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Creation of an inventory of quality markers used to evaluate pharmacokinetic literature: A systematic review

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journal contribution
submitted on 2023-03-15, 08:05 and posted on 2023-03-15, 10:36 authored by Alaa Bahaa Eldeen Soliman, Shane Ashley Pawluk, Kyle John Wilby, Ousama Rachid

What is known and objective

Robust critical appraisal tools for clinical pharmacokinetic studies are limited. Before development of such a tool is possible, quality markers (items deemed important for credibility of study results) must be identified. We aim to create an inventory of quality markers intended for the appraisal of clinical pharmacokinetic studies and to categorize identified markers into associated domains of study quality.

Methods

Medline via ProQuest central (1946–Sep 2020, EMBASE (1974–Sep 2020), Cochrane database of systematic reviews, Google and Google Scholar were searched using the following search categories: pharmacokinetics, reporting guidelines and quality markers. Reference lists of the identified articles were searched manually. Any article (review, study or guideline) reporting quality markers related to the appraisal of pharmacokinetic literature was eligible for inclusion. Articles were further screened and limited to those reported in English on human subjects only. Cell-based and animal-based pharmacokinetic studies were excluded. Extracted data from included articles included identified or perceived markers of quality and baseline article data. Identified quality markers were then categorized according to manuscript reporting domains (abstract, introduction/background, methodology, results, discussion and conclusion).

Results and discussion

Of 789 studies identified, 17 articles were included for extraction of quality markers. A total of 35 quality markers were identified across eight categories. The most frequently reported quality markers were related to method (13/35) and result sections (6/35). Quality markers encompassed all aspects of study design and reporting and were both similar and different to established reporting checklists for clinical pharmacokinetic studies.

What is new and conclusion

The inventory of quality markers is now suitable to undergo further testing for inclusion in a tool designed for the appraisal of clinical pharmacokinetic studies.

Other Information

Published in: Journal of Clinical Pharmacy and Therapeutics
License: http://creativecommons.org/licenses/by-nc-nd/4.0/
See article on publisher's website: http://dx.doi.org/10.1111/jcpt.13543

History

Language

  • English

Publisher

Wiley

Publication Year

  • 2021

Institution affiliated with

  • Qatar University