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Active, Not Recruiting

NCT Number: NCT07705204

Adverse Events Among Hospitalized Patients in China

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Adverse Event

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Adverse event incidence

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

    The proportion of admissions with at least one adverse event.

Secondary outcomes

  1. Types of adverse event

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

  2. Preventability of adverse event

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

    Adverse event with 6-point Likert scale scores ≥4 were considered preventable.

  3. Severity of adverse events

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

    Severity was graded using the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) classification.

  4. Sensitivity of adverse event detection methods

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

    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).

  5. Specificity of adverse event detection methods

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

    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).

  6. Positive predictive value (PPV) of adverse event detection methods

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

    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).

  7. Negative predictive value (NPV) of adverse event detection methods

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

    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).

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Beijing Hepingli Hospital
  • Beijing Longfu Hospital
  • Beijing No.6 Hospital
  • Beijing Puren Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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