CT and Radiologist RCT
How Important is a Clinical Data for a Radiologist? A Double-Blinded Randomized Controlled Trial of Radiologic Interpretation of Ventral Hernias Following Selectively-Provided Clinical Information
1 other identifier
interventional
7
1 country
1
Brief Summary
The use of computed tomography (CT) imaging is rapidly increasing in healthcare. Despite physicians' growing reliance on radiological assessments, however, the reliability and accuracy of reads are highly variable. Inconsistencies may result from multiple factors. The researchers hypothesize that the presence and quality of clinical information will affect radiologist's assessment of CT scans for the presence/absence of a ventral hernia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2017
CompletedFirst Posted
Study publicly available on registry
April 19, 2017
CompletedStudy Start
First participant enrolled
May 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2020
CompletedApril 13, 2020
April 1, 2020
2.9 years
April 14, 2017
April 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Hernia detected on CT
proportion of hernias detected on CT
CT taken within 1 year
Study Arms (3)
Accurate Clinical Exam Findings
OTHERRadiologists will be provided with accurate clinical exam data.
Inaccurate Clinical Exam Findings
OTHERRadiologists will be provided with purposefully incorrect clinical exam data
No Clinical Exam Findings
OTHERRadiologists will be not be provided with any clinical exam data
Interventions
Findings found on clinical exam of a patient the radiologist will be reading CT scans of.
Inaccurate findings are given to the radiologists
No clinical exam findings are given to the radiologists
Eligibility Criteria
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Sponsors & Collaborators
Study Sites (1)
UT Health at Lyndon B. Johnson General Hospital
Houston, Texas, 77026, United States
Related Publications (1)
Cherla DV, Bernardi K, Blair KJ, Chua SS, Hasapes JP, Kao LS, Ko TC, Matta EJ, Moses ML, Shiralkar KG, Surabhi VR, Tammisetti VS, Viso CP, Liang MK. Importance of the physical exam: double-blind randomized controlled trial of radiologic interpretation of ventral hernias after selective clinical information. Hernia. 2019 Oct;23(5):987-994. doi: 10.1007/s10029-018-1856-3. Epub 2018 Nov 14.
PMID: 30430273DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 14, 2017
First Posted
April 19, 2017
Study Start
May 5, 2017
Primary Completion
April 10, 2020
Study Completion
April 10, 2020
Last Updated
April 13, 2020
Record last verified: 2020-04