• Title/Summary/Keyword: reporting

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A comprehensive quality analysis of randomized controlled clinical trials of Asian ginseng and American ginseng based on the CONSORT guideline

  • Chen, Weijie;Li, Xiuzhu;Chen, Zhejie;Hao, Wei;Yao, Peifen;Li, Meng;Liu, Kunmeng;Hu, Hao;Wang, Shengpeng;Wang, Yitao
    • Journal of Ginseng Research
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    • v.46 no.1
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    • pp.71-78
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    • 2022
  • Ginseng is an international herb that has been used for thousands of years. Two species most commonly applied and investigated in the ginseng family are Asian ginseng and American ginseng. The number of randomized controlled clinical trials (RCTs) has conspicuously increased, driven by the rapid development of ginseng. However, the reporting of RCT items of ginseng is deficient because of different trial designs and reporting formats, which is a challenge for researchers who are looking for the data with high quality and reliability. Thus, this study focused on providing an extensive analysis of these two species and examined the quality of the RCTs, based on the Consolidated Standards of Reporting Trials (CONSORT) guideline. Ninety-one RCTs conducted from 1980 to 2019 that were related to Asian ginseng and American ginseng used singly met our inclusion criteria. We found that the reporting quality of the two species has improved during the past 40 years. Publication date and sample size were significantly associated with the reporting quality. Rigorous RCTs designed for the species of ginseng are warranted, which can shed light on product research and development of ginseng in the future.

Signal Detection for Adverse Events of Finasteride Using Korea Adverse Event Reporting System (KAERS) Database (의약품이상사례보고시스템 데이터베이스를 이용한 피나스테리드의 약물유해반응 실마리 정보 탐색)

  • Baek, Ji-Won;Yang, Bo Ram;Choi, Subin;Shin, Kwang-Hee
    • Korean Journal of Clinical Pharmacy
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    • v.31 no.4
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    • pp.324-331
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    • 2021
  • To investigate signals of adverse drug reactions of finasteride by using the Korea Adverse Events Reporting System (KAERS) database. This pharmacovigilance was based on the database of the drug-related adverse reactions reported spontaneously to the KAERS from 2013 to 2017. This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of finasteride. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The signals of finasteride were compared with those of the other drugs; dutasteride (similar mechanism of action), minoxidil (different mechanism but similar indications for alopecia), silodosin (different mechanism but similar indications for BPH). It was examined whether the detected signals exist in drug labels in Korea. The total number of adverse event-drug pairs was reported 2,665,429 from 2013 to 2017, of which 1,426 were associated with finasteride. The number of investigated signals of finasteride was 42. The signals that did not include in the drug label were 29 signals, including mouth dry, hypotension, dysuria etc. The signal of finasteride was similar to that of dutasteride and silodosin but was different to that of minoxidil. Early detection of signals through pharmacovigilance is important to patient safety. We investigated 29 signals of finasteride that do not exist in drug labels in Korea. Further pharmacoepidemiological studies should be needed to evaluate the signal causality with finasteride.

Trends in infection-related patient safety incident reporting before and during the COVID-19 pandemic in Korea (COVID-19 대유행 시기 전후 국내 감염관련 환자안전 사고 보고 현황 분석)

  • Eun-Jin Kim;Yeon-Hwan Park
    • Journal of Korean Biological Nursing Science
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    • v.25 no.2
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    • pp.95-104
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    • 2023
  • Purpose: The purpose of this study was to analyze the trends and characteristics of infection-related patient safety incident reporting before and during the coronavirus disease 2019 (COVID-19) pandemic in Korea, and to provide basic data for preventing infection-related patient safety incidents and improving their management. Methods: A cross-sectional analysis of secondary national data (Patient Safety Reporting Data) was conducted. In total, 517 infection-related patient safety incidents reported from 2018 to 2021 were analyzed. Changes in the number of reports before and during the COVID-19 pandemic and differences in variables related to infection-related patient safety incidents were analyzed using the chi-square test and independent t-test in SPSS 29.0. Results: This study found that infection-related patient safety incidents decreased during the COVID-19 pandemic compared to before the pandemic. Furthermore, incident-related characteristics, such as the type of healthcare organization, severity of harm, and post-incident actions, changed during the COVID-19 pandemic. Conclusion: The many changes in the infection control system and practices during the COVID-19 pandemic may have contributed to a decrease in the reporting of infection-related patient safety incidents. It is hoped that longitudinal studies on patient safety incidents related to the pandemic and analytical studies on factors influencing patient safety incidents will continue to be conducted to prevent and improve patient safety incidents.

A Systematic Review and Quality Assessment of Scalp Acupuncture for Musculoskeletal Diseases: Focused on Randomized Controlled Trials (근골격계 질환의 두침치료에 대한 체계적 문헌 고찰과 질 평가: 무작위 배정 대조 임상연구를 중심으로)

  • Do-Hun Kong;Byung-Cheul Shin
    • Journal of Korean Medicine Rehabilitation
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    • v.33 no.4
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    • pp.61-78
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    • 2023
  • Objectives This systematic review aimed to analyze the effectiveness, safety and the reporting quality of scalp acupuncture (SA) treatment for musculoskeletal disease (MSD). Methods Eleven databases were systematically searched up to July 12th 2023. Randomized controlled trials (RCTs) of SA treatment for MSD were selected manually by the inclusion criteria. The risk of bias of RCTs was assessed using the Cochrane's Risk of Bias (RoB) 1.0 and the reporting quality of studies was evaluated using Consolidated Standards of Reporting Trials (CONSORT) 2010 statement and Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) 2010 checklist. Results Ten clinical studies were met the inclusion criteria. Most of studies reported SA treatment significantly alleviated pain and functional disability of MSD patients and no serious adverse effects were reported. In RoB assessment, blinding of participants and personnel was found to have the highest RoB and allocation concealment was found to have the most unclear RoB. In CONSORT 2010 statement evaluation, all studies reported 15.3 items (41.4%) on average. In STRICTA 2010 checklist evaluation, all studies reported 11.2 items (65.9%) on average. Conclusions The systematic review found that SA treatment may alleviate pain and functional disability of MSD patients and have little severe adverse effect. The reporting quality of included studies was mainly low, therefore, further studies with strict adherence to the CONSORT and STRICTA checklist should be encouraged.

Investigating the Status of WHO VigiAccess Adverse Drug Event Reporting and Exploring its Potential for Application Using Anti-Obesity Agents as Examples (VigiAccess를 통한 WHO의 약물 이상사례 보고 현황 검색과 그 활용 가능성 탐색 : 비만 치료제를 중심으로)

  • Mikyung Kim
    • The Journal of Internal Korean Medicine
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    • v.45 no.1
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    • pp.55-74
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    • 2024
  • Objectives: This study reviewed the status of adverse event (AE) reporting in VigiAccess using anti-obesity agents as examples and explored the possibility of its use and future challenges. Methods: AE reports related to some representative drugs among herbal medicines (HMs), complex HM prescriptions, ingredients of supplements, and over-the-counter and prescription medicines were investigated using VigiAccess on February 1, 2024. Results: AE reports on prescription drugs were overwhelmingly higher than those on HMs or supplements. Although most reports were submitted from North America, reports on Ephedra sinica and green tea extract (GTE) were more from Asia and Europe, respectively. The female population reported more, and the difference in the sex ratio was the smallest for Ephedra spp. The age group was concentrated on young adults, but many older patients reported GLP-1 receptor agonist-related AEs. Symptoms related to the gastrointestinal and nervous systems were most commonly reported, but mental and cardiac disorders were common in Ephedra-type HMs. Hepatobiliary disorders are also commonly found in GTE-related reports. Conclusions: VigiAccess was useful for easily checking the global status of AE reporting for prescription drugs. However, several limitations were observed in using VigiAccess for HMs because of the few reports. Thus, it is necessary to increase the number of reports by education and to promote AE reporting among HM prescribers and users. The full range of HMs should be included in the pharmacovigilance system, and the coding and classification of HMs should be revised.

Highlights of the 2023 Bethesda System for Reporting Thyroid Cytopathology, 3rd Edition (갑상선 세침흡인세포검사 2023년 베데스다 시스템, 3판의 하이라이트)

  • Dong Eun Song
    • Korean Journal of Head & Neck Oncology
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    • v.40 no.1
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    • pp.1-5
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    • 2024
  • The Bethesda System for Reporting Thyroid Cytopathology (TBSRCT) is crucial for cytopathologists to use a standardized, category-based reporting system for thyroid fine needle aspirations and is effective for clear communication with the referring physicians. The new Bethesda System for Reporting Thyroid Cytopathology, the third edition in 2023, provides several key updates. The most important update is the assignment of only single name for each of the six diagnostic categories: (I) nondiagnostic; (II) benign; (III) atypia of undetermined significance; (IV) follicular neoplasm; (V) suspicious for malignancy; and (VI) malignant. An implied risk of malignancy (ROM) for each of six categories has been updated based on extensively published data since the second edition of TBSRTC in 2017 and offers both an average ROM for each category and the expected range of cancer risk. Estimated final ROM after excluding "Noninvasive Follicular Thyroid Neoplasm with Papillary Like Nuclear Features (NIFTP)" for each of six categories has been updated based on the reported mean decreases in the ROM if excluding NIFTP. For atypia of undetermined significance (AUS) category, the subcategorization is simplified and more formalized into 2 subgroups, AUS-nuclear atypia or AUS-other, based on the implied ROM and molecular profiling. For the pediatric thyroid disease, pediatric ROMs and management algorithms are newly added for the same six reporting categories for this age group. New or revised disease nomenclatures including high-grade follicular-derived carcinoma has been updated according to the recently published 2022 World Health Organization Classification of Thyroid Neoplasms. Brand new two chapters are added including clinical perspectives and imaging studies (Chap. 13) and the use of molecular and other ancillary tests (Chap. 14). The atlas is updated with new images to illustrate more effectively for new disease entity and diagnostic criteria.

Content Analysis on Newspaper Public Opinion Survey - The 17th Presidential Election of Korea -

  • Choi, Kyung-Ho
    • Journal of the Korean Data and Information Science Society
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    • v.19 no.2
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    • pp.431-441
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    • 2008
  • A public opinion poll's importance is at this time increasing now. Especially, a news report with a fair and objective execution and investigative reporting Moral Code is very important. But a research on the basis of investigative reporting Moral Code is not yet carried out. In this paper, with the center of a public opinion poll involved in the 17th Presidential Election of Korea, investigative reporting Moral Code has been analyzed measurably how well observed in the Press. Furthermore, it has been compared with findings carried out in the year 2002. Finally, through comparing response rate with actual results acquired in a survey of public opinion, I proposed a response rate acquisition.

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The Effect of Multiple Energy Detector on Evidence Theory Based Cooperative Spectrum Sensing Scheme for Cognitive Radio Networks

  • Khan, Muhammad Sajjad;Koo, Insoo
    • Journal of Information Processing Systems
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    • v.12 no.2
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    • pp.295-309
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    • 2016
  • Spectrum sensing is an essential function that enables cognitive radio technology to explore spectral holes and resourcefully access them without any harmful interference to the licenses user. Spectrum sensing done by a single node is highly affected by fading and shadowing. Thus, to overcome this, cooperative spectrum sensing was introduced. Currently, the advancements in multiple antennas have given a new dimension to cognitive radio research. In this paper, we propose a multiple energy detector for cooperative spectrum sensing schemes based on the evidence theory. Also, we propose a reporting mechanism for multiple energy detectors. With our proposed system, we show that a multiple energy detector using a cooperative spectrum sensing scheme based on evidence theory increases the reliability of the system, which ultimately increases the spectrum sensing and reduces the reporting time. Also in simulation results, we show the probability of error for the proposed system. Our simulation results show that our proposed system outperforms the conventional energy detector system.

A Study of Test Method for Position Reporting Accuracy of Airborne Camera (항공기 탑재용 카메라 위치출력오차 측정방안 연구)

  • Song, Dae-Buem;Yoon, Yong-Eun
    • Journal of the Korea Institute of Military Science and Technology
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    • v.16 no.5
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    • pp.646-652
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    • 2013
  • PRA(Position Reporting Accuracy) for EO/IR(Electro-Optic/Infrared) airborne camera is an important factor in geo-pointing accuracy. Generally, rate table is used to measure PRA of gimbal actuated camera like EO/IR. However, it is not always possible to fix an EUT(Equipment for Under Test) to rate table due to capacity limit of the table on the size and weight of the object(EUT). Our EO/IR is too big and heavy to emplace on it. Therefore, we propose a new verification method of PRA for airborne camera and assess the validity of our proposition. In this method we use collimator, angle measuring instrument, 6 dof motion simulator, optical surface plate, leveling laser, inclinometer and poster(for alignment).

A Review of the Statistical Analysis used in Clinical Articles Published on Journal of Korean Neurosurgical Society

  • Kang, Wee-Chang
    • Journal of Korean Neurosurgical Society
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    • v.40 no.4
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    • pp.304-308
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    • 2006
  • Statistical analyses used in clinical articles published on the Journal of Korean Neurosurgical Society were identified and appropriateness of statistical aspects in reporting results was assessed. Forty seven clinical articles were selected in this study, which were published from February, 2005 to February, 2006 on the journal. The frequency of statistical analysis was as follows : descriptive statistics only 24 [51.1%]. one type of statistical method 10 [21.3%], two or more methods 13 [27.6%]. An assessment of statistical aspects was performed in 24 clinical articles reporting inferential statistics. Ten articles [41.7%] did not adequately describe or reference all statistical methods used. There were six articles [25.0%] not reporting the confidence level used as the critical criteria of the statistical significance. In thirteen articles [54.2%] it seems more appropriate to implement multivariate analyses in addition to univariate analyses. We recommend that the journal readers should concentrate on improving their knowledge of basic statistics and statistical review for manuscripts submitted should be sought from professionals in the fields of biostatistics and epidemiology.