UMIN-CTR Clinical Trial

Public title

The influence of overstated abstract conclusions on clinical clinicians' impression of the intervention: randomized controlled trial

Acronym

DOCTOR study(Do Overstated Conclusions Trick Our Readers?)

Scientific Title

The influence of overstated abstract conclusions on clinical clinicians' impression of the intervention: randomized controlled trial

Scientific Title:Acronym

DOCTOR study(Do Overstated Conclusions Trick Our Readers?)

Region

Japan

Condition

Clinicians

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

1. To investigate the extent that overstatements in abstract conclusions influence primary care clinicians' impression of the particular intervention discussed in randomized controlled trial.
2. To evaluate the critical appraisal skills in primary care doctors

Basic objectives2

Others

Basic objectives -Others

Empirical research of the impact of reporting bias

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Evaluation of the effectiveness of the intervention discussed in the given abstract. The answers will be given on a scale of 0-10.
1.How likely do you think that Intervention A would be beneficial to patients? (0: not at all 10: very likely)

Key secondary outcomes

2. How likely do you think this conclusion is valid? (0: not at all 10: very likely)
3. How likely do you want to read the full text of this study?
(0: not at all 10: very likely)
4. When you answered the above questions, which part of the abstract did you refer to the most? ( background / methods / results / conclusion)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Volunteers are directed to the DOCTOR study website specially made for this research. Once they register, participants will be automatically randomly assigned to either of the two arms (with overstatement or without overstatement) and asked to read a RCT abstract. "With" abstract exaggerates the abstract conclusion section in favor of intervention. "Without" group participants will read the abstract that was rewritten by investigators to remove the overstatement.

We will select five abstracts from the pre-existing database of published reports in psychiatry RCTs dated between 2011 and 2014. The database was selected based on the following criteria: 1.superiority RCT with two arms, 2.claiming effectiveness of intervention in abstract conclusion, 3.targeting common illness that primary care doctor are likely to encounter in clinical setting 4.the impact factor of journal equal or higher than 3. We will translate them into Japanese.

We will define overstatement as inconsistency in primary outcome results between full-text results and those deduced from the abstract conclusion. Two or more investigators independently assessed for overstatements for each report.

In both group, to keep the conclusion in consistent with other sections of abstract, we standardize methods and results sections by adding information on primary outcomes (e.g. OR, RR, CI, p-value) obtained from the full-text.

The results of secondary outcomes and subgroup analysis will be removed. The names of treatment and control will be changed to intervention A and control B to minimize bias.

Interventions/Control_2

"Without" group participants will read the abstract that was rewritten by investigators to remove the overstatement.
For the control "without" arm, we will rewrite the conclusion section of abstract following these rules: a. when all primary outcomes were non-significant, we will re-write as "Intervention A was not more effective than control B in terms of..."
b. When one primary outcome (PO1) was significant but the other (PO2) was non-significant, we will re-write as
"Intervention A was more effective than control B in terms of PO1, but not more effective in PO2"
In both group, to keep the conclusion in consistent with other sections of abstract, we standardize methods and results sections by adding information on primary outcomes (e.g. OR, RR, CI, p-value) obtained from the full-text.

The results of secondary outcomes and subgroup analysis will be removed. The names of treatment and control will be changed to intervention A and control B to minimize bias.

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

We will recruit volunteers among members of Japan Primary Care Association by invitation e-mails. Interested individuals can access to the DOCTOR study site via the link attached to the invitation e-mail. They are asked to give particulars and answer the screening questions and if they meet the inclusion criteria and agree to participate, then they will proceed to the next page and start the session. The screening criteria are as follows:
1. A member of Japan Primary Care Association
2. Medical doctor
3. With clinical practice of more than 2 years
4. Currently in clinical practice
5. Have chance to get information on new clinical research/trials

Key exclusion criteria

Medical doctors who mainly work at research laboratories or educational institutions

Target sample size

510

Name of lead principal investigator

1st name
Middle name
Last name	Kiyomi Shinohara

Organization

Kyoto University Graduate School of Medicine/School of Public Health

Division name

Department of Health Promotion and Human Behavior

Zip code

Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto 606-8501 JAPAN

TEL

075-753-9491

Email

shinohara.kiyomi.75r@st.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kiyomi Shinohara

Organization

Kyoto University Graduate School of Medicine/School of Public Health

Division name

Department of Health Promotion and Human Behavior

Zip code

Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto 606-8501 JAPAN

TEL

075-753-9491

Homepage URL

Email

doctor.study.pc@gmail.com

Institute

Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health

Institute

Department

Personal name

Organization

Japan Primary Care Association

Organization

Division

Category of Funding Organization

Non profit foundation

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

On the study web site

Date of disclosure of the study information

2016

Year

12

Month

18

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://bmjopen.bmj.com/content/7/12/e018355

Number of participants that the trial has enrolled

Results

The overstatements in abstract conclusions did not significantly influence the primary care physicians's evaluations of the intervention effect when necessary information about the primary outcomes was distinctly reported.

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

2016

Year

12

Month

16

Day

Date of IRB

Anticipated trial start date

2017

Year

01

Month

17

Day

Last follow-up date

2017

Year

02

Month

08

Day

Date of closure to data entry

2017

Year

02

Month

08

Day

Date trial data considered complete

2017

Year

02

Month

08

Day

Date analysis concluded

2018

Year

02

Month

14

Day

Other related information

Registered date

2016

Year

12

Month

18

Day

Last modified on

2018

Year

02

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029121