College of Pharmacy, QU Health, Qatar University, Doha, Qatar.
Children's & Women's Health Centre of British Columbia, Provincial Health Services Authority, British Columbia, Canada.
Int J Clin Pharm. 2022 Aug;44(4):894-903. doi: 10.1007/s11096-022-01390-y. Epub 2022 Mar 20.
Critical appraisal aids in assessing the quality of scientific literature, which is central to the practice of evidence-based medicine. Several tools and guidelines are available for critiquing and assessing the quality of specific study types. However, limited guidance exists for critical appraisal of clinical pharmacokinetic studies.
We aimed to achieve experts' consensus regarding the quality markers for clinical pharmacokinetic studies in an attempt to develop a critical appraisal tool.
Quality markers related to clinical pharmacokinetic studies, were derived from the published literature and categorized according to manuscript reporting domains (abstract, introduction/background, methodology, results, discussion, and conclusion). Questions that aid in appraising pharmacokinetic studies were formulated from these quality markers. Experts were involved in a modified Delphi process to achieve a consensus regarding the formulated questions. The proposed tool was pilot tested on 30 recently published clinical pharmacokinetic studies. Inter-observer agreement was measured to determine the reliability of the included items.
Twenty-five experts consented to participate. Three rounds of a modified Delphi survey were required to generate a consensus for a 21-item tool aimed at appraising the quality of clinical pharmacokinetic studies. When applied to 30 recently published clinical pharmacokinetic studies, most items scored fair to moderate levels of agreement (61.90-95.24%).
The clinical pharmacokinetic critical appraisal tool (CACPK) developed in this study consisted of 21 items aimed at helping an end-user to determine the quality of a pharmacokinetic study. Further studies are warranted to reaffirm the validity and reliability of the CACPK tool.
评价有助于评估科学文献的质量，这是循证医学实践的核心。有几种工具和指南可用于评价和评估特定研究类型的质量。然而，对于临床药代动力学研究的评价，指导有限。
我们旨在就临床药代动力学研究的质量标志物达成专家共识，以期开发一种评价工具。
从已发表的文献中提取与临床药代动力学研究相关的质量标志物，并根据手稿报告领域（摘要、引言/背景、方法、结果、讨论和结论）进行分类。从这些质量标志物中制定了有助于评价药代动力学研究的问题。专家参与了一项改良 Delphi 流程，就制定的问题达成共识。该拟议工具在 30 篇最近发表的临床药代动力学研究中进行了试点测试。通过测量观察者间的一致性来确定纳入项目的可靠性。
25 名专家同意参与。需要三轮改良 Delphi 调查才能就一项旨在评价临床药代动力学研究质量的 21 项工具达成共识。当应用于 30 篇最近发表的临床药代动力学研究时，大多数项目的评分处于公平到中等水平的一致性（61.90-95.24%）。
本研究开发的临床药代动力学评价工具（CACPK）由 21 项旨在帮助最终用户确定药代动力学研究质量的项目组成。需要进一步的研究来确认 CACPK 工具的有效性和可靠性。
