• 제목/요약/키워드: Randomized clinical trials

검색결과 947건 처리시간 0.024초

DESIGN AND ANALYSIS OF RANDOMIZED CLINICAL TRIALS REQUIRING PROLONGED OBSERVATION OF EACH PATIENT I. INTRODUCTION AND DESIGN

  • Peto R.;Pike M.C.;Armitage P.;Breslow N.E.;Cox D.R.;Howard S.V.;Mantel N.;Mcpherson K.;Peto J.;Smith P.G.
    • 대한예방의학회:학술대회논문집
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    • 대한예방의학회 1994년도 교수 연수회(역학)
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    • pp.206-233
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    • 1994
  • The Medical Research Council has for some years encouraged collaborative clinical trials in leukaemia and other cancers, reporting the results in the medical literature. One unreported result which deserves such publication is the development of the expertise to design and analyse such trials. This report was prepared by a group of British and American statisticians, but it is intended for people without any statistical expertise. Part!, which appears in this issue, discusses the design of such trials; Part II, which will appear separately in the January 1977 issue of the Journal, gives full instructions for the statistical analysis of such trials by means of life tables and the logrank test, including a worked example, and discusses the interpretation of trial results, including brief reports of particular trials. Both parts of this report are relevant to all clinical trials which study time to death, and would be equally relevant to clinical trials which study time to other particular classes of untoward event: first stroke, perhaps, or first relapse, metastasis, disease recurrence, thrombosis, transplant rejection, or death from a particular cause. Part I, in this issue, collects together ideas that have mostly already appeared in the medical literature, but Part II, next month, is the first simple account yet published for non-statistical physicians of how to analyse efficiently data from clinical trials of survival duration. Such trials include the majority of all clinical trials of cancer therapy; in cancer trials, however, it may be preferable to use these statistical methods to study time to local recurrence of tumour, or to study time to detectable metastatic spread, in addition to studying total survival. Solid tumours can be staged at diagnosis; if this, or any other available information in some other disease is an important determinant of outcome, it can be used to make the overall logrank test for the whole heterogeneous trial population more sensitive, and more intuitively satisfactory, for it will then only be necessary to compare like with like, and not, by chance, Stage I with Stage III.

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Barriers to Participation in a Randomized Controlled Trial of Qigong Exercises Amongst Cancer Survivors: Lessons Learnt

  • Loh, Siew Yim;Lee, Shing Yee;Quek, Kia Fatt;Murray, Liam
    • Asian Pacific Journal of Cancer Prevention
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    • 제13권12호
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    • pp.6337-6342
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    • 2012
  • Background: Clinical trials on cancer subjects have one of the highest dropout rates. Barriers to recruitment range from patient-related, through institutional-related to staff-related factors. This paper highlights the low response rate and the recruitment barriers faced in our Qigong exercises trial. Materials and Method: The Qigong trial is a three-arm trial with a priori power size of 114 patients for 80% power. The University Malaya Medical Centre database showed a total of 1,933 patients from 2006-2010 and 751 patients met our inclusion criteria. These patients were approached via telephone interview. 131 out of 197 patients attended the trial and the final response rate was 48% (n=95/197). Results: Multiple barriers were identified, and were regrouped as patient-related, clinician-related and/or institutional related. A major consistent barrier was logistic difficulty related to transportation and car parking at the Medical Centre. Conclusions: All clinical trials must pay considerable attention to the recruitment process and it should even be piloted to identify potential barriers and facilitators to reduce attrition rate in trials.

아토피피부염의 침 치료 임상연구 동향 (Trend for Acupuncture treatment Clinical Trial on Atopic Dermatitis)

  • 박수연;최정화;정민영;이기현
    • 한방안이비인후피부과학회지
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    • 제33권1호
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    • pp.45-55
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    • 2020
  • Objectives : The objective of this study is to review the Trend of clinical trials conducted with the acupuncture treatment on Atopic Dermatitis. Methods : Through 4 foreign online databases(PubMed, Cochrane library, EMBASE, CNKI) and 3 domestic online databases(NDSL, RISS, OASIS), we searched for clinical studies performed acupuncture treatment for Atopic Dermatitis from 2010 to December 2019. Only randomized controlled trials(RCT) was selected and anlayzed according to the research method. Results : A total 4 studies were reviewed. LI11, ST36, SP10 were most frequently used acupoints in acupuncture treatment. Among the evaluation indexes, SCORAD, VAS, DLQI were used most. In most of the 4 studies, acupuncture treatment showed significant therapeutic effects. Conclusions : These results suggest that it is necessary to develop more detailed standards about Acupuncture treatment method as the method of acupuncture is getting more diverse, and objective tools are needed in evaluating Atopic Dermatitis.

The effects of EMG-triggered functional electrical stimulation on upper extremity function in stroke patients

  • Kim, Young
    • Physical Therapy Rehabilitation Science
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    • 제2권1호
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    • pp.1-6
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    • 2013
  • Objective: The aim of this review is to explore the latest intervention trends and effects of EMG-triggered functional electrical stimulation on the upper extremity functions in stroke patients. Design: Systematic review on clinical trials. Methods: A systematic literature search was performed to identify clinical trials evaluating the effects of EMG-triggered functional electrical stimulation (EMG-FES) and task-oriented EMG-triggered FES on the hand functions in stroke patients. Literature review was conducted with the following key words: hand function, functional electrical stimulation, task-oriented, stroke. Results: Ten clinical trials were included; 8 of them were randomized controlled trial, 1 was block-randomized, and 1 was a pre-post comparison study. A positive effect of electrical stimulation was reported in the patient groups that were treated with functional electrical stimulation combined with specific tasks, and volitional muscle contraction-triggered stimulation that was synchronized with tasks. Motor capabilities of the hand and arm were improved after the rehabilitation. Conclusions: EMG-triggered electrical stimulation may be more effective than non-triggered electrical stimulation in facilitating the hand functions in stroke patients in terms of muscle strength and voluntary muscle contraction of the paretic hand and arm. Triggered electrical stimulation can be even more effective when it is combined with specific tasks.

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CNKI로 검색한 소아 수두의 한약 내복 치료에 대한 임상연구 동향 - 2000년대 이후 RCT 연구를 중심으로- (Review of Clinical Studies of Oral Herbal Medicine Treatment for Pediatric Chickenpox using CNKI Database - Focused on Chinese Randomized Controlled Trials after 2000s -)

  • 최정윤;김장현;민상연
    • 대한한방소아과학회지
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    • 제34권3호
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    • pp.18-36
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    • 2020
  • Objectives The purpose of this study is to analyze Chinese randomized controlled trials (RCTs), and to evaluate the effectiveness and safety of the oral herbal medicine treatment for pediatric chickenpox. Methods We searched RCTs after 2000s from the China National Knowledge Infrastructure (CNKI). Afterwards, the year of publication, demographic information, duration of chickenpox, intervention, treatment duration, outcome measure, results and adverse events were investigated and analyzed for this study. Results 21 RCTs out of 219 studies were collected and analyzed. Although each composition of the herbal medicine was different, they have common ingredients such as 清熱解毒, 散結消腫, 疏散風熱, 涼血解毒, 解表散風 in order to make efficacy of 清熱解毒, 散結消腫, 疏散風熱, 涼血解毒, 解表散風. The oral herbal medicine showed better efficacy and safety to improve clinical symptoms such as total efficacy, cure rate, antipyretic time, antipruritic time, scab time, anti-rash time, hospitalization period and herpes recovery time compared to the western medicine treatment. Conclusions These results show that the oral herbal medicine treatment on chickenpox in children may be more effective in reducing of clinical symptoms compared to the western medicine treatment.

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

  • 조현우;이현엽;허광호;황의형;신미숙;신병철
    • 척추신경추나의학회지
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    • 제7권2호
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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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Success rate of nitrous oxide-oxygen procedural sedation in dental patients: systematic review and meta-analysis

  • Rossit, Marco;Gil-Manich, Victor;Ribera-Uribe, Jose Manuel
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제21권6호
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    • pp.527-545
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    • 2021
  • The aim of this systematic review was to determine the success rate of nitrous oxide-oxygen procedural sedation (NOIS) in dentistry. A systematic digital search was conducted for publications or reports of randomized controlled trials evaluating the clinical performance of NOIS. Abstracts of research papers were screened for suitability, and full-text articles were obtained for those who met the inclusion and exclusion criteria accordingly. The quality of the studies was assessed using the revised Cochrane risk-of-bias tool (RoB 2). A total of 19 articles (eight randomized clinical trials with parallel intervention groups and 11 crossover trials), published between May 1988 and August 2019, were finally selected for this review. The studies followed 1293 patients reporting NOIS success rates, with a cumulative mean value of 94.9% (95% CI: 88.8-98.9%). Thirteen trials were conducted on pediatric populations (1098 patients), and the remaining six were conducted on adults (195 patients), with cumulative efficacy rates of 91.9% (95% CI: 82.5-98.1%) and 99.9% (95% CI: 97.7-100.0%), respectively. The difference was statistically significant (P = 0.002). Completion of treatment and Section IV of the Houpt scale were the most used efficacy criteria. Within the limitations of this systematic review, the present study provides important information on the efficacy rate of NOIS. However, further well-designed and well-documented clinical trials are required and there is a need to develop guidelines for standardization of criteria and definition of success in procedural sedation. Currently, completion of treatment is the most used parameter in clinical practice, though many others also do exist at the same time. To maximize NOIS efficacy, clinicians should strictly consider appropriate indications for the procedure.

긴장성두통에 대한 한약치료: 체계적 문헌고찰 및 메타분석 (Herbal Medicine for Tension-type Headache: Systematic Review and Meta Analysis of Randomized Controlled Trials)

  • 최은지;권찬영;한경훈;김종우;정선용
    • 동의신경정신과학회지
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    • 제26권4호
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    • pp.383-406
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    • 2015
  • Objectives: People with tension-type headache generally take pain relievers, but long term dependency causes problems as well as side effects. The present study aimed to provide clinical evidence of herbal medicine for tension-type headache by systematic review of randomized controlled trials on the effect of herbal medicine for tension-type headache. Methods: Randomized or quasi-randomized controlled trials that verified effects of herbal medicine intervention on patients with tension-type headache were included in the study. A literature search of English, Japanese, Chinese, Korean databases was performed. The selected literature were assessed by Jadad scale and Risk of Bias. Results: Herein, 40 reports were selected from a total of 157. Meta-analyses of 2 trials indicated that the effective rate was significantly higher in the herbal medicine treatment group, as compared to the placebo control (risk ratio: 1.49, 95% confidence interval (CI): 1.23 to 1.80, p<0.0001, I2=0%). Four trials that compared herbal medicine with routine care with routine care only group showed a significantly higher effective rate of benefits for herbal medicine with routine care, as compared to routine care only (RR: 1.57, 95% CI: 1.18 to 2.10, p=0.002, I2=0%). Conclusions: The effective rate was significantly higher than control and adverse events were less in the treatment group. Pattern analysis (辨證) indicated that the studies on wind-fire pattern (風火證) were highest. Yougeun-bang (柔筋方) in prescription and Paeoniae Radix Alba (白芍藥) in medicinal herbs were most used. This finding could be widely utilized in future clinical practice and form the basis for the development of clinical practice guidelines in advance.

비만 치료 한약의 무작위 대조임상시험에 대한 체계적 분석 (Systematic Review of Randomized Controlled Trials on Herbal Medicine for Treatment of Human Obesity)

  • 박정현;남종경;권동현;김호준;이명종
    • 한방재활의학과학회지
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    • 제19권3호
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    • pp.33-46
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    • 2009
  • Objectives : The objective of the study was to summarize randomized clinical trials(RCTs) that have assessed the effectiveness of herbal medicine on treatment of obesity and to propose better process of study. Methods : NLM Medline(pubmed), EMBASE, the Cochrane library, Science Direct, EBSCO, 4 Korean medical databases were systematically searched and 4 Korean medical journals were manually searched for clinical trials investigating the efficacy of herbal medicines on treatment of overweight or obese people from 1998 to 2008. The methodological quality was assessed using a Jadad score and validity was assessed using Oxford Pain Validity Scale(OPVS). Results : 14 RCTs met all the inclusion criteria. The methodological and ethical quality of the trials was generally low. The mean score by Jadad was 2.6 and the mean score of validity was 11.2. Complex herbal medicine was used in 8 RCTs and single herbal medicine was used in 6 RCTs. Except 1 RCT, the other RCTs reported positive effects of herbal medicine on treatment of obesity. Herbal medicines didn't seem to affect toxicity. In general adverse events relevant with the therapy were minor, but more than half of RCTs did not report about the safety or adverse events of herbal medicine, questioning their reliability. Conclusions : Although most RCTs concluded the efficacy and safety of herbal medicines on treatment of obesity, the quality of trials was low in general. Further rigorous clinical trials using complex herbal medicine should be performed.

산후신통의 한방 치료에 대한 무작위대조군연구에 관한 고찰 (Review of Randomized Controlled Trials on Korean Traditional Medicine Treatment for Postpartum Pain)

  • 노은지;최수지;김동일
    • 대한한방부인과학회지
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    • 제33권2호
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    • pp.90-111
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    • 2020
  • Objectives: The purpose of this study was to analyze randomized controlled trials (RCTs) related to the effect and safety of Korean Traditional Medicine treatment for postpartum pain, and to suggest desirable future clinical research trend. Methods: Randomized controlled trials (RCTs) on postpartum pain were searched using domestic and foreign search engines to investigate the effect and safety of Korean Traditional Medicine on postpartum pain, and 12 studies were selected as a result. Results: There were 4 studies using Acupoint Therapy, 3 studies using Herbal Medicine, 3 studies using Using Acupoint Therapy and Herbal Medicine together, and 2 studies using Manipulative Therapy for postpartum pain. As control interventions, non-treatment, other Korean Traditional Medicine treatment, or Western medicine were used. All the studies reported a significant effect in experimental group compared to the control group, with no or minor side effects. Conclusions: Korean Traditional Medicine treatment showed effectiveness and safety for postpartum pain. In the future, it is necessary to eliminate the ambiguity of recruiting subjects and to study the most effective application method of Korean Traditional Medicine treatment for postpartum pain.