UMIN-CTR Clinical Trial

Public title

An exploratory analysis for identifying factors associated with the primary care physicians' interpretation of the rigor of overstated abstract conclusions

Acronym

An exploratory analysis for identifying factors associated with the primary care physicians' interpretation of the rigor of overstated abstract conclusions

Scientific Title

An exploratory analysis for identifying factors associated with the primary care physicians' interpretation of the rigor of overstated abstract conclusions

Scientific Title:Acronym

An exploratory analysis for identifying factors associated with the primary care physicians' interpretation of the rigor of overstated abstract conclusions

Region

Japan

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

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yasushi Tsujimoto

Organization

Kyoto University

Division name

Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine

Zip code

Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto

TEL

09015982834

Email

yssh0108@yahoo.co.jp

Name of contact person

1st name
Middle name
Last name	Yasushi Tsujimoto

Organization

Kyoto University

Division name

Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine

Zip code

Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto

TEL

09015982834

Homepage URL

Email

yssh0108@yahoo.co.jp

Institute

Kyoto University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

02

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

02

Month

22

Day

Date of IRB

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

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

Registered date

2017

Year

02

Month

23

Day

Last modified on

2018

Year

03

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030168