UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語
プロトコル登録の遵守率の系統的レビューのメタ疫学研究

英語
Adherence to protocol registration of systematic reviews published in high-impact-factor journals: meta-epidemiological study

一般向け試験名略称/Acronym

日本語
プロトコル登録の遵守率の系統的レビューのメタ疫学研究

英語
Adherence to protocol registration of systematic reviews published in high-impact-factor journals: meta-epidemiological study

科学的試験名/Scientific Title

日本語
プロトコル登録の遵守率の系統的レビューのメタ疫学研究

英語
Adherence to protocol registration of systematic reviews published in high-impact-factor journals: meta-epidemiological study

科学的試験名略称/Scientific Title:Acronym

日本語
プロトコル登録の遵守率の系統的レビューのメタ疫学研究

英語
Adherence to protocol registration of systematic reviews published in high-impact-factor journals: meta-epidemiological study

試験実施地域/Region

日本/Japan

対象疾患名/Condition

日本語
[Criteria for considering studies for this review]
We will include any systematic reviews or meta-analysis for interventions. Studies will be excluded if the reviews are for diagnostic test accuracy, non-randomized studies or meta-epidemiology. Eligibility will be assessed by two authors (H.T and Y.T.) independently. Differences regarding eligibility will be resolved by consensus and with the help of the senior author (Y.K.).
[Data collection and analysis]
[Selection of studies]
We will start with the review of titles of the articles identified in the initial research and proceed to review of abstracts, whose titles might be of relevance, and finally identify eligible studies on the basis of their full text.

英語
[Criteria for considering studies for this review]
We will include any systematic reviews or meta-analysis for interventions. Studies will be excluded if the reviews are for diagnostic test accuracy, non-randomized studies or meta-epidemiology. Eligibility will be assessed by two authors (H.T and Y.T.) independently. Differences regarding eligibility will be resolved by consensus and with the help of the senior author (Y.K.).
[Data collection and analysis]
[Selection of studies]
We will start with the review of titles of the articles identified in the initial research and proceed to review of abstracts, whose titles might be of relevance, and finally identify eligible studies on the basis of their full text.

疾患区分1/Classification by specialty

該当せず/Not applicable

疾患区分2/Classification by malignancy

悪性腫瘍/Malignancy

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語
[Review question]
This review will be performed to evaluate the quality of systematic reviews in high-impact-factor journals. We will investigate adherence to protocol registration of the reviews.

英語
[Review question]
This review will be performed to evaluate the quality of systematic reviews in high-impact-factor journals. We will investigate adherence to protocol registration of the reviews.

目的2/Basic objectives2

その他/Others

目的2 -その他詳細/Basic objectives -Others

日本語
[Rationale]
Thanks to dissemination of method of systematic reviews, anyone can tackle systematic reviews. There are abundant of systematic reviews for healthcare intervention, and there are duplication or overlap of reviews. Duplication of reviews may lead alpha error.
In addition, drug company come to use systematic reviews of the effects of their product as marketing tools because clinicians put much values on systematic reviews. However, there are concerns of publication bias or selective outcome reporting of systematic reviews.
Protocol registration was disseminated as the PRISMSA statement in 2009 to avoid duplication and publication bias. In order to detect potential alpha error or selective outcome reporting, we will investigate adherence to protocol registration.

英語
[Rationale]
Thanks to dissemination of method of systematic reviews, anyone can tackle systematic reviews. There are abundant of systematic reviews for healthcare intervention, and there are duplication or overlap of reviews. Duplication of reviews may lead alpha error.
In addition, drug company come to use systematic reviews of the effects of their product as marketing tools because clinicians put much values on systematic reviews. However, there are concerns of publication bias or selective outcome reporting of systematic reviews.
Protocol registration was disseminated as the PRISMSA statement in 2009 to avoid duplication and publication bias. In order to detect potential alpha error or selective outcome reporting, we will investigate adherence to protocol registration.

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
[Primary Outcome]
Adherence to protocol registration

英語
[Primary Outcome]
Adherence to protocol registration

副次アウトカム評価項目/Key secondary outcomes

日本語
[Secondary Outcome]
1. Number of systematic reviews that refer directly to PRISMA statement
2. Adherence to protocol registration among systematic reviews that refer directly to the PRISMA statement
3. Publication bias in each registered and unregistered systematic reviews

英語
[Secondary Outcome]
1. Number of systematic reviews that refer directly to PRISMA statement
2. Adherence to protocol registration among systematic reviews that refer directly to the PRISMA statement
3. Publication bias in each registered and unregistered systematic reviews

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

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

日本語
[inclusion criteria]
the Journal Citation Reports 2013 のgeneral internal medicineでtop 10 journalsに掲載されたシステマテックレビュー
[Data extraction and management]
Two authors (H.T. and Y.T.) will review titles and abstracts identified by the searches independently. They will independently detect protocol registration information from abstract or full text if needed. In addition, each author will check reference of the PRISMA statement.. Disagreements will be resolved by consensus and with the help of the senior investigator (Y.K.).
[Searches]

[Search method]
We will select the 10 journals classified by the Journal Citation Reports 2013 as general internal medicine journal associated with the highest impact factors; we will exclude the Cochrane Database of Systematic Reviews because protocol registration is strictly performed in articles published in the database. We will search MEDLINE (source, PubMed, between August 1st 2009 and June 30th 2015) using the journal names and "Search Strategy Used to Create the Systematic Reviews Subset on PubMed" last modified February 2015; the search will be not subject to language restrictions. We will select systematic reviews for any randomized intervention. We will exclude systematic reviews for diagnostic test accuracy and systematic reviews for non-randomized observational studies

英語
[inclusion criteria]
the 10 journals classified by the Journal Citation Reports 2013 as general internal medicine journal associated with the highest impact factors

[Data extraction and management]
Two authors (H.T. and Y.T.) will review titles and abstracts identified by the searches independently. They will independently detect protocol registration information from abstract or full text if needed. In addition, each author will check reference of the PRISMA statement.. Disagreements will be resolved by consensus and with the help of the senior investigator (Y.K.).
[Searches]
[Search method]
We will select the 10 journals classified by the Journal Citation Reports 2013 as general internal medicine journal associated with the highest impact factors; we will exclude the Cochrane Database of Systematic Reviews because protocol registration is strictly performed in articles published in the database. We will search MEDLINE (source, PubMed, between August 1st 2009 and June 30th 2015) using the journal names and "Search Strategy Used to Create the Systematic Reviews Subset on PubMed" last modified February 2015; the search will be not subject to language restrictions. We will select systematic reviews for any randomized intervention. We will exclude systematic reviews for diagnostic test accuracy and systematic reviews for non-randomized observational studies

除外基準/Key exclusion criteria

日本語
the Cochrane Database of Systematic Reviews

英語
the Cochrane Database of Systematic Reviews

目標参加者数/Target sample size

1

責任研究者/Name of lead principal investigator

日本語

名
ミドルネーム
姓	辻本　啓

英語

名
ミドルネーム
姓	TSUJIMOTO Hiraku

所属組織/Organization

日本語
兵庫県立尼崎総合医療センター

英語
Hyogo Prefectural Amagasaki General Medical Center

所属部署/Division name

日本語
臨床研究推進ユニット

英語
Hospital Care Research Unit

郵便番号/Zip code

住所/Address

日本語
兵庫県尼崎市東難波二丁目17番77号

英語
Higashinaniwa 2-17-77, Amagasaki, Hyogo, Japan

電話/TEL

+816-6480-7000

Email/Email

hira.to.ber3598@gmail.com

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	辻本　啓

英語

名
ミドルネーム
姓	TSUJIMOTO Hiraku

組織名/Organization

日本語
兵庫県立尼崎総合医療センター

英語
Hyogo Prefectural Amagasaki General Medical Center

部署名/Division name

日本語
臨床研究推進ユニット

英語
Hospital Care Research Unit

郵便番号/Zip code

住所/Address

日本語
兵庫県尼崎市東難波二丁目17番77号

英語
Higashinaniwa 2-17-77, Amagasaki, Hyogo, Japan

電話/TEL

+816-6480-7000

試験のホームページURL/Homepage URL

Email/Email

hira.to.ber3598@gmail.com

機関名/Institute

日本語
その他

英語
Hyogo Prefectural Amagasaki General Medical Center

機関名/Institute
（機関選択不可の場合）

日本語
兵庫県立尼崎総合医療センター

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
Hyogo Prefectural Amagasaki General Medical Center

機関名/Organization
（機関選択不可の場合）

日本語
兵庫県立尼崎総合医療センター

組織名/Division

日本語

組織の区分/Category of Funding Organization

地方自治体/Local Government

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

住所/Address

日本語

英語

電話/Tel

Email/Email

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

2015

年

07

月

07

日

プロトコル掲載URL/URL releasing protocol

試験結果の公開状況/Publication of results

最終結果が公表されている/Published

結果掲載URL/URL related to results and publications

http://www.jclinepi.com/article/S0895-4356(17)30181-6/pdf

組み入れ参加者数/Number of participants that the trial has enrolled

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

2015

年

07

月

06

日

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

2015

年

07

月

07

日

フォロー終了(予定)日/Last follow-up date

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
[Analysis]
[Strategy for data synthesis]
First, we examined rate of systematic reviews that refer directly to protocol registration among all the identified reviews.
Second, we examined adherence rate of protocol registration among systematic reviews that refer directly to the PRISMA statement.
Finally, we plot estimates of study findings (the log odds ratio) against their standard error in order to investigate publication bias in each registered or unregistered systematic reviews.
In addition, the Egger test will be used to examine publication bias.

[Analysis of subgroups or subsets]
To identify factors associated with the adherences to protocol registration, we will examine the following a priori defined possible predictors using univariate analysis: year of publication, sources of trial funding, journal, journal impact factor, region in which the study was led, sample size and citation of the PRISMA statement. The important factors strongly associated with protocol registration (P< 0.2, by univariate analysis) will be further analyzed by logistic regression.

英語
[Analysis]
[Strategy for data synthesis]
First, we examined rate of systematic reviews that refer directly to protocol registration among all the identified reviews.
Second, we examined adherence rate of protocol registration among systematic reviews that refer directly to the PRISMA statement.
Finally, we plot estimates of study findings (the log odds ratio) against their standard error in order to investigate publication bias in each registered or unregistered systematic reviews.
In addition, the Egger test will be used to examine publication bias.

[Analysis of subgroups or subsets]
To identify factors associated with the adherences to protocol registration, we will examine the following a priori defined possible predictors using univariate analysis: year of publication, sources of trial funding, journal, journal impact factor, region in which the study was led, sample size and citation of the PRISMA statement. The important factors strongly associated with protocol registration (P< 0.2, by univariate analysis) will be further analyzed by logistic regression.

登録日時/Registered date

2015

年

07

月

04

日

最終更新日/Last modified on

2017

年

02

月

28

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/ctr/ctr_view.cgi?recptno=R000021062

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021062