Journal of the National Institute of Public Health
Online ISSN : 2432-0722
Print ISSN : 1347-6459
ISSN-L : 1347-6459
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Toward introduction of CDISC to clinical research and public health
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  • Type: Preface
    2019 Volume 68 Issue 3 Pages 193
    Published: 2019
    Released: September 14, 2019
    JOURNALS OPEN ACCESS
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  • David R. Bobbitt, Bess LeRoy, Amy Palmer, Mike Hamidi, Rhonda Facile, ...
    Type: Review
    2019 Volume 68 Issue 3 Pages 194-201
    Published: August 01, 2019
    Released: September 14, 2019
    JOURNALS OPEN ACCESS

    More than 20 years ago, data scientists, statisticians, and researchers met to develop the data standards to facilitate the submission of clinical research results to the regulatory authorities; it is the beginning of the Clinical Data Interchange Standards Consortium (CDISC). The data to prove the safety of medicines and medical devices has wide-ranged requirements concerning the origin of data, methods of data collection, data tabulation method, consistency of contents. So CDISC has various standards such as SEND, CDASH, SDTM, ADaM, and ODM to support clinical research protocol. As a result of collaborating with other researcher groups and maintaining the standard, it has been endorsed by regulators around the world and has become the global standard for clinical research. The Pharmaceuticals and Medical Devices Integration Agency (PMDA) in Japan, and the U.S. Food and Drug Administration (FDA) in the United States make the obligation to the submission of clinical trial data with CDISC standards. Furthermore, in recent years, the CDISC Library in machine-readable format has been released so that the developers can automatically generate programs and data conforming to the CDISC standard, and implementation trials with CDISC Library are being conducted by volunteers of the CDISC 360 project. The scope of CDISC is extended to general clinical research now. Therapeutic Area User Guides (TAUGs) covers clinical research on tumors, vascular diseases, neurological diseases, infections etc. The National Cancer Institute (NCI), the world's largest funding agency, built the Cancer Data Research Commons (CDRC), the platform for sharing data submitted by researchers. The stored data is required to comply with CDISC standards. As the CDISC standard is the comprehensive standard for data quality control and research management, it is infiltrating all area related to medical research that develop new, safe, and effective medical devices and treatment methods. CDISC may contribute to further acceleration to research and development. Real Word Data (RWD) also tends to have low quality, but it is expected that quality will be improved by incorporating CDISC standards into management of these data. CDISC is taking into consideration the use of observational research.

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  • Takahiro Kiuchi
    Type: review-article
    2019 Volume 68 Issue 3 Pages 202-211
    Published: 2019
    Released: September 14, 2019
    JOURNALS OPEN ACCESS

    Overview of CDISC Standards: Although CDISC (Clinical Data Interchange Standards Consortium) Standards were initially developed as specifications for electronic regulatory submission of new drugs in the United States, they now cover all areas of electronic clinical research data manipulation. Due to regulations of the FDA (Food and Drug Administration) and PMDA (Pharmaceuticals and Medical Devices Agency), CDISC Standards have become popular in pharmaceutical companies all over the world. Academia has the advantage over pharmaceutical companies concerning the application of CDISC Standards to EDC (Electronic Data Capture) and data extraction from EHR (Electronic Health Record), because it is not subject to strict regulatory rules.

    Past achievements of Japanese academia concerning CDISC application and current status: Japanese academia actually preceded the United States concerning the actual application of CDISC Standards. For example, UMIN (University hospital Medical Information Network) and Fukushima Medical University succeeded in performing the first actual clinical trial using CDISC-based EDC in the world, and Shizuoka Cancer Center Hospital was the first in the world to extract CDISC ODM (Operational Data Model)-based data from its EHR. In spite of the prior achievements, the application of CDISC Standards for clinical research have not since prevailed in Japan. A specification for electronic exchange of clinical trial data, InterMediate Electronic Standard (IMES), was developed, but it was not promoted internationally in English, and thus could not in any way compete with CDISC Standards as international standard. When it was clear that the adoption of IMES was obsolete, SS-MIX, which was a Japanese local standard developed for healthcare information exchange, came to be used for clinical research data manipulation.

    Future applications of CDISC Standards in Japan: It should be emphasized that, if we develop a standard specification, we ought to aim for an international, not local, standard by promoting it to the world and that we should abandon our standard specification if it cannot be an international standard. From this viewpoint, we should strongly promote the application of CDISC Standards for clinical research in Japan. Academic institutions should lead the promotion, using public and other funds.

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  • Eizen Kimura, Satoshi Ueno
    Type: review-article
    2019 Volume 68 Issue 3 Pages 212-218
    Published: 2019
    Released: September 14, 2019
    JOURNALS OPEN ACCESS

    Abstract Swift data collection and response across borders become urgent issues in various fields, and the public health sector is no exception. It is necessary to develop and disseminate elemental technology to realize an environment that enables high-quality data collection and management conforming clinical research proto col; collection, integration, and analysis of data in various scenes, and can be released in real-time through standardization of information content and exchange methods. In this paper, we introduce the historical background and development philosophy of FHIR and CDISC standards as the main-stream medical infor mation standards and the use cases in the field of public health with these standards. A promising approach in the field of public health in the future is to operate FHIR for collecting information originating from healthcare settings and CDISC standards for surveillance in general.

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  • Satoshi Ueno, Reiko Shimizu, Harumasa Nakamura
    Type: review-article
    2019 Volume 68 Issue 3 Pages 219-228
    Published: 2019
    Released: September 14, 2019
    JOURNALS OPEN ACCESS

    Many neuromuscular diseases, including muscular dystrophies, are intractable and rare, and the development of effective treatments is required. In order to develop new drugs/treatments, it is necessary to gather data such as patient background information and symptoms. A patient registry (disease registration system) can register patient information and provide epidemiological data of patients to governments, researchers and pharmaceutical companies. In addition, the data collected in a patient registry enables pharmaceutical companies to understand the patient’s situation and provide patients with clinical trial information and information on new drug development. In the area of neuromuscular diseases, TREAT-NMD (Treat NeuroMuscular Disease) was established in Europe in 2007 as an international initiative, and a patient registry was launched as one of its activities. Following TREAT-NMD, in 2009, the muscular dystrophy patient registration system (Registry of Muscular Dystrophy: Remudy) was instituted in Japan, and the patient registry is currently being operated by National Center of Neurology and Psychiatry. The Clinical Innovation Network (CIN) is an infrastructure for clinical development that utilizes disease registration information such as patient registries. Since 2016, CIN has been developing and operating an efficient clinical trial using disease registration information and infrastructure that enables the utilization of real-world data (RWD). Remudy has been harmonized with TREAT-NMD. Data standardization is useful for promoting international data utilization, and it is widely used at present, considering the use of application data for approval. For the purposes, it is essential to use certain international standards. The CDISC standards are international guidelines used in medical research with a consistent specification for planning, data collection, data tabulation, and analysis, and they are also used as a standard for approval application data. In addition, CDISC also publishes for each Therapeutic Area (TA) Standards such as Duchenne muscular dystrophy (DMD). When considering the utilization of RWD, it is important to use the CDISC standards because they can ensure data traceability and contribute to quality control of data through standardization. However, CDISC standards are not universal, and it is necessary to consider the research system and environment, such as through comparison of other domestic and international standards, measurement methods in clinical practice, measurement environments, evaluation indices, and so on. This paper describes a patient registry and standardization in the area of neuromuscular diseases as a case study to activate data utilization.

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  • Shinji Kobayashi
    Type: Review
    2019 Volume 68 Issue 3 Pages 229-234
    Published: 2019
    Released: September 14, 2019
    JOURNALS OPEN ACCESS

    Recently, so called Big Data has been remarked upon as a resources of machine learning-based artificial intelligence. Moreover, healthcare data have been integrated for clinical use and secondary use, including clinical research, public health, and so on.

    However, the lack of interoperability has blocked the reuse of clinical data. Standardization of terminology will improve the efficiency of data collection, data quality, and reuse of data.

    In this article, we describe the problems that exist in processing clinical data with machines using terminology and concept models.

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  • Yoshihiro Aoyagi
    Type: review-article
    2019 Volume 68 Issue 3 Pages 235-239
    Published: 2019
    Released: September 14, 2019
    JOURNALS OPEN ACCESS

    Many discussions on secondary use of data are being conducted according to the computerization of medical information. Particularly in the R&D field, real world data is expected to reduce development costs and improve quality. Some countries require the provision of clinical data during the reimbursement procedure. What is important when using data secondarily is data standardization. HL7 is the standards that is often mentioned when using electronic health record, but CDISC standardization is more necessary when conducting R&D. Here we report an approach about the CDISC standardization of electronic health records to use in R&D. Furthermore, we introduce other efforts in Japan and other countries. CDISC standardization of electronic health records makes efficiency and reliability improvement in the process from generation points of data to analysis, whereas there are some restrictions and issues in applying the CDISC Standards to electronic health records. In this paper, we report these pros and cons and discuss the prospects in the standardization of them.

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Article
  • Soichiro Kato, Yoshihiro Yamaguchi
    Type: Commentary
    2019 Volume 68 Issue 3 Pages 240-249
    Published: 2019
    Released: September 14, 2019
    JOURNALS OPEN ACCESS

    Japan has developed specialized procedures for responding to earthquakes and typhoons prior to other events because of its geopolitical status. However, public health emergency preparedness targets have exponentially widened to include various objectives, including management of vulnerable persons, under several types of disaster events, which occasionally occur in combination. Recently, the United States of America (USA) and several European countries have reformed their emergency preparedness to confront the situation of terrorism and health pandemics. These efforts are expected to develop to systematic plans based on high-level information sharing and inter- and intra-national cooperation. Establishment and amendment of applicable laws have had huge effects on the framework in each country. Therefore, in this article, we review the Pandemic and All-Hazards Preparedness Act (PAHPA), its reauthorization act, and articles reporting related procedures in USA. PAHPA mandated the Department of Health and Human Services in the USA to assume a leading role to strengthen public health emergency preparedness and reform the nation's overall health security strategy. The act explicitly describes setting priorities, efficiently solving problems, ensuring surge capacity needs are met, among other activities. These reforms out of the USA suggest that laws related to an all-hazards approach could effectively guide public health emergency preparedness by enhancing cooperation, developing information technology utilization, setting targets, and distributing emergency preparedness budgets.

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  • Keiko Natsume, Manabu Ichikawa, Hiroko Okuda, Hiroshi Yoshida, Yasuhir ...
    Type: Research Data
    2019 Volume 68 Issue 3 Pages 250-258
    Published: 2019
    Released: September 14, 2019
    JOURNALS OPEN ACCESS

    The uneven distribution of disaster relief services during the Great East Japan Earthquake of 2011 has been criticized. Moreover, timely and appropriate distribution of disaster relief services was not successfully completed during the Kumamoto Earthquake. Consequently, the Ministry of Health, Labour and Welfare decided to construct a plan for healthcare and medical support in preparation for large-scale disasters. In this study, we applied simulation technology, tabletop exercise scenarios in which stakeholders are able to quantitatively assess healthcare and medical support needs of every hospital and shelter. The participating stakeholders in this tabletop exercise examined the current local Government’s disaster system from the acute to chronic phases. Thus, we elucidate how the tabletop exercise was developed and identify the issues that were extracted after the exercise to improve the community’s resilience to disaster.

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  • Hiroko Okuda, Tetsuji Yokoyama, Fumi Takeda, Tomofumi Sone
    Type: Original
    2019 Volume 68 Issue 3 Pages 259-269
    Published: August 01, 2019
    Released: September 14, 2019
    JOURNALS OPEN ACCESS

    Objectives: This study aimed to clarify the process of coping with conflicts as recognized by managers of Public Health Nurses (PHNs) when assessing on-the-job performance.

    Methods: We conducted semi-structured interviews with eight PHN managers from different organizations (e.g., municipalities) and positions. All participants were selected through snowball sampling conducted from December 2017 to March 2018. All resulting data were analyzed according to a qualitative descriptive methodology.

    Results: The average number of years of experience of PHNs was 31.5 years and average number of years of experience of PHNs managers was 10.5 years. Of the eight participants, three worked in prefectures, three worked in city ordinance and core city capacities, and two worked in municipalities. Further, two were managers, four were chiefs, and two were chiefs-of-directors. Interviewees discussed a total of 18 job-related events. Among these, the target conflicts were related to eight “PHN,” followed by seven “clerk,” and three “other.” Regarding the positions involved, there were eight “supervisors (top),” four “subordinates,c three “equivalent,” and three “other.” Conflicts were caused by various factors, including reviews of existing work and activity structures, new work, and capacity developmental methods. A category analysis was also conducted based on the actual focuses of conflict recognition and coping. A category analysis based on the actual focuses of conflict recognition and coping revealed that “preparation for conflict recognition and coping” contained 17 subcategories, eight categories, 21 subcategories, 10 categories, three subcategories for “coping behavior for resolving differences,” and two categories were extracted as “coping process management.” Results indicated that PHNs attempted various strategies after recognizing conflicts, including [Clarifying the actual differences of opinion] and [Early corresponding regarding potentially undesired situations]. Attempted conflict resolutions included [Building trust], [Interventions that considered the standpoints of the other party], [Qualifying opportunities], and [Finding compromises]. Additionally, PHNs aimed to alleviate problems by [Establishing a system of progress management]and [Conducting evaluations and providing feedback].

    Conclusion: The interviewed PHNs managers were aware of conflicts between various subjects both in and outside their organizations. These results suggest the importance of effective actions, including direct problem interventions, the elucidation of perceived conflict factors, the careful implementation of preemptive measures, efforts to understand and evaluate progress, and situational feedback.

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  • Kota Ninomiya, Hiroshi Mizushima, Hideaki Kinoshita, Kyoko Imamura
    Type: Report
    2019 Volume 68 Issue 3 Pages 270-278
    Published: 2019
    Released: September 14, 2019
    JOURNALS OPEN ACCESS

    Although Japan started taking measures against intractable and rare diseases earlier than other countries, the performance of Japan's research on such diseases has been low compared with Western countries. However, as most of such diseases are inheritable and some are unevenly distributed among regions, Japan needs to improve its research performance in this field, considering that it is the only Asian country developing new drugs. Further, the number of Designated intractable/rare diseases has increased since the Act on Medical Care for Patients with Intractable/Rare Diseases was implemented. Moreover, Japanese medical researchers now need to find treatments for more diseases with a small budget compared to the budget of Western countries; consequently, they must improve their research performance.

    Therefore, this study first revealed the factors that significantly affect Japan's research expenses on intractable and rare diseases by using multiple regression analysis. Research materials were mainly reports from research groups supported by Health and Labour Sciences Research Grants for research on intractable diseases from the Ministry of Health, Labour and Welfare of Japan in FY 2017. After confirming whether the increase and decrease in expenses is consistent with the purpose of the research project, we examined the causes and considered possible solutions.

    The factors of the increase in expenses were as follows: “research period,” “number of research group members,” “number of papers published by the research group in the previous year,” “clinical examination and biobanking,” and “management of patient registry.” Further, the factors of the decrease in expenses included “implementation of basic research.” As all changes were reasonably explained based on the purpose of the research project, the research expenses were found to be properly distributed.

    However, specifically, quite a few research groups redundantly implemented “clinical examination and biobanking” and “management of patient registry” from the beginning by themselves; this seems to be one of the causes of the increase in expenses. As both these factors are internationally considered to be effective in research on such diseases, some countries are trying to build a centralized research infrastructure as a countermeasure for their expensive cost. Therefore, in conclusion, considering the rapid construction of research infrastructure since the launch of AMED (Japan Agency for Medical Research and Development), it is desirable that research infrastructure specialized in intractable and rare diseases be built to support the overlapping tasks in a centralized way through cooperation and the appropriate sharing of roles with other infrastructure.

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