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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000018189
受付番号 R000021062
科学的試験名 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
一般公開日(本登録希望日) 2015/07/07
最終更新日 2017/02/28

※ 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。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title 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 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 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 Adherence to protocol registration of systematic reviews published in high-impact-factor journals: meta-epidemiological study
科学的試験名/Scientific Title 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 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 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 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/Condition
対象疾患名/Condition [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.
[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/Objectives
目的1/Narrative objectives1 [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.
[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 [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.
[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

評価/Assessment
主要アウトカム評価項目/Primary outcomes [Primary Outcome]
Adherence to protocol registration
[Primary Outcome]
Adherence to protocol registration
副次アウトカム評価項目/Key secondary outcomes [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
[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

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 [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
[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 the Cochrane Database of Systematic Reviews the Cochrane Database of Systematic Reviews
目標参加者数/Target sample size 1

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

ミドルネーム
辻本 啓

ミドルネーム
TSUJIMOTO Hiraku
所属組織/Organization 兵庫県立尼崎総合医療センター Hyogo Prefectural Amagasaki General Medical Center
所属部署/Division name 臨床研究推進ユニット Hospital Care Research Unit
郵便番号/Zip code
住所/Address 兵庫県尼崎市東難波二丁目17番77号 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/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム
辻本 啓

ミドルネーム
TSUJIMOTO Hiraku
組織名/Organization 兵庫県立尼崎総合医療センター Hyogo Prefectural Amagasaki General Medical Center
部署名/Division name 臨床研究推進ユニット Hospital Care Research Unit
郵便番号/Zip code
住所/Address 兵庫県尼崎市東難波二丁目17番77号 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

実施責任組織/Sponsor
機関名/Institute その他 Hyogo Prefectural Amagasaki General Medical Center
機関名/Institute
(機関選択不可の場合)
兵庫県立尼崎総合医療センター
部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Hyogo Prefectural Amagasaki General Medical Center
機関名/Organization
(機関選択不可の場合)
兵庫県立尼崎総合医療センター
組織名/Division
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


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

住所/Address

電話/Tel
Email/Email

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

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
2015 07 07

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 最終結果が公表されている/Published

結果/Result
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

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 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2015 07 06
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 07 07
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/Other
その他関連情報/Other related information [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.
[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.

管理情報/Management information
登録日時/Registered date
2015 07 04
最終更新日/Last modified on
2017 02 28


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=R000021062
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021062

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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