous Information Governance framework (including Health Regulatory Authorisation liaison), inter-party governance processes and patient engagement. All patient identifiable information is pseudonymised or removed within the NHS before it is transferred to Monitor Deloitte. Prior to data extraction and at any time patients may opt out of data sharing, while all usage of the dataset is controlled by a multi-stakeholder Governance Board.  Results: The IfC team have overcome multiple challenges to establish this cross-industry and cross-care setting partnership. The Real-World Evidence Lab provides more comprehensive coverage of patient activity than existing research datasets (e.g., HES or CPRD), capturing key treatments such as dialysis, high-cost cancer drugs, and specialist diabetes services, and is the only such dataset incorporating community pharmacy.  Conclusions: IfC creates a unique opportunity to understand the local population and their care pathways with more granularity than previously possible, while the cross-provider nature of IfC creates opportunities to collaboratively address LHE improvement opportunities. PRM67 VIRTUAL CONSULTATION SYSTEM: A WEB-BASED PLATFORM TO ASSESS COMPLEX CLINICAL CASES THROUGH SHARING OF DIAGNOSTIC IMAGES AND REPORTS Saraceno D 1, Ortali M 1, Covezzoli A 1, De Rosa M 1, Czauderna P 2 Interuniversity Consortium, Casalecchio di Reno, Italy, 2Medical University of Gdansk, Gdansk, Poland .

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1CINECA

Objectives: Diagnostic images and reports are essential to diagnose a wide range of conditions and diseases. Experience at individual treatment centers is limited and research efforts are often fragmented, and, furthermore, patient series are relatively small, even at multicenter level. In such setting central review of diagnosis and treatment is frequently offered in order to evaluate difficult cases.  Methods: Cineca developed a secure web-based platform in collaboration with representatives from several Pediatric Oncology International Associations (SIOPEL, GPOH, COG, and JPLT). The efforts were supported by a grant from FP7 EU-funded Project ENCCA (European Network for Cancer Research in Children and Adolescents). The platform named Virtual Consultation System is an innovative tool aimed to collaborative review clinical cases with the possibility to share images in high quality, providing a tool for easily transfer files of big size.  Results: The web systemsupports researchers in management of complex clinical cases through online consultations among experts world-wide and integrates tools for Tumor Board review. Consultation process is completely managed through structured data (e-CRFs) and final opinion is sent back to the requesting physician through the platform. Patient data and images are stored electronically in a database through a secure web infrastructure for research/ training/elearning and the platform includes an integrated DICOM browser for radiology and virtual microscope for pathology without quality loss. The tool is also fully integrated with a videoconferencing system. The main output is a report containing the collective findings, conclusions and recommendations for the further treatment of the patient.  Conclusions: Virtual Consultation System can be considered a very valuable tool for case consultation and tumor board where clinicians need to share expertise and get consultation from other colleagues in different areas of the world in order to facilitate access to the best expert care to all children with cancer or rare disease in Europe without travelling.

class II, III or IV from WHO.  Methods: Systematic review of the literature. It was included systematic reviews, Meta-analyzes and randomized clinical trials comparing placebo and macitentan in outcomes such as morbi-mortality, death or hospitalization for PAH, adverse events and serious adverse events. The quality of the evidence was evaluated by the GRADE tool and the risk of bias in clinical trials with the Cochrane methodology.  Results: A randomized, double-blind, with 492 participants (115 weeks follow-up period) was found and comparing macitentan vs. placebo, obtaining results such as morbidity and mortality: HR 0.55 (CI 97.5%; 0.39 to 0.76), absolute risk reduction of 16.65% (95% CI 7.86 - 25.07). Mortality or hospitalization: HR 0.50 (CI 97.5%, 0.34 -0.75; P < 0.001) absolute risk reduction 15.23% (95% CI 6.67 - 23.5). Serious adverse events (at least 1 per patient): RR 0.82 (95% CI 0.68 to 0.98), absolute risk reduction 9.98% (95% CI 1.14 - 18.60).  Conclusions: Patients treated for 115 weeks with macitentan had a 16.65% reduction in the occurrence of death outcomes, atrioseptostomy, lung transplantation, initiation of therapy with prostanoids or worsening of pulmonary arterial hypertension. Similarly, with the use of macitentan there is an absolute risk reduction of 15.23% for the outcome death or hospitalization for PAH. Serious adverse events are presented 10% less in patients treated with macitentan. PRM69 AN OPEN-SOURCE ANALYTIC VISUALIZATION PACKAGE FOR COMPLEX TREATMENT PATTERNS IN R Wilson J B 1, Korol E 1, Goring S J 2, Tao R 1, Goring S 1 Consulting, Vancouver, BC, Canada .

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1ICONplc, Vancouver, BC, Canada, 2Dash

Objectives: Understanding real world treatment patterns can be challenging. Many different treatment pathways exist for patients; treatment regimens may change through additions, discontinuations, dosage modifications, and switches between agents within or across drug classes. Changes to treatment regimens may be related to new treatments coming to market, treatment tolerability or effectiveness, changes in disease severity, cure, or death; and missing data further increases complexity. Treatment intricacy reduces the adequacy of tabular data representations, and may obscure broad-scale trends. Our objectives were: 1) to develop a package of well-constructed graphical representations to enable a clear understanding of patterns of care and facilitate identifying gaps in care and areas needing improved management; and 2) to display the package outputs using simulated data.  Methods: We conducted a literature review to identify the types of graphical representations currently used for displaying treatment patterns, and to detect gaps in data representation. Based on our findings, we developed an open-source R package, to facilitate analysis of treatment data through a family of customizable data visualizations, including a set of visualizations newly applied to treatment pattern data. We demonstrate its output using simulated data for 1,000 hypothetical patients.  Results: We present fully worked examples from simulated data to demonstrate the power of these data visualization techniques for representing the complexities of treatment patterns in visually appealing and easy-to-interpret plots.  Conclusions: This approach to data visualization can be applied to realworld data to help decision makers and practicing physicians understand how individuals’ treatments are changing over time and allow them to make informed decisions about patient care. The open source nature of the package helps support broader access, and an open framework for feedback, continued innovation and interoperability with other R packages. It will be of particular benefit in representing treatment data from difficult-to-treat and refractory patients. PRM70 CURATING AN ELECTRONIC HEALTH RECORD RESEARCH QUERY DEFINITION LIBRARY Lohnes M 1, Parker C 2, Kamauu A W 1 1Anolinx LLC, Salt Lake City, UT, USA, 2Intermountain Healthcare, Logan, UT, USA .

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Simbaqueba E 1, Gomez L M 2, Huerfano C 3, Tamayo C 1, Palomino R A 1 1Health-e International, Bogota, Colombia, 2Biotoscana Farma, Bogota, Colombia, 3Universidad Nacional de Colombia, Bogota, Colombia

Objectives: Widespread adoption of electronic health records (EHRs) results in a wealth of data in structured/codified and unstructured/uncodified electronic formats. Research studies seeking to use these data require translation of narrative research protocols into EHR-friendly queries. This involves interpretation of the protocols, distillation into distinctive query-level components and determination of appropriate code value sets (list of ICD-9 codes, procedure codes, medication codes, etc.). In addition, for studies conducted across multiple disparate EHR data sources, it is essential to ensure queries are conducted in a consistent and comparable manner. EHR-friendly query definitions provide the necessary granularity of information needed to conduct consistent queries across multiple EHR data sources. The objective is to develop and demonstrate the value of a curated EHR research query definition library to improve efficiency of EHR research queries.  Methods: A standard format for electronic research query definitions was established following federal EHR certification standards. A logic format was developed to articulate the research protocol into informaticist terms that lead to data analyst-friendly query statements. Healthcare industry standard vocabulary terminologies are used to develop code value sets. A hosting library was developed to maintain version control and repurposing of developed definitions.  Results: Our query definition format, content and time-savings were validated through an iterative process with multiple healthcare informatics systems across a variety of disease therapy areas, including but not limited to: cardiovascular, CNS/neurology, metabolics, nephrology, oncology, pulmonology/respiratory, etc.  Conclusions: An EHR-compatible format for research query definitions expedites the process of data query and analysis. Our Query Definition Library of protocol-specific validated query definitions standardizes queries and expedites future definition development. It also provides ready access to curated standardized EHR-compatible research query definitions to support clinical research studies.

Objectives: To determine the effectiveness and safety of macitentan in the treatment of patients older than 12 years diagnosed with hereditary or idiopathic pulmonary hypertension or pulmonary arterial hypertension related to a) connective tissue disease, b) congenital systemic-to-pulmonary shunts c) infection HIV, d) the use of drugs or toxic exposure. These patients should would find in functional

PRM71 USING READILY AVAILABLE ADMINISTRATIVE DATA ELEMENTS TO PREDICT FUTURE MEDICATION NON-ADHERENCE AMONG COPD PATIENTS WITH EMPLOYER-SPONSORED INSURANCE

PRM68 EFFECTIVENESS AND SAFETY OF MACITENTAN IN THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION .

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