• 제목/요약/키워드: Clinical review

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Historical Controls, Data Banks, and Randomized Trials in Clinical Research: A Review

  • Fleming Thomas R.
    • 대한예방의학회:학술대회논문집
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    • 대한예방의학회 1994년도 교수 연수회(역학)
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    • pp.265-269
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    • 1994
  • A brief review is presented of the strengths and weaknesses of historical controls, data banks, and randomized trials in the evaluation of clinical treatment. Use of pre randomized versus postrandomized informed consent is discussed. Recommendations are made for the development of an appropriate clinical research strategy.

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위식도 역류질환에 대한 한의학 연구 경향 분석: 국내 논문을 중심으로 (The Review of Domestic Research on Traditional Korean Medicine for Gastroesophageal Reflux Disease)

  • 남현서
    • 대한한의학회지
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    • 제44권2호
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    • pp.70-105
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    • 2023
  • This study was conducted to examine the current status of traditional korean medicine studies on gastroesophageal reflux disease in Korea, identify deficiencies, and suggest the direction of future medicine research methods to lay the foundation for traditional korean medicine treatment. All domestic papers on the korean traditional treatment of gastroesophageal reflux disease were selected among the literature published until August 2022 in six domestic databases. A total of 52 selected research data were classified into experimental research papers, clinical research papers, and review papers. In experimental papers, to evaluate the effectiveness of treatment, improvement of esophageal mucosal lesions, anti-inflammatory mechanisms, antioxidant mechanisms, esophageal mucosal protection mechanisms, gastric peristalsis control, and gastric acid secretion inhibition mechanisms were used as evaluation measures. In the clinical research paper, the basis for diagnosis of cases was clinical symptoms through medical history listening and diagnosis through visits to hospitals in the past. The average treatment period was 40.7 days, and the duration of treatment was not significantly affected by the duration of the disease. The most widely used Korean medicine treatment intervention was herbal medicine. There were 3 literature review studies, 3 systematic literature review and meta-analysis studies, 1 comparative review study for clinical trial guideline development, all using Chinese papers. This study included all domestic papers on gastroesophageal reflux disease to identify the research trend of the Korean oriental medicine community, and based on this, it is meaningful to confirm areas that need to be supplemented in future research plans.

Operational issues of the Institutional Animal Care and Use Committee in Korea

  • Ahn, Na;Park, Jaehak;Roh, Sangho
    • Journal of Veterinary Science
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    • 제23권4호
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    • pp.59.1-59.5
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    • 2022
  • Korean Institutional Animal Care and Use Committee (IACUC) is currently facing some operational pressing issues. 1) Review of the animal protocol containing controversial technology. 2) Review of the multi-institution animal protocol. 3) Review of veterinary clinical trials for client-owned animals. 4) Delay in the review process in large institutions with a single IACUC. Here, the following three solutions are proposed to address the above issues. 1) Establishment of public IACUC. 2) Establishment of the Veterinary Clinical Study Committee as an advisory body to the IACUC. 3) Operating multiple committees rather than increasing the number of committee members on a single committee.

한의학교육에서 객관구조화진료시험과 진료수행평가에 대한 연구 동향과 후속 연구 및 교육에 대한 제언: 주제범위 문헌고찰 (Presentation on Research Trends and Suggestion for further research and education on Objective Structured Clinical Examination and Clinical Performance Examination in Korean Medicine Education: Scoping Review)

  • 신진영;고예림;송창진;조은별;임정태
    • 대한예방한의학회지
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    • 제26권2호
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    • pp.87-112
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    • 2022
  • Objectives : This study reviewed existing studies on clinical examination of Korean medicine to investigate the trends and gaps of existing research on clinical performance examination (CPX) or objective structured clinical examination (OSCE) in Korean medicine education. Methods : We conducted a scoping review according to the five steps suggested by Arksey and O'Malley. Six databases(RISS, OASIS, KMBASE, KISS, ScienceON, and DBpia) were searched and studies published from 2012 to July 15, 2022 were considered. The subjects of the study were limited to domestic studies about OSCE or CPX conducted in Korean medicine education. Results : Among the 25 selected papers, 17 studies implemented OSCE or CPX in practice. Those studies were conducted in 8 clinical departments and 9 of them used standardized patients. All 14 survey studies reported positive answers in satisfaction, efficacy, and self-assessment. OSCE, CPX scoring items were developed by modifying existing tools or developing through expert surveys or through literature review and significant cases. Conclusions : This study is expected to be used as basic data for following studies and promote clinical examination. From now on, the colleges of Korean medicine should proceed research on large-scale students about extended subjects through various research methods to obtain objective results that can be generalized and acquire validity and reliability. In order to promote such research, it is necessary to induce cooperation from institutions related to Korean Medicine and local universities to develop modules, implement, and conduct post-evaluation.

임상시험심사위원회의 임무와 운영 (Mission and Operation of Institutional Review Board)

  • 김용진
    • Journal of Yeungnam Medical Science
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    • 제30권2호
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    • pp.73-78
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    • 2013
  • An institutional review board (IRB) should independently safeguard the right, safety, and well-being of all clinical trial subjects. It should consist of members who are qualified and experienced to review and evaluate the science, medical aspects, and ethics of the proposed trial. They have to pursue continuing efforts to improve the standards of review. The levels of review include the full board review, expedited review, continuing review, or exempt from review, while the levels of decision-making include approval, conditional approval, deferred approval, and disapproval. Investigators must follow the approved protocols and regulations honestly, and it is the IRB's mission to audit clinical trial sites as well.

한약을 사용한 암환자 대상 임상시험에서의 항암 효능 평가변수 고찰 (A Review of Anticancer Efficacy Outcome Measures in Clinical Trials of Herbal Medicine for Cancer Patients)

  • 전천후;강민준;신원빈;송진영;박현석;양운호;여운석
    • 대한예방한의학회지
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    • 제28권1호
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    • pp.119-130
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    • 2024
  • Objectives : The objective of this review is to examine the variety of evaluation parameters utilized in clinical trials that assess the anticancer efficacy of herbal medicine, focusing on the importance of including both symptomatic management and direct anticancer effectiveness. Methods : A detailed literature review was conducted across PubMed, Embase, and the Cochrane Library to identify clinical trials investigating the antitumor efficacy of herbal medicine. The search was performed on February 22, 2024. This review specifically examined the employed outcome measures, which were then categorized and analyzed to understand their relevance and application in evaluating the anticancer properties of herbal medicine. Results : From an initial search of 900 records, 15 clinical trials were selected for in-depth analysis after deduplication and screening. These studies evaluated the efficacy of herbal medicine across various cancers, including hepatocellular carcinoma, colorectal cancer, and breast cancer, using outcome measures such as survival rates, disease control rates, and quality of life improvements. The research spanned multiple countries, primarily in East Asia and the United States, reflecting a global interest in herbal medicine as a complementary approach to cancer treatment. The present study demonstrated that herbal medicine, especially when used alongside standard treatments, potentially improved clinical outcomes and patient well-being. Conclusions : The findings of this review highlight the need for a broader focus on the full range of therapeutic capabilities of herbal medicine, including its direct anticancer effects, in the management of cancer patients. Future oncology research involving herbal medicine should integrate a wide spectrum of clinical endpoints to fully ascertain its impact on cancer treatment and patient health.

맥진기를 활용한 대사증후군 대상 임상연구 고찰 (A Review on Clinical Studies on Metabolic Disease Using a Pulse Tonometry Device)

  • 김지혜;전영주
    • 대한한방내과학회지
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    • 제39권4호
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    • pp.612-623
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    • 2018
  • Objective: The aim of this research was to investigate the current status and limitations of the clinical use of a pulse tonometry device (PTD). Methods: We searched online medical databases, including Oriental Medicine Advanced Searching Integrated System (OASIS), Research Information Sharing Service (RISS), DataBase Periodical Information Academic (DBpia) and PubMed, for clinical studies of metabolic diseases that used PTD. We selected articles on the clinical application of the PTD but excluded duplicate articles, clinical studies without the PTD, and non-clinical studies. In the first screening, 551 articles were selected. Ultimately, we found 10 articles and classified the articles according to the following diseases: hyperlipidemia, diabetes, overweight and obesity, hypertension, and metabolic disease. Results: Of the 10 selected articles, 4 were focused on hypertension. Two articles were focused on overweight or obesity and two articles were focused on the metabolic disease. Conclusions: This study was the first attempt to conduct a systematic review on clinical studies of metabolic disease using the PTD as a primary outcome. We suggest that the standard of pulse wave parameters and operating procedures for the PTD should be further developed. The results of this study are expected to be used as basic information for the planning and progression of clinical studies of metabolic syndrome using PTD.

한의학의 치매관련 임상연구 동향분석과 제안 (Literature Review and suggestions : dementia clinical studies in Korean Oriental Medicine)

  • 김우영;전원경;허은정;박상영;한창현
    • 한국한의학연구원논문집
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    • 제17권2호
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    • pp.39-46
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    • 2011
  • Objectives : This study was aimed to review the trend of dementia clinical studies in Korean Oriental Medicine and to suggest better clinical studies. Method : We collected 26 papers on dementia clinical studies in the internet site OASIS using the keyword 'Dementia'. Then we analyzed them. Results : There were 26 clinical study papers that were published between 1996 and 2010. Observational studies account for 61% of total clinical studies, whereas experimental studies account for only 31%. Effects of treatment in experimental studies was evaluated mainly by MMSE-K and K-DRS. Treatment period of experimental studies was longer than 100days. Conclusions : High quality experimental studies like randomized clinical trial(RCT) and intervention studies which use syndrome differentiation(辨證) have not yet been published. It is necessary to research and develop duration of treatment effect and tools for evaluating treatment effects.

외래 호흡기계 질환에서 항생제 사용에 대한 후향적 평가방안 (Retrospective Drug Utilization Review of Antibiotics for Respiratory Tract Infection(RTI) in Ambulatory Outpatient Care)

  • 김동숙;배그린;김수경;이학선;김윤진;이숙향
    • 한국임상약학회지
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    • 제22권4호
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    • pp.291-303
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    • 2012
  • As respiratory tract infections (RTI) account for about 60% of all antibiotic prescriptions in outpatient care setting, there are significant concerns about emerging resistance that are largely due to the excessive or inappropriate use of antibacterial agents for viral respiratory infections. This study was aimed to develop retrospective drug utilization review (DUR) program of antibiotics for RTIs using Delphi methods. Retrospective DUR criteria of antibiotics for RTIs were identified based on clinical practice guidelines and opinion of experts. Expert panel members were clinical doctors and pharmacists and Delphi method was applied by survey on 16 members of panels. The claim data from Korean Health Insurance Review & Assessment (HIRA) were used to examine trends in outpatient antibiotic prescription between Janunary to December of 2008. As results, Quality index for RTI was assessed for the claim type, antibiotics use of quantity, duration, number and cost. Antibiotic prescription rate for RTIs, Defined Daily Dose (DDD), and duration of antibiotics use were more recognized as significant quality index by experts' opinion. Use of first line agents suggested by guidelines was low and duration of antibiotics use was shorter compared to the recommendations. Antibiotics were over prescribed for RITs. However, dose and duration of antibiotics were under-used.

근건이완수기요법에 대한 Scoping Review 및 임상활용 방향 제언 (A Scoping Review of Musculotendinous Releasing Manual Therapy and Suggestions for Clinical Application)

  • 박정식;송윤경
    • 한방비만학회지
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    • 제23권1호
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    • pp.18-27
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    • 2023
  • Objectives: The purpose of this study was to review the studies of musculotendinous releasing manual therapy and suggestions for clinical application. Methods: Derive research questions using the scoping review methodology. Searching for related studies, the studies were selected, and the data were analyzed and reported. We searched domestic database for studies on musculotendinous releasing manual therapy reported till April 2023. We reviewed 82 studies excluding duplicate studies and 13 studies were selected. Results: Five studies were literature studies and eight studies were clinical studies. Among the five literature studies, two studies investigating and analyzing general manual therapy, one study investigating manual therapy applied to frozen shoulders, and one systematic literature review to investigate the economic effects of manual therapy, one study using tools. There was one study examining research trends in manual therapy. Eight clinical studies were conducted on patients with Achilles tendinitis, tennis elbow, meralgia paresthetica and obesity. Conclusions: Musculotendinous releasing manual therapy is thought to be applicable not only to musculoskeletal disease but also to changes in body shape due to connective tissue.