UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000021933
Receipt No. R000025295
Official scientific title of the study Utilization of Clinical Trials Registries in Systematic Reviews: A State of Emergency in Emergency Medicine?
Date of disclosure of the study information 2016/05/15
Last modified on 2016/04/16 (Ver. 1)

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Basic information
Official scientific title of the study Utilization of Clinical Trials Registries in Systematic Reviews: A State of Emergency in Emergency Medicine?
Title of the study (Brief title) Clinical trials registry search in the top 20 emergency medicine journals
Region
North America

Condition
Condition Emergency medical interventions
Classification by specialty
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study assesses the frequency of clinical trials registry utilization in systematic reviews and meta-analysis published in the top 20 emergency medicine journals between 2007 and 2016. Searching clinical trials registries for unpublished data is encouraged and is likely to dramatically improve the validity of conclusions reached about effect sizes calculated by systematic reviews and meta-analyses. Recent studies have shown that omission of clinical trials registry data is prevalent across different specialties. This is the most comprehensive study to date to address this question in the emergency medicine specialty, assessing the issue over the past 8 years in the top specialty journals.
Basic objectives2 Others
Basic objectives -Others Increase awareness of clinical trials registry use in emergency medicine systematic reviews and meta-analyses
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Frequency of clinical trials registry search by journal
2. Temporal trend of clinical trials registry use
Key secondary outcomes 1. Use of clinical trials registries data in each publication

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Study must be a systematic review or a meta-analysis published between January 1st, 2007 and April 31st, 2016. Additionally, the study must have been published in any of the top 20 journals within the emergency medicine specialty, as rated by the h-5 index
Key exclusion criteria Any publication that is not a systematic review or meta-analysis (e.g. editorials, letters, primary studies, etc.)
Target sample size 300

Research contact person
Name of lead principal investigator Vadim Yerokhin
Organization Oklahoma State University, Center for Health Sciences
Division name Advanced Analytics: Branch of Vassar Research Team
Address 1111 W 17th st Tulsa, OK, USA 74137
TEL 9185821972
Email vadim.yerokhin@okstate.edu

Public contact
Name of contact person Vadim Yerokhin
Organization Oklahoma State University Center for Health Sciences
Division name Advanced Analytics: Branch of Vassar Research Team
Address 1111 W 17th st Tulsa, OK, USA 74137
TEL 9185821972
Homepage URL
Email vadim.yerokhin@okstate.edu

Sponsor
Institute Oklahoma State University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Not applicable
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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
2016 Year 05 Month 15 Day

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 10 Month 15 Day
Anticipated trial start date
2015 Year 12 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information This is a systematic review of literature published between 2007 and 2016 in the top 20 emergency medicine journals.

Management information
Registered date
2016 Year 04 Month 16 Day
Last modified on
2016 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025295