• Title/Summary/Keyword: Real world evidence

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Establishment of an International Evidence Sharing Network Through Common Data Model for Cardiovascular Research

  • Seng Chan You;Seongwon Lee;Byungjin Choi;Rae Woong Park
    • Korean Circulation Journal
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    • v.52 no.12
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    • pp.853-864
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    • 2022
  • A retrospective observational study is one of the most widely used research methods in medicine. However, evidence postulated from a single data source likely contains biases such as selection bias, information bias, and confounding bias. Acquiring enough data from multiple institutions is one of the most effective methods to overcome the limitations. However, acquiring data from multiple institutions from many countries requires enormous effort because of financial, technical, ethical, and legal issues as well as standardization of data structure and semantics. The Observational Health Data Sciences and Informatics (OHDSI) research network standardized 928 million unique records or 12% of the world's population into a common structure and meaning and established a research network of 453 data partners from 41 countries around the world. OHDSI is a distributed research network wherein researchers do not own or directly share data but only analyzed results. However, sharing evidence without sharing data is difficult to understand. In this review, we will look at the basic principles of OHDSI, common data model, distributed research networks, and some representative studies in the cardiovascular field using the network. This paper also briefly introduces a Korean distributed research network named FeederNet.

Clinical Application of Digital Therapeutics for Insomnia (불면증 디지털 치료제의 임상 적용)

  • Cho, Chul-Hyun
    • Sleep Medicine and Psychophysiology
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    • v.28 no.1
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    • pp.6-12
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    • 2021
  • Insomnia is one of the most common sleep disorders experienced by modern people, and treatment is often not adequate due to various limitations. Digital therapeutics for insomnia are expected to play a revolutionary role in supplementing and satisfying unmet needs in real-world clinical treatment. Digital therapeutics for insomnia were developed based on cognitive-behavioral therapy for insomnia, which is the first standard treatment for insomnia. The effectiveness of digital therapeutics for insomnia developed by several companies has been proven through well-designed clinical research. Various approaches have been used for practical application of digital therapeutics for insomnia. Thus far, meaningful results have been drawn, but there are areas that need to be improved upon based on real-world evidence. Sleep researchers need to validate the safe and effective application of digital therapeutics for the treatment of insomnia.

Structural Breaks, Manufacturing Revolutions, and Economic Catch-up: Empirical Validation of Historical Evidence from South Korea

  • SALAHUDDIN, Taseer;YULEK, Murat A.
    • The Journal of Asian Finance, Economics and Business
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    • v.9 no.1
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    • pp.13-24
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    • 2022
  • The main goal of this study is to look at how South Korea can catch up to the rest of the world through policy-driven structural change and manufacturing revolutions. To achieve the objective, this study used annual data on real exports and real GDP from the World Development Indicator WDI of South Korea for the period 1960 to 2019. The study's goal is to use econometrics to detect this policy-driven structural change trend. Multiple nonlinear Granger causality test was used to accomplish this. The findings revealed structural breaks and nonlinearities in the dynamic link between South Korea's real GDP and real exports. Furthermore, results also show evidence of multiple structural breaks in South Korean data. South Korea's economic catch-up was the result of a constant reevaluation of industrial policies, readjustment, and structural change to constantly explore and utilize comparative advantage, realizing economies of scale at the global level, and reallocating and redistribution of resources towards productive sectors with high value-added output, according to econometric analysis. If South Korea would have not done this structural change this miracle to escape the middle-income trap would not have been possible. These findings support the descriptive evidence of structural change in favor of manufacturing revolutions and value addition industry development in South Korea.

Regulatory innovation for expansion of indications and pediatric drug development

  • Park, Min Soo
    • Translational and Clinical Pharmacology
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    • v.26 no.4
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    • pp.155-159
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    • 2018
  • For regulatory approval of a new drug, the most preferred and reliable source of evidence would be randomized controlled trials (RCT). However, a great number of drugs, being developed as well as already marketed and being used, usually lack proper indications for children. It is imperative to develop properly evaluated drugs for children. And expanding the use of already approved drugs for other indications will benefit patients and the society. Nevertheless, to get an approval for expansion of indications, most often with off-label experiences, for drugs that have been approved or for the development of pediatric indications, either during or after completing the main drug development, conducting RCTs may not be the only, if not right, way to take. Extrapolation strategies and modelling & simulation for pediatric drug development are paving the road to the better approval scheme. Making the use of data sources other than RCT such as EHR and claims data in ways that improve the efficiency and validity of the results (e.g., randomized pragmatic trial and randomized registry trial) has been the topic of great interest all around the world. Regulatory authorities should adopt new methodologies for regulatory approval processes to adapt to the changes brought by increasing availability of big and real world data utilizing new tools of technological advancement.

Data-Linking Infrastructure for the Health Technology Assessment (의료기술평가 기반으로서의 데이터 연계)

  • Park, Chong Yon
    • The Journal of Health Technology Assessment
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    • v.6 no.2
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    • pp.81-87
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    • 2018
  • With the recent change of healthcare environment including rapid technological development, evidences are more and more important and necessary to support relevant policies in health technology assessment to provide safe and effective health services, utilizing medical resources efficiently. Despite of the emphasis on the importance of real world data and real world evidence in health care research, current infrastructure supporting clinical research is considerably weak due to absence of legal and institutional basis. However, in accordance with the Article 26 of the Health and Medical Technology Promotion Act, there is a limited legal apparatus that can be used only in public data with other dataset for the purpose of healthcare technology assessment at the National Evidence-based Collaborating Agency. Although the use of linked data from various sources was often required in the field of clinical research, it was not yet working well due to insufficient environmental conditions. In order to support the decision-making of medical practice and health care policies, data-linking platform for clinical research is needed. If the legal system that can link up to the data of the private institutions without violating the significant value such as the protection of private informations is established, it will be a decisive foundation reinforcing the researches and policy making processes for the improvement of the national health care system.

Should TPP Be Formed? On the Potential Economic, Governance, and Conflict-Reducing Impacts of the Trans-Pacific Partnership Agreement

  • Bergstrand, Jeffrey H.
    • East Asian Economic Review
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    • v.20 no.3
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    • pp.279-309
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    • 2016
  • The proposed Trans-Pacific Partnership (TPP) is a free trade agreement among 12 Pacific Rim countries whose joint gross domestic products (GDPs) account for 36 percent of world GDP and whose mutual trade accounts for approximately 24 percent of world trade. As for most proposed free trade agreements (FTAs), trade economists have provided ex ante computable general equilibrium (CGE) estimates to predict the trade, employment, and real per capita income effects of this agreement, such as ITC (2016). This paper-intended to complement these studies-examines the potential impacts of TPP beyond such traditional CGE estimates, taking a broader economic, governance, and historical perspective. First, we contrast these traditional CGE trade and welfare estimates that treat all firms within an industry as homogeneous with more recent CGE analyses that allow firms' productivities to be heterogeneous. We show that the latter models' trade predictions are much more consistent with ex post empirical evidence of average trade effects of FTAs. Second, empirical evidence now strongly confirms the existence of FTA "contagion." We review this evidence and show that predictive models of the evolution of FTAs indicate that the TPP should be formed. With China now having formed 12 FTAs and negotiating five new ones (including a sixteen member Asia-Pacific FTA), the United States would likely face considerable trade diversion without the TPP. Third, we examine empirical evidence on the likely further economic growth implications of FTAs by reducing firms' uncertainty over trade relations and trade policies. Fourth, we examine empirical evidence on the additional impact of FTAs on consolidating democratic institutions in countries. The TPP would likely help consolidate some of the less mature democracies. Fifth, we examine empirical evidence on the reductions of conflicts (and enhanced peace) between countries owing to the formations of FTAs. We conclude the paper noting that the potential net benefits to member countries of the proposed TPP extend well beyond the real income gains to households based upon traditional CGE models.

Understanding of Clinical Trials and Application to the Real Practice (임상시험의 단계별 이해 및 실제)

  • Choi, SungKu
    • Korean Journal of Biological Psychiatry
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    • v.19 no.4
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    • pp.153-158
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    • 2012
  • Understanding of a clinical trial is essential in developing clinical guideline and adopting evidence based practice. In designing and executing clinical trials, following ethical requirements should be considered : social value, scientific validity, fair subject selection, informed consent, favorable risk-benefit ratio, institutional review board, and respect for human subjects. According to the stage of drug development, purpose of trials, accumulated scientific data, clinical trials for drug development are classified as phase 1, 2, 3, and 4. Phases of clinical trials can be overlapped and the judgment of entering into the next phase should be considered highly strategically. In reading, evaluating and interpreting clinical trial reports, various skills and challenges exist. Patient sample composition, trial duration, selection of endpoints, responders and non-responders, placebo effect, patient recruitment, and extrapolation to the real world are the examples of those challenges. Treatment success will come from the well balanced approach of evidence based decision making and consideration of specific single case.

Instrumentation on structural health monitoring systems to real world structures

  • Teng, Jun;Lu, Wei;Wen, Runfa;Zhang, Ting
    • Smart Structures and Systems
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    • v.15 no.1
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    • pp.151-167
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    • 2015
  • Instrumentation on structural health monitoring system imposes critical issues for applying the structural monitoring system to real world structures, for which not only on the configuration and geometry, but also aesthetics on the system to be monitored should be considered. To illustrate this point, two real world structural health monitoring systems, the structural health monitoring system of Shenzhen Vanke Center and the structural health monitoring system of Shenzhen Bay Stadium in China, are presented in the paper. The instrumentation on structural health monitoring systems of real world structures is addressed by providing the description of the structure, the purpose of the structural health monitoring system implementation, as well as details of the system integration including the installations on the sensors and acquisition equipment and so on. In addition, an intelligent algorithm on stress identification using measurements from multi-region is presented in the paper. The stress identification method is deployed using the fuzzy pattern recognition and Dempster-Shafer evidence theory, where the measurements of limited strain sensors arranged on structure are the input data of the method. As results, at the critical parts of the structure, the stress distribution evaluated from the measurements has shown close correlation to the numerical simulation results on the steel roof of the Beijing National Aquatics Center in China. The research work in this paper can provide a reference for the design and implementation of both real world structural health monitoring systems and intelligent algorithm to identify stress distribution effectively.

Trend and Implication of Primary Care Evaluation in U.S. (미국의 일차의료 평가 동향 및 시사점: 미국의 리얼월드 평가 안내서를 중심으로)

  • Suh, Youshin;Kim, Hee-Sun;Yoo, Bit-Na;Kim, Jin-Hee;Park, Chong Yon
    • The Journal of Health Technology Assessment
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    • v.6 no.2
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    • pp.88-94
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    • 2018
  • This review aims to provide implications for relevant domestic policies and researches from Patient-Centered Medical Home (PCMH), a reinforcement model for primary care and its evaluations in the United States. As chronic diseases became dominant, changes in the health care delivery system in which primary care is central was required. The United States initiated primary care-reinforcing policies based on the PCMH following the increased demand for evidence-based health care policies. The current activities of the United States such as sharing research tools used to evaluate primary care interventions and circulating evaluation findings provide examples to Korea. Systematic evaluations for primary care interventions are required and appropriate methods using various types of data to reflect the real-world settings should be prepared. It is necessary to conduct policy assessment studies of public interests considering regional context. Support for the researches to make and advance from the existing environment must be examined.

Treatment Strategies of Improving Quality of Care in Patients With Heart Failure

  • Se-Eun Kim;Byung-Su Yoo
    • Korean Circulation Journal
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    • v.53 no.5
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    • pp.294-312
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    • 2023
  • Heart failure (HF) is a global health problem closely related to morbidity and mortality. As the burden of HF increases, it is necessary to manage and treat this condition well. However, there are differences between real-world practice and guidelines for the optimal treatment for HF. Patient-related, healthcare provider-related, and health system-related factors contribute to poor adherence to optimal care. This review article aims to examine HF treatment patterns and treatment adherence in real-world practice, identify clinical gaps to suggest ways to improve the quality of care for HF and clinical outcomes for patients with HF. Although it is important to optimize treatment based on evidence-based guidelines to the greatest extent, it is known that there is still poor treatment adherence, and many patients do not receive guideline-directed medical therapy, especially at the early stages. To improve medication adherence, qualitative evaluation through performance measurement, as well as education of patients, caregivers and medical staff through a multidisciplinary approach are important.