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%). 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.
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.
Background: Robust critical appraisal tools for pharmacokinetic studies are lacking. The aim of this study is to develop a valid and reliable critical appraisal tool for clinical pharmacokinetic studies. Methodology: A systematic review was conducted through Embase and Pubmed to identify quality markers of clinical pharmacokinetic studies. Quality-related questions were formulated to help in appraising pharmacokinetic studies. Experts were approached to participate in a modified Delphi process to achieve their consensus regarding the formulated questions based on percentage of agreement between panelists, median and interquartile range. Content and face validity of the tool were assessed twice and by a psychometric expert. Four raters were selected to apply the tool on 30 clinical pharmacokinetic articles to calculate Kappa values to determine interrater and intra-rater reliability. Results: Quality markers of clinical pharmacokinetic studies were identified from fifteen articles. Sixty-four quality-related questions were formulated, but 42 were assessed by twenty-five panelists, who consented to participate in the modified Delphi process rounds. In round 1, 12 out of 42 items reached ≥80 % of agreement, median ≥ 4, and interquartile range ≤ 1. In round 2, 6 out of 28 items met ≥80% of agreement, a median ≥ 4, and interquartile range < 1. In round 3, 3 out of 3 items achieved ≥80% of agreement, a median ≥ 4, and interquartile range < 1. This tool proved to be valid and reliable in appraising retrospective and prospective clinical pharmacokinetic, bioequivalence, and population pharmacokinetic studies. Conclusion: A valid and reliable clinical pharmacokinetic critical appraisal tool containing twenty-one questions was developed
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.