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

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 critic...

Descripción completa

Detalles Bibliográficos
Autores principales: Soliman, Alaa Bahaa Eldeen, Pawluk, Shane Ashley, Wilby, Kyle John, Rachid, Ousama
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9393138/
https://www.ncbi.nlm.nih.gov/pubmed/35307788
http://dx.doi.org/10.1007/s11096-022-01390-y
Descripción
Sumario: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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11096-022-01390-y.

Ejemplares similares