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Early Warning and Follow-up System Construction for Critical Abnormal Findings in Health Check-ups and Evaluation of Its Effectiveness: A Clinical Research Protocol for a Prospective Cohort Study

Early Warning and Follow-up System Construction for Critical Abnormal Findings in Health Check-ups and Evaluation of Its Effectiveness: A Clinical Research Protocol for a Prospective Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119182
Enrollment
Unknown
Registered
2026-02-24
Start date
2026-02-28
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Routine Management Group: Individuals who underwent "routine or non-standardized early warning and follow-up" during the period from October 2021 to January 2026, prior to the implementation of the st
Intervention Group: All individuals enrolled in the health examination program after the formal implementation of the system in February 2026, who received "standardized early warning and active follo

Sponsors

West China Tianfu Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adults (>=18 years) who, during the specified study period, undergo health examinations at our center and are identified as having "critical abnormal findings." The definition of "critical abnormal findings" is based on the Expert Consensus on Management of Critical Abnormal Findings in Health Examinations, including but not limited to: Category A (Requiring Emergency Intervention): e.g., electrocardiographic findings suggestive of acute myocardial infarction, CT findings indicating cerebral hemorrhage, severe hyperkalemia (serum potassium >= 6.5 mmol/L). Category B (Requiring Specialist Referral): e.g., imaging findings suspicious for malignancy (e.g., pulmonary nodules = 8 mm with malignant features, thyroid nodules classified as TI-RADS 4 or higher), gastric biopsy pathology showing high-grade intraepithelial neoplasia. Category C (Requiring Regular Monitoring): e.g., fasting blood glucose >= 13.9 mmol/L, estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m². 2. Participants must also have available contact information to enable follow-up.

Exclusion criteria

Exclusion criteria: 1. For the retrospective cohort: records with missing data exceeding 30% for key variables (e.g., details of abnormal findings, contact information, whether medical consultation was sought). 2. For the prospective cohort: Individuals unable or unwilling to provide informed consent; 3. Those whose detected abnormalities are already confirmed as previously known conditions under stable follow-up, with no need for changes in management based on the current alert; 4. Individuals with severe mental illness, cognitive impairment, or absence of a legal guardian, rendering them unable to engage in basic communication.

Design outcomes

Primary

MeasureTime frame
Incidence of the composite endpoint of cancer and major adverse cardiovascular and cerebrovascular events (MACE).;Early treatment rate for critical abnormal findings.;

Secondary

MeasureTime frame
Effective alert information receipt rate.;Detection rate and composition ratio of critical abnormal findings.;All-cause mortality.;Patient anxiety level score;Patient satisfaction score;Loss to follow-up rate/Adherence;

Countries

China

Contacts

Public ContactHuairong Tang

West China Tianfu Hospital, Sichuan University

1651682099@qq.com+86 28 6066 0099

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026