Adverse Events Among Hospitalized Patients in China

Adverse Events Among Hospitalized Patients: A Multicenter Evaluation of Four Detection Methods

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Adverse Event
• Intervention / Treatment: Other: Not applicable- observational study

• Study Type: Observational
• Enrollment (Actual): 2807

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Peking Union Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Adverse event with 6-point Likert scale scores ≥4 were considered preventable.	During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge
Severity of adverse events	Severity was graded using the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) classification.	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	Admission-level sensitivity was calculated for the Harvard Medical Practice Study (HMPS), Global Trigger Tool (GTT), Patient Safety Indicators (PSIs), and incident reporting systems (IRSs).	After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
Specificity of adverse event detection methods	Admission-level specificity was calculated for the Harvard Medical Practice Study (HMPS), Global Trigger Tool (GTT), Patient Safety Indicators (PSIs), and incident reporting systems (IRSs).	After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
Positive predictive value (PPV) of adverse event detection methods	Admission-level positive predictive value (PPV) was calculated for the Harvard Medical Practice Study (HMPS), Global Trigger Tool (GTT), Patient Safety Indicators (PSIs), and incident reporting systems (IRSs).	After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
Negative predictive value (NPV) of adverse event detection methods	Admission-level negative predictive value (NPV) was calculated for the Harvard Medical Practice Study (HMPS), Global Trigger Tool (GTT), Patient Safety Indicators (PSIs), and incident reporting systems (IRSs).	After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Beijing Longfu Hospital; Beijing Hepingli Hospital; Beijing No.6 Hospital; Beijing Puren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2025
• Primary Completion (Actual): March 11, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Patient Safety; Adverse event (AE); Harvard Medical Practice Study (HMPS); Global Trigger Tool (GTT); Patient Safety Indicator (PSI); Incident Reporting System (IRS)
• Other Study ID Numbers: I-25PJ1969

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No