• Title/Summary/Keyword: CONSORT

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The quality of Reports on Randomized Controlled Trials abstracts from Korean Science Citation Index journal and NEJM; Evaluation and Comparison of adherence to the CONSORT Statement (CONSORT statement를 기반으로 한 국내 Science Citation Index 저널과 NEJM의 Randomized Controlled Trial의 abstracts 질적 비교 평가 연구)

  • Kyung, Eun-Jung;Kim, Hyo-Seon;Kim, Eun-Young
    • Korean Journal of Clinical Pharmacy
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    • v.22 no.2
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    • pp.131-136
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    • 2012
  • Objective: This study evaluated and compared the adherence to the CONSORT for quality of reports on the randomized controlled trials (RCT) abstracts by four major Korean Science Citation Index (SCI) journals and The New England Journal of Medicine (NEJM). Methods: A descriptive analysis of published RCT abstracts in Korean SCI journals and NEJM from 2007/01 to 2011/06 was conducted by two reviewers, independently extracting data from a PubMed search. A modification of CONSORT for abstract was used including 16 checklist items. Reporting of checklist items for individual group was conducted to compare adherence patterns between two groups. Results: We identified the potential 57 RCT abstracts from Korean SCI and 50 from NEJM meeting our inclusion criteria; among them, three abstracts from Korean SCI and one from NEJM were excluded. Among total 16 checklist items based on CONSORT statement, Korean SCI journals and NEJM were statistically equivalent in 4 items; Korean journals were better in three items and NEJM were in nine. The methodological quality domains were inadequately reported in both journals: allocation concealment about 1.9% and 4.0%, and blinding 44.4% and 40.8%. In general, The CONSORT adherence of NEJM was better than that of Korean SCI in the method and result domain (p < 0.0001). Conclusions: The quality of NEJM reporting of RCT abstracts was better than that of Korean SCI, in general. This study on adherence of RCT reports from Korean SCI journals and NEJM abstracts to the CONSORT statement reveals that there is a need for improvement, especially Korean SCI. Further investigation on the quality of RCT reports and ways to improve reporting quality is required.

Consolidated Standards of Reporting Trials: The Reporting Guideline for Randomized Controlled Trials (Consolidated Standards of Reporting Trials의 소개: 무작위 대조군 연구의 보고 지침)

  • Jung, Hoi-In;Kim, Hee-Eun
    • Journal of dental hygiene science
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    • v.14 no.3
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    • pp.269-275
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    • 2014
  • Recently, there are lots methodologies to improve the quality of research in medical and public health fields. One of them is to checking a process of research with a reporting guideline before reporting paper. Especially, reporting guideline for randomized controlled trials (RCTs) is the consolidated standards of reporting trials (CONSORT). Therefore, this review describes the latest version of the CONSORT statement, CONSORT 2010, including intent, background, and contents of this. The CONSORT statement comprises a checklist of essential items that should be included in reports of RCTs and a diagram for documenting the flow of participants through a trial. This report guideline aims at providing guidance to authors about how to improve the reporting of their trials. As consulting the CONSORT, authors could be strictly reported about research methods and results. From this review, we expect to elevate the quality of such research about dental hygiene and to establish the foundation for evidence-based dental hygiene.

Quality Assessment of Studies on Randomized Controlled Trials (RCTs) of Acupuncture Treatment for Mild Cognitive Impairment: Based on the STRICTA and CONSORT Guidelines (경도인지장애의 침 치료에 대한 무작위배정 대조 임상시험(RCT) 연구 논문에 대한 질 평가 : STRICTA와 CONSORT 지침을 바탕으로)

  • Shin, Yeo-og;Heo, Woo-young;Lee, In
    • The Journal of Internal Korean Medicine
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    • v.40 no.6
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    • pp.1101-1111
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    • 2019
  • Objective: The purpose of this study was to investigate quality of reporting acupuncture intervention for mild cognitive impairment (MCI) based on the STRICTA and CONSORT guidelines Methods: We searched for randomized controlled trial studies of acupuncture treatment for MCI in the MEDLINE (PubMed) database. Once the online search was completed, studies were selected manually by the inclusion criteria, and the selected studies were evaluated by STRICTA and CONSORT guidelines. Results: Five studies were included. The most frequently selected points for acupuncture treatment of MCI were on the head, such as GV20, EX-HN1, GV24, and GB20. By STRICTA guidelines, all items from STRICTA were reported except three items on the checklist. By CONSORT guidelines, apart from six items which were not available, quality assessment was performed with 31 items. Eighteen items were reported by 80% of the studies. Four items were reported by 40% of the studies and another four items were reported by 20% of the studies. One item was not reported in all studies. Conclusion: Most items were reported by STRICTA guidelines, whereas many items were insufficiently reported based on CONSORT guidelines. This needs to be considered in future RCTs of acupuncture treatment for MCI.

Using of the "Consolidated Standards of Reporting Trials:CONSORT" to heighten quality of Medical Education study (의학교육연구의 질을 향상시키기 위한 '연구보고의 표준' 의 활용)

  • Yoo, Ji-Soo
    • Korean Medical Education Review
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    • v.10 no.2
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    • pp.25-44
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    • 2008
  • Objectives: Through using of the strong research method like a Randomized Controlled Trial: RCT, we have to heighten quality of Medical Education study. I'd like to introduce "CONSORT", which stands for Consolidated Standards of Reporting Trials. Contents: Preventive Service Task Force(200l) in USA proposed Levels of evidence for enlarging evidence-based Practice: EBP. And the CONSORT was introduced, which encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials (RCTs). the CONSORT has 13 guides like these: 1. How participants were allocated to interventions 2. Scientific background and explanation of rationale 3. Eligibility criteria for participants. The settings and locations where the data were collected. 4. Precise details of the interventions intended for each group and how and when they were actually administered 5. Specific objectives and hypotheses 6. Clearly defined primary and secondary outcome measures, When applicable. any methods to enhance the quality of measurements (e.g., multiple observations, training of assessors) 7. How sample size was determined. When applicable, explanation of any interim analyses and stopping rules 8. Method used to generate the random allocation sequence, Details of any restriction [of randomization] 9. Method used to implement the random allocation sequence 10. Who generated the allocation sequence, who enrolled participants. and who assigned participants to their groups 11. Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated 12. Statistical methods used to compare groups for primary outcome(s), Methods for additional analyses, such as subgroup analyses and adjusted analyses 13. Flow of participants through each stage (a diagram is strongly recommended) Specifically, for each group report the numbers of participants randomly assigned. receiving intended treatment, completing the study protocol. and analyzed for the primary outcome. Results and Conclusion: Randomized Controlled Trial: RCT guided of CONSORT will contribute to do stronger evidence-based medical studies.

Orally Administered Korean Herbal Medicine Medications of Randomized Controlled Trials Published in the Journal of Korean Medicine and Related Journals: A Narrative Analysis using CONSORT-CHM 2017 (CONSORT-CHM 2017 지침에 근거한 대한한의학회지 및 회원학회지에 투고된 경구투여 한약 중재를 활용한 무작위 배정 비교 임상 연구(RCT)의 양적, 질적 평가 연구)

  • Se-hun Moon;Jung-ho Jo;Seung-kwan Choi;Yun-hee Han;Hyeon-jun Woo;Byeong-hyeon Jeon;Won-bae Ha;Jung-han Lee
    • The Journal of Internal Korean Medicine
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    • v.44 no.6
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    • pp.1212-1242
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    • 2023
  • Objectives: This study aims to explore the current usage status of orally administered Korean herbal medicine in randomized controlled trials (RCTs) published in the Journal of Korean Medicine and member journals using the CONSORT-Chinese Herbal Medicine Formulas 2017 (CONSORT-CHM 2017) checklist. Methods: We searched the OASIS, RISS, and KMBASE archives as well as the websites of the Journal of Korean Medicine and 45 member journals to identify RCTs that used herbal interventions. Two independent researchers searched and categorized the RCTs and performed a quantitative evaluation by journal, study design, and target disease, as well as qualitative evaluation of the literature using CONSORT-CHM 2017. Results: After the search, 66 articles were selected. The quantitative evaluation resulted in 13 articles (19.6%) that were published in the Journal of Korean Medicine and 12 articles (18.1%) in the Journal of Internal Korean Medicine. In terms of study design, 62 articles (93.9%) were parallel, 4 articles (6%) were crossover, and 2-arm parallel study designs were the most common in 45 articles (68.2%). In terms of the study participants, physiological characteristics and mechanisms in healthy individuals were the most common in 21 studies (31.8%) and obesity in 9 studies (13.6%). In terms of assessing completeness in the CONSORT-CHM 2017 items, 29 articles were rated high, 31 were rated moderate, and 6 were rated low. Items 4a, 6a, and 7a had low reporting rates (≤ 30%), while items 2a, 2b, and 12a were completely reported in all studies. Conclusion: Future RCTs using orally administered Korean herbal medicine need to be reported completely, and the CONSORT-CHM 2017 checklist can be a helpful tool for this purpose.

Quantity and Quality Assessment of Randomized Controlled Trials in the Atopic Dermatitis (아토피 피부염 무작위배정 임상연구 논문 질 평가)

  • Park, Hye-Joo;Kwon, Ji-Hye;Yoo, Jong-Hyang
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.27 no.4
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    • pp.45-57
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    • 2014
  • Objective : This study aims to provide fundamental data for new directions(the improvement directions) from searching research papers of randomized controlled trials among thesis of Atopic Dermatitis related to oriental medicine in Korea from 2004 to 2014 and identifying the problem and level of a clinical study through an assessment of the quality, CONSORT statement. Methods : Data was collected through the Koreanstudies Information Service System(KISS). Two experts in Oriental Medicine reviewed the title and abstract in thesis, the results of searching the title, "Atopic dermatitis" and topic, "oriental medicine" at KISS, and then they handsearched Randomized Controlled Trials related to oriental medicine in Korea. According to guidelines defined by CONSORT statement, they assessed whether 37 items were followed by guidelines at yes or no answers in order to evaluate the quality as well. They assessed the definition of each item independently. After comparing, they made a decision on the item of different outcomes through an agreement with a third party. Results : Total number of randomized controlled trials in Atopic Dermatitis related to oriental medicine is eleven. A randomized controlled trial was first published in 2007. One or two papers associated it were released every year except 2013. 9 papers of them were approved by Institutional Review Board and were received written consent. The study included between 20 to 40 subjects for 2-arm parallel study design. The effect of treatment was observed for 4 to 8 weeks. On average, the number followed guidelines was 18.64 among those of 37 CONSORT statement and 50.38% of them was followed overall. Conclusion : As an interest about randomized controlled trials was increased, it was needed to care the standard providing information of CONSORT statement on randomized controlled trials related to oriental medicine in Korea. It is suggested to provide more clear information about it, so that it can be a motive for improving quality of the journal in oriental medicine.

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA) : Extending the CONSORT Statement (STRICTA(침 임상연구에서 중재 보고를 위한 표준) 개정판: CONSORT Statement의 확충안)

  • Lee, Hyang-Sook;Cha, Su-Jin;Park, Hi-Joon;Seo, Jung-Chul;Park, Jong-Bae J.;Lee, Hye-Jung
    • Korean Journal of Acupuncture
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    • v.27 no.3
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    • pp.1-23
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    • 2010
  • Objectives and methods : The Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group, and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. Results : The new STRICTA checklist, which is an official extension of CONSORT, includes six items and 17 sub-items. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background, and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word "controlled" in STRICTA is replaced by "clinical", to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. Conclusions : It is intended that the revised STRICTA, in conjunction with both the main CONSORT Statement and extension for nonpharmacologic treatment, will raise the quality of reporting of clinical trials of acupuncture.

The Quality Assessment of Reporting of Intervention Studies on Sasang Constitutional Diet (사상체질 식이 중재연구 보고에 대한 질 평가)

  • Kim, Ji Hwan;Lee, Ju Ah
    • Journal of Sasang Constitutional Medicine
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    • v.32 no.4
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    • pp.11-28
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    • 2020
  • Objectives The purpose of this study was to evaluate quality of reporting of intervention studies on Sasang Constitutional diet (SCD) based on the Consolidated Standards for Reporting of Trials (CONSORT) and Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statements. Methods We searched for Randomized controlled trials (RCT) and Non randomized studies for intervention (NRSI) on SCD in 4 databases and other sources, selected them by the inclusion criteria, and then evaluated quality of reporting of them. Results 1. A total of 10 studies (1 RCT and 9 NRSI) from 1999 to 2006 were selected and evaluated. The detailed items of up to 78%, at least 40%, and median value of 59% in the CONSORT and TREND statements were not reported. 2. One RCT was reporting 4 (11%) sufficiently, and 4 (11%) insufficiently among the 37 detailed items in the CONSORT statement while it was not reporting 29 (78%) items. 3. Nine NRSI were reporting 7 (12%) items sufficiently, and 2 (3%) items insufficiently among the 58 detailed items in the TREND statement while they were not reporting 15 (26%) items. Twenty (34%) items in the TREND statement were reported in some papers but not in more than half. Conclusions The quality of reporting of intervention studies on SCD has been assessed to be generally low. Subsequent researchers are recommended to select an appropriate statement for research design, and use it as a checklist from the time of designing the study to the time of reporting.

A Study on Costume of Gan Tack -in case of Hyaegyunggung$\cdot$Hong- (간택복식고 -혜경관 홍씨를 중심으로-)

  • Kim Jung Ock
    • Journal of the Korean Society of Clothing and Textiles
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    • v.4 no.1_2
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    • pp.35-42
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    • 1980
  • Gan Tack is meetings for marriage in Royal Families only. There are three selection courses before the final decision of one person, and it done with a view to finding the best person in the country. On the history of costume, it was greatly changed in Yungjo's period. In this thesis, I studied the costumes of king Yungjo, Jungsungwanghu who is the consort of Yungjo, Inwonwanghu who is the consort of the late king, Sunhigung who is a seraglio of Yungjo, Ongjus who are King's daughters by seraglios, Sanggungs who are court ladies, Yumo who is a wet nurse, and etc., for Gan Tack with Hyaegyunggung-Hong who is chosen the consort of Prince, and research the Dresses, which are Jugori, Chima, Dangui, Gonryongpo, and Wonsam. The girls who attend Gan Tack dress up Jugori whose color is yellow, Chima whose color is red, and Dangui whose color is green. King wears in Gonryongpo, the Consorts in Wonsam, and the court ladies and Ongjus in Dangui, of course, there are differences of the colors and ornaments on the ranks. Finally, I hope this thesis will be of great help to the costume of historical dramas.

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THERMAL EFFECTS ON THE STRAIN ENERGY RELEASE RATE FOR EDGE DELAMINATION IN CRACKED LAMINATED COMPOSITES

  • Soutis, C.;Kashtalyan, M.
    • Proceedings of the Korean Society of Propulsion Engineers Conference
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    • 2001.04a
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    • pp.1-6
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    • 2001
  • In this paper, edge delaminations in cracked composite plates are analytically investigated. A theoretical model based upon a sub-laminate approach is used to determine the strain energy release rate, $G^{ed}$, in [$\pm$$\theta_m$/$90_n$]$_s$ carbon/epoxy laminates loaded in tension. The analysis provides closed-form expressions for the reduced stiffness due to edge delamination and matrix cracking and the total energy release rate. The parameters controlling the laminate behaviour are identified. It is shown that the available energy for edge delamination is increased notably due to transverse ply cracking. Also thermal stresses increase substantially the strain energy release rate and this effect is magnified by the presence of matrix cracking. Prediction for the edge delamination onset strain is presented and compared with experimental data. The analysis could be applied to ceramic matrix composite laminates where similar mechanisms develop, but further experimental evidence is required.

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