Vaccine microarray patch self-administration: An innovative approach to improve pandemic and routine vaccination rates.

The high-density microprojection array patch (HD-MAP) is a novel vaccine delivery system with potential for self-administered vaccination. HD-MAPs provide an alternative to needle and syringe (N&S) vaccination. Additional advantages could include reduced cold-chain requirements, reduced vaccine dose, reduced vaccine wastage, an alternative for needle phobic patients and elimination of needlestick injuries. The drivers and potential benefits of vaccination by self-administering HD-MAPs are high patient acceptance and preference, higher vaccination rates, speed of roll-out, cost-savings, and reduced sharps and environmental waste. The HD-MAP presents a unique approach in pandemic preparedness and routine vaccination of adults. It could alleviate strain on the healthcare workforce and allows vaccine administration by minimally-trained workers, guardian or subjects themselves. Self-vaccination using HD-MAPs could occur in vaccination hubs with supervision, at home after purchasing at the pharmacy, or direct distribution to in-home settings. As a result, it has the potential to increase vaccine coverage and expand the reach of vaccines, while also reducing labor costs associated with vaccination. Key challenges remain around shifting the paradigm from medical professionals administrating vaccines using N&S to a future of self-administration using HD-MAPs. Greater awareness of HD-MAP technology and improving our understanding of the implementation processes required for adopting this technology, are critical factors underpinning HD-MAP uptake by the public.

Omitting pre-operative coagulation screening tests in hip fracture patients: stopping the financial cascade?

BACKGROUND: Coagulation screening continues as a standard of care in many hip fracture pathways despite the 2011 guidelines from the Association of Anaesthetists of Great Britain and Ireland (AAGBI) which recommend that such screening be performed only if clinically indicated. This study aims to evaluate the use of pre-operative coagulation screening and explore its financial impact. METHODS: Prospective data was collected in accordance with the "Standardised Audit of Hip Fractures in Europe" (SAHFE) protocol. All patients admitted to our hospital with hip fractures during a 12-month period from November 2011 to November 2012 were analysed. Data including coagulation results and the use of vitamin K or blood products were collected retrospectively from the hospital computer system. Patient subgroup analysis was performed for intraoperative blood loss, post-operative blood units transfused, haematoma formation and gastrointestinal haemorrhage. RESULTS: 814 hip fractures were analysed. 91.4% (n=744) had coagulation tests performed and 22.0% (n=164) had an abnormal result. Of these, 55 patients were taking warfarin leaving 109 patients who had abnormal results and were not taking warfarin. When this group (n=109) was compared to those who had normal test results (n=580) and to all other patients (n=705) there was no difference in intraoperative blood loss (p=0.79, 0.78), postoperative transfusion (p=0.38, 0.30), postoperative haematoma formation (p=0.79, 1.00), or gastrointestinal haemorrhage (p=0.45, 1.00), respectively. In those who were not taking warfarin, but had abnormal results, none had treatment to reverse their coagulopathy with either vitamin K or blood products. By omitting pre-operative coagulation tests in patients who are not taking warfarin, we estimate a financial saving of between £66,500 and £432,250 per annum. CONCLUSIONS: This study supports the hypothesis that routine pre-operative coagulation screening is unnecessary in hip fracture patients unless they take warfarin or have a known coagulopathy. Moreover, its omission represents significant cost-saving potential.

Detecting a thienopyridine effect by platelet reactivity assessment and its implications for risk stratification.

BACKGROUND: On-treatment platelet reactivity (OTR) is a predictor of clinical outcomes in patients receiving thienopyridine therapy. OBJECTIVE: To assess whether point-of-care platelet reactivity testing can discriminate between patients who have and have not received a thienopyridine. PATIENTS/METHODS: This was an analysis of a randomized, multicenter, pharmacodynamic trial. Subjects with coronary artery disease treated with aspirin were randomly assigned to clopidogrel 75 mg daily or prasugrel 10 mg daily for 7 days. Platelet reactivity assessment with the VerifyNow P2Y12 test was performed before study drug admistration and 24 h after the final dose. Optimal cut-offs for a detectable drug effect were identified by the use of receiver operating characteristic curve analysis. RESULTS: A total of 54 subjects were enrolled and completed the study. The c-statistic for the identification of a thienopyridine effect was highly significant (0.93, P < 0.001), including for the clopidogrel and prasugrel groups considered separately (P < 0.001 for both). The optimal cut-off was < 213 P2Y12 reaction units (PRU), which provided a sensitivity of 80% and a specificity of 98%. This cut-off provided a sensitivity of 58% and a specificity of 100% for a clopidogrel effect, and a sensitivity of 100% and specificity of 96% for a prasugrel effect. CONCLUSIONS: OTR of < 213 PRU is highly specific for exposure to either clopidogrel or prasugrel. This may be useful in the management of thienoypridine-treated patients who require surgery. Furthermore, this diagnostic cut-off is similar to levels of OTR that have been associated with ischemic events in thienopyridine-treated patients, supporting the contention that a lack of drug effect is the mechanistic basis for the prognostic relationship between OTR and clinical outcomes.

Resilient parenting of preschool children at developmental risk.

BACKGROUND: Given the great benefits of effective parenting to child development under normal circumstances, and the even greater benefits in the face of risk, it is important to understand why some parents manage to be effective in their interactions with their child despite facing formidable challenges. This study examined factors that promoted effective parenting in the presence of child developmental delay, high child behaviour problems, and low family income. METHOD: Data were obtained from 232 families at child age 3 and 5 years. Using an adapted ABCX model, we examined three risk domains (child developmental delay, child behaviour problems, and low family income) and three protective factors (mother's education, health, and optimism). The outcome of interest was positive parenting as coded from mother-child interactions. RESULTS: Levels of positive parenting differed across levels of risk. Education and optimism appeared to be protective factors for positive parenting at ages 3 and 5, and health appeared to be an additional protective factor at age 5. There was an interaction between risk and education at age 3; mothers with higher education engaged in more positive parenting at higher levels of risk than did mothers with less education. There was also an interaction between risk and optimism at age 3; mothers with higher optimism engaged in more positive parenting at lower levels of risk than did mothers with less optimism. The risk index did not predict change in positive parenting from age 3-5, but the protective factor of maternal health predicted positive changes. CONCLUSIONS: This study examined factors leading to positive parenting in the face of risk, a topic that has received less attention in the literature on disability. Limitations, future directions, and implications for intervention are discussed.

Predicting maternal parenting stress in middle childhood: the roles of child intellectual status, behaviour problems and social skills.

BACKGROUND: Parents of children with intellectual disabilities (ID) typically report elevated levels of parenting stress, and child behaviour problems are a strong predictor of heightened parenting stress. Interestingly, few studies have examined child characteristics beyond behaviour problems that may also contribute to parenting stress. The present longitudinal study examined the contribution of child social skills to maternal parenting stress across middle childhood, as well as the direction of the relationship between child social skills and parenting stress. METHOD: Families of children with ID (n = 74) or typical development (TD) (n = 115) participated over a 2-year period. Maternal parenting stress, child behaviour problems and child social skills were assessed at child ages six and eight. RESULTS: Child social skills accounted for unique variance in maternal parenting stress above and beyond child intellectual status and child behaviour problems. As the children matured, there was a significant interaction between child social skills and behaviour problems in predicting parenting stress. With respect to the direction of these effects, a cross-lagged panel analysis indicated that early parenting stress contributed to later social skills difficulties for children, but the path from children's early social skills to later parenting stress was not supported, once child behaviour problems and intellectual status were accounted for. CONCLUSION: When examining parenting stress, child social skills are an important variable to consider, especially in the context of child behaviour problems. Early parenting stress predicted child social skills difficulties over time, highlighting parenting stress as a key target for intervention.

Behaviour/mental health problems in young adults with intellectual disability: the impact on families.

BACKGROUND: The present authors studied the impact of dual diagnosis [i.e. intellectual disability (ID) and mental disorder] in young adults on their mothers' perceived levels of stress and decisions about placement. METHODS: The mothers of 103 young adults with severe ID were interviewed using a 2-3-h in-depth protocol of measures designed to assess their child's adaptive functioning, maladaptive behaviour, mental health problems and negative impact on the family, as well as their own thoughts on out-of-home placement. The Scales of Independent Behavior--Revised Problem Behavior Scale assessed problem behaviours and the Reiss Screen assessed mental disorder. RESULTS: These measures were highly correlated (r = 0.64), but tapped some different domains of maladaptive behaviour and proved to be most predictive when employed together. Behaviour and/or mental health (B/MH) problems significantly predicted the mothers' perceived negative impact of the young adult on the family, even after controlling for other young adult characteristics. These problems also predicted the family's steps toward seeking out-of-home placement, as did better young adult health and the mother's higher educational attainment; stress did not predict additional variance in placement once these variables were accounted for. CONCLUSIONS: The discussion focuses on the implications for service provision to families of young adults with B/MH problems.

Cost comparison of antibacterial therapies for serious infections. A New Zealand 3-hospital study.

OBJECTIVE: The first aim was to identify and determine the economic costs of the regimens currently used in 3 New Zealand hospitals in the treatment of bacterial infections in haematology patients with febrile neutropenia and in intensive care patients with severe infections. The second was to develop a spreadsheet-based decision analytic model for use by hospital decision-makers as an aid in evaluating the comparative cost of drug regimens. DESIGN AND SETTING: The research utilised time and motion and microcosting techniques. The analytical perspective adopted for the study was that of a hospital administrator or clinical manager. PATIENTS AND INTERVENTIONS: Patients were eligible for inclusion in the study if either they were treated with the imipenem/cilastatin monotherapy, or could have been treated with this regimen. The final analysis considered 360 patient-treatment days and 8 antibacterials. MAIN OUTCOME MEASURES AND RESULTS: Drug acquisition cost ranged from 4.52 New Zealand dollars ($NZ; 1997 values) per patient-treatment day for gentamicin to $NZ104.81 for imipenem. The cost per patient-treatment day (when other cost components such as fluid additives, giving sets and needles were added) ranged from $NZ8.75 for gentamicin to $NZ129.12 for tazobactam. Drug acquisition cost, as a percentage of total drug preparation and administration cost, ranged from 52% for gentamicin to 93% for piperacillin. Giving sets and intravenous (i.v.) fluids were found to be important cost items when they were required specifically for the treatment regimen. There was a mean monitoring rate of 0.40 at a cost of $NZ6.41 per patient-treatment day for gentamicin. It was estimated that nephrotoxicity could add between $NZ23 and $NZ43 per day to the cost of aminoglycoside treatment. CONCLUSIONS: Although the small sample sizes of the study mean that results should be regarded as indicative rather than conclusive, there were sufficient information to construct a working model and show how the total cost of an antibacterial regimen could be evaluated in practical terms. The important cost drivers were found to be drug cost, the use of fluids and giving sets, and monitoring.

Immunization tracking systems: experience of the CDC Vaccine Safety Datalink sites.

Recognizing the potential of large databases within HMOs for the evaluation of vaccine safety, the Centers for Disease Control and Prevention (CDC) funded the Vaccine Safety Datalink project, linking outcome and vaccine exposure information at Group Health Cooperative of Puget Sound, Kaiser Permanente Northwest, Kaiser Permanente Medical Care Program Northern California, and Southern California Kaiser Permanente. Integral to the Vaccine Safety Datalink Project was the development of Immunization Tracking Systems at each site; this report describes the effort required to establish these tracking systems. Essential requirements are the methods used to insure data quality and to educate system users. Tracking systems can be a valuable means for assessing vaccine coverage, evaluating barriers to complete immunization, and studying the effectiveness of interventions design to improve immunization coverage. Finally, we report on recent efforts to link HMO Immunization Tracking Systems with developing regional tracking systems.

A case for permitting altruistic surrogacy.

Canada's Royal Commission on New Reproductive Technologies rejects all forms of surrogacy arrangement under the rubric of objecting to commercial surrogacy. Noncommercial surrogacy arrangements, however, can be defended against the commission's objections. They can be viewed as cases of giving a benefit or service to another in a way that expresses benevolence, and establishes a relationship between surrogates and prospective 'social' parents that allows mutual understanding and reciprocal personal interaction between them.

Nonpharmacologic approaches to the treatment of atrial fibrillation and atrial flutter.

The high prevalence of atrial fibrillation, the associated morbidity and mortality, the absence of safe and effective drug therapy, and an increased understanding of the pathophysiologic basis of atrial fibrillation and flutter have collectively led to the development of novel nonpharmacologic treatments for the management of these arrhythmias, including the CORRIDOR and MAZE surgical procedures, catheter-based ablation and modification of AV conduction, catheter-based ablation of atrial flutter and fibrillation, and internal atrial defibrillation. These surgical and catheter-based techniques offer potentially curative therapy while sparing the long-term risk of antiarrhythmic drug therapy. For patients with typical atrial flutter, catheter ablation affords to cure rate in excess of 70%. As technological innovations further facilitate identification and ablation of the critical isthmus in the floor of the right atrium, success rates should improve substantially. For patients with atrial fibrillation, AV junction ablation with implantation of a rate-responsive ventricular pacemaker should be considered palliative therapy, as should modification of AV junction conduction. The MAZE procedure offers very high cure rates, but because it currently involves open heart surgery, patient selection is critical. Catheter-based procedures emulating aspects of the MAZE procedure may one day offer cure rates comparable to those of the surgery itself, but additional research and technological development are necessary to further define and refine the minimal effective procedure, and then to facilitate the placement of contiguous, full-thickness lesions in precise three-dimensional configurations. In the interim, the implantable automatic atrial defibrillator may offer a means for rapidly restoring sinus rhythm without the risks of long-term antiarrhythmic drug therapy.

Psychiatric assessment of patients with life-threatening cardiac arrhythmias.

OBJECTIVE: This article describes the development of a protocol specifically designed for the psychiatric assessment of patients with life-threatening ventricular arrhythmias. METHOD: Psychiatric assessment occurs in the context of a team approach in which the cardiologist has a pivotal role. Initial findings and one-year follow-up data on the first twenty-five patients evaluated psychiatrically are presented. RESULTS: Findings tend to confirm that psychiatric complaints are common on initial assessment and suggest that patients with life-threatening ventricular arrhythmias who do not use the psychological mechanism of denial and volunteer psychological complaints may constitute a subgroup of patients who would be more amenable to psychiatric intervention compared to those denying psychological complaints at initial psychiatric interview. CONCLUSION: Psychiatrists and associated professionals should become more involved with patients with life-threatening cardiac arrhythmias.

Consumer nemesis of the 80s: rising health care cost.

Health care costs have increased so dramatically in the last 25 years that government, the health care industry, health insurance industry and most recently consumers are taking steps to counteract this progressing nemesis. Factors that have significantly influenced this increase in health care cost, such as third-party payments, advances in medical technology, increased profit motive, wasteful and insufficient care, and the growing population of older Americans are examined. Efforts by government, business, industry, and consumers to control health care costs and the resulting trends are identified.