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Adverse Events Among Hospitalized Patients in China

10. juli 2026 opdateret af: 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

2807

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse event incidence
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Types of adverse event
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Peking Union Medical College Hospital

Samarbejdspartnere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. august 2025

Primær færdiggørelse (Faktiske)

11. marts 2026

Studieafslutning (Anslået)

1. oktober 2026

Datoer for studieregistrering

Først indsendt

6. juli 2026

Først indsendt, der opfyldte QC-kriterier

10. juli 2026

Først opslået (Faktiske)

15. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • I-25PJ1969

Plan for individuelle deltagerdata (IPD)

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INGEN

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