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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025317
Receipt No. R000029121
Scientific Title The influence of overstated abstract conclusions on clinical clinicians' impression of the intervention: randomized controlled trial
Date of disclosure of the study information 2016/12/18
Last modified on 2018/02/13

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Basic information
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
Condition Clinicians
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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)

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

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

Funding Source
Organization Japan Primary Care Association
Organization
Division
Category of Funding Organization Non profit foundation
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 On the study web site

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
Other related information

Management information
Registered date
2016 Year 12 Month 18 Day
Last modified on
2018 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029121

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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