UMIN-CTR Clinical Trial

Basic information
Public title	Association between statistical significance and publication status and time to publication among systematic reviews
Acronym	Association between statistical significance and publication status and time to publication among systematic reviews
Scientific Title	Association between statistical significance and publication status and time to publication among systematic reviews
Scientific Title:Acronym	Association between statistical significance and publication status and time to publication among systematic reviews
Region	Japan

Condition
Condition	Systematic reviews
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to evaluate the association between statistical significance and other factors of possible influence and publication status using a number of criteria (full publication in a journal article, submission to any journals, presentation of an abstract at a meeting).
Basic objectives2	Others
Basic objectives -Others	To investigate publication bias and time-lag bias
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Our primary outcome is (i) time from protocol registration to the publication of SRs, defined as the time from the registration date to the acceptance date.
Key secondary outcomes	Secondary outcomes will include (ii) proportion of SRs published in journal articles, (iii) a composite outcome of full-publication or presentation at scientific conferences, and (iv) submission to any journals.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All SR protocols of interventions of randomized controlled trials registered in the PROSPERO by 31st Dec 2014 will be eligible.
Key exclusion criteria	We will exclude SRs whose analysis has not been completed and SRs without quantitative synthesis. We will exclude Cochrane protocols and reviews. We will also exclude SRs of diagnostic test accuracy and prognosis, and SRs with network meta-analysis, individual patient data meta-analyses.
Target sample size	220

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasushi Tsujimoto
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Healthcare Epidemiology
Zip code
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL	+81-75-753-9467
Email	yssh0108@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Yasushi Tsujimoto
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Healthcare Epidemiology
Zip code
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL	+81-75-753-9467
Homepage URL
Email	yssh0108@yahoo.co.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	This study is supported in part by JSPS KAKENHI (Grant-in-Aid for Scientific Research) Grant Number 17K19808.
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 24 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 01 Month 26 Day

Other
Other related information	This study aims to investigate whether or not publication bias and time lag bias in SRs based on statistical significance exist.

Management information
Registered date	2017 Year 07 Month 21 Day
Last modified on	2019 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031688

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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