• 제목/요약/키워드: Randomized allocation

검색결과 55건 처리시간 0.023초

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

  • 류덕현;노석선
    • 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.

한약물을 이용한 암 치료 관련 무작위 배정 임상시험에 대한 고찰 (Review of Randomized Controlled Trials using Herbal Remedies on Cancer Patients)

  • 박봉기;왕경화;조정효;손창규
    • 대한한의학회지
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    • 제31권5호
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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.

한약을 이용한 chemotherapy-induced peripheral neuropathy (CIPN) 치료 관련 무작위 배정 임상 시험에 대한 고찰 (A review of herbal medicines for chemotherapy induced peripheral neuropathy)

  • 박봉기
    • 대한암한의학회지
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    • 제21권2호
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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.

층화 혼합 승법 양적속성 확률화응답모형 (A Stratified Mixed Multiplicative Quantitative Randomize Response Model)

  • 이기성;홍기학;손창균
    • Journal of the Korean Data Analysis Society
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    • 제20권6호
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    • pp.2895-2905
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    • 2018
  • Lee(2016a)는 Bar-Lev et al.(2004)의 모형에 무관한 변수를 추가하여 민감한 변수, 변환된 변수 그리고 무관한 변수 중에서 확률장치에 의해 선택된 질문에 응답하도록 하는 승법 양적 확률화응답모형을 제안하였다. 본 연구에서는 Bar-Lev et al.(2004)이 제안한 강요 양적속성 승법모형에 무관한 변수와 강요응답을 새롭게 추가한 혼합 승법 양적속성 확률화응답모형을 제안하였다. 그리고 무관한 변수에 대한 정보를 아는 경우와 모르는 경우로 나누어 민감한 양적속성을 추정할 수 있는 이론적 체계를 구축하였다. 또한, 모집단이 층화되어 있을 때에도 제안한 모형의 적용이 가능하도록 층화 혼합 승법 양적속성 확률화응답모형으로 확장하였고 층화추출에 있어서 비례배분과 최적배분 문제를 다루었다. 마지막으로 기존의 승법모형인 Eichhorn-Hayre(1983) 모형, Bar-Lev et al.(2004) 모형, Gjestvang-Singh(2007) 모형, Lee(2016a) 모형이 제안한 혼합 승법 양적속성 확률화응답모형의 특수한 형태임을 확인할 수 있었고, Bar-Lev et al.(2004) 모형과의 효율성 비교 결과 $C_x$값이 작을수록 그리고 $C_z$값이 클수록 제안한 혼합 승법 양적속성 확률화응답모형이 Bar-Lev et al.(2004)의 모형보다 효율적이었다.

층화 가법 양적속성 확률화응답모형 (An Additive Stratified Quantitative Attribute Randomized Response Model)

  • 이기성;안승철;홍기학;손창균
    • 응용통계연구
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    • 제27권2호
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    • pp.239-247
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    • 2014
  • 본 논문에서는 사회적으로나 개인적으로 매우 민감한 조사에서 조사하고자 하는 모집단이 여러 개의 층으로 구성되어 있고, 각 층이 양적인 속성으로 되어 있는 경우에 Himmelfarb-Edgell의 가법 모형과 Gjestvang-Singh의 가법 모형에 단순임의추출법 대신에 층화추출법을 적용한 층화 가법 양적속성 확률화응답모형을 제안하였다. 제안한 두 모형으로부터 각 층의 양적속성에 대한 모평균의 추정뿐만 아니라 모집단 전체 모평균에 대한 추정을 할 수 있는 이론적 체계를 마련하였다. 그리고 제안한 두 모형에서 비례배분과 최적배분 문제를 다루었으며, 각 배분법에 따른 분산식을 도출하였다. 마지막으로 두 층화 가법 양적속성 확률화응답모형들 간의 효율성을 비교해 본 결과 Gjestvang-Singh의 층화 가법 모형이 Himmelfarb-Edgell의 층화 가법 모형보다 효율적으로 나타났고, 특히 hh값이 작을수록 즉, 제시한 모형의 특성이 직접질문에 가까워질수록 Gjestvang-Singh의 층화 가법 모형의 효율성이 커짐을 알 수 있었다.

3단계 층화확률화응답모형 (Three-Stage Strati ed Randomize Response Model)

  • 김종민;채성산
    • 응용통계연구
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    • 제23권3호
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    • pp.533-543
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    • 2010
  • 직접면접으로 민감한 질문을 할때 발생하는 무응답이나 거짓응답의 문제를 개선하고자 Warner (1965)가 최초로 제안한 확률화응답모형에 관한 연구는 이후 많은 연구자들에 의해 개선, 발전되어 오고 있다. 본 연구에서 표본은 층화임의복원추출법에 의해 추출되었으며, 표본배분은 최적배분법에 의해 배분되었다. 한편, Kim과 Elam (2005)의 2단계 층화확률화응답모형을 확장한 3단계 층화확률화응답모형을 사용하였다. Kim과 Elam (2005)의 2단계 층화확률화응답모형과 상대효율을 비교한 결과 본 논문에서 제시한 3단계 층화확률화모형의 효율성이 상대적으로 높다는 결과가 도출되었다. 그러나 2단계확률화응답모형을 3단계로 확장함으로써 상대적으로 효율성은 증대되지만 반대로 조사과정의 어려움이 예상된다.

The Effects of Advance Care Planning on Decision Conflict and Psychological Distress: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

  • Yeun, Young-Ran
    • Journal of Hospice and Palliative Care
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    • 제24권3호
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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.

CONSORT statement를 기반으로 한 국내 Science Citation Index 저널과 NEJM의 Randomized Controlled Trial의 abstracts 질적 비교 평가 연구 (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)

  • 경은정;김효선;김은영
    • 한국임상약학회지
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    • 제22권2호
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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.

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

  • 박혜련;노석선
    • 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.

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Comparative evaluation of efficacy of Physics Forceps versus conventional forceps in pediatric dental extractions: a prospective randomized study

  • Elicherla, Sainath Reddy;Bandi, Sujatha;Nunna, Mahesh;Saikiran, Kanamarlapudi Venkata;Sahithi, Varada;Nuvvula, Sivakumar
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제21권6호
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    • pp.547-556
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    • 2021
  • Background: This study aimed to determine the efficacy of Physics Forceps in pediatric dental extractions. Methods: This was a double-blind, randomized controlled trial with a parallel-arm design and identical allocation ratio (1:1). Children (n=104) were randomly divided into two groups for extraction of mandibular primary teeth (group I: Physics Forceps; group II: conventional forceps). The outcome variables assessed in the study were the time taken for extraction, pre- and postoperative anxiety (using RMS pictorial scale), incidence of fractured teeth, and postoperative pain on the first and third days (using the Wong-Baker faces pain scale). Results: A significant reduction (P < 0.001) in intraoperative time, anxiety, and incidence of tooth fracture was confined to group I. The pain significantly reduced from the first to the third postoperative day in both groups, but the mean reduction in RMS scores in the physics forceps group was far better than that in the conventional forceps group. Conclusion: Physics Forceps aid in extraction of primary teeth with minimal trauma to supporting structures, as well as reducing anxiety in the pediatric population.