Gustave Roussy, Projet CAPRI, Villejuif F-94805, France; Equipe d'accueil "Management des organisations de santé", Ecoles de Hautes Etudes en Santé Publique, Rennes F-35000, France.
Gustave Roussy, Département de Pharmacie Clinique, Villejuif F-94805, France.
Eur J Cancer. 2015 Feb;51(3):427-35. doi: 10.1016/j.ejca.2014.12.002. Epub 2014 Dec 27.
Drug-related iatrogenic effects are common in oncology because chemotherapy is toxic. The evaluation of the application of the guidelines may be a way to understand the occurrence of adverse drug-related event (ADE). There is no specific method for identifying ADEs and measuring harm to patients in oncology.
Our objective was to develop and test an Oncology Trigger Tool (OTT) for ADEs and to describe ADE characteristics and incidence.
A clinical advisory panel identified situations at high risk of ADE occurrence and built 22 triggers with, in each case, an analysis flowchart to confirm or refute occurrence. The OTT was used to review 288 random admissions (Oct. 2010-Sept. 2011) and measure ADE incidence and severity (CTCAE 4.03 - Common Terminology Criteria for Adverse Events). Tool feasibility (time required), inter-rater (IR) reproducibility and positive predictive value (PPV) were measured.
Overall, 884 triggers were detected and 122 ADEs, with 42.4 ADEs/100 admissions or 46.0 ADEs/1000 patient-days, and a 31.1% rate of severe ADEs. The most common ADEs were hyperglycaemia (14.5%), unplanned drug-related admission within 30 days (13.7%) and opiate-induced constipation (12.1%). Unplanned drug-related admission was the most serious (82.4% incidence of severe harm). Mean time for OTT implementation was 21.8 min; IR reproducibility was high (κ=0.965 (trigger); κ=0.935 (ADE); κ=0.853 (harm)); PPV 22-trigger version was 20.7%.
ADE analysis flowcharts coupled with standardised grading of harm considerably reduced IR variability, thus providing a robust oncology-focused trigger tool for use in ADE audits and hospital comparisons. The involvement of a clinical advisory panel in tool development should help drive changes for improving practice. Further research on the OTT is warranted.
由于化疗具有毒性,因此肿瘤学中药物相关的医源性效应较为常见。评估指南的应用情况可能是了解不良药物相关事件(ADE)发生的一种方法。目前尚无专门用于确定肿瘤学中 ADE 并测量对患者伤害的方法。
我们旨在开发和测试一种用于 ADE 的肿瘤学触发工具(OTT),并描述 ADE 的特征和发生率。
临床顾问小组确定了发生 ADE 风险较高的情况,并构建了 22 个触发器,每个触发器都有一个分析流程图以确认或反驳事件的发生。使用 OTT 回顾了 288 例随机入院患者(2010 年 10 月至 2011 年 9 月),并根据 CTCAE 4.03(不良事件常用术语标准)测量了 ADE 的发生率和严重程度。还测量了工具的可行性(所需时间)、内部一致性(IR)可重复性和阳性预测值(PPV)。
共检测到 884 个触发器和 122 个 ADE,每 100 例住院患者中有 42.4 个 ADE(46.0 个 ADE/1000 患者天),严重 ADE 发生率为 31.1%。最常见的 ADE 是高血糖(14.5%)、30 天内计划外与药物相关的入院(13.7%)和阿片类药物引起的便秘(12.1%)。计划外与药物相关的入院是最严重的(严重伤害发生率为 82.4%)。OTT 实施的平均时间为 21.8 分钟;IR 可重复性高(触发器的κ值为 0.965;ADE 的 κ 值为 0.935;伤害的 κ 值为 0.853);22 个触发器版本的 PPV 为 20.7%。
将 ADE 分析流程图与伤害的标准化分级相结合,大大降低了 IR 的变异性,从而为 ADE 审核和医院比较提供了一种稳健的、专注于肿瘤学的触发工具。临床顾问小组参与工具的开发应该有助于推动实践的改进。需要进一步研究 OTT。