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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033079
Receipt No. R000037723
Scientific Title Exploring possible sources of bias in diagnostic test accuracy beyond the QUADAS (Quality Assessment of Diagnostic Accuracy Studies): a study protocol for a meta-epidemiological study
Date of disclosure of the study information 2018/06/22
Last modified on 2018/06/21

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Basic information
Public title Exploring possible sources of bias in diagnostic test accuracy beyond the QUADAS (Quality Assessment of Diagnostic Accuracy Studies): a study protocol for a meta-epidemiological study
Acronym Exploring possible sources of bias in diagnostic test accuracy:study protocol
Scientific Title Exploring possible sources of bias in diagnostic test accuracy beyond the QUADAS (Quality Assessment of Diagnostic Accuracy Studies): a study protocol for a meta-epidemiological study
Scientific Title:Acronym Exploring possible sources of bias in diagnostic test accuracy:study protocol
Region
Japan

Condition
Condition Systematic reviews
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of our study is to explore possible sources of bias in diagnostic test accuracy (DTA) beyond the QUADAS (Quality Assessment of Diagnostic Accuracy Studies) tool.
Basic objectives2 Others
Basic objectives -Others To investigate the impact of study characteristics in DTA
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Study characteristics to be estimated will include publication year (before 2003 or after 2004), impact factor of publication journal, country (high or middle/low income), type of language (English or not), sample size, healthcare setting (primary healthcare or not), funding source (industrial sponsorship or not), publication status (full-publication or not), and number of study centers (single center or multicenter).
Key secondary outcomes

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 We will include systematic reviews (SRs) in which the authors evaluate the DTA of one or more tests against a reference standard. We will only include DTA reviews with meta-analyses that include 10 or more primary studies and provide data to reconstruct 2*2 tables.
Key exclusion criteria We will exclude narrative reviews, genomic reviews, animal reviews, reviews that apply a language or quality restriction, reviews that assess the analytical validity of tests, and reviews that only evaluate other measures of diagnostic performance such as reproducibility and reliability.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Onishi
Organization Kobe University Graduate School of Medicine
Division name Department of Rheumatology and Clinical Immunology
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL 81-78-382-6207
Email aonishi@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Onishi
Organization Kobe University Graduate School of Medicine
Division name Department of Rheumatology and Clinical Immunology
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL 81-78-382-6207
Homepage URL
Email aonishi@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization self funding
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
2018 Year 06 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is the first study to explore possible sources of bias in diagnostic test accuracy studies beyond the QUADAS (Quality Assessment of Diagnostic Accuracy Studies) tool.

Management information
Registered date
2018 Year 06 Month 21 Day
Last modified on
2018 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037723

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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