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

<h2>Background</h2> <p>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, limit...

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Main Author: Alaa Bahaa Eldeen Soliman (14151519) (author)
Other Authors: Shane Ashley Pawluk (11014418) (author), Kyle John Wilby (14151486) (author), Ousama Rachid (14158917) (author)
Published: 2022
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Summary:<h2>Background</h2> <p>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.</p> <h2>Aim</h2> <p>We aimed to achieve experts’ consensus regarding the quality markers for clinical pharmacokinetic studies in an attempt to develop a critical appraisal tool.</p> <h2>Method</h2> <p>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.</p> <h2>Results</h2> <p>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%).</p> <h2>Conclusion</h2> <p>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.</p><h2>Other Information</h2> <p> Published in: International Journal of Clinical Pharmacy<br> License: <a href="https://creativecommons.org/licenses/by/4.0" target="_blank">https://creativecommons.org/licenses/by/4.0</a><br>See article on publisher's website: <a href="http://dx.doi.org/10.1007/s11096-022-01390-y" target="_blank">http://dx.doi.org/10.1007/s11096-022-01390-y</a></p>