• Title/Summary/Keyword: CONSORT statement

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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.

Quantity and Quality Assessment of Randomized Controlled Trials in the Atopic Dermatitis (아토피 피부염 무작위배정 임상연구 논문 질 평가)

  • Park, Hye-Joo;Kwon, Ji-Hye;Yoo, Jong-Hyang
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.27 no.4
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    • pp.45-57
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    • 2014
  • Objective : This study aims to provide fundamental data for new directions(the improvement directions) from searching research papers of randomized controlled trials among thesis of Atopic Dermatitis related to oriental medicine in Korea from 2004 to 2014 and identifying the problem and level of a clinical study through an assessment of the quality, CONSORT statement. Methods : Data was collected through the Koreanstudies Information Service System(KISS). Two experts in Oriental Medicine reviewed the title and abstract in thesis, the results of searching the title, "Atopic dermatitis" and topic, "oriental medicine" at KISS, and then they handsearched Randomized Controlled Trials related to oriental medicine in Korea. According to guidelines defined by CONSORT statement, they assessed whether 37 items were followed by guidelines at yes or no answers in order to evaluate the quality as well. They assessed the definition of each item independently. After comparing, they made a decision on the item of different outcomes through an agreement with a third party. Results : Total number of randomized controlled trials in Atopic Dermatitis related to oriental medicine is eleven. A randomized controlled trial was first published in 2007. One or two papers associated it were released every year except 2013. 9 papers of them were approved by Institutional Review Board and were received written consent. The study included between 20 to 40 subjects for 2-arm parallel study design. The effect of treatment was observed for 4 to 8 weeks. On average, the number followed guidelines was 18.64 among those of 37 CONSORT statement and 50.38% of them was followed overall. Conclusion : As an interest about randomized controlled trials was increased, it was needed to care the standard providing information of CONSORT statement on randomized controlled trials related to oriental medicine in Korea. It is suggested to provide more clear information about it, so that it can be a motive for improving quality of the journal in oriental medicine.

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA) : Extending the CONSORT Statement (STRICTA(침 임상연구에서 중재 보고를 위한 표준) 개정판: CONSORT Statement의 확충안)

  • Lee, Hyang-Sook;Cha, Su-Jin;Park, Hi-Joon;Seo, Jung-Chul;Park, Jong-Bae J.;Lee, Hye-Jung
    • Korean Journal of Acupuncture
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    • v.27 no.3
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    • pp.1-23
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    • 2010
  • Objectives and methods : The Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group, and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. Results : The new STRICTA checklist, which is an official extension of CONSORT, includes six items and 17 sub-items. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background, and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word "controlled" in STRICTA is replaced by "clinical", to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. Conclusions : It is intended that the revised STRICTA, in conjunction with both the main CONSORT Statement and extension for nonpharmacologic treatment, will raise the quality of reporting of clinical trials of acupuncture.

Consolidated Standards of Reporting Trials: The Reporting Guideline for Randomized Controlled Trials (Consolidated Standards of Reporting Trials의 소개: 무작위 대조군 연구의 보고 지침)

  • Jung, Hoi-In;Kim, Hee-Eun
    • Journal of dental hygiene science
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    • v.14 no.3
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    • pp.269-275
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    • 2014
  • Recently, there are lots methodologies to improve the quality of research in medical and public health fields. One of them is to checking a process of research with a reporting guideline before reporting paper. Especially, reporting guideline for randomized controlled trials (RCTs) is the consolidated standards of reporting trials (CONSORT). Therefore, this review describes the latest version of the CONSORT statement, CONSORT 2010, including intent, background, and contents of this. The CONSORT statement comprises a checklist of essential items that should be included in reports of RCTs and a diagram for documenting the flow of participants through a trial. This report guideline aims at providing guidance to authors about how to improve the reporting of their trials. As consulting the CONSORT, authors could be strictly reported about research methods and results. From this review, we expect to elevate the quality of such research about dental hygiene and to establish the foundation for evidence-based dental hygiene.

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.

A Systematic Review of Clinical Trials on Acupuncture on the Post-stroke Muscle Spasticity (중풍 후 강직의 침구치료에 대한 계통적 연구)

  • Seo, Byung-Kwan;Baek, Yong-Hyeon;Park, Dong-Suk
    • Journal of Acupuncture Research
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    • v.27 no.6
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    • pp.1-10
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    • 2010
  • Objectives : The aim of this systematic review was to assess the efficacy of acupuncture and its relevant modality on post-stroke muscle spasticity Methods : We included 7 randomized controlled trials(RCTs) and 1 crossover study on acupuncture on the post-stroke muscle spasticity. Articles searches were performed in various databases in October 2009. Eight studies from 38 articles met the inclusion criteria and were used to assess the quality of clinical trials by means of Jadad scale, STRICTA, CONSORT statement and cochrane-handbook for systematic reviews of interventions. Results : Electrical stimulation such as electroacupuncture and TENS on acupoints was used in five studies. Repeatition of electroacupuncture showed significant decrease of the post-stroke muscle spasticity and persistence of the effect. Only three studies were assessed high quality as the methodological assessment tool(Jadad scale) and none of the studies matched STRICTA recommendations. Conclusions : This systematic review shows that there is beneficial effects of electroacupuncture on the post-stroke muscle spasticity. Further study of large population with high methodological quality will be needed.

Reporting Guidelines for Health Promotion Research (건강증진 연구 보고지침)

  • Yoo, Seung-Hyun
    • Korean Journal of Health Education and Promotion
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    • v.29 no.4
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    • pp.83-99
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    • 2012
  • Objectives: The purpose of this review is to introduce reporting guidelines for health promotion research in an effort to enhance systematic structure and quality of health promotion research reported in academic papers. Methods: Widely accepted guidelines were selected for description, which focus on 4 distinct types of research design. Checklists and flow diagrams are described and compared. Results: CONSORT Statement is reporting guidelines for randomized controlled trials with a 25-item checklist and a flow diagram. TREND Statement with a 22-item checklist is to guide reporting of health research in nonrandomized design. STROBE Statement is a compiled guidelines for observational health research, accompanied by a 22-item checklist in a combined edition. PRISMA Statement consists of a 27-item checklist and a flow diagram, providing guidelines for reporting systematic reviews and meta-analyses. All items on the checklists and flow diagrams were introduced and discussed. Conclusion: Solid understanding of research designs and adoption of reporting guidelines will enhance the quality of research with information on internal and external validity. Education and training of researchers on the research reporting is required along with systems level adoption of efforts for research enhancement.

The Quality Assessment of Reporting of Intervention Studies on Sasang Constitutional Diet (사상체질 식이 중재연구 보고에 대한 질 평가)

  • Kim, Ji Hwan;Lee, Ju Ah
    • Journal of Sasang Constitutional Medicine
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    • v.32 no.4
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    • pp.11-28
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    • 2020
  • Objectives The purpose of this study was to evaluate quality of reporting of intervention studies on Sasang Constitutional diet (SCD) based on the Consolidated Standards for Reporting of Trials (CONSORT) and Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statements. Methods We searched for Randomized controlled trials (RCT) and Non randomized studies for intervention (NRSI) on SCD in 4 databases and other sources, selected them by the inclusion criteria, and then evaluated quality of reporting of them. Results 1. A total of 10 studies (1 RCT and 9 NRSI) from 1999 to 2006 were selected and evaluated. The detailed items of up to 78%, at least 40%, and median value of 59% in the CONSORT and TREND statements were not reported. 2. One RCT was reporting 4 (11%) sufficiently, and 4 (11%) insufficiently among the 37 detailed items in the CONSORT statement while it was not reporting 29 (78%) items. 3. Nine NRSI were reporting 7 (12%) items sufficiently, and 2 (3%) items insufficiently among the 58 detailed items in the TREND statement while they were not reporting 15 (26%) items. Twenty (34%) items in the TREND statement were reported in some papers but not in more than half. Conclusions The quality of reporting of intervention studies on SCD has been assessed to be generally low. Subsequent researchers are recommended to select an appropriate statement for research design, and use it as a checklist from the time of designing the study to the time of reporting.

Which is the Best Chinese Herb Injection Based on the FOLFOX Regimen for Gastric Cancer? A Network Meta-analysis of Randomized Controlled Trials

  • Wang, Jian-Cheng;Tian, Jin-Hui;Ge, Long;Gan, Yu-Hong;Yang, Ke-Hu
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.12
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    • pp.4795-4800
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    • 2014
  • Background: Few studies have directly compared clinical efficacy and safety among Chinese herb injections (CHIs) for gastric cancer (GC). The present study aimed to compare CHIs combined with FOLFOX regimens for GC to show which provides the best CHIs results. Materials and Methods: 9 electronic databases and 6 gray literature databases were comprehensive searched in April 20, 2013. According to inclusion and exclusion criteria, two reviewers independently selected and assessed the included trials. The risk of bias tool described in the Cochrane Handbook version 5.1.0 and CONSORT statement were used to assess the quality of the trials. All calculations and graphs were performed and produced using ADDIS 1.16.5 software. Results: A total of 541 records were searched and 38 RCTs met the inclusion criteria (2,761 participants), involving 10 CHIs. The results of network meta-analysis showed that compared with FOLFOX alone, combinations with Kanglaite, Astragalus polysaccharides, Cinobufacini, or Yadanziyouru injections could furthest strengthen ORR, improve the quality of life, reduce nausea and vomiting, and reduce the incidence of leukopenia (III-IV). Conclusions: Kanglaite injection, Astragalus polysaccharides injection, Yadanziyouru injection were superior to other CHIs in clinical efficacy and safety for GC. The conclusions now need to be confirmed by large sample size direct head-to-head studies.

Randomized Controlled Clinical Trials in the Journal of Korean Society of Chuna Manual Medicine for Spine and Nerves: A Quantitative and Qualitative Analysis (척추신경추나의학회지에 수록된 무작위대조임상 연구의 양적, 질적 분석)

  • Cho, Hyun-Woo;Lee, Hyeon-Yeop;Heo, Kwang-Ho;Hwang, Eui-Hyoung;Shin, Mi-Suk;Shin, Byung-Cheul
    • The Journal of Korea CHUNA Manual Medicine for Spine and Nerves
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    • v.7 no.2
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    • pp.15-23
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    • 2012
  • Objectives: The aim of this study is to assess the quantity and quality of randomized controlled clinical trials (RCTs) published in the journal of Korean Society of Chuna Manual Medicine for Spine and Nerves (KSCMSN). Methods: All relevant RCTs were selected and extracted. Data extract of RCTs from all the articles published in the jounal of KSCMSN up to now, quantity assessment was made on the study design, sample size, intervention, control group and medical condition. of the consolidated standards of reporting trials (CONSORT) check list. Assessment was performed by 2 independent reviewers and disagreement was discussed based on concensus. Results: Among the 276 articles, 10 RCTs were published. 1st articles were published in 2003 and half of RCTs were published in 2011. All RCTs were parallel 2-arm designed. Average sample size was 29.2 per study and 14.6 per arm. Main intervention was consisted as acupuncture 40%, pharmacopuncture 30% and Chuna 30%. Average of adequacy of CONSORT check list was 10.3% and overall reports were insufficient. Conclusions: Though RCTs published in jounal of KSCMSN were increasing, the quality remains low. KSCMSN should make a effort to follow the CONSORT statement and improve the quantity and quality of studies.

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