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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018668
Receipt No. R000021617
Scientific Title Overstatements in abstract conclusions claiming effectiveness of interventions in psychiatry: A study protocol for a meta-epidemiological investigation
Date of disclosure of the study information 2015/08/14
Last modified on 2015/08/31

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Basic information
Public title Overstatements in abstract conclusions claiming effectiveness of interventions in psychiatry: A study protocol for a meta-epidemiological investigation
Acronym Study protocol; a meta-epidemiological investigation in overstatements in abstract conclusions
Scientific Title Overstatements in abstract conclusions claiming effectiveness of interventions in psychiatry: A study protocol for a meta-epidemiological investigation
Scientific Title:Acronym Study protocol; a meta-epidemiological investigation in overstatements in abstract conclusions
Region
Japan

Condition
Condition Mental disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to evaluate overstated abstract conclusions in comparison to the corresponding full text results in trials claiming effectiveness of interventions in psychiatry. We will also examine their predictors.
Basic objectives2 Others
Basic objectives -Others Meta-epidemiologic study on reporting bias
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The proportion of studies showing overstatements in the abstract conclusion compared to the full text results relative to all the included trials.
Key secondary outcomes The proportion (shown as relative to all the included trials) of studies showing overstatements in abstract conclusion among those studies claiming superiority of intervention of treatment. The proportion of studies that exhibit overstatements among those that claim partial effectiveness of intervention.

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 All randomized controlled trials published in 2014 claiming effectiveness of intervention for mental disorder(s) in their abstract conclusions. The selection will cover any and all kinds of interventions.
Key exclusion criteria Studies with an abstract conclusion in which the primary outcomes were declared, and explicitly stated that there was no significant difference between the intervention and control arm in the primary outcomes. In addition, we will exclude studies without conclusion or discussion section in the abstract, trials with more than two arms, and unpublished trials. Secondary analysis studies, feasibility studies, and cost effectiveness studies will not be included either.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinohara, Kiyomi
Organization Kyoto University Graduate School of Medicine/School of Public Health
Division name Health Promotion and Human Behaviour
Zip code
Address Yoshida-Konoe Cho Sakyo-ku, Kyoto
TEL 0757539491
Email shinohara.kiyomi.75r@st.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinohara, Kiyomi
Organization Kyoto University Graduate School of Medicine/School of Public Health
Division name Health Promotion and Human Behaviour
Zip code
Address Yoshida-Konoe Cho Sakyo-ku, Kyoto
TEL 0757539491
Homepage URL http://ebmh.med.kyoto-u.ac.jp/r-ebm.html
Email shinohara.kiyomi.75r@st.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine/School of Public Health
Institute
Department

Funding Source
Organization none
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
2015 Year 08 Month 14 Day

Related information
URL releasing protocol http://ebmh.med.kyoto-u.ac.jp/r-ebm.html
Publication of results Unpublished

Result
URL related to results and publications http://ebmh.med.kyoto-u.ac.jp/r-ebm.html
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 Open public recruiting
Date of protocol fixation
2015 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 03 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2016 Year 01 Month 31 Day

Other
Other related information We will source RCTs published in 2014 from Cochrane Register of Controlled Trials (CENTRAL) that claim effectiveness of any intervention for mental disorders. The abstract conclusions will be categorised into three types: superior (only stating significant superiority of intervention to control), limited (suggesting intervention was partially significantly superior to control), and equal (claiming equal effectiveness of intervention as control). The full texts will also be classified as one of the following based on the primary outcome results: significant (all primary outcomes were statistically significant in favour of the intervention), mixed (primary outcomes included both significant and non-significant results), or all non-significant results. By comparing the abstract conclusion classification and that of the corresponding full text, we will assess whether each study exhibited overstatements in its abstract conclusion.

Management information
Registered date
2015 Year 08 Month 14 Day
Last modified on
2015 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021617

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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