• 혜화의학회지
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• 제24권1호
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• pp.15-24
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• 2015

Objectives : This study was carried out to assess the risk of bias of clinical trials on acne treatment with herbal medicine that have been published in Korea. Methods : 7 electronic databases in Korea were searched for clinical trials on acne treatment. Two independent reviewers selected clinical trials on herbal medicine treatment for acne. Selected studies are categorized according to DAMI(Study Design Algorithm for Medical literature of Intervention). RCTs are assessed according to Cochrane RoB(Risk of Bias), non-randomized studies(Before-after studies) are assessed according to RoBANS(Risk of Bias Assessment tool for Non-randomized Study). Results : After selection process, 25 articles are left. Among 25 articles, 3 RCTs and 4 before-after studies are finally included. In RCTs, the proportion of 'unclear' is high in criteria of 'random sequence generation', 'allocation concealment', and 'blinding'. In before-after studies, 'high' is high in criteria of 'blinding for outcome assessment' and 'incomplete outcome data'. Conclusions : Considering the above results of the assessment, it is necessary to conduct more well designed clinical trials on acne treatment with herbal medicine.

• 혜화의학회지
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• 제24권1호
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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.

• 한방안이비인후피부과학회지
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• 제30권2호
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• pp.1-18
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• 2017

Objectives : This review 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 Korean medicines to alopecia and provides the newest reason of effectiveness of herbs to alopecia. Methods : Data were collected through electronic database including NDSL, KISS, KMBASE, Koreantk, OASIS, KoreaMed, KISTI, Pubmed, Cochrane CENTRAL and CINAHL. Two experts in Oriental Medicine 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 trial, 13 non-randomized controlled trials and 3 case reports. This study evaluate 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. Conclusions : Korean medicine intervention can be an effective for treatment in alopecia. It was evaluated by hair density, thickness and expert panel assessment of photographs and all results are statistically significant. But enhancing levels of evidence, we must try to reduce bias in researches and report a safety, protocol and IRB.

• Safety and Health at Work
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• 제12권2호
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• pp.174-183
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• 2021

Background: Toluene diisocyanate (TDI) is a highly reactive chemical that causes sensitization and has also been associated with increased lung cancer. A risk assessment was conducted based on occupational epidemiologic estimates for several health outcomes. Methods: Exposure and outcome details were extracted from published studies and a NIOSH Health Hazard Evaluation for new onset asthma, pulmonary function measurements, symptom prevalence, and mortality from lung cancer and respiratory disease. Summary exposure-response estimates were calculated taking into account relative precision and possible survivor selection effects. Attributable incidence of sensitization was estimated as were annual proportional losses of pulmonary function. Excess lifetime risks and benchmark doses were calculated. Results: Respiratory outcomes exhibited strong survivor bias. Asthma/sensitization exposure response decreased with increasing facility-average TDI air concentration as did TDI-associated pulmonary impairment. In a mortality cohort where mean employment duration was less than 1 year, survivor bias pre-empted estimation of lung cancer and respiratory disease exposure response. Conclusion: Controlling for survivor bias and assuming a linear dose-response with facility-average TDI concentrations, excess lifetime risks exceeding one per thousand occurred at about 2 ppt TDI for sensitization and respiratory impairment. Under alternate assumptions regarding stationary and cumulative effects, one per thousand excess risks were estimated at TDI concentrations of 10 - 30 ppt. The unexplained reported excess mortality from lung cancer and other lung diseases, if attributable to TDI or associated emissions, could represent a lifetime risk comparable to that of sensitization.

• 대한물리치료과학회지
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• 제30권4호
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• pp.82-91
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• 2023

Background: Randomized controlled trials (RCTs) provide evidence on the effectiveness and safety of interventions and inform systematic reviews and guideline preparation for clinical application. However, methodological flaws can occur in many RCTs, and Cochrane's risk of bias version 2 (RoB2) can be used to evaluate RCTs' risk of bias (RoB). However, physical therapy RCTs in Korea did not confirm RoB. Therefore, the purpose of this study was to evaluate RoB using RoB2 in RCTs published in the Korean Physical Therapy Journal. Design: Review. Methods: The RCTs subject to evaluation were RCTs published in 11 physical therapy journals in Korea from 2018 to 2022. RoB2 evaluated a total of five domains: bias arising from the randomization process, bias due to deviations from intended interventions, bias due to missing outcome data, bias in measurement of the outcome, and bias in selection of the reported result. Results: A total of 616 RCTs were evaluated. As for bias arising from the randomization process, high risk was the highest at 555 (90.1%), followed by low risk at 41 (6.7%) and some concerns at 20 (3.2%). For bias due to deviations from intended interventions, the proportion of some concerns was the highest at 390 (63.3%), followed by high risk at 218 (35.4%) and low risk at 8 (1.3%). As for the bias due to missing outcome data, the rate of low risk was the highest at 399 (64.8%), followed by high risk at 159 (25.8%) and some concerns at 58 (9.4%). As for bias in measurement of the outcome, high risk was the highest at 294 (47.7%), followed by low risk at 224 (36.4%) and some concerns at 98 (15.9%). In the bias due to missing outcome data, the ratio of high risk was the highest at 610 (99%), followed by low risk at 4 (0.7%) and some concerns at 2 (0.3%). Conclusion: Most of the RoB evaluation results of RCTs published in the Korean Physical Therapy Journal were rated as high risk. Methodological quality of RCTs needs to be improved.

• 한국농공학회논문집
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• 제55권4호
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• pp.73-82
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• 2013

The main objective of this study was to evaluate Representative Concentration Pathways (RCP) scenarios-based flood risk at a Si-Gun level. A bias correction using a quantile mapping method with the Generalized Extreme Value (GEV) distribution was performed to correct future precipitation data provided by the Korea Meteorological Administration (KMA). A series of proxy variables including CN80 (Number of days over 80 mm) and CX3h (Maximum precipitation during 3-hr) etc. were used to carry out flood risk assessment. Indicators were normalized by a Z-score method and weighted by factors estimated by principal component analysis (PCA). Flood risk evaluation was conducted for the four different time periods, i.e. 1990s, 2025s, 2055s, and 2085s, which correspond to 1976~2005, 2011~2040, 2041~2070, and 2071~2100. The average flood risk indices based on RCP4.5 scenario were 0.08, 0.16, 0.22, and 0.13 for the corresponding periods in the order of time, which increased steadily up to 2055s period and decreased. The average indices based on RCP8.5 scenario were 0.08, 0.23, 0.11, and 0.21, which decreased in the 2055s period and then increased again. Considering the average index during entire period of the future, RCP8.5 scenario resulted in greater risk than RCP4.5 scenario.

• Korean Journal of Acupuncture
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• 제37권3호
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• pp.131-144
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• 2020

Objectives : The aim of this study is to analyze the details of acupuncture treatment methods and the reporting quality of acupuncture on Carpal Tunnel Syndrome (CTS). Methods : Search was conducted in Pubmed, EMBASE, and Cochrane Library for acupuncture studies on CTS. The reporting quality of acupuncture treatment was assessed using the following guidelines: Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) for analyzing the method of acupuncture treatment, Consolidated Standards of Reporting Trials (CONSORT) for analyzing study design and study process, and Risk of Bias (ROB) for analyzing bias. The number of reported items was calculated and evaluated as a proportion. The reported proportion of each study was classified into three grades: Grade A (% score ≥75), Grade B (50≤ % score <75), and Grade C (% score <50). Results : A total of 9 Randomized Controlled Trials (RCTs) were included in this study. All trials reported 12 items (66.67%) on average in STRICTA guidelines. Five studies were conducted with manual acupuncture and 3 studies were conducted with electroacupuncture. PC7 (Daereung) was most frequently used to treat CTS. In STRICTA guideline evaluation, 3 studies were classified as Grade A, 5 studies were classified as Grade B, and 1 study was classified as Grade C. In the CONSORT statement assessment, all trials reported an average of 20.56 items. Of the 9 RCTs, 6 studies were classified as Grade B and 3 studies were classified as Grade C. In ROB assessment, most studies showed a low (63.49%) or unclear (26.98%) risk of bias. The selective reporting bias and the incomplete outcome data bias were found to have the lowest risk of bias, and the allocation concealment of selection bias was found to have the most unclear risk of bias. Conclusions : Recent acupuncture studies on CTS showed moderate reporting quality. However, more detailed reports on acupuncture are still needed to establish more solid evidence of acupuncture treatment.

• 한방재활의학과학회지
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• 제24권4호
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• pp.49-60
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• 2014

Objectives The purpose of this study is to research current trends of acupuncture treatment of lumbar herniated intervertebral disc using the PubMed database. Methods We set up the search strategy and investigated clinical trials on acupuncture treatment of lumbar herniated intervertebral disc through PubMed search. This study analyzed previous researched papers published from January 1st, 2000 to April 30th, 2014, and classified them by publication year, journal names, types of literature, treatment methods and evaluation scales. To assess the quality of the reviewed literature, randomized controlled trial (RCT) studies were assessed by Cochrane's risk of bias (ROB) tool and non-RCT studies were assessed by risk of bias for non-randomized studies (RoBANS). Results We found 35 studies on the acupuncture treatment of lumbar herniated intervertebral disc. Papers on this topic have been published, on average, three to four times annually in 9 journals since the mid-2000's. The journal with the largest number of publications was Chinese Acupuncture & Moxibustion, and most of articles were classified as RCT. Acupuncture treatment was performed individually or together with other treatments. The most frequently used pain evaluation index was visual analogue scale (VAS). The index of effective rate was used frequently but there was a lack of objectivity. In regards to the quality of the studies, outcome assessment in RCT showed that random sequence generation, allocation concealment, and the blinding of participants and personnel increase potential of risk of bias. For non-RCT assessment, outcome showed that confounding variable, measurement of intervention were at high risk of bias. Conclusions In order to obtain objective clinical evidence of acupuncture treatment of lumbar herniated intervertebral disc, further clinical studies should be designed to minimize the risk of bias, using STRICTA with larger sample sizes.

• Journal of Acupuncture Research
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• 제32권3호
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• pp.135-146
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• 2015

Objectives : This study was designed to evaluate clinical evidence of moxibustion treatment for knee pain. Methods : All processes were independently carried out by three investigators. A literature search was performed in 3 databases from their inception to May 2015. Ten reports were found based on their title, abstract and text. Following this, data extraction and analysis were done using a risk of bias(ROB) and through an assessment of multiple systematic reviews(AMSTAR). Results : 10 studies(6RCT, 2SR, 2CR) were included. Generally, indirect moxibustion was used for knee pain, but only one study indicated the use of direct moxibustion. Moxibustion was shown to be effective in treating knee pain, and the number of required treatments was fourteen on average. In assessing risk of bias, indefinite and uncertain information made all included trials subject to a high risk of bias. On the other hand, SR showed all evaluation items in the assessment of multiple systematic reviews, with the exception of an included or excluded studies list. Conclusions : Because of deficient study design or limited research planning, there is not sufficient evidence to allow for any conclusion about the efficacy of moxibustion for knee pain. Therefore, well-designed high quality trials are needed from now on.

• 한국직업건강간호학회지
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• 제29권4호
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• pp.342-353
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• 2020

Purpose: This study aimed to systematically review literature and conduct a meta-analysis to comprehensively identify and evaluate the effects of workplace risk assessment-based ergonomic intervention on work-related muscular-skeletal disorders in workers. Methods: We searched the Ovid-Medline, EMBASE, and Cochrane library and up to 2018 using search terms such as muscular-skeletal, disorder, impairment, work-related muscular-skeletal disorders, ergonomic, intervention, management with no language limitations; screened reference lists; and contacted experts in the field. Results: We identified 545 references and included 13 randomized controlled tests (3,368 workers). We judged nine studies to have a low risk of bias, while the other four studies have a high risk of bias. Conclusion: Ergonomic intervention based on risk assessment in the workplace did not significantly differ in terms of the intensity of pain or duration of workers in the workplace, but low-quality evidence decreased the frequency of musculoskeletal disorder pain in three to six months moderate-quality evidence and in six to nine months low-quality evidence. Besides, low-quality evidence to reduce discomfort and moderate-quality evidence to improve worker posture. Therefore, ergonomic intervention based on the assessment of risk factors in the workplace should be applied to reduce pain frequency and discomfort and improve workers posture among musculoskeletal disorders.