UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028325
Receipt number R000031688
Scientific Title Association between statistical significance and publication status and time to publication among systematic reviews
Date of disclosure of the study information 2017/07/24
Last modified on 2019/02/01 11:19:13

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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 or person

Institute

Kyoto University

Institute

Department

Personal name



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

Value
https://center6.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