Writing for Health: Rationale and Protocol for a Randomized Controlled Trial of Internet-Based Benefit-Finding Writing for Adults With Type 1 or Type 2 Diabetes
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Diabetes mellitus is Australia's fastest growing chronic disease, and has high comorbidity with depression. Both subthreshold depression and diabetes distress are common amongst people with type 1 or type 2 diabetes, and are associated with poorer diabetes self-care. A need exists for low-intensity self-help interventions for large numbers of people with diabetes and diabetes distress or subthreshold depression, as part of a stepped-care approach to meeting the psychological needs of people with diabetes. Benefit-finding writing is a very brief intervention that involves writing about any positive thoughts and feelings about a stressful experience, such as an illness. Benefit-finding writing has been associated with increases in positive affect and positive growth, and has demonstrated promising results in trials amongst other clinical populations. However, benefit-finding writing has not yet been examined in people with diabetes.The aim of this randomized controlled trial (RCT) is to evaluate the efficacy of an Internet-based benefit-finding writing (iBFW) intervention for adults with type 1 or type 2 diabetes (compared to a control writing condition) for reducing diabetes distress and increasing benefit-finding in diabetes, and also improving a range of secondary outcomes.A two-arm RCT will be conducted, using the online program Writing for Health. Adults with type 1 or type 2 diabetes living in Australia will be recruited using diabetes-related publications and websites, and through advertisements in diabetes services and general practitioners' offices. Potential participants will be referred to the study-specific website for participant information and screening. All data will be collected online. Participants will be randomized to either iBFW about diabetes, or a control writing condition of writing about use-of-time. Both conditions involve three daily sessions (once per day for three consecutive days) of 15-minute online writing exercises. Outcome measures will be administered online at baseline, one-month, and three-month follow-ups.This trial is currently underway. The primary outcomes will be diabetes distress and benefit-finding in diabetes. Secondary outcomes will be depression, anxiety, diabetes self-care, perceived health, and health care utilization. We aim to recruit 104 participants. All stages of the study will be conducted online using the Writing for Health program. Group differences will be analyzed on an intention-to-treat basis using mixed models repeated measures. Linguistic analyses of the writing exercise scripts, and examinations of the immediate emotional responses to the writing exercises, will also be undertaken.This RCT will be the first study to examine iBFW for adults with type 1 or type 2 diabetes. If iBFW is found to be efficacious in reducing diabetes distress and improving diabetes self-care and other outcomes, iBFW may offer the potential to be a low-cost, easily accessible self-help intervention to improve the wellbeing of adults with diabetes.Australia and New Zealand Clinical Trials Registry (ACTRN12615000241538).Objective To evaluate the therapeutic effects of one visit root canal therapy(RCT) and several visit RCT for cracked teeth.Methods Cracked teeth with pulposis or apical disease were randomized to receive one visit RCTor several visit RCT,their responses were compared.Results The long-term therapeutic effects of one visit RCT were batter than those of several visit RCT,but the differences were not significant.The concomitant symptoms were significantly less and treatment time was significantly shorter in one visit RCT group as compared with several visit RCT group.Conclusion One visit RCT is recommended for the RCT of cracked teeth.
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Objective:In order to clarify the actual situations of the randomized control trial(RCT)or quasi-randomized trial(QRT)and prospective clinical experimental researches in the journals of opthalmology,the related materials from 7 major journals of opthalmology from the start publication up to the year of 1999 were hand searched.Method:We handsearching These journals hand searched. and according to the criteria of RCT and QCT were included according to Cochrane Center handsearch standards.Results:Seven Ophthalmologic Journals had 21317 papers,the RCT and QCT 280 papers were included,about 1.31%,A tolal of 7428 papers were in 179 issues of China Ophthalmologic Journal,62 papers could be included,about 0.84%.The RCT and QCT in the year of 60s are rare,after 1970,RCT and CCT increased year by year.Conclusion:As the Evidence-Based Medicine becoming gradually accepted of in clinical ophthalmology,the RCT and CCT would likely to be increased year by year in ophthalmologic journals.
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Zen Nihon Shinkyu Gakkai zasshi (Journal of the Japan Society of Acupuncture and Moxibustion) (2010)
【目的】質の高い鍼灸の臨床研究デザインについて啓発を図る目的で、 18施設の教員28名を対象に、 腰痛の被験者評価者マスク・sham鍼対照RCTの模擬実践を行った。 【方法】対象者を評価者、 治療者、 被験者に分けてそれぞれの役割を担当しながら研究デザインの理解を深めさせた。 この試みの教育効果を評価するために、 模擬RCT実践前後にEvidence-Based Medicine (EBM) の必要性、 RCT用語の理解度についてVisual Analogue Scale (VAS) を用いた質問調査を行った。 【結果】RCTの理解度はVAS値が58.0±27.2から75.7±25.7に上昇し、 また、 RCT用語の理解度も上昇した。 模擬終了後に19名が今後RCTの実施および教育への導入を検討すると回答した。 【結論】模擬RCTはRCTの理解度を高め鍼灸教育への導入を促進させる効率のよい実践法であることが示唆された。
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無作為化比較試験（RCT, randomized controlled trial）が新しい治療法の効果を評価するためにヒトに施される実験であり，かつまた，それが最も質の高い科学的なエビデンスを提供してくれる唯一の研究デザインであることは世界的に広く認められた事実である．一方，日本では，RCT に対する関心とその重要性への認識は低く，薬効評価の分野でも質の高い RCT はきわめて少なかった．最近の科学的根拠に基づく医療（EBM）の流行により RCT に対する関心は高まっているものの，RCT を正しく理解して実践できる臨床医，製薬メーカの臨床開発担当者は少ない．このことは補完代替医療の評価においても全く同様にあてはまる．RCT を正しく理解し，デザインし，その結果を正しく評価できる研究者，実務家の養成は急務である．本小論では，RCT とは何か，RCT をデザインする上で必要不可欠な統計学的考え方を解説する．
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Objective To evaluate the clinical responses and effects after one visit RCT and several visits RCT. Meth-ods Cracked teeth with endodontitis or periapical disease were randomized into 2 groups according to they were treated by one visit RCT or several visits RCT,and their clinical responses and effects. Results The long-term effects of one visit RCT was better than that of several visits RCT. But There was no statistical differences between two groups. The clinical responses and treating time were reduced dramatically after one visit RCT was used. Conclusion One visit RCT is recom-mended for the cracked teeth RCT.
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The chapter discusses the randomized clinical trial (RCT) with noncompliance, in which only patients assigned to an experimental treatment group can have access to the experimental treatment, the simple noncompliance RCT. For certain treatments, such as flu vaccine or quitting smoking, it is not ethical to randomly assign high-risk patients to receive either the treatment or the placebo. Thus, to alleviate the ethical concern in application of the traditional RCT, the randomized encouragement design (RED) is often suggested. Based on whether noncompliance can occur in only one or both of the two randomized groups, the randomized consent designs can be classified as a single-consent randomized design (SCRD) and a double-consent randomized design (DCRD). Controlled Vocabulary Terms randomized controlled trial
Completely randomized design
Research Design
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为试用(一致) 陈述报导的巩固的标准已经证明了是为报导使随机化的控制试用(RCT ) 的质量的一个有效标准的目的。然而，大多数中国医药杂志没资助 CONSORT 陈述。关于在中国医药杂志的 RCT 的报导质量的当前的状况仍然是不清楚的。学习的目的是在在 5 本领先的中国医药杂志出版的报纸上评估 RCT 的报导质量。没有一致和在 2004 采用了一致的基于证据的药(杂志类型 2 ) 的中国杂志的采纳，我们用报导质量评估了 232 份原来的 RCT 报纸的方法在 5 本中国医药杂志(杂志类型 1 ) 从 2001 ～ 2006 基于一致陈述可伸缩。我们为报导优秀规模和每份 RCT 报告的 6 个核心项目测量了 26 个项目的包括，把 20 给了每个项目并且计算了在每份报告和包括单个项目的报告的比例获得的全部的分数。从 2001 ～ 2003 的 RCT 试用(采纳前时期) 的报导质量从 2004 ～ 2006 与那相比(采纳以后的时期) 。结果 RCT 的平均报导质量是中等的(吝啬的分数， 15.18 ) ，并且 6 个核心项目的吝啬的分数是低的(吝啬的分数， 1.09 ) 在 5 本领先的杂志。在全部的分数和在采纳前时期(20012003 ) 和采纳以后的时期(20042006 ) 之间的 6 个核心项目的分数的差别是统计上重要的(P=0.003；P=0.000 ) 。在杂志类型和时期之间的相互作用不是重要的(F=0.76；P=0.383 ) 。我们断定报导在杂志类型 1 和 2 之间的质量的变化趋势不是不同的。但是至于顺序隐匿和 intention-to-treat 分析的核心项目，当与杂志类型 1 作比较时，增加为杂志类型 2 是更大的(P=0.038；P=0.016 ) 。在 5 本领先的中国医药杂志的 RCT 试用的报导质量正在改进的结论。然而，在 RCT 试用的重要项目的缺乏仍然是一个严重问题。我们为在中国在基于证据的药上在中国医药杂志和持续教育试用陈述报导推荐巩固的标准的赞助。
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現在の医療においてEBMを意識しない日はないと言ってもよいだろう．一方，近年は，そのピラミッドヒエラルキーの最上位に位置するRCT（無作為化比較対照試験）の結果のみが強調される風潮がある．しかし，そもそもRCTの結果のみに依存して日々の臨床をこなしていけるだろうか．また本来，EBMとは，エビデンスとしての臨床試験のデータ・医師の経験と技量・患者の特性の三つを考慮して，個々の患者に最適の医療を提供することに本質があるはずである．そこで本稿では，EBMをよりよく活用していくためにも，これまでのRCTの具体的事例を題材として，RCTの強さと限界を論じたい．
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Background. Very elderly subjects (VES; aged 80 years or older) constitute a special population as they frequently present multiple diseases (polypathology). Results from trials on general adult populations therefore cannot be extrapolated to VES. We performed a census of randomized controlled trials (RCT) on VES published between 1990 and 2002, and carried out a descriptive and methodological analysis of these RCT/VES, comparing them with matched RCT on general adult populations (control RCT, RCT/C).
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