Impact of a clinical decision support system on paediatric drug dose prescribing: a randomised within-subject simulation trial.

BACKGROUND: Drug dosing errors are among the most frequent causes of preventable harm in paediatrics. Due to the complexity of paediatric pharmacotherapy and the working conditions in healthcare, it is not surprising that human factor is a well-described source of error. Thus, a clinical decision support system (CDSS) that supports healthcare professionals (HCP) during the dose prescribing step provides a promising strategy for error prevention. METHODS: The aim of the trial was to simulate the dose derivation step during the prescribing process. HCPs were asked to derive dosages for 18 hypothetical patient cases. We compared the CDSS PEDeDose, which provides a built-in dose calculator to the Summary of Product Characteristics (SmPC) used together with a pocket calculator in a randomised within-subject trial. We assessed the number of dose calculation errors and the time needed for calculation. Additionally, the effect of PEDeDose without using the built-in calculator but with a pocket calculator instead was assessed. RESULTS: A total of 52 HCPs participated in the trial. The OR for an erroneous dosage using the CDSS as compared with the SmPC with pocket calculator was 0.08 (95% CI 0.02 to 0.36, p<0.001). Thus, the odds of an error were 12 times higher while using the SmPC. Furthermore, there was a 45% (95% CI 39% to 51%, p<0.001) time reduction when the dosage was derived using the CDSS. The exploratory analysis revealed that using only PEDeDose but without the built-in calculator did not substantially reduce errors. CONCLUSION: Our results provide robust evidence that the use of the CDSS is safer and more efficient than manual dose derivation in paediatrics. Interestingly, only consulting a dosing database was not sufficient to substantially reduce errors. We are confident the CDSS PEDeDose ensures a higher safety and speeds up the prescribing process in practice.

Description of a clinical decision support tool with integrated dose calculator for paediatrics.

Medication errors, especially dosing errors are a leading cause of preventable harm in paediatric patients. The paediatric patient population is particularly vulnerable to dosing errors due to immaturity of metabolising organs and developmental changes. Moreover, the lack of clinical trial data or suitable drug forms, and the need for weight-based dosing, does not simplify drug dosing in paediatric or neonatal patients. Consequently, paediatric pharmacotherapy often requires unlicensed and off-label use including manipulation of adult dosage forms. In practice, this results in the need to calculate individual dosages which in turn increases the likelihood of dosing errors. In the age of digitalisation, clinical decision support (CDS) tools can support healthcare professionals in their daily work. CDS tools are currently amongst the gold standards in reducing preventable errors. In this publication, we describe the development and core functionalities of the CDS tool PEDeDose, a Class IIa medical device software certified according to the European Medical Device Regulation. The CDS tool provides a drug dosing formulary with an integrated calculator to determine individual dosages for paediatric, neonatal, and preterm patients. Even a technical interface is part of the CDS tool to facilitate integration into primary systems. This enables the support of the paediatrician directly during the prescribing process without changing the user interface.Conclusion: PEDeDose is a state-of-the-art CDS tool for individualised paediatric drug dosing that includes a certified calculator. What is Known: • Dosing errors are the most common type of medication errors in paediatric patients. • Clinical decision support tools can reduce medication errors effectively. Integration into the practitioner's workflow improves usability and user acceptance. What is New: • A clinical decision support tool with a certified integrated dosing calculator for paediatric drug dosing. • The tool was designed to facilitate integration into clinical information systems to directly support the prescribing process. Any clinical information system available can interoperate with the PEDeDose web service.

Measurement of magnesium absorption and retention in type 2 diabetic patients with the use of stable isotopes.

BACKGROUND: Magnesium deficiency has been associated with type 2 diabetes and may reduce insulin sensitivity and impair glucose tolerance. The etiology of magnesium depletion in diabetes is unclear. Animal studies suggest that diabetes may impair magnesium absorption; however, there are no published data on magnesium absorption in humans with diabetes. OBJECTIVE: Magnesium absorption from a test meal and the excretion and retention of magnesium were compared between patients with type 2 diabetes and healthy control subjects. DESIGN: A meal labeled with 10 mg (26)Mg isotopic label was administered, and stool and urine samples were collected for 10 and 6 d, respectively. Apparent absorption was calculated as the difference between the oral dose of (26)Mg isotopic label and the total amount of the isotopic label excreted in the feces. Magnesium retention was calculated from the apparent absorption and urinary excretion of (26)Mg isotopic label in the 6 d after administration. RESULTS: Mean (+/- SD) values for fractional magnesium absorption in the diabetic patients and the control subjects were 59.3 +/- 7.0% and 57.6 +/- 8.5%, respectively (NS). Mean (+/- SD) urinary magnesium excretion values in the diabetic patients and the control subjects were 11.2 +/- 2.6% and 11.7 +/- 3.8%, respectively (NS); retention values were 54.2 +/- 7.1% and 51.4 +/- 6.1%, respectively (NS). CONCLUSION: Dietary magnesium absorption and retention are not impaired in patients with reasonably well-controlled type 2 diabetes.

Low plasma magnesium in type 2 diabetes.

QUESTIONS UNDER STUDY/PRINCIPLES: Magnesium depletion has a negative impact on glucose homeostasis and insulin sensitivity in type 2 diabetic patients. Low plasma magnesium concentration is a highly specific indicator of poor magnesium status. In the USA and some European countries, plasma magnesium concentrations have been found to be decreased in diabetics. The aim of this study was to compare plasma magnesium concentrations of type 2 diabetics and healthy controls in Switzerland. METHODS: Plasma magnesium concentrations were determined in 109 type 2 diabetics and 156 age- and sex-matched healthy controls. RESULTS: Mean (+/- SD) plasma magnesium concentrations of the diabetics and controls were 0.77 +/- 0.08 and 0.83 +/- 0.07 mmol/L, respectively (p <0.001). Plasma magnesium concentrations were below the normal reference range in 37.6% of the diabetic patients and 10.9% of the control subjects (p <0.001). Plasma magnesium was not correlated with glycemic control as measured by HbA1c. CONCLUSIONS: Lower plasma magnesium concentrations and poor magnesium status are common in type 2 diabetics in Zurich, Switzerland.