Albert Einstein College of Medicine, Bronx, New York.
Department of Otorhinolaryngology-Head and Neck Surgery, Montefiore Medical Center, Bronx, New York.
JAMA Otolaryngol Head Neck Surg. 2023 May 1;149(5):424-429. doi: 10.1001/jamaoto.2023.0169.
Categorization systems for adverse events are not standardized across care settings and specialties and do not always include near miss events (events where there was potential for patient harm, but where no actual harm occurred), making it difficult to effectively assess patient safety for quality improvement.
To develop and assess interrater agreement on a classification system for adverse events reporting that incorporates events in both inpatient and outpatient settings across medical and surgical subspecialties including near miss events.
DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional study in a tertiary care center including 174 patient cases occurring from 2018 to 2020 was carried out. Data were abstracted from a Department of Otorhinolaryngology-Head and Neck Surgery Quality Assurance database. The cases were comprised of near miss and adverse events occurring in adult and pediatric patients in inpatient, outpatient, and emergency department settings. The ratings took place in March and April of 2022.
Four raters (2 attending physicians and 2 senior resident physicians) were recruited to classify these cases according to 3 classification systems: the National Coordinating Council for Medication Error Reporting and Prevention (NCC-MERP), Clavien-Dindo, and our novel Quality Improvement Classification System (QICS).
The primary outcome was overall interrater agreements using Fleiss κ.
Across all 4 raters grading 174 cases, the NCC-MERP, Clavien-Dindo, and QICS received a κ score. Fair-to-moderate interrater reliability was observed between the resident and attending physician groups across the 3 classification systems: NCC-MERP (κ = 0.33; 95% CI, 0.30-0.35), Clavien-Dindo (κ = 0.47; 95% CI, 0.43-0.50), and QICS (κ = 0.42; 95% CI, 0.39-0.44). Strong interrater concordance was observed for complications across all scenarios.
This cross-sectional study found that the new QICS classification scheme was applicable to wide-ranging clinical scenarios with a focus on patient-centered outcomes including near miss events. In addition, QICS allowed for the comparison of patient outcome data in a multitude of settings.
不良事件分类系统在护理环境和专业之间没有标准化，并且并不总是包括险些事件（即有可能对患者造成伤害，但实际上并未造成伤害的事件），这使得难以有效地评估患者安全以进行质量改进。
开发并评估一种不良事件报告分类系统的组内一致性，该系统涵盖了医疗和外科专业的住院和门诊环境中的事件，包括险些事件。
设计、环境和参与者：这是一项在三级护理中心进行的横断面研究，纳入了 2018 年至 2020 年期间发生的 174 例患者病例。数据从耳鼻喉头颈外科质量保证数据库中提取。这些病例包括住院、门诊和急诊科成人和儿科患者的险些和不良事件。评分于 2022 年 3 月和 4 月进行。
招募了 4 名评分员（2 名主治医生和 2 名高级住院医生），根据 3 种分类系统对这些病例进行分类：国家协调委员会药物错误报告和预防（NCC-MERP）、Clavien-Dindo 和我们新的质量改进分类系统（QICS）。
主要结果是使用 Fleiss κ 评估总体组内一致性。
在对 174 例病例进行评分的所有 4 名评分员中，NCC-MERP、Clavien-Dindo 和 QICS 的 κ 得分为：（0.33; 95%置信区间 [CI]，0.30-0.35），Clavien-Dindo（κ=0.47; 95%CI，0.43-0.50）和 QICS（κ=0.42; 95%CI，0.39-0.44）。在所有 3 种分类系统中，住院医生和主治医生组之间观察到的并发症的组内一致性较高。
这项横断面研究发现，新的 QICS 分类方案适用于广泛的临床情况，重点是包括险些事件在内的以患者为中心的结果。此外，QICS 允许在多种环境下比较患者的结局数据。
