UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the Computed Tomography missed findings in the Emergency Department of Emergency Medical Center
Title of the study (Brief title)	Evaluation of the Computed Tomography missed findings in the Emergency Department
Region	Japan

Condition
Condition	Emergency Disease
Classification by specialty	Radiology Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We reveal the risk factors of primary doctor's missed findings and discrepancies in interpretation related to treatment plan in computed tomography at the emergency department.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The presence of missed findings and discrepancies in interpretation related to emergency treatment plan
Key secondary outcomes	Computed tomography scan parts of missed findings and discrepancies in interpretation Details of missed findings and discrepancies in interpretation Influence to treatment plan of missed findings and discrepancies in interpretation cases

Base
Study type	Observational

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	Cases of ambulance transport to and walk in emergency medical center
Key exclusion criteria	Cases of death at emergency department Cases of no computed tomography Principal investigator judged inappropriate cases
Target sample size	15000

Research contact person
Name of lead principal investigator	Yonemitu Takafumi
Organization	Wakayama Medical University
Division name	Department of Emergency and Critical Care Medicine
Address	811-1 Kimiidera, Wakayama 641-8510, Japan
TEL	+81-73-441-0603
Email	mirage10261976@mac.com

Public contact
Name of contact person	Yonemitu Takafumi
Organization	Wakayama Medical University
Division name	Department of Emergency and Critical Care Medicine
Address	811-1 Kimiidera, Wakayama 641-8510, Japan
TEL	+81-73-441-0603
Homepage URL
Email	mirage10261976@mac.com

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Wakayama Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	和歌山県立医科大学付属病院(和歌山県)

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 03 Month 18 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	In order to consider the risk factor of missed findings and discrepancies in interpretation, we make a comparison between findings by medical doctors and by radiologists in computed tomography of emergency department. The study design is the cohort study. The way for subscription of object persons is computed tomography of emergency department from April 2013 to March 2016. The measuring item is the presence of missed findings and discrepancies by medical doctors.

Management information
Registered date	2016 Year 03 Month 31 Day
Last modified on	2016 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024936