• Journal of Acupuncture Research
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• v.24 no.1
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• pp.127-135
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• 2007

Objectives: To evaluate the methodological quality of Korean Acupuncture Clinical trials Methods : Two independent researchers reviewed 12 protocols of Acupuncture clinical trials which were conducted in Korea 2006. Also, Survey Principal Investigator of those was conducted. We compare the results of protocol review with investigator reponses of actual practice. Quality assessment consisted of 5 items including random sequence generation, randomization method, allocation concealment, subject blinding, assessor blinding. Results : Randomization was performed using the proper procedure to insure that treatment assignment is unbiased and concealed from subjects in all clinical trials, According to protocols, 6(50%) of 12 clinical trials used computer-generated random numbers, 6(50%) remaining trials didn't describe the randomization method. Also all trials used appropriate randomization methods on the basis of the survey results: 8 trials used computer-generated random number, 2 used random table. Of 7 protocols in which allocation concealment was stated, 5(71%) reported appropriate method (Calling a central office or statisticians, Sealed opaque envelopes). However according to survey, 5(42%) of 12 trials used inappropriate allocation concealment (Keeping a master randomization list and referring to when subject entered the trial). In addition, the result of protocol review and survey response was not coincident in 5(42%) trials. Subject blinding was conducted in all except 1 clinical trials. Although 11(92%) of 12 trials were conducted using assessor blinding in actual practice, only 7(58%) reported that in protocol. Conclusion : Although randomization and blinding were conducted adequately, allocation concealment was used inadequately, Not only appropriate allocation concealment, but also every quality assessment item including randomization, blinding should be stated in more detail in protocol.

• Journal of Physiology & Pathology in Korean Medicine
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• v.25 no.5
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• pp.927-933
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• 2011

This study aimed to evaluate the quality of herbal medicine-related RCT (Randomized controlled clinical trial) papers. 79 papers were searched from the domestic Hakjin paper list, and 16 papers of them were evaluated in terms of the Jadad Quality Assessment Scale and the adequacy of allocation concealment, and ethical validity. The evaluation results from Jadad Quality Assessment Scale showed that 15 papers showed high quality with the Jadad score of 3 points or higher, and none of the papers had a problem with randomization and double-blinding. The evaluation results from adequacy of allocation concealment showed that 3 of the papers were executed proper allocation concealment, and all of them had 5 points of Jadad score. IRB (Institutional Review Board) approval and written consent was investigated for the evaluation of ethical validity, and 12 papers had the IRB approval, and 14 papers had written consent. The papers published before 2005 were absent of IRB approval and written consent, and none of the papers had IRB approval number. From the above results, it is concluded that rigorous clinical research led high quality of research papers, and the ethical aspect of clinical researches are getting more important to protect the rights of research participants.

• The Journal of Korean Medicine
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• v.30 no.5
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• pp.115-126
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• 2009

Objective: By assessing the quality of methodology and synthesis of results of RCTs (Randomized Controlled Clinical Trials) with herbal acupuncture (pharmacopuncture), we hope to help with administrating herbal acupuncture therapy in clinic and conducting RCT with herbal acupuncture. Methods: Reports of RCT conducted in Korea published in medical journals until February 2009 were collected. We surveyed elementary information of RCTs, evaluated randomization, double-blinding, allocation concealment and put together the results of RCTs by seven clinical topics. Results: 38 RCTs with herbal acupuncture were selected, then adequate methods for randomization and allocation concealment were found in 39% and 5% of studies. Complete double-blinding and a clear accounting of all participants were conducted in 42% and 50% of reports. The synthesis of RCTs revealed that herbal acupuncture was useful and effective on degenerative gonarthritis, omarthralgia on cerebrovascular accident, acute ankle sprain, back sprain, neck sprain, headache, rheumatoid arthritis and tennis elbow, generally. Conclusions: Although further improvement in quality of methodology of RCTs with herbal acupuncture is required, clinical usefulness of herbal acupuncture was shown especially on disorders of musculoskeletal system via RCTs.

• The Journal of Korean Medicine
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• v.31 no.5
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• pp.12-32
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• 2010

Objective: This study aimed to review herbal remedy-based RCTs on cancer patients in order to produce helpful information for clinical study of herbal medicine in the future. Methods: We collected all RCTs using herbal remedies on cancer patients from Pubmed and Cochrane databases until November 1st, 2009. Elementary information such as nation where performed, clinical question, design, randomization, double-blinding and allocation concealment were analyzed. Results: 153 RCTs were finally selected. 119 RCTs were conduced in China while only 2 were done in Korea. The most frequent targeted cancer was lung cancer as 29 RCTs. The main clinical questions included improvement of quality of life, elongation of survival rate and regression of tumor being 83, 62 and 55 respectively. 112 RCTs used herbal remedies with western therapy. Adequate methods for randomization and allocation concealment were found in 37% and 10% of trials respectively. Conclusions: We found that herbal remedies are used on cancer patients in aspects of both caring for the human body and tumor treatment itself. The study might provide us useful data for cancer-related clinical study using herbal remedies in the future.

• Journal of Korean Traditional Oncology
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• v.21 no.2
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• pp.51-61
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• 2016

Background : Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect in cancer patients who were exposed to chemotherapy. CIPN impacts on the quality of life and could delay chemotherapy. The aim of this review was to assess the therapeutic effectiveness of herbal medicine in CIPN patients. Methods : Randomized controlled trials (RCTs) were included in this review. We searched MEDLINE, Cochrane database, EMBASE, CNKI, Wanfang and four Korean databases without restrictions on time or language. The risk of bias was assessed using the Cochrane risk of bias tool. Results : Eleven RCTs involving 706 patients met the inclusion criteria. Eleven different herbal medicines were examined in the included trials. Almost RCTs showed insufficiency in the reporting randomization method and allocation concealment. One trial used allocation concealment and a double-blinding method. Five studies reported that participants dropped out of RCTs and conducted an 'as-treated analysis'. One trials reported adverse effects of herbal medicine. In ten of the eleven trials, the use of herbal medicine had shown significant differences in clinical symptoms or nerve conduction velocity. Conclusions : The use of herbal medicines for CIPN showed significant improvements in the management of CIPN. However, conclusions cannot be drawn because of the generally low quality of methodology and low quantity of data for each single herbal medicine. Further rigorous trials are needed.

• Journal of Haehwa Medicine
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• v.24 no.1
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• pp.25-36
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• 2015

Objective : This study aims to evaluate a risk of bias by Risk of Bias tool and RoBANS(Risk of Bias Assessment tool for Non-randomized Study) tool for clinical trial papers proving treatment effect of herbs to alopecia and provides the newest reason of effectiveness of herbs to alopecia. Methos : Data were collected through electronic database including NDSL, KISS, KMBASE, Koreantk, OASIS, KoreaMed, KISTI, Pubmd, Cochrane CENTRAL and CINAHL. Two experts in Oriental Medince assessed risk of bias of randomized controlled trials by Cochrane group's Risk of Bias tool and non-randomized controlled trials by RoBANS tool after searching, reviewing and selecting papers. Results : Total number of selected trials is 20 including 4 randomized controlled trials, 13 non-randomized controlled trials and 3 case reports. This study evaluates the risk of bias of 17 papers including 4 randomized controlled trials and 13 non-randomized controlled trials except 3 case reports by risk of bias tool and RoBANS tool. All papers of randomized controlled trials are evaluated unclear for random sequence generation and allocation concealment as there are no word on them. And all papers of non-randomized controlled trials are evaluated unclear for blinding of outcome assessments and relatively low for others. Conclusion : We must try to specify concretely methods of allocation concealment after planning and practicing it for reducing a selection bias in randomized controlled trials. Also report a reason of missing value and blinding outcome assessments. And we have to agonize and mention methods of blinding of researchers for reducing a detection bias in non-randomized controlled trials.

• The Journal of Korean Institute of Communications and Information Sciences
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• v.33 no.7B
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• pp.583-591
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• 2008

This paper proposes a resource allocation algorithm for minimizing the overall distortion of multiple users in orthogonal frequency division multiplex (OFDM). The proposed algorithm exploits the diversity of multiuser and the rate-distortion function using packet distortion model in a system with limited resources. We first induce a rate-distortion function considering error concealment and error propagation properties of H.264 video structures. Then we perform adaptive resource allocation utilizing multiuser diversity for minimizing the overall video quality degradation. We also consider the proportional rate which is pre-determined for each user. Simulation results show that compared to the previous time division multiple access method and the resource allocation method maximizing data rate, the proposed rate allocation algorithm substantially improves the received video quality.

• Journal of Hospice and Palliative Care
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• v.24 no.3
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• pp.144-153
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• 2021

Purpose: Advance care planning (ACP) is widely understood to improve end-of-life care. This systematic review and meta-analysis aimed to examine the effects of ACP interventions on decision conflict and psychological distress. Methods: A search of PubMed, CINAHL, CENTRAL, EMBASE, KISS, KoreaMed, and RISS was conducted in November 2020. The study included randomized controlled trials. Data were pooled using fixed- and random-effects models. Results: Fourteen studies were identified that cumulatively included 1,548 participants. ACP interventions were effective in alleviating decision conflict (d=-0.53; 95% CI: -0.83 to -0.23), depression (d=-1.22; 95% CI: -1.71 to -0.74) and anxiety (d=-0.76; 95% CI: -1.12 to -0.39). Conclusion: ACP interventions have significant positive effects on reducing decision conflict and psychological distress. A high level of bias was shown related to allocation concealment and blinding. The results of this study are expected to be useful for end-of-life care providers to improve the effectiveness of ACP interventions.

• Journal of Music and Human Behavior
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• v.10 no.2
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• pp.1-33
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• 2013

The aim of this study was to systematically review the latest clinical trials in music medicine and medical music therapy for pediatric patients. Thirteen databases were searched to obtain randomized controlled/crossover design studies published between the year 2000 and 2012 in English language. Out of 1012 articles retrieved in the initial search, fifteen studies were identified based on an exclusion criteria. Overall, selected articles involved children 1 month to 18 years, sample size of 11 to 150, and total participants of 987. Studies were classified and compared as music medicine or music therapy studies through a systematic synthesis assessing general characteristics, methodological quality, measured outcomes, types of interventions and the study results. Seven music medicine and eight music therapy studies measured seven dependent variables using thirty-six different measurement tools with a large heterogeneity in the selection, type, and method of music interventions. Evaluation of the methodological quality revealed that many studies did not provide a full report of the research method, and did not meet some or most methodological standards, such as randomization, allocation concealment, double or partial blinding, and intention to treat analysis. Although overall research results were positive if not significant, poor methodological quality and heterogeneity in design and intervention strategies raise the question of research bias and trustworthiness issues. The systematic review concluded that music may have a valuable clinical effect in addressing the physical and psychosocial needs of hospitalized children, although more rigorous, homogeneous and replicable studies are greatly needed.

• The Journal of Korean Obstetrics and Gynecology
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• v.24 no.4
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• pp.105-113
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• 2011

Objectives: To examine the current status of clinical research in oriental medicine, and to assess 'risk of bias'(ROB) of randomized clinical trials(RCTs) in oriental medicine in Korea. Methods: Special committee for EBM, KOMS(Korean Oriental Medicine Society) reviewed 17 journals related to oriental medicine in Korea (from the first issue to May 2010), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 2, 2010), and PubMed (1966 to May 2010). Then we selected eligible RCTs in terms of oriental medicine, and assessed 'risk of bias'. Results: We reviewed 12,653 articles from the 17 journals, and 41 articles from CENTRAL and PubMed. After non-clinical articles were excluded, 1,004 articles were left. Among them, the number of eligible studies in terms of oriental medicine was 306. In these eligible studies, 130 were RCTs. Of RCTs, 69 were on acupuncture, 25 on herbal medicine. The proportion of 'unclear' is high in the criteria of 'Allocation concealment', 'Blinding of participants and personnel', 'Blinding of outcome assessment' and 'Other bias'. On the other hand, 'low' has high in the criteria of 'Incomplete outcome data' and 'Selective reporting'. Conclusions: Risk of bias on oriental medicine is unclear in terms of 'allocation concealment' and 'blinding'. For high-quality research in oriental medicine, further research should be needed on randomization and blinding in the RCTs.