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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031654
Receipt No. R000036147
Scientific Title Studies contributing and not contributing individual participant data (IPD) in IPD meta-analyses
Date of disclosure of the study information 2018/03/10
Last modified on 2018/03/09

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Basic information
Public title Studies contributing and not contributing individual participant data (IPD) in IPD meta-analyses
Acronym Studies contributing and not contributing individual participant data (IPD) in IPD meta-analyses
Scientific Title Studies contributing and not contributing individual participant data (IPD) in IPD meta-analyses
Scientific Title:Acronym Studies contributing and not contributing individual participant data (IPD) in IPD meta-analyses
Region
Japan

Condition
Condition randomized controlled trials that are eligible for IPD meta-analysis
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to quantify data availability bias among SRs with IPD meta-analysis with less than 100% retrieval rate.
Basic objectives2 Others
Basic objectives -Others to assess RCT-level factors associated with the provision of IPD data, and (ii)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Our primary outcome is a discrepancy of AD meta-analytic results between RCTs contributing IPD and RCTs not contributing to IPD
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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 therapeutic RCTs included in SRs that fulfill the following criteria will be eligible: (i) SRs with IPD meta-analysis, (ii) SRs that include only RCTs comparing an active intervention against a control condition in terms of a dichotomous outcome, (iii) SRs that report full reference list of the included RCTs, and (iv) SRs written in English.
Key exclusion criteria The following SRs will be excluded: (v) SRs published before 2011, (vi) SRs where all included RCTs provide IPD data, (vii) SRs of diagnostic or prognostic studies, and (vii) SRs with network meta-analysis.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Tsujimoto
Organization Kyoto University Graduate School of Medicine
Division name Department of Healthcare Epidemiology
Zip code
Address Yoshida Konoe-cho, Sakyo-ku, Kyoto
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 Kyoto University Graduate School of Medicine
Division name Department of Healthcare Epidemiology
Zip code
Address Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL 81-75-753-9467
Homepage URL http://ebmh.med.kyoto-u.ac.jp/files/Protocol%20for%20a%20study%20on%20data%20availability%20bias.pdf
Email yssh0108@yahoo.co.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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
2018 Year 03 Month 10 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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 09 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 03 Month 09 Day
Last modified on
2018 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036147

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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