UMIN-CTR Clinical Trial

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

Mental disorders

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Others,meta-analysis etc

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

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

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

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

Institute

Kyoto University Graduate School of Medicine/School of Public Health

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

2015

Year

08

Month

14

Day

URL releasing protocol

http://ebmh.med.kyoto-u.ac.jp/r-ebm.html

Publication of results

Unpublished

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

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 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.

Registered date

2015

Year

08

Month

14

Day

Last modified on

2015

Year

08

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021617