Abstract 19074: Relationship Between Hospital Procedure Volume and Complications Following Congenital Cardiac Catheterization: a Report from the IMPACT® Registry

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Andrew C Glatz ◽  
Natalie M Jayaram ◽  
Michael L O’Byrne ◽  
Yan Li ◽  
Paul S Chan ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Cardiac Catheterization ◽  
Left Ventricular ◽  
Major Adverse Event ◽  
Procedural Volume ◽  
Procedure Volume ◽  
Annual Volume ◽  
Air Embolus ◽  
The Impact

Background: The association between institutional procedural volume and outcomes has been demonstrated for many procedures within the field of cardiology, but whether this relationship pertains to congenital cardiac catheterization is unknown. Methods: Using the IMPACT® (Improving Pediatric and Adult Congenital Treatment) Registry, we identified all catheterizations between 2011 and 2013 at 64 U.S. centers. Programs were categorized as small (<150 cases/year), medium (150 to 300 cases/year), large (300-500 cases/ year), and very large (>500 cases/ year). Hierarchical logistic regression, adjusted for patient and procedural characteristics, was used to determine the association between annual procedural volume and occurrence of a major adverse event (cardiac arrest; arrhythmia requiring permanent pacemaker; tamponade; air embolus; embolic stroke; device malposition, thrombus, or embolization; new requirement for dialysis; event requiring extracorporeal membrane oxygenation or left ventricular assist device; unplanned cardiac, vascular, or other surgery; or subsequent cardiac catheterization). Results: Among 64 hospitals, there were 19 small, 15 medium, 19 large, and 11 very large programs. Among 33,825 catheterizations, a major adverse event occurred in 711 (2.1%). In unadjusted analysis, major adverse events differed based upon annual volume, with a major adverse event occurring in 79 (2.8%) cases at small, 145 (2.3%) cases at medium, 234 (2.1%) cases at large, and 253 (1.9%) cases at very-large programs (p=0.01). After adjusting for patient and procedural risk factors, there was no association between annual procedure volume and occurrence of a major adverse event (odds ratio 0.96 [95% Confidence Interval=0.90, 1.04] per increase in annual volume of 100, p=0.32). There was no interaction between procedure-type risk group and volume on outcomes (p=0.49). Conclusions: Although the unadjusted risk of adverse events was lower in centers performing more catheterizations for congenital heart disease, this association between center volume and outcomes did not persist after adjustment for patient and procedural case-mix. The hospital sample size and low event rate may have limited our ability to detect significant differences.

scholarly journals The Irish National Adverse Event Study-2 (INAES-2): longitudinal trends in adverse event rates in the Irish healthcare system

2021 ◽  
pp. bmjqs-2020-011122 ◽  
Author(s):  
Warren Connolly ◽  
Natasha Rafter ◽  
Ronan M Conroy ◽  
Cornelia Stuart ◽  
Anne Hickey ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Positive Impact ◽  
Retrospective Chart Review ◽  
Published Data ◽  
National Programmes ◽  
Event Rates ◽  
Hospital Associated Infections ◽  
Design And Methods ◽  
The Impact

ObjectivesTo quantify the prevalence and nature of adverse events in acute Irish hospitals in 2015 and to assess the impact of the National Clinical Programmes and the National Clinical Guidelines on the prevalence of adverse events by comparing these results with the previously published data from 2009.Design and methodsA retrospective chart review of 1605 admissions to eight Irish hospitals in 2015, using identical methods to those used in 2009.ResultsThe percentage of admissions associated with one or more adverse events was unchanged (p=0.48) at 14% (95% CI=10.4% to 18.4%) in 2015 compared with 12.2% (95% CI=9.5% to 15.5%) in 2009. Similarly, the prevalence of preventable adverse events was unchanged (p=0.3) at 7.4% (95% CI=5.3% to 10.5%) in 2015 compared with 9.1% (95% CI=6.9% to 11.9%) in 2009. The incidence densities of preventable adverse events were 5.6 adverse events per 100 admissions (95% CI=3.4 to 8.0) in 2015 and 7.7 adverse events per 100 admissions (95% CI=5.8 to 9.6) in 2009 (p=0.23). However, the percentage of preventable adverse events due to hospital-associated infections decreased to 22.2% (95% CI=15.2% to 31.1%) in 2015 from 33.1% (95% CI=25.6% to 41.6%) in 2009 (p=0.01).ConclusionAdverse event rates remained stable between 2009 and 2015. The percentage of preventable adverse events related to hospital-associated infection decreased, which may represent a positive impact of the related national programmes and guidelines.

Clinical and information governance proposes; human fallibility disposes

2014 ◽  
Vol 19 (2) ◽  
pp. 94-109 ◽  
Author(s):  
Karen Renaud
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Education And Training ◽  
Clinical Governance ◽  
Complex Nature ◽  
Content Type ◽  
Information Governance ◽  
Governance Tools ◽  
The Impact ◽  
And Training

Purpose – There is a strong drive within the UK's National Health Service (NHS) towards ensuring quality and reducing adverse events. This incorporates clinical governance, which applies to clinical activities, and information governance, which applies to preserving the confidentiality, availability and integrity of patient information. The purpose of this paper is to consider why humans make errors, how the current governance tools can minimise the incidence of such errors and the causatives that can increase the likelihood of an error. Errors sometimes lead to adverse events, which have to be reported. The latest adverse event reports from NHS Scotland, recently published on the BBC website, were analysed to identify major themes that emerged from the recommendations made by the investigative teams. These themes are then discussed in terms of how the current clinical governance tools should be applied to further reduce the incidence of adverse events. A revised clinical governance diagram that more clearly depicts the cross-cutting nature of the themes that emerged from the analysis is proposed. Finally some opportunities for future research are identified. Design/methodology/approach – Qualitative analysis of adverse incidence reports in order to identify causatives. Used the insights delivered by this analysis in order to propose a change to Scally and Donaldson's clinical governance diagram. Findings – A clear reliance on education and training by adverse event review teams was found, which suggests that they do not really understand what causes error, and they do not acknowledge the impact of the situation on the actors. Also – a tendency to define processes to cover all eventualities, even though some situations cannot be encoded as processes. The main insight is that there are a number of cross-cutting concerns which means that the original clinical governance diagram would benefit from a level of integration which is not currently present. Research limitations/implications – The analysed reports were severely redacted which meant that nuances of the situation could have been missed by the researcher. However, the recommendations were never redacted so the researcher focused on these. Practical implications – The paper, in general, highlights the need for a more nuanced approach to clinical governance and less reliance on education and training as the universal panacea. Social implications – Over reliance on education and training puts the blame on the person, and does not acknowledge the causatives in the situation. Acknowledging the more complex nature of the problem makes adverse events less blame-worthy and more likely to lead to real learning and effective mitigation. Originality/value – The author is not aware of anyone else having analysed these reports.

scholarly journals Procedural Risk in Congenital Cardiac Catheterization (PREDIC 3 T)

2021 ◽  
Author(s):  
Brian P. Quinn ◽  
Mary Yeh ◽  
Kimberlee Gauvreau ◽  
Fatima Ali ◽  
David Balzer ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Cardiac Catheterization ◽  
Assessment Tools ◽  
Risk Category ◽  
Patient Risk ◽  
High Severity ◽  
Case Type ◽  
Vulnerability Score ◽  
Risk Categories

Background Advancements in the field, including novel procedures and multiple interventions, require an updated approach to accurately assess patient risk. This study aims to modernize patient hemodynamic and procedural risk classification through the creation of risk assessment tools to be used in congenital cardiac catheterization. Methods and Results Data were collected for all cases performed at sites participating in the C3PO (Congenital Cardiac Catheterization Project on Outcomes) multicenter registry. Between January 2014 and December 2017, 23 119 cases were recorded in 13 participating institutions, of which 88% of patients were <18 years of age and 25% <1 year of age; a high‐severity adverse event occurred in 1193 (5.2%). Case types were defined by procedure(s) performed and grouped on the basis of association with the outcome, high‐severity adverse event. Thirty‐four unique case types were determined and stratified into 6 risk categories. Six hemodynamic indicator variables were empirically assessed, and a novel hemodynamic vulnerability score was determined by the frequency of high‐severity adverse events. In a multivariable model, case‐type risk category (odds ratios for category: 0=0.46, 1=1.00, 2=1.40, 3=2.68, 4=3.64, and 5=5.25; all P ≤0.005) and hemodynamic vulnerability score (odds ratio for score: 0=1.00, 1=1.27, 2=1.89, and ≥3=2.03; all P ≤0.006) remained independent predictors of patient risk. Conclusions These case‐type risk categories and the weighted hemodynamic vulnerability score both serve as independent predictors of patient risk for high‐severity adverse events. This contemporary procedure‐type risk metric and weighted hemodynamic vulnerability score will improve our understanding of patient and procedural outcomes.

scholarly journals Evaluating the use of the EORTC patient-reported outcome measures for improving inter-rater reliability of CTCAE ratings in a mixed population of cancer patients: study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Lisa M. Wintner ◽  
◽  
Johannes M. Giesinger ◽  
Monika Sztankay ◽  
Andrew Bottomley ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Adverse Event ◽  
Adverse Events ◽  
Controlled Trial ◽  
Control Group ◽  
Rater Reliability ◽  
Randomized Controlled ◽  
Patient Reported ◽  
The Impact

Abstract Background In oncology, detection and tracking of adverse events are of top priority and rely mostly on the Common Terminology Criteria for Adverse Events (CTCAE). Besides, clinical trials use as well patient-reported outcomes (PROs) to assess those adverse events, which are only accessible through patient self-reporting, such as fatigue, pain, and sleep disorders. Especially those issues that are not visible from the outside are often misinterpreted and underestimated by mere provider ratings. This trial aims at evaluating the impact of providing PRO data to providers on the accuracy of adverse event assessment in terms of inter-rater reliability of CTCAE ratings. Methods The trial uses a cross-sectional, unblinded, randomized controlled trial design with two trial arms and a single assessment time point. Eligible patients (aged 18 and above, any cancer diagnosis, currently under treatment, inpatient or day clinic setting, present symptom burden, no psychiatric or mental problems, written informed consent) complete an electronic version of the EORTC QLQ-C30 and 16 additional questions taken from the EORTC Item Library. PRO data is immediately processed and made available to CTCAE rating providers for conducting their ratings during the medical encounter. Patients are randomly assigned 1:1 to the intervention group (providers see PRO results on the same screen as the CTCAE rating) and the control group (no access to PRO data during the CTCAE rating). A superiority analysis will compare the inter-rater reliability (using intra-class correlation (ICC) coefficients) between the control and the intervention groups for each adverse event evaluated. Discussion The presented trial will demonstrate potential benefits of using PRO measures to improve the reliability of CTCAE ratings in cancer trials and the identification of adverse events. The new insights gained may lead to a new strategy for evaluating adverse events in clinical trials by combining patient and provider ratings. This might also have implications for daily clinical practice and cancer registries. Trial registration ClinicalTrials.gov NCT04066868. Registered on August 26, 2019. Competence Center for Clinical Trials of the Medical University of Innsbruck 20190513-2007. Registered on May 14, 2019. (version 6.0, March 18, 2019)

scholarly journals Using patients’ experiences of adverse events to improve health service delivery and practice: protocol of a data linkage study of Australian adults age 45 and above

BMJ Open ◽  
2014 ◽  
Vol 4 (10) ◽  
pp. e006599 ◽  
Author(s):  
Merrilyn Walton ◽  
Jennifer Smith-Merry ◽  
Reema Harrison ◽  
Elizabeth Manias ◽  
Rick Iedema ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Data Linkage ◽  
Health Service Delivery ◽  
Control Group ◽  
Contextual Knowledge ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Hospitalised Patients ◽  
The Impact

IntroductionEvidence of patients’ experiences is fundamental to creating effective health policy and service responses, yet is missing from our knowledge of adverse events. This protocol describes explorative research redressing this significant deficit; investigating the experiences of a large cohort of recently hospitalised patients aged 45 years and above in hospitals in New South Wales (NSW), Australia.Methods and analysisThe 45 and Up Study is a cohort of 265 000 adults aged 45 years and above in NSW. Patients who were hospitalised between 1 January and 30 June 2014 will be identified from this cohort using data linkage and a random sample of 20 000 invited to participate. A cross-sectional survey (including qualitative and quantitative components) will capture patients’ experiences in hospital and specifically of adverse events. Approximately 25% of respondents are likely to report experiencing an adverse event. Quantitative components will capture the nature and type of events as well as common features of patients’ experiences. Qualitative data provide contextual knowledge of their condition and care and the impact of the event on individuals. Respondents who do not report an adverse event will report their experience in hospital and be the control group. Statistical and thematic analysis will be used to present a patient perspective of their experiences in hospital; the characteristics of patients experiencing an adverse event; experiences of information sharing after an event (open disclosure) and the other avenues of redress pursued. Interviews with key policymakers and a document analysis will be used to create a map of the current practice.Ethics and disseminationDissemination via a one-day workshop, peer-reviewed publications and conference presentations will enable effective clinical responses and service provision and policy responses to adverse events to be developed.

scholarly journals Clozapine and hematologic adverse reactions: Impact of the Risk Evaluation and Mitigation Strategy program

2020 ◽  
Vol 10 (3) ◽  
pp. 70-75
Author(s):  
Eric P. Borrelli ◽  
Erica Y. Lee ◽  
Aisling R. Caffrey
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Risk Evaluation ◽  
Treatment Effectiveness ◽  
Adverse Event Reporting System ◽  
Fold Increase ◽  
Time Frame ◽  
Mitigation Strategy ◽  
Future Research ◽  
The Impact

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).

scholarly journals 37 Impact of Adverse Events on the Older Inpatient Population- A Subgroup Analysis of the Irish National Adverse Events Study (INAES)

2019 ◽  
Vol 48 (Supplement_3) ◽  
pp. iii1-iii16
Author(s):  
Warren Connolly ◽  
Natasha Rafter ◽  
Anne Hickey ◽  
Ronan Conroy ◽  
Sarah Condell ◽  
...  
Keyword(s):  
Adverse Event ◽  
Length Of Stay ◽  
Adverse Events ◽  
Older Patients ◽  
Retrospective Chart Review ◽  
Healthcare Management ◽  
Adverse Event Rate ◽  
Permanent Disability ◽  
Inpatient Population ◽  
The Impact

Abstract Background Adverse events are any injuries caused by healthcare management, which result in disability, increased length of stay or death. The Irish National Adverse Event Study (INAES)(1) used the Harvard Medical Practice, 2-step methodology of retrospective chart review(2) to determine the adverse event rate in the Irish inpatient cohort. Methods We further analysed the INAES data in order to calculate the prevalence and determine the impact of adverse events on the older inpatient population. Results INAES captured 1574 randomly selected adult inpatient admissions from 8 hospitals across the Republic of Ireland in 2009. 53% were female and the median age was 55years (IQR 37years to 72years). The prevalence of adverse events was higher in those aged ≥65 compared to those aged < 65 (15.4% versus 9.3% P < 0.001). When an adverse event did occur it was more likely to result in death in the ≥65 years old group (11.4% versus 2.1%, p = 0.01). Furthermore, it was 9 times more likely that an admission would result in a fatal adverse event in those aged ≥65 compared to those aged < 65 years. A further 9% of adverse events in the ≥65 age group resulted in permanent disability and over half were thought to be preventable. Older patients who suffered from an adverse event had an increased length of stay compared to older patients who did not suffer an adverse event (16days versus 6days, p <0.001) at a cost of €9,090 for each adverse-event-associated admission. Conclusion Older inpatients are more likely to suffer from an adverse event than their younger counterparts. These adverse events are more likely to contribute to increased morbidity but over half are preventable. The follow-up INAES-2 study, which is currently underway, will determine if an improvement has been made after implementation of the National Clinical Programmes.

TM2-2 Analysis of adverse events in the management of chronic headache by occipital nerve stimulation

2019 ◽  
Vol 90 (3) ◽  
pp. e13.2-e13
Author(s):  
S Miller ◽  
L Watkins ◽  
M Matharu
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Nerve Stimulation ◽  
Event Rate ◽  
Adverse Event Rate ◽  
Occipital Nerve Stimulation ◽  
Occipital Nerve ◽  
Significant Difference ◽  
Event Rates ◽  
The Impact

ObjectivesTo analyse long-term adverse events of occipital nerve stimulation (ONS).DesignProspective open-label observational study.Subjects134 patients with refractory headaches implanted between 2007–2014 in a single specialised centre.MethodsInformation was collected on ONS device, implantable pulse generator (IPG) site and adverse event rates. The impact of implanter experience and the association between IPG site and adverse event rates was also explored.ResultsMean follow up was 46 months (6–108 months). A total of 139 adverse events were recorded in 75 patients (56%). A total of 59 additional surgeries were needed in 39 patients. A significant difference was seen in the rates of adverse events recorded between 2007–2010 and 2011–2014 (60.7% vs 42.6%, p=0.002). A significant reduction in ONS revision was seen over time (25.7% vs 5.9%, p=0.002). Analysis of adverse events with IPG site showed those with abdominal implants recorded higher adverse event rate that those with an IPG in the chest (65.8% vs 40.3%, p=0.004).ConclusionsIn specialist centres, adverse event rates of ONS can be much lower than reported in the literature. Our results suggest implanter experience and IPG site both have an effect on adverse event rate.

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