• Title/Summary/Keyword: Quality of clinical trial

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Impact of Dual-Hemisphere Transcranial Direct Current Stimulation Combined with Modified Constraint-Induced Movement Therapy on Upper Limb Function in Chronic Stroke: A Single Blinded Randomized Controlled Trial (수정된 강제 유도 운동치료와 결합된 이중 반구 경두개 직류 자극이 만성 뇌졸중의 팔 기능에 미치는 영향 : 단일 맹검 무작위 통제 시험)

  • Kim, Sunho
    • Journal of The Korean Society of Integrative Medicine
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    • v.8 no.2
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    • pp.11-20
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    • 2020
  • Purpose : The purpose of this study was to research the effects of dual-hemisphere transcranial direct current stimulation (dual tDCS) and modified constraint-induced movement therapy (mCIMT) to improve upper extremity motor function after stroke. Methods : The study period was from August 2019 to November 2019, and included 24 patients who met the selection criteria. Participants were divided into 2 groups: dual tDCS and mCIMT, and sham dual tDCS and mCIMT group. Dual tDCS and mCIMT group performed mCIMT immediately after applying dual tDCS for 20 minutes, and sham dual tDCS and mCIMT group performed mCIMT immediately after applying sham tDCS for 20 minutes without turning on the power source. Total interventions were conducted 5 times per week for 4 weeks, and mCIMT was conducted for 30 minutes per session for both experimental and control groups. Fugl-Meyer assessment (FMA) and Motor Activity Log scale (MAL) were analyzed before and after 4 weeks of intervention. Results : Both experimental and control groups showed significant changes in FMA, Amount of Use (AOU), and Quality of Movement (QOM) of MAL. When the differences between groups was compared using ANCOVA, the experimental group showed a greater improvement in FMA and AOU of MAL than the control group. Conclusion : In order to enhance the effect of improving upper limb function of stroke patients, dual tDCS could be applied to provide more effective treatment in the clinical setting. Further studies will be needed in larger groups of stroke patients, including long-term follow-up, and multi-group comparisons through the establishment of anodal tDCS and mCIMT, cathodal tDCS, and mCIMT groups to clarify the effects of dual tDCS. In addition, research is needed to establish a protocol for tDCS, and this evidence-based intervention protocol is expected to be used in the clinical setting as an interventional method for various purposes.

Effects of ASPAN's Evidence-based Clinical Practice Guidelines for Promotion of Hypothermia of Patients with Total Knee Replacement Arthroplasty (슬관절 전치환술 환자의 저체온 관리를 위한 ASPAN의 근거기반 임상실무 가이드라인 적용 효과)

  • Yoo, Je Bog;Park, Hyun Ju;Chae, Ji Yeoun;Lee, Eun Ju;Shin, Yoo Jung;Ko, Justin Sangwook;Kim, Nam Cho
    • Journal of Korean Academy of Nursing
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    • v.43 no.3
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    • pp.352-360
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    • 2013
  • Purpose: In this study an examination was done of the effects of the American Society of PeriAnesthesia Nurses (ASPAN) Evidence-Based Clinical Practice Guidelines on body temperature, shivering, thermal discomfort, and time to achieve normothermia in patients undergoing total knee replacement arthroplasty (TKRA) under spinal anesthesia. Methods: This study was an experimental study with a randomized controlled trial design. Participants (n=60) were patients who underwent TKRA between December 2011 and March 2012. Experimental group (n=30) received active and passive warming measures as described in the ASPAN's guidelines. Control group (n=30) received traditional care. Body temperature, shivering, thermal discomfort, time to achieve normothermia were measured in both groups at 30 minute intervals. Results: Experimental group had slightly higher body temperature compared to control group (p=.002). Thermal discomfort was higher in the experimental group before surgery but higher in the control group after surgery (p=.034). It decreased after surgery (p=.041) in both groups. Time to achieve normothermia was shorter in the experimental group (p=.010). Conclusion: ASPAN's guidelines provide guidance on measuring patient body temperature at regular intervals and on individualized and differentiated hypothermia management which can be very useful in nursing care, particularly in protecting patient safety and improving quality of nursing.

A Literature Review on the Application of the Propensity Score Matching Method in the Field of Asian Oncology (한의 종양학 연구 분야에서의 Propensity Score Matching Method 적용에 대한 문헌 고찰)

  • Dong-hyeon, Kim;Jong-hee, Kim;Hwa-seung, Yoo;So-jung, Park
    • Journal of Korean Traditional Oncology
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    • v.27 no.1
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    • pp.25-36
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    • 2022
  • The Randomized Control Trial (RCT) is the most well-established and widely used statistical methodology in clinical research; however, applying thorough RCT to cancer patients presents challenges such as ethical concerns, high costs, short clinical periods, and limitations in collecting various side effects. To address this issue, the propensity score matching method, which takes advantage of the benefits of observational research while compensating for the drawbacks of randomized control trials, is used in a variety of fields. In recent years, 28 studies on the effectiveness of Korean medicine on tumors have been conducted abroad using the Propensity Score Matching Method, but none have been conducted in Korea. The majority of studies have focused on liver cancer, colon cancer, lung cancer, and stomach cancer, with endpoints such as survival time, incidence rate, quality of life, and treatment outcomes revealing statistical differences in how Korean medicine intervention affects treatment outcomes. As a result, well-established studies using the propensity matching score methodology should be useful in evaluating the impact of Korean medicine in oncology treatments.

A Systematic Review from the Journals under the Korean Oriental Medical Society (대한한의학회지 및 대한한의학회 산하 정회원 학회의 학술진흥재단 등재지에 대한 비염 임상연구의 체계적 고찰)

  • Lee, Kyu-Sun;Park, Dong-Hee;Kim, Gae-Eun;Bang, Ji-Hyun;Kim, Jae-Hwan;Choi, Joon-Yong;Jung, Hee-Jae;Jung, Sung-Ki
    • The Journal of Korean Medicine
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    • v.31 no.5
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    • pp.1-11
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    • 2010
  • Objectives: This study aimed to evaluate any clinical studies regarding rhinitis published by the Korean Oriental Medical Society and its sub-societies for future rigorous clinical research. Methods: Every article relevant to rhinitis was initially obtained from journals of the Korean Oriental Medical Society and its sub-societies by electronic search at journal web sites or manual searches. Journals were limited to those registered with the Korea Research Foundation. From initial findings, two independent reviewers selected clinical articles and these articles were further analyzed separately by predefined criteria according to prospective and retrospective studies. For prospective studies, quality assessment was also conducted. Results: From 36 initially obtained articles, 17 were finally analyzed. 2 articles were randomized controlled studies, 6 articles were prospective whereas 9 were retrospective. In the prospective articles, there were no randomized controlled trials and the other non-randomized studies had no control group with several problems of quality regarding pre-calculated study size and unbiased assessment. None of the retrospective studies described rhinitis diagnosis objectively and outcome measures were either non-relevant to rhinitis or non-validated. Conclusions: Further well-designed randomized controlled studies for rhinitis are mandatory and more rigorous non-randomized controlled studies should be conducted.

A Review on Treatment of Essential Tremor in Traditional Chinese Medicine (본태성 진전에 대한 중의학 연구동향)

  • Shin, A-Ri;Bae, Yeong-Long;Lim, Jae-Yu;Lee, Seung-Hwan;Kim, Sang-Ho;Lim, Jung-Hwa
    • Journal of Oriental Neuropsychiatry
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    • v.28 no.2
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    • pp.95-107
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    • 2017
  • Objectives: This study was performed to review studies on Essential Tremor (ET) in Traditional Chinese medicine (TCM). Methods: We reviewed papers in the China National Knowledge Infrastructure (CNKI) from 2007~2016. Search keywords were 原发性震颤, 特发性震颤, essential tremor and idiopathic tremor, and excluded non-clinical studies, non-related to ET or TCM studies, theses for degrees and non-Randomized Controlled Trial (RCT). The quality of the articles was assessed by Jadad scale and the Risk of Bias (RoB). Results: Thirteen studies were selected. 'Criteria for the diagnosis of ET' was most frequently used as diagnostic criteria. 'Tremor rating scale' was primarily used for outcome measurement. Meta-analysis of nine trials revealed the effective rate of acupuncture and Western medicine (WM+Acu) groups was significantly higher compared to the WM group (RR: 1.48, 95 percent CI: 1.20 to 1.82, p=0.0002, $I^2=0$ percent) and tremor rating scale was also significantly decreased in the treatment group (MD: -1.35, 95 percent CI: -2.17 to -0.54, p=0.001, $I^2=0$ percent). Also, effective rates of Electro-acupuncture (EA) and Chinese herbal medicine (CHM) groups were significantly higher than that of the WM group {(RR: 1.53, 95 percent CI: 1.22 to 1.92, p=0.0003, $I^2=0$ percent) in EA vs. WM and (RR: 1.35, 95 percent CI: 1.16 to 1.57, p<0.0001, $I^2=0$ percent) in CHM vs. WM}. However, the quality of selected clinical studies was poor. Conclusions: Treatment of ET in TCM may be more effective and safe than in Western medicine. Therefore, we hope this study will lead to further clinical research on treatment of ET in Korean medicine.

A Randomized Controlled Trial Comparing Clinical Outcomes and Toxicity of Lobaplatin- Versus Cisplatin-Based Concurrent Chemotherapy Plus Radiotherapy and High-Dose-Rate Brachytherapy for FIGO Stage II and III Cervical Cancer

  • Wang, Ji-Quan;Wang, Tao;Shi, Fan;Yang, Yun-Yi;Su, Jin;Chai, Yan-Lan;Liu, Zi
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.14
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    • pp.5957-5961
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    • 2015
  • Background: We designed this randomized controlled trial (RCT) to assess whether lobaplatin-based concurrent chemotherapy might be superior to cisplatin-based concurrent chemotherapy for FIGO stage II and III cervical cancer in terms of efficacy and safety. Materials and Methods: This prospective, open-label RCT aims to enroll 180 patients with FIGO stage II and III cervical cancer, randomly allocated to one of the three treatment groups (cisplatin $15mg/m^2$, cisplatin $20mg/m^2$ and lobaplatin $35mg/m^2$), with 60 patients in each group. All patients will receive external beam irradiation (EBRT) and high-dose-rate intracavitary brachytherapy (HDR-ICBT). Patients in cisplatin $15mg/m^2$ and $20mg/m^2$ groups will be administered four cycles of $15mg/m^2$ or $20mg/m^2$ cisplatin intravenously once weekly from the second week to the fifth week during EBRT, while patients inthe lobaplatin $35mg/m^2$ group will be administered two cycles of $35mg/m^2$ lobaplatin intravenously in the second and fifth week respectively during pelvic EBRT. All participants will be followed up for at least 12 months. Complete remission rate and progression-free survival (PFS) will be the primary endpoints. Overall survival (OS), incidence of adverse events (AEs), and quality of life will be the secondary endpoints. Results: Between March 2013 and March 2014, a total of 61 patients with FIGO stage II and III cervical cancer were randomly assigned to cisplatin $15mg/m^2$ group (n=21), cisplatin $20mg/m^2$ group (n=21) and lobaplatin $35mg/m^2$ group (n=19). We conducted a preliminary analysis of the results. Similar rates of complete remission and grades 3-4 gastrointestinal reactions were observed for the three treatment groups (P=0.801 and 0.793, respectively). Grade 3-4 hematologic toxicity was more frequent in the lobaplatin group than the cisplatin group. Conclusions: This proposed study will be the first RCT to evaluate whether lobaplatin-based chemoraiotherapy will have beneficial effects, compared with cisplatin-based chemoradiotherapy, on complete remission rate, PFS, OS, AEs and quality of life for FIGO stage II and III cervical cancer.

Advances in Radiation Oncology in New Millennium in Korea (21세기 방사선종양학의 전망:최근의 진보와 한국에서의 발전)

  • Huh, Seung-Jae;Park, Chan-Il
    • Radiation Oncology Journal
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    • v.18 no.3
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    • pp.167-176
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    • 2000
  • The objective of recent radiation therapy is to improve the quality of treatment and the after treatment quality of life. In Korea, sharing the same objective, significant advancement was made due to the gradual increase of patient number and rapid increase of treatment facilities. The advancement includes generalization of three-dimensional conformal radiotherapy (3D-CRT), application of linac-based stereotactic radiosurgery (SRS), and furthermore, the introduction of intensity modulated radiation therapy (IMRT). Authors in this paper prospectively review the followings: the advancement of radiation oncology in Korea, the recent status of four-dimensional radiation therapy, IMRT, the concept of the treatment with biological conformity, the trend of combined chemoradiotherapy, the importance of internet and radiation oncology information management system as influenced by the revolution of information technology, and finally the global trend of telemedicine in radiation oncology. Additionally, we suggest the methods to improve radiotherapy treatment, which include improvement of quality assurance (QA) measures by developing Koreanized QA protocol and system, regional study about clinical protocol development for phase three clinical trial, suggestion of unified treatment protocol and guideline by academic or research societies, domestic generation of treatment equipment's or system, establishment of nationwide data base of radiation-oncology-related information, and finally patterns-of-care study about major cancers.

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Herbal Medicine (Hyeolbuchukeo-tang, Xuefu Zhuyu Decoction) for Insomnia Disorder: A Systematic Review and Meta-analysis of Randomized Controlled Trials (불면장애에 대한 혈부축어탕의 체계적 문헌 고찰 및 메타분석 연구)

  • Kim, Dong-Hee;Lee, Seung-Hwan;Lim, Jung-Hwa;Kim, Sang-Ho;Lee, Sang-Hyup;Kim, Bo-Kyung
    • Journal of Oriental Neuropsychiatry
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    • v.28 no.4
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    • pp.319-332
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    • 2017
  • Objectives: The present study aimed to provide clinical evidence on the effect of herbal medicine, Hyeolbuchukeo-tang or Xuefu Zhuyu decoction for the treatment of primary insomnia using a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: This study included RCTs that verified the effects of Hyeolbuchukeo-tang or Xuefu Zhuyu decoction for the treatment of primary insomnia. Literature searches of English, Chinese and Korean databases were performed, and the selected literature was assessed for investigating the risk of bias. Results: The analysis included 10 RCTs. The Chinese Classification of Mental Disorders-3 was most frequently used to define the diagnostic criteria for Hyeolbuchukeo-tang or Xuefu Zhuyu decoction intervention in patients with primary insomnia. The effective rate was the most commonly used outcome measure. A meta-analysis revealed that the effective rate, the Pittsburgh Sleep Quality Index, and the Athens Insomnia Scale in the Modified Xuefu Zhuyu decoction (MXZD) group were higher compared to Western Medicine (WM) group (RR: 1.17, 95% Cl: 1.08 to 1.26, p<0.0001, $I^2$=0/MD: -1.29, 95% Cl: -2.09 to -0.49, p=0.002, $I^2$=0%/MD: -0.99, 95% Cl: -1.81 to -0.18, p=0.02, $I^2$=15%). The effective rate of the MXZD+WM group was significantly different compared to the WM group (RR: 1.28, 95% Cl: 1.11 to 1.47, p=0.0006, $I^2$=2%). The included RCTs were of relatively poor quality and had small sample sizes. Conclusions: Treatment with Hyeolbuchukeo-tang or Xuefu Zhuyu decoction was found to be effective in treating primary insomnia. However, the included RCTs were of relatively poor quality and had small sample sizes. It is hypothesized that this study could serve as a foundation for further clinical studies on the development of diagnosis and treatment methods for primary insomnia based on Korean medicine.

An Analysis of Domestic Medicine Study Tendency on Obesity -Focused on The Korean Journal of Obesity- (비만에 대한 국내 의학계의 최근 연구 동향 분석 -대한비만학회지를 중심으로-)

  • Kim, Doo Hee;Shin, Woo Suk;Kim, Dong Hwan;Jeong, Yeon Jae;Im, Han Bit;Park, Won Hyung;Cha, Yun Yeop
    • Journal of Korean Medicine for Obesity Research
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    • v.13 no.1
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    • pp.1-9
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    • 2013
  • Objectives: This study was performed to analyze the recent trend of the studies about obesity in medicine and to provide background for futher studies. Methods: All of the article were selected in "The Korean Journal of Obesity". Search were conducted through "http://kosso.or.kr" with the search word "obesity". Collected articles were classified into clinical study, experimental study, literary study, case report. Results: One hundred eighty four studies were included and analyzed in terms of study design, subject, intervention, period, obesity index and so on. The numbers of clinical studies, literary studies, experimental studies, case reports were respectively 143 (77.7%), 26 (14.1%), 2 (1.1%) and 7 (3.8%). In clinical studies, observational studies were 112 (78.3%) and intervention studies were 31 (21.7%). And most of sample sizes were more than 100 and less than 499. Body mass index, waist circumstance, body fat percent were major criteria of clinical study. Most of the subjects on obesity were about relation with another disease or experimental results and diagnosis. According to classification by the kinds of intervention, diet, exercise, drug, behavior were respectively 22, 18, 8, and 8. More than fourty percent of intervention studies were studied for 12 weeks. Conclusions: To improve the quality of Korean Medicine study for obesity, we need to recruiting big sample size and activate randomized clinical trial.

Effects of garlic intake on cancer: a systematic review of randomized clinical trials and cohort studies

  • Lee, Jounghee;Zhao, Naisi;Fu, Zhuxuan;Choi, Jihee;Lee, Hae-Jeung;Chung, Mei
    • Nutrition Research and Practice
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    • v.15 no.6
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    • pp.773-788
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    • 2021
  • BACKGROUND/OBJECTIVES: Due to the rapid increase of global cancer incidence and mortality and a high level of interest in cancer prevention, a systematic review of garlic intake and cancer risk is needed. SUBJECTS/METHODS: We implemented a systematic review to examine the effects of varying levels of garlic intake on cancer. We conducted comprehensive literature searches in three electronic databases (MEDLINE, Embase, and Web of Science) for studies published between database inception and July or September of 2018. Two investigators independently screened abstracts and full-texts, extracted data, and assessed risk of bias (RoB). A total of one medium-quality randomized controlled trial (RCT) and 13 cohort studies graded as high RoB were included. RESULTS: The 1-year follow-up results from a RCT showed that a significant decrease in the number and size of colorectal adenomas among participants with colorectal adenomas who received high-dose aged garlic extract (AGE) compared with those who received low-dose AGE (P < 0.05). The results of prospective observational studies provided inconsistent associations of colorectal cancer risk with garlic supplements and garlic intake as food. CONCLUSIONS: In summary, the AGE was effective in reducing the number and magnitude of colorectal adenomas in one RCT, but there were inconsistent associations between garlic intake and colorectal cancer in cohort studies. Therefore, we could not draw a firm conclusion regarding the effects of garlic on cancer, because the current strength of evidence is inadequate due to a lack of number of high-quality RCTs.