|الملخص||Background: Critical appraisal process is central to the practice of evidence-based
medicine that aids in assessing the quality of the published scientific knowledge. To
our knowledge, there is no critical appraisal tool for clinical pharmacokinetics studies.
Therefore, this study aimed to develop the first valid and reliable clinical
pharmacokinetics critical appraisal tool.
Methodology: A systematic review was conducted through Embase and Pubmed to
identify quality markers related to clinical pharmacokinetic studies. Questions that
helped in appraising pharmacokinetic studies were formulated from these quality
markers. Twenty-five clinical pharmacokinetics experts were involved in a modified
Delphi process to achieve their consensus regarding the formulated questions.
Percentage of agreement between panelists, median and interquartile range were
calculated for each question to determine whether they achieved expert’s consensus.
Content and face validity of the developed critical appraisal tool were assessed twice
through modified Delphi process and by a psychometric expert. Four raters were
selected to apply the developed tool on 30 clinical pharmacokinetic articles to evaluate
the inter-rater and intra-rater reliability by calculating Kappa values for each of them.
Results: Quality markers of clinical pharmacokinetic studies were identified out of
fifteen articles included in the systematic review which encompassed 19 subcategories, most of them were related to the methods and results subcategories. The modified
Delphi process consisted of 3 rounds. Sixty-four quality-related questions were
formulated out of these quality markers to appraise clinical pharmacokinetics studies
but 42 were sent to round 1. Of 42 items,12 items reached ≥80 % of agreement, median
≥ 4, and interquartile range ≤ 1 consensus from experts. In round 2, of 25 questions, 6
items met ≥80% of agreement, a median ≥ 4, and interquartile range < 1 from experts.
In round 3, of 3 questions, 3 items achieved ≥80% of agreement, a median ≥ 4, and
interquartile range < 1 from experts. Twenty-one questions achieved expert consensus
to be included in the final critical appraisal tool. This tool proved to be valid and reliable
to help end-users in appraising retrospective and prospective clinical pharmacokinetics,
bioequivalence, and population pharmacokinetics studies.
Conclusion: A clinical pharmacokinetics critical appraisal tool consisting of twenty
one questions was developed.