Adverse Event
Conditions
Keywords
Adverse event (AE), Harvard Medical Practice Study (HMPS), Global Trigger Tool (GTT), Patient Safety Indicator (PSI), Incident Reporting System (IRS), Patient Safety
Brief summary
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.
Interventions
OTHERNot applicable- observational study
This is a retrospective cross-sectional study based on medical record review. The study assesses AE incidence and characteristics and compares AE detection methods, with no intervention administered to participants.
Sponsors
Peking Union Medical College Hospital
Beijing No.6 Hospital
Beijing Longfu Hospital
Beijing Puren Hospital
Beijing Hepingli Hospital
Study design
Observational model
CASE_CROSSOVER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event incidence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Types of adverse event | During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge | — |
| Preventability of adverse event | 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. |
| Severity of adverse events | 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. |
| Sensitivity of adverse event detection methods | 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). |
| Specificity of adverse event detection methods | 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). |
| Positive predictive value (PPV) of adverse event detection methods | 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). |
| Negative predictive value (NPV) of adverse event detection methods | 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). |
Countries
China
Outcome results
None listed