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IDEAS-AAP System Diagnoses Acute Abdominal Pain

Primary Purpose

Artificial Intelligence, Diagnoses Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Artificial intelligence assistant system
Sponsored by
Renmin Hospital of Wuhan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Artificial Intelligence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males or females who are over 18 years old;
  2. After qualified medical education and obtained the Certificate of medical practitioner;

Exclusion Criteria:

  1. Physicians without qualified medical education and didn't obtain the Certificate of medical practitioner;
  2. The researcher believes that the subjects are not suitable for participating in clinical trials.

Sites / Locations

  • Renmin Hospital of Wuhan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental: with Artificial intelligence assistant system

No Intervention: without Artificial intelligence assistant system

Arm Description

The physicians were additionally provided with the feature extracted by the system, a list of suspicious diagnoses predicted by IDEAS-AAP, and corresponding diagnostic criteria according to guidelines. After the readers get the examination results, the IDEAS-AAP will renew its diagnosis prediction. IDEAS-AAP extracted feature from electronic health record, provided a list of suspicious diagnoses, and corresponding diagnostic criteria according to guidelines. After the readers get the examination results, the IDEAS-AAP will renew its diagnosis prediction.

Outcomes

Primary Outcome Measures

The accuracy of clinical diagnosis.
Calculation method = number of right cases / total number of cases 100%

Secondary Outcome Measures

Accuracy of the prediction of disease based on whole electronic health record
Calculation method = number of right cases / total number of cases 100%
The prediction of disease based on whole electronic health record and criteria matching
Calculation method = number of right cases / total number of cases 100%
Time cost of EHR reading

Full Information

First Posted
August 9, 2022
Last Updated
November 3, 2022
Sponsor
Renmin Hospital of Wuhan University
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1. Study Identification

Unique Protocol Identification Number
NCT05497258
Brief Title
IDEAS-AAP System Diagnoses Acute Abdominal Pain
Official Title
Computer-aided, Evidence-based System Improved Clinical Diagnostic Accuracy of Certificated-Physicians in Acute Abdominal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renmin Hospital of Wuhan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a study to validate the effect of the intelligent diagnostic evidence-based analytic system in acute abdominal pain augmentation. Included physicians were randomly assigned into control or AI-assisted group. In this experiment, the whole electronic health record of each acute abdominal pain patient was divided into two parts, signs and symptoms recording (including chief complaint, present history, physical examination, past medical history, trauma surgery history, personal history, family history, obstetrical history, menstrual history, blood transfusion history, drug allergy history) and auxiliary examination recording (including laboratory examination and radiology report). For each case, the control group readers will first read the signs and symptoms recording of electronic health record and make a clinical diagnosis. Then the readers have to decide to either order a list of auxiliary examinations or confirm the clinical diagnosis without further examination. If the readers choose to order examinations, the corresponding examination results will be feedback to the readers, and the readers can then decide to either continue to order a list of auxiliary examinations or make a confirming diagnosis. Such cycle will last until the reader make a confirming diagnosis. For the AI-assisted readers, the physicians were additionally provided with the feature extracted by IDEAS-AAP, a list of suspicious diagnoses predicted by IDEAS-AAP, and corresponding diagnostic criteria according to guidelines. After the readers get the examination results, the IDEAS-AAP will renew its diagnosis prediction
Detailed Description
In recent years, with the continuous development of science and technology, the range of diagnostic tests and biomarkers for disease and treatment modalities has increased exponentially, and medical information has become increasingly complex. This requires the clinician to comprehensively evaluate the patient's condition, so as to choose the best examination and treatment. However, for the complex symptoms in the actual clinical environment, the corresponding diseases are numerous; In the face of complex and heavy clinical work, how to extract the important characteristics of patients' diseases faster and more accurately to achieve high-quality and accurate diagnosis and treatment is the key problem to be solved at present. For example, in the field of digestion, the chief complaint of abdominal pain is one of the most common clinical symptoms of patients seeking medical treatment, and some acute abdominal pain, such as gastrointestinal ulcer perforation, strangulated intestinal obstruction, acute obstructive suppurative cholangitis and other urgent onset, narrow treatment time window, high mortality. Clinicians must make a quick diagnosis and distinguish between those that require emergency intervention and those that do not in order to manage patients in a timely manner and avoid catastrophic events. However, the causes of abdominal pain are many and the mechanisms are complex. In addition, since pain is a subjective sensation and is greatly influenced by subjective factors, there are no clear objective indicators to determine whether or not and the degree of pain, and it is extremely challenging to correctly diagnose and interpret abdominal pain. To this end, the clinician must take a detailed history and perform a thorough physical examination when evaluating a patient's abdominal pain. In recent years, artificial intelligence technology has developed rapidly, especially in the field of medicine has been widely applied research, mainly reflected in the diagnosis and differential diagnosis of diseases, prognosis judgment and clinical decision analysis. Some studies have shown that in terms of auxiliary pathology and imaging diagnosis, AI has reached or even exceeded the average diagnostic level of corresponding specialists. Most of these studies focus on pattern recognition based on images, and the logical judgment based on natural language using medical records information is still in the preliminary development stage. There are no relevant reports on integrating comprehensive information of large medical records to make intelligent prediction of digestive tract diseases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Artificial Intelligence, Diagnoses Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental: doctor with AI-assisted system;Control:without AI-assisted system
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: with Artificial intelligence assistant system
Arm Type
Experimental
Arm Description
The physicians were additionally provided with the feature extracted by the system, a list of suspicious diagnoses predicted by IDEAS-AAP, and corresponding diagnostic criteria according to guidelines. After the readers get the examination results, the IDEAS-AAP will renew its diagnosis prediction. IDEAS-AAP extracted feature from electronic health record, provided a list of suspicious diagnoses, and corresponding diagnostic criteria according to guidelines. After the readers get the examination results, the IDEAS-AAP will renew its diagnosis prediction.
Arm Title
No Intervention: without Artificial intelligence assistant system
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Artificial intelligence assistant system
Intervention Description
The AI-assisted diagnosis system can provide the direction of disease diagnosis in real time and assist the doctor to give the final diagnosis
Primary Outcome Measure Information:
Title
The accuracy of clinical diagnosis.
Description
Calculation method = number of right cases / total number of cases 100%
Time Frame
one week
Secondary Outcome Measure Information:
Title
Accuracy of the prediction of disease based on whole electronic health record
Description
Calculation method = number of right cases / total number of cases 100%
Time Frame
one week
Title
The prediction of disease based on whole electronic health record and criteria matching
Description
Calculation method = number of right cases / total number of cases 100%
Time Frame
one week
Title
Time cost of EHR reading
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females who are over 18 years old; After qualified medical education and obtained the Certificate of medical practitioner; Exclusion Criteria: Physicians without qualified medical education and didn't obtain the Certificate of medical practitioner; The researcher believes that the subjects are not suitable for participating in clinical trials.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Honggang Yu, MD
Organizational Affiliation
Renmin Hospital of Wuhan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China

12. IPD Sharing Statement

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IDEAS-AAP System Diagnoses Acute Abdominal Pain

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