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利用者名:
UMIN ID:

試験進捗状況 開始前/Preinitiation
UMIN試験ID UMIN000042464
受付番号 R000048472
科学的試験名
一般公開日(本登録希望日) 2020/11/16
最終更新日 2020/11/16

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
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基本情報/Basic information
一般向け試験名/Public title
How Is Standardized Mean Difference Computed, Reported and Interpreted in Randomized Controlled Trials
一般向け試験名略称/Acronym
How Is SMD Computed, Reported and Interpreted in RCTs
科学的試験名/Scientific Title
A Meta-epidemiological Study about How Standardized Mean Difference Is Computed, Reported and Interpreted in Randomized Controlled Trials
科学的試験名略称/Scientific Title:Acronym
A Meta-epidemiological Study about How SMD Is Computed, Reported and Interpreted in RCTs
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition
Not limited. General medicine, internal medicine, surgery, psychiatry, psychology.
疾患区分1/Classification by specialty
内科学一般/Medicine in general 外科学一般/Surgery in general
精神神経科学/Psychiatry
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
We aim to investigate currently how the term "effect size" is used, how standardized mean difference (SMD) is computed and reported in randomized controlled trials, and how different the values would be if using different approaches to calculate it.
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others
Whether the reported SMD is reproducible based on available data.
試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2 説明的/Explanatory
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes
(1) Study characteristics of RCTs that report SMD; (2) The term and method used to compute the reported SMD; (3) Comparison between reported SMD and SMD which we calculate based on different approaches
副次アウトカム評価項目/Key secondary outcomes
(1) How RCTs interpret the results in terms of SMD: focusing on whether it is comparable with previous studies (based on same method), and whether it is compared to a standard. (2) Relationship between reporting condition, calculation method and sub-discipline, journal.

基本事項/Base
試験の種類/Study type その他・メタアナリシス等/Others,meta-analysis etc

試験デザイン/Study design
基本デザイン/Basic design
ランダム化/Randomization
ランダム化の単位/Randomization unit
ブラインド化/Blinding
コントロール/Control
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms
介入の目的/Purpose of intervention
介入の種類/Type of intervention
介入1/Interventions/Control_1

介入2/Interventions/Control_2

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit

適用なし/Not applicable
年齢(上限)/Age-upper limit

適用なし/Not applicable
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
We will include RCTs published on high-impact journals, which report any SMDs for any continuous outcomes. We restrict the eligible studies to those published on high-impact journals, because we consider that the method used compute the SMD would be better addressed, and results would be more comprehensively provided. Multifactorial RCTs, and crossover RCTs that report results of the first period are eligible.
除外基準/Key exclusion criteria
We will exclude RCTs which use the term "effect size" or "SMD" in a nonspecific way (i.e. sample size calculation), but not for the outcome. We will exclude cluster randomization, quasi-randomized trials, and crossover RCTs whose first period result is not available.
目標参加者数/Target sample size 60

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Yan
ミドルネーム
Luo
所属組織/Organization
Kyoto University Graduate School of Medicine
所属部署/Division name
Department of Health Promotion and Human Behavior
郵便番号/Zip code 606-8501
住所/Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
電話/TEL +81-75-753-9491
Email/Email lilacluo@gmail.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Yan
ミドルネーム
Luo
組織名/Organization
Kyoto University Graduate School of Medicine
部署名/Division name
Department of Health Promotion and Human Behavior
郵便番号/Zip code 606-8501
住所/Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
電話/TEL +81-75-753-9491
試験のホームページURL/Homepage URL
Email/Email lilacluo@gmail.com

実施責任組織/Sponsor
機関名/Institute その他 Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
Kyoto University Ethics Commitee
住所/Address
Kyoto University Graduate School of Medicine, Yoshida Konoe-cho, Sakyo-ku, Kyoto
電話/Tel +81-75-753-4680
Email/Email ethcom@kuhp.kyoto-u.ac.jp

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions Kyoto University (Kyoto)

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2020 11 16

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 開始前/Preinitiation
プロトコル確定日/Date of protocol fixation
2020 11 01
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2020 11 10
フォロー終了(予定)日/Last follow-up date
2021 04 01
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information
Eligible studies: We will include RCTs published on high-impact journals*, which report any SMDs for any continuous outcomes. We restrict the eligible studies to those published on high-impact journals, because we consider that the method used compute the SMD would be better addressed, and results would be more comprehensively provided. Multifactorial RCTs are eligible, while cluster randomization or quasi-randomized trials will be excluded. As for crossover RCTs, we will only include those whose SMD for the first period is reported.
*General medicine: New England Journal of Medicine, Lancet, JAMA, BMJ, PLoS Medicine, BMC Medicine; Internal medicine: Annals of Internal Medicine, JAMA Internal Medicine; Surgery: JAMA Surgery, Annals of Surgery; Psychiatry: Lancet Psychiatry, JAMA Psychiatry (Archives of General Psychiatry), World Psychiatry, American Journal of Psychiatry, British Journal of Psychiatry; Psychology: Psychological Bulletin, Behavioral and Brain Sciences, Psychological Inquiry, Trends in Cognitive Sciences, Perspectives on Psychological Science.

Data collection: (1) General information of the study; (2) The term, modeling and calculation methods, point estimate and 95% CI, and its interpretation of SMD; (3) Necessary data for us to calculate SMDs using different approaches.

Data analysis: We will calculate SMDs based on different approaches (using endpoint mean or change score mean, endpoint SD or change score SD or baseline SD, when data is available). We will compare the calculation results with the reported SMD.

管理情報/Management information
登録日時/Registered date
2020 11 16
最終更新日/Last modified on
2020 11 16


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000048472
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048472

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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