• 한방재활의학과학회지
• /
• 제27권4호
• /
• pp.111-119
• /
• 2017

Objectives Clinical pathway (CP), is management plans that display goals for patients and have led to improve outcomes for many diseases. In Korea, Interest in Korean medicine's stabilization (Clinical pathway, Clinical Practice Guideline) is increasing, But the number of studies is scare. Method and Analysis This trials composes nonequivalent control group pretest-posttest design to conduct clincal pathway trial for the acute pain after back surgery. The subjects were 10 control patients with back surgery, and 10 experimental patients with application of integrative CP. Each group patient will observed 6 weeks. We check validation of CP. Also we compared the patient's status using the pain, function, Quality of life index between the two groups. Discussion This trial is the first CP for the acute pain after back surgery using integrative medicine concepts. Aim of this trial is to find the effectiveness and validity of clincal pathway for acute pain after back surgery.

• 대한한의학방제학회지
• /
• 제30권4호
• /
• pp.241-248
• /
• 2022

Objective : The purpose of this trial is to observe the preliminary effects of Salvia plebeia (SP) extract on quality of life in patients with solid cancer. Methods : This is a prospective, open-label, single-arm, and single-dose clinical trial. Twenty participants who have been diagnosed with solid cancer between the ages of 20 and 65 will be included. All participants will be administered SP granules for 12 weeks. Data will be collected at 4, 8, and 12 weeks after enrollment. The primary outcome is quality of life, using the Korean version of the Functional Assessment Cancer Therapy-General questionnaire. Secondary outcomes include tumor markers in blood tests for each cancer type, soluble programmed death-ligand 1, the percentage of natural killer cells among lymphocytes, ratio of T-helper and T-suppressor cells, ratio of total T, T-helper, T-suppressor, and B cells in lymphocytes, level of C-reactive protein, and tumor size via radiology examination. Safety will be assessed by clinical laboratory tests and monitoring of adverse events. Discussion : This study aims to observe the effects of an oral administration of SP preparations in patients with solid cancer on changes in quality of life and an improvement in immune function. It is expected to provide objective evidence of the effect and safety of SP for patients with solid cancer. Trial registration: KCT0007315 (Clinical Research Information Service)

• Journal of Gastric Cancer
• /
• 제5권2호
• /
• pp.79-88
• /
• 2005

질 관리란 진료 행위의 표준화 작업과 행위의 다양한 평가를 통해서 더 나은 치료 결과를 얻고자 이루어지는 체계적이고 종합적인 작업이다. 일반적으로 외과 영역의 질 관리는 항암화학치료나 방사선치료에 비해 적용이 어려운 것으로 알려져 있다. 하지만 최근 다기관 전향적 임상시험이 활발히 진행되면서, 두 가지의 수술법을 비교하거나 수술 전후 보조요법의 유용성을 확인하는 임상 연구에서 있어서 수술의 질 관리의 중요성이 점점 더 강조되고 있다. 위암의 경우 몇몇 대규모 전향적 임상시험이 시행되었으나 수술의 질 관리가 만족할 만한 수준으로 유지된 경우는 많지 않다. 유럽에서 시행되었던 D1-D2 림프절 절제술 비교 임상시험은 수술의 질 관리에 많은 노력을 기울인 연구였으나 우리나라의 실정과는 차이가 있는 반면, 현재 일본에서 시행 중인 D2와 D2 및 대동맥 주위림프절 절제술을 비교하는 임상시험에서는 우리에게도 적용 가능한 질 관리 프로그램이 다수 포함되어 있다. 향후 위암 수술에서의 다기관 무작위 전향적 임상시험을 성공적으로 수행하기 위해서는 learning curve 와 연간 증례 수를 고려한 치료자의 선택, 다양한 교육 및 의견 교류를 통한 수술 방법의 표준화, 체계적이고 통일된 전향적 데이터베이스 프로그램의 개발, 표준화된 수술 후 환자 관리 프로그램의 개발, 표준화된 수술 후 환자 관리 프로그램의 개발, 병리 검사 및 병리 기록의 표준화 등이 요구된다. 하지만 지나치게 세세한 표준화 작업 및 너무 많은 감시 프로그램은 환자 및 치료자 대상군 확보를 어렵게 만들고 프로토콜 위반율을 높일 수 있다는 점을 염두에 두어야 할 것이다.

• Journal of Acupuncture Research
• /
• 제27권1호
• /
• pp.109-116
• /
• 2010

Objectives : Since The Journal of Korean Acupuncture and Moxibustion Society(JKAMS) started publishing in 1984, randomised controlled trials(RCTs) and non-randomised clinical studies(NRSs) consistently have increased in quality and quantity. There has been no study on quality assessment of NRSs. Thus, this study evaluted non-randomised comparative clinical trials in the JKAMS to assess the quantity and quality. Methods : Upon extracting NRSs for assessing the intervention effects from all the articles published in the JKAMS from 1984 to 2009, assessments were made on methodological index for non-randomised studies(MINORS). Also, the analysis were made upon the proportion of non-randomised comparative clinical trials within original articles. The mean scores by research methods and years, and total scores and mean scores of yearly research methods were analyzed. Results : A total of 44 trials on non-randomised comparative clinical trials were selected. In 1980s, 4.3% of the total selected original articles, in 1990s, 4.1%, and in 2000s 14.2% were NRSs. According to the research designs, the mean scores of MINORS were Case-control study 18.3, Controlled before and after 18.5, Quasi randomised trial 18.5, and non randomised trial 17.9(out of 24), respectively. Cross-sectional study was the most frequently used(41.9%). Conclusion : Although NRSs consistently increased in quantity, the assessed mean scores were low and most articles used Cross-sectional study. Thus, there should be studied using appropriate research methods in the future.

• 생물정신의학
• /
• 제19권4호
• /
• pp.159-163
• /
• 2012

An appropriate research design for hypotheses and purposes leads to a good quality of research results. In this review article, we summarized the types of research methods and described the characteristics of clinical trials. Research designs are categorized into observational studies and experimental ones, depending on data collecting methods. In an observational study, there are cross-sectional, cohort and case-control studies. Parallel groups design and crossover trial studies are representative designs in a randomized controlled trial study, a kind of experimental study. Clinical researchers should understand the characteristics of clinical research designs including advantages and disadvantages and choose the suitable design according to their study purposes and the nature of collected data or subjects.

• Korean Journal of Acupuncture
• /
• 제28권3호
• /
• pp.177-186
• /
• 2011

Objectives : The aim of this study is to review clinical trials using Qigong exercise on patients with hypertension and to assess their methodology and results. Methods : Electronic literature searches for clinical trials (randomized trial, non-randomized trial, before-after study) of Qigong exercise were performed in 21 electronic databases (5 international databases and 16 Korean databases). English, Korean or Chinese articles were included. Laboratory or animal studies were excluded. Results : A total of 11 studies met the inclusion criteria. Five randomized controlled trials, Four non-randomized trials and two before-after studies were included. Seven studies used self-developed Qigong exercise. Two studies used Guolin Qigong exercise and two studies used Qigong exercise with an anti-hypertension drug. Of the nine randomized trials or non-randomized trials, four studies used an anti-hypertension drug control and three studies used waiting list controls. Compared to baseline, a change in blood pressure after the Qigong exercise treatment was significant in all studies. However, the results effect of blood pressure between Qigong exercise and controlled trials were not consistent. Conclusions : There are low-quality clinical trials of Qigong exercise for hypertension. To evaluate the effects of Qigong exercise, more rigorous trials are warranted.

• 동의생리병리학회지
• /
• 제24권4호
• /
• pp.566-570
• /
• 2010

This review was conducted to investigate clinical trial trend, clinical effect, and study methods of forest healing. Literature search was performed using the search engines of eight electronic databases from inception to march 2010 without language limitation. The search terms were "forest healing", "forest experience", "forest therapy", "forest treatment", "clinical trial", and "clinical study". Inclusion criteria were randomized controlled trials (RCTs) among all kinds of study searched about forest healing. Selection literature and data extraction was performed by authors(SH Sun and SG Lee) independently. Total three studies were selected finally. The methodological quality in all study was low because of poor reporting. Study indications were metal health, depression, self-esteem, and stress. The scale of studies was very small, which was the level of pilot study. There were no description for obtaining informed consent and being reviewed by Institutional Review Board (IRB), and could be any problems for statistical method in any studies. It is difficult to accept the fact that each studies had the significant effect for study indications in the results of studies. It is concluded that the evidence that health healing have a significant effect is insufficient. Further systematic and methodological study and well-designed clinical trial will be needed.

• 동의생리병리학회지
• /
• 제31권4호
• /
• pp.233-237
• /
• 2017

In this study, we report on the procedure of developing a guideline for clinical research protocol using moxibustion. Systematic review of the literature about moxibustion was conducted as a preliminary study to make basic content. Review and consulting by experts from each field was conducted to improve the quality. And we made checklist by arranging keypoint of this guideline. This guideline, Moxibustion Randomized Controlled Clinical Trial Guideline(MOXRATE), aims to be a guide for future researchers in planning clinical study using moxibustion as an intervention. MOXRATE also reports on an ethical issues.

• 한방안이비인후피부과학회지
• /
• 제20권3호
• /
• pp.138-146
• /
• 2007

Objective : To observe the trend in clinical study on atopic dermatitis(AD) over the last 3 years in order to develop a study methodology of AD in Oriental Medicine. Methods : Using the Pub med on line site; search terms: atopic dermatitis, field as title/abstract, limitation as published in the last 3 years, only items with links to full text, Humans, Clinical Trial, English. I observed the study contents of all this research and focused on the classification of treatments. I also observed of AD clinical trials registered on a clinical trial site(www.clinicaltrial.gov) on 23rd of June, 2007: study contents, localization and study designs. Results : Through the Pub Med site, I found 169 articles. Classified according to study subject, the studies related to treatment were 114(67.5%); physiology, pathology and prevention 12(7.1%); Diagnosis and Evaluation(7.1%); psychological aspects including quality of life 10(5.9%); diet and management 10(5.9%); epidemiology 7(4.1%); and others 7(4.1%). However, the treatment study of herb-medicine as intervention showed only 1 article. Futhermore, it wasn't based on Oriental Medicine philosophy. In the clinical trial site, there were 31 studies in which patients were recruited or planned for the future. The study on efficacy and safety of the medicine produced 14 trials, 5 comparative trials, 2 phototherapy, 2 diagnosis, 6 physiology and pathology, and 2 epidemiology. The trial institutions were concentrated in U.S.A. Conclusion : I suggest we'd better try to make a good clinical guideline and standardization of diagnosis and herb-medicine in order to develop a clinical study methodology of AD as soon as possible in the future. Even though it 's very hard to find the study methodology, we should aim to achieve positive results and show the evidence of the efficacy and safety of herb-medicine treatment for AD using Oriental Medicine.

• Journal of Cardiovascular Imaging
• /
• 제31권3호
• /
• pp.135-141
• /
• 2023

BACKGROUND: Global longitudinal strain (GLS) is an accurate and reproducible parameter of left ventricular (LV) systolic function which has shown meaningful prognostic value. Fast, user-friendly, and accurate tools are required for its widespread implementation. We aim to compare a novel web-based tool with two established algorithms for strain analysis and test its reproducibility. METHODS: Thirty echocardiographic datasets with focused LV acquisitions were analyzed using three different semi-automated endocardial GLS algorithms by two readers. Analyses were repeated by one reader for the purpose of intra-observer variability. CAAS Qardia (Pie Medical Imaging) was compared with 2DCPA and AutoLV (TomTec). RESULTS: Mean GLS values were -15.0 ± 3.5% from Qardia, -15.3 ± 4.0% from 2DCPA, and -15.2 ± 3.8% from AutoLV. Mean GLS between Qardia and 2DCPA were not statistically different (p = 0.359), with a bias of -0.3%, limits of agreement (LOA) of 3.7%, and an intraclass correlation coefficient (ICC) of 0.88. Mean GLS between Qardia and AutoLV were not statistically different (p = 0.637), with a bias of -0.2%, LOA of 3.4%, and an ICC of 0.89. The coefficient of variation (CV) for intra-observer variability was 4.4% for Qardia, 8.4% 2DCPA, and 7.7% AutoLV. The CV for inter-observer variability was 4.5%, 8.1%, and 8.0%, respectively. CONCLUSIONS: In echocardiographic datasets of good image quality analyzed at an independent core laboratory using a standardized annotation method, a novel web-based tool for GLS analysis showed consistent results when compared with two algorithms of an established platform. Moreover, inter- and intra-observer reproducibility results were excellent.