• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• v.30 no.4
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• pp.136-144
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• 2019

Early identification and intervention for autism spectrum disorder (ASD) were reported to be important for outcomes or clinical courses. However, there have been a few robust evidences for effectiveness of early intervention until now. This review aims to identify the effectiveness of early intervention by investigating the randomized controlled trial (RCT) of early intervention for autism. There are some RCT studies using behavioral program. Although there are some significant findings, the outcome measurements and small sample size are the limitations. Further studies are needed.

• Therapeutic Science for Rehabilitation
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• v.9 no.2
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• pp.27-38
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• 2020

Introduction : This review aims to introduce an intention-to-treat analysis(ITT) method and demonstrate the importance of rigorous utilization of this method to researchers in Korea. Discussion : ITT analysis includes all data as results in randomized control trials (RCT). Thereby the result of RCT is high validated to adapt in the real-world so that the result should be expected at clinical practice. Therefore, many RCT quality assessment tools include the question of the utilization of ITT analysis in individual trials. However, many researchers omit to report ITT, not utilize ITT or use ITT incorrectly. Conclusion : Through this review, more Korean researchers may understand and utilize ITT which is expected to enhance the quality of RCT papers.

• 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.

• Journal of Korean Medicine Rehabilitation
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• v.23 no.3
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• pp.87-106
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• 2013

Objectives We will provide basic information on bee venom clinical tests and aid the practical use of bee venom in such tests, through examination of RCT research related to bee venom that was reported domestically. Methods We collected 365 articles on Bee venom study result from the OASIS system using the Keyword 'bee venom, apitoxin, apitherapy, bee sting'. The initially selected theses were primarily screened for clinical research. Out of these, case studies and non randomized controlled trial (non-RCT) were ruled out. As a result, 39 studies of randomized controlled trial (RCT) research were chosen as the subjects of study. Results RCT research related to bee venom was first presented in 2003, and 39 studies have been published until 2012. 18 studies were tests to confirm the effectiveness of bee venom, 7 studies were comparisons between SBV and BV, and 13 studies were comparisons with other types of treatment. Research conducted through appropriate randomization methods were 20 studies, and inappropriate randomization methods were used in 19 studies. In therms of Jadad score, 12 studies received 4~5 points, 15 studies received 1-3 points, and 12 studies received zero point. Conclusions In order to assure good quality RCT research, appropriate guidelines should be provided, and proper evaluation standards should be established. In-depth study is needed concerning the difference of responses to treatment according to the types of treatment received. A standardization of treatment should be reached as a result.

• The Journal of Pediatrics of Korean Medicine
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• v.26 no.1
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• pp.46-59
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• 2012

Objectives The purpose of this study is to investigate recent clinical studies on effect of acupuncture for rhinitis in other countries. We have analyzed the studies on effect of acupuncture for rhinitis within randomized controlled trial(RCT), reviewed for 11 years (from 2001 to 2011). Methods The search database includes PubMed. To narrow the search, the following key search terms were used: 'rhinitis, acupuncture'. The search was limited to the publication date from 2001 to 2011. Results Total 20 studies were selected: RCT(13), review(5), case report(1), and cost effectiveness study(1). In RCT, 9 studies used acupuncture only, and 8 studies of them have revealed that acupuncture is effective on rhinitis. In review, 3 studies are systematic review, 2 studies are no systematic review. Among systematic review, 2 studies have revealed partial effectiveness of acupuncture for rhinitis, but they suggested the necessity of further studies. Conclusions Domestic studies on effect of acupuncture for rhinitis are necessary. For more accurate results, controlled, large scale and well designed studies are recommended.

• The Journal of the Korea Contents Association
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• v.13 no.12
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• pp.1036-1047
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• 2013

In this study, we applied the time series analysis to the randomized controlled trial (RCT) researches related to insomnia for finding international trends. The data used in the analysis of 379 of ClinicalTrials, Web of Science was the of 132 by several keyword related with 'Insomnia' and 'Randomized Clinical Trial'. In ClinicalTials, RCT studies for insomnia, drug, cognitive behavioral therapy, depression were the key words make up the main network. In WOS, 'melatonin' key word was added in the main network. In addition to, we found the characteristic that the elderly and female subjects were steady studied.

• 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.

• 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.

• Korean Journal of Acupuncture
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• v.29 no.4
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• pp.581-597
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• 2012

Objectives : To explore the experiences of patients with chronic low back pain(CLBP) in a randomized controlled trial(RCT) of acupuncture. Methods : Five qualitative focus group interviews were conducted at three Korean Medicine Hospitals. Two to 4 participants from the same group(real or sham acupuncture) in the RCT of acupuncture for CLBP discussed their experiences and perceptions of the clinical trial and the acupuncture treatment. Transcribed data were read independently by researchers and analyzed to categorize information and identify themes. Results : A total of 14 participants were included. Most of them discovered positive aspects of being a study subject and a patient. They recognized the differences between experimental and real-world clinical settings such as formal procedures of treatment, and different acupuncture device. Participants also expressed the weaker sensation of acupuncture compared to the previous experience. Especially, they were well aware of the 'subjects' role themselves, thus they observed their changes of symptom closely. As subjects were generally satisfied with their treatment and they had a good feeling to acupuncture after the trial, they expressed their willingness to participate in the future clinical trial of acupuncture. Conclusions : Our finding suggests that the Korean patients' experience of participating in an RCT was generally positive. Their tendency to perform the 'subject' role might affect the trial's process or overall results.

• The Korea Journal of Herbology
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• v.25 no.3
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• pp.131-137
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• 2010

Objectives：In this study, we surveyed papers about Oriental herbal medicines(prescriptions and herbs) for dementia. Method：We collected 64 research papers on Oriental herbal medicines(prescriptions and herbs) for dementia in the internet site OASIS using the keyword dementia. Then we analysed them according to year, research method, etc. Result & Conclusion：The absolute majority of research papers on Oriental herbal medicines(prescriptions and herbs) for dementia was experimental papers. And there were not enough clinical papers. In the future, we have to perform more studies such as RCT(Randomized Controlled Trial) and research papers on combined medication of the oriental and the western medicines for dementia.