Biosimilars of low‐molecular‐weight heparin products: fostering competition or reducing ‘biodiversity’?

The term ‘biosimilars’ is used to qualify products developed to be similar to an original biological drug. Biosimilars are much more complicated to develop than a generic version of small‐molecule drugs and this is especially true for low‐molecular‐weight heparins (LMWHs). Evidence on the antithrombotic management of acute coronary syndromes (ACS) showed that the introduction into the market of biosimilars approved on the basis of simple biological criteria, without robust data from comparative clinical trials, may be hazardous. Moreover, the mixtures of LMWH polysaccharide chains, some immunoallergic properties and potential contamination during the extraction process raise safety concerns. As was the case for the biosimilar erythropoietin, there is the risk that only copies of the most commercially successful LMWHs will be marketed, thus jeopardizing the ‘biodiversity’ now ensured by the presence of several LMWHs, each with unique features that support the use of an individual LMWH as first‐choice therapy in certain categories of patients.     

Is obstetric thromboprophylaxis with low‐molecular‐weight heparin effective? Yes,if administered properly

See also Roeters van Lennep JE, Meijer E, Klumper FJ, Middeldorp JM, Bloemenkamp KW, Middeldorp S. Prophylaxis with low‐dose low‐molecular‐weight heparin during pregnancy and postpartum: is it effective? J Thromb Haemost 2011: 9: 473–80; Patel JP, Patel RK, Graham Davies J, Arya R. Prophylaxis with low‐dose low molecular weight heparin during pregnancy and the puerperium: is it effective? A rebuttal. J Thromb Haemost 2011: 9: 1269–71; Lindqvist PG, Epstein E, Olsson H. Does an active sun exposure habit lower the risk of venous thrombotic events? A D‐lightful hypothesis. J Thromb Haemost 2009; 7: 605–10.DOI: 10.1111/j.1538‐7836.2011.04383.x .     

Who needs to care about small,dense low‐density lipoproteins?

BACKGROUND: Increasing evidence suggest that the 'quality' rather than only the 'quantity' of low-density lipoprotein (LDL) exerts a great influence on the cardiovascular risk. Small, dense LDL seem to be an important predictor of cardiovascular events and progression of coronary artery disease (CAD) and their predominance has been accepted as an emerging cardiovascular risk factor by the National Cholesterol Education Program Adult Treatment Panel III. DISCUSSION: Some studies showed in past years that small, dense LDL are usually elevated in patients at very high cardiovascular risk, such as those with CAD and type 2 diabetes. More recently elevated levels of these particles have been found in other categories of patients at high cardiovascular risk, such as those with non-coronary forms of atherosclerosis (e.g. with carotid artery disease, aortic abdominal aneurysm and peripheral arterial disease) and metabolic diseases (with polycystic ovary syndrome and growth hormone deficiency); notably, in most of them, the predominance of small, dense LDL characterised their type of dyslipidaemia, alone or in combination with elevated triglycerides and reduced high-density lipoproteins cholesterol concentrations. CONCLUSIONS: The therapeutical modulation of small, dense LDL have been shown to significantly reduce cardiovascular risk and weight reduction and increased physical activity may constitute first-line therapy. In addition, lipid-lowering drugs are able to favourably alter these particles and fibrates and nicotinic acid seem to be the most effective agents. Promising data are also available with the use of rosuvastatin, the latest statin introduced in the market, and ezetimibe, a cholesterol absorption inhibitor.     

Among very‐low‐birth‐weight neonates is red blood cell transfusion an independent risk factor for subsequently developing a severe intraventricular hemorrhage?

BACKGROUND: A severe intraventricular hemorrhage (IVH) in a preterm neonate can result in life‐long disabilities or death. Pathogenic mechanisms responsible for IVH are incompletely understood. We postulated that if the timing of a severe IVH could be approximated by serial ultrasound, potentially relevant antecedents could be identified. STUDY DESIGN AND METHODS: We retrospectively identified all very‐low‐birth‐weight (VLBW) neonates in our health system, over a 5‐year period, with an initial head ultrasound showing no hemorrhage but a subsequent ultrasound showing a Grade 3 or 4. Controls that did not develop an IVH were matched with cases using demographic features and degree of illness measures. RESULTS: Fifty‐four cases were matched (1:2) with controls. No differences were found between cases and controls in initial pH, sepsis, ventilation, coagulation studies, or proportion with severe thrombocytopenia. However, during the period when the head ultrasound was normal, cases were more likely to have had a red blood cell (RBC) transfusion (p < 0.001). In 94% of the cases the sequence was 1) no IVH, 2) RBC transfusion, and 3) severe IVH. With the use of logistic regression, each subsequent RBC transfusion during the first week was determined to double the risk of a severe IVH (each transfusion increases relative risk, 2.02; 95% confidence interval, 1.54‐3.33). Sensitivity analysis indicated a high likelihood that RBC transfusion, independent of hemoglobin level or other factors, increases the risk of developing a severe IVH. CONCLUSION: These findings suggest a new hypothesis. Namely, RBC transfusions given before the development of an IVH are an independent risk factor for developing a severe IVH.     

Nursing migration: global treasure hunt or disaster‐in‐the‐making?

International nurse migration--moving from one country to another in the search of employment--is the focus of this article. The majority of member states of the World Health Organization report a shortage, maldistribution and misutilisation of nurses. International recruitment has been seen as a solution. The negative effects of international migration on the 'supplier' countries may be recognised today but are not effectively addressed. Nurse migration is motivated by the search for professional development, better quality of life and personal safety. Pay and learning opportunities continue to be the most frequently reported incentives for nurse migration, especially by nurses from less-developed countries. Career opportunities were considered key incentives for nurses emigrating from high-income countries. Language was reported to be a significant barrier. The positive global economic/social/professional development resulting from international migration needs to be weighed against a substantial 'brain and skills drain' experienced by supplier countries. The vulnerable status of migrant nurses is also of concern in certain cases. The focus on short-term solutions as opposed to resolving the problem of a worldwide shortage of nurses causes great concern. Recent initiatives attempt to curb or channel international recruitment. The delicate balance between recognising the right of individual nurses to migrate and a collective concern for the health of a nation's population must be achieved.     

Pacemaker‐mediated tachycardia in a dual‐lead CRT‐D: What is the mechanism?

A 73‐year‐old gentleman with dilated cardiomyopathy, left bundle branch block and a left ventricular (LV) ejection fraction of 20% was implanted with two LV leads in a tri‐ventricular cardiac resynchronisation therapy defibrillator (CRT‐D) trial. As a part of the trial he was programmed with fusion‐based CRT therapy with dual LV lead only pacing. The patient presented to local heart failure service 12 years after implant, after a positive response to CRT therapy, with increase in fatigue, shortness of breath and bilateral pitting oedema. The patient sent a remote monitoring transmission that suggested loss of capture on one of the LV leads. This coupled with atrial ectopics was producing a high burden of pacemaker‐mediated tachycardia (PMT) that was not seen when both LV leads had been capturing. What is the mechanism for this? Dual LV‐lead tri‐ventricular leads have been shown to have variable improvements in CRT response but with an increased complexity of implant procedure. This is the first case report of PMT‐induced heart failure exacerbation in a tri‐ventricular device following loss of LV capture of one lead.     

Are parent‐reported repetitive and restricted behaviours associated with psychological problems in pre‐school‐aged children?

This study surveys the association of restricted and repetitive behaviours in pre-school children with their emotional and behavioural problems. Parents of 504 pre-school children selected by cluster sampling participated and filled in the questionnaires including repetitive and restricted behaviour (RRB) scale and the Strengths and Difficulties Questionnaire. The parents reported repetitive and restrictive behaviours are gender-related in pre-school-aged children. Hyperactivity and emotional problems are significantly in association with all the four types of repetitive and restrictive behaviours. Prosocial problems score is in association with 'reaction to change' subscale score. Children with higher scores of conduct problems have higher rates of 'sensorimotor stereotypies', 'reaction to change' and 'modulation insufficiency'. Pre-school children with a higher rate of RRBs are more hyperactive and have more emotional problems than those with lower rates of RRBs. Conduct problems are more common in children with 'sensorimotor stereotypies', 'reaction to change' and 'modulation insufficiency' problems. Repetitive and restricted behaviours are associated with mental health problems in pre-school-aged children.     

Is modified brief assertiveness training for nurses effective? A single‐group study with long‐term follow‐up

Aim

To evaluate the long‐term effectiveness of modified brief assertiveness training (with cognitive techniques) for nurses.

Background

Most assertiveness training takes a long time to conduct; thus, briefer training is required for universal on‐the‐job training in the workplace.

Methods

In this single‐group study, nurses received two 90‐min training sessions with a 1‐month interval between sessions. The degree of assertiveness was assessed by using the Rathus Assertiveness Schedule as the primary outcome, at four time points: pre‐ and post‐training, 3‐month follow‐up and 6‐month follow‐up.

Results

A total of 33 nurses received the training, and the mean Rathus Assertiveness Schedule score improved from ?14.2 (SD  = 16.5) pre‐training to ?10.5 (SD  = 18.0) post‐training (p  <  .05). These improvements were maintained until the 6‐month follow‐up. The pre–post effect size of 0.22 (indicating small effect) was larger than the effect sizes ranging from ?0.56 to 0.17 (no effect) reported in previous studies that used brief training.

Conclusions

Modified brief assertiveness training seems feasible and may achieve long‐term favourable outcomes in improving assertiveness among nurses.

Implications for Nursing Management

The ease of implementation of assertiveness training is important because creating an open environment for communication leads to improved job satisfaction, improved nursing care and increased patient safety.

     

Combat‐Related Blast‐Induced Neurotrauma: A Public Health Problem?

The purpose of this article is to raise nurses' awareness of the significance and potential public health impact of combat-related blast-induced neurotrauma (BINT) in U.S. troops returning from Afghanistan and Iraq. A comprehensive review of the current literature on BINT was completed by the author, based primarily on combat-related blast exposure in the military population. She found that it is necessary to theorize about potential etiologies for mild traumatic brain injury in the military population since the literature suggests that neurological and psychological trauma resulting from military duty may be linked to exposure to blasts. Identification of potential risk factors for BINT in the military population provides direction for scientific inquiry into this emerging phenomenon. Gaps in current knowledge and its health implications for future scientific study in nursing are presented.