UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022374
Receipt number R000025787
Scientific Title Outcome Reporting Biases in Hematology Medical Journals: A review of trends in recent medical literature
Date of disclosure of the study information 2016/05/20
Last modified on 2016/12/20 03:56:07

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Basic information

Public title

Outcome Reporting Biases in Hematology Medical Journals: A review of trends in recent medical literature

Acronym

Reporting bias in medical literature

Scientific Title

Outcome Reporting Biases in Hematology Medical Journals: A review of trends in recent medical literature

Scientific Title:Acronym

Reporting bias in medical literature

Region

North America


Condition

Condition

Outcome reporting bias

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of our project will be to investigate selective outcome reporting and outcome reporting bias in high impact factor hematology journals from 2010-2015.

Basic objectives2

Others

Basic objectives -Others

To examine journals for outcome reporting bias, trends in possible bias, and external influencing factors.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Are there discrepancies between reported primary and secondary outcomes in registered and published randomized controlled trials in high impact journals from 2010-2015?

Key secondary outcomes

1. Are there discrepancies favoring statistically significant outcomes?
2. Are there any correlations between funding source and likelihood of outcome reporting bias?
3. Are there temporal trends in outcome reporting bias?


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

Studies including:
1.RCTs
2.RCTs that utilize a crossover method
3.Follow-up on previously performed RCTs that are analyzing different primary outcomes at a later time point.
that were published in the journals: Circulation Research, Blood, Leukemia, Stem Cells, and Arteriosclerosis, Thrombosis, and Vascular Biology between January 1, 2010 and December 31, 2015.

Key exclusion criteria

All other study designs were excluded including:
1. Observational studies (including cohort, case-control, and cross sectional)
2. Meta-analyses
3. Ongoing studies
4. Commentary or discussion pieces
5. Articles with only a title or lacking an abstract
6. Simulation-based studies
7. Animal/ in vitro studies

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Cole Wayant

Organization

Oklahoma State University Center for Health Sciences

Division name

College of Osteopathic Medicine

Zip code


Address

1111 W. 17th St.

TEL

918-582-1972

Email

cole.wayant@okstate.edu


Public contact

Name of contact person

1st name
Middle name
Last name Cole Wayant

Organization

Oklahoma State University Center for Health Sciences

Division name

College of Osteopathic Medicine

Zip code


Address

1111 W. 17th St.

TEL

918-582-1972

Homepage URL

http://www.healthsciences.okstate.edu

Email

cole.wayant@okstate.edu


Sponsor or person

Institute

Oklahoma State University Center for Health Sciences

Institute

Department

Personal name



Funding Source

Organization

n/a

Organization

Division

Category of Funding Organization

Self funding

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

2016 Year 05 Month 20 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

2016 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 30 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2016 Year 07 Month 01 Day

Date analysis concluded

2016 Year 07 Month 01 Day


Other

Other related information

Systematic review


Management information

Registered date

2016 Year 05 Month 20 Day

Last modified on

2016 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025787


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name