- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07705204
Adverse Events Among Hospitalized Patients in China
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Beijing Municipality
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Beijing, Beijing Municipality, Kiina, 100730
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Peking Union Medical College
-
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Adverse event incidence
Aikaikkuna: 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.
|
During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Types of adverse event
Aikaikkuna: 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
Aikaikkuna: 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.
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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
Aikaikkuna: 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.
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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
Aikaikkuna: 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
|
|
Specificity of adverse event detection methods
Aikaikkuna: 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).
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After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
|
|
Positive predictive value (PPV) of adverse event detection methods
Aikaikkuna: 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
Aikaikkuna: 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).
|
After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
|
Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
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Avainsanat
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