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Reporting adverse events in a surgical trial for complex congenital heart disease: the Pediatric Heart Network experience.

ABSTRACT: The purpose of this analysis was to evaluate a novel strategy for reporting adverse events in the Pediatric Heart Network's randomized surgical trial of systemic-pulmonary artery shunt versus right ventricle-pulmonary artery conduit in infants with hypoplastic left heart syndrome. The strategy was developed to align the reporting process with the needs of a surgical trial while maintaining participant safety.Adverse event reporting was analyzed for 2 groups of study subjects: those randomized to a trial arm during a period in which a standard adverse event reporting system was used (period 1) and those randomized after institution of a system that focused serious adverse event reporting on 6 sentinel events (period 2). The analysis encompassed the period from randomization (Norwood surgery) to hospital discharge from stage II surgery. Adverse event rates were compared using a Poisson regression model for the number of events per subject.From period 1 to period 2, the rate of serious adverse events requiring expedited reporting decreased as expected (0.42 vs 0.14/subject/month of follow-up; P < .001). Subjects with a serious (sentinel) adverse event in period 2 had a significantly higher rate of death and cardiac transplantation.The new adverse event reporting system successfully targeted subjects at highest risk, while decreasing the administrative burden associated with adverse event reports. This methodology may be of benefit in trials evaluating surgical or device-based interventions and in critically ill populations where many common clinical events would qualify as serious adverse events in the context of a drug trial.

SUBMITTER: Virzi L

PROVIDER: S-EPMC3144300 | biostudies-literature | 2011 Sep

REPOSITORIES: biostudies-literature

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Reporting adverse events in a surgical trial for complex congenital heart disease: the Pediatric Heart Network experience.

Virzi Lisa L Pemberton Victoria V Ohye Richard G RG Tabbutt Sarah S Lu Minmin M Atz Teresa C TC Barnard Teresa T Dunbar-Masterson Carolyn C Ghanayem Nancy S NS Jacobs Jeffrey P JP Lambert Linda M LM Lewis Alan A Pike Nancy N Pizarro Christian C Radojewski Elizabeth E Teitel David D Xu Mingfen M Pearson Gail D GD

The Journal of thoracic and cardiovascular surgery 20110312 3

<h4>Objective</h4>The purpose of this analysis was to evaluate a novel strategy for reporting adverse events in the Pediatric Heart Network's randomized surgical trial of systemic-pulmonary artery shunt versus right ventricle-pulmonary artery conduit in infants with hypoplastic left heart syndrome. The strategy was developed to align the reporting process with the needs of a surgical trial while maintaining participant safety.<h4>Methods</h4>Adverse event reporting was analyzed for 2 groups of s ...[more]

PMID: 21397260

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Project description:Background:Congenital lung malformations (CLM) are a gamut of lesions that originate throughout the embryonic period and manifest in the neonatal or sporadically in the prenatal period, characteristically might stay well for some time, to be found inadvertently or to present with complications. In the 13 years from Jan. 2003 to Dec. 2015, this prospective cohort study included consecutive pediatric patients under 12 years old, who presented either emergently or electively with any variety of CLM. The lesions encompassed in this assortment were congenital lobar emphysema (CLE), congenital pulmonary airway malformation (CPAM), bronchogenic cysts (BC), and bronchopulmonary sequestration (BPS). Results:Sixty-eight pediatric patients with CLM were operated at our institution; 18 CPAMs, 22 CLEs, 19 BPSs (17 intralobar and 2 extralobar), and 9 patients with BCs. The patients' age ranged from 1 to 54 months (mean age of 10.73?±?9.73 months), with overall male gender predominance (61.76%). Both CLE and CPAM had a male predominance, while BC and BPS had equivocal gender distribution. CLE patients had the earliest presentation at 2.89?±?1.5 months and congenital cystic adenomatoid malformations (CCAM) had the latest presentation at 21.78?±?15.6 months (F?=?15.27, p?<?0.0001). Lobectomy was the commonest procedure performed. Fifty-nine lobectomies were performed (21 LUL, 15 RLL, 14 LLL, 8 RUL, and 1 middle lobectomy). Six cystectomies were performed for BC. Twenty-three cases (33.8%) had postoperative complications that were mainly significant or prolonged air leak (13.24%), pneumonia (5.88%), 3 cases of hemothorax (4.4%), pulmonary atelectasis in 2 patients (2.94%), 1 patient developed effusion (1.47%), and there were 2 mortalities. Conclusions:CLM must be in mind in the differential diagnoses of any case with repeated infection, respiratory distress, or radiological abnormalities. Surgery in the form of lobectomy or lesser resection is generally safe.

Project description:Background Clinical risk factors in neonatal cardiac surgery do not fully capture discrepancies in outcomes. Targeted metabolomic analysis of plasma from neonates undergoing heart surgery with cardiopulmonary bypass was performed to determine associations with clinical outcomes. Methods and Result Samples and clinical variables from 149 neonates enrolled in the Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass trial with surgical treatment for congenital heart disease between 2012 and 2016 were included. Blood samples were collected before skin incision, immediately after cardiopulmonary bypass, and 12 hours after surgery. Outcomes include composite morbidity/mortality (death, extracorporeal membrane oxygenation, cardiac arrest, acute kidney injury, and/or hepatic injury) and a cardiac composite (extracorporeal membrane oxygenation, cardiac arrest, or increase in lactate level), hepatic injury, and acute kidney injury. Targeted metabolite levels were determined by high-resolution tandem liquid chromatography and mass spectrometry. Principal component and regression analyses were used to assess associations between metabolic profiles and outcomes, with 2 models created: a base clinical model and a base model+metabolites. Of the 193 metabolites examined, 40 were detected and quantified. The first principal component, principal component 1, was composed mostly of preoperative metabolites and was significantly associated with the composite morbidity/mortality, cardiac composite, and hepatic injury outcomes. In regression models, individual metabolites also improved model performance for the composite morbidity/mortality, cardiac composite, and hepatic injury outcomes. Significant disease pathways included myocardial injury (false discovery rate, 0.00091) and heart failure (false discovery rate, 0.041). Conclusions In neonatal cardiac surgery, perioperative metabolites were associated with postoperative outcomes and improved clinical model outcome associations. Preoperative metabolite levels alone may improve risk models and provide a basis for optimizing perioperative care.

Project description:Background Women with congenital heart disease are considered at high risk for adverse events. Therefore, we aim to establish 2 prediction models for mothers and their offspring, which can predict the risk of adverse events occurred in pregnant women with congenital heart disease. Methods and Results A total of 318 pregnant women with congenital heart disease were included; 213 women were divided into the development cohort, and 105 women were divided into the validation cohort. Least absolute shrinkage and selection operator was used for predictor selection. After validation, multivariate logistic regression analysis was used to develop the model. Machine learning algorithms (support vector machine, random forest, AdaBoost, decision tree, k-nearest neighbor, naïve Bayes, and multilayer perceptron) were used to further verify the predictive ability of the model. Forty-one (12.9%) women experienced adverse maternal events, and 93 (29.2%) neonates experienced adverse neonatal events. Seven high-risk factors were discovered in the maternal model, including New York Heart Association class, Eisenmenger syndrome, pulmonary hypertension, left ventricular ejection fraction, sinus tachycardia, arterial blood oxygen saturation, and pregnancy duration. The machine learning-based algorithms showed that the maternal model had an accuracy of 0.76 to 0.86 (area under the receiver operating characteristic curve=0.74-0.87) in the development cohort, and 0.72 to 0.86 (area under the receiver operating characteristic curve=0.68-0.80) in the validation cohort. Three high-risk factors were discovered in the neonatal model, including Eisenmenger syndrome, preeclampsia, and arterial blood oxygen saturation. The machine learning-based algorithms showed that the neonatal model had an accuracy of 0.75 to 0.80 (area under the receiver operating characteristic curve=0.71-0.77) in the development cohort, and 0.72 to 0.79 (area under the receiver operating characteristic curve=0.69-0.76) in the validation cohort. Conclusions Two prenatal risk assessment models for both adverse maternal and neonatal events were established, which might assist clinicians in tailoring precise management and therapy in pregnant women with congenital heart disease.

Project description:BackgroundIn Japan, Mycobacterium avium complex lung disease (MAC-LD) is the most common in nontuberculous mycobacterial lung disease. Patients often experience adverse events, resulting in the discontinuation of treatment, which causes treatment failure. The JADER (Japanese Adverse Drug Event Report) database is a database of adverse events that allows us to collect real-world data on adverse events. We can collect large-scale data cost-effectively and detect signals of potential adverse events such as reporting odds ratio (ROR) by using spontaneous reporting systems. In this study, we aimed to elucidate the adverse events of clarithromycin (CAM), ethambutol (EB), and rifampicin (RFP) using the JADER database.MethodsWe included cases of MAC-LD between April 2004 and June 2017. We investigated sex, age, and medications that may have caused the adverse events, outcomes, and time of onset. We calculated the safety signal index as the ROR. Time-to-event analysis was performed using the Weibull distribution.ResultsThe total number of adverse events of CAM, EB, and RFP was 2780, with 806 patients. In the overall adverse events, hematologic and lymphatic disorders were the most common adverse events, with 17.3%, followed by eye disorders (16.6%), and hepatobiliary disorders (14.0%). The outcomes were as follows: recovery, 40.0%; remission, 27.1%; non-recovery, 11.2%; and death, 7.1%. Regarding the most common onset time of CAM, EB, and RFP was within 120 days at 40%, 181-300 days at 43.6%, and within 120 days at 88.5%. For CAM, the RORs of infections and infestations, hepatobiliary system disorders, and immune system disorders were 4.13 (95% confidence interval [CI], 2.3-7.44), 2.61 (95% CI, 1.39-4.91), and 2.38 (95% CI, 1.04-5.44). For EB, the ROR of eye disorders was 215.79 (95% CI, 132.62-351.12). For RFP, the RORs of renal and urinary tract disorders and investigations were 7.03 (95% CI, 3.35-14.77) and 6.99 (95% CI, 3.22-15.18). The β value of EB was 2.07 (95% CI, 1.48-2.76), which was classified as a wear-out failure type.ConclusionsFor MAC-LD, the adverse event which has the highest ROR is infections and infestations in CAM, eye disorders in EB, renal and urinary tract disorders in RFP. Adverse events of EB occur after 180 days, whereas the adverse events of CAM and RFP occur early in the course of treatment.

Dataset Information

Reporting adverse events in a surgical trial for complex congenital heart disease: the Pediatric Heart Network experience.

Publications

Reporting adverse events in a surgical trial for complex congenital heart disease: the Pediatric Heart Network experience.

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