PDF(Pubmed)
Abstract：
BACKGROUND: 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.
OBJECTIVE: We aimed to achieve experts\' consensus regarding the quality markers for clinical pharmacokinetic studies in an attempt to develop a critical appraisal tool.
METHODS: 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.
RESULTS: 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%).
CONCLUSIONS: 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.
OBJECTIVE: We aimed to achieve experts\' consensus regarding the quality markers for clinical pharmacokinetic studies in an attempt to develop a critical appraisal tool.
METHODS: 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.
RESULTS: 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%).
CONCLUSIONS: 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.
摘要：
背景：批判性评估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批评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关键评估，存在有限的指导。
目的：我们旨在就临床药代动力学研究的质量指标达成专家共识，试图开发一种关键的评估工具。
方法：与临床药代动力学研究相关的质量标记，来自已发表的文献，并根据手稿报告领域(摘要，介绍/背景，方法论，结果，讨论,和结论）。从这些质量标记中提出了有助于评估药代动力学研究的问题。专家们参与了修改后的德尔菲程序，以就所提出的问题达成共识。所提出的工具在最近发表的30项临床药代动力学研究中进行了初步测试。衡量了观察员之间的协议，以确定所包含项目的可靠性。
结果：25位专家同意参与。需要进行三轮改良的Delphi调查才能为旨在评估临床药代动力学研究质量的21项工具达成共识。当应用于最近发表的30项临床药代动力学研究时，大多数项目得分中等至中等水平（61.90-95.24%）。
结论：本研究中开发的临床药代动力学关键评估工具（CACPK）由21个项目组成，旨在帮助最终用户确定药代动力学研究的质量。需要进一步的研究来重申CACPK工具的有效性和可靠性。
目的：我们旨在就临床药代动力学研究的质量指标达成专家共识，试图开发一种关键的评估工具。
方法：与临床药代动力学研究相关的质量标记，来自已发表的文献，并根据手稿报告领域(摘要，介绍/背景，方法论，结果，讨论,和结论）。从这些质量标记中提出了有助于评估药代动力学研究的问题。专家们参与了修改后的德尔菲程序，以就所提出的问题达成共识。所提出的工具在最近发表的30项临床药代动力学研究中进行了初步测试。衡量了观察员之间的协议，以确定所包含项目的可靠性。
结果：25位专家同意参与。需要进行三轮改良的Delphi调查才能为旨在评估临床药代动力学研究质量的21项工具达成共识。当应用于最近发表的30项临床药代动力学研究时，大多数项目得分中等至中等水平（61.90-95.24%）。
结论：本研究中开发的临床药代动力学关键评估工具（CACPK）由21个项目组成，旨在帮助最终用户确定药代动力学研究的质量。需要进一步的研究来重申CACPK工具的有效性和可靠性。
