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

Abstract

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.

A Systematic Critical Review of Clinical Pharmacokinetics of Torasemide

“…For quality appraisal, all included articles were assessed using the Oxford quality scoring system or Jadad scoring, 23 Critical Appraisal Skills Program (CASP), 24 and "Critical Appraisal of Clinical Pharmacokinetic" (CACPK) tool. 25 One author (A.W.S.) initially screened all titles and abstracts that met the eligibility criteria.…”

Rivaroxaban Pharmacokinetics in Obese Subjects: A Systematic Review

“…Two reviewers (MA and AA or OR) independently conducted the risk of bias assessment, and any differences were resolved through consensus by the research team. Two different appraisal tools were used to assess the methodological quality of the selected studies: the Crowe Critical Appraisal Tool (CCAT) and the Critical Appraisal of Clinical Pharmacokinetic Studies (CACPK) tool [66][67][68]. The CCAT tool was chosen to be used as it was designed to assess the quality of varying types of research designs.…”

“…In addition to the tool, two appendices were used to guide in answering some specific questions within the 'study design and experimental methods' section of the CACPK tool. Each question has a rating scale of 'yes', 'no', 'I do not know', and 'not applicable' [68].…”

Modified Delphi analysis of the clinical guideline “Sedation of patients in the departments of anesthesiology, intensive care and intensive care”

“…Метод Дельфи является хорошо зарекомендовавшим себя методом достижения консенсуса мнения экспертов в медицине и позволяет специалистам неза висимо друг от друга добиваться взаимного согласия, отвечая на серию анкет и анонимно обмениваясь мнениями для продвижения обсуждения в каждом последующем раунде [13,14]. Вопросы и критерии проводимого анализа были разработаны в соответствии с рекомендациями по использованию модифицированного метода Дельфи для клинических и фармакокинетических исследований [15]. Достижение согласия участников опроса было проведено в три этапа: подготовительный этап, этап обсуждений и этап выработки консенсусного заключения.…”