Adverse Events Among Hospitalized Patients: A Multicenter Evaluation of Four Detection Methods
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,807
- 试验地点
- 1
- 主要终点
- Adverse event incidence
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years and a length of stay of at least 24 hours
排除标准
- •Patients admitted primarily for psychiatric disorders, palliative care, or rehabilitation were excluded.
结局指标
主要结局
Adverse event incidence
时间窗: 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.
次要结局
- 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)
- Severity of adverse events(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(After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions)
- Specificity of adverse event detection methods(After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions)
- Positive predictive value (PPV) of adverse event detection methods(After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions)
- Negative predictive value (NPV) of adverse event detection methods(After completion of AE screening, adjudication, and re-review of randomly sampled screen-negative admissions)
研究者
Wei Jiang
Associate Professor
Peking Union Medical College Hospital