Hébert Guillaume, Netzer Florence, Kouakou Sylvain Landry, Lemare François, Minvielle Etienne
Département de Pharmacie Clinique, Gustave Roussy, 114 Rue Edouard Vaillant, 94805, Villejuif, France.
Research Team 'Management des Organisations de Santé' (EA 7348), École de Hautes Études en Santé Publique, 15 Avenue du Professeur Léon-Bernard, 35043, Rennes Cedex, France.
Int J Clin Pharm. 2018 Apr;40(2):376-385. doi: 10.1007/s11096-017-0542-3. Epub 2018 Feb 14.
Background Adverse drug events (ADEs) occur frequently in oncology and justify continuous assessment and monitoring. There are several methods for detecting them, but the trigger tool method seems the most appropriate. Although a generic tool exists, its use for ADEs in oncology has not been convincing. The development of a focused version is therefore necessary. Objective To provide an oncology-focused trigger tool that evaluates the prevalence, harm, and preventability in a standardised method for pragmatic use in ADE surveillance. Setting Hospitals with cancer care in France. Method The tool has been constructed in two steps: (1) constitution of an oncology-centred list of ADEs; 30 pharmacists/practitioners in cancer care from nine hospitals selected a list of ADEs using a method of agreement adapted from the RAND/UCLA Appropriateness Method; and (2) construction of three standardised dimensions for the characterisation of each ADE (including causality, severity, and preventability). Main outcome measure The main outcome measure was validation of the tool, including preventability criteria. Results The tool is composed of a final list of 15 ADEs. For each ADE, a 'reviewer form' has been designed and validated by the panel. It comprises (1) the trigger(s), (2) flowcharts to guide the reviewer, (3) criteria for grading harm, and (4) a standardised assessment of preventability with 6-14 closed sentences for each ADE in terms of therapeutic management and/or prevention of side-effects. Conclusion A complete 'ready-to-use' tool for ADE monitoring in oncology has been developed that allows the assessment of three standardised dimensions.
药物不良事件（ADEs）在肿瘤学中频繁发生，因此有必要持续进行评估和监测。检测ADEs有多种方法，但触发工具法似乎最为合适。尽管存在通用工具，但其在肿瘤学中用于ADEs的效果并不令人信服。因此，开发一个针对性的版本很有必要。目的：提供一种针对肿瘤学的触发工具，以标准化方法评估ADEs在监测中的发生率、危害和可预防性，便于实际应用。地点：法国提供癌症护理的医院。方法：该工具分两步构建：（1）构建以肿瘤学为中心的ADEs清单；来自9家医院的30名癌症护理药剂师/从业者采用改编自兰德/加州大学洛杉矶分校适宜性方法的共识法选出一份ADEs清单；（2）为每个ADE构建三个标准化维度以进行特征描述（包括因果关系、严重程度和可预防性）。主要结局指标：主要结局指标是工具的验证，包括可预防性标准。结果：该工具由15种ADEs的最终清单组成。针对每种ADE，设计了一份“审核表单”并经专家组验证。它包括（1）触发因素，（2）指导审核人员的流程图，（3）危害分级标准，以及（4）针对每种ADE在治疗管理和/或副作用预防方面通过6 - 14个封闭式语句进行的可预防性标准化评估。结论：已开发出一种完整的、“即用型”肿瘤学ADE监测工具，可对三个标准化维度进行评估。
