Aims
Dexmedetomidine (dexdor®) is approved in the European Union (EU) for sedation of adults in the intensive care unit (ICU). The present observational, retrospective study was requested by the European Medicines Agency to investigate dexmedetomidine use in clinical practice, with a particular focus on off‐label use, including the paediatric population.
Methods
Study countries and sites were chosen from those with highest dexmedetomidine use, based on sales. Site selection (blind) was conducted by a multispecialist, independent group. Anonymized data on demographics, treatment indication, dexmedetomidine dosing, concomitant medications and treatment effectiveness were collected retrospectively from records of all dexmedetomidine‐treated patients at the site during the enrolment period. Informed consent was waived, to avoid influencing the prescribing of dexmedetomidine. Recruitment was completed within 18 months of first site initiation.
Results
Data from 2000 patients were collected from 16 hospitals in four EU countries (Finland 750, Poland 505, Germany 470, Austria 275). The median age was 62 years, with more males (70.2%) than females. Dexmedetomidine was primarily used in the adult ICU (86.0%) for ICU sedation (78.6%) and mostly dosed according the product label. The intended sedative effect was obtained in 84.9% of administrations. Paediatric use (5.9% of patients, mostly in Austria and Finland) occurred mainly in the adult or paediatric ICU (75.6%) for sedation (67.2%).
Conclusions
Overall, most patients were treated with dexmedetomidine according to the product labelling. Use in children was limited but significant and similar in scope to that in adults. Administrations not fully according to the product labelling usually occurred in an ICU environment and reflected extensively investigated clinical uses of dexmedetomidine.
The only advantage of the Davis pipette is that patients can take their own sample without the need to attend a clinic or to see a doctor; it might therefore be possible to reach a larger proportion of the population at risk. However, the low rate of detection would necessitate repeated screenings of each patient at fairly short time-intervals, and although the initial response might be good, it could prove difficult to persuade women to take repeated samples, especially in view of the complaints from the clinics participating in this survey. Like Macgregor and her colleagues, we think that the cytopipette is not an appropriate instrument for urban-community-screening programmes.
ConclusionsOur results leave us in no doubt that when a cervical cytology specimen is taken by a doctor the Ayre smear is a more effective method than the Davis cytopipette in the detection of malignancy. The Davis method has been extensively used in Denmark (Bredahl et al., 1965) al., 1962, 1963) and subsequently both have been found useful in patients with rheumatoid arthritis (Coodley, 1963;Young, 1963
An open, single centre study was carried out to evaluate the accuracy of the Spuncrit (Micro Diagnostics, Bethlehem, PA, USA) infra-red analyser which can be used for near-patient testing to measure haematocrit and estimate haemoglobin concentration. The primary comparison was with the Sysmex NE1500 (Tao Medical) analyser situated in the main hospital laboratory. Secondary comparison was with the Ciba Corning 288 (Ciba Corning Diagnostics Ltd, Halstead, UK) blood gas analyser currently used for near-patient testing in the Northern General Hospital. A total of 217 samples from 50 patients was analysed. The Pearson's correlation coefficients for haematocrit and haemoglobin concentration between the Spuncrit and Sysmex NE1500 and between the Spuncrit and Ciba Corning 288 were all close, between 0.85 and 0.92. The method of Bland and Altman was used to assess agreement between the results of the Spuncrit and the Sysmex NE1500. The agreement for haematocrit was good with 2 SD of the Spuncrit results being between -5.66 and +4.42% of the measurement from the Sysmex NE1500. In conclusion, the Spuncrit haematocrit measurement agreed well with results from the central laboratory, but the estimated haemoglobin concentrations agreed less well and three reasons are discussed.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.