• Title/Summary/Keyword: blinding

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The Quality of Reporting of Intervention Studies in the Korean Journal of Women Health Nursing (KJWHN): Based on the TREND Guidelines (여성건강간호학회지에 게재된 중재 연구 논문보고의 질 평가: TREND 지침에 근거하여)

  • Kim, Myounghee;Cheon, Suk-Hee;Jun, Eun-Mi;Kim, Sue;Song, Ju-Eun;Ahn, Sukhee;Oh, Hyun-Ei;Lee, Eun-Joo
    • Women's Health Nursing
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    • v.19 no.4
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    • pp.306-317
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    • 2013
  • Purpose: This study was done to evaluate quality of reports of non-randomized controlled quasi-experimental study articles published in the Korean Journal of Women Health Nursing (KJWHN). Methods: A search was done for experimental studies assessing intervention effects among all articles published in the KJWHN from 2008 to 2013. Original articles were reviewed and analyzed according to the 22 checklist items of the guidelines for Transparent Reporting for Evaluations with Non-randomized Designs (TREND). Results: Thirty-five articles on experimental studies were identified. The evaluation of the quality of reporting in these experimental studies found that there was a wide variety in the level of satisfying the TREND checklist. In particular, according to TREND topics, low levels of reporting quality were found for "title & abstract (only for information on how units were allocated to the intervention)", "outcomes in methods", "assignment in methods", "blinding in methods", "recruitment in results", "baseline data in results", "interpretation in discussion (especially intervention mechanism and success or barriers), "generalizability in discussion". Conclusion: Results indicate that adherence to TREND guidelines varied in experimental studies published in the KJWHN suggesting the recommendation that for higher levels of complete reporting, TREND guidelines be used in reports on experimental studies.

Using of the "Consolidated Standards of Reporting Trials:CONSORT" to heighten quality of Medical Education study (의학교육연구의 질을 향상시키기 위한 '연구보고의 표준' 의 활용)

  • Yoo, Ji-Soo
    • Korean Medical Education Review
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    • v.10 no.2
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    • pp.25-44
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    • 2008
  • Objectives: Through using of the strong research method like a Randomized Controlled Trial: RCT, we have to heighten quality of Medical Education study. I'd like to introduce "CONSORT", which stands for Consolidated Standards of Reporting Trials. Contents: Preventive Service Task Force(200l) in USA proposed Levels of evidence for enlarging evidence-based Practice: EBP. And the CONSORT was introduced, which encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials (RCTs). the CONSORT has 13 guides like these: 1. How participants were allocated to interventions 2. Scientific background and explanation of rationale 3. Eligibility criteria for participants. The settings and locations where the data were collected. 4. Precise details of the interventions intended for each group and how and when they were actually administered 5. Specific objectives and hypotheses 6. Clearly defined primary and secondary outcome measures, When applicable. any methods to enhance the quality of measurements (e.g., multiple observations, training of assessors) 7. How sample size was determined. When applicable, explanation of any interim analyses and stopping rules 8. Method used to generate the random allocation sequence, Details of any restriction [of randomization] 9. Method used to implement the random allocation sequence 10. Who generated the allocation sequence, who enrolled participants. and who assigned participants to their groups 11. Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated 12. Statistical methods used to compare groups for primary outcome(s), Methods for additional analyses, such as subgroup analyses and adjusted analyses 13. Flow of participants through each stage (a diagram is strongly recommended) Specifically, for each group report the numbers of participants randomly assigned. receiving intended treatment, completing the study protocol. and analyzed for the primary outcome. Results and Conclusion: Randomized Controlled Trial: RCT guided of CONSORT will contribute to do stronger evidence-based medical studies.

Complementary and Alternative Medicine for Oral Health : a Literature Review of Randomized Controlled Clinical Trials (구강건강에 이용되는 보완대체의학 치료: 무작위대조임상연구를 통한 문헌적 고찰)

  • Kim, Da-Hee;Choi, Gwang-Ho;Hwang, Eui-Hyoung;Heo, Kwang-Ho;Kim, Yong-Deok;Shin, Byung-Cheul
    • Journal of Society of Preventive Korean Medicine
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    • v.18 no.3
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    • pp.23-39
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    • 2014
  • Objective : This review aims at analyzing Complementary and Alternative Medicine (CAM) therapies, using for oral health to know current use of CAM in dental area by analyzing randomized controlled clinical trials (RCTs). Method : We searched the following 6 electronic databases until 1 July 2014. : Pubmed, Medline, Embase, Allied and Complementary Medicine Database(AMED), Cumulative Index to Nursing and Allied Health Literature(CINAHL), the Cochrane Library. We included parallel RCTs and cross-over RCTs that assessed the efficacy of CAM regardless of blinding and language. Results : A total of 154 RCT articles were included. There were 2-arm parallel study design(69.5%), 3-arm parallel study design(20.8%), 4-arm parallel study design(4.5%) and Cross-over design(5.2%). Complementary and alternative medicine RCTs in oral health tend to increase in the early-2000s and in the mid-2010s. In addition, 154 citations were classified according to diseases and interventions that categorized Natural Products studies(68.2%), Mind and Body Practices studies(31.8%). We classified in detail that vitamin and mineral therapies(29.9%), dietary supplements(24.7%), acupuncture(23.3%), Herbal medicine(13.6%), homeopathy (2.6%), energy therapies(2.6%), Massage(1.9%), biofeedback(0.6%), traditional medicine(0.6%). Conclusion : Increasing publications and diverse interventions regarding CAM for oral health is observed by analyzing RCTs from the literature review. Further studies are needed to be performed as systematic reviews to verify their effectiveness and the research to inquire into side effect.

Study on methodology about clinical effect of single point acupuncture in patients with hypertension (단일경혈을 이용한 침의 임상효과에 관한 방법론 연구 - 고혈압 환자를 중심으로 -)

  • Son, Yang-Sun;Yeo, Soo-Jung;Kim, Yoon-Ju;Park, You-Sun;Lim, Sabina
    • Korean Journal of Acupuncture
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    • v.29 no.1
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    • pp.23-36
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    • 2012
  • Objectives : This study was conducted to investigate effective treatment point selection method using oppressive pain in acupoints as elementary attempt for standard methodology of clinical acupuncture studies. Methods : Twenty seven subjects with hypertension or within prehypertension category - systolic and diastolic blood pressure (BP) over 120/80mmHg - were divided into two groups, oppressive pain point treatment group and oppressive painless point treatment group. In oppressive pain point treatment group, single point acupuncture (SPA) was conducted for 16 sessions during 8 weeks on most oppressive painful point among 6 selected acupuncture points used in previous trials and clinic. As a SPA intervention, 15 minutes with deqi sensation- elevating manipulation was conducted on the treatment acupoint. Same process was conducted in oppressive painless point treatment group on most oppressive painless point with subject blinding. Results : Significant reduction was observed in both systolic and diastolic BP after short time intervention (15.5/8.8 mmHg, 10.7/7.1 mmHg, P<0.05, respectively at 1 week) and maintained for 8 weeks intervention period in all groups (12.8/8.0 mmHg, 19.4/12.6 mmHg, P<0.05, respectively). No significant difference of BP change between oppressive pain point treatment group (N=10) and oppressive painless point treatment group (N=9) was observed during 8 weeks study period. Conclusions : SPA treatment as used in this pilot study was effective for lowering BP in mild hypertensive population, but oppressive pain in acupoint had no effect on treatment. This present result suggests the possibility of SPA for hypertension treatment regardless of oppressive pain.

Transactivation potential of the C-terminus of human ALG-2 (Human ALG-2 C-말단의 전사활성화 능력 분석)

  • Kim, Keun-Soo;Kim, Eun-Hee
    • The Journal of Natural Sciences
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    • v.11 no.1
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    • pp.89-94
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    • 1999
  • ALG-2 (apoptosis linked gene-2) is a 22 kDa calcium-binding protein necessary for apoptosis induced by various stimuli in lymphocyte. The transactivation of human ALG-2 was assessed in yeast as a fusion protein with the DNA binding domains (DBDs) of LexA. The C-terminal of hALG-2 (93-191 amino acid) exhibited transacitivation of the reporter gene, LacZ, whereas the full-length hALG-2 (1-91 amino acid) and its N-terminal (1-98 amino acid) did not. The transactivation of LacZ reporter was driven more strongly (more than 2.7-fold increase) by the C-terminus of hALG-2 than by the B42, as a positive control for transactivation. Hence, our data suggested a possible regulatory role of the N-termini of hALG-2 upon transactivation.

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Systematic Review and Meta-analysis on Acupotomy for Piriformis Muscle Syndrome (이상근증후군의 도침치료에 대한 체계적 문헌고찰 및 메타 분석)

  • Park, Song-Mi;Jung, Sue-un;Park, Jung-Hyeon;Do, Hyun-jeong;Cho, Sung-Woo
    • Journal of Korean Medicine Rehabilitation
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    • v.31 no.2
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    • pp.25-40
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    • 2021
  • Objectives This study was conducted to analyze the effect of using acupotomy for piriformis muscle syndrome. Methods The databases used for the search were PubMed, Embase, Cochrane library, China National Knowledge Infrastructure (CNKI), Koreanstudies Information Service System (KISS), Research Information Sharing Service (RISS), Oriental Medicine Advanced Searching Integrated System (OASIS), KMbase, and National Digital Science Library (NDSL). The literature was searched using a total of 9 domestic and foreign databases. randomized controlled trial using only acupotomy as an intervention was selected. The selected studies are analyzed the risk of bias through Cochrane risk of bias, and meta-analysis was performed using Revman. Results As a result of meta-analysis of 11 selected studies, acupotomy was more effective than nerve block and acupuncture. In terms of visual analog scale and immediate analgesic effect, acupotomy did not have statistically significant results compared to other treatment methods. meta-analysis of electro-acupuncture and acupotomy showed no significant results. Conclusions When acupotomy is applied as a treatment for piriformis muscle syndrome, it is more effective than nerve block and acupuncture. but most of the studies have been judged as 'unclear' in the risk of bias assessment. Due to characteristics of treatment group and control group's intervention, It is judged that the blinding of the participant was not properly implemented. Therefore, it is considered that high-quality studies are necessary to supplement the problems in the future.

The Therapeutic Efficacy of Herbal Medicine for Chemotherapy-Induced Peripheral Neuropathy: A Systematic Review and Meta-Analysis (항암화학요법 유발 말초신경병증에 대한 한약의 치료 효과: 체계적 문헌고찰 및 메타 분석)

  • Kim, Eun Hye;Yoon, Jee-hyun;Lee, Jee Young;Yoon, Seong Woo
    • Journal of Korean Traditional Oncology
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    • v.25 no.2
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    • pp.23-36
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    • 2020
  • Objective: This study was aimed to report the therapeutic effects of herbal medicine on chemotherapy-induced peripheral neuropathy (CIPN). Methods: The prior studies were searched from the databases included PubMed, Cochrane Library, EMBASE, CNKi, CiNii, KISS, NDSL, KMBASE, and OASIS until September 2020. The main search keywords were chemotherapy, peripheral neuropathy, and herbal medicine, and only randomized controlled trials that analyzed the therapeutic efficacy of herbal medicine were included. The Cochrane's Risk of Bias was used for assessment of the risk of bias and the Review Manager 5.3 program was used for meta-analysis. Meta-analyses were grouped by the administration routes of herbal medicines (oral administration or topical use). Results: Nine studies with a total of 563 participants were included. Compared with usual care, the effective rate was higher in oral administrated herbal medicine (RR 1.67, 95% CI 1.25 to 2.23; p<0.001, I2=31%). In addition, topical herbal medicine showed an significantly higher effective rate than placebo (RR 2.20, 95% CI 1.52 to 3.18; p<0.001, I2=0%) and usual care (RR 2.24, 95% CI 1.74 to 2.89; p<0.001, I2=66%). There was no severe adverse effect in all participants. Conclusions: Herbal medicine appears to improve neuropathy caused by chemotherapy in cancer patients more than conventional therapy of CIPN. However, as there is heterogeneity between the included studies and a lack of blinding, further well-designed researches are more needed.

Clinical Benefit of Computerized Cognitive Therapy in Patients with Brain Disease : A Systematic Review and Meta-Analysis (뇌질환 환자에서 전산화 인지치료의 임상적 유용성 : 체계적 고찰 및 메타분석)

  • Song, Seungil;Park, Sowon
    • Journal of The Korean Society of Integrative Medicine
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    • v.8 no.4
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    • pp.277-289
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    • 2020
  • Purpose : This study aims to confirm the clinical usefulness of computerized cognitive therapy program for patients with brain diseases in Korea and to present basic data that can confirm the effectiveness of computerized cognitive therapy program to experts related to rehabilitation in the future. Methods : A systematic review and meta-analysis research method was used to confirm the clinical effectiveness of computerized cognitive therapy applied to patients with brain diseases in Korea. Based on the national institute of health and medical colleges association (NECA) systematic literature manual and preferred reporting items for systematic reviews and meta-analysis (PRISMA) guidelines for conducting research through systematic review and meta-analysis methods. Systematic review was PICOST-SD was used to research and select papers. For meta-analysis, the data was input and analyzed separately by literature result using the revman manager 5.3 program and the results were presented visually through tables and forest, funnel plot figure. Results : As a result of comprehensive analysis of the contents of the finally selected literature, it as found that studies on stroke and dementia were mainly conducted. In addition, through the evaluation of the quality of the literature, most of the existing computerized cognitive therapy studies were identified as high-quality studies, but the results were insufficient for randomization and blinding. And through meta-analysis, the clinical effectiveness of computerized cognitive therapy on cognitive function, activities of daily living, and visual perception function of patients with brain disease was found. Conclusion : The research literature that applied computerized cognitive therapy to brain disease subjects was comprehensively analyzed and identified. It is thought that this could be used as basic data on the characteristics of cognitive therapy that should be applied to patients with brain diseases in the future and the usefulness of computerized cognitive therapy program in actual clinical practice.

Randomized Controlled Trials of Acupuncture for Healthy Volunteers in Korea: A Systematic Review (국내에서 수행된 건강인 대상 침 관련 무작위 대조 임상연구에 대한 체계적 문헌 고찰)

  • Sagong, Hye-Seon;Kim, Hyun-Tae;Heo, In;Shin, Byung-Cheul
    • Journal of Korean Medicine Rehabilitation
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    • v.31 no.1
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    • pp.137-147
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    • 2021
  • Objectives Domestic acupuncture research is being actively conducted in various fields. The aim of this study is to systematically analyze the current acupuncture randomized controlled trials (RCTs) conducted on healthy volunteers. Methods We searched RCTs by the search terms of (acupuncture & random & healthy) in 10 electronic databases and related journals. Then, we analyzed the characteristics and assessed the risk of bias by Cochrane tool. Results Finally, 49 acupuncture RCTs on health volunteers were included in our analysis. The purpose of research could be classified into five major categories: (1) checking the effects on physiological function, (2) comparing the effects of different acupuncture/acupuncture methods, (3) a study confirming improvement after inducing a specific condition, (4) a sham acupuncture study, and (5) a comparison of acupuncture sense. The Cochrane risk of bias was generally high, especially only 1 trial adopted allocation concealment (1/49, 2.0%) and 9 ones with assessor blinding (9/49, 18.4%). Conclusions Acupuncture RCTs in healthy subjects have confirmed various effects in various age/sex groups. However the research quality should be updated for future clinical research and to draw clear conclusion within rigorous methodology.

Acupotomy for Carpal Tunnel Syndrome: A Systematic Review and Meta-Analysis (수근관증후군에 대한 도침치료의 효과: 체계적 문헌 고찰과 메타분석)

  • Jeong, Jae-Min;Sul, Jae-Uk;Kim, Seon-Jong;Seon, Yun-Gwon;Choi, Ji-Min;Noh, Hui-Jeong;Choi, Jin-Bong
    • Journal of Korean Medicine Rehabilitation
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    • v.32 no.3
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    • pp.55-64
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    • 2022
  • Objectives The objective of this study was to assess the effectiveness of acupotomy for carpal tunnel syndrome. Methods Based on seven domestic and foreign databases. We analyzed the randomized controlled trials using acupotomy for carpal tunnel syndrome. The treatment group was treated with acupotomy and the control group was no restrictions on treatment methods. Results In this study, the effect of acupuncture treatment for carpal tunnel syndrome was investigated. Each study reported that acupotomy could be an effective treatment for carpal tunnel syndrome. However, as a result of meta-analysis of Levine carpal tunnel syndrome questionnaire scores, visual analog scale, and sensory nerve conduction velocity, the results were more clinically significant than those of the control group. Due to the small number of randomized controlled trial studies and the nature of acupotomy treatment, blinding of interventions was impossible, resulting in a high risk of bias. Conclusions In this regard, it is thought that well-planned randomized controlled studies on patients with carpal tunnel syndrome are needed in the future to secure the clinical evidence for acupotomy treatment.