Adverse Events Among Hospitalized Patients in China
10 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Actual)
2807
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100730
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Peking Union Medical College
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra de probabilidad
Población de estudio
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.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adverse event incidence
Periodo de tiempo: During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge.
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The proportion of admissions with at least one adverse event.
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During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Types of adverse event
Periodo de tiempo: 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
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Preventability of adverse event
Periodo de tiempo: During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge
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Adverse event with 6-point Likert scale scores ≥4 were considered preventable.
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During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge
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Severity of adverse events
Periodo de tiempo: During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge
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Severity was graded using the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) classification.
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During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge
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Sensitivity of adverse event detection methods
Periodo de tiempo: After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
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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).
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After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
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Specificity of adverse event detection methods
Periodo de tiempo: After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
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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).
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After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
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Positive predictive value (PPV) of adverse event detection methods
Periodo de tiempo: After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
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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).
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After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
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Negative predictive value (NPV) of adverse event detection methods
Periodo de tiempo: After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
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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).
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After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
28 de agosto de 2025
Finalización primaria (Actual)
11 de marzo de 2026
Finalización del estudio (Estimado)
1 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
6 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de julio de 2026
Publicado por primera vez (Actual)
15 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- I-25PJ1969
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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