The Application of the PDCA Management Model in Improving the Diagnostic Accuracy of AIG

August 13, 2024 updated by: Ningbo No. 1 Hospital
Autoimmune gastritis is currently relatively rare in China due to its insidious onset, diverse clinical manifestations involving multiple systems such as digestive, hematological, and nervous systems, and its association with other autoimmune diseases. It can also be complicated by hyperplastic gastric polyps, gastric neuroendocrine tumors, gastric adenocarcinoma, and other diseases, making it prone to clinical misdiagnosis. As a form of gastritis in the post-Helicobacter pylori era, its detection rate has been gradually increasing with the continuous improvement of endoscopic technology in China. Applying the PDCA cycle management in disease diagnosis can significantly improve the detection rate of the disease, benefiting patients. Through the PDCA management model, this study further enhanced gastroenterologists' understanding of this disease from various aspects, aiming to improve the clinical diagnosis of autoimmune gastritis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Ningbo, Zhejiang, China, 315000
        • Ningbo First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Endoscopy center gastroenterologists in our hospital in 2024

Description

Inclusion Criteria:

Endoscopy center gastroenterologists in our hospital in 2024

Exclusion Criteria:

Doctors who withdrew from the PDCA management midway and stopped undergoing gastroscopy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
not received PDCA training
no intervention
PDCA training
The group of endoscopists underwent PDCA training to observe whether it ultimately improved the diagnosis rate of autoimmune gastritis.
Behavioral: PDCA training
Improve diagnostic rate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy of AIG
Time Frame: 4months

To diagnose Autoimmune Gastritis (AIG), the following two criteria must be simultaneously met:

Endoscopic or histopathological findings, or both, that are consistent with the characteristics of autoimmune gastritis.

Positive gastric autoantibody status, including the presence of anti-parietal cell antibodies (PCA) or anti-intrinsic factor antibodies (IFA), or both.
4months
The suspected diagnosis rate of AIG
Time Frame: 4months
If only the endoscopic or histopathological findings, or both, are consistent with the characteristics of autoimmune gastritis, but the gastric autoantibody status (anti-parietal cell antibodies or anti-intrinsic factor antibodies) is not confirmed to be positive, then the case should be considered as a suspected case of Autoimmune Gastritis (AIG).
4months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parietal Cell Antibody（PCA）
Time Frame: 4months
PCA is an important indicator in the diagnosis of AIG.
4months
IF-Ab
Time Frame: 4months
IFA is an important indicator in the diagnosis of AIG.
4months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ningbo No. 1 Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-091A-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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