Publications by authors named "Alexandra Hall"

22 Publications

  • Page 1 of 1

Cardiac Biomarkers in Pediatrics: An Undervalued Resource.

Clin Chem 2021 Jun 14. Epub 2021 Jun 14.

CALIPER Program, Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON, Canada.

Background: The clinical use of common cardiac biomarkers, such as brain natriuretic peptides and troponins, has traditionally been limited to adult populations in the assessment of heart failure and acute coronary syndrome, respectively. While many have discounted the value of these markers in pediatric populations, emerging evidence suggests they may be useful in the diagnosis and prognostication of many cardiac and noncardiac pathologies in neonates, children, and adolescents, and an increasing number of pediatric hospitals are routinely measuring cardiac markers in their clinical practice.

Content: This review summarizes and critically evaluates the current literature regarding the application of cardiac biomarkers for clinical decision-making in the pediatric population. Main potential clinical indications discussed herein include primary cardiac disease, immune-related conditions, and noncardiac disease. Important diagnostic and interpretative challenges are also described in relation to each potential indication.

Summary: Despite a general lack of clinical awareness regarding the value of cardiac biomarkers in pediatrics, there is increasing literature to support their application in various contexts. Cardiac biomarkers should be considered an undervalued resource in the pediatric population with potential value in the diagnosis and prognosis of myocarditis, congenital heart disease, and heart failure, as well as in the assessment of severity and cardiac involvement in immune-related and other systemic conditions. While interpretation remains challenging in pediatrics due to the age- and sex-specific dynamics occurring throughout growth and development, this should not prevent their application. Future research should focus on defining evidence-based cut-offs for specific indications using the most up-to-date assays.
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http://dx.doi.org/10.1093/clinchem/hvab063DOI Listing
June 2021

Pediatric Reference Intervals for Critical Point-of-Care Whole Blood Assays in the CALIPER Cohort of Healthy Children and Adolescents.

Am J Clin Pathol 2021 May 29. Epub 2021 May 29.

CALIPER Program, Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, Canada.

Objectives: Point-of-care testing (POCT) is being increasingly adopted to support clinical care. Data for critical care parameters in healthy children on POCT instruments are lacking. We established comprehensive reference standards for several whole blood parameters on the Radiometer ABL90 FLEX PLUS blood gas analyzer in the Canadian Laboratory Initiative on Paediatric Reference Intervals (CALIPER) cohort.

Methods: Approximately 300 healthy children and adolescents (age range, birth to <19 years; sex, boys and girls) were recruited with informed consent. Venous whole blood was collected (using heparinized syringes) and rapidly analyzed at the point of collection for pH, Pco2, Po2, carboxyhemoglobin, methemoglobin, lactate, and electrolytes on the ABL90 FLEX PLUS instrument. Reference intervals were established according to Clinical and Laboratory Standards Institute guidelines.

Results: Of the parameters assessed, 6 required age partitioning; none required sex partitioning. Reference value distributions were consistent across the pediatric age range, demonstrating higher variation in the early neonatal period.

Conclusions: This study established reference standards for 10 critical care analytes in the CALIPER cohort for the first time. These data contribute to our understanding of normative pediatric values for venous electrolytes, metabolites, and blood gases on a modern POCT instrument, facilitating test interpretation in clinical settings that use these assays.
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http://dx.doi.org/10.1093/ajcp/aqab064DOI Listing
May 2021

Pediatric reference interval verification for common biochemical assays on the Abbott Alinity system.

Clin Chem Lab Med 2021 May 19. Epub 2021 May 19.

CALIPER Program, Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON, Canada.

Objectives: The quality of clinical laboratory service depends on quality laboratory operations and accurate test result interpretation based on reference intervals (RIs). As new analytical systems continue to be developed and improved, previously established RIs must be verified. The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) has established comprehensive RIs for many biomarkers on several analytical systems. Here, published CALIPER RIs for 28 chemistry assays on the Abbott ARCHITECT were assessed for verification on the newer Alinity system.

Methods: An analytical validation was first completed to assess assay performance. CALIPER serum samples (100) were analyzed for 28 chemistry assays on the Alinity system. The percentage of results falling within published pediatric ARCHITECT reference and confidence limits was determined for each analyte. Based on Clinical and Laboratory Standards Institute (CLSI) guidelines, if ≥90% of test results fell within confidence limits of ARCHITECT assay RIs, they were considered verified.

Results: Of the 28 assays assessed, 26 met the criteria for verification. Reference values for calcium and magnesium did not meet the criteria for verification with 87% and 35% falling within previously established ARCHITECT confidence limits, respectively. However, both assays could be verified using pediatric RIs provided in the Abbott Alinity package insert.

Conclusions: In this study, CALIPER ARCHITECT RIs were verified on the Alinity system for several chemistry assays. These data demonstrate excellent concordance for most assays between the Abbott ARCHITECT and Alinity systems and will assist in the implementation of the Alinity system in pediatric healthcare institutions.
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http://dx.doi.org/10.1515/cclm-2021-0336DOI Listing
May 2021

Pediatric reference intervals for endocrine markers and fertility hormones in healthy children and adolescents on the Siemens Healthineers Atellica immunoassay system.

Clin Chem Lab Med 2021 May 6. Epub 2021 May 6.

CALIPER Program, Department of Pediatric Laboratory Medicine, Hospital for Sick Children, Toronto, ON, Canada.

Objectives: Rapid development in childhood and adolescence combined with lack of immunoassay standardization necessitates the establishment of age-, sex-, and assay-specific reference intervals for immunochemical markers. This study established reference intervals for 11 immunoassays on the new Siemens Healthineers Atellica® IM Analyzer in the healthy CALIPER cohort.

Methods: A total of 600 healthy participants (birth to 18 years) were recruited from the community, and serum samples were collected with informed consent. After sample analysis, age- and sex-specific differences were assessed, and outliers were removed. Reference intervals were established using the robust method (40-<120 participants) or nonparametric method (≥120 participants).

Results: Of the 11 immunoassays studied, nine required age partitioning (i.e., dehydroepiandrosterone-sulfate, estradiol, ferritin, folate, follicle-stimulating hormone, luteinizing hormone, progesterone, testosterone, vitamin B12), and seven required sex partitioning. Free thyroxine and thyroid-stimulating hormone demonstrated no significant age- and/or sex-specific differences.

Conclusions: Overall, the age- and sex-specific trends observed closely mirrored those previously reported by CALIPER on other platforms as well as other internationally recognized studies. However, established lower and upper limits demonstrated some discrepancies between published values from healthy cohorts on alternate analytical systems, highlighting differences between manufacturers and the need for platform-specific reference intervals for informed pediatric clinical decision-making.
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http://dx.doi.org/10.1515/cclm-2021-0050DOI Listing
May 2021

Continuous reference intervals for 19 endocrine, fertility, and immunochemical markers in the CALIPER cohort of healthy children and adolescents.

Clin Biochem 2021 Apr 18. Epub 2021 Apr 18.

CALIPER Program, Pediatric Laboratory Medicine & Molecular Medicine, The Hospital for Sick Children, Toronto, ON, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada. Electronic address:

Background: Reference intervals are traditionally partitioned into discrete ranges by major covariates such as age and sex. However, discrete reference intervals often oversimplify the complex relationship between analyte concentration and age. Continuous reference intervals have been suggested to more accurately represent this complex relationship, particularly in pediatrics. The objective of this study was to establish continuous reference intervals for endocrine, fertility, and additional immunochemical parameters in the CALIPER cohort of healthy children and adolescents.

Methods: Continuous reference intervals from 1 to 18.5 years of age were established using retrospective CALIPER data collected from healthy Canadian children and adolescents. Continuous reference intervals (2.5th and 97.5th percentiles) were determined for 19 parameters by nonparametric quantile regression. Total and yearly flagging rates were calculated for the upper and lower continuous reference limits and compared to previously published partitioned reference limits.

Results: Continuous reference intervals were established for 19 endocrine, fertility, and additional immunochemical parameters, with 11 requiring sex-specific reference curves. Continuous reference intervals assessed both visually and by flagging rate analysis more accurately represented the relationship between analyte concentration and age, particularly for parameters with complex reference value patterns.

Conclusion: This is the first comprehensive report to establish continuous reference intervals for several immunochemical parameters including endocrine and fertility markers in a healthy paediatric Canadian cohort. The ability of continuous reference intervals to provide a better estimate of age-related changes in reference values suggest their potential to improve paediatric laboratory test result interpretation and clinical decision-making.
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http://dx.doi.org/10.1016/j.clinbiochem.2021.04.014DOI Listing
April 2021

Early language screening and intervention can be delivered successfully at scale: evidence from a cluster randomized controlled trial.

J Child Psychol Psychiatry 2021 Mar 30. Epub 2021 Mar 30.

University of Oxford, Oxford, UK.

Background: It is well established that oral language skills provide a critical foundation for formal education. This study evaluated the effectiveness of the Nuffield Early Language Intervention (NELI) programme in ameliorating language difficulties in the first year of school when delivered at scale.

Methods: We conducted a cluster randomized controlled trial (RCT) in 193 primary schools (containing 238 Reception classrooms). Schools were randomly allocated to either a 20-week oral language intervention or a business-as-usual control group. All classes (N = 5,879 children) in participating schools were screened by school staff using an automated App to assess children's oral language skills. Screening identified 1,173 children as eligible for language intervention: schools containing 571 of these children were allocated to the control group and 569 to the intervention group.

Results: Children receiving the NELI programme made significantly larger gains than the business-as-usual control group on a latent variable reflecting standardized measures of language ability (d = .26) and on the school-administered automated assessment of receptive and expressive language skills (d = .32). The effects of intervention did not vary as a function of home language background or gender.

Conclusions: This study provides strong evidence for the effectiveness of a school-based language intervention programme (NELI) delivered at scale. These findings demonstrate that language difficulties can be identified by school-based testing and ameliorated by a TA delivered intervention; this has important implications for educational and social policy.
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http://dx.doi.org/10.1111/jcpp.13415DOI Listing
March 2021

Pediatric evaluation of clinical specificity and sensitivity of SARS-CoV-2 IgG and IgM serology assays.

Clin Chem Lab Med 2021 05 22;59(6):e235-e237. Epub 2021 Jan 22.

CALIPER Program, The Hospital for Sick Children, Toronto, ON, Canada.

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http://dx.doi.org/10.1515/cclm-2020-1822DOI Listing
May 2021

Complex biological patterns of hematology parameters in childhood necessitating age- and sex-specific reference intervals for evidence-based clinical interpretation.

Int J Lab Hematol 2020 Dec 12;42(6):750-760. Epub 2020 Aug 12.

CALIPER Program, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON, Canada.

Introduction: Hematology laboratory parameters are among the most routinely ordered tests in support of adult and pediatric care. However, appropriate interpretation of test results has been a challenge in pediatrics since accurate and up-to-date reference intervals that reflect the dynamic physiological changes associated with growth and development have not been available. Critical gaps continue to exist in pediatric hematology reference intervals for modern laboratory platforms. To address this gap, this study establishes age- and sex-specific reference intervals for 25 hematology parameters in the CALIPER cohort of healthy children and adolescents using a common platform, the Sysmex XN-3000 analytical system.

Methods: Fresh whole blood samples collected from a total of 641 healthy children and adolescents (birth to <21 years) with informed consent were analyzed for 25 hematological parameters on the Sysmex XN-3000 Hematology Analyzer. Age- and sex-specific reference standards were calculated based on Clinical and Laboratory Standards Institute guidelines.

Results: Of the 25 analytes assessed, 19 required age-partitioning and seven required sex-partitioning (ie, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, red blood cell distribution width-SD, red blood cell distribution width-CV, and monocyte percentage). Age- and sex-specific differences mostly coincided with the onset of puberty.

Conclusion: This study establishes a comprehensive database of pediatric reference intervals for hematology parameters in the CALIPER cohort using the widely used Sysmex XN-3000 analytical platform. These data highlight the dynamic hematological profile observed in healthy children and adolescents and the need for reference interval stratification by age and sex.
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http://dx.doi.org/10.1111/ijlh.13306DOI Listing
December 2020

Pathophysiology of COVID-19: Mechanisms Underlying Disease Severity and Progression.

Physiology (Bethesda) 2020 09;35(5):288-301

Molecular Medicine, Research Institute, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.

The global epidemiology of coronavirus disease 2019 (COVID-19) suggests a wide spectrum of clinical severity, ranging from asymptomatic to fatal. Although the clinical and laboratory characteristics of COVID-19 patients have been well characterized, the pathophysiological mechanisms underlying disease severity and progression remain unclear. This review highlights key mechanisms that have been proposed to contribute to COVID-19 progression from viral entry to multisystem organ failure, as well as the central role of the immune response in successful viral clearance or progression to death.
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http://dx.doi.org/10.1152/physiol.00019.2020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7426542PMC
September 2020

CALIPER Hematology Reference Standards (I).

Am J Clin Pathol 2020 08;154(3):330-341

CALIPER Program, Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, Canada.

Objectives: Accurate hematologic test interpretation based on normative reference standards is critical to ensure appropriate clinical decision making. However, healthy pediatric reference data for most hematology parameters are lacking. To address this gap, this study establishes age- and sex-specific hematologic reference standards in the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) cohort of healthy children and adolescents.

Methods: Fresh whole blood samples collected from a total of 566 healthy children and adolescents (birth to <21 years) with informed consent were analyzed for 47 hematologic parameters on the Beckman Coulter DxH 900. Age- and sex-specific reference standards were calculated based on the Clinical and Laboratory Standards Institute guidelines.

Results: Reference value distributions for most hematology parameters demonstrated dynamic changes across the pediatric age range with significant age-specific differences observed for 39 of the 47 parameters examined. Sex-specific differences were also observed for eight hematologic parameters, primarily during and after puberty.

Conclusions: This study establishes a robust database of pediatric reference standards for 47 hematologic parameters in the CALIPER cohort for the first time. These comprehensive reference value data sets report potentially important and physiologically relevant trends in hematologic markers, clearly demonstrating the need for pediatric reference standards for hematologic test interpretation.
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http://dx.doi.org/10.1093/ajcp/aqaa059DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7403759PMC
August 2020

CALIPER Hematology Reference Standards (II).

Am J Clin Pathol 2020 08;154(3):342-352

CALIPER Program, Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, Canada.

Objectives: The objective of this study was to establish comprehensive age- and sex-specific reference intervals for hematologic parameters in the CALIPER cohort of healthy children and adolescents.

Methods: A total of 536 healthy children and adolescents (birth to 21 years) were recruited with informed consent, and whole blood samples were analyzed for 27 hematologic parameters on the Beckman Coulter DxH 520 system. Age- and sex-specific pediatric reference standards were established. Reference values obtained on the DxH 520 were also compared with data obtained on a larger laboratory-based instrument (DxH 900).

Results: Most hematologic parameters showed significant age- and/or sex-specific changes during growth and development. Of the 27 hematologic parameters, all except four (mean corpuscular hemoglobin concentration, basophil percentage, low hemoglobin density, immature cell percentage) required age partitioning, and eight required sex partitioning.

Conclusions: This study establishes a robust pediatric hematology reference database that will assist in more accurate test result interpretation. Our data clearly demonstrate significant variation in hematologic parameter concentrations in children and adolescents, necessitating the use of pediatric-specific reference standards.
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http://dx.doi.org/10.1093/ajcp/aqaa057DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7403758PMC
August 2020

A scoping review of importation and predictive models related to vector-borne diseases, pathogens, reservoirs, or vectors (1999-2016).

PLoS One 2020 15;15(1):e0227678. Epub 2020 Jan 15.

Department of Population Medicine, Ontario Veterinary College, University of Guelph, Guelph, Ontario, Canada.

Background: As globalization and climate change progress, the expansion and introduction of vector-borne diseases (VBD) from endemic regions to non-endemic regions is expected to occur. Mathematical and statistical models can be useful in predicting when and where these changes in distribution may happen. Our objective was to conduct a scoping review to identify and characterize predictive and importation models related to vector-borne diseases that exist in the global literature.

Methods: A literature search was conducted to identify publications published between 1999 and 2016 from five scientific databases using relevant keywords. All publications had to be in English or French, and include a predictive or importation model on VBDs, pathogens, reservoirs and/or vectors. Relevance screening and data characterization were performed by two reviewers using pretested forms. The data were analyzed using descriptive statistics.

Results: The search initially identified 19 710 unique articles, reports, and conference abstracts. This was reduced to 428 relevant documents after relevance screening and data charting. About half of the models used mathematical techniques, and the remainder were statistical. Most of the models were predictive (87%), rather than importation (5%). The most commonly investigated diseases were malaria and dengue fever. Around 12% of the publications did not report all the parameters used in their model. Only 29% of the models incorporated the impacts of climate change.

Conclusions: A wide variety of mathematical and statistical models on vector-borne diseases exist. Researchers creating their own mathematical and/or statistical models may be able to use this scoping review to be informed about the diseases and/or regions, parameters, model types, and methodologies used in published models.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0227678PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6961930PMC
April 2020

Influence of ethnicity on biochemical markers of health and disease in the CALIPER cohort of healthy children and adolescents.

Clin Chem Lab Med 2020 03;58(4):605-617

CALIPER Program, Clinical Biochemistry, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.

Background Accurate pediatric reference intervals (RIs) for laboratory tests determined in a healthy pediatric population are essential for correct laboratory test interpretation and clinical decision-making. In pediatrics, RIs require partitioning by age and/or sex; however, the need for partitioning based on ethnicity is unclear. Here, we assessed the influence of ethnicity on biomarker concentrations in the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) cohort of healthy children and adolescents and compared the results with the National Health and Nutrition Examination Survey (NHANES). Methods A total of 52 biomarkers were measured in a multiethnic population of 846-1179 healthy children (aged 5 to <19 years) upon informed consent. Biomarker concentrations were retrospectively compared between four major ethnic groups (i.e. Black, Caucasian, East Asian, and South Asian, determined by parental ethnicity). Retrospective results were verified prospectively using an additional 500 healthy pediatric samples with equal sample size across ethnicities. Ethnic-specific differences were assessed based on statistical significance and biological and analytical variations. Appropriate age-, sex-, and ethnic-specific RIs were calculated. Results Ethnic-specific differences were not observed for 34 biomarkers examined in the retrospective analysis, while 18 demonstrated statistically significant ethnic differences. Among these, seven analytes demonstrated ethnic-specific differences in the prospective analysis: vitamin D, amylase, ferritin, follicle-stimulating hormone (FSH), immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM). Analysis of select NHANES data confirmed CALIPER findings. Conclusions This is the first comprehensive Canadian pediatric study examining ethnic-specific differences in common biomarkers. While the majority of biomarkers did not require ethnic partitioning, ethnic-specific RIs were established for seven biomarkers showing marked differences. Further studies in other populations are needed to confirm our findings.
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http://dx.doi.org/10.1515/cclm-2019-0876DOI Listing
March 2020

User-driven design of child restraint information to reduce errors in use: a pilot randomised controlled trial.

Inj Prev 2020 10 17;26(5):432-438. Epub 2019 Sep 17.

Neuroscience Research Australia, University of New South Wales, Sydney, New South Wales, Australia

Background: Incorrect use of child restraints is a long-standing problem that increases the risk of injury in crashes. We used user-centred design to develop prototype child restraint instructional materials. The objective of this study was to evaluate these materials in terms of comprehension and errors in the use of child restraints. The relationship between comprehension and errors in use was also explored.

Methods: We used a parallel-group randomised controlled trial in a laboratory setting. The intervention group (n=22) were provided with prototype materials and the control group (n=22) with existing instructional materials for the same restraint. Participants installed the restraint in a vehicle buck, secured an appropriately sized mannequin in the restraint and underwent a comprehension test. Our primary outcome was overall correct use, and our secondary outcomes were (1) comprehension score and (2) percent errors in the installation trial.

Results: There was 27% more overall correct use (p=0.042) and a higher mean comprehension score in the intervention group (mean 17, 95% CI 16 to 18) compared with the control group (mean 12, 95% CI 10 to 14, p<0.001). The mean error percentage in the control group was 23% (95% CI 16% to 31%) compared with 14% in the intervention group (95% CI 8% to 20%, p=0.056). For every one point increase in comprehension, there was an almost 2% (95% CI -2.7% to -1.0%) reduction in errors (y=45.5-1.87x, p value for slope <0.001).

Conclusions: Consumer-driven design of informational materials can increase the correct use of child restraints. Targeting improved comprehension of informational materials may be an effective mechanism for reducing child restraint misuse.
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http://dx.doi.org/10.1136/injuryprev-2019-043380DOI Listing
October 2020

Cardiac changes during the peri-menopausal period in a VCD-induced murine model of ovarian failure.

Acta Physiol (Oxf) 2019 09 31;227(1):e13290. Epub 2019 May 31.

Department of Biomedical Sciences, University of Guelph, Guelph, Ontario, Canada.

Aim: Cardiovascular disease (CVD) risk is lower in pre-menopausal females vs age matched males. After menopause risk equals or exceeds that of males. CVD protection of pre-menopausal females is ascribed to high circulating oestrogen levels. Despite experimental evidence that oestrogen are cardioprotective, oestrogen replacement therapy trials have not shown clear benefits. One hypothesis to explain the discrepancy proposed hearts remodel during peri-menopause. Peri-menopasual myocardial changes have never been investigated, nor has the ability of oestrogen to regulate heart function during peri-menopause.

Methods: We injected female mice with 4-vinylcyclohexene diepoxide (VCD, 160 mg/kg/d IP) to cause gradual ovarian failure over 120d and act as a peri-menopausal model RESULTS: Left ventricular function assessed by Langendorff perfusion found no changes in VCD-injected mice at 60 or 120 days compared to intact mice. Cardiac myofilament activity was altered at 60 and 120 days indicating a molecular remodelling in peri-menopause. Myocardial TGF-β1 increased at 60 days post-VCD treatment along with reduced Akt phosphorylation. Acute activation of oestrogen receptor-α (ERα) or -β (ERβ) depressed left ventricular contractility in hearts from intact mice. ER-regulation of myocardial and myofilament function, and myofilament phosphorylation, were disrupted in the peri-menopausal model. Disruption occurred without alterations in total ERα or ERβ expression.

Conclusions: This is the first study to demonstrate remodelling of the heart in a model of peri-menopause, along with a disruption in ER-dependent regulation of the heart. These data indicate that oestrogen replacement therapy initiated after menopause affects a heart that is profoundly different from that found in reproductively intact animals.
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http://dx.doi.org/10.1111/apha.13290DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7379283PMC
September 2019

Understanding resilience as it affects the transition from the UK Armed Forces to civilian life.

Rand Health Q 2018 Oct 11;8(2). Epub 2018 Oct 11.

There has been growing interest among policy officials, charity representatives and academic experts in understanding the transition process of UK Service leavers. While recent evidence suggests that resilience is important for a successful transition, no systematic review has been undertaken on this topic before this study. FiMT commissioned RAND Europe to research whether - and how - resilience can affect individual transition pathways and outcomes for UK Service leavers.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6183778PMC
October 2018

Can child restraint product information developed using consumer testing sustain correct use 6 months after child restraint purchase? Study protocol for a cluster randomised controlled trial.

Inj Prev 2019 06 7;25(3):175-179. Epub 2018 Mar 7.

Injury Prevention, Neuroscience Research Australia, Randwick, New South Wales, Australia.

Background: With long-standing and widespread high rates of errors in child restraint use, there is a need to identify effective methods to address this problem. Information supplied with products at the point of sale may be a potentially efficient delivery point for such a countermeasure. The aim of this study is to establish whether product materials developed using a consumer-driven approach reduce errors in restraint use among purchasers of new child restraint systems.

Methods: A cluster randomised controlled trial (cRCT) will be conducted. Retail stores (n=22) in the greater Sydney area will be randomised into intervention sites (n=11) and control sites (n=11), stratified by geographical and socioeconomic indicators. Participants (n=836) will enter the study on purchase of a restraint. Outcome measures are errors in installation of the restraint as observed by a trained researcher during a 6-month follow-up home assessment, and adjustment checks made by the parent when the child is placed into the restraint (observed using naturalistic methods). Process evaluation measures will also be collected during the home visit. An intention-to-treat approach will be used for all analyses. Correct use and adjustment checks made by the parent will be compared between control and intervention groups using a logistic regression model. The number of installation errors between groups will be compared using Poisson regression.

Discussion: This cRCT will determine the effectiveness of targeted, consumer-driven information on actual error rates in use of restraints. More broadly, it may provide a best practice model for developing safety product information.

Trial Registration Number: ACTRN12617001252303p; Pre-results.
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http://dx.doi.org/10.1136/injuryprev-2017-042571DOI Listing
June 2019

Purification and immunogenicity of hemagglutinin from highly pathogenic avian influenza virus H5N1 expressed in Nicotiana benthamiana.

Hum Vaccin Immunother 2017 02 8;13(2):306-313. Epub 2016 Dec 8.

d Fraunhofer USA Center for Molecular Biotechnology , Newark , DE , USA.

Highly pathogenic avian influenza (HPAI) H5N1 is an ongoing global health concern due to its severe sporadic outbreaks in Asia, Africa and Europe, which poses a potential pandemic threat. The development of safe and cost-effective vaccine candidates for HPAI is considered the best strategy for managing the disease and addressing the pandemic preparedness. The most potential vaccine candidate is the antigenic determinant of influenza A virus, hemagglutinin (HA). The present research was aimed at developing optimized expression in Nicotiana benthamiana and protein purification process for HA from the Malaysian isolate of H5N1 as a vaccine antigen for HPAI H5N1. Expression of HA from the Malaysian isolate of HPAI in N. benthamiana was confirmed, and more soluble protein was expressed as truncated HA, the HA1 domain over the entire ectodomain of HA. Two different purification processes were evaluated for efficiency in terms of purity and yield. Due to the reduced yield, protein degradation and length of the 3-column purification process, the 2-column method was chosen for target purification. Purified HA1 was found immunogenic in mice inducing H5 HA-specific IgG and a hemagglutination inhibition antibody. This paper offers an alternative production system of a vaccine candidate against a locally circulating HPAI, which has a regional significance.
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http://dx.doi.org/10.1080/21645515.2017.1264783DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5328219PMC
February 2017

Intrauterine contraception in nulliparous women: a prospective survey.

J Fam Plann Reprod Health Care 2016 Jan 8;42(1):36-42. Epub 2015 Apr 8.

Nurse Practitioner, Gannett Health Services, Cornell University, Ithaca, NY, USA.

Background: Intrauterine contraception is a first-line option for young women, yet relatively few prospective studies have been performed in nulliparous women using currently available devices, and many providers are still reluctant to provide this option.

Methods: Between January 2012 and June 2014, 109 nulliparous women, aged 18-30 years, who had an intrauterine device (IUD) placed at a student health clinic [88 levonorgestrel-intrauterine system (LNG-IUS) users and 21 Cu T 380A (IUD) users] were surveyed at 1, 6, 12 and 18 months after insertion.

Results: Overall satisfaction was high; at follow-up survey 83% of 100 women (mean use 13.4 months) were 'happy' or 'very happy' with their IUD, and there were no differences in satisfaction between the two IUD types. Some 75% of participants stated that the insertion procedure went 'very well', despite 78% rating insertion pain as moderate to severe, and 46% experiencing vasovagal symptoms. The 12-month continuation rate was 89%, with discontinuations for expulsion (3%), side effects (6%), lack of anticipated benefit (1%) and pregnancy (1%). Users of the Cu T 380A were more likely to have heavy menses (74% vs 2%; p<0.0001) or moderate to severe cramping (68% vs 20%; p=0.0002) compared with LNG-IUS users. There were no uterine perforations or diagnoses of pelvic inflammatory disease. The rate of failed insertions during the study period was 6.2%.

Conclusions: Despite significant symptoms with insertion, intrauterine contraception is safe, effective and ultimately well tolerated in nulliparous women and should be provided to this population in both university and community health settings.
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http://dx.doi.org/10.1136/jfprhc-2014-101046DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4717389PMC
January 2016

Zn(2+)-selective switch of duplex to hairpin DNA.

Inorg Chem 2015 Apr 9;54(7):3084-6. Epub 2015 Mar 9.

Department of Chemistry, University at Buffalo, the State University of New York, Amherst, New York 14260, United States.

DNA sequences that undergo large changes in secondary structure upon binding of small molecules are the basis for molecular switches. Here we report a Zn(2+) complex that promotes the conversion of a fully complementary DNA double helix into DNA hairpins. The conformational switch is promoted by an isolated Zn(2+) complex or by free ZnCl2 and a macrocyclic ligand. The switch is selective for Zn(2+) over biologically relevant transition-metal ions including Cu(2+) and Fe(2+). The dual ligand/DNA switch is an approach that may improve the selectivity for metal-ion-sensing applications.
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http://dx.doi.org/10.1021/ic503074pDOI Listing
April 2015

The Future of Public Health: A Horizon Scan.

Rand Health Q 2014 Dec 30;4(3):18. Epub 2014 Dec 30.

Public Health England (PHE) commissioned RAND Europe to undertake a horizon scanning study exploring the future of public health and related scientific services. This work was intended to help inform thinking at the strategic level within PHE, firstly in relation to the wider vision of the Agency (which was only established in April 2013) and, secondly, in relation to the proposals for the creation of an integrated public health science hub. The study is based on a literature review, a brief Delphi exercise using the ExpertLens platform and key informant interviews with a range of PHE staff and external experts. It focuses on the different future public health science needs and the extent to which an integrated science hub could serve PHE as it evolves over the next twenty years. Thus, the study considers PHE's future remit and objectives in order that decisions about an integrated and co-located science hub be made in context and with reference to expert perceptions about the future.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5396209PMC
December 2014

Electronic medical records and the transgender patient: recommendations from the World Professional Association for Transgender Health EMR Working Group.

J Am Med Inform Assoc 2013 Jul-Aug;20(4):700-3. Epub 2013 Apr 30.

Department of Family and Community Medicine, University of California, San Francisco, San Francisco, California 94114, USA.

Transgender patients have particular needs with respect to demographic information and health records; specifically, transgender patients may have a chosen name and gender identity that differs from their current legally designated name and sex. Additionally, sex-specific health information, for example, a man with a cervix or a woman with a prostate, requires special attention in electronic health record (EHR) systems. The World Professional Association for Transgender Health (WPATH) is an international multidisciplinary professional association that publishes recognized standards for the care of transgender and gender variant persons. In September 2011, the WPATH Executive Committee convened an Electronic Medical Records Working Group comprised of both expert clinicians and medical information technology specialists, to make recommendations for developers, vendors, and users of EHR systems with respect to transgender patients. These recommendations and supporting rationale are presented here.
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http://dx.doi.org/10.1136/amiajnl-2012-001472DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3721165PMC
September 2013