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Adverse Events Among Hospitalized Patients in China

10 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Événement indésirable

Intervention / Traitement

Autre: Not applicable- observational study

Type d'étude

Observationnel

Inscription (Réel)

2807

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Chine
- Beijing Municipality
  - Beijing, Beijing Municipality, Chine, 100730
    - Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Peking Union Medical College

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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.

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Adverse event incidence Délai: 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.

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Types of adverse event Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Peking Union Medical College Hospital

Collaborateurs

Beijing Longfu Hospital

Beijing Hepingli Hospital

Beijing No.6 Hospital

Beijing Puren Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

28 août 2025

Achèvement primaire (Réel)

11 mars 2026

Achèvement de l'étude (Estimé)

1 octobre 2026

Dates d'inscription aux études

Première soumission

6 juillet 2026

Première soumission répondant aux critères de contrôle qualité

10 juillet 2026

Première publication (Réel)

15 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)