Importance of the physical exam: double-blind randomized controlled trial of radiologic interpretation of ventral hernias after selective clinical information
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Increasingly, radiologic imaging is obtained as part of the pathway in diagnosing ventral hernias. Often, radiologists receive incomplete or incorrect clinical information from clinicians. Objective: The aim of the study is to determine if clinical exam findings alter radiological interpretation of ventral hernias on CT.
This is a single-institution double-blind, randomized trial. All patients with a recent abdominal/pelvic CT scan seen in various surgical clinics were enrolled. A surgeon blinded to the CT scan findings performed a standardized physical examination and assessed for the presence of a ventral hernia. Seven independent radiologists blinded to the study design reviewed the scans. Each radiologist received one of three types of clinical exam data per CT: accurate (correct), inaccurate (purposely incorrect), or none. Allocation was random and stratified by the presence of clinical hernia. The primary outcome was the proportion of radiologic hernias detected, analyzed by chi square.
115 patients were enrolled for a total of 805 CT scan reads. The proportion of hernias detected differed by up to 25% depending on if accurate, no, or inaccurate clinical information was provided. Inaccurate clinical data in patients with no hernia on physical exam led to a significant difference in the radiologic hernia detection rate (54.3% versus 35.7%, p = 0.007). No clinical data in patients with a hernia on physical exam led to a lower radiologic hernia detection rate (75.0% versus 93.8%, p = 0.001).
The presence and accuracy of clinical information provided to radiologists impacts the diagnosis of abdominal wall hernias in up to 25% of cases. Standardization of both clinical and radiologic examinations for hernias and their reporting are needed.
Clinicaltrials.gov, Number NCT03121131, https://clinicaltrials.gov/ct2/show/NCT03121131.
KeywordsUmbilical hernia Ventral hernia Incisional hernia Radiologic diagnosis Radiologic accuracy Provider information
Compliance with ethical standards
Conflict of interest
The authors have no conflict of interest or anything to disclose. DC: declares no conflict of interest. KB: declares no conflict of interest. KB: declares no conflict of interest. SC: declares no conflict of interest. JH: declares no conflict of interest. LK: declares no conflict of interest. TK: declares no conflict of interest. EM: declares no conflict of interest. MM: declares no conflict of interest. KS: declares no conflict of interest. VS: declares no conflict of interest. VT: declares no conflict of interest. CV: declares no conflict of interest. ML: declares no conflict of interest.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Human and animal rights
This experiments complies with the current laws of the United States on medical research.
With institutional review board oversight and approval, all patients received a written consent of participation, however, for participating radiologists a written consent was waived. Radiologist received a letter of information explaining the broadscope of the project, voluntary nature of participation, risks and benefits, and contact information in the event of questions or to withdraw from the study.
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