UMIN-ICDS 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語

英語
Evaluating the relationship between industry sponsorship and conflicts of interest among systematic review authors on pharmacological therapies for alcohol use disorder and the nature of results and conclusions of these reviews

一般向け試験名略称/Acronym

日本語

英語
AUD-FCOI

科学的試験名/Scientific Title

日本語

英語
Evaluating the relationship between industry sponsorship and conflicts of interest among systematic review authors on pharmacological therapies for alcohol use disorder and the nature of results and conclusions of these reviews

科学的試験名略称/Scientific Title:Acronym

日本語

英語
AUD-FCOI

試験実施地域/Region

北米/North America

対象疾患名/Condition

日本語

英語
Alcohol Use Disorder

疾患区分1/Classification by specialty

精神神経科学/Psychiatry	成人/Adult

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1/Narrative objectives1

日本語

英語
Objectives: Our primary objectives are (i) to characterize the nature and types of conflicts of interest (both disclosed and undisclosed) of systematic review authors and (ii) to determine whether the direction of meta-analytic pooled effect estimates, when provided, and narrative results and conclusions from systematic reviews may be influenced by having systematic review authors with conflicts of interest. Our secondary objectives will be to evaluate (i) whether an association exists between risk of bias and financial conflicts of interest of systematic review authors; and (ii) whether a relationship exists between sponsorship of systematic reviews and their reported results and conclusions.

目的2/Basic objectives2

有効性/Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語

英語

試験の性質1/Trial characteristics_1

試験の性質2/Trial characteristics_2

試験のフェーズ/Developmental phase

主要アウトカム評価項目/Primary outcomes

日本語

英語
Objectives: Our primary objectives are (i) to characterize the nature and types of conflicts of interest (both disclosed and undisclosed) of systematic review authors and (ii) to determine whether the direction of meta-analytic pooled effect estimates, when provided, and narrative results and conclusions from systematic reviews may be influenced by having systematic review authors with conflicts of interest. Our secondary objectives will be to evaluate whether an association exists between risk of bias and financial conflicts of interest of systematic review authors

副次アウトカム評価項目/Key secondary outcomes

日本語

英語
(ii) whether a relationship exists between sponsorship of systematic reviews and their reported results and conclusions.

試験の種類/Study type

その他・メタアナリシス等/Others,meta-analysis etc

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

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

日本語

英語

介入2/Interventions/Control_2

日本語

英語

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

18

歳/years-old

以上/<=

年齢（上限）/Age-upper limit

90

歳/years-old

未満/>

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語

英語
Eligibility Criteria: To be included in our study, the study design must be a systematic review and or meta-analysis. We will use the PRISMA P deNAfinition of a systematic review meta-analysis, which states that a systematic review is a systematic review is a review of a clearly formulated question that uses systematic and explicit methods to identify, select, and critically appraise relevant research, and to collect and analyze data from the studies that are included in the review. Statistical methods (meta-analysis) may or may not be used to analyze and summarize the results of the included studies. Meta-analysis refers to the use of statistical techniques in a systematic review to integrate the results of included studies. 1. Furthermore, studies will be included if they compare at least one pharmacologic therapy to another (or in combination) or if they compare a pharmacologic therapy to an nonpharmacologic therapy, such as verbal alcoholism therapy. We will include all pharmacologic therapies, regardless of whether they are indicated for treatment of AUD (acamprosate, naltrexone, and disulfiram) or whether they are used off label. We will include studies along the following stages of progression: (i) stabilization following excessive use of alcohol, (ii) relapse prevention, or (iii) recovery maintenance. Furthermore, to qualify for inclusion, systematic reviews must have been published between September of 2016 and December of 2019. Only systematic reviews published in English and reviews that synthesize studies of human or animal data will be included.

除外基準/Key exclusion criteria

日本語

英語
Eligibility Criteria: To be included in our study, the study design must be a systematic review and or meta-analysis. We will use the PRISMA P deNAfinition of a systematic review meta-analysis, which states that a systematic review is a systematic review is a review of a clearly formulated question that uses systematic and explicit methods to identify, select, and critically appraise relevant research, and to collect and analyze data from the studies that are included in the review. Statistical methods (meta-analysis) may or may not be used to analyze and summarize the results of the included studies. Meta-analysis refers to the use of statistical techniques in a systematic review to integrate the results of included studies. 1. Furthermore, studies will be included if they compare at least one pharmacologic therapy to another (or in combination) or if they compare a pharmacologic therapy to an nonpharmacologic therapy, such as verbal alcoholism therapy. We will include all pharmacologic therapies, regardless of whether they are indicated for treatment of AUD (acamprosate, naltrexone, and disulfiram) or whether they are used off label. We will include studies along the following stages of progression: (i) stabilization following excessive use of alcohol, (ii) relapse prevention, or (iii) recovery maintenance. Furthermore, to qualify for inclusion, systematic reviews must have been published between September of 2016 and December of 2019. Only systematic reviews published in English and reviews that synthesize studies of human or animal data will be included.

目標参加者数/Target sample size

40

責任研究者/Name of lead principal investigator

日本語

名
ミドルネーム
姓

英語

名	Matt
ミドルネーム
姓	Vassar

所属組織/Organization

日本語

英語
Oklahoma State University Center for Health Sciences

所属部署/Division name

日本語

英語
Department of Psychiatry and Behavioral Sciences

郵便番号/Zip code

74107

住所/Address

日本語

英語
1111 W 17th St. Tulsa, OK 74107

電話/TEL

9185821972

Email/Email

matt.vassar@okstate.edu

試験問い合わせ窓口担当者/Name of contact person

日本語

名
ミドルネーム
姓

英語

名	Matt
ミドルネーム
姓	Vassar

組織名/Organization

日本語

英語
Oklahoma State University Center for Health Sciences

部署名/Division name

日本語

英語
Department of Psychiatry and Behavioral Sciences

郵便番号/Zip code

74107

住所/Address

日本語

英語
1111 W 17th St. Tulsa, OK 74107

電話/TEL

9185821972

試験のホームページURL/Homepage URL

Email/Email

matt.vassar@okstate.edu

機関名/Institute

日本語
その他

英語
Oklahoma State University Center for Health Sciences

機関名/Institute
（機関選択不可の場合）

日本語

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
その他

英語
Oklahoma State University Center for Health Sciences

機関名/Organization
（機関選択不可の場合）

日本語

組織名/Division

日本語

組織の区分/Category of Funding Organization

海外/Outside Japan

研究費拠出国/Nationality of Funding Organization

日本語

英語

共同実施組織/Co-sponsor

日本語

英語

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

日本語

英語

組織名/Organization

日本語

英語
Oklahoma State University Center for Health Sciences

住所/Address

日本語

英語
1111 W 17th St. Tulsa, OK 74107

電話/Tel

9185821972

Email/Email

matt.vassar@okstate.edu

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

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2020

年

01

月

10

日

プロトコル掲載URL/URL releasing protocol

OSF.IO

試験結果の公開状況/Publication of results

未公表/Unpublished

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

50

主な結果/Results

日本語

英語

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

日本語

英語

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

日本語

英語

参加者の流れ/Participant flow

日本語

英語

有害事象/Adverse events

日本語

英語

評価項目/Outcome measures

日本語

英語

個別症例データ共有計画/Plan to share IPD

日本語

英語

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

日本語

英語

試験進捗状況/Recruitment status

試験終了/Completed

プロトコル確定日/Date of protocol fixation

2020

年

01

月

09

日

倫理委員会による承認日/Date of IRB

2020

年

01

月

09

日

登録・組入れ開始（予定）日/Anticipated trial start date

2020

年

01

月

09

日

フォロー終了(予定)日/Last follow-up date

2021

年

01

月

01

日

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

その他関連情報/Other related information

日本語

英語
Data Collection Process: Data extraction will be performed by the same investigators MC and MH who performed the initial screening. As before, they will be blinded to the other investigators decisions. After data extraction, both investigators will meet and resolve any discrepancies. JMA and MV will be available for third party adjudication on an as needed basis.

登録日時/Registered date

2020

年

01

月

10

日

最終更新日/Last modified on

2020

年

01

月

10

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000044607

英語
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044607