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The Feasibility Study for Real-time Remote CT Reading for Suspected Acute Appendicitis Using iPhone (Telemedicine)

Primary Purpose

Telemedicine

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Remote CT reading using the iPhone
CT reading using LCD monitor
Sponsored by
Hanyang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Telemedicine focused on measuring Telemedicine, appendicitis, remote consultation

Eligibility Criteria

33 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Board certified emergency physicians with a clinical experience of 5 years and over.

Exclusion Criteria:

  • Corrected eyesight < 20/30
  • Color weakness or blindness

Sites / Locations

  • Hanyang university guri hospital, Department of emergency medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I

Group II

Arm Description

The raters in this group one firstly reviewed the CT scans numbered from one to 60 using LCD monitor and after mandatory rests of 20 minutes, reviewed the remaining CT examinations numbered from 61 to 120 using iPhone with TeamViewer at their first visit. They visited twice with an interval of four weeks and reviewed the CT scans using revered devices at each session.

The raters in this group II firstly reviewed the CT scans numbered from one to 60 using iPhone with TeamViewer and 61 to 120 with the LCD monitor. They visited twice with an interval of four weeks and reviewed the CT scans using revered devices at each session.

Outcomes

Primary Outcome Measures

Diagnostic performance between iPhone and LCD monitor
Dorfman-Berbaum-Metz method with RSCORE and semi-parametric estimation of ROC indices by using the DMB-MRMC software (version 2.3, available at http://perception.radiology.uiowa.edu) 95% confidence interval The reviewers and cases are taken as random factors
Diagnostic accuracy between the iPhone and the LCD monitor
◆ Sensitivity, specificity gold standard: The pathology report and the results of clinical follow up grade 1, 2 and 3 = negative appendicitis findings grade 4 and 5 = positive appendicitis findings McNemar's test to compare the sensitivity and specificity between the iPhad and the LCD monitor

Secondary Outcome Measures

Full Information

First Posted
April 7, 2014
Last Updated
May 6, 2014
Sponsor
Hanyang University
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1. Study Identification

Unique Protocol Identification Number
NCT02108717
Brief Title
The Feasibility Study for Real-time Remote CT Reading for Suspected Acute Appendicitis Using iPhone
Acronym
Telemedicine
Official Title
The Feasibility Study for Remote CT Reading for Suspected Acute Appendicitis Using iPhone With Remote Control System in Realtime Under the Ambient Bright.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hanyang University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Purpose - The investigators aim to evaluate the feasibility of iPhone based remote control system as a real-time remote CT reading tool for suspected appendicitis under 3G network and the suboptimal illumination. Methods A total of 120 abdominal CT examinations; sixty had no findings of appendicitis, while the other sixty showed signs of acute appendicitis, were selected. The 16 raters reviewed these images using an LCD monitor of the PACS workstation and also an iPhone which was connected to the PACS workstation via remote control system, grading the probability of presence of acute appendicitis on each examination by a five Likert scale. The investigators will compare the diagnostic performance between two devices.
Detailed Description
The 16 raters were randomly divided into two groups The raters in group one reviewed the CT examinations numbered from one to 60 using LCD monitor and reviewed the remaining CT examinations numbered from 61 to 120 using iPhone with TeamViewer at their first visit The other group firstly reviewed the CT scans numbered from one to 60 using iPhone with TeamViewer and 61 to 120 with the LCD monitor. They visited twice with an interval of four weeks and reviewed the CT scans using revered devices at each session. The raters were instructed to rate the likelihood of the presence or absence of appendicitis in each case using a five-Likert scale (1 = obvious no appendicitis, 2 = unlikely appendicitis, 3 = unsure, 4 = likely appendicitis, 5 = obvious appendicitis).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telemedicine
Keywords
Telemedicine, appendicitis, remote consultation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
The raters in this group one firstly reviewed the CT scans numbered from one to 60 using LCD monitor and after mandatory rests of 20 minutes, reviewed the remaining CT examinations numbered from 61 to 120 using iPhone with TeamViewer at their first visit. They visited twice with an interval of four weeks and reviewed the CT scans using revered devices at each session.
Arm Title
Group II
Arm Type
Experimental
Arm Description
The raters in this group II firstly reviewed the CT scans numbered from one to 60 using iPhone with TeamViewer and 61 to 120 with the LCD monitor. They visited twice with an interval of four weeks and reviewed the CT scans using revered devices at each session.
Intervention Type
Device
Intervention Name(s)
Remote CT reading using the iPhone
Other Intervention Name(s)
Smartphone (A1530, iPhone 5S, USA)
Intervention Type
Device
Intervention Name(s)
CT reading using LCD monitor
Other Intervention Name(s)
LCD monitor (MX210, EIZO, Japan)
Primary Outcome Measure Information:
Title
Diagnostic performance between iPhone and LCD monitor
Description
Dorfman-Berbaum-Metz method with RSCORE and semi-parametric estimation of ROC indices by using the DMB-MRMC software (version 2.3, available at http://perception.radiology.uiowa.edu) 95% confidence interval The reviewers and cases are taken as random factors
Time Frame
within one day
Title
Diagnostic accuracy between the iPhone and the LCD monitor
Description
◆ Sensitivity, specificity gold standard: The pathology report and the results of clinical follow up grade 1, 2 and 3 = negative appendicitis findings grade 4 and 5 = positive appendicitis findings McNemar's test to compare the sensitivity and specificity between the iPhad and the LCD monitor
Time Frame
within one day

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
33 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Board certified emergency physicians with a clinical experience of 5 years and over. Exclusion Criteria: Corrected eyesight < 20/30 Color weakness or blindness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Seung Kang, MD
Organizational Affiliation
Hanyang University
Official's Role
Study Director
Facility Information:
Facility Name
Hanyang university guri hospital, Department of emergency medicine
City
Guri
State/Province
GyeongGido
ZIP/Postal Code
471-701
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22067287
Citation
Choi HJ, Lee JH, Kang BS. Remote CT reading using an ultramobile PC and web-based remote viewing over a wireless network. J Telemed Telecare. 2012 Jan;18(1):26-31. doi: 10.1258/jtt.2011.110412. Epub 2011 Nov 8.
Results Reference
background
PubMed Identifier
22146833
Citation
Choudhri AF, Carr TM 3rd, Ho CP, Stone JR, Gay SB, Lambert DL. Handheld device review of abdominal CT for the evaluation of acute appendicitis. J Digit Imaging. 2012 Aug;25(4):492-6. doi: 10.1007/s10278-011-9431-9.
Results Reference
background
PubMed Identifier
23404630
Citation
Park JB, Choi HJ, Lee JH, Kang BS. An assessment of the iPad 2 as a CT teleradiology tool using brain CT with subtle intracranial hemorrhage under conventional illumination. J Digit Imaging. 2013 Aug;26(4):683-90. doi: 10.1007/s10278-013-9580-0.
Results Reference
background
PubMed Identifier
25700617
Citation
Kim C, Kang B, Choi HJ, Park JB. A Feasibility Study of Real-Time Remote CT Reading for Suspected Acute Appendicitis Using an iPhone. J Digit Imaging. 2015 Aug;28(4):399-406. doi: 10.1007/s10278-015-9775-7.
Results Reference
derived
Links:
URL
http://www.displaymate.com/Smartphone_ShootOut_2.htm
Description
Displaymate: Flagship Smartphone Display Technology Shoot-Out
URL
http://www.akamai.com/dl/akamai/akamai-soti-q313.pdf?WT.mc_id=soti_Q313
Description
The State of the Internet, 3rd Quarter, 2013
URL
http://www.diagnosticimaging.com/conference-reports/scar2005/article/113619/1198917
Description
Hayes JC. Monitor's megapixels do not affect image interpretation

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The Feasibility Study for Real-time Remote CT Reading for Suspected Acute Appendicitis Using iPhone

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