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Protocol for a randomised controlled trial comparing two CPAP levels to prevent extubation failure in extremely preterm infants

BMJ Open. 2021 Jun 23;11(6):e045897. doi: 10.1136/bmjopen-2020-045897.

ABSTRACT

INTRODUCTION: Respiratory distress syndrome is a complication of prematurity and extremely preterm infants born before 28 weeks’ gestation often require endotracheal intubation and mechanical ventilation. In this high-risk population, mechanical ventilation is associated with lung injury and contributes to bronchopulmonary dysplasia. Therefore, clinicians attempt to extubate infants as quickly and use non-invasive respiratory support such as nasal continuous positive airway pressure (CPAP) to facilitate the transition. However, approximately 60% of extremely preterm infants experience ‘extubation failure’ and require reintubation. While CPAP pressures of 5-8 cm H2O are commonly used, the optimal CPAP pressure is unknown, and higher pressures may be beneficial in avoiding extubation failure. Our trial is the Extubation CPAP Level Assessment Trial (ÉCLAT). The aim of this trial is to compare higher CPAP pressures 9-11 cm H2O with a current standard pressures of 6-8 cmH2O on extubation failure in extremely preterm infants.

METHODS AND ANALYSIS: 200 extremely preterm infants will be recruited prior to their first extubation from mechanical ventilation to CPAP. This is a parallel group randomised controlled trial. Infants will be randomised to one of two set CPAP pressures: CPAP 10 cmH2O (intervention) or CPAP 7 cmH2O (control). The primary outcome will be extubation failure (reintubation) within 7 days. Statistical analysis will follow standard methods for randomised trials on an intention to treat basis. For the primary outcome, this will be by intention to treat, adjusted for the prerandomisation strata (GA and centre). We will use the appropriate parametric and non-parametric statistical tests.

ETHICS AND DISSEMINATION: Ethics approval has been granted by the Monash Health Human Research Ethics Committees. Amendments to the trial protocol will be submitted for approval. The findings of this study will be written into a clinical trial report manuscript and disseminated via peer-reviewed journals (on-line or in press) and presented at national and international conferences.Trial registration numberACTRN12618001638224; pre-results.

PMID:34162644 | DOI:10.1136/bmjopen-2020-045897

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A questionnaire validated using local treatment guidelines may better predict future asthma risk: MARGIN study

Respir Investig. 2021 Jun 20:S2212-5345(21)00081-2. doi: 10.1016/j.resinv.2021.05.001. Online ahead of print.

ABSTRACT

BACKGROUND: Asthma patients often feel satisfied with their current treatment, even when they have been diagnosed as uncontrolled by physicians. The present study investigated the differences in the evaluation of asthma control levels between patients and physicians, and the prediction of future risks.

METHODS: Asthma patients receiving inhaled corticosteroid/long-acting beta-2 agonists for 4 weeks or more were enrolled and followed-up for 24 weeks. Asthma control levels were evaluated using the following guidelines: Asthma Prevention and Management Guideline, Japan (JGL) and Global Initiative for Asthma (GINA) by physicians, and the Japan Asthma Control Survey (JACS) and a 6-item Asthma Control Questionnaire (ACQ6) by patients, at weeks 0 and 24. Analysis for predictive factors influencing exacerbation was performed using JGL, GINA, JACS, and ACQ6 at week 0.

RESULTS: A total of 420 patients were enrolled. Comparison of the distribution of asthma control levels assessed by physicians and patients showed no statistically significant difference between JGL and JACS (P = 0.19), suggesting a symmetric distribution, while ACQ6 demonstrated a significant difference versus JGL and GINA (both P < 0.001). The predictive factors for exacerbation were unscheduled visits based on GINA (rate ratio; 0.25, 95% CI; 0.14, 0.44), and the use of oral steroids on 3 consecutive days based on JGL (rate ratio; 0.42, 95% CI 0.22, 0.82) and JACS (rate ratio; 0.22, 95% CI; 0.13, 0,40).

CONCLUSIONS: Our study suggests that evaluation based on treatment guidelines and the questionnaire validated according to the local treatment guidelines is important for improved assessment of asthma control levels and the reduction of future risk.

CLINICAL TRIAL REGISTRATION NUMBER: UMIN000030419.

PMID:34162527 | DOI:10.1016/j.resinv.2021.05.001

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Application of Capillary Electrophoresis in Monoclonal Gammopathies and the Cutoff Value of Monoclonal Protein in Differential Diagnosis of Multiple Myeloma and Other Monoclonal Gammopathies

Ann Clin Lab Sci. 2021 May;51(3):400-407.

ABSTRACT

OBJECTIVE: Monoclonal protein (MP) exists in various diseases, and capillary electrophoresis (CE) has been widely used to detect MP. However, there is not much research on the application value of MP in the differential diagnosis of monoclonal gammopathies. This study aimed to explore MP’s cutoff value for the differential diagnosis of multiple myeloma (MM) and other monoclonal gammopathies (MGs).

METHODS: A retrospective analysis of 8167 cases was conducted. Serum MP was detected by CE, and the patients’ clinical information was collected from the clinical database of our hospital.

RESULTS: 985 cases had MP with high peaks, and 91.1% were diagnosed with malignant diseases. The MP showed small peaks in 471 cases, and only 24.4% were diagnosed with malignant diseases. Among the MPs, the IgG-κ type was the most common type, followed by the IgG-λ, IgA-κ, IgA-λ, free λ light chain, IgM-κ, free κ light chain, double clone, and IgM-λ types. Differences in the MP of the IgG, IgA, IgM, and FLC types between the MM group and MGUS group were statistically different (P<0.01). The MP of the IgG, IgA, and FLC types showed clear specificity and sensitivity in discriminating MM from other monoclonal gammopathies in ROC curve analysis. Serum IgM had statistical significance in the differential diagnosis between WM and other MGs (P<0.01). However, there was no statistical significance in the differential diagnosis between MM and other MGs (P=0.140). The cutoff values of the MP of the IgG, IgA, and FLC types were >18.67g/L, >13.86g/L, and >10.15g/L, respectively, for the differential diagnosis of MM and other MGs. The cutoff value of the MP of IgM for the WM diagnosis was >37.75 g/L.

CONCLUSION: CE has good clinical application value in the diagnosis of monoclonal gammopathies, and MP can be used in the differential diagnosis of MM and other monoclonal gammopathies.

PMID:34162571

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Mediation effect of arterial stiffness on ideal cardiovascular health and stroke

Nutr Metab Cardiovasc Dis. 2021 May 18:S0939-4753(21)00227-1. doi: 10.1016/j.numecd.2021.05.006. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: Ideal cardiovascular health (CVH) metrics was associated with stroke, but the causal pathway was poorly investigated. Arterial stiffness was a major factor associated with both ideal CVH metrics and stroke. This study aimed to investigate whether the effect of ideal CVH metrics on stroke was mediated and enhanced by arterial stiffness.

METHODS AND RESULTS: A total of 15,297 participants were included in current study. Arterial stiffness was measured by brachial-ankle pulse wave velocity (baPWV). Causal mediation analyses were used to separate the overall effects of ideal CVH metrics on stroke into indirect effects (mediated by arterial stiffness) and direct effects (mediated through pathways other than arterial stiffness). After a median follow-up of 5.88 years, 324 total stroke events (292 ischemic stroke and 31 hemorrhagic stroke) occurred. Mediation analysis showed 23.94% of the relation between ideal CVH and total stroke was mediated by baPWV (95% confidence interval [CI] of the indirect effect: 0.93-0.95). Further analysis showed the ideal CVH < median combined with baPWV ≥1400 cm/s was associated with the highest risk of total stroke (hazard ratio: 5.62; 95% CI, 3.53-8.96), compared with CVH ≥ median combined with baPWV < 1400 cm/s. Similar results were observed for ischemic stroke, but not for hemorrhagic stroke.

CONCLUSIONS: Arterial stiffness played a mediating role in the associations between ideal CVH metrics and risk of total and ischemic stroke. Combined ideal CVH metrics and baPWV is a reasonable and useful tool for the assessment and prevention of stroke.

PMID:34162503 | DOI:10.1016/j.numecd.2021.05.006

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Postoperative outcomes of ureteroscopy for pediatric urolithiasis: A secondary analysis of the National Surgical Quality Improvement Program Pediatric

J Pediatr Urol. 2021 Jun 10:S1477-5131(21)00304-1. doi: 10.1016/j.jpurol.2021.06.004. Online ahead of print.

ABSTRACT

INTRODUCTION: Incidence of pediatric urinary stone disease (PUSD) has increased over recent decades. Innovations in ureteroscopic technology has expanded the role of endourologic stone management in children. However, there is currently no consensus on the optimal use of ureteroscopy (URS) within the heterogenous PUSD population.

OBJECTIVE: The primary objective was to investigate the rate of 30-day unplanned readmissions in pediatric patients after URS. The secondary objective was to examine the influence of demographic, perioperative, postoperative, and reoperation variables as predictors of an increased risk of unplanned readmission in this sample.

STUDY DESIGN: A secondary analysis was performed on retrospectively collected data from the National Surgical Quality Improvement Program Pediatric between 2015 and 2018. Pediatric patients diagnosed with PUSD and treated with URS were identified. Patients undergoing concurrent or additional surgeries during the URS procedure were excluded. Data on demographic, perioperative, postoperative, and unplanned reoperation variables were examined for their possible influence on 30-day unplanned readmissions. Descriptive statistics were used to characterize the study cohort. Continuous and categorical variables were analyzed using independent samples t-test, one-way ANOVA with Tukey post-hoc test, and Chi-square Tests or Fisher’s Exact Test, respectfully. Multivariate analysis was performed using stepwise logistic regression.

RESULTS: A total of 2510 patients were identified within the study period. The majority of children undergoing URS were between 12 and 18 years of age (66.1%), female (56.9%), and had renal calculi (45.2%). Of these, 162 (6.5%) experienced a 30-day unplanned readmission related to the URS procedure. The most common reasons for an unplanned readmission was urinary tract infection (31.4%), new/unresolved stone (28.3%), and postoperative pain (8.2%). Multivariate modelling showed that females (Relative Risk [RR]: 2.03; 95% Confidence Interval [95%CI]: 1.34-3.07), patients with renal stones (RR: 1.77; 95%CI: 1.10-2.83), and inpatients at the time of surgery (RR: 1.61; 95%CI: 1.03-2.51) were more at risk of an unplanned readmission within 30-days of an URS procedure.

CONCLUSION: This study reports on short-term unplanned readmission rates in pediatric patients who underwent an URS procedure. Further it highlights possible predictors of unplanned readmission rates within a sampling of patients from NSQIP affiliated institutions. The findings from this study can be used to guide future studies around the safe use of URS in pediatric patients.

PMID:34162516 | DOI:10.1016/j.jpurol.2021.06.004

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Diabetes Mellitus as the Major Factor of Prolonged Hospitalisation in Mild or Moderate COVID-19 Pneumonia

Exp Clin Endocrinol Diabetes. 2021 Jun 23. doi: 10.1055/a-1468-4296. Online ahead of print.

NO ABSTRACT

PMID:34161995 | DOI:10.1055/a-1468-4296

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Dinoprostone vaginal insert (DVI) versus adjunctive sweeping of membranes and DVI for term induction of labor

J Obstet Gynaecol Res. 2021 Jun 23. doi: 10.1111/jog.14907. Online ahead of print.

ABSTRACT

AIM: To compare the efficacy and safety of dinoprostone vaginal insert (DVI) alone versus DVI with adjunctive sweeping of membranes (ASM) for induction of labor (IOL).

METHODS: Single-center, prospective, randomized controlled trial; women with singleton term pregnancies, cervical dilation ≥1 and <3 cm, intact membranes allocated to either DVI or DVI with ASM. The primary outcome was vaginal delivery within 24 h of insertion. Secondary outcomes included mean time from insertion to delivery, tachysystole, operative delivery for non-reassuring fetal status (NRFS), tocolytics, fetal outcomes, pain information, and subject satisfaction.

RESULTS: One hundred and four received DVI (Group 1) alone and 104 DVI with ASM (Group 2). The rate of vaginal delivery within 24 h was 53% versus 56%, cesarean rate 8.7% versus 10.6% in Groups 1 and 2 respectively. Although the duration of labor was similar in both groups, about 6% of women required additional ripening with dinoprostone vaginal tablets in Group 2 compared to 11.5% in Group 1 (p-value = 0.2). The frequency of hyperstimulation syndrome, failed induction, analgesic requirements, and fetal outcomes were comparable. The majority (83%-86%) in either cohort were satisfied with their labor experience. Multivariate logistic regression demonstrated a slightly better chance for vaginal delivery within 24 h (odds ratio [OR] 1.22 [95% confidence interval, CI 0.65-2.29]; p-value 0.53] for DVI with ASM, although statistically insignificant. Younger maternal age and multiparity (OR 10.36 [95% CI 4.88-23.67]; p-value <0.0001) contributed to successful IOL.

CONCLUSION: DVI with ASM is at least as efficacious as DVI for cervical ripening with no increase in morbidity. Although DVI with ASM group less often needed additional dinoprostone tablets to complete the process of IOL (p-value = 0.2), adjunctive sweeping has not been shown to have a significant impact on the duration of labor or mode of delivery.

PMID:34162016 | DOI:10.1111/jog.14907

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Overview of epidemiological studies of nuclear workers: opportunities, expectations, and limitations

J Radiol Prot. 2021 Jun 23. doi: 10.1088/1361-6498/ac0df4. Online ahead of print.

ABSTRACT

Epidemiological studies of those exposed occupationally to ionising radiation offer an important opportunity to directly check the assumptions underlying the international system of radiological protection against low-level radiation exposures. Recent nuclear worker studies, notably the International Nuclear Workers Study (INWORKS) and studies of the Mayak workforce in Russia, provide powerful investigations of a wide range of cumulative photon doses received at a low dose-rate over protracted periods, and broadly confirm radiation-related excess risks of leukaemia and solid cancers at around the levels predicted by standard risk models derived mainly from the experience of the Japanese atomic-bomb survivors acutely exposed principally to gamma radiation. However, the slope of the dose-response for solid cancers expressed in terms of the excess relative risk per unit dose, ERR/Gy, differs between INWORKS and Mayak, such that when compared with the slope derived from the atomic-bomb survivors, INWORKS does not provide obvious support for the use in radiological protection of a Dose and Dose-Rate Effectiveness Factor (DDREF) greater than 1 whereas the Mayak workforce apparently does. This difference could be a chance effect, but it could also point to potential problems with these worker studies. Of particular concern is the adequacy of recorded doses received in the early years of operations at older nuclear installations, such as the potential for “missed” photon doses. A further issue is how baseline cancer rates may influence radiation-related excess risks. There is scope for a considerable increase in the statistical power of worker studies, with longer follow-up capturing more deaths and incident cases of cancer, and further workforces being included in collaborative studies, but the difficulties posed by dosimetry questions should not be ignored and need to be the subject of detailed scrutiny.

PMID:34161930 | DOI:10.1088/1361-6498/ac0df4

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Application of Risk Scores for Hepatocellular Carcinoma in Patients with Chronic Hepatitis B: Current Status and Future Perspective

Semin Liver Dis. 2021 Jun 23. doi: 10.1055/s-0041-1730924. Online ahead of print.

ABSTRACT

Accurate risk prediction for hepatocellular carcinoma (HCC) among patients with chronic hepatitis B (CHB) may guide treatment strategies including initiation of antiviral therapy and also inform implementation of HCC surveillance. There have been 26 risk scores developed to predict HCC in CHB patients with (n = 14) or without (n = 12) receiving antiviral treatment; all of them invariably include age in the scoring formula. Virological biomarkers of replicative activities (i.e., hepatitis B virus DNA level or hepatitis B envelope antigen status) are frequently included in the scores derived from patients with untreated CHB, whereas measurements that gauge severity of liver fibrosis and/or reserve of hepatic function (i.e., cirrhosis diagnosis, liver stiffness measurement, platelet count, or albumin) are essential components in the scores developed from treated patients. External validation is a prerequisite for clinical application but not yet performed for all scores. For the future, higher predictive accuracy may be achieved with machine learning based on more comprehensive data.

PMID:34161993 | DOI:10.1055/s-0041-1730924

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Differential activation of neuroinflammatory pathways in children with seizures: A cross-sectional study

Seizure. 2021 May 31;91:150-158. doi: 10.1016/j.seizure.2021.05.022. Online ahead of print.

ABSTRACT

PURPOSE: Inflammation plays a crucial role in epileptogenesis. We analyzed inflammatory cytokines in plasma and saliva from children with seizures and healthy controls and measured their associations with HHV6 and EBV infection.

METHODS: We analyzed plasma from 36 children within 24 h of seizures (cases) and 43 healthy controls and saliva from 44 cases and 44 controls with a multiplex immunoassay. Saliva from all controls and 65 cases and blood from 26 controls and 35 cases were also analyzed by PCR for viral DNA. Primary outcome was cytokine levels in cases vs. controls. Secondary outcomes included detection of HHV-6 and EBV viral DNA in cases vs. controls and viral loads in cases vs. controls. Statistical analysis included the Wilcoxon Rank Sum test, Fisher’s exact test, ANOVA, and Spearman correlation.

RESULTS: Compared to controls, patients had higher levels of CCL11 (p = 0.0018), CCL26 (p<0.001), IL10 (p = 0.044), IL6 (p<0.001), IL8 (p = 0.018), and MIP1β (p = 0.0012). CCL11 was higher with 3 or more seizures (p = 0.01), seizures longer than 10 min (p = 0.001), and when EEG showed focal slowing (p = 0.02). In saliva, febrile seizures had higher levels of IL-1β (n = 7, p = 0.04) and new onset seizures had higher IL-6 (n = 15, p = 0.02). Plasma and saliva cytokine levels did not show a correlation. The frequency of HHV-6 and EBV detection was similar across groups and not different than controls. We found no correlation between viral load and cytokine levels.

CONCLUSIONS: We showed differential activation of neuroinflammatory pathways in plasma from different seizure etiologies compared to controls, unrelated to viral infection.

PMID:34161903 | DOI:10.1016/j.seizure.2021.05.022