Impact of a screen, triage and treat program for identifying chronic disease risk in Indigenous children.

BACKGROUND: The First Nations Community Based Screening to Improve Kidney Health and Prevent Dialysis project was a point-of-care screening program in rural and remote First Nations communities in Manitoba that aimed to identify and treat hypertension, diabetes and chronic kidney disease. The program identified chronic disease in 20% of children screened. We aimed to characterize clinical screening practices before and after intervention in children aged 10-17 years old and compare outcomes with those who did not receive the intervention. METHODS: This observational, prospective cohort study started with community engagement and followed the principles of ownership, control, access and possession (OCAP). We linked participant data to administrative data at the Manitoba Centre for Health Policy to assess rates of primary care and nephrology visits, disease-modifying medication prescriptions and laboratory testing (i.e., glycosylated hemoglobin [HbA1c], estimated glomerural filtration rate [eGFR] and urine albumin- or protein-to-creatinine ratio). We analyzed the differences in proportions in the 18 months before and after the intervention. We also conducted a 1:2 propensity score matching analysis to compare outcomes of children who were screened with those who were not. RESULTS: We included 324 of 353 children from the screening program (43.8% male; median age 12.3 yr) in this study. After the intervention, laboratory testing increased by 5.8% (95% confidence interval [CI] 1.1% to 10.1%) for HbA1c, by 9.9% (95% CI 4.2% to 15.5%) for eGFR and by 6.2% (95% CI 2.3% to 10.0%) for the urine albumin- or protein-to-creatinine ratio. We observed significant improvements in laboratory testing in screened patients in the group who were part of the program, compared with matched controls. INTERPRETATION: Chronic disease surveillance and care increased significantly in children after the implementation of a point-of-care screening program in rural and remote First Nation communities. Interventions such as active surveillance programs have the potential to improve the chronic disease care being provided to First Nations children.

Impact of point-of-care screening for hypertension, diabetes and progression of chronic kidney disease in rural Manitoba Indigenous communities.

BACKGROUND: In 2013-2015, we conducted point-of-care screening for hypertension, diabetes and chronic kidney disease in rural and remote Indigenous communities in Manitoba, Canada. In this study, we aimed to determine whether optimal follow-up care was provided, defined as proportion of individuals with appropriate kidney disease laboratory testing, medication prescriptions and physician visits. METHODS: We linked screening data from participants to provincial administrative data sets to evaluate whether frequencies of laboratory testing, prescriptions of disease-modifying medications, and primary care and nephrology visits differed in the 18 months before and after screening. We also conducted a propensity score matching analysis to compare outcomes between screened and unscreened adults. RESULTS: Of 1353 adults who received the screening intervention and who had complete administrative data available, 44% were at risk of kidney failure at screening. Among these individuals, frequencies of comprehensive laboratory testing (estimated glomerular filtration rate and urine albumin to creatinine ratio) improved by 17.0% (95% confidence interval [CI] 11.5 to 22.5), anti-hyperglycemic medications improved by 4.4% (95% CI 1.0 to 7.8), and nephrology visits for participants meeting referral criteria improved by 5.9% (95% CI 3.4 to 8.5). We observed significant improvements in laboratory testing, antihyperglycemic medications and nephrology visits in the screened group compared with the 1:1 matched comparison group. INTERPRETATION: Point-of-care screening programs in rural and remote Indigenous communities are adaptable methods for increasing awareness, monitoring risk and treating chronic diseases. Interventions such as the development of a national screening program could improve chronic disease care in high-risk populations.

Kidney Check Point-of-Care Testing-Furthering Patient Engagement and Patient-Centered Care in Canada's Rural and Remote Indigenous Communities: Program Report.

PURPOSE OF PROGRAM: Access to health care services remains a significant barrier for many Indigenous people's living in rural and remote regions of Canada. Driven by geographical isolation and compounded by socioeconomic and environmental disparities, individuals living under these circumstances face disproportionately poor health outcomes. Kidney Check is a comprehensive screening, triage, and treatment initiative working to bring culturally safe preventive care to rural and remote Indigenous communities across Manitoba, Ontario, BC, Alberta, and Saskatchewan. The project's patient-oriented approach addresses concerns raised by kidney patients and their caregivers using culturally safe practices. Using the various expertise of their multidisciplinary team, Kidney Check seeks to further collaborative efforts to improve access to preventive health care for these groups. Meaningful engagement with patients, communities, and local health care stakeholders ensures Indigenous voices are heard and incorporated into the project in a way that promotes shared decision-making and sustainability. SOURCES OF INFORMATION: As an affiliate program of the Can-SOLVE CKD Network, Kidney Check's guiding priorities were developed over 3 years of patient consultation and finalized during 2 workshops held with more than 30 patients, caregivers, Indigenous peoples, researchers, and policy makers using a modified Delphi process. Today, patients continue to participate in project development via 2 governing bodies: The Patient Governance Circle and the Indigenous Peoples Engagement and Research Council (IPERC). METHODS: Modeled after the Indigenous-led 2015 FINISHED project in Manitoba, Kidney Check employs point-of-care testing to identify diabetes, hypertension, and chronic kidney disease (CKD) in individuals, ages 10 and above, regardless of pre-existing risk factors. The Kidney Check team consists of 4 working groups: project leadership, provincial management, local community partners, and patient partners. By using and building on existing relationships between local and provincial health care stakeholders and various Indigenous communities, the program furthers collaborative efforts to bridge gaps in health equity. KEY FINDINGS: The Kidney Check program has established an infrastructure that integrates patient engagement at all stages of the program from priority setting to deployment and dissemination strategies. LIMITATIONS: While we encourage and offer screening services to all, many still choose not to attend for a variety of reasons which may introduce selection bias. Kidney Check uses patient engagement as a foundational component of the program; however, there is currently a limited amount of research documenting the benefits of patient engagement in health care settings. More formal qualitative evaluations of these activities are needed. In addition, as the COVID-19 pandemic has halted screening procedures in most communities, we currently do not have quantitative data to support the efficacy of the Kidney Check program. IMPLICATIONS: For many Indigenous people, lack of accessibility to health care services is compounded by sociopolitical barriers that disrupt relationships between patients and providers. Meaningful engagement presents one opportunity to ensure the voices and perspectives of Indigenous patients and communities are incorporated into health services. In addition, this screening paradigm has shown to be cost effective as shown by analyses done on the FINISHED screening program.

OBJECTIFS DU PROGRAMME: L'accès aux services de santé demeure un obstacle important pour de nombreuses populations autochtones vivant dans les régions rurales et éloignées du Canada. En raison de l'isolement géographique et de disparités environnementales et socio-économiques, les personnes vivant dans ces situations sont confrontées à de pauvres conditions de santé. Kidney Check est une initiative complète de dépistage, de triage et de traitement qui vise à offrir des soins préventifs et respectueux de leurs valeurs culturelles aux communautés autochtones rurales et éloignées du Manitoba, de l'Ontario, de la Colombie-Britannique, de l'Alberta et de la Saskatchewan. L'approche axée sur le patient répond aux préoccupations soulevées par les patients atteints de néphropathies et leurs soignants grâce à des pratiques adaptées à leur culture. En exploitant les compétences d'une équipe multidisciplinaire, Kidney Check s'efforce de poursuivre les efforts de collaboration visant l'amélioration de l'accès à des soins de santé préventifs pour ces groupes. Un engagement significatif des patients, des communautés et des acteurs locaux du secteur de la santé garantit que les voix autochtones sont entendues et intégrées dans le projet d'une manière qui favorise la pérennité et la prise de décision partagée. SOURCES: Kidney Check étant un programme affilié du réseau CAN-SOLVE CKD, ses priorités directrices ont été élaborées à partir d'une consultation de 3 ans auprès des patients et finalisées au cours de deux ateliers utilisant une version modifiée de la méthode Delphi et réunissant plus d'une trentaine de patients, soignants, membres des communautés autochtones, chercheurs et décideurs. Les patients continuent à ce jour de participer au développement du projet par l'entremise de deux organes directeurs: le Conseil des patients et le Conseil de la recherche et de l'engagement des peuples autochtones (IPICER). MÉTHODOLOGIE: Inspiré du projet de dépistage FINISHED mené en 2015 auprès des Autochtones du Manitoba, Kidney Check utilise des tests au point de service pour dépister le diabète, l'hypertension et l'insuffisance rénale chronique chez les personnes âgées de 10 ans et plus, quels que soient les facteurs de risque préexistants. L'équipe de Kidney Check se compose de quatre groupes de travail: direction du projet, gestion provinciale, partenaires communautaires locaux et patients partenaires. En utilisant et en s'appuyant sur les relations existantes entre les intervenants locaux et provinciaux du secteur de la santé et les diverses communautés autochtones, le programme favorise les efforts de collaboration pour combler les écarts en matière d'équité en santé. PRINCIPAUX RÉSULTATS: Le programme Kidney Check a mis en place une infrastructure impliquant la participation des patients à toutes les étapes du programme, de l'établissement des priorités aux stratégies de déploiement et de diffusion. LIMITES: Nous encourageons et offrons ces services de dépistage à tous, mais, pour diverses raisons, beaucoup choisissent de ne pas y participer, ce qui peut introduire un biais de sélection. La participation des patients est un élément fondamental du programme Kidney Check; néanmoins, les avantages d'un engagement des patients dans les établissements de soins de santé demeurent peu documentés. Davantage d'évaluations qualitatives formelles de ces activités sont donc nécessaires. De plus, la pandémie de COVID-19 ayant interrompu les procédures de dépistage dans la plupart des collectivités, nous ne disposons pas actuellement de données quantitatives pour soutenir l'efficacité du programme. CONCLUSION: Pour de nombreuses populations autochtones, le manque d'accessibilité aux services de santé est aggravé par des obstacles sociopolitiques qui perturbent les relations entre les patients et les fournisseurs de soins. La participation significative des patients et des communautés autochtones permet d'assurer que leurs voix et perspectives soient intégrées dans les services de santé. En outre, ce paradigme de dépistage s'est révélé rentable, comme le montrent les analyses effectuées sur le programme de dépistage FINISHED.

Is Assisted Peritoneal Dialysis a Solution for Northern Manitoba?

Background: End-stage kidney disease (ESKD) continues to fundamentally impact the lives of First Nations (FN) patients. Home peritoneal dialysis (PD) offers patients more mobility and flexibility, but few Manitoba FNs have availed themselves of this option. Objective: This paper discusses Manitoba FNs' experience of PD, to highlight enablers and barriers to expanding the use of PD in rural and remote Manitoba communities. Methods: We analyzed interviews of individuals living with ESKD (N = 14), family caregivers (N = 14) and healthcare providers and administrators (N = 27). Results: Barriers to PD uptake include medical suitability, patients' distrust of home modalities and fear in their ability to manage. Other factors include limited family support and lack of appropriate housing. Conclusions: Assisted peritoneal dialysis (APD) is an emerging model where PD supplies are centrally located, and where a cohort of PD patients can provide mutual support with added assistance from an APD worker. This model could mitigate existing treatment barriers.

Very Preterm Infants with Technological Dependence at Home: Impact on Resource Use and Family.

OBJECTIVE: To examine the impact of medical complexity among very preterm infants on health care resource use, family, and neurodevelopmental outcomes at 18 months' corrected age. METHODS: This observational cohort study of Canadian infants born < 29 weeks' gestational age in 2009-2011 compared infants with and those without medical complexity defined as discharged home with assistive medical technology. Health care resource use and family outcomes were collected. Children were assessed for cerebral palsy, deafness, blindness, and developmental delay at 18 months. Logistic regression analysis was performed for group comparisons. RESULTS: Overall, 466/2,337 infants (20%) needed assistive medical technology at home including oxygen (79%), gavage feeding (21%), gastrostomy or ileostomy (20%), CPAP (5%), and tracheostomy (3%). Children with medical complexity were more likely to be re-hospitalized (OR 3.6, 95% CI 3.0-4.5) and to require ≥2 outpatient services (OR 4.4, 95% CI 3.5-5.6). Employment of both parents at 18 months was also less frequent in those with medical complexity compared to those without medical complexity (52 vs. 60%, p < 0.01). Thirty percent of children with medical complexity had significant neurodevelopmental impairment compared to 13% of those without medical complexity (p < 0.01). Lower gestational age, lower birth weight, bronchopulmonary dysplasia, sepsis, and surgical necrotizing enterocolitis were associated with a risk of medical complexity. CONCLUSION: Medical complexity is common following very preterm birth and has a significant impact on health care use as well as family employment and is more often associated with neurodevelopmental disabilities. Efforts should be deployed to facilitate care coordination upon hospital discharge and to support families of preterm children with medical complexity.

Evaluation of the Abbott ARCHITECT™ cytomegalovirus IgM/IgG, rubella IgM/IgG, and syphilis treponemal antibodies enzyme immunoassays in a mother and child health center population.

This study evaluated the concordance of Architect™ chemiluminescent microparticle immunoassays with Captia™ ELISA for cytomegalovirus (CMV) IgM and IgG, with Enzygnost™ and Captia™ ELISA for rubella IgM and IgG and with Trep-Sure™ ELISA for syphilis treponemal antibodies in a mixed pediatric and obstetrical population. Total agreement between assays and Kappa statistic value were 82.5% (95% CI: 75.6-87.7) and 0.65 (95% CI: 0.54-0.77) for CMV IgM, 82.8% (95% CI: 76.7-87.6) and 0.65 (95% CI: 0.55-0.75) for CMV IgG, 89.2% (95% CI: 82.9-93.4) and 0.56 (95% CI: 0.36-0.75) for rubella IgM, 88.6% (95% CI: 82.9-92.6) and 0.74 (95% CI: 0.63-0.84) for rubella IgG, and 97.9% (95% CI: 94.5-99.4) and 0.89 (95% CI: 0.79-1.00) for syphilis treponemal antibodies. This study demonstrates that the Architect™ chemiluminescent microparticle immunoassays correlate well with other FDA-approved ELISA assays in this specific population.

Screening for kidney disease in Indigenous Canadian children: The FINISHED screen, triage and treat program.

BACKGROUND: Indigenous populations are disproportionately affected by kidney failure at younger ages than other ethnic groups in Canada. As symptoms do not occur until disease is advanced, early kidney disease risk is often unrecognized. OBJECTIVES: We sought to evaluate the yield of community-based screening for early risk factors for kidney disease in youth from rural Indigenous communities in Canada. METHODS: The FINISHED project screened 11 rural First Nations communities in Manitoba, Canada after community and school engagement. The results for the 10- to 17-year olds are reported here. Body mass index (BMI), blood pressure, estimated glomerular filtration rate (eGFR), hemoglobin A1c's (HbA1c) and urine albumin-to-creatinine ratios (ACR) were assessed. All children were triaged and referred to either primary or tertiary care, depending on risk. RESULTS: A total of 353 were screened (estimated 22.4% of population). The median age was 12 years (IQR 10 to 13), 55% were female and 55% were overweight or obese. Overall, 21.8% of children had at least one abnormality. Hypertension was identified in 5.4% and 11.9% had prehypertension. None of the children had an eGFR < 60 ml/min/1.73 m2 however 10.5% had an ACR > 3 mg/mmol and 6.2% had an eGFR < 90 ml/min/1.73 m2 suggestive of early kidney disease. Diabetes was identified in 1.4%, and 1.4% had HbA1c's between 6.1% and 6.49%. CONCLUSIONS: Risk factors for chronic kidney disease are highly prevalent in rural Indigenous children. More research is required to confirm the persistence of these findings, and to evaluate the efficacy of screening children to prevent or delay progression to kidney failure.

Remote Dwelling Location Is a Risk Factor for CKD Among Indigenous Canadians.

INTRODUCTION: Rural and remote indigenous individuals have a high burden of chronic kidney disease (CKD) when compared to the general population. However, it has not been previously explored how these rates compare to urban-dwelling indigenous populations. METHODS: In a recent cross-sectional screening study, 1346 adults 18 to 80 years of age were screened for CKD and diabetes across 11 communities in rural and remote areas in Manitoba, Canada, as part of the First Nations Community Based Screening to Improve Kidney Health and Prevent Dialysis (FINISHED) program. An additional 284 Indigenous adults who resided in low-income areas in the city of Winnipeg, Manitoba, Canada were screened as part of the NorWest Mobile Diabetes and Kidney Disease Screening and Intervention Project. RESULTS: Our findings indicate that a gradient of CKD and diabetes prevalence exists for Indigenous individuals living in different geographic areas. Compared to urban-dwelling Indigenous individuals, rural-dwelling individuals had more than a 2-fold (2.1, 95% CI = 1.4-3.1) increase in diabetes whereas remote-dwelling individuals had a 4-fold (4.1, 95% CI = 2.8-6.0) increase, and more than a 3-fold (3.1, 95% CI = 2.2-4.5) increase in CKD prevalence. CONCLUSION: Although these results highlight the relative importance of geography in determining the prevalence of diabetes and CKD in Indigenous Canadians, geography is but an important surrogate of other determinants, such as poverty and access to care.

Diagnostic Accuracy of Novel and Traditional Rapid Tests for Influenza Infection Compared With Reverse Transcriptase Polymerase Chain Reaction: A Systematic Review and Meta-analysis.

BACKGROUND: Rapid and accurate influenza diagnostics can improve patient care. PURPOSE: To summarize and compare accuracy of traditional rapid influenza diagnostic tests (RIDTs), digital immunoassays (DIAs), and rapid nucleic acid amplification tests (NAATs) in children and adults with suspected influenza. DATA SOURCES: 6 databases from their inception through May 2017. STUDY SELECTION: Studies in English, French, or Spanish comparing commercialized rapid tests (that is, providing results in <30 minutes) with reverse transcriptase polymerase chain reaction reference standard for influenza diagnosis. DATA EXTRACTION: Data were extracted using a standardized form; quality was assessed using QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies 2) criteria. DATA SYNTHESIS: 162 studies were included (130 of RIDTs, 19 of DIAs, and 13 of NAATs). Pooled sensitivities for detecting influenza A from Bayesian bivariate random-effects models were 54.4% (95% credible interval [CrI], 48.9% to 59.8%) for RIDTs, 80.0% (CrI, 73.4% to 85.6%) for DIAs, and 91.6% (CrI, 84.9% to 95.9%) for NAATs. Those for detecting influenza B were 53.2% (CrI, 41.7% to 64.4%) for RIDTs, 76.8% (CrI, 65.4% to 85.4%) for DIAs, and 95.4% (CrI, 87.3% to 98.7%) for NAATs. Pooled specificities were uniformly high (>98%). Forty-six influenza A and 24 influenza B studies presented pediatric-specific data; 35 influenza A and 16 influenza B studies presented adult-specific data. Pooled sensitivities were higher in children by 12.1 to 31.8 percentage points, except for influenza A by rapid NAATs (2.7 percentage points). Pooled sensitivities favored industry-sponsored studies by 6.2 to 34.0 percentage points. Incomplete reporting frequently led to unclear risk of bias. LIMITATIONS: Underreporting of clinical variables limited exploration of heterogeneity. Few NAAT studies reported adult-specific data, and none evaluated point-of-care testing. Many studies had unclear risk of bias. CONCLUSION: Novel DIAs and rapid NAATs had markedly higher sensitivities for influenza A and B in both children and adults than did traditional RIDTs, with equally high specificities. PRIMARY FUNDING SOURCE: Québec Health Research Fund and BD Diagnostic Systems.

Screening for chronic kidney disease in Canadian indigenous peoples is cost-effective.

Canadian indigenous (First Nations) have rates of kidney failure that are 2- to 4-fold higher than the non-indigenous general Canadian population. As such, a strategy of targeted screening and treatment for CKD may be cost-effective in this population. Our objective was to assess the cost utility of screening and subsequent treatment for CKD in rural Canadian indigenous adults by both estimated glomerular filtration rate and the urine albumin-to-creatinine ratio. A decision analytic Markov model was constructed comparing the screening and treatment strategy to usual care. Primary outcomes were presented as incremental cost-effectiveness ratios (ICERs) presented as a cost per quality-adjusted life-year (QALY). Screening for CKD was associated with an ICER of $23,700/QALY in comparison to usual care. Restricting the model to screening in communities accessed only by air travel (CKD prevalence 34.4%), this ratio fell to $7,790/QALY. In road accessible communities (CKD prevalence 17.6%) the ICER was $52,480/QALY. The model was robust to changes in influential variables when tested in univariate sensitivity analyses. Probabilistic sensitivity analysis found 72% of simulations to be cost-effective at a $50,000/QALY threshold and 93% of simulations to be cost-effective at a $100,000/QALY threshold. Thus, targeted screening and treatment for CKD using point-of-care testing equipment in rural Canadian indigenous populations is cost-effective, particularly in remote air access-only communities with the highest risk of CKD and kidney failure. Evaluation of targeted screening initiatives with cluster randomized controlled trials and integration of screening into routine clinical visits in communities with the highest risk is recommended.

Time to Positivity of Blood Cultures in Infants 0 to 90 Days Old Presenting to the Emergency Department: Is 36 Hours Enough?

BACKGROUND: Continuous monitoring blood culture systems (CMBCS) now allow for more rapid detection of microbial growth. We aimed to determine whether a 36-hour period was sufficient to detect all blood cultures positive for pathogenic bacteria in infants 0 to 90 days old undergoing a septic workup in the emergency department of a tertiary care pediatric center. METHODS: We performed a retrospective study of all positive blood cultures collected in these infants over a 5-year time period (from March 13, 2008 to July 29, 2013). Bottles were incubated in a CMBCS. The time to positivity (TTP) was calculated from time of blood culture registration into the laboratory system to time of Gram stain. Medical charts were reviewed for relevant clinical information. Cultures were classified as pathogenic or contaminant using microorganism type and clinical presentation. RESULTS: Three thousand five hundred fifty-nine blood cultures were collected. Of these, 98 (2.8%) were positive. Fifty-two (53.1%) were deemed pathogenic and 46 (46.9%) were deemed contaminant, for a true prevalence of bacteremia of 1.5%. At 24, 36, 48, and 50 hours, 87.8% (86 of 98), 96.9% (95 of 98), 99% (97 of 98), and 100% (98 of 98) of all cultures were positive. Considering only pathogenic organisms, 96.1% (50 of 52) and 100% (52 of 52) were positive at 24 and 36 hours. Mean TTP for pathogens and contaminants was 14.40 and 23.18 hours, respectively (P < .001). CONCLUSIONS: An incubation period of 36 hours is sufficient to detect 100% of blood cultures positive for a pathogenic organism in our population.

The Prevalence of CKD in Rural Canadian Indigenous Peoples: Results From the First Nations Community Based Screening to Improve Kidney Health and Prevent Dialysis (FINISHED) Screen, Triage, and Treat Program.

BACKGROUND: Indigenous Canadians have high rates of risk factors for chronic kidney disease (CKD), in particular diabetes. Furthermore, they have increased rates of complications associated with CKD, such as kidney failure and vascular disease. Our objective was to describe the prevalence of CKD in this population. STUDY DESIGN: Cross-sectional cohort. SETTING & PARTICIPANTS: Indigenous (First Nations) Canadians 18 years or older screened as part of the First Nations Community Based Screening to Improve Kidney Health and Prevent Dialysis (FINISHED) project, an initiative completed in 2015 that accomplished community-wide screening in 11 rural communities in Manitoba, Canada. PREDICTORS: Indigenous ethnicity and geographic location (communities accessible by road compared with those accessible only by air). OUTCOME: Prevalence of CKD, presumed based on a single ascertainment of urine albumin-creatinine ratio (UACR) ≥ 30mg/g and/or estimated glomerular filtration rate (eGFR)<60mL/min/1.73m(2). MEASUREMENTS: Kidney function measured by eGFR (CKD-EPI creatinine equation) and UACR. RESULTS: 1,346 adults were screened; 25.5% had CKD, defined as UACR≥30mg/g or eGFR<60mL/min/1.73m(2). Communities accessible by road had a lower prevalence of CKD (17.6%) than more remote communities accessible only by air (34.4%). Of those screened, 3.3% had reduced kidney function (defined as eGFR<60mL/min/1.73m(2)). Severely increased albuminuria was present in 5.0% of those screened. LIMITATIONS: Presumption of chronicity based on a single ascertainment. There is a possibility of sampling bias, the net direction of which is uncertain. CONCLUSIONS: We found a 2-fold higher prevalence of CKD in indigenous Canadians in comparison to the general population and a prevalence of severely increased albuminuria that was 5-fold higher. This is comparable to patients with diabetes and/or hypertension. Public health strategies to screen, triage, and treat all Canadian indigenous peoples with CKD should be considered.

Evaluation of the abbot Architect(™) epstein-barr virus viral capsid antigen IgM, viral capsid antigen IgG and nuclear antigen IgG assays in a pediatric and adult population.

BACKGROUND: The detection of antibodies against Epstein-Barr viral capsid (VCA) and nuclear (EBNA) antigens is routinely performed with different commercially available immunoassays. OBJECTIVES: In this study, we evaluated the concordance and performance of the Architect(™) chemiluminescent microparticle immunoassays (CMIAs) using Captia(™) enzyme linked immunosorbent assays (ELISA) for VCA IgM, and standard immunofluorescence (IF) assays for VCA IgG and EBNA IgG as comparative techniques. STUDY DESIGN: Sera were selected from a heterogeneous population including pediatric and adult patients. RESULTS: Concordance between CMIAs and comparative assays was high with total agreement percentages of 84,1% (95% CI: 77.8-88.9) for VCA IgM, 90,6% (95% CI: 84.2-94.7) for EBNA IgG and 98,0% (95% CI: 93.9-99.6) for VCA IgG. Moreover, kappa statistic values showed good to excellent correlation with values of 0.68 (95% CI: 0.57-0.79) for VCA IgM, 0.73 (95% CI: 0.58-0.87) for EBNA IgG and 0.95 (95% CI: 0.89-1.00) for VCA IgG. A correlation was observed between positivity levels on CMIAs and semi-quantitative fluorescence intensity on IF for VCA IgG and EBNA IgG assays. With regard to an accepted gold standard IF assays, CMIA was 98,1% (95% CI: 93.3-99.8) sensitive and 97,4% (95% CI: 86.5-99.9) specific for the detection of VCA IgG. For the detection of EBNA IgG, it was 92,2% (95% CI: 85.1-96.6) sensitive and 84,6% (95% CI: 65.1-95.6) specific. CONCLUSION: In summary, we demonstrated that the CMIA EBV antibody detection panel has high performance and high concordance with other commercially available immunoassays.

Evaluation of a fluorescent immunoassay rapid test (Sofia™) for detection of influenza A+B and RSV in a tertiary pediatric setting.

In response to the lack of sensitivity and reproducibility of previously marketed rapid antigen detection tests, a novel fluorescent immunoassay was recently developed. This new assay offers rapidity and automated reading. More characterization of this assay is needed. The aim of this study was to assess diagnostic performance of Sofia influenza A+B and respiratory syncytial virus (RSV) while compared to traditional viral cell culture. A total of 416 respiratory samples were analyzed prospectively with both methods in a tertiary pediatric center. Sensitivity and specificity of the Sofia™ test were 90.0% and 98.0% for influenza A, 90.9% and 98.9% for influenza B, and 87.7% and 94.7% for RSV compared to traditional cell culture. Overall, Sofia influenza A+B and RSV assays performed well in comparison to culture in a pediatric population.

Addition of long-acting beta2-agonists to inhaled corticosteroids for chronic asthma in children.

BACKGROUND: Long-acting beta2-agonists (LABA) in combination with inhaled corticosteroids (ICS) are increasingly prescribed for children with asthma. OBJECTIVES: To assess the safety and efficacy of adding a LABA to an ICS in children and adolescents with asthma. To determine whether the benefit of LABA was influenced by baseline severity of airway obstruction, the dose of ICS to which it was added or with which it was compared, the type of LABA used, the number of devices used to deliver combination therapy and trial duration. SEARCH METHODS: We searched the Cochrane Airways Group Asthma Trials Register until January 2015. SELECTION CRITERIA: We included randomised controlled trials testing the combination of LABA and ICS versus the same, or an increased, dose of ICS for at least four weeks in children and adolescents with asthma. The main outcome was the rate of exacerbations requiring rescue oral steroids. Secondary outcomes included markers of exacerbation, pulmonary function, symptoms, quality of life, adverse events and withdrawals. DATA COLLECTION AND ANALYSIS: Two review authors assessed studies independently for methodological quality and extracted data. We obtained confirmation from trialists when possible. MAIN RESULTS: We included in this review a total of 33 trials representing 39 control-intervention comparisons and randomly assigning 6381 children. Most participants were inadequately controlled on their current ICS dose. We assessed the addition of LABA to ICS (1) versus the same dose of ICS, and (2) versus an increased dose of ICS.LABA added to ICS was compared with the same dose of ICS in 28 studies. Mean age of participants was 11 years, and males accounted for 59% of the study population. Mean forced expiratory volume in one second (FEV1) at baseline was ≥ 80% of predicted in 18 studies, 61% to 79% of predicted in six studies and unreported in the remaining studies. Participants were inadequately controlled before randomisation in all but four studies.There was no significant group difference in exacerbations requiring oral steroids (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.70 to 1.28, 12 studies, 1669 children; moderate-quality evidence) with addition of LABA to ICS compared with ICS alone. There was no statistically significant group difference in hospital admissions (RR 1.74, 95% CI 0.90 to 3.36, seven studies, 1292 children; moderate-quality evidence)nor in serious adverse events (RR 1.17, 95% CI 0.75 to 1.85, 17 studies, N = 4021; moderate-quality evidence). Withdrawals occurred significantly less frequently with the addition of LABA (23 studies, 471 children, RR 0.80, 95% CI 0.67 to 0.94; low-quality evidence). Compared with ICS alone, addition of LABA led to significantly greater improvement in FEV1 (nine studies, 1942 children, inverse variance (IV) 0.08 L, 95% CI 0.06 to 0.10; mean difference (MD) 2.99%, 95% CI 0.86 to 5.11, seven studies, 534 children; low-quality evidence), morning peak expiratory flow (PEF) (16 studies, 3934 children, IV 10.20 L/min, 95% CI 8.14 to 12.26), reduction in use of daytime rescue inhalations (MD -0.07 puffs/d, 95% CI -0.11 to -0.02, seven studies; 1798 children) and reduction in use of nighttime rescue inhalations (MD -0.08 puffs/d, 95% CI -0.13 to -0.03, three studies, 672 children). No significant group difference was noted in exercise-induced % fall in FEV1, symptom-free days, asthma symptom score, quality of life, use of reliever medication and adverse events.A total of 11 studies assessed the addition of LABA to ICS therapy versus an increased dose of ICS with random assignment of 1628 children. Mean age of participants was 10 years, and 64% were male. Baseline mean FEV1 was ≥ 80% of predicted. All trials enrolled participants who were inadequately controlled on a baseline inhaled steroid dose equivalent to 400 µg/d of beclomethasone equivalent or less.There was no significant group differences in risk of exacerbation requiring oral steroids with the combination of LABA and ICS versus a double dose of ICS (RR 1.69, 95% CI 0.85 to 3.32, three studies, 581 children; moderate-quality evidence) nor in risk of hospital admission (RR 1.90, 95% CI 0.65 to 5.54, four studies, 1008 children; moderate-quality evidence).No statistical significant group difference was noted in serious adverse events (RR 1.54, 95% CI 0.81 to 2.94, seven studies, N = 1343; moderate-quality evidence) and no statistically significant differences in overall risk of all-cause withdrawals (RR 0.96, 95% CI 0.67 to 1.37, eight studies, 1491 children; moderate-quality evidence). Compared with double the dose of ICS, use of LABA was associated with significantly greater improvement in morning PEF (MD 8.73 L/min, 95% CI 5.15 to 12.31, five studies, 1283 children; moderate-quality evidence), but data were insufficient to aggregate on other markers of asthma symptoms, rescue medication use and nighttime awakening. There was no group difference in risk of overall adverse effects, A significant group difference was observed in linear growth over 12 months, clearly indicating lower growth velocity in the higher ICS dose group (two studies: MD 1.21 cm/y, 95% CI 0.72 to 1.70). AUTHORS' CONCLUSIONS: In children with persistent asthma, the addition of LABA to ICS was not associated with a significant reduction in the rate of exacerbations requiring systemic steroids, but it was superior for improving lung function compared with the same or higher doses of ICS. No differences in adverse effects were apparent, with the exception of greater growth with the use of ICS and LABA compared with a higher ICS dose. The trend towards increased risk of hospital admission with LABA, irrespective of the dose of ICS, is a matter of concern and requires further monitoring.

Diagnostic Accuracy of Rapid Antigen Detection Tests for Respiratory Syncytial Virus Infection: Systematic Review and Meta-analysis.

Respiratory syncytial virus (RSV) rapid antigen detection tests (RADT) are extensively used in clinical laboratories. We performed a systematic review and meta-analysis to evaluate the accuracy of RADTs for diagnosis of RSV infection and to determine factors associated with accuracy estimates. We searched EMBASE and PubMed for diagnostic-accuracy studies of commercialized RSV RADTs. Studies reporting sensitivity and specificity data compared to a reference standard (reverse transcriptase PCR [RT-PCR], immunofluorescence, or viral culture) were considered. Two reviewers independently extracted data on study characteristics, diagnostic-accuracy estimates, and study quality. Accuracy estimates were pooled using bivariate random-effects regression models. Heterogeneity was investigated with prespecified subgroup analyses. Seventy-one articles met inclusion criteria. Overall, RSV RADT pooled sensitivity and specificity were 80% (95% confidence interval [CI], 76% to 83%) and 97% (95% CI, 96% to 98%), respectively. Positive- and negative-likelihood ratios were 25.5 (95% CI, 18.3 to 35.5) and 0.21 (95% CI, 0.18 to 0.24), respectively. Sensitivity was higher in children (81% [95% CI, 78%, 84%]) than in adults (29% [95% CI, 11% to 48%]). Because of this disparity, further subgroup analyses were restricted to pediatric data (63 studies). Test sensitivity was poorest using RT-PCR as a reference standard and highest using immunofluorescence (74% versus 88%; P < 0.001). Industry-sponsored studies reported significantly higher sensitivity (87% versus 78%; P = 0.01). Our results suggest that the poor sensitivity of RSV RADTs in adults may preclude their use in this population. Furthermore, industry-sponsored studies and those that did not use RT-PCR as a reference standard likely overestimated test sensitivity.

Mass screening for chronic kidney disease in rural and remote Canadian first nations people: methodology and demographic characteristics.

BACKGROUND: Screening the general population for Chronic Kidney Disease is not currently recommended.. Rural and remote Canadian First Nations people suffer a disproportionate burden of Kidney Failure. The Fi rst N at i ons Community Based S creening to Improve Kidney He alth and Prevent D ialysis ( FINISHED ) project intends to test the hypothesis that a mobile, mass screening initiative available to all First Nations people 10 years of age and older residing in rural and/or remote communities, is feasible, will improve health outcomes and is cost effective. OBJECTIVES: The objective of this manuscript is to describe the key elements required to design, implement and evaluate such a program and describe key characteristics of our screened cohort. DESIGN: Methods and cohort description. SETTING: 11 First Nations communities within 2 Tribal Councils in Manitoba, Canada. PATIENTS: All First Nations individuals between the ages of 10-80 living in the 11communities were eligible for the screening initiative. MEASUREMENTS: Screening Rates achieved within communities. METHODS: An interdisciplinary team partnership was established between the Diabetes Integration Project and the Manitoba Renal Program. Stakeholder consultation was obtained and protocols developed to mass screen community members using point of care testing equipment. All people screened were risk stratified, counselled and referred to nephrologists as required in real time, based on risk. RESULTS: As of August 31, 2014, 1480 people in 11 communities over 2 Tribal Councils have been successfully screened. A mean screening rate of 21% of all community members eligible (aged 10-80) has been achieved. All patients at intermediate or high risk of kidney failure have been seen by nephrologists within 1 month of screening. LIMITATIONS: Long term outcomes of kidney failure rates not assessed for at least 5 years. Alternative public health initiatives to reduce kidney failure not investigated. CONCLUSIONS: Point of care mass screening, real time risk prediction and counselling of First Nations people at high risk of Kidney Failure is feasible in rural and remote communities. Further analysis of this cohort will describe theepidemiology of CKD in these communities, and test the cost effectiveness of this strategy.

CONTEXTE: Présentement, le dépistage universel systématique des maladies rénales chroniques est une pratique ni recommandée ni souhaitée. Les membres des Premières Nations du Canada qui vivent en région rurale ou éloignée sont aux prises avec un fardeau d'insuffisance rénale beaucoup plus lourd que le reste de la population. Le projet de dépistage des maladies rénales et de prévention de la dialyse des communautés des Premières Nations, l'initiative FINISHED (pour First Nations Community Based Screening to Improve Kidney Health and Prevent Dialysis), a pour but de tester l'hypothèse suivante : le dépistage universel des membres des Premières Nations de 10 ans ou plus et vivant en régions éloignées ou rurales au moyen d'une unité de service mobile est un projet faisable, rentable, et qui aura des répercussions positives sur la santé des communautés desservies. OBJECTIFS DE L'ÉTUDE: L'objectif principal de cet article est, d'une part, la description détaillée des principaux éléments nécessaires à la conception, l'implémentation et l'évaluation d'un programme de cette envergure, et d'autre part, la production de données préliminaires décrivant les caractéristiques de base de la cohorte dépistée. TYPE D'ÉTUDE: Éléments méthodologiques et description de la cohorte. LIEU DE L'ÉTUDE: 11 communautés des Premières Nations provenant de 2 conseils de bande du Manitoba, au Canada. PATIENTS: Tous les membres des communautés des Premières Nations sélectionnées, âgés de 10 à 80 ans, étaient admissibles à l'initiative de dépistage. MESURES: Taux de dépistage atteint au sein des communautés. MÉTHODES: Une équipe multidisciplinaire, issue d'une collaboration entre le Diabetes Integration Project et le Manitoba Renal Program a été formée pour le projet. Après une vaste consultation des parties prenantes, les protocoles et les lignes directrices de fonctionnement du dépistage universel des membres de la communauté, utilisant l'équipement de dépistage disponible aux points de service, ont été développés. Les personnes dépistées ont été classées selon leur niveau de risque; après consultation, un suivi avec un néphrologue a été initié, si nécessaire au moment de l'évaluation. RÉSULTAT DE L'ÉTUDE: Au 31 août 2014, 1480 personnes provenant des 11 communautés des 2 conseils de bande ont été dépistées avec succès. Le taux de dépistage moyen de l'ensemble des membres admissibles (âgés de 10 à 80 ans) atteint est de 21%. Tous les patients aux prises avec un risque élevé ou modéré d'insuffisance rénale ont été rencontrés par des équipes multidisciplinaires en néphrologie, à l'intérieur d'une période d'un mois suivant le dépistage. LIMITES DE L'ÉTUDE: Les répercussions à long terme des taux d'insuffisance rénale n'avaient pas été évaluées depuis un minimum de 5 ans. Les initiatives de santé publique complémentaires visant à diminuer les taux d'insuffisance rénale n'ont pas été examinées. CONCLUSIONS: Il est faisable d'effectuer le dépistage universel, la prévision du risque de maladie et la consultation en temps réel des membres des Premières Nations à haut risque d'insuffisance rénale, à partir de points de service, en région rurale ou éloignée. Une analyse plus poussée de cette cohorte pourra faire ressortir les données épidémiologiques actuelles sur la maladie rénale chronique au sein des communautés visées, et permettra d'évaluer la rentabilité de cette stratégie, dont le but est la réduction du fardeau d'insuffisance rénale, et des répercussions engendrées par les complications qui en découlent.

Intermittent versus daily inhaled corticosteroids for persistent asthma in children and adults.

BACKGROUND: Daily inhaled corticosteroids (ICS) are the recommended mainstay of treatment in children and adults with persistent asthma. However, often, ICS are used intermittently by patients or recommended by physicians to be used only at the onset of exacerbations. OBJECTIVES: The aim of this review was to compare the efficacy and safety of intermittent versus daily ICS in the management of children and adults with persistent asthma and preschool-aged children suspected of persistent asthma. SEARCH METHODS: We searched the Cochrane Airways Group Specialised Register of trials (CAGR) and the ClinicalTrials.gov web site up to October 2012. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared intermittent ICS versus daily ICS in children and adults with persistent asthma. No co-interventions were permitted other than rescue relievers and oral corticosteroids used during exacerbations. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion, methodological quality and extracted data. The primary efficacy outcome was the number of patients with one or more exacerbations requiring oral corticosteroids and the primary safety outcome was the number of patients with serious adverse health events. Secondary outcomes included exacerbations, lung function tests, asthma control, adverse effects, withdrawal rates and inflammatory markers. Equivalence was assumed if the risk ratio (RR) estimate and its 95% confidence interval (CI) were between 0.9 and 1.1. Quality of the evidence was assessed using GRADE. MAIN RESULTS: Six trials (including one trial testing two relevant protocols) met the inclusion criteria for a total of seven group comparisons. The four paediatric trials (two involving preschool children and two school-aged children) and two adult parallel-group trials, lasting 12 to 52 weeks, were of high methodological quality. A total of 1211 patients with confirmed, or suspected, persistent asthma contributed to the meta-analyses. There was no statistically significant group difference in the risk of patients experiencing one or more exacerbations requiring oral corticosteroids (1204 patients; RR 1.07; 95% CI 0.87 to 1.32; the large confidence interval translates into a risk of exacerbations in the intermittent ICS group varying between 17% and 25%, assuming a 19% risk with daily ICS). Age, severity of airway obstruction, step-up protocol used during exacerbations and trial duration did not significantly influence the primary efficacy outcome. No group difference was observed in the risk of patients with serious adverse health events (1055 patients; RR 0.82; 95% CI 0.33 to 2.03). Compared to the daily ICS group, the intermittent ICS group displayed a smaller improvement in change from baseline peak expiratory flow rate (PEFR) by 2.56% (95% CI -4.49% to -0.63%), fewer symptom-free days (standardised mean difference (SMD) -0.15 (95% CI -0.28 to -0.03), fewer asthma control days -9% (95% CI -14% to -4%), more use of rescue ß2-agonists by 0.12 puffs/day (95% CI 0 to 0.23) and a greater increase from baseline in exhaled nitric oxide of 16.80 parts per billion (95% CI 11.95 to 21.64). There was no significant group difference in forced expiratory volume in one second (FEV1), quality of life, airway hyper-reactivity, adverse effects, hospitalisations, emergency department visits or withdrawals. In paediatric trials, intermittent ICS (budesonide and beclomethasone) were associated with greater growth by 0.41 cm change from baseline (532 children; 95% CI 0.13 to 0.69) compared to daily treatment. AUTHORS' CONCLUSIONS: In children and adults with persistent asthma and in preschool children suspected of persistent asthma, there was low quality evidence that intermittent and daily ICS strategies were similarly effective in the use of rescue oral corticosteroids and the rate of severe adverse health events. The strength of the evidence means that we cannot currently assume equivalence between the two options.. Daily ICS was superior to intermittent ICS in several indicators of lung function, airway inflammation, asthma control and reliever use. Both treatments appeared safe, but a modest growth suppression was associated with daily, compared to intermittent, inhaled budesonide and beclomethasone. Clinicians should carefully weigh the potential benefits and harm of each treatment option, taking into account the unknown long-term (> one year) impact of intermittent therapy on lung growth and lung function decline.