• 제목/요약/키워드: RCT(Randomized Controlled Trial)

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학령기 아동의 성교육에 대한 통합적 고찰 (Integrative Review of Sex Education for School Age Children)

  • 이재영;제민지
    • 한국학교보건학회지
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    • 제30권3호
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    • pp.251-265
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    • 2017
  • Purpose: This study is an integrative review to analyze articles about sex education for school age children in Korean journals. This study explored the year, methods, major variables and key findings of previous studies. Methods: Five electronic databases and eleven journals of nursing in Korean language were searched to find studies done until 2017. 75 papers published from 1995 to 2017 were selected (43 were survey studies and 32 were intervention studies). Results: Among the intervention studies, there was no Randomized Controlled Trial (RCT) study. Most intervention studies were conducted to change sexual knowledge and sexual attitudes. Among the survey studies, Q methodology and content analysis were used. The subjects' sexual knowledge and sexual consciousness were measured low in some studies. The sex education for school age children was composed of elementary school students' perception, understanding and needs related to sex. In addition, sex education was carried out to improve students' informational aspects such as sexual knowledge, prevention of sexual violence and secondary sexual character as well as emotional aspects such as sexual attitude. However, research on sexual consciousness, sexual values and sexual identity was insufficient. Conclusion: In order to develop an effective sex education program for school age children, it is necessary to consider the degree of their perception, understanding and needs and reflect both the social and cultural aspects as well as the informational and emotional aspects.

뚜렛 장애에 대한 추나요법의 효과: 체계적 문헌 고찰 및 메타분석 (Chuna Manual Therapy for Tourette's Syndrome: A Systematic Review and Meta-Analysis)

  • 김현지;이은별;김채영;안희덕
    • 척추신경추나의학회지
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    • 제17권1호
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    • pp.21-33
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    • 2022
  • Objectives To assess the effectiveness of Chuna manual therapy in patients with Tourette's syndrome. Methods We queried nine electronic databases using the keywords "Tourette's Syndrome" and "tuina OR chuna" to identify RCTs that investigated the effectiveness of Chuna manual therapy in patients with Tourette's syndrome. Results Thirteen RCTs were selected according to the inclusion criteria. A systematic review showed that Chuna manual therapy can have a curative effect on patients with Tourette's syndrome. Conclusions In this study, 13 RCTs reported that Chuna manual therapy was effective for Tourette's syndrome. These findings provide a basis for its clinical use. However, all studies involved populations belonging to the same country. Many studies lacked details of the research methodology. Therefore, further studies are required to produce high-quality evidence.

한의학 연구에 있어 의료서비스연구가 갖는 의의 고찰 (Study on the Significance of Health Services Research Methods for Studying Traditional Korean Medicine)

  • 박유리;서상록;김영진;김유리;김재효;안성훈;손인철
    • Korean Journal of Acupuncture
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    • 제27권2호
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    • pp.79-94
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    • 2010
  • Objectives : Many researchers in western societies raised questions on methodological limitations of randomized controlled trial (RCT) for studying Complementary and Alternative Medicine (CAM), and they have tried to find alternatives to RCT. Some of them recently have interest in health service research as one of the alternatives. Discussing the significance of health services research in CAM studies will be helpful to guide the researchers in Korea who are also interested in developing an appropriate research methodology for traditional Korean medicine. Methods : Previous studies on methodological issues of studying CAM and health service researches published in western societies until 2009 were searched mainly from Pubmed. The definition, main research domains, and research methods of health service research and the significance of it for researches on CAM were summarized. Results & Conclusions : Health service researches are important in two aspects. First, health service researches evaluate the actual practice of CAM, including the individualized diagnosis as well as treatment and interaction between practitioners and patients. Second, when evaluating the outcomes, they put an emphasis on subjective evaluation by patients as well as objective evaluation by doctors. Thus, it can reflect the treatment goals of CAM which is improving the overall quality of life and the physical and psychological health. Therefore, health services researches such as descriptive studies, qualitative studies, outcomes studies including economic evaluation, and whole systemic research should be more utilized in order for studying traditional Korean medicine.

산후병 및 산후관리에 대한 국내 한의학 임상 연구 동향 분석 (An Analysis of Clinical Research Trends on Interventions of Oriental Medicine for Postpartum Disease and Postpartum Care)

  • 김누리;이은희
    • 대한한방부인과학회지
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    • 제35권1호
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    • pp.34-58
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    • 2022
  • Objectives: This study was performed to analyze the interventions of Oriental Medicine which had been commonly used for postpartum disease and postpartum care. Methods: We searched research on the interventions for postpartum disease and postpartum care in 4 domestic search engines. After that, we conducted eligibility screening based on inclusion and exclusion criteria. Results: 1. We selected total 50 studies. There were 2 randomized controlled trial (RCT), 5 non-RCT, 35 case reports, 8 case series within the 6~8 weeks after childbirth. 2. Of the 35 case reports, several interventions were used : acupuncture (22), moxibustion (11), cupping therapy (7), pharmacopuncture (5), chuna manipulation (4), herbal medicine (34). The most common symptoms were musculoskeletal symptoms (8), followed by postpartum depression (7). Various prescriptions and acupoints of oriental medicine were used depending on the diseases or symptoms. 3. Of the 8 case series, 382 subjects in 5 case series had taken Saenghwa-tang-gagam. And Acupuncture, moxibustion, cupping therapy (5), pharmacopuncture (1) were used as an intervention. 4. The most commonly used acupoint is 腎兪 (BL23) in the pain including postpartum back pain and 三陰交 (SP6), 關元 (CV4) in the postpartum care. 關元 (CV4) is the most commomly used moxibustion point not only the postpartum disease but also the postpartum care. Conclusions: In clinical studies of oriental medicine related to postpartum disease and postpartum care, pain-related clinical studies that belong to or progress to Sanhupung were the most common (30%), and among them, postpartum low back pain studies were the most common (20%). Based on this, we believe that large-scale clinical studies with high quality using oriental interventions including chuna and pharmacopuncture are needed to establish guidelines for the management of pain treatment including postpartum back pain.

중풍(中風) 재활(再活)의 침치료(鍼治療) 효과(效果)에 대한 고찰(考察) -최근 RCT(Randomized controlled trial) 논문을 중심으로- (The Study on the Effectiveness of Acupuncture in Stroke Rehabilitation)

  • 김정은;이재동;강성길
    • Journal of Acupuncture Research
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    • 제22권1호
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    • pp.211-221
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    • 2005
  • 본 논문은 지금까지의 침 치료와 중풍재활에 관해 쓰인 논문들을 살펴보고 그들의 연구방법, 실험과정, 결과들을 분석 평가하여 침 치료가 중풍 재활 치료에 유의함을 가지는지 알아보고자 하였다. 이를 위해 pubmed와 science direct, EBSCO를 검색하고 경희의료원 의학도서관에 소장된 비전산화 저널 자료에 대한 수기 조사를 병행하여 논문 원문 16편을 얻을 수 있었으며 다음과 같은 결론을 얻었다. 1. 검색을 통해 원문을 얻은 논문은 모두 16편이었으며, 그중 9편의 논문이 RCT논문이었다. 2. 중풍 재활치료로써 침 치료가 환자의 전반적 운동기능향상 및 일상생활과 생활의 질의 향상에 유의한 효과를 보인다고 보고한 논문이 3편이었으며, 다른 세 논문은 침 치료가 유의한 효과를 보이지 않는다고 보고하였다. 3. 중풍 후 증상인 spasticity에 대한 두 논문 중 상지의 spasticity에 관련한 논문은 침 치료가 유의하다고 보고하였으며, 하지의 spasticity에 관련한 논문은 이와 반대로 유의하지 않다고 보고하였다. 4. 침 치료와 자세조절에 관한 논문 1편은 침 치료가 중풍 후 자세 조절의 정상화를 촉진시키는데 유의하다고 보고하였다. 5. 9편의 논문 중 침 치료가 유의한 효과를 보고한 논문의 Jadad score는 2점, 2점, 1점, 1점, 1점으로 낮게 나타났으며 유의한 효과를 보이지 않는다고 보고한 논문의 Jadad score는 5 점, 5점, 3점, 1점으로 높게 나타났다.

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알레르기성 비염에 대한 한약 및 양약 국소비강외용제의 효과 비교 : 체계적 문헌 고찰 (Comparison of the Effects of Topical Nasal Application on Allergic Rhinitis between Korean and Western Medicine : A Systematic Review of Randomized Controlled Trials)

  • 조효림;오세희;김선혜;성원석;홍승욱;김은정
    • 한방안이비인후피부과학회지
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    • 제32권4호
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    • pp.62-89
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    • 2019
  • Objectives : The purpose of this study is to evaluate the effectiveness and safety of topical nasal application of Herbal medicine compared with Western medicine in the treatment of Allergic Rhinitis(AR). Methods : Electronic databases including Cochrane library, PubMed, EMBASE, CNKI, KMBASE, KISS, NDSL, OASIS, KISS and KJTK(Korean Traditional Knowledge Portal) were searched by the keywords such as 'allergic rhinitis', 'nasal sprays', 'herbal medicine', 'plant extracts', and 'external application'. The quality of each RCTs was assessed by Cochrane Collaboration of 'Risk of bias(RoB) Tool'. Results : 19 RCTs were finally selected from 1419 references screened. 19 RCTs were compared with the effects of topical nasal application of Herbal medicine and Western medicine. Based on the symptom scores from 13 RCTs, topical nasal application of herbal medicine generally has a better effect on relief of AR. The two treatments have similar effects on improving the level of specific factors like IgE, IgG, IL-13, $uLTD_4$ in blood and urine. 8 RCTs showed adverse effects(AEs) in both groups and severe AEs were not reported. Conclusions : This study shows that topical nasal application of herbal medicine can improve symptoms and related factors of allergic rhinitis. Well-designed RCT studies with low risk of bias should be conducted to confirm these findings.

비만 치료 한약 무작위 대조 임상시험에서의 음식 섭취량과 운동량 실태분석 (Analysis of Food Intake and Physical Activity in Randomized Controlled Trials on Herbal Medicine for Treatment of Human Obesity)

  • 김두희;신우석;박원형;차윤엽;송윤경;안민윤;고성규
    • 한방비만학회지
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    • 제13권2호
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    • pp.58-65
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    • 2013
  • Objectives: The objective of this study was to analyse the methods being used to control food intake and physical activity in RCTs of human obesity. Methods: A total of 21 randomized controlled trials (RCTs) were investigated. Nine of which were domestic studies from "http://oasis.kiom.re.kr" and the other of which were foreign studies from systematic reviews of RCTs on herbal medicine for treatment of human obesity. Results: According to domestic studies, "low calorie diet" were recommended in five cases of the domestic studies, "maintain current dietary habit" were recommended in two and no information on diet was two. Considering the seven cases where the information on diet was available, patients' food intake were checked at every visit in six cases. Only two cases among the six had been dropped owing to the violation of dietary habit by patients. Exercises were prohibited in two cases, "maintain current level of phisical activity" were recommended in three cases and, from the rest, no information was available. The level of physical activity were not strictly controlled by any means hence no drop out. According to foreign studies, "low calorie diet" were recommended in two cases, "very low calorie diet (less than 700 kcal/day)" in one case, "maintain current dietary habit" in two cases, "do not eat fat" in two cases and no information was available in the rest five cases. Exercises which concerns spending about 300 kcal/day was recommended in one case, "moderate exercise" were recommended in three cases, "maintain current level of physical activity" were recommended in three cases and no information available in the rest five cases. Conclusions: In order to improve the accuracy of RCT, for the dietary side, researchers should record patient food intake at every visit by means of 24-hour dietary recall methods. This can be supplemented by multiple choice survey that are designed to help patients to diagnose themselves more accurately leading to less bias. For the exercise side, it is highly recommended to confine the exercises to walking only so as to quantify the amount of physical activity more easily by using pedometer.

Efficacy and Safety of COVID-19 Vaccines in Adolescents: Systematic Review of Randomized Controlled Studies and Observational Studies

  • Soo-Han Choi;Su-Yeon Yu;Jimin Kim;Miyoung Choi;Youn Young Choi;Jae Hong Choi;Ki Wook Yun;Young June Choe
    • Pediatric Infection and Vaccine
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    • 제31권1호
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    • pp.12-24
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    • 2024
  • 본세계적으로 소아 코로나바이러스 감염 2019 (COVID-19) 환자 수가 질병 초기와 비교하여 증가하고 있으며, 이는 고도로 전염성이 있는 중증 급성 호흡기 증후군 코로나바이러스 변이와 성인 COVID-19 백신 접종 증가와 관련이 있다. 본 연구는 청소년 대상 COVID-19 백신 접종의 무작위 임상시험 (randomized controlled trial, RCT) 후향적 관찰연구를 대상으로 신속 체계적 문헌고찰과 메타 분석을 수행했다. 체계적 문헌고찰 결과, 17개의 연구가 최종적으로 포함되었다. 메타 분석 결과, 청소년 대상 예방접종은 후향적 관찰 연구에서 COVID-19 감염을 예방하는 데 유의미하게 효과적이었으나 (risk ratio [RR], 0.29; 95% confidence interval [CI], 0.22-0.37; I2=100%), RCT보다 COVID-19 감염을 예방하는 효과가 낮았다 (RR, 0.05; 95% CI, 0.01-0.27). 5개의 후향적 관찰 연구에서, 국민 10만 명당 심근염 및/또는 심낭염 비율은 2.33명 (95% CI, 0.97-5.61 명)이었다. 성별 및 백신 접종 횟수에 따른 하위 그룹 분석 결과, 남성 (국민 10만 명당 5.35 명) 및 두 번째 접종 (국민 10만 명당 9.71명)은 여성 (국민 10만 명당 1.09명) 및 첫 번째 접종 (국민 10만 명당 1.61명)보다 심근염 및/또는 심낭염 발생률이 유의하게 높았다. 본 연구에서는 청소년을 대상으로 mRNA COVID-19 백신을 접종하는 것은 RCT 및 관찰연구 모두에서 COVID-19에 대해 효과적이었다. 또한 청소년 대상 BNT162b2 백신의 안전성 결과를 탐색하였으며, 성별 및 백신 접종 횟수에 따른 안전성의 차이를 확인했다. 향후 mRNA COVID-19 예방접종 후 부작용 발생은 계속 모니터링할 필요가 있다.

B형 및 C형 간염에 대한 한약 치료의 효과 - 체계적 고찰 연구 (Herbal Medicine for the Treatment of Viral Hepatitis B and C: A Systematic Review of Randomized Controlled Trials)

  • 김승모;이유리;조나경;최홍식;김경순
    • 대한한방내과학회지
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    • 제42권4호
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    • pp.455-474
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    • 2021
  • 본 연구는 B형 및 C형 간염에 대한 한약 치료의 효과를 평가하기 위해 무작위 임상연구를 대상으로 체계적 문헌고찰 및 메타분석을 시행하였다. 검색엔진은 EMBASE, Pubmed, NDSL, KMBASE, KISS, KISTI, Koreamed, Koreantk, Oasis database를 이용하였으며 국내의 검색 엔진 키워드는 '간염' 또는 '바이러스성간염', '한약', '무작위 배정 임상시험'을, 국외 검색 엔진 키워드는 'hepatitis' or 'viral hepatitis' and 'herbal medicine' or 'traditional chinese medicine' and 'randomized controlled trial'을 이용하였다. 연구 결과 15개의 무작위배정 임상시험을 선택되었으며, 그 중 통계적으로 유의미한 결과를 나타낸 연구는 한약과 양약 복합치료군이 양약을 투여한 대조군에 비해 HBV DNA loss에서 높은 효과를 보였다. 한약과 양약 복합치료군이 양약을 투여한 대조군에 비해 HBeAg loss에서 통계적으로 유의한 효과를 보였으며, 한약과 양약 복합치료군이 양약을 투여한 대조군에 비해 ALT가 감소하였다. 본 연구는 B형 및 C형 간염환자를 대상으로 한약의 효과를 확인하기 위해 기존에 시행된 RCT 연구를 대상으로 체계적 문헌고찰을 시행하였으며, 한약과 양약의 복합치료가 양약 단독치료에 비해 치료효과가 더 높은 것으로 나타났다.

CONSORT-CHM 2017 지침에 근거한 대한한의학회지 및 회원학회지에 투고된 경구투여 한약 중재를 활용한 무작위 배정 비교 임상 연구(RCT)의 양적, 질적 평가 연구 (Orally Administered Korean Herbal Medicine Medications of Randomized Controlled Trials Published in the Journal of Korean Medicine and Related Journals: A Narrative Analysis using CONSORT-CHM 2017)

  • 문세훈;조정호;최승관; 한윤희;우현준;전병현;하원배;이정한
    • 대한한방내과학회지
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    • 제44권6호
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    • pp.1212-1242
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    • 2023
  • Objectives: This study aims to explore the current usage status of orally administered Korean herbal medicine in randomized controlled trials (RCTs) published in the Journal of Korean Medicine and member journals using the CONSORT-Chinese Herbal Medicine Formulas 2017 (CONSORT-CHM 2017) checklist. Methods: We searched the OASIS, RISS, and KMBASE archives as well as the websites of the Journal of Korean Medicine and 45 member journals to identify RCTs that used herbal interventions. Two independent researchers searched and categorized the RCTs and performed a quantitative evaluation by journal, study design, and target disease, as well as qualitative evaluation of the literature using CONSORT-CHM 2017. Results: After the search, 66 articles were selected. The quantitative evaluation resulted in 13 articles (19.6%) that were published in the Journal of Korean Medicine and 12 articles (18.1%) in the Journal of Internal Korean Medicine. In terms of study design, 62 articles (93.9%) were parallel, 4 articles (6%) were crossover, and 2-arm parallel study designs were the most common in 45 articles (68.2%). In terms of the study participants, physiological characteristics and mechanisms in healthy individuals were the most common in 21 studies (31.8%) and obesity in 9 studies (13.6%). In terms of assessing completeness in the CONSORT-CHM 2017 items, 29 articles were rated high, 31 were rated moderate, and 6 were rated low. Items 4a, 6a, and 7a had low reporting rates (≤ 30%), while items 2a, 2b, and 12a were completely reported in all studies. Conclusion: Future RCTs using orally administered Korean herbal medicine need to be reported completely, and the CONSORT-CHM 2017 checklist can be a helpful tool for this purpose.