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Evaluation of the quality and value of data sources for postmarket surveillance of the safety of cough and cold medications in children.

ABSTRACT: BACKGROUND:The purpose of this report is to evaluate the quality of data sources used to study cough and cold medication (CCM) safety in children via the Pediatric Cough and Cold Safety Surveillance System. METHODS:The System utilized the National Poison Data System (NPDS), FDA Adverse Event Reporting System (FAERS), English-language medical literature, manufacturer postmarket safety databases, and news/media reports to identify cases from January 2008 through September 2016. Each data source was evaluated by the proportion of detected cases determined to be eligible (met case criteria) and the proportion determined to be evaluable (able to determine causal relationship between adverse event and exposure). RESULTS:A total of 7184 unique cases were identified from 27,597 detected reports. Of these, 6447 (89.7%) were evaluable. The data source with the highest volume of detected cases was news/media; however, only 0.3% of those cases were eligible for panel review and only 0.2% (24 out of 13,450 cases) were evaluable. The data source with the highest proportion of eligible and evaluable cases was NPDS with 7691 detected cases, 6113 (79.5%) eligible cases, and 5587 (72.6%) evaluable cases. CONCLUSIONS:The data sources utilized to evaluate the safety profile of pediatric CCMs yielded variable detection and evaluation rates, but overall provided a comprehensive look at exposures that otherwise cannot be studied in clinical trials. While this study suggests that each source made a valuable contribution and that evaluable cases are generalizable, improvements are needed in case completeness and accuracy to enhance the quality of postmarket safety evaluations.

SUBMITTER: Green JL

PROVIDER: S-EPMC6303866 | biostudies-other | 2018 Dec

REPOSITORIES: biostudies-other

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Evaluation of the quality and value of data sources for postmarket surveillance of the safety of cough and cold medications in children.

Green Jody L JL Reynolds Kate M KM Banner William W Bond G Randall GR Kauffman Ralph E RE Palmer Robert B RB Paul Ian M IM Dart Richard C RC

BMC medical research methodology 20181222 1

<h4>Background</h4>The purpose of this report is to evaluate the quality of data sources used to study cough and cold medication (CCM) safety in children via the Pediatric Cough and Cold Safety Surveillance System.<h4>Methods</h4>The System utilized the National Poison Data System (NPDS), FDA Adverse Event Reporting System (FAERS), English-language medical literature, manufacturer postmarket safety databases, and news/media reports to identify cases from January 2008 through September 2016. Each ...[more]

PMID: 30577764

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Project description:BackgroundCough is the most common symptom presenting to doctors. The quality of cough (productive or wet vs dry) is used clinically as well as in epidemiology and clinical research. There is however no data on the validity of cough quality descriptors. The study aims were to compare (1) cough quality (wet/dry and brassy/non-brassy) to bronchoscopic findings of secretions and tracheomalacia respectively and, (2) parent's vs clinician's evaluation of the cough quality (wet/dry).MethodsCough quality of children (without a known underlying respiratory disease) undergoing elective bronchoscopy was independently evaluated by clinicians and parents. A 'blinded' clinician scored the secretions seen at bronchoscopy on pre-determined criteria and graded (1 to 6). Kappa (K) statistics was used for agreement, and inter-rater and intra-rater agreement examined on digitally recorded cough. A receiver operating characteristic (ROC) curve was used to determine if cough quality related to amount of airway secretions present at bronchoscopy.ResultsMedian age of the 106 children (62 boys, 44 girls) enrolled was 2.6 years (IQR 5.7). Parent's assessment of cough quality (wet/dry) agreed with clinicians' (K = 0.75, 95%CI 0.58-0.93). When compared to bronchoscopy (bronchoscopic secretion grade 4), clinicians' cough assessment had the highest sensitivity (0.75) and specificity (0.79) and were marginally better than parent(s). The area under the ROC curve was 0.85 (95%CI 0.77-0.92). Intra-observer (K = 1.0) and inter-clinician agreement for wet/dry cough (K = 0.88, 95%CI 0.82-0.94) was very good. Weighted K for inter-rater agreement for bronchoscopic secretion grades was 0.95 (95%CI 0.87-1). Sensitivity and specificity for brassy cough (for tracheomalacia) were 0.57 and 0.81 respectively. K for both intra and inter-observer clinician agreement for brassy cough was 0.79 (95%CI 0.73-0.86).ConclusionsDry and wet cough in children, as determined by clinicians and parents has good clinical validity. Clinicians should however be cognisant that children with dry cough may have minimal to mild airway secretions. Brassy cough determined by respiratory physicians is highly specific for tracheomalacia.

Project description:ContextCarbon monoxide (CO) exposure can be life-threatening. Suspected and confirmed cases of CO poisoning warranting health care in New York City (NYC) are reportable to the NYC Poison Control Center (PCC).ObjectivesWe evaluated 4 hospital-based sources of CO surveillance data to identify ways to improve data capture and reporting.DesignSuspected and confirmed CO poisoning records from October 2015 through December 2016 were collected from the NYC emergency department (ED) syndromic surveillance system, New York State Statewide Planning and Research Cooperative System (SPARCS) ED billing data, NYC PCC calls made from hospitals, and the Electronic Clinical Laboratory Reporting System (ECLRS). Syndromic and SPARCS records were person- and visit-matched. SPARCS and ECLRS records were also matched to PCC records on combinations of name, demographic characteristics, and visit information.SettingHospitals in NYC.ParticipantsIndividuals who visited NYC hospitals for CO-related health effects.Main outcome measuresWe assessed the validity of syndromic data, with SPARCS records as the gold standard. We matched SPARCS and ECLRS records to PCC records to analyze reporting rates by case characteristics.ResultsThe sensitivity of syndromic surveillance was 60% (225 true-positives detected among 372 visit-matched SPARCS cases), and positive predictive value was 46%. Syndromic records often missed CO flags because of a nonspecific or absent International Classification of Diseases code in the diagnosis field. Only 15% of 428 SPARCS records (total includes 56 records not visit-matched to syndromic) and 16% of 199 ECLRS records were reported to PCC, with male sex and younger age associated with higher reporting.ConclusionsMandatory reporting makes PCC useful for tracking CO poisoning in NYC, but incomplete reporting and challenges in distinguishing between confirmed and suspected cases limit its utility. Simultaneous tracking of the systems we evaluated can best reveal surveillance patterns.

Project description:ImportanceChildhood suicidality (ie, suicidal ideation or attempts) rates are increasing, and attention-deficit/hyperactivity disorder (ADHD) and externalizing symptoms are common risk factors associated with suicidality. More data are needed to describe associations of ADHD pharmacotherapy with childhood suicidality.ObjectiveTo investigate the associations of ADHD pharmacotherapy with externalizing symptoms and childhood suicidality.Design, setting, and participantsIn this cohort study, cross-sectional and 1-year-longitudinal associations were examined using data (collected during 2016-2019) from the Adolescent Brain Cognitive Development (ABCD) Study, a large, diverse US sample of children aged 9 to 11 years. Data analysis was performed from November to December 2020.ExposuresMain and interaction associations of externalizing symptoms (hyperactivity ADHD symptoms, oppositional defiant, and conduct disorder symptoms) and ADHD medication treatment (methylphenidate and amphetamine derivatives, α-2-agonists, and atomoxetine) at baseline assessment.Main outcomes and measuresChild-reported suicidality (past and present at baseline; current at longitudinal assessment). Covariates were age, sex, race/ethnicity, parents' education, marital status, and concomitant child psychiatric pharmacotherapy (antidepressants and antipsychotics).ResultsAmong 11 878 children at baseline assessment (mean [SD] age, 9.9 [0.6] years; 6196 boys [52.2%]; 8805 White [74.1%]), 1006 (8.5%) were treated with ADHD medication and 1040 (8.8%) reported past or current suicidality. Externalizing symptoms (median [range], 1 [0-29] symptom count) were associated with suicidality (for a change of 1 SD in symptoms, odds ratio [OR], 1.34; 95% CI, 1.26-1.42; P < .001), as was ADHD medication treatment (OR, 1.32; 95% CI, 1.06-1.64; P = .01). ADHD medication use was associated with less suicidality in children with more externalizing symptoms (significant symptom-by-medication interaction, B = -0.250; SE = 0.086; P = .004), such that for children who were not receiving ADHD medications, there was an association between more externalizing symptoms and suicidality (for a change of 1 SD in symptoms, OR, 1.42; 95% CI, 1.33-1.52; P < .001); however, for children who were receiving ADHD medication, there was no such association (OR, 1.15; 95% CI, 0.97-1.35; P = .10). The association with medication remained even when covarying for multiple confounders, including risk and protective factors for suicidality in ABCD, and was replicated in 1-year longitudinal follow-up. Sensitivity analyses matching participants with high numbers of externalizing symptoms taking and not taking ADHD medication treatment confirmed its association with less suicidality.Conclusions and relevanceThese findings suggest that ADHD medication treatment is associated with less suicidality in children with substantial externalizing symptoms and may be used to inform childhood suicide prevention strategies.

Dataset Information

Evaluation of the quality and value of data sources for postmarket surveillance of the safety of cough and cold medications in children.

Publications

Evaluation of the quality and value of data sources for postmarket surveillance of the safety of cough and cold medications in children.

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