Analysis of Studies on High-Risk Infants and Quality Assessment of Intervention Studies

PURPOSE: It is critical that evidence from research is applied to everyday nursing practice to improve the quality of care and health outcomes. Aims of this study were to review high-risk infant related studies published in major nursing and non-nursing journals in Korea and to assess the quality of intervention studies. METHODS: Through the Korean literature search engine of RISS.KR the authors identified 132 studies, and two researchers evaluated each of these studies using the analysis criteria. The quality of intervention studies was assessed using the van Tulder Scale. RESULTS: Among the studies, 40.2% were either thesis or dissertation and 86.4% were quantitative studies. Convenience sampling was the most commonly used sampling method. All experimental studies were quasi-experiment except one pre-experiment study. Sensory stimulation and kangaroo care were the most common interventions for high-risk infants. Over half of the intervention studies were assessed to be "low risk of bias" but both randomization and blinding processes were not adequately satisfied in most of the studies. CONCLUSION: Findings of this study suggest that high-risk infants are more likely to be recruited for experimental studies but types of interventions were very limited. To provide evidence-based care for high-risk infants, rigorously conducted experimental studies should be encouraged.

A Simple Dosing Scheme for Intravenous Busulfan Based on Retrospective Population Pharmacokinetic Analysis in Korean Patients

Busulfan is an antineoplastic agent with a narrow therapeutic window. A post-hoc population pharmacokinetic analysis of a prospective randomized trial for comparison of four-times daily versus once-daily intravenous busulfan was carried out to search for predictive factors of intravenous busulfan (iBu) pharmacokinetics (PK). In this study the population PK of iBu was characterized to provide suitable dosing recommendations. Patients were randomized to receive iBu, either as 0.8 mg/kg every 6 h or 3.2 mg/kg daily over 4 days prior to hematopoietic stem cell transplantation. In total, 295 busulfan concentrations were analyzed with NONMEM. Actual body weight and sex were significant covariates affecting the PK of iBu. Sixty patients were included in the study (all Korean; 23 women, 37 men; mean [SD] age, 36.5 [10.9] years; weight, 66.5 [11.3] kg). Population estimates for a typical patient weighing 65 kg were: clearance (CL) 7.6 l/h and volume of distribution (Vd) 32.2 l for men and 29.1 L for women. Inter-individual random variabilities of CL and Vd were 16% and 9%. Based on a CL estimate from the final PK model, a simple dosage scheme to achieve the target AUC0-inf (defined as median AUC0-inf with a once-daily dosage) of 26.18 mg/lxhr, was proposed: 24.79xABW0.5 mg q24h, where ABW represents the actual body weight in kilograms. The dosing scheme reduced the unexplained interindividual variabilities of CL and Vd of iBu with ABW being a significant covariate affecting clearance of iBU. We propose a new simple dosing scheme for iBu based only on ABW.