• Title/Summary/Keyword: blinding

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A Systematic Review on Nurse-Led Transitional Care Programs for Discharged Patients from Hospital to Home (퇴원환자를 위한 간호사 주도 전환 프로그램의 내용과 효과에 관한 체계적 문헌고찰)

  • Lee, Hyun Joo;Kim, Yukyung;Oh, Eui Geum
    • Journal of Korean Clinical Nursing Research
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    • v.23 no.3
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    • pp.376-387
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    • 2017
  • Purpose: This study was to systematically review the contents and effects of nurse-led transitional care programs for discharged patients from hospital to home. Methods: Randomized controlled trials published between 2005 and 2015 were searched in Pubmed, Embase, Cochrane(Central Register of Controlled Trials) and CINAHL. Data were analyzed using Cochrane Review Manager(Revman) software 5.3. Results: Nine studies were selected and analyzed. Patient assessment, education and discharge planning were included in pre-discharge phase. Referring, communication and care planning were performed by nurses in transition phase. Home and phone visits, monitoring and multidisciplinary advices were included in post-discharge phase. Various outcome measures such as hospital utilization(30 days readmission and emergency department visit), quality of life, and cost were used to identify effectiveness of nurse-led transitional care programs. 30 days readmission(OR=.73, 95% CI 0.54, 0.98; p=.03) and emergency department visit(OR=.67, 95% CI 0.50, 0.88; p=.005) were statistically significant in meta-analysis. However, participant blinding was not done in seven studies which put at the risk of performance bias. Conclusion: The results indicated that nurse-led transitional care program is effective in reducing unnecessary hospital utilization. Nevertheless, small sample size and risk at performance bias are the limitation of this study. Thus, we suggest that well-designed randomized controlled trials need to be conducted.

The Effect of Bee Venom Acupuncture(BVA) on acute Ankle Sprain : A Randomized Controlled Trial and double blinding - Pilot study (급성 족관절 염좌에 대한 봉약침 효과-무작위대조시험, 이중맹검)

  • Song, Ho-Seub
    • Journal of Pharmacopuncture
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    • v.8 no.2
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    • pp.11-16
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    • 2005
  • Objective : The aim of the study was to investigate the therapeutic effect of BVA in the treatment of patients with acute ankle sprain. Design : A prospective randomized double-blind study of BVA was conducted. Setting : The study was done in the Kyungwon University Seoul Hospital from August 1st, 2004 to June 15th, 2005. Patients : 30 patients diagnosed with acute ankle sprain, especially 2nd degree on the Ankle grade pain chart(AGPC) participated in the study, who were divided into two groups (A and B) randomly by a coordinator flipping a coin. Group A and B were relevant to control and BVA group respectively, of which a coordinator never informed any other participant involved. Eventually 13 of 17 in group A and 11 of 13 in Group B finished all the process of the clinical trial. Intervention : In both group A and B, The Procedure of acupuncture treatment was made similar by appearance that four acupoints such as 坵墟(GB40), 中封(LR4), 商丘(SP5), 解谿(ST41) of the injured side were selected and Normal saline aqua-acupuncture(control, as a placebo) or BVA was done and then acupuncture at 坵墟(GB40), 中封(LR4), 商丘(SP5), 解谿(ST41), 足三里(ST36), 陽陵泉(G34) of the affected side was given again. the needles were retained for 20 minutes under the infrared rays. The treatment was given daily for a week. Outcome Measures : Ankle-Hindfoot Scale (AHS) and Visual Analogue Scale(VAS) were followed by three treatments. Statistical Analysis : Analysis regarding variations in AHS and VAS is carried out by applying Mann-Whitney test and Wilcoxon signed rank test sign test with level of significance at 5%. Results : At the end of the treatment, there was significant statistical differences between the two groups in VAS and AHS as well, while at the 3rd day only a VAS showed statistical significance. In each group, both VAS and AHS showed statistical significance along with duration of treatment. Conclusions : BVA was thought to be effective alternatives for relieving symptoms of acute ankle sprain, although further study was needed on the large scale.

The quality of Reports on Randomized Controlled Trials abstracts from Korean Science Citation Index journal and NEJM; Evaluation and Comparison of adherence to the CONSORT Statement (CONSORT statement를 기반으로 한 국내 Science Citation Index 저널과 NEJM의 Randomized Controlled Trial의 abstracts 질적 비교 평가 연구)

  • Kyung, Eun-Jung;Kim, Hyo-Seon;Kim, Eun-Young
    • Korean Journal of Clinical Pharmacy
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    • v.22 no.2
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    • pp.131-136
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    • 2012
  • Objective: This study evaluated and compared the adherence to the CONSORT for quality of reports on the randomized controlled trials (RCT) abstracts by four major Korean Science Citation Index (SCI) journals and The New England Journal of Medicine (NEJM). Methods: A descriptive analysis of published RCT abstracts in Korean SCI journals and NEJM from 2007/01 to 2011/06 was conducted by two reviewers, independently extracting data from a PubMed search. A modification of CONSORT for abstract was used including 16 checklist items. Reporting of checklist items for individual group was conducted to compare adherence patterns between two groups. Results: We identified the potential 57 RCT abstracts from Korean SCI and 50 from NEJM meeting our inclusion criteria; among them, three abstracts from Korean SCI and one from NEJM were excluded. Among total 16 checklist items based on CONSORT statement, Korean SCI journals and NEJM were statistically equivalent in 4 items; Korean journals were better in three items and NEJM were in nine. The methodological quality domains were inadequately reported in both journals: allocation concealment about 1.9% and 4.0%, and blinding 44.4% and 40.8%. In general, The CONSORT adherence of NEJM was better than that of Korean SCI in the method and result domain (p < 0.0001). Conclusions: The quality of NEJM reporting of RCT abstracts was better than that of Korean SCI, in general. This study on adherence of RCT reports from Korean SCI journals and NEJM abstracts to the CONSORT statement reveals that there is a need for improvement, especially Korean SCI. Further investigation on the quality of RCT reports and ways to improve reporting quality is required.

Quality Assessment of Randomized Controlled Trials using Herbal Remedies in Korea (국내 한약 처방을 이용한 무작위 배정 임상연구논문의 질 평가)

  • Kim, Yun-Young;Yoo, Jong-Hyang;Lee, Su-Kyung;Lee, Si-Woo
    • 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.

Analysis and Countermeasure on RSA Algorithm Having High Attack Complexity in Collision-Based Power Analysis Attack (충돌 전력 분석 공격에 높은 공격 복잡도를 갖는 RSA 알고리즘에 대한 취약점 분석 및 대응기법)

  • Kim, Suhri;Kim, Taewon;Jo, Sungmin;Kim, HeeSeok;Hong, Seokhie
    • Journal of the Korea Institute of Information Security & Cryptology
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    • v.26 no.2
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    • pp.335-344
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    • 2016
  • It is known that power analysis is one of the most powerful attack in side channel analysis. Among power analysis single trace attack is widely studied recently since it uses one power consumption trace to recover secret key of public cryptosystem. Recently Sim et al. proposed new exponentiation algorithm for RSA cryptosystem with higher attack complexity to prevent single trace attack. In this paper we analyze the vulnerability of exponentiation algorithm described by Sim et al. Sim et al. applied message blinding and random exponentiation splitting method on $2^t-ary$ for higher attack complexity. However we can reveal private key using information exposed during pre-computation generation. Also we describe modified algorithm that provides higher attack complexity on collision attack. Proposed algorithm minimized the reuse of value that are used during exponentiation to provide security under single collision attack.

A Study on the Warranty of Seaworthiness and the Principle of Utmost Good Faith in the Marine Insurance Act 1906 -With Judgement of the Star Sea Case- (영국해상보험법상의 감항담보와 최대선의원칙에 관한 연구 -Star Sea호 사건판결을 중심으로-)

  • Han, Nak-Hyun
    • THE INTERNATIONAL COMMERCE & LAW REVIEW
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    • v.33
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    • pp.191-219
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    • 2007
  • Section 39(5) of Marine Insurance Act 1906 concerns the case where with the privity of the assured, the ship is sent to sea in an unseaworthy state. The underwriters argue that the assured had"blind-eye knowledge" of the particular respect in which the ship was unseaworthy. Blind-eye knowledge requires a conscious reason for blinding the eye. There must be at least a suspicion of a truth about which one do not want to know and which one refuse to investigate. What has caused greater difficulty is the broad provision in s.17 which appears to be unlimited in its scope. The expression "utmost good faith" appears to derive from the idea of uberrimae fidei, words which indeed appear in the sidenote. The concept of uberrima fides does not appear to have derived from civil law and it has been regarded as unnecessary in civilian systems. S.17 raises many questions. But only two of them are critical to the decision of the present appeal-the fraudulent claim question and the litigation question. It is however necessary to discuss them in the context of a consideration of the problematic character of s.17. In the Star Sea Case, for the defendants to succeed in their defence under this part of the case the defendants have to show that claim was made fraudulently. They have failed to obtain a finding of fraud. It is not enough that until part of the way through the trial the owners failed to disclose to the defendants would have wished to see in order to provide them with some, albeit inadequate, evidential support for their alleged defence under s.39(5). The defence under s.17 fails. The Purpose of this work is to analyze the Star Sea Case, and to explore problems of the MIA relating to the judgement of this case.

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The Recent Trends of Clinical Research on General Anxiety Disorder in Chinese Herbal Medicine (범불안장애의 중의학 약물 임상시험 최신 동향)

  • No, Dong-Jin;Lee, Sang-Ryong;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
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    • v.20 no.4
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    • pp.79-89
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    • 2009
  • Objectives : To address suitable method for designing clinical trial intervening Traditional Korean Herbal Medicine on General anxiety disorder through the recent clinical research in Chinese Herbal Medicine. Methods : Randomized, controlled trials(RCTs) of treatment of general anxiety disorder intervening herbal medicine were searched through CNKI databases. We examined several item of studies and evaluated using Jadad scale. We searched articles in CNKI with the key word "General anxiety disorder or 廣範性焦慮症", among them we selected the clinical trial studies related with herbal medicine except for case reports, studies of acupuncture therapy or west medicines. Results : 11 RCT studies of herbal medicine met inclusion criteria. The Studies used CCMD-3, HAMA as inclusion tool and mainly HAMA as a evaluation tool. Studies were progressed for 2-8 weeks, mostly used various positive control. Experiment medicine were mainly 理氣劑, 安神劑. In most studies, experiment group made similar or higher efficacy in comparison with control group. Mean Jadad score of studies was $1.3{\pm}0.67$, and only one study was double-blinded among 11 studies. Conclusions : RCT studies on general anxiety disorder of chinese herbal medicine tend to focus on investigating effect of herbal medicine through setting positive control group with CCMD-3 and HAMA. But, most studies had low quality of trial, for lack of pattern identification, evaluation and inclusion tool of chinese medicine. Clinical trials of general anxiety disorder should provide good quality by randomization, double-blinding, and multi-site trial.

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A sham moxibustion device and Masking test (가짜뜸 개발 및 Masking test)

  • Park, Ji-Eun;Han, Chang-Hyun;Kang, Kyung-Won;Shin, Mi-Suk;Oh, Dal-Seok;Choi, Sun-Mi
    • Korean Journal of Oriental Medicine
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    • v.13 no.1 s.19
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    • pp.93-100
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    • 2007
  • TObjectives: Develop a sham moxibustion and determine whether subjects can distinguish a sham moxibustion from a real moxibustion. Design: Single-blinded, randomized, placebo-controlled clinical trial Methods: Sham and real moxibustion resemble each other in appearance, burning procedure, but the base of the sham moxibustion isolates the moxa-producing heat and smoke. This device was tested in a clinical trial in which subjects received moxibustion at Zhongwan(CV12), Mingmen(GV4), Quchi(LI11), Zusanli(ST36), Taichong(LR3)), Hegu(LI4). Volunteers(n=32) were given pre-treatment questionnaire to assess their experience in getting moxibustion therapy and performing it. They randomized into treatment(n=16) or sham controlled group(n=16), received moxibustion according their groups. After treatments, the effectiveness of blinding was assessed. Results: There were no significant differences between two groups in sex, age, moxibustion experience. In the treatment group and the sham group, the number of subjects who believed they received real moxibustion or sham is not different significantly.(P=.668) The consistency of a moxibustion type which subjects received actually and the their guess about that, isn't different significantly in two groups.(P=.465) Conclusion: The sham moxibustion was successfully validated in this study, The results demonstrate that this sham moxibustion blinds subjects and can be used as effective placebo-control in moxibustion clinical trials.

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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.

Systematic Review on Traditional Chinese Herbal Medicine Treatment for Antibiotic Associated Diarrhea (항생제 연관성 설사의 중의약 치료 효과에 대한 체계적 고찰)

  • Chang, Seju;Lee, Myeong-Jong;Kim, Hojun
    • Journal of Korean Medicine Rehabilitation
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    • v.27 no.4
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    • pp.85-96
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    • 2017
  • Objectives To summarize and evaluate the efficacy of traditional Chinese herbal medicine (TCHM) treatment for antibiotic associated diarrhea (AAD). Methods Eight electronic databases were searched from their inception to August 2017. Randomized controlled trials (RCTs) assessing the efficacy of TCHM treatment for AAD were included. The risk of bias was assessed using the Cochrane risk of bias assessment tool. Data analysis was performed using RevMan software version 5.3. Results Seventeen RCTs involving 1138 patients with AAD were included for qualitative synthesis. TCHM treatment improved total effective rate (TER). However, the results that TER in experimental group was significantly higher than in control group were different between the included studies. TCHM enema treatment improved TER, but not significantly higher than control group. The most frequently used herbal formulas were Gamiwekwanjeon, Gamiinsampaedoksan, and Samryungbaekchulsan. The most frequently used TCHMs were Atractylodes macrocephala (Bai Zhu), Dioscorea batatas (Shan Yao). Within the studies documenting the adverse events, no serious adverse events associated with TCHM treatment were observed. Conclusions Evidence of TCHM treatment efficacy for AAD is encouraging, but not conclusive, because of the low methodological qualities, diversity of TCHM treatment prescriptions. Further well-designed RCTs with rigorous randomization and blinding method are needed to confirm these results.