Hemocompatibility-related Adverse Events Following HeartMate II Left Ventricular Assist Device Implantation between Japan and United States.

Background: Left ventricular assist device (LVAD) therapy has improved the clinical outcomes in advanced heart failure patients, however, this may differ between countries. We aimed to compare outcomes between Japanese and US LVAD cohorts. Methods: For 416 consecutive LVAD patients who received HeartMate II LVAD implantation and completed a one-year follow-up, age-matched Japanese patients (the Japanese registry for mechanically assisted circulatory support (J-MACS) group) and the US patients were compared for their clinical outcomes. Results: 154 J-MACS patients and 77 US patients were compared. Survival, free from hemocompatibility-related adverse events (HRAEs) in the J-MACS was statistically comparable with the US (75% vs. 63%, p = 0.79). J-MACS had more disabling strokes than the US (0.221 vs. 0.052/patient-year, p = 0.005), whereas there was less nonsurgical bleeding (0.045 vs. 0.117/patient-year, p = 0.024). The net hemocompatibility score was statistically comparable between the groups (1.54 vs. 1.19 points/patient, p = 0.99). Post-LVAD prothrombin time with international normalized ratio (INR) <1.5 (odds ratio 4.07) was a risk factor for HRAEs in J-MACS, whereas INR >3.0 (odds ratio 5.71) was a risk factor in the US (p < 0.05 for both). Conclusion: In the age-matched cohorts, the J-MACS group experienced more strokes, while the US group had more bleedings. "Tailor-made" therapeutic strategy might be required for each country, given the unique variation of HRAE incidence among each country.

When Are Adverse Outcome Pathways and Associated Assays "Fit for Purpose" for Regulatory Decision-Making and Management of Chemicals?

There have been increasing demands for chemical hazard and risk assessments in recent years. Chemical companies have expanded internal product stewardship initiatives, and jurisdictions have increased the regulatory requirements for the manufacture and sale of chemicals. There has also been a shift in chemical toxicity evaluations within the same time frame, with new methodologies being developed to improve chemical safety assessments for both human health and the environment. With increased needs for chemical assessments coupled with more diverse data streams from new technologies, regulators and others tasked with chemical management activities are faced with increasing workloads and more diverse types of data to consider. The Adverse Outcome Pathway (AOP) framework can be applied in different scenarios to integrate data and guide chemical assessment and management activities. In this paper, scenarios of how AOPs can be used to guide chemical management decisions during research and development, chemical registration, and subsequent regulatory activities such as prioritization and risk assessment are considered. Furthermore, specific criteria (e.g., the type and level of AOP complexity, confidence in the AOP, as well as external review and assay validation) are proposed to examine whether AOPs and associated tools are fit for purpose when applied in different contexts. Certain toxicity pathways are recommended as priority areas for AOP research and development, and the continued use of AOPs and defined approaches in regulatory activities are recommended. Furthermore, a call for increased outreach, education, and enhanced use of AOP databases is proposed to increase their utility in chemicals management. Integr Environ Assess Manag 2019;15:633-647. © 2019 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Effect of a medicines management model on medication-related readmissions in older patients admitted to a medical acute admission unit-A randomized controlled trial.

RATIONALE, AIMS, AND OBJECTIVES: Medication-related problems are frequent and can lead to serious adverse events resulting in increased morbidity, mortality, and costs. Medication use in frail older patients is even more complex. The aim of this study was to investigate the effect of a pharmacist-led medicines management model among older patients at admission, during inpatient stay and at discharge on medication-related readmissions. METHOD: A randomized controlled trial conducted at the acute admission unit in a Danish hospital with acutely admitted medical patients, randomized to either a control group or one of two intervention groups. The intervention consisted of pharmacist-led medication review and patient interview upon admission (intervention ED) or pharmacist-led medication review and patient interview upon admission, medication review during inpatient stay, and medication report and patient counselling at discharge (intervention STAY). RESULTS: In total, 600 patients were included. The pharmacist identified 920 medication-related problems with 57% of the recommendations accepted by the physician. After 30 days, 25 patients had a medication-related readmission, with no statistical significant difference between the groups on either primary or secondary outcomes. CONCLUSIONS: This study showed that a clinical pharmacist can be used to identify and solve medication-related problems, but this study did not find any effect on the selected outcomes. The frequency of medication-related readmissions was low, leaving little room for improvement. Future research should consider other study designs or outcome measures.

Everything safe? ­ Risk situations in advanced home care from the point of view of ventilated patients and their relatives / Alles sicher? ­ Risikosituationen in der häuslichen Intensivpflege aus Sicht beatmeter Patienten und ihrer Angehörigen.

Background: The number of home mechanically ventilated (HMV) patients has been growing for years. However, little is known about requirements, processes and effects of advanced home care, provided in distance from clinics and doctors. To date, safety related aspects of the above mentioned issues have scarcely been examined. Aim: Users of advanced home care were asked about their experiences and about situations in which they felt safe or unsafe. The aim was to gain insights into the daily care provision, explore safety risks from the users' point of view, and to develop new approaches to enhance patient safety in home care for the severely ill. Method: A qualitative explorative study has been carried out, based on semi-structured interviews (ventilated patients N = 21; relatives N = 15). Sampling, data collecting and data analysis were guided by principles of Grounded Theory. Results: Risk situations occur when (non-)verbal communication offers of HMV patients are overseen or misunderstood, patient- or technology related monitoring tasks are neglected, if coordination and collaboration requirements are undervalued and if negotiation processes as well as education and supervision needs are disregarded. Furthermore, nurses' lack of competence, self-confidence and professionalism may produce risk situations. Conclusion: Listen carefully to patients and relatives can help to identify quality shortcomings in advanced home care, to prevent risk situations and to develop patient-centered safety concepts for this particular setting.

Analysis of adverse events as a contribution to safety culture in the context of practice development / Die Analyse unerwünschter Ereignisse als Beitrag zur Sicherheitskultur im Kontext der Praxisentwicklung.

Background: Analysing adverse events is an effective patient safety measure. Aim: We show, how clinical nurse specialists have been enabled to analyse adverse events with the "Learning from Defects-Tool" (LFD-Tool). Method: Our multi-component implementation strategy addressed both, the safety knowledge of clinical nurse specialists and their attitude towards patient safety. The culture of practice development was taken into account. Results: Clinical nurse specialists relate competency building on patient safety due to the application of the LFD-tool. Applying the tool, fosters the reflection of adverse events in care teams. Conclusion: Applying the "Learning from Defects-Tool" promotes work-based learning. Analysing adverse events with the "Learning from Defects-Tool" contributes to the safety culture in a hospital.

[About unification of indices of the possibility of disease occurrence in risk assessment methodology and the determination of the probability of non-carcinogenic effects in toxicological-hygienic, clinical and epidemiological studies and according to data about health-seeking behavior].

In the methodology for the assessment of the risk the possibility of the disease occurrence under the impact of carcinogenic and non-carcinogenic substances is measured by different indices. This leads to the fact that within the single methodology there are used various scores for such similar index as the risk of the disease occurrence, as a result carcinogens and systemic toxicants happen to be inconsistent from this point of view. At the same time, unlike carcinogens risk indices for systemic toxicants do not allow to evaluate the number of possible diseases in the population during the corresponding period of time, because they contain no information about their probability. Obviously, from this point of view, the characteristics of carcinogenic risk have certain advantages. Therefore, noncarcinogenic risk should be assessed by the similar indices as carcinogenic ones. However, an obstacle to this is the fact that in toxicological-hygienic, clinical and epidemiological studies, according to the results of which there is determined the risk for systemic toxicants, the impact of non-lethal levels of the exposure is established not in separate individuals, as for carcinogens, but according to mean-group values of indices of the state of the body as the identification of the nonspecific effect under relatively non high doses (concentrations) in the single person is fairly difficult. Such data do not allow to estimate the probability of the break of the effect. Also the data concerning seeking for the medical help, considering repeated medical resource utilization due to protract diseases or afflictions occurring repeatedly in a person several times for the considered period of time fail to be the estimation of the probability for the disease occurrence. For the obtaining of the possibility of unification of the carcinogenic and non-carcinogenic indices of risk in the paper there are presented methods for the determination of the probability of non-carcinogenic effects in toxicological-hygienic, clinical and epidemiological studies, as well as according to statistical data on the seeking for the medical help, taking into account the repeated appeals of the protract or re-emerging diseases.