• Title/Summary/Keyword: Risk of Bias

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TheAssessment of risk of bias in randomized controlled trials published in the Korean Journal of Physical Therapy: A 2018~2022 review (한국 물리치료 학술지에 무작위대조연구의 비뚤림 위험 평가: 2018~2022년 검토)

  • Jae Hyun Lim;Chi Bok Park;Byeong Geun Kim
    • Journal of Korean Physical Therapy Science
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    • v.30 no.4
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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.

The Assessment of Risk of Bias on Clinical Trials of Korean Medicine for Alopecia (탈모증의 한약제제 임상연구에 대한 비뚤림 위험 평가)

  • Ryu, Deok-hyun;Roh, Seok-sun
    • 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.

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A Systematic Review of Clinical Researches of Korean Medicine for Alopecia (탈모증의 한약제제 치료효과에 대한 체계적 문헌 고찰)

  • Ryu, Deok-Hyun;Roh, Seok-Sun
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.30 no.2
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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.

A Systematic Review on the Effects of Group Art Therapy on the Older with Dementia (집단미술치료가 치매 노인에게 미치는 영향에 대한 체계적 고찰)

  • Kim, Do-Yoen;Lee, Hye-Mi;Bae, Ji-Woo;Jung, Nam-Hae
    • Journal of The Korean Society of Integrative Medicine
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    • v.10 no.4
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    • pp.71-81
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    • 2022
  • Purpose : This study aimed to present evidence by analyzing the characteristics and effectiveness of group art therapy interventions through an examination of domestic studies on group art therapy for older people with dementia. Methods : The database used DBpia, Riss, and Google Scholar, and the research period was from 2016 to November 2021. For the selected studies, the level of evidence was analyzed, bias evaluation was performed, and patient, intervention, comparison, and outcome were analyzed. For the evaluation of bias, the risk of bias assessment tool for non-randomized study (RoBANS) and Cochrane's risk of bias (RoB) were used. Results : As for the level of evidence of the included studies, level I consisted of five studies, and levels II and III each had one article. As a result of the bias evaluation of five studies through RoB, a "low risk of bias" was found for incomplete result data, selective result reporting, and others, except for four unclear evaluation areas. The "low risk of bias" ratio was 0~25 % in the evaluation of bias in two studies through RoBANS. For the evaluation tool, cognitive evaluation tool was used the most while mini-mental state examination-Korea was used the most frequently. For the intervention method, the most frequently used was group art therapy that employed recall in three studies, while collage, Korean painting, use of paper media, and procedural memory were used in each of the other studies. Each intervention was found to be significantly effective overall. Conclusion : This study provided clinical evidence by systematically reporting research on group art therapy for older people with dementia. In the future, it is necessary to check the effect of group art therapy on various areas other than cognition for older people with dementia. Moreover, the study should be conducted with the risk of bias sufficiently taken into consideration.

The Assessment of Risk of Bias on Clinical Studies of Herbal Treatment for Acne (여드름의 한약 치료 임상연구에 대한 비뚤림 위험 평가)

  • Park, Hye-ryun;Roh, Seok-sun
    • Journal of Haehwa Medicine
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    • v.24 no.1
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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.

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Effects of Trust, Stigma, Optimistic Bias on Risk Perception of Nuclear Power Plants (원자력발전소에 대한 공중의 신뢰, 낙인과 낙관적 편향성이 위험인식에 미치는 효과)

  • Song, Hae-Ryong;Kim, Won-Je
    • The Journal of the Korea Contents Association
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    • v.13 no.3
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    • pp.162-173
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    • 2013
  • This study was to examine the effect of trust, stigma, optimistic bias on risk perception of nuclear power plants. For this study, we carried out a survey targeting residents, total of 383, living in Seoul. The findings showed that trust of general public on nuclear power plants influenced negatively on stigma. Second, trust of general public on nuclear power plants influenced not significantly on optimistic bias. Third, stigma of general public on nuclear power plants influenced positively on risk perception. Fourth, optimistic bias of general public on nuclear power plants influenced negatively on risk perception.

The Effects of Message Frame and Involvement on Optimistic Bias (위험인식의 낙관적 편견에 대한 프레임과 관여도의 역할)

  • Lee, Min-Young;Lee, Jae-Shin
    • Korean journal of communication and information
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    • v.48
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    • pp.191-210
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    • 2009
  • In this study, we examined the influence of news frame and involvement on risk perception. Based on individuals' optimistic bias in risk judgement and the third-person effect theory, we developed research hypotheses. An experiment was conducted in which 243 undergraduate and graduate students participated. Results indicated that societal level risk judgements were relatively invariant across experimental conditions but personal level risk judgements were influenced by the news frame and individuals' involvement in irradiated food. Based on the results, we provide explanations concerning when and how optimistic bias takes place in each experimental condition.

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Risk Assessment for Toluene Diisocyanate and Respiratory Disease Human Studies

  • PARK, Robert M.
    • Safety and Health at Work
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    • v.12 no.2
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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.

A Systematic Review on the Reporting Quality of Acupuncture Treatment for Carpal Tunnel Syndrome (손목터널증후군에 사용된 침 치료 보고의 질 평가)

  • Hyun, Ji-Yoon;Shin, Joo-eun;Im, Chae-Jeong;Park, Ji-Yeun
    • Korean Journal of Acupuncture
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    • v.37 no.3
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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.

The Research Trends on the Acupuncture Treatment of Lumbar Herniated Intervertebral Disc Using PubMed Database (PubMed 검색을 통한 요추 추간판 탈출증의 침치료 연구 동향)

  • Shin, Woo-Suk;Park, Won-Hyung;Cha, Yun-Yeop
    • Journal of Korean Medicine Rehabilitation
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    • v.24 no.4
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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.