Augusta University Medical Center, Augusta, GA, USA.
UW Health - University Hospital, Madison, WI, USA.
Am J Health Syst Pharm. 2023 Oct 25;80(21):1557-1563. doi: 10.1093/ajhp/zxad138.
Research pharmacy effort required to safely and compliantly manage investigational products (IP) varies between studies. No validated tool exists in the United States to evaluate these differences in effort. The Vizient Pharmacy Research Committee Investigational Drug Services (IDS) Subcommittee previously developed a systematic complexity scoring tool (CST) through expert consensus to assign a complexity score for pharmacy effort. This project seeks to develop and validate complexity categories based on CST scores.
Vizient member institutions in IDS assigned a CST complexity score and a perceived complexity category (low, medium, or high) for study initiation and maintenance. Receiver operating characteristic (ROC) curve analysis defined the best CST score cutoff points for each complexity category. Comparing the CST-assigned to the user-perceived complexity category determined whether the CST-assigned complexity category aligned with practitioner assignment.
A total of 322 responses were used to determine complexity score categories. The AUC values for study initiation and maintenance were 0.79 (P < 0.001) for the low/medium boundary and 0.80 (P < 0.001) for the medium/high boundary, suggesting the performance of the CST is good. The agreement between CST-assigned and user-perceived complexity categories was 60% for study initiation and 58% for maintenance. The Kendall rank correlation coefficient between the raters and ROC categories was strong, with a value of 0.48 for study initiation and 0.47 for maintenance.
Development of the CST allows IDS pharmacies to objectively measure the complexity of clinical trials, which is a significant step towards assessing workload and guiding resource allocation.
研究不同研究之间安全合规管理研究产品（IP）所需的药学工作量存在差异。在美国，尚无经过验证的工具可评估这些工作量差异。Vizient 药学研究委员会调查药物服务（IDS）小组委员会之前通过专家共识制定了一个系统的复杂性评分工具（CST），以分配药学工作量的复杂性评分。本项目旨在根据 CST 评分开发和验证复杂性类别。
IDS 中的 Vizient 成员机构为研究启动和维持分配 CST 复杂性评分和感知复杂性类别（低、中或高）。接收者操作特征（ROC）曲线分析为每个复杂性类别定义了最佳 CST 评分临界值。比较 CST 分配的复杂性类别和用户感知的复杂性类别，以确定 CST 分配的复杂性类别是否与从业者的分配一致。
共使用 322 份回复来确定复杂性评分类别。低/中边界的 AUC 值为 0.79（P<0.001），中/高边界的 AUC 值为 0.80（P<0.001），表明 CST 的性能良好。研究启动和维持的 CST 分配与用户感知的复杂性类别之间的一致性分别为 60%和 58%。评分者和 ROC 类别之间的 Kendall 秩相关系数较强，研究启动时为 0.48，维持时为 0.47。
CST 的开发使 IDS 药房能够客观地衡量临床试验的复杂性，这是评估工作量和指导资源分配的重要一步。
