UMIN-CTR Clinical Trial

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

[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

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

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

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

[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

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

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

Institute

Hyogo Prefectural Amagasaki General Medical Center

Institute

Department

Personal name

Organization

Hyogo Prefectural Amagasaki General Medical Center

Organization

Division

Category of Funding Organization

Local Government

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

07

Month

07

Day

URL releasing protocol

Publication of results

Published

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

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 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.

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