UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An exploratory analysis for identifying factors associated with the primary care physicians' interpretation of the rigor of overstated abstract conclusions
Title of the study (Brief title)	An exploratory analysis for identifying factors associated with the primary care physicians' interpretation of the rigor of overstated abstract conclusions
Region	Japan

Condition
Condition	The original eligible criteria were volunteers among medical doctors of Japan Primary Care Association; clinical experience of 2 years or more; currently in clinical practice; having chance to get information on new clinical research/trials.
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore factors associated with the primary care physicians' interpretation of the rigor of overstated abstract conclusions
Basic objectives2	Others
Basic objectives -Others	exposures and outcomes
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Our primary outcome was rating the overstate abstract conclusion as "rigor". The definition of the primary outcome is based on rating 5 or more against the question "How likely do you think this conclusion is rigor (0-10)?"
Key secondary outcomes	We will conduct the following secondary analysis to confirm if the factors associated with rigor rating in the primary analysis are dependent on the existence of overstatement. We will add the factors to interaction terms in the model and check the interaction between the factors and overstatement, using the full analysis set of the DOCTOR study

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	1. Volunteers among medical doctors of Japan Primary Care Association 2. Medical doctor 3. Clinical experience of 2 years or more 4. Currently in clinical practice 5. Having chance to get information on new clinical research/trials. In the present study
Key exclusion criteria	Mainly working at an educational or a research institution
Target sample size	286

Research contact person
Name of lead principal investigator	Yasushi Tsujimoto
Organization	Kyoto University
Division name	Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL	09015982834
Email	yssh0108@yahoo.co.jp

Public contact
Name of contact person	Yasushi Tsujimoto
Organization	Kyoto University
Division name	Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL	09015982834
Homepage URL
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)

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 02 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 22 Day
Anticipated trial start date	2017 Year 02 Month 23 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	The following factors are suspected to associate with rigor rating 1. Sex 2. Postgraduate year (3-5, 6-20. 21-) 3. Main workplace (clinic or hospital) 4. Board certification 5. PhD 6. The way to get information on new clinical research/trials (self-searching for articles or other) 7. Number of abstracts read for the last month 8. EBM (Evidence Based Medicine) seminar or workshop attendance 9. An experience to conduct clinical research as a primary investigator

Management information
Registered date	2017 Year 02 Month 23 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=R000030168