Efficacy and safety of luseogliflozin in patients with type 2 diabetes mellitus: a systematic review and meta-analysis.

PURPOSE: Owing to the absence of the most recent evidence on the efficacy and safety of luseogliflozin, our study aimed to conduct a systematic review and meta-analysis of luseogliflozin in patients with type 2 diabetes mellitus. METHODS: A comprehensive search of electronic databases like PubMed, Cochrane CENTRAL, and Google Scholar was performed from the inception to the 31st of August 2023 to identify the randomized controlled trials (RCTs) that examined the glucose and body weight lowering efficacy and safety outcomes of luseogliflozin in comparison with control or other active treatments. The fixed or random-effect model was used based on the heterogeneity identified using the I2 statistic and Cochran's Q test. RESULTS: Out of 50 non-duplicate articles identified through database searching, 8 RCTs (11 studies) with 1922 patients were included in this study. The efficacy outcomes like HbA1c (MD: -0.59%; 95% CI: -0.90, -0.29; P < 0.001), FPG (MD: -16.01 mg/dL; 95% CI: -19.46, -12.57; P < 0.001), PPG (MD: -36.63 mg/dL; 95% CI: -43.71, -29.55; P < 0.001) and body weight (MD: -1.66 kg; 95% CI: -2.23, -1.12; P < 0.001) were significantly reduced with luseogliflozin compared to the control group. Regarding the safety outcomes, there was no statistically significant difference between the two groups for hypoglycemia (OR: 1.14; 95% CI: 0.70, 1.84; P = 0.60). However, pollakiuria (OR: 4.08; 95% CI: 1.71, 9.69; P < 0.001) and any ADRs (OR: 2.04; 95% CI: 1.33, 3.14; P < 0.001) were significantly higher in the luseogliflozin group compared to the control. CONCLUSION: The current study identified a significant improvement in efficacy outcomes of HbA1c, FPG, PPG, and body weight in the luseogliflozin group. Non-significant safety results may be due to a smaller population size and fewer studies. Hence, long-term multicentric RCTs are needed to identify the safety and efficacy in a diversified population.

Clinical characteristics, genetic profile and short-term outcomes of children with primary hyperoxaluria type 2: a nationwide experience.

BACKGROUND: Three types of primary hyperoxaluria (PH) are recognized. However, data on PH type 2 (PH2), caused by defects in the GRHPR gene, are limited. METHODS: We reviewed the medical records of patients < 18 years of age with genetically-proven PH2 from seven centres across India to identify the age of onset, patterns of clinical presentation, short-term outcomes and genetic profile, and to determine if genotype-phenotype correlation exists. RESULTS: We report 20 patients (all with nephrolithiasis or nephrocalcinosis) diagnosed to have PH2 at a median (IQR) age of 21.5 (7, 60) months. Consanguinity and family history of kidney stones were elicited in nine (45%) and eight (40%) patients, respectively. The median (IQR) serum creatinine at PH2 diagnosis was 0.45 (0.29, 0.56) mg/dL with the corresponding estimated glomerular filtration rate being 83 (60, 96) mL/1.73 m2/min. A mutational hotspot (c.494 G > A), rare in Caucasians, was identified in 12 (60%) patients. An intronic splice site variant (c.735-1G > A) was noted in five (25%) patients. Four (20%) patients required surgical intervention for stone removal. Major adverse kidney events (mortality or chronic kidney disease (CKD) stages 3-5) were noted in six (30%) patients at a median (IQR) follow-up of 12 (6, 27) months. Risk factors for CKD progression and genotype-phenotype correlation could not be established. CONCLUSIONS: PH2 should no longer be considered an innocuous disease, but rather a potentially aggressive disease with early age of presentation, and possible rapid progression to CKD stages 3-5 in childhood in some patients. A mutational hotspot (c.494 G > A variant) was identified in 60% of cases, but needs further exploration to decipher the genotype-phenotype correlation.

Risk of pancreatitis and pancreatic carcinoma for anti-diabetic medications: findings from real-world safety data analysis and systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: The existing evidence from pre- and post-marketing studies is conflicting on the risk of pancreatic events for anti-diabetic medications. RESEARCH DESIGN AND METHODS: A retrospective case/non-case study was conducted by using spontaneous reports on pancreatic events for anti-diabetic medications from the FDA Adverse Event Reporting System (FAERS) and VigiBase. Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), and Information Component (IC) were calculated by a disproportionality analysis. Furthermore, PubMed, Google Scholar, Scopus, and ClinicalTrials.gov were systematically searched for randomized controlled trials (RCTs) on anti-diabetic drugs with pancreatic outcomes. RESULTS: The FAERS data analysis found strong signals on incretin mimetics causing pancreatic events, with sitagliptin having the highest risk [PRR = 24.2, lower bound (LB) ROR = 24.4, IC025 = 4.4 for pancreatitis, and PRR = 15.4, LB ROR = 14.9, IC025 = 3.8 for pancreatic carcinoma]. Empagliflozin was the most pancreatitis-risk sodium-glucose co-transporter-2 inhibitor [PRR = 4.0, LB ROR = 3.5, IC025 = 1.8]. VigiBase reiterated these findings and identified some new signals for novel anti-diabetics. Meta-analysis revealed that the incidence of pancreatitis and pancreatic carcinoma with anti-diabetic medications was insignificant. However, compared to the placebo/active comparator, gliptins had a higher risk of acute pancreatitis (OR 1.44; 95% CI 1.03, 2.01; P = 0.03). CONCLUSION: Evidence from the post-marketing safety data analysis identified a strong association between incretin mimetics and pancreatic events. Fewer events in RCTs may justify insignificant meta-analysis results.

We conducted this research to identify the risk of pancreatitis and pancreatic carcinoma among anti-diabetic medications from pre-and post-marketing evidence available from clinical trials data and pharmacovigilance databases (FAERS, VigiBase). A disproportionality analysis of pharmacovigilance data was done to statistically check whether the selected drug-event pairs were frequently reported from the database (known as a 'signal'). We performed further signal refinement analysis using OpenVigil 2.1 on the generated signals to check whether the signal sustains even after removing co-prescribed medications possessing the same risk. Also, conducted a systematic review of randomized controlled trials for evidence generation regarding the pancreatic safety of the medications. The findings from real-world data indicated that, among all anti-diabetics, incretin mimetics and sulfonylurea compounds produced signals for both pancreatitis and pancreatic carcinoma. Notable pancreatitis risk was also identified for newer anti-diabetics like SGLT-2 inhibitors. The findings from the meta-analysis of clinical trials indicated a 44% risk of DPP-4 inhibitors in causing acute pancreatitis and a 60% risk of GLP-1 agonists in elevating the lipase level, compared to placebo/active comparator. Thus, the study raises concerns over the risk of pancreatitis and pancreatic carcinoma among the users of anti-diabetic medications, especially incretin mimetics.

Biomarkers for prediction of acute kidney injury in pediatric patients: a systematic review and meta-analysis of diagnostic test accuracy studies.

BACKGROUND: Severity of acute kidney injury (AKI) confers higher odds of mortality. Timely recognition and early initiation of preventive measures may help mitigate the injury further. Novel biomarkers may aid in the early detection of AKI. The utility of these biomarkers across various clinical settings in children has not been evaluated systematically. OBJECTIVE: To synthesize the currently available evidence on different novel biomarkers for the early diagnosis of AKI in pediatric patients. DATA SOURCES: We searched four electronic databases (PubMed, Web of Science, Embase, and Cochrane Library) for studies published between 2004 and May 2022. STUDY ELIGIBILITY CRITERIA: Cohort and cross-sectional studies evaluating the diagnostic performance of biomarkers in predicting AKI in children were included. PARTICIPANTS AND INTERVENTIONS: Participants in the study included children (aged less than 18 years) at risk of AKI. STUDY APPRAISAL AND SYNTHESIS METHODS: We used the QUADAS-2 tool for the quality assessment of the included studies. The area under the receiver operating characteristics (AUROC) was meta-analyzed using the random-effect inverse-variance method. Pooled sensitivity and specificity were generated using the hierarchical summary receiver operating characteristic (HSROC) model. RESULTS: We included 92 studies evaluating 13,097 participants. Urinary NGAL and serum cystatin C were the two most studied biomarkers, with summary AUROC of 0.82 (0.77-0.86) and 0.80 (0.76-0.85), respectively. Among others, urine TIMP-2*IGFBP7, L-FABP, and IL-18 showed fair to good predicting ability for AKI. We observed good diagnostic performance for predicting severe AKI by urine L-FABP, NGAL, and serum cystatin C. LIMITATIONS: Limitations were significant heterogeneity and lack of well-defined cutoff value for various biomarkers. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: Urine NGAL, L-FABP, TIMP-2*IGFBP7, and cystatin C showed satisfactory diagnostic accuracy in the early prediction of AKI. To further improve the performance of biomarkers, they need to be integrated with other risk stratification models. SYSTEMATIC REVIEW REGISTRATION: PROSPERO (CRD42021222698). A higher resolution version of the Graphical abstract is available as "Supplementary information".

Effect of garlic extract on markers of lipid metabolism and inflammation in coronary artery disease (CAD) patients: A systematic review and meta-analysis.

Several preclinical studies have focused on the beneficial effects of garlic on cardiovascular diseases, but the results were inconsistent. We performed a systematic review and meta-analysis on the effect of garlic powder tablets and aged garlic extract (AGE) in CAD patients, mainly focusing on blood pressure, coronary artery calcification, lipid profile, and inflammatory markers. We searched PubMed, Cochrane CENTRAL, and Google Scholar to identify randomized controlled trials which examined garlic's effect on CAD patients. The standardized mean difference with 95% CI was calculated using fixed-effect or random-effect models. Garlic has shown statistically significant changes of HDL (SMD = 0.18; 95% CI = -0.00 to 0.37; p = .05); LDL (SMD = -0.27; 95% CI = -0.46 to -0.08; p = .004), apolipoprotein-A (SMD = 0.68; 95% CI = 0.24 1.13; p = .002), C-RP (SMD = -0.59; 95% CI = -0.92 to -0.25; p = .0007), IL-6 (SMD = -1.08; 95% CI = -2.17 to 0.01; p = .05), homocysteine (SMD = -0.66; 95% CI = -1.04 to -0.28; p = .0007) and CAC score (SMD = -1.61; 95% CI = -2.66 to -0.57; p = .003). In the case of subgroup analysis, the overall effect was significantly effective in reducing TC, LDL levels and improving HDL levels in CV risk patients. Our study findings provide consistent evidence that intake of garlic reduces CVD risk factors. However, garlic could be considered a safe natural medicine to debilitate inflammation in CAD patients.

Efficacy, safety, and tolerability of isoniazid preventive therapy for tuberculosis in people living with HIV.

OBJECTIVE: The aim of this study was to systematically assess the efficacy, safety, and tolerability of isoniazid preventive therapy (IPT) for tuberculosis (TB) in people with HIV (PWH). DESIGN: A systematic review and meta-analysis. METHODS: A thorough literature search was performed using PubMed, Cochrane CENTRAL, and Google Scholar from their inception to June 30, 2021. All randomized controlled trials (RCTs) investigating the efficacy, safety, or tolerability of IPT on PWH compared with placebo or active comparators were included in the study. The heterogeneity among the studies was identified by using the I2 statistic and Cochran's Q test. RESULTS: Out of the 924 nonduplicate RCTs identified through database searching and other sources, 26 studies comprising 38 005 patients were included. The overall effect estimate identified the reduction of active TB incidence [odds ratio (OR) 0.69; 95% confidence interval (95% CI) 0.57-0.84; P  < 0.001], but not all-cause mortality (OR 0.91; 95% CI 0.82, 1.02; P  = 0.10) with IPT compared with the control. In addition, no significant association was identified between the use of IPT and the risk of peripheral neuropathy (OR 1.50; 95% CI 0.96-2.36; P  = 0.08) and hepatotoxicity (OR 1.21; 95% CI 0.97-1.52; P  = 0.09). CONCLUSION: This systematic review and meta-analysis identified a significant reduction in the incidence of active TB, but not all-cause mortality, among PWH who received IPT compared with the control. Lesser number of outcomes may be the reason for nonsignificant results in terms of safety outcomes of IPT. Therefore, there is a need for extensive and long-term studies to address these issues further, especially in TB/HIV endemic areas.

Comparative efficacy and safety of oral nifedipine with other antihypertensive medications in the management of hypertensive disorders of pregnancy: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Hypertensive disorders of pregnancy are the most frequently occurring medical condition during pregnancy, resulting in fetal and/or maternal morbidity and mortality. This meta-analysis compared the efficacy and safety of nifedipine with other antihypertensive medications used in hypertensive disorders of pregnancy. METHODOLOGY: A comprehensive search was performed using PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar. The meta-analysis was carried out using Review Manager Software, and the pooled effect estimate was generated as standardized mean difference and odds ratio with 95% confidence interval and two-sided P -value. RESULTS: The meta-analysis was comprised of 22 randomized control trials with 2595 participants. It was found that meantime and number of doses required to achieve target blood pressure were lower in the nifedipine group ( P  < 0.05). Even though it is statistically insignificant, fetal APGAR (Appearance, Pulse, Grimace, Activity, and Respiration) scores less than seven favors nifedipine intervention. Furthermore, none of the fetal or maternal secondary outcomes were found significant. CONCLUSION: Nifedipine was found to be more effective than other antihypertensive medications to reduce blood pressure, particularly in patients with severe hypertension. However, future clinical studies, including real-world data are necessary to establish the safety profile of nifedipine concerning the fetal outcomes in hypertensive pregnant women.

Pediatric Ventilation Liberation: Bundled Extubation Readiness and Analgosedation Pathways Decrease Mechanical Ventilation Duration and Benzodiazepine Exposure.

BACKGROUND: Recent studies reported that children on mechanical ventilation who were managed with an analgosedation approach and standardized extubation readiness testing experienced better outcomes, including decreased delirium and invasive mechanical ventilation duration. METHODS: This was a quality improvement project in a 24-bed pediatric ICU within a single center, including subjects ≤ 18 years old who required invasive mechanical ventilation via an oral or nasal endotracheal tube. The aim was to decrease the invasive mechanical ventilation duration for all the subjects by 25% within 9 months through the development and implementation of bundled benzodiazepine-sparing analgosedation and extubation readiness testing clinical pathways. RESULTS: In the pre-implementation cohort, there were 274 encounters, with 253 (92.3%) that met inclusion for ending in an extubation attempt. In the implementation cohort, there were 367 encounters with 332 (90.5%) that ended in an extubation attempt. The mean invasive mechanical ventilation duration decreased by 23% (Pre 3.95 d vs Post 3.1 d; P = .039) after the implementation without a change in the mean pediatric ICU length of stay (Pre 7.5 d vs Post 6.5 d; P = .42). No difference in unplanned extubation (P > .99) or extubation failure rates (P = .67) were demonstrated. Sedation levels as evaluated by the mean State Behavioral Scale were similar (Pre -1.0 vs Post -1.1; P = .09). The median total benzodiazepine dose administered decreased by 75% (Pre 0.4 vs Post 0.1 mg/kg/ventilated day; P < .001). No difference in narcotic withdrawal (Pre 17.8% vs Post 16.4%; P = .65) or with delirium treatment (Pre 5.5% vs Post 8.7%; P = .14) was demonstrated. CONCLUSIONS: A multidisciplinary, bundled benzodiazepine-sparing analgosedation and extubation readiness testing approach resulted in a reduction in mechanical ventilation duration and benzodiazepine exposure without impacting key balancing measures. External validity needs to be evaluated in similar centers and consensus on best practices developed.

Diagnostic accuracy of renal angina index alone or in combination with biomarkers for predicting acute kidney injury in children.

Early recognition of patients at risk for severe acute kidney injury (AKI) by renal angina index (RAI) may help in the early institution of preventive measures. Objective was to evaluate performance of RAI alone or in combination with biomarkers in predicting severe AKI (KDIGO stage 2 and 3 or equivalent) and receipt of kidney replacement therapy (KRT) in critically ill children. We searched PubMed, EMBASE, Web of Sciences, and CENTRAL for studies published till May 2021. Search terms included acute kidney injury, pediatrics, adolescent, renal angina index, and biomarker. Proceedings of relevant conferences and references of included studies were also scrutinized. Two reviewers independently assessed the study eligibility. Cohort and cross-sectional studies evaluating the diagnostic performance of RAI in predicting AKI or receipt of KRT in children were included. Eligible participants were the children less than 18 years with RAI assessment on day 0 ofadmission. We followed PRISMA-DTA guidelines and used the QUADAS-2 tool for quality assessment. A bivariate model for meta-analysis was used to calculate the summary estimates of diagnostic parameters. Major outcomes were the diagnostic accuracy of RAI (≥ 8) alone or with biomarkers in predicting severe AKI and KRT receipt. Diagnostic accuracy was reported using summary sensitivity, specificity, and area under the curve (AUC). Overall, 22 studies (24 reports, 14,001 participants) were included. RAI ≥ 8 on day 0 has summary sensitivity, specificity, and AUC of 0.86 (95% CI, 0.77-0.92), 0.77 (0.68-0.83), and 0.88 (0.85-0.91) respectively for prediction of severe AKI on day 3. In comparison, a combination of RAI and urinary neutrophil gelatinase-associated lipocalin (NGAL) showed summary sensitivity, specificity, and AUC of 0.76 (0.62-0.85), 0.89 (0.74-0.96), and 0.87 (0.84-0.90) respectively for predicting severe AKI. The sensitivity, specificity, and AUC of RAI for predicting receipt of KRT were 0.82 (0.71-0.90), 0.74 (0.66-0.81), and 0.85 (0.81-0.88) respectively. In meta-regression, only the study setting (sepsis vs. heterogenous) was associated with heterogeneity. We observed substantial heterogeneity among eligible studies. Five studies had concerns in patient selection, and seven studies also had applicability concerns in patient selection for this review. Moderate certainty evidence showed that RAI ≥ 8 has good predicting ability in recognizing children at risk of severe AKI and receipt of KRT. The combination of urinary NGAL and RAI further improves the predicting ability (low-certainty evidence). Further studies are required on the context-driven assessment of novel biomarkers in the early prediction of AKI in RAI-positive children. Systematic review registration number: CRD4202122268. A higher resolution version of the Graphical abstract is available as Supplementary information.

A Digital Chairside Technique for an Accurate Evaluation of the Taper of the Prepared Teeth for the Restoration of Crowns and Fixed Partial Dentures.

AIM: The aim of the article was to provide a digital chairside method for the objective evaluation of the taper of prepared abutment teeth retaining a fixed partial denture (FPD). BACKGROUND: According to research, the taper of the abutment teeth supporting an FPD has a direct effect on both retention and stress transmission to the abutment teeth. However, no approaches have been documented in the literature that objectively quantify the taper of the prepared teeth chairside, in a simple and cost-effective manner. TECHNIQUE: The proposed technique utilized an intraoral camera with an on-the-go (OTG) connection, and a silicone dental bite block. The images of the prepared teeth were captured using this camera from the facial aspect. An indigenous program was developed using the MATLAB (Matrix Laboratory 2013) software for the analysis of the images and the taper of each abutment tooth was calculated in degrees using the software. CONCLUSION: The novel, chairside, digital technique utilizes an intraoral camera and a computer-generated software package to quantify and evaluate the taper of abutment teeth efficiently. This, in turn, can help minimize the errors in the treatment of FPD and improve the retention of the prosthesis. CLINICAL SIGNIFICANCE: The current technique enables the clinician to avoid over-preparation of the abutment teeth by assessing its taper chairside. This digital technique can be a beneficial alternative to the existing procedures for an accurate assessment of taper, especially for the inexperienced operator. Hence, the quality of retention, and thereby the long-term success of the crowns and FPDs, can be enhanced. This article was presented as a postgraduate paper titled "Scan and Plan" on March 6, 2020, at 22nd IPS (Indian Prosthodontic Society) PG Convention, Kochi, India.

Non-antibiotic interventions for prevention of urinary tract infections in children: a systematic review and meta-analysis of randomized controlled trials.

A considerable proportion of children experience a recurrence of urinary tract infection (UTI) following the first episode. While low-dose antibiotic prophylaxis has been the mainstay for the prevention of UTI, recent evidence raised concerns over their efficacy and safety. Hence, we aim to systematically synthesize evidence on the efficacy and safety of non-antibiotic prophylactic interventions for UTI. Using keywords related to study population (children) and intervention (non-antibiotic), we searched CENTRAL, Embase, PubMed, and Web of Science for randomized controlled trials (RCTs) published until August 2020. RCTs comparing any non-antibiotic interventions with placebo/antibiotics for prevention of UTIs in children were considered eligible. We used a random-effect model to provide pooled estimates. Sixteen trials evaluating 1426 participants were included. Cranberry was as effective as antibiotic prophylaxis (RR: 0.92; 95% CI: 0.56-1.50) but better than placebo/no therapy (RR: 0.48; 95% CI: 0.28-0.80) in reducing UTI recurrence. Probiotic therapy was more effective in reducing UTI recurrence (RR: 0.52; 95% CI: 0.29-0.94) when compared with placebo. While probiotic therapy was not better than antibiotics prophylaxis in preventing UTI (RR: 0.82; 95% CI: 0.56-1.21), they have a lower risk of antibiotic resistance (RR: 0.38; 95% CI: 0.21-0.69).Conclusion: Cranberry products and probiotics are the two non-antibiotic interventions that have been chiefly evaluated, reduce the risk of UTI recurrence when compared with placebo in children with a normal urinary tract. The findings from this systematic review suggest that while cranberry and probiotics may be used, there is a definite need to identify better and more acceptable non-antibiotic interventions. What is Known: • Efficacy of the low-dose antibiotic is controversial in preventing UTI and it is associated with increase in the risk of antimicrobial resistance. • Non-antibiotic interventions such as cranberry products are effective in preventing UTI recurrence in adults. What is New: • Cranberry products are effective in reducing the recurrence of UTI in children with normal urinary tract. • Low-quality evidence suggests that probiotics can be a potential prophylactic measure to reduce recurrence of UTI in the pediatric population.

Challenging Convention: Daytime Versus Nighttime Extubation in the Pediatric ICU.

BACKGROUND: The majority of pediatric extubations occur during day shift hours. There is a time-dependent relationship between mechanical ventilation duration and complications. It is not known if extubation shift (day vs night) correlates with pediatric extubation outcomes. Pediatric ventilation duration may be unnecessarily prolonged if extubation is routinely delayed until day shift hours. METHODS: We hypothesized that extubation failure would not correlate with shift of extubation and that ventilation duration at first extubation and that length of stay in the pediatric ICU (PICU) would be shorter for children extubated at night. This was a retrospective cohort study within one tertiary care, 24-bed, academic PICU. RESULTS: 582 ventilation encounters were included, representing 517 unique subjects. Status epilepticus was a more common diagnosis among night shift extubations (P = .005), whereas surgical airway conditions were more common among day shift extubations (P = .02). Mechanical ventilation duration at first extubation (37.6 vs 62.5 h, P < .001) and length of stay in the PICU (2.8 vs 4.5 d, P < .001) were shorter for night shift extubations. The extubation failure rate was 10.3% for day shift and 8.1% for night shift (P = .40). Logistic regression modeling at the level of the unique subject indicated that extubation shift was not associated with extubation failure (P = .44). The majority of re-intubation events occurred on the shift opposite of extubation. There was no difference in complications according to shift of re-intubation (P = .72). CONCLUSIONS: Extubation failure was not independently associated with extubation shift in this single-center study. Ventilation liberation should be considered at the first opportunity dictated by clinical data and patient-specific factors rather than by the time of day at centers with similar resources.

Quality Improvement Methodology to Optimize Safe Early Mobility in a Pediatric Intensive Care Unit.

Utilization of robust quality improvement methodology in conjunction with traditional interventions to enhance an Early Mobility program (EMP) in a tertiary pediatric intensive care unit (PICU). METHODS: EMP was implemented in our PICU in May 2017. The percentage of appropriate physical and occupational therapist consults were determined. We also evaluated the activity levels received by the patient and the levels for which they qualified based on their medical condition. Failure Modes and Effects Analysis (FMEA) was performed to identify potential complications related to the mobilization of critically ill children. We created 4 simulation scenarios based on FMEA prioritized results. RESULTS: After the implementation of EMP, appropriate physical and occupational therapist consults significantly increased (P < 0.0001). However, most patients still failed to receive the optimal level of activity recommended by protocol. This failure was partly due to concern for safety events during mobilization. FMEA identified vital sign changes [Risk Priority Number (RPN) 97.8], staff injury (RPN 64), and pain/anxiety (RPN 60.5) as potential safety events. We performed various in-situ simulation sessions based on these potential events. In post-simulation evaluations, 100% of participants agreed that the simulation experience would improve their performance in the actual clinical setting. Feedback from simulations led to the development of an EM patient safety checklist and clinical pathway. CONCLUSIONS: We describe a novel technique of using FMEA to develop scenarios that simulate potential adverse events to optimize safe EM in PICU. An EM checklist and pathway can guide in the implementation of safe EMP.

Ultrasound Imaging of Renal Cysts in Children.

Renal cysts can be focal or diffuse and unilateral or bilateral. In childhood, most renal cysts are due to hereditary diseases rather than simple cysts or acquired cystic diseases, unlike adults. Inherited cystic diseases can be ciliopathies due to a primary ciliary defect (as in polycystic kidney diseases and nephronophthisis). Acquired causes include obstructive cystic dysplasia, dyselectrolytemia, and acquired cysts in renal replacement therapy. The final diagnosis requires a multispecialty approach, including radiology, pathology, and genetics. Imaging is a very important component in treating patients with cystic renal diseases. This article discusses the ultrasound findings of cystic renal diseases in children, along with a brief discussion of other imaging modalities and a suggested ultrasound reporting format.

The United States' potential blood donor pool: updating the prevalence of donor-exclusion factors on the pool of potential donors.

BACKGROUND/CASE STUDIES: Despite decreased blood use, there are supply limitations. Therefore, it is important to determine the number of people potentially eligible to donate blood. This study updates an analysis from 2007 to estimate the pool of eligible blood donors in the United States. STUDY DESIGN/METHODS: We developed a revised epidemiologic model to account for changes in donor exclusion factors based on AABB standards. Donor exclusionary factors were identified and epidemiologic databases selected to enumerate the population prevalence of the donor exclusion factors. Prevalence data were adjusted for age, duration of exclusion, and comorbidities. The number of excluded individuals is calculated to estimate the current size of the eligible blood donor pool. The current study incorporates changes in demographic characteristics that have altered the pool of eligible blood donors. RESULTS/FINDINGS: The pool of eligible blood donors increased by approximately 93.9 million from 111 million persons in 2007 to 204.9 million persons in 2018, while the population of the United States increased by 34 million persons (from 293 million to 327 million). The number of donor exclusion factors increased from 31 to 38. Overall, the pool of eligible blood donors increased from 37.9% to 62.6% of the total population. The single largest change impacting the pool of eligible blood donors is the inclusion of individuals 65 years and older, increasing the eligible blood donor pool by 51 million of the new 93.9 million persons However, this increase in number of potential donors 65 years and older is offset by a corresponding increase in the prevalence of donor exclusion factor impact in individuals aged 65 years and above. CONCLUSION: A very large number of people are potentially eligible to donate blood. Therefore, blood supply limitations appear to be due to other factors. We suggest that these factors are differences in social commitments by changing demographic populations and the elimination of high-cost blood collection operations by blood suppliers.

Membrane-filtration based plasma exchanges for atypical hemolytic uremic syndrome: Audit of efficacy and safety.

BACKGROUND: While complement blockade with eculizumab is recommended as first-line therapy of atypical hemolytic uremic syndrome (aHUS), plasma exchanges (PEX) remain the chief option for anti-factor H (FH) antibody associated disease and when access to eculizumab is limited. METHODS: We reviewed adverse events (AEs) and adverse outcomes (eGFR <30 mL/min/1.73 m2 or death), in all patients with aHUS managed with membrane-filtration based PEX at one tertiary care center over 5.5 years. RESULTS: During January 2013 to June 2018, 109 patients with aHUS (74 with antibodies to FH), aged median (range) 7.6 (0.5-18) year weighing 22.1 (6-90) kg, underwent 2024 sessions of PEX. AE, in 12.1% patients, were usually self-limiting and included chills (5.5%), vomiting/abdominal pain (3.3%), hypotension (1.6%), urticaria (1.5%), seizures (0.2%), hypocalcemia (0.2%), and hemorrhage (0.1%); plasma hypersensitivity and severe reactions were rare. Rate of catheter-related infections was 1.45/1000 catheter-days. Filter reuse (OR 1.69; 95% CI 1.26-2.26; P < .001) and >20 sessions of PEX/patient (OR 1.99; 95% CI 1.27-3.10; P = .002) were independently associated with adverse events; infusion of IV calcium gluconate during PEX was protective (OR 0.26; 95% CI 0.16-0.43; P < .001). Hematological remission was achieved in 96.3% patients after 6 (5-8) PEX sessions; 80.8% and 89.6% patients were dialysis independent by one and 3 months, respectively. CONCLUSIONS: PEX is safe and associated with satisfactory short-term outcomes in children with aHUS. Prolonged PEX and filter-reuse are associated with complications.