Adverse EventNCT07705204
Adverse Events Among Hospitalized Patients in China
An observational study of Adverse Event, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Event
- What is being tested?
- Not applicable- observational study
- How many people
- 2,807 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- age ≥18 years and a length of stay of at least 24 hours
Who cannot join
- Patients admitted primarily for psychiatric disorders, palliative care, or rehabilitation were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Peking Union Medical College
Beijing, Beijing Municipality, 100730
About this study
Official title: 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.
- Conditions
- Adverse Event
- Being tested
- Not applicable- observational study
- Keywords
- Adverse event (AE), Harvard Medical Practice Study (HMPS), Global Trigger Tool (GTT), Patient Safety Indicator (PSI), Incident Reporting System (IRS), Patient Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event incidence
The proportion of admissions with at least one adverse event.
Measured: During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge.
Secondary outcomes (7)
Types of adverse event
Measured: During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge
Preventability of adverse event
Adverse event with 6-point Likert scale scores ≥4 were considered preventable.
Measured: During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge
Severity of adverse events
Severity was graded using the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) classification.
Measured: 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
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).
Measured: After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
Specificity of adverse event detection methods
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).
Measured: After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
Positive predictive value (PPV) of adverse event detection methods
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).
Measured: After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
Negative predictive value (NPV) of adverse event detection methods
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).
Measured: After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start28 Aug 2025
- Primary completion11 Mar 2026
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse EventStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 2,807 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing No.6 Hospital, Beijing Longfu Hospital, Beijing Puren Hospital, Beijing Hepingli Hospital
- Responsible party
- Principal investigator, Wei Jiang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705204
- Sponsor's protocol ID
- I-25PJ1969
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Events Among Hospitalized Patients: A Multicenter Evaluation of Four Detection Methods
- ClinicalTrials.gov ID
- NCT07705204
- Acronym / sponsor ID
- I-25PJ1969
- Conditions
- Adverse Event
- Keywords
- Adverse event (AE), Harvard Medical Practice Study (HMPS), Global Trigger Tool (GTT), Patient Safety Indicator (PSI), Incident Reporting System (IRS), Patient Safety
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,807 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing No.6 Hospital, Beijing Longfu Hospital, Beijing Puren Hospital, Beijing Hepingli Hospital
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- age ≥18 years and a length of stay of at least 24 hours
Key exclusion criteria (1 listed)
- Patients admitted primarily for psychiatric disorders, palliative care, or rehabilitation were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyThis 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. | Other | – |
Primary outcome
Adverse event incidence
Time frame: 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.
7 secondary outcomes
Types of adverse event
Time frame: During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge
Preventability of adverse event
Time frame: During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge
Severity of adverse events
Time frame: 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
Time frame: After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
Specificity of adverse event detection methods
Time frame: After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
Positive predictive value (PPV) of adverse event detection methods
Time frame: After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
Negative predictive value (NPV) of adverse event detection methods
Time frame: After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Event, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event incidence (time frame: During the index admission, including review of relevant prior hospitalization records and all available records through 30 days after discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.