Abstract PR525

Abstract

Background & Objectives: To help readers assess validity, a checklist for consistent reporting in clinical pharmacokinetics (PK) studies was recently developed.1 The objective of this study was to assess compliance with the ClinPK Statement of clinical PK studies conducted in adult intensive care units for selected analgesics and sedatives delivered for 24h or more. Materials & Methods: We performed a literature search of study articles using MEDLINE (1946-Oct 2015) and EMBASE (1974-Oct 2015). All studies published in English and Chinese, conducted in adult intensive care units with patients sedated with midazolam, propofol, dexmedetomidine, sufentanil, alfentanil, morphine or fentanyl infusion for 24h or more, and reporting PK parameters were included. For each study, three independent reviewers assessed the applicability and compliance with each item in the ClinPK checklist. Chi-square tests were used to compare the compliance rates for each item between our study and those of the general clinical PK studies reported by Kanji et al.1 Results: Of the 1039 unique studies identified, 28 studies (published between 1985 and 2013) were included. The median compliance rate among studies was 80.5% (IQR 67.0% to 86.0%). Fifteen studies were deemed to be compliant, i.e. reporting > 80% of necessary items. Six items had < 60% compliance rate in current study (Table 1).Table 1.: Comparison of itemized compliance with ClinPK by studyConclusion: Most prolonged sedation and analgesia studies were substantially compliant with the ClinPK Statement, however, important missing data, such as appropriate identification of co-variates, reporting of study withdrawals, and funding sources and conflict of interests for authors were common. There were differences in study reporting rates, likely because of study selection.