Dataset Information

Exploring the association of hemoglobin level and adverse events in children with cancer presenting with fever in neutropenia.

ABSTRACT:

Background

In children and adolescents with fever in neutropenia (FN) during chemotherapy for cancer, hemoglobin ?90 g/L at presentation with FN had been associated with adverse events (AE). This analysis explored three hypothetical pathophysiological mechanisms potentially explaining this counterintuitive finding, and further analyzed the statistical association between hemoglobin and AE.

Methods

Two of 8 centers, reporting on 311 of 421 FN episodes in 138 of 215 patients participated in this retrospective analysis based on prospectively collected data from three databases (SPOG 2003 FN, transfusion and hematology laboratories). Associations with AE were analyzed using mixed logistic regression.

Results

Hemoglobin was ?90 g/L in 141 (45%) of 311 FN episodes, specifically in 59/103 (57%) episodes with AE, and in 82/208 (39%) without (OR, 2.3; 99%CI, 1.1-4.9; P?=?0.004). In FN with AE, hemoglobin was bimodally distributed with a dip around 85 g/L. There were no significant interactions for center, age and sex. In multivariate mixed logistic regression, AE was significantly and independently associated with leukopenia (leukocytes <0.3 G/L; OR, 3.3; 99%CI, 1.1-99; P?=?0.004), dehydration (hemoglobinPresentation/hemoglobin8-72 hours ?1.10 in untransfused patients; OR, 3.5; 99%CI, 1.1-11.4; P?=?0.006) and non-moderate anemia (difference from 85 g/L; 1.6 per 10 g/L; 1.0-2.6; P?=?0.005), but not with recent transfusion of packed red blood cells (pRBC), very recent transfusion of pRBC or platelets, or with hemoglobin ?90 g/L as such.

Conclusions

Non-moderate anemia and dehydration were significantly and relevantly associated with the risk of AE in children with cancer and FN. These results need validation in prospective cohorts before clinical implementation.

SUBMITTER: Ammann RA

PROVIDER: S-EPMC4096594 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Exploring the association of hemoglobin level and adverse events in children with cancer presenting with fever in neutropenia.

Ammann Roland A RA Niggli Felix K FK Leibundgut Kurt K Teuffel Oliver O Bodmer Nicole N

PloS one 20140714 7

<h4>Background</h4>In children and adolescents with fever in neutropenia (FN) during chemotherapy for cancer, hemoglobin ≥90 g/L at presentation with FN had been associated with adverse events (AE). This analysis explored three hypothetical pathophysiological mechanisms potentially explaining this counterintuitive finding, and further analyzed the statistical association between hemoglobin and AE.<h4>Methods</h4>Two of 8 centers, reporting on 311 of 421 FN episodes in 138 of 215 patients partici ...[more]

PMID: 25020130

Similar Datasets

Project description:ImportanceThe adverse effects from the long-term use of oral corticosteroids are known, but, to our knowledge, few studies have reported the risk of corticosteroid bursts, particularly among children.ObjectiveTo quantify the associations of corticosteroid bursts with severe adverse events, including gastrointestinal (GI) bleeding, sepsis, pneumonia, and glaucoma, in children.Design, setting, and participantsThis study used data derived from the National Health Insurance Research Database in Taiwan from January 1, 2013, to December 31, 2017, on children younger than 18 years of age and used a self-controlled case series design. Data were analyzed from January 1 to July 30, 2020.ExposureOral corticosteroid bursts (defined as oral corticosteroid use for ≤14 days).Main outcomes and measuresIncidence rates were calculated of 4 severe adverse events (GI bleeding, sepsis, pneumonia, and glaucoma) in children who did or did not receive corticosteroid bursts. Conditional fixed-effect Poisson regression was used to estimate incidence rate ratios (IRRs) of severe adverse events within 5 to 30 days and 31 to 90 days after initiation of corticosteroid bursts.ResultsAmong 4 542 623 children, 23% (1 064 587; 544 268 boys [51.1%]; mean [SD] age, 9.7 [5.8] years) were prescribed a single corticosteroid burst. The most common indications were acute respiratory tract infections and allergic diseases. The incidence rate differences per 1000 person-years between children administered a single corticosteroid burst and those not prescribed corticosteroids were 0.60 (95% CI, 0.55-0.64) for GI bleeding, 0.03 (95% CI, 0.02-0.05) for sepsis, 9.35 (95% CI, 9.19-9.51) for pneumonia, and 0.01 (95% CI, 0.01-0.03) for glaucoma. The IRRs within 5 to 30 days after initiating corticosteroid bursts were 1.41 (95% CI, 1.27-1.57) for GI bleeding, 2.02 (95% CI, 1.55-2.64) for sepsis, 2.19 (95% CI, 2.13-2.25) for pneumonia, and 0.98 (95% CI, 0.85-1.13) for glaucoma; the IRRs within the subsequent 31 to 90 days were 1.10 (95% CI, 1.02-1.19) for GI bleeding, 1.08 (95% CI, 0.88-1.32) for sepsis, 1.09 (95% CI, 1.07-1.11) for pneumonia, and 0.95 (95% CI, 0.85-1.06) for glaucoma.Conclusions and relevanceThis study suggests that corticosteroid bursts, which are commonly prescribed for children with respiratory and allergic conditions, are associated with a 1.4- to 2.2-fold increased risk of GI bleeding, sepsis, and pneumonia within the first month after initiation of corticosteroid therapy that is attenuated during the subsequent 31 to 90 days.

Project description:ImportanceChildren of parents expressing limited comfort with English (LCE) or limited English proficiency may be at increased risk of adverse events (harms due to medical care). No prior studies have examined, in a multicenter fashion, the association between language comfort or language proficiency and systematically, actively collected adverse events that include family safety reporting.ObjectiveTo examine the association between parent LCE and adverse events in a cohort of hospitalized children.Design, setting, and participantsThis multicenter prospective cohort study was conducted from December 2014 to January 2017, concurrent with data collection from the Patient and Family Centered I-PASS Study, a clinician-family communication and patient safety intervention study. The study included 1666 Arabic-, Chinese-, English-, and Spanish-speaking parents of general pediatric and subspecialty patients 17 years and younger in the pediatric units of 7 North American hospitals. Data were analyzed from January 2018 to May 2020.ExposuresLanguage-comfort data were collected through parent self-reporting. LCE was defined as reporting any language besides English as the language in which parents were most comfortable speaking to physicians or nurses.Main outcomes and measuresThe primary outcome was adverse events; the secondary outcome was preventable adverse events. Adverse events were collected using a systematic 2-step methodology. First, clinician abstractors reviewed patient medical records, solicited clinician reports, hospital incident reports, and family safety interviews. Then, review and consensus classification were completed by physician pairs. To examine the association of LCE with adverse events, a multivariable logistic regression was conducted with random intercepts to adjust for clustering by site.ResultsOf 1666 parents providing language-comfort data, 1341 (80.5%) were female, and the mean (SD) age of parents was 35.4 (10.0) years. A total of 147 parents (8.8%) expressed LCE, most of whom (105 [71.4%]) preferred Spanish. Children of parents who expressed LCE had higher odds of having 1 or more adverse events compared with children whose parents expressed comfort with English (26 of 147 [17.7%] vs 146 of 1519 [9.6%]; adjusted odds ratio, 2.1; 95% CI, 1.2-3.7), after adjustment for parent race and education, complex chronic conditions, length of stay, site, and the intervention period. Similarly, children whose parents expressed LCE were more likely to experience 1 or more preventable adverse events (adjusted odds ratio, 2.3; 95% CI, 1.2-4.2).Conclusions and relevanceHospitalized children of parents expressing LCE were twice as likely to experience harms due to medical care. Targeted strategies are needed to improve communication and safety for this vulnerable group of children.

Project description:BackgroundLimited data are available on adverse events among children admitted to hospital. The Canadian Paediatric Adverse Events Study was done to describe the epidemiology of adverse events among children in hospital in Canada.MethodsWe performed a 2-stage medical record review at 8 academic pediatric centres and 14 community hospitals in Canada. We reviewed charts from patients admitted from April 2008 through March 2009, evenly distributed across 4 age groups (0 to 28 d; 29 to 365 d; > 1 to 5 yr and > 5 to 18 yr). In stage 1, nurses and health records personnel who had received training in the use of the Canadian Paediatric Trigger Tool reviewed medical records to detect triggers for possible adverse events. In stage 2, physicians reviewed the charts identified as having triggers and described the adverse events.ResultsA total of 3669 children were admitted to hospital during the study period. The weighted rate of adverse events was 9.2%. Adverse events were more frequent in academic pediatric centres than in community hospitals (adjusted odds ratio [OR] 2.98, 95% confidence interval [CI] 1.65-5.39). The incidence of preventable adverse events was not significantly different between types of hospital, but nonpreventable adverse events were more common in academic pediatric centres (adjusted OR 4.39, 95% CI 2.08-9.27). Surgical events predominated overall and occurred more frequently in academic pediatric centres than in community hospitals (37.2% v. 21.5%, relative risk [RR] 1.7, 95% CI 1.0-3.1), whereas events associated with diagnostic errors were significantly less frequent (11.1% v. 23.1%, RR 0.5, 95% CI 0.2-0.9).InterpretationMore children have adverse events in academic pediatric centres than in community hospitals; however, adverse events in the former are less likely to be preventable. There are many opportunities to reduce harm affecting children in hospital in Canada, particularly related to surgery, intensive care and diagnostic error.

Project description:ImportanceRituximab is among the most frequently used immunotherapies in pediatrics. Few studies have reported long-term adverse events associated with its use for children.ObjectiveTo describe the use of rituximab and to assess whether its use is associated with short- or long-term adverse events, infections, or time to immune reconstitution in a diverse group of young people.Design, setting, and participantsThis retrospective cohort study included 468 patients aged younger than 21 years who received rituximab for diverse indications between October 1, 2010, and December 31, 2017, at Texas Children's Hospital, a large pediatric referral hospital. Patterns of adverse events, infections, and immune recovery are described. Data analyses were conducted from December 2019 to June 2020.ExposureOne or more doses of rituximab.Main outcomes and measuresAdverse drug events (eg, anaphylaxis), incidence of mild and severe infections, and time to recovery of B lymphocyte subset counts and immunoglobulin levels. Survival models and logistic regression analyses and were used to identify associated risk factors of infectious and noninfectious adverse drug events.ResultsWe identified 468 patients receiving at least 1 dose of rituximab. The total follow-up time was 11 713 person-months. Of the 468 patients, 293 (62.6%) were female, the median (interquartile range) age at receipt of dose was 14.3 (9.9-16.8) years, and 209 (44.7%) were self-reported White Hispanic. Adverse events associated with rituximab infusion occurred in 72 patients (15.4%), and anaphylaxis occurred in 17 patients (3.6%). Long-term adverse events, such as prolonged neutropenia and leukoencephalopathy, were absent. Infections occurred in 224 patients (47.9%); 84 patients (17.9%) had severe infections, and 3 patients (0.6%) had lethal infections. Concurrent use of intravenous chemotherapy, treatment of systemic lupus erythematosus, neutropenia, and use of intravenous immunoglobulin were associated with increased risk of infection. Among 135 patients (28.8%) followed up to B cell count recovery, CD19+ or CD20+ cell numbers normalized in a median of 9.0 months (interquartile range, 5.9-14.4 months) following rituximab use; 48 of 95 patients (51%) evaluated beyond a year had low-for-age B cell counts. Recovery of CD27+ memory B cell number occurred in a median of 15.7 months (interquartile range, 6.0-22.7 months). Among patients with normal baseline values, low immunoglobulin G (IgG) levels developed in 67 of 289 patients (23.2%) and low IgM levels in 118 of 255 patients (40.8%); of these patients evaluated beyond 12 months from rituximab, 16 of 117 (13.7%) had persistently low IgG and 37 (33.9%) of 109 had persistently low IgM.Conclusions and relevanceRituximab is well tolerated among young people and is associated with few serious adverse events, but infections are common, corresponding to a prolonged period of B cell count recovery often lasting for longer than a year. Further examination of strategies to prevent infections following rituximab should be pursued.

Dataset Information

Exploring the association of hemoglobin level and adverse events in children with cancer presenting with fever in neutropenia.

Background

Methods

Results

Conclusions

Publications

Exploring the association of hemoglobin level and adverse events in children with cancer presenting with fever in neutropenia.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets