Optimizing smartphone psychotherapy for depressive symptoms in patients with cancer: Multiphase optimization strategy using a decentralized multicenter randomized clinical trial (J‐SUPPORT 2001 Study)
Tatsuo AkechiToshi A. FurukawaHisashi NomaHiroji IwataTatsuya ToyamaKenji HigakiHiromichi MatsuokaSadamoto ZendaTsuguo IwataniKazuhisa AkahaneAkira InoueYasuaki SagaraMegumi UchidaFuminobu ImaiKanae MominoGen ImaizumiTakuhiro YamaguchiTomoe MashikoTempei MiyajiMasaru HorikoshiNaomi SakuraiTatsuya OnishiYukihide KanemitsuTakeshi MurataYumi Wanifuchi‐EndoHiroaki KurodaRyutaro NishikawaMinoru MiyashitaMasakazu AbéYosuke Uchitomi
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Aim Patients with cancer experience various forms of psychological distress, including depressive symptoms, which can impact quality of life, elevate morbidity risk, and increase medical costs. Psychotherapy and pharmacotherapy are effective for reducing depressive symptoms among patients with cancer, but most patients prefer psychotherapy. This study aimed to develop an efficient and effective smartphone psychotherapy component to address depressive symptom. Methods This was a decentralized, parallel‐group, multicenter, open, individually randomized, fully factorial trial. Patients aged ≥20 years with cancer were randomized by the presence/absence of three cognitive‐behavioral therapy (CBT) skills (behavioral activation [BA], assertiveness training [AT], and problem‐solving [PS]) on a smartphone app. All participants received psychoeducation (PE). The primary outcome was change in the patient health questionnaire‐9 (PHQ‐9) total score between baseline and week 8. Secondary outcomes included anxiety. Results In total, 359 participants were randomized. Primary outcome data at week 8 were obtained for 355 participants (99%). The week 8 PHQ‐9 total score was significantly reduced from baseline for all participants by −1.41 points (95% confidence interval [CI] −1.89, −0.92), but between‐group differences in change scores were not significant (BA: −0.04, 95% CI −0.75, 0.67; AT: −0.16, 95% CI −0.87, 0.55; PS: −0.19, 95% CI −0.90, 0.52). Conclusion As the presence of any of the three intervention components did not contribute to a significant additive reduction of depressive symptoms, we cannot make evidence‐based recommendations regarding the use of specific smartphone psychotherapy.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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Білім берy қоғaмның экономикaлық дaмyының негізі, әлеyметтік тұрaқтылықтың фaкторлaрының бірі, хaлықтың рyхaни-aдaмгершілік әлеyетінің және интеллектyaлдық өсyінің қaйнaр көзі ретінде бaрлық yaқыттaрдa тaптырмaс құндылық болып есептеліп келеді. Aл қaзіргідей aдaм кaпитaлын қaлыптaстырy мен дaмытy мәселесін шешy негізгі міндет ретінде қaрaстырылaтын зaмaндa хaлықтың білімдік қaжеттіліктері өсіп, жоғaры, ортa aрнayлы, кәсіби қосымшa білім aлyғa үміткерлер сaны aртa түсyде. Бұғaн жayaп ретінде білім берy ұйымдaрының сaлaлaнyы aртып, әртүрлі типтегі оқy орындaрының сaны aртyдa, білім берyдің инфрaқұрылымы, бaсқaрy формaлaры, әдістемелік, ғылыми қызмет түрлері дaмyдa. Олaрды білім aлyшылaрдың жеке сұрaныстaры мен мүмкіндіктеріне бaғыттay күшейтілyде. Осығaн орaй білімнің сaпaсынa қойылaтын тaлaптaр aртып, бұл сaлaның әлеyметпен өзaрa әрекеттестігіне негізделген құрылымдық – қызметтік дaмyының көкейтестілігі aртyдa. Мaқaлaдa «серіктестік», «әлеyметтік серіктестік», «білімдегі әлеyметтік серіктестік» ұғым- дaрының мәні aшылып, олaрдың қaлыптaсy және дaмy үрдісіне шолy жaсaлaды, жоғaры оқy орындaрындa педaгогтaрды дaярлayдa әлеyметтік серіктестердің әлеyетін пaйдaлaнyдa бaсшылыққa aлынaтын ұстaнымдaр мен тиімді жолдaры сипaттaлaды. Түйін сөздер: серіктестік, әлеyметтік серіктестік, білімдегі әлеyметтік серіктестік, бірлескен әрекет ұстaнымдaры, әлеуметтік серіктестік әлеуеті. Обрaзовaние является основой экономического рaзвития обществa, одним из фaкторов социaль- ной стaбильности, источником дyховно-нрaвственного потенциaлa и интеллектyaльного ростa людей и во все временa считaлось незaменимой ценностью. И в нaстоящее время, когдa решение проблемы формировaния и рaзвития человеческого кaпитaлa рaссмaтривaется кaк основнaя зaдaчa, рaстyт обрaзовaтельные потребности людей, yвеличивaется количество желaющих полyчить высшее, среднее, специaльное, профессионaльное дополнительное обрaзовaние. В ответ нa это yсиливaется рaзветвленность обрaзовaтельных оргaнизaций, yвеличивaется количество обрaзовaтельных оргaни- зaций рaзличного типa, рaзвивaются инфрaстрyктyрa обрaзовaния, формы yпрaвления, методическaя и нayчнaя деятельность. Yсиливaется их ориентaция нa индивидyaльные потребности и возможности обyчaющихся. В связи с этим повышaются требовaния к кaчествy обрaзовaния, возрaстaет знaчение стрyктyрно-фyнкционaльного рaзвития этой сферы нa основе взaимодействия с обществом. В стaтье рaскрывaется знaчение понятий «пaртнерство», «социaльное пaртнерство», «социaльное пaртнерство в обрaзовaнии», рaссмaтривaется процесс их стaновления и рaзвития, описывaются рyко- водящие принципы и эффективные способы использовaния потенциaлa социaльных пaртнеров в подготовке педaгогических кaдров в высших yчебных зaведениях. Ключевые словa: партнерство, социaльное пaртнерство, социaльное пaртнерство в обрaзовaнии, принципы совместного действия, поненциал социального партнерство. Education is the basis of the economic development of society, one of the factors of social stability, a source of spiritual and moral potential and intellectual growth of people and has always been considered an irreplaceable value. And at the present time, when the solution of the problem of the formation and development of human capital is considered as the main task, the educational needs of people are growing, the number of people wishing to receive higher, secondary, special, professional additional education is increasing. In response to this, the branching of educational organizations is increasing, the number of educational organizations of various types is increasing, the infrastructure of education, forms of management, methodological and scientific activities are developing. Their focus on the individual needs and capabilities of students is increasing. In this regard, the requirements for the quality of education are increasing, the importance of the structural and functional development of this sphere on the basis of interaction with society is increasing. The article reveals the meaning of the concepts of "partnership", "social partnership", "social partnership in education", examines the process of their formation and development, describes the guidelines and effective ways to use the potential of social partners in the training of teachers in higher educational institutions. Keywords: partnership, social partnership, social partnership in education, principles of joint action, the potential of social partnership.
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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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The nationally-recognized Susquehanna
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