Diagnostic Accuracy of Portable, Handheld Point-of-Care Tests vs Laboratory-Based Bilirubin Quantification in Neonates: A Systematic Review and Meta-analysis.

Importance: Quantification of bilirubin in blood is essential for early diagnosis and timely treatment of neonatal hyperbilirubinemia. Handheld point-of-care (POC) devices may overcome the current issues with conventional laboratory-based bilirubin (LBB) quantification. Objective: To systematically evaluate the reported diagnostic accuracy of POC devices compared with LBB quantification. Data Sources: A systematic literature search was conducted in 6 electronic databases (Ovid MEDLINE, Embase, Web of Science Core Collection, Cochrane Central Register of Controlled Trials, CINAHL, and Google Scholar) up to December 5, 2022. Study Selection: Studies were included in this systematic review and meta-analysis if they had a prospective cohort, retrospective cohort, or cross-sectional design and reported on the comparison between POC device(s) and LBB quantification in neonates aged 0 to 28 days. Point-of-care devices needed the following characteristics: portable, handheld, and able to provide a result within 30 minutes. This study was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline. Data Extraction and Synthesis: Data extraction was performed by 2 independent reviewers into a prespecified, customized form. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. Meta-analysis was performed of multiple Bland-Altman studies using the Tipton and Shuster method for the main outcome. Main Outcomes and Measures: The main outcome was mean difference and limits of agreement in bilirubin levels between POC device and LBB quantification. Secondary outcomes were (1) turnaround time (TAT), (2) blood volumes, and (3) percentage of failed quantifications. Results: Ten studies met the inclusion criteria (9 cross-sectional studies and 1 prospective cohort study), representing 3122 neonates. Three studies were considered to have a high risk of bias. The Bilistick was evaluated as the index test in 8 studies and the BiliSpec in 2. A total of 3122 paired measurements showed a pooled mean difference in total bilirubin levels of -14 µmol/L, with pooled 95% CBs of -106 to 78 µmol/L. For the Bilistick, the pooled mean difference was -17 µmol/L (95% CBs, -114 to 80 µmol/L). Point-of-care devices were faster in returning results compared with LBB quantification, whereas blood volume needed was less. The Bilistick was more likely to have a failed quantification compared with LBB. Conclusions and Relevance: Despite the advantages that handheld POC devices offer, these findings suggest that the imprecision for measurement of neonatal bilirubin needs improvement to tailor neonatal jaundice management.

Better assessment of neonatal jaundice at home (BEAT Jaundice @home): protocol for a prospective, multicentre diagnostic study.

INTRODUCTION: Severe neonatal hyperbilirubinaemia can place a neonate at risk for acute bilirubin encephalopathy and kernicterus spectrum disorder. Early diagnosis is essential to prevent these deleterious sequelae. Currently, screening by visual inspection followed by laboratory-based bilirubin (LBB) quantification is used to identify hyperbilirubinaemia in neonates cared for at home in the Netherlands. However, the reliability of visual inspection is limited. We aim to evaluate the effectiveness of universal transcutaneous bilirubin (TcB) screening as compared with visual inspection to: (1) increase the detection of hyperbilirubinaemia necessitating treatment, and (2) reduce the need for heel pricks to quantify bilirubin levels. In parallel, we will evaluate a smartphone app (Picterus), and a point-of-care device for quantifying total bilirubin (Bilistick) as compared with LBB. METHODS AND ANALYSIS: We will undertake a multicentre prospective cohort study in nine midwifery practices across the Netherlands. Neonates born at a gestational age of 35 weeks or more are eligible if they: (1) are at home at any time between days 2 and 8 of life; (2) have their first midwife visit prior to postnatal day 6 and (3) did not previously receive phototherapy. TcB and the Picterus app will be used after visual inspection. When LBB is deemed necessary based on visual inspection and/or TcB reading, Bilistick will be used in parallel. The coprimary endpoints of the study are: (1) hyperbilirubinaemia necessitating treatment; (2) the number of heel pricks performed to quantify LBB. We aim to include 2310 neonates in a 2-year period. Using a decision tree model, a cost-effectiveness analysis will be performed. ETHICS AND DISSEMINATION: This study has been approved by the Medical Research Ethical Committee of the Erasmus MC Rotterdam, Netherlands (MEC-2020-0618). Parents will provide written informed consent. The results of this study will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Dutch Trial Register (NL9545).

Effect of smoke-free policies in outdoor areas and private places on children's tobacco smoke exposure and respiratory health: a systematic review and meta-analysis.

BACKGROUND: Smoke-free policies in outdoor areas and semi-private and private places (eg, cars) might reduce the health harms caused by tobacco smoke exposure (TSE). We aimed to investigate the effect of smoke-free policies covering outdoor areas or semi-private and private places on TSE and respiratory health in children, to inform policy. METHODS: In this systematic review and meta-analysis, we searched 13 electronic databases from date of inception to Jan 29, 2021, for published studies that assessed the effects of smoke-free policies in outdoor areas or semi-private or private places on TSE, respiratory health outcomes, or both, in children. Non-randomised and randomised trials, interrupted time series, and controlled before-after studies, without restrictions to the observational period, publication date, or language, were eligible for the main analysis. Two reviewers independently extracted data, including adjusted test statistics from each study using a prespecified form, and assessed risk of bias for effect estimates from each study using the Risk of Bias in Non-Randomised Studies of Interventions tool. Primary outcomes were TSE in places covered by the policy, unplanned hospital attendance for wheezing or asthma, and unplanned hospital attendance for respiratory tract infections, in children younger than 17 years. Random-effects meta-analyses were done when at least two studies evaluated policies that regulated smoking in similar places and reported on the same outcome. This study is registered with PROSPERO, CRD42020190563. FINDINGS: We identified 5745 records and assessed 204 full-text articles for eligibility, of which 11 studies met the inclusion criteria and were included in the qualitative synthesis. Of these studies, seven fit prespecified robustness criteria as recommended by the Cochrane Effective Practice and Organization of Care group, assessing smoke-free cars (n=5), schools (n=1), and a comprehensive policy covering multiple areas (n=1). Risk of bias was low in three studies, moderate in three, and critical in one. In the meta-analysis of ten effect estimates from four studies, smoke-free car policies were associated with an immediate TSE reduction in cars (risk ratio 0·69, 95% CI 0·55-0·87; 161 466 participants); heterogeneity was substantial (I2 80·7%; p<0·0001). One additional study reported a gradual TSE decrease in cars annually. Individual studies found TSE reductions on school grounds, following a smoke-free school policy, and in hospital attendances for respiratory tract infection, following a comprehensive smoke-free policy. INTERPRETATION: Smoke-free car policies are associated with reductions in reported child TSE in cars, which could translate into respiratory health benefits. Few additional studies assessed the effect of policies regulating smoking in outdoor areas and semi-private and private places on children's TSE or health outcomes. On the basis of these findings, governments should consider including private cars in comprehensive smoke-free policies to protect child health. FUNDING: Dutch Heart Foundation, Lung Foundation Netherlands, Dutch Cancer Society, Dutch Diabetes Research Foundation, Netherlands Thrombosis Foundation, and Health Data Research UK.

Downsized cryopreserved and standard-sized allografts for right ventricular outflow tract reconstruction in children: long-term single-institutional experience.

OBJECTIVES: The objective of this study was to determine long-term results with bicuspidalized allografts compared to non-bicuspidalized allografts in children under 2 years undergoing primary correction of the right ventricular outflow tract. METHODS: Thirty-five consecutive bicuspidalized allografts were compared to 45 consecutive non-bicuspidalized allografts implanted during the same period. Valve-related events were analysed with Kaplan-Meier and Cox-regression techniques. Mixed-effects modelling was used to analyse serial echocardiographic measurements of pulmonary gradient. In addition, a systematic review with meta-analysis of the published literature concerning implantation of bicuspidalized allografts was performed. RESULTS: Perioperative characteristics and in-hospital mortality [bicuspidalized 5 (14.3%), non-bicuspidalized 6 (13.3%)] were comparable (P = 0.902). Bicuspidalized allografts were smaller (14.7 vs 16.5 mm, P = 0.023) and always (100%) of pulmonary origin compared to 26 (57.8%) of the standard-sized allografts. There were no differences in late mortality between the bicuspidalized and non-bicuspidalized group (6.7% vs 7.7%, P = 0.798) or freedom from allograft replacement at 10 years (82 ± 10% and 71 ± 8%, for bicuspidalized and non-bicuspidalized allografts, respectively). Evolution of peak pulmonary gradient (P = 0.273) was comparable between bicuspidalized and non-bicuspidalized allografts. Meta-analysis showed a pooled early and late mortality for bicuspidalized allograft patients of 10.72% [95% confidence interval (CI) 6.13-18.75] and 1.6% per year (95% CI 0.99-2.79), respectively. Pooled estimated late reintervention and replacement rates were 5.94% per year (95% CI 3.42-10.30) and 3.78% per year (95% CI 2.69-5.32), respectively. CONCLUSIONS: Bicuspidalization seems to be a viable alternative to combat limited supply of small-sized allografts with acceptable survival and reintervention rates comparable to non-bicuspidalized allografts.