Adverse Events Among Hospitalized Patients in China

NCT07705204 | Active Not Recruiting DMC

• 1 other identifier: I-25PJ1969
• Study Type: observational
• Target: 2,807
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the incidence and characteristics of adverse events (AEs) among hospitalized patients in China and to compare 4 commonly used methods for detecting these events. The main questions it aims to answer are: How common are AEs among hospitalized patients, and what are their characteristics (types, severity, and preventability) in China? How do 4 commonly used methods, including the Harvard Medical Practice Study (HMPS), Global Trigger Tool (GTT), Patient Safety Indicators (PSIs), and incident reporting systems (IRSs), compare in detecting AEs? Researchers review randomly selected medical records from 5 hospitals in China to identify AEs, assess their type, severity, and preventability, and evaluate the performance of the 4 detection methods.

Conditions

Adverse Event

Keywords

Adverse event (AE); Harvard Medical Practice Study (HMPS); Global Trigger Tool (GTT); Patient Safety Indicator (PSI); Incident Reporting System (IRS); Patient Safety

Outcome Measures

Primary Outcomes (1)

• Adverse event incidence

  The proportion of admissions with at least one adverse event.

  During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge.

Secondary Outcomes (7)

• Types of adverse event

  During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge

• Preventability of adverse event

  During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge

• Severity of adverse events

  During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge

• Sensitivity of adverse event detection methods

  After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions

• Specificity of adverse event detection methods

  After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions

Interventions

Not applicable- observational study OTHER

This is a retrospective cross-sectional study based on medical record review. The study assesses AE incidence and characteristics and compares AE detection methods, with no intervention administered to participants.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consisted of inpatient admissions to 5 participating public general hospitals in Beijing, China, during 2024. Eligible admissions were identified according to predefined inclusion and exclusion criteria. Stratified random sampling was used, with sample sizes allocated in proportion to hospital admission volumes. Within each site, eligible admissions were randomly selected with equal selection probabilities. The final study sample included 2,843 admissions.

You may qualify if:

• age ≥18 years and a length of stay of at least 24 hours

You may not qualify if:

• Patients admitted primarily for psychiatric disorders, palliative care, or rehabilitation were excluded.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Beijing No.6 Hospital: collaborator
• Beijing Longfu Hospital: collaborator
• Beijing Puren Hospital: collaborator
• Beijing Hepingli Hospital: collaborator

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Peking Union Medical College

Beijing, Beijing Municipality, 100730, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 15, 2026
• Study Start: August 28, 2025
• Primary Completion: March 11, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)