UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033079
Receipt number 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 15:49:00

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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 or person

Institute

Kobe University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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