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Planned variation in preanalytical conditions to evaluate biospecimen stability in the National Children's Study (NCS).

ABSTRACT: BACKGROUND:Preanalytical conditions encountered during collection, processing, and storage of biospecimens may influence laboratory results. The National Children's Study (NCS) is a planned prospective cohort study of 100,000 families to examine the influence of a wide variety of exposures on child health. In developing biospecimen collection, processing, and storage procedures for the NCS, we identified several analytes of different biochemical categories for which it was unclear to what extent deviations from NCS procedures could influence measurement results. METHODS:A pilot study was performed to examine effects of preanalytic sample handling conditions (delays in centrifugation, freezing delays, delays in separation from cells, additive delay, and tube type) on concentrations of eight different analytes. A total of 2825 measurements were made to assess 15 unique combinations of analyte and handling conditions in blood collected from 151 women of childbearing age (? 20 individuals per handling condition). RESULTS:The majority of analytes were stable under the conditions evaluated. However, levels of plasma interleukin-6 and serum insulin were decreased in response to sample centrifugation delays of up to 5.5 h post-collection (p<0.0001). In addition, delays in freezing centrifuged plasma samples (comparing 24, 48 and 72 h to immediate freezing) resulted in increased levels of adrenocorticotropic hormone (p=0.0014). CONCLUSIONS:Determining stability of proposed analytes in response to preanalytical conditions and handling helps to ensure high-quality specimens for study now and in the future. The results inform development of procedures, plans for measurement of analytes, and interpretation of laboratory results.

SUBMITTER: Mechanic L

PROVIDER: S-EPMC4100775 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature

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Planned variation in preanalytical conditions to evaluate biospecimen stability in the National Children's Study (NCS).

Mechanic Leah L Mendez Armando A Merrill Lori L Rogers John J Layton Marnie M Todd Deborah D Varanasi Arti A O'Brien Barbara B Meyer Iii William A WA Zhang Ming M Schleicher Rosemary L RL Moye Jack J

Clinical chemistry and laboratory medicine 20131201 12

<h4>Background</h4>Preanalytical conditions encountered during collection, processing, and storage of biospecimens may influence laboratory results. The National Children's Study (NCS) is a planned prospective cohort study of 100,000 families to examine the influence of a wide variety of exposures on child health. In developing biospecimen collection, processing, and storage procedures for the NCS, we identified several analytes of different biochemical categories for which it was unclear to wha ...[more]

PMID: 23924524

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Project description:A challenge for large-scale environmental health investigations such as the National Children's Study (NCS), is characterizing exposures to multiple, co-occurring chemical agents with varying spatiotemporal concentrations and consequences modulated by biochemical, physiological, behavioral, socioeconomic, and environmental factors. Such investigations can benefit from systematic retrieval, analysis, and integration of diverse extant information on both contaminant patterns and exposure-relevant factors. This requires development, evaluation, and deployment of informatics methods that support flexible access and analysis of multiattribute data across multiple spatiotemporal scales. A new "Tiered Exposure Ranking" (TiER) framework, developed to support various aspects of risk-relevant exposure characterization, is described here, with examples demonstrating its application to the NCS. TiER utilizes advances in informatics computational methods, extant database content and availability, and integrative environmental/exposure/biological modeling to support both "discovery-driven" and "hypothesis-driven" analyses. "Tier 1" applications focus on "exposomic" pattern recognition for extracting information from multidimensional data sets, whereas second and higher tier applications utilize mechanistic models to develop risk-relevant exposure metrics for populations and individuals. In this article, "tier 1" applications of TiER explore identification of potentially causative associations among risk factors, for prioritizing further studies, by considering publicly available demographic/socioeconomic, behavioral, and environmental data in relation to two health endpoints (preterm birth and low birth weight). A "tier 2" application develops estimates of pollutant mixture inhalation exposure indices for NCS counties, formulated to support risk characterization for these endpoints. Applications of TiER demonstrate the feasibility of developing risk-relevant exposure characterizations for pollutants using extant environmental and demographic/socioeconomic data.

Project description:ImportanceIdentifying high priority pediatric conditions is important for setting a research agenda in hospital pediatrics that will benefit families, clinicians, and the health care system. However, the last such prioritization study was conducted more than a decade ago and used International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes.ObjectivesTo identify conditions that should be prioritized for comparative effectiveness research based on prevalence, cost, and variation in cost of hospitalizations using contemporary data at US children's hospitals.Design, setting, and participantsThis retrospective cohort study of children with hospital encounters used data from the Pediatric Health Information System database. Children younger than 18 years with inpatient hospital encounters at 45 tertiary care US children's hospitals between January 1, 2016, and December 31, 2019, were included. Data were analyzed from March 2020 to April 2021.Main outcomes and measuresThe condition-specific prevalence and total standardized cost, the corresponding prevalence and cost ranks, and the variation in standardized cost per encounter across hospitals were analyzed. The variation in cost was assessed using the number of outlier hospitals and intraclass correlation coefficient.ResultsThere were 2 882 490 inpatient hospital encounters (median [interquartile range] age, 4 [1-12] years; 1 554 024 [53.9%] boys) included. Among the 50 most prevalent and 50 most costly conditions (total, 74 conditions), 49 (66.2%) were medical, 15 (20.3%) were surgical, and 10 (13.5%) were medical/surgical. The top 10 conditions by cost accounted for $12.4 billion of $33.4 billion total costs (37.4%) and 592 815 encounters (33.8% of all encounters). Of 74 conditions, 4 conditions had an intraclass correlation coefficient (ICC) of 0.30 or higher (ie, major depressive disorder: ICC, 0.49; type 1 diabetes with complications: ICC, 0.36; diabetic ketoacidosis: ICC, 0.33; acute appendicitis without peritonitis: ICC, 0.30), and 9 conditions had an ICC higher than 0.20 (scoliosis: ICC, 0.27; hypertrophy of tonsils and adenoids: ICC, 0.26; supracondylar fracture of humerus: ICC, 0.25; cleft lip and palate: ICC, 0.24; acute appendicitis with peritonitis: ICC, 0.21). Examples of conditions high in prevalence, cost, and variation in cost included major depressive disorder (cost rank, 19; prevalence rank, 10; ICC, 0.49), scoliosis (cost rank, 6; prevalence rank, 38; ICC, 0.27), acute appendicitis with peritonitis (cost rank, 13; prevalence rank, 11; ICC, 0.21), asthma (cost rank, 10; prevalence rank, 2; ICC, 0.17), and dehydration (cost rank, 24; prevalence rank, 8; ICC, 0.18).Conclusions and relevanceThis cohort study found that major depressive disorder, scoliosis, acute appendicitis with peritonitis, asthma, and dehydration were high in prevalence, costs, and variation in cost. These results could help identify where future comparative effectiveness research in hospital pediatrics should be targeted to improve the care and outcomes of hospitalized children.

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Planned variation in preanalytical conditions to evaluate biospecimen stability in the National Children's Study (NCS).

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Planned variation in preanalytical conditions to evaluate biospecimen stability in the National Children's Study (NCS).

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