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Adverse Events Among Hospitalized Patients in China

10 juli 2026 bijgewerkt door: Wei Jiang, Peking Union Medical College Hospital

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Nadelige gebeurtenis

Interventie / Behandeling

Ander: Not applicable- observational study

Studietype

Observationeel

Inschrijving (Werkelijk)

2807

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Adverse event incidence Tijdsspanne: 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.	During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge.

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Types of adverse event Tijdsspanne: During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge		During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge
Preventability of adverse event Tijdsspanne: 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.	During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge
Severity of adverse events Tijdsspanne: 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.	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 Tijdsspanne: 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).	After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
Specificity of adverse event detection methods Tijdsspanne: 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).	After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
Positive predictive value (PPV) of adverse event detection methods Tijdsspanne: 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).	After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
Negative predictive value (NPV) of adverse event detection methods Tijdsspanne: 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).	After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Peking Union Medical College Hospital

Medewerkers

Beijing Longfu Hospital

Beijing Hepingli Hospital

Beijing No.6 Hospital

Beijing Puren Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 augustus 2025

Primaire voltooiing (Werkelijk)

11 maart 2026

Studie voltooiing (Geschat)

1 oktober 2026

Studieregistratiedata

Eerst ingediend

6 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 juli 2026

Eerst geplaatst (Werkelijk)

15 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)