Comparison of two alternative study designs in assessment of medicines utilisation in neonates

Abstract

BackgroundEstimates of prevalence are known to be affected by the design of cross-sectional studies. A pan-European study provided an opportunity to compare the effect of two cross-sectional study designs on estimates of medicines use.MethodsA Service evaluation survey (SES) and a web-based point-prevalence study (PPS) were conducted as part of a European study of neonatal exposure to excipients. Neonatal units from all European Union countries plus Iceland, Norway, Switzerland and Serbia were invited to participate. All medicines prescribed to neonates were recorded during three-day and one-day study periods in the SES and PPS, respectively. In the PPS individual demographic and prescription data were also collected.To compare the probabilities that a particular medicine would be reported by each study multilevel mixed effects logistic regression models with crossed random effects were applied. The relationship between medicines exposure at the unit and individual levels in the PPS data was assessed using polynomial regression with square root transformation.ResultsOf 31 invited countries 20 and 21 with 115 and 89 units joined the SES and PPS, respectively. Out of 5,572,859 live births in invited countries in 2010 a higher proportion was covered by units participating in the SES compared to the PPS (11% vs 6%, respectively; OR 1.89; 95% CI 1.87-1.89). A greater number of active pharmaceutical ingredients (API), manufacturers and trade names were registered in the SES compared to the PPS. High correlation between the two studies in frequency of use for each specified API was seen (R2 = 0.86). The average probability of a department to use a given API was greater in the SES compared to the PPS (OR 2.36; 95% CI 2.05-2.73) with higher frequency of use and longer average duration of prescription further increasing the difference. The polynomial regression model described the correlation between APIs exposure on unit and individual level well (R2 = 0.93).ConclusionThe simple data structure and longer study period of the SES resulted in improved recruitment and higher likelihood of capture for a given API. The frequency of use at the unit level appears a good surrogate of individual exposure rates.

High variability in the dosing of commonly used antibiotics revealed by a Europe-wide point prevalence study: implications for research and dissemination

“…Of the 31 invited European countries 21 with 89 NICUs in 73 hospitals participated in the study (Figure 1 ) [ 14 , 19 ]. Intermediate and 3 rd level intensive care units predominated in all participating countries [ 15 ]. The median number of neonates reported per country was 45 (quartile range 26.5–65).…”

“…A sub-analysis of the multicentre single day PPS of the European Study of neonatal Exposure to Excipients (ESNEE), detailed elsewhere, was performed [ 14 , 15 ]. The study included 27 European Union countries plus Iceland, Norway, Switzerland and Serbia.…”

Potentially harmful excipients in neonatal medicines: a pan-European observational study

“…A multicentre web-based point prevalence study was performed as a part of the European study of neonatal exposure to excipients 26 27…”

Drug prescription pattern in European neonatal units

“…The European Study of Neonatal Exposure to Excipients (ESNEE) was a pan-European project that aimed to describe the use of pharmaceutical excipients in neonatal drugs. For this purpose data on drug use in neonatal units were collected as previously described [10]. In this substudy of ESNEE we aimed to describe the use of drugs in European neonatal units and explore how geographic region and GA influence their consumption.…”

“…A multicenter, single-day point prevalence study (PPS) was performed as detailed elsewhere [2,7,10]. Briefly, all units with >50% neonatal admissions in 27 European Union countries plus Iceland, Norway, Serbia and Switzerland, were invited to participate.…”