UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018189
Receipt number R000021062
Scientific Title Adherence to protocol registration of systematic reviews published in high-impact-factor journals: meta-epidemiological study
Date of disclosure of the study information 2015/07/07
Last modified on 2017/02/28 23:38:06

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Basic information

Public title

Adherence to protocol registration of systematic reviews published in high-impact-factor journals: meta-epidemiological study

Acronym

Adherence to protocol registration of systematic reviews published in high-impact-factor journals: meta-epidemiological study

Scientific Title

Adherence to protocol registration of systematic reviews published in high-impact-factor journals: meta-epidemiological study

Scientific Title:Acronym

Adherence to protocol registration of systematic reviews published in high-impact-factor journals: meta-epidemiological study

Region

Japan


Condition

Condition

[Criteria for considering studies for this review]
We will include any systematic reviews or meta-analysis for interventions. Studies will be excluded if the reviews are for diagnostic test accuracy, non-randomized studies or meta-epidemiology. Eligibility will be assessed by two authors (H.T and Y.T.) independently. Differences regarding eligibility will be resolved by consensus and with the help of the senior author (Y.K.).
[Data collection and analysis]
[Selection of studies]
We will start with the review of titles of the articles identified in the initial research and proceed to review of abstracts, whose titles might be of relevance, and finally identify eligible studies on the basis of their full text.

Classification by specialty

Not applicable

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

[Review question]
This review will be performed to evaluate the quality of systematic reviews in high-impact-factor journals. We will investigate adherence to protocol registration of the reviews.

Basic objectives2

Others

Basic objectives -Others

[Rationale]
Thanks to dissemination of method of systematic reviews, anyone can tackle systematic reviews. There are abundant of systematic reviews for healthcare intervention, and there are duplication or overlap of reviews. Duplication of reviews may lead alpha error.
In addition, drug company come to use systematic reviews of the effects of their product as marketing tools because clinicians put much values on systematic reviews. However, there are concerns of publication bias or selective outcome reporting of systematic reviews.
Protocol registration was disseminated as the PRISMSA statement in 2009 to avoid duplication and publication bias. In order to detect potential alpha error or selective outcome reporting, we will investigate adherence to protocol registration.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

[Primary Outcome]
Adherence to protocol registration

Key secondary outcomes

[Secondary Outcome]
1. Number of systematic reviews that refer directly to PRISMA statement
2. Adherence to protocol registration among systematic reviews that refer directly to the PRISMA statement
3. Publication bias in each registered and unregistered systematic reviews


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

[inclusion criteria]
the 10 journals classified by the Journal Citation Reports 2013 as general internal medicine journal associated with the highest impact factors

[Data extraction and management]
Two authors (H.T. and Y.T.) will review titles and abstracts identified by the searches independently. They will independently detect protocol registration information from abstract or full text if needed. In addition, each author will check reference of the PRISMA statement.. Disagreements will be resolved by consensus and with the help of the senior investigator (Y.K.).
[Searches]
[Search method]
We will select the 10 journals classified by the Journal Citation Reports 2013 as general internal medicine journal associated with the highest impact factors; we will exclude the Cochrane Database of Systematic Reviews because protocol registration is strictly performed in articles published in the database. We will search MEDLINE (source, PubMed, between August 1st 2009 and June 30th 2015) using the journal names and "Search Strategy Used to Create the Systematic Reviews Subset on PubMed" last modified February 2015; the search will be not subject to language restrictions. We will select systematic reviews for any randomized intervention. We will exclude systematic reviews for diagnostic test accuracy and systematic reviews for non-randomized observational studies

Key exclusion criteria

the Cochrane Database of Systematic Reviews

Target sample size

1


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name TSUJIMOTO Hiraku

Organization

Hyogo Prefectural Amagasaki General Medical Center

Division name

Hospital Care Research Unit

Zip code


Address

Higashinaniwa 2-17-77, Amagasaki, Hyogo, Japan

TEL

+816-6480-7000

Email

hira.to.ber3598@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name TSUJIMOTO Hiraku

Organization

Hyogo Prefectural Amagasaki General Medical Center

Division name

Hospital Care Research Unit

Zip code


Address

Higashinaniwa 2-17-77, Amagasaki, Hyogo, Japan

TEL

+816-6480-7000

Homepage URL


Email

hira.to.ber3598@gmail.com


Sponsor or person

Institute

Hyogo Prefectural Amagasaki General Medical Center

Institute

Department

Personal name



Funding Source

Organization

Hyogo Prefectural Amagasaki General Medical Center

Organization

Division

Category of Funding Organization

Local Government

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 07 Month 07 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.jclinepi.com/article/S0895-4356(17)30181-6/pdf

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

Completed

Date of protocol fixation

2015 Year 07 Month 06 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 07 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

[Analysis]
[Strategy for data synthesis]
First, we examined rate of systematic reviews that refer directly to protocol registration among all the identified reviews.
Second, we examined adherence rate of protocol registration among systematic reviews that refer directly to the PRISMA statement.
Finally, we plot estimates of study findings (the log odds ratio) against their standard error in order to investigate publication bias in each registered or unregistered systematic reviews.
In addition, the Egger test will be used to examine publication bias.

[Analysis of subgroups or subsets]
To identify factors associated with the adherences to protocol registration, we will examine the following a priori defined possible predictors using univariate analysis: year of publication, sources of trial funding, journal, journal impact factor, region in which the study was led, sample size and citation of the PRISMA statement. The important factors strongly associated with protocol registration (P< 0.2, by univariate analysis) will be further analyzed by logistic regression.


Management information

Registered date

2015 Year 07 Month 04 Day

Last modified on

2017 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021062


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name