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Adverse Events Among Hospitalized Patients in China

2026年7月10日更新者：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.

調査の概要

状態

積極的、募集していない

条件

有害事象

介入・治療

他の：Not applicable- observational study

研究の種類

観察的

入学 (実際)

2807

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

中国
- Beijing Municipality
  - Beijing、Beijing Municipality、中国、100730
    - Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Peking Union Medical College

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

大人
高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Adverse event incidence 時間枠：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.

二次結果の測定

結果測定	メジャーの説明	時間枠
Types of adverse event 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Peking Union Medical College Hospital

協力者

Beijing Longfu Hospital

Beijing Hepingli Hospital

Beijing No.6 Hospital

Beijing Puren Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年8月28日

一次修了 (実際)

2026年3月11日

研究の完了 (推定)

2026年10月1日

試験登録日

最初に提出

2026年7月6日

QC基準を満たした最初の提出物

2026年7月10日

最初の投稿 (実際)

2026年7月15日

学習記録の更新

投稿された最後の更新 (実際)