Procedural characteristics and adverse events in diagnostic and interventional catheterisations in paediatric and adult CHD: initial report from the IMPACT Registry

2015 ◽  
Vol 26 (1) ◽  
pp. 70-78 ◽  
Author(s):  
Robert N. Vincent ◽  
John Moore ◽  
Robert H. Beekman ◽  
Lee Benson ◽  
Lisa Bergersen ◽  
...  

AbstractObjectivesTo report procedural characteristics and adverse events on data collected in the registry.BackgroundThe IMPACT – IMproving Paediatric and Adult Congenital Treatment – Registry is a catheterisation registry of paediatric and adult patients with CHD undergoing diagnostic and interventional cardiac catheterisation. We are reporting the procedural characteristics and adverse events of patients undergoing diagnostic and interventional catheterisation procedures from January, 2011 to March, 2013.MethodsDemographic, clinical, procedural, and institutional data elements were collected at the participating centres and entered via either a web-based platform or software provided by American College of Cardiology-certified vendors, and were collected in a secure, centralised database. Centre participation was voluntary.ResultsDuring the time frame of data collection, 19,797 procedures were entered into the IMPACT Registry. Procedures were classified as diagnostic only (35.4%); one of six specific interventions (23.8%); other or multiple interventions (40.7%); and were further broken down into four age groups. Anaesthesia was used in 84.1% of diagnostic procedures and 87.8% of interventional ones. Adverse events occurred in 10.0% of diagnostic and 11.1% of interventional procedures.ConclusionsThe IMPACT Registry is gathering data to set national benchmarks for diagnostic and certain specific interventional procedures. We are seeing little differences in procedural characteristics or adverse events in diagnostic procedures compared with interventional procedures overall, but there is significant variation in adverse events amongst age categories. Risk stratification and patient acuity scores will be required for further analysis of these differences.

2015 ◽  
Vol 26 (6) ◽  
pp. 1202-1212 ◽  
Author(s):  
Ralf Holzer ◽  
Robert Beekman ◽  
Lee Benson ◽  
Lisa Bergersen ◽  
Natalie Jayaram ◽  
...  

AbstractObjectivesThe objective of this study was to report procedural characteristics and adverse events on the data collected in the IMproving Paediatric and Adult Congenital Treatment registry.BackgroundThe IMproving Paediatric and Adult Congenital Treatment– registry is a catheterisation registry focussed on paediatric and adult patients with congenital heart disease who are undergoing diagnostic catheterisations and catheter-based interventions. This study reports procedural characteristics and adverse events of patients who have undergone selected catheterisation procedures from January, 2011 to June, 2013.MethodsDemographic, clinical, procedural, and institutional data elements were collected at participating centres and entered via either a web-based platform or software provided by the American College of Cardiology-certified vendors, and were collected in a secure, centralised database. For the purpose of this study, procedures that were not classified as one of the ‘core’ IMproving Paediatric and Adult Congenital Treatment procedures originally chosen for additional data collection were identified and selected for further data analysis.ResultsDuring the time frame of data collection, a total of 8021 cases were classified as other procedures and/or multiple procedures. The most commonly performed case types – isolated or in combination with other procedures – were right ventricular biopsy in 3433 (42.8%), conduit/MPA interventions in 979 (12.3%), and systemic pulmonary artery collateral occlusion in 601 (7.5%). For the whole cohort, adverse events of any severity occurred in 957 (12.0%) cases, whereas major adverse events occurred in 113 (1.4%) cases; six patients (0.1%) died in the catheterisation laboratory.ConclusionsThe IMproving Paediatric and Adult Congenital Treatment registry has provided important data on the frequency and spectrum of cardiac catheterisation procedures performed in the present era. For many procedures, more data and work are needed to identify more subtle differences between case categories, especially as it relates to the incidence of major adverse events, and to further develop a risk-adjustment methodology to allow equitable comparisons among institutions.


2020 ◽  
Vol 10 (3) ◽  
pp. 70-75
Author(s):  
Eric P. Borrelli ◽  
Erica Y. Lee ◽  
Aisling R. Caffrey

Abstract Introduction In October 2015, the Food and Drug Administration (FDA) instituted an update to the mandatory Risk Evaluation and Mitigation Strategy (REMS) program for clozapine to improve safety monitoring of hematologic events. However, the impact of the clozapine REMS program on reporting of hematologic adverse events has not been quantified. Methods We assessed adverse event reports for agranulocytosis, granulocytopenia, leukopenia, and neutropenia from the FDA Adverse Event Reporting System (FAERS) for a 1-year time period before (October 2014 to September 2015, pre-REMS) and after (October 2015 to September 2016, post-REMS) the implementation of the clozapine REMS program. The AERSMine platform was used to capture historical effect estimates (October 2004 to September 2014). Reporting odds ratios (ROR), proportional reporting ratios (PRR), and corresponding Taylor series 95% confidence intervals (CIs) were calculated for hematologic events with clozapine compared with all other medications using OpenEpi. Results Reporting rates for agranulocytosis, granulocytopenia, leukopenia, and neutropenia with clozapine all increased from the pre-REMS to post-REMS time frames, ranging from a 2-fold increase with leukopenia to a 40-fold increase with neutropenia; the composite measure of all hematologic reports had a 12-fold increase. During the post-REMS time frame, the ROR increased by 1691% (111.4, 95% CI 100.6-123.4) compared with the pre-REMS time frame (7.1, 95% CI 5.2-9.6), and the PRR increased by 1280% (83.1, 95% CI 76.8-90.0 vs 6.9, 95% CI 5.1-9.4) for the composite outcome. Discussion We observed significant increases in reports of hematologic adverse events with clozapine after the introduction of the clozapine REMS program. Future research should explore the impact of the less stringent exclusionary and discontinuation criteria on utilization (eg, expanded access) and clinical outcomes (eg, treatment effectiveness and adverse events).


Author(s):  
Renae K. Rich ◽  
Francesqca E. Jimenez ◽  
Susan E. Puumala ◽  
Sheila DePaola ◽  
Kathy Harper ◽  
...  

Objective: This research aimed to evaluate the quantitative effects of new hospital design on adult inpatient outcomes. Background: Tenets of evidence-based healthcare design, notably single-patient acuity-adaptable and same-handed rooms, decentralized nursing stations, onstage offstage layout, and access to nature were expected to promote patient healing and increase patient satisfaction, while decreasing adverse events. Methods: Patient healing was operationalized through length of stay (LOS) and patient safety through three adverse events: falls, hospital-acquired infections (HAI), and medication-related events. Standard patient surveys captured patient satisfaction. Patient records from 2013 through 2017 allowed for equivalent time periods surrounding the move to the new hospital in August 2015. Stratified by hospital division where significant, pre/post comparisons utilized proportional hazards or logistic regression models as appropriate; interrupted time series analyses afforded longitudinal interpretations. Results: Observed higher postmove LOS was due to previously increasing trends, not increases after the move. In surgical and trauma units, a constant increase in falls was unaffected by the move. Medication events decreased consistently over time; medication events with harm dropped significantly after the move. No change in HAI was found. Significant improvement on most relevant patient satisfaction items occurred after the move. Call button response decreased immediately after the move but subsequently improved. Conclusion: Results did not clearly indicate a net change in adult inpatient outcomes of healing and safety due to the hospital design. There was evidence that the new hospital improved patient satisfaction outcomes related to the environment, including comfort, noise, temperature, and aesthetics.


2021 ◽  
Vol 12 ◽  
Author(s):  
Candice E. Crocker ◽  
Alix J. E. Carter ◽  
Jason G. Emsley ◽  
Kirk Magee ◽  
Paul Atkinson ◽  
...  

Cannabis use is a modifiable risk factor for the development and exacerbation of mental illness. The strongest evidence of risk is for the development of a psychotic disorder, associated with early and consistent use in youth and young adults. Cannabis-related mental health adverse events precipitating Emergency Department (ED) or Emergency Medical Services presentations can include anxiety, suicidal thoughts, psychotic or attenuated psychotic symptoms, and can account for 25–30% of cannabis-related ED visits. Up to 50% of patients with cannabis-related psychotic symptoms presenting to the ED requiring hospitalization will go on to develop schizophrenia. With the legalization of cannabis in various jurisdiction and the subsequent emerging focus of research in this area, our understanding of who (e.g., age groups and risk factors) are presenting with cannabis-related adverse mental health events in an emergency situation is starting to become clearer. However, for years we have heard in popular culture that cannabis use is less harmful or no more harmful than alcohol use; however, this does not appear to be the case for everyone. It is evident that these ED presentations should be considered another aspect of potentially harmful outcomes that need to be included in knowledge mobilization. In the absence of a clear understanding of the risk factors for mental health adverse events with cannabis use it can be instructive to examine what characteristics are seen with new presentations of mental illness both in emergency departments (ED) and early intervention services for mental illness. In this narrative review, we will discuss what is currently known about cannabis-related mental illness presentations to the ED, discussing risk variables and outcomes both prior to and after legalization, including our experiences following cannabis legalization in Canada. We will also discuss what is known about cannabis-related ED adverse events based on gender or biological sex. We also touch on the differences in magnitude between the impact of alcohol and cannabis on emergency mental health services to fairly present the differences in service demand with the understanding that these two recreational substances may impact different populations of individuals at risk for adverse events.


2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 326-326
Author(s):  
Sadiqa Mahmood ◽  
Eli Schwamm ◽  
Kenneth L. Kehl ◽  
Brett Glotzbecker ◽  
Robert Andrews ◽  
...  

326 Background: The immune checkpoint inhibitors (ICIs) confer a risk of unique inflammatory immune-related adverse events (irAEs), which are highly distinct from the adverse events historically observed with cytotoxic therapy. To develop a strategy for easier identification and mitigation of irAEs, we sought to understand the frequency of ED visits and hospitalizations in 90 days following ICI start by implementing a rapid learning system (RLS). Methods: We convened an Immunotherapy Toxicities Management Committee with representatives from the Center for Immuno-Oncology, Quality and Patient Safety, and Informatics to draft a series of recommendations for the development of an irAE rapid learning system. The Committee requested an audit of all irAEs between June 2015 and April 2018 by drug, event type (clinical diagnosis), outcomes (including ED visits, hospitalization with length of stay, and death), and time-frame (days since beginning ICI course). An automated pipeline was created to merge structured data from the Electronic Health Record (Epic) and billing system (EPSi). This data was used to design a tool which consisted of an automated dashboard to monitor patient and enable interventions. Results: Over the course of 3 years, a total of 2,020 unique patients receiving ICIs were seen. 918 were treated with Pembrolizumab (45.4%), 768 with Nivolumab (38.0%), 234 with Atezolizumab (11.6%), 111 with Nivolumab & Ipilmumab (5.6%), 68 with Ipilimumab (3.4%), 9 with Durvalumab (0.4%), and 9 with Avelumab (0.4%). ED visits and hospitalization rates over 90 days were similar among the three most prescribed therapies, ranging from 332 unique patient events in the Pembrolizumab Cohort (36.1%) to 96 unique patient events in the Atezolizumab cohort (41.0%). Conclusions: The dashboard is effective tool to build a RLS for irAEs. The immediate output of this tool is using natural language processing (NLP) to distinguish between irAEs related ED visits and hospitalizations or regular disease progression, and measure the impact of interventions including (a) developing standardized algorithms for monitoring for irAEs, (b) designing an educational program for providers, and (c) developing an inpatient and outpatient immunotherapy toxicity management service.


2003 ◽  
Vol 73 (5) ◽  
pp. 335-342 ◽  
Author(s):  
Alexy ◽  
Kersting ◽  
Sichert-Hellert

Intake of vitamins A, C, and E was evaluated and age and time trends were assessed on the basis of 3-day weighed dietary records (n = 5121) of 2- to 18-year old boys (n = 417) and girls (n = 425) enrolled in the DONALD Study (Dortmund Nutritional and Anthropometric Longitudinally Designed Study) 1986–2001. Intake of vitamin A remains stable over time, intake of vitamin C increases linearly, and intake of vitamin E follows a nonlinear trend. Age trends of vitamins A and C (per MJ) were nonlinear with a minimum at the beginning adolescence, while intake of vitamin E (per MJ) increased linearly. Girls had higher nutrient densities but lower intakes expressed as percent of reference values. Fortified food in total had a higher impact on time trends of nutrient intake than other single food groups defined here. Our results point to the impact of the food industry on long-term nutrient intake, but also underline the necessity of nutrition education even in young age groups to improve vitamin intake.


2020 ◽  
Vol 59 (04) ◽  
pp. 294-299 ◽  
Author(s):  
Lutz S. Freudenberg ◽  
Ulf Dittmer ◽  
Ken Herrmann

Abstract Introduction Preparations of health systems to accommodate large number of severely ill COVID-19 patients in March/April 2020 has a significant impact on nuclear medicine departments. Materials and Methods A web-based questionnaire was designed to differentiate the impact of the pandemic on inpatient and outpatient nuclear medicine operations and on public versus private health systems, respectively. Questions were addressing the following issues: impact on nuclear medicine diagnostics and therapy, use of recommendations, personal protective equipment, and organizational adaptations. The survey was available for 6 days and closed on April 20, 2020. Results 113 complete responses were recorded. Nearly all participants (97 %) report a decline of nuclear medicine diagnostic procedures. The mean reduction in the last three weeks for PET/CT, scintigraphies of bone, myocardium, lung thyroid, sentinel lymph-node are –14.4 %, –47.2 %, –47.5 %, –40.7 %, –58.4 %, and –25.2 % respectively. Furthermore, 76 % of the participants report a reduction in therapies especially for benign thyroid disease (-41.8 %) and radiosynoviorthesis (–53.8 %) while tumor therapies remained mainly stable. 48 % of the participants report a shortage of personal protective equipment. Conclusions Nuclear medicine services are notably reduced 3 weeks after the SARS-CoV-2 pandemic reached Germany, Austria and Switzerland on a large scale. We must be aware that the current crisis will also have a significant economic impact on the healthcare system. As the survey cannot adapt to daily dynamic changes in priorities, it serves as a first snapshot requiring follow-up studies and comparisons with other countries and regions.


Author(s):  
Alistair Fox

This book investigates the coming-of-age genre as a significant phenomenon in New Zealand’s national cinema, tracing its development from the 1970s to the present day. A preliminary chapter identifies the characteristics of the coming-of-age film as a genre, tracing its evolution and the influence of the French New Wave and European Art Cinema, and speculating on the role of the genre in the output of national cinemas. Through case studies of fifteen significant films, including The God Boy, Sleeping Dogs, The Scarecrow, Vigil, Mauri, An Angel at My Table, Heavenly Creatures, Once Were Warriors, Rain, Whale Rider, In My Father’s Den, 50 Ways of Saying Fabulous, Boy, Mahana, and Hunt for the Wilderpeople, subsequent chapters examine thematic preoccupations of filmmakers such as the impact of repressive belief systems and social codes, the experience of cultural dislocation, the expression of a Māori perspective through an indigenous “Fourth Cinema,” bicultural relationships, and issues of sexual identity, arguing that these films provide a unique insight into the cultural formation of New Zealanders. Given that the majority of films are adaptations of literary sources, the book also explores the dialogue each film conducts with the nation’s literature, showing how the time frame of each film is updated in a way that allows these films to be considered as a register of important cultural shifts that have occurred as New Zealanders have sought to discover their emerging national identity.


2020 ◽  
Vol 16 (4) ◽  
pp. 715-729
Author(s):  
T.N. Savina

Subject. To achieve a high level of economic security is a key priority of national development. Employment reveals one of the most important aspects of social development of the individual that is associated with his or her needs satisfaction in the sphere of employment and is boon to economic security. Objectives. The purpose of the study is to show the impact of unemployment on economic security in employment. Methods. I apply such scientific methods as dialectical, historical and logical unity, structural and functional analysis, traditional techniques of economic analysis and synthesis. The methods of multivariate statistical and comparative analysis serve as a methodological basis of the study. To determine the indicator of unemployment, I use the band theory. Results. I underpin the growing role of employment in ensuring economic security. The paper presents a comprehensive assessment of the unemployment status and a comparative analysis of the indicator in the Republic of Mordovia, the Volga Federal District, and the Russian Federation as a whole. I identify trends in the average duration of unemployment, show the distribution of unemployed by level of education and age groups. Conclusions. The average annual unemployment rate in the Republic of Mordovia is lower than in Russia and the Volga Federal District. The findings may be useful for public authorities to substantiate their employment policy at both macro- and meso-levels, for designing programs and strategies for socio-economic development of regions and the social security doctrine, as well as in practical activities of employment services.


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