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. 2022 Aug;44(4):894-903.
doi: 10.1007/s11096-022-01390-y. Epub 2022 Mar 20.

The use of a modified Delphi technique to develop a critical appraisal tool for clinical pharmacokinetic studies

Alaa Bahaa Eldeen Soliman  1 , Shane Ashley Pawluk  2   3 , Kyle John Wilby  4 , Ousama Rachid  5   6   7
Affiliations

The use of a modified Delphi technique to develop a critical appraisal tool for clinical pharmacokinetic studies

Alaa Bahaa Eldeen Soliman et al. Int J Clin Pharm. 2022 Aug.

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.

Aim: We aimed to achieve experts' consensus regarding the quality markers for clinical pharmacokinetic studies in an attempt to develop a critical appraisal tool.

Method: 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%).

Conclusion: 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.

Keywords: Clinical pharmacokinetics; Critical appraisal; Critical appraisal tool; Pharmacokinetics; Quality markers; Reporting checklist.

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Conflict of interest statement

Alaa Soliman, Shane Pawluk, Kyle Wilby, and Ousama Rachid have no conflicts of interest that are relevant to the content of this study.

Figures

Fig. 1
Fig. 1
The modified Delphi flow chart of all rounds
See this image and copyright information in PMC

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