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Key Points: Question: Can novice clinicians accurately estimate gestational age using a low-cost, battery-powered ultrasonography probe with integrated artificial intelligence (AI) image interpretation? Findings: This prospective study enrolled 400 pregnant individuals with due dates confirmed by first-trimester ultrasonography. At follow-up visits randomly assigned throughout gestation, novice clinicians using an AI-enabled device estimated gestational age as accurately as credentialed sonographers using traditional ultrasonography devices (difference, 0.2 days). Meaning: Obstetrical care in low-resource settings may benefit from reliable gestational age assessment using AI integration with point-of-care ultrasonography. Importance: Accurate assessment of gestational age (GA) is essential to good pregnancy care but often requires ultrasonography, which may not be available in low-resource settings. This study developed a deep learning artificial intelligence (AI) model to estimate GA from blind ultrasonography sweeps and incorporated it into the software of a low-cost, battery-powered device. Objective: To evaluate GA estimation accuracy of an AI-enabled ultrasonography tool when used by novice users with no prior training in sonography. Design, Setting, and Participants: This prospective diagnostic accuracy study enrolled 400 individuals with viable, single, nonanomalous, first-trimester pregnancies in Lusaka, Zambia, and Chapel Hill, North Carolina. Credentialed sonographers established the "ground truth" GA via transvaginal crown-rump length measurement. At random follow-up visits throughout gestation, including a primary evaluation window from 14 0/7 weeks' to 27 6/7 weeks' gestation, novice users obtained blind sweeps of the maternal abdomen using the AI-enabled device (index test) and credentialed sonographers performed fetal biometry with a high-specification machine (study standard). Main Outcomes and Measures: The primary outcome was the mean absolute error (MAE) of the index test and study standard, which was calculated by comparing each method's estimate to the previously established GA and considered equivalent if the difference fell within a prespecified margin of ±2 days. Results: In the primary evaluation window, the AI-enabled device met criteria for equivalence to the study standard, with an MAE (SE) of 3.2 (0.1) days vs 3.0 (0.1) days (difference, 0.2 days [95% CI, −0.1 to 0.5]). Additionally, the percentage of assessments within 7 days of the ground truth GA was comparable (90.7% for the index test vs 92.5% for the study standard). Performance was consistent in prespecified subgroups, including the Zambia and North Carolina cohorts and those with high body mass index. Conclusions and Relevance: Between 14 and 27 weeks' gestation, novice users with no prior training in ultrasonography estimated GA as accurately with the low-cost, point-of-care AI tool as credentialed sonographers performing standard biometry on high-specification machines. These findings have immediate implications for obstetrical care in low-resource settings, advancing the World Health Organization goal of ultrasonography estimation of GA for all pregnant people. Trial Registration: ClinicalTrials.gov Identifier: NCT05433519 This prospective diagnostic study examines the accuracy of an AI-enabled ultrasonography tool in estimating gestational age when used by those with no prior training in sonography. [ABSTRACT FROM AUTHOR]

Background Obstructive uropathy (OU) is a leading cause of pediatric kidney injury. Accurate prediction of kidney disease progression may improve clinical outcomes. We aimed to examine discrimination and accuracy of a validated kidney failure risk equation (KFRE), previously developed in adults, in children with OU. Methods We identified 118 children with OU and an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m.sup.2 in the Chronic Kidney Disease in Children study, a national, longitudinal, observational cohort. Each patient's 5-year risk of kidney failure was estimated using baseline data and published parameters for the 4- and 8-variable KFREs. Discriminative ability of the KFRE was estimated using the C statistic for time-to-event analysis. Sensitivity and specificity were evaluated across varying risk thresholds. Results Among the 118 children, 100 (85%) were boys, with median baseline age of 10 years (interquartile range, 6-14). Median eGFR was 42 mL/min/1.73m .sup.2 (32-53), with a median follow-up duration of 4.5 years (2.7-7.2); 23 patients (19.5%) developed kidney failure within 5 years. The 4-variable KFRE discriminated kidney failure risk with a C statistic of 0.75 (95% CI, 0.68-0.82). A 4-variable risk threshold of [greater than or equal to] 30% yielded 82.6% sensitivity and 75.0% specificity. Results were similar using the 8-variable KFRE. Conclusions In children with OU, the KFRE discriminated the 5-year risk of kidney failure at C statistic values lower than previously published in adults but comparable with suboptimal values reported in the overall CKiD population. The 8-variable equation did not improve model discrimination or accuracy, suggesting the need for continued research into additional, disease-specific markers., Author(s): Yuri V. Sebastião [sup.1] , Jennifer N. Cooper [sup.1] [sup.2] [sup.3] , Brian Becknell [sup.4] [sup.5] , Christina B. Ching [sup.4] [sup.6] , Daryl J. McLeod [sup.1] [sup.6] Author [...]

Background Congenital obstructive uropathy (OU) is a leading cause of pediatric kidney failure, representing a unique mechanism of injury, in part from renal tubular stretch and ischemia. Tubular injury biomarkers have potential to improve OU-specific risk stratification. Methods Patients with OU were identified in the Chronic Kidney Disease in Children (CKiD) study. 'Cases' were defined as individuals receiving any kidney replacement therapy (KRT), while 'controls' were age- and time-on-study matched and KRT free at last study visit. Urine and plasma neutrophil gelatinase-associated lipocalin (NGAL), interleukin 18 (IL-18), and liver-type fatty acid-binding protein (L-FABP) levels were measured at enrollment and annually and compared between cases and controls. Urine values were normalized to urine creatinine. Results In total, 22 cases and 22 controls were identified, with median (interquartile range) ages of 10.5 (9.0-13.0) and 15.9 (13.9-16.9) years at baseline and outcome, respectively. At enrollment there were no differences noted between cases and controls for any urine (u) or plasma (p) biomarker measured. However, the mean pNGAL and uL-FABP/creatinine increased throughout the study period in cases (15.38 ng/ml per year and 0.20 ng/ml per mg/dl per year, respectively, p = 0.01 for both) but remained stable in controls. This remained constant after controlling for baseline glomerular filtration rate (GFR). Conclusions In children with OU, pNGAL and uL-FABP levels increased over the 5 years preceding KRT; independent of baseline GFR. Future studies are necessary to identify optimal cutoff values and to determine if these markers outperform current clinical predictors., Author(s): Daryl J. McLeod [sup.1] [sup.2] , Yuri V. Sebastião [sup.2] , Christina B. Ching [sup.1] [sup.3] , Jason H. Greenberg [sup.4] , Susan L. Furth [sup.5] , Brian Becknell [...]

Background Obstructive uropathy (OU) is a common cause of end-stage renal disease (ESRD) in children. Children who escape the newborn period with mild-to-moderate chronic kidney disease (CKD) continue to be at increased risk. The predictive ability of clinically available markers throughout childhood is poorly defined. Methods Patients with OU were identified in the Chronic Kidney Disease in Children Study. The primary outcome of interest was renal replacement therapy (RRT) (cases). Controls were age matched and defined as patients within the OU cohort who did not require RRT during study follow-up. Results In total, 27 cases and 41 age-matched controls were identified. Median age at baseline and age at outcome measurement were 10 vs. 16 years, respectively. First available glomerular filtration rate (GFR) (36.9 vs. 53.5 mL/min per 1.73 m.sup.2), urine protein/creatinine (Cr) (0.40 vs. 0.22 mg/mg) and microalbumin/Cr (0.58 vs. 0.03 mg/mg), and serum CO.sub.2 (20 vs. 22 mmol/L) and hemoglobin (12.4 vs. 13.2 g/dL) differed significantly between cases and controls, respectively. GFR declined 3.07 mL/min per 1.73 m.sup.2/year faster in cases compared to that in controls (p < 0.0001). Urine protein/Cr and microalbumin/Cr increased by 0.16 and 0.11 per year more in cases compared to those in controls, respectively (p [less than or equal to] 0.001 for both). Serum phosphate increased by 0.11 mg/dL and serum albumin and hemoglobin decreased by 0.04 (g/dL) and 0.14 (g/dL) per year more for cases compared to those for controls, respectively (p < 0.05 for all). Conclusions Age-specific baseline and longitudinal measures of readily available clinical measures predict progression to ESRD in children with mild-to-moderate CKD from OU., Author(s): Daryl J. McLeod [sup.1] [sup.2] , Christina B. Ching [sup.1] [sup.3] , Yuri V. Sebastião [sup.2] , Jason H. Greenberg [sup.4] , Susan L. Furth [sup.5] , Kirk M. [...]

Importance: Nonoperative management with antibiotics alone has the potential to treat uncomplicated pediatric appendicitis with fewer disability days than surgery.Objective: To determine the success rate of nonoperative management and compare differences in treatment-related disability, satisfaction, health-related quality of life, and complications between nonoperative management and surgery in children with uncomplicated appendicitis.Design, Setting, and Participants: Multi-institutional nonrandomized controlled intervention study of 1068 children aged 7 through 17 years with uncomplicated appendicitis treated at 10 tertiary children's hospitals across 7 US states between May 2015 and October 2018 with 1-year follow-up through October 2019. Of the 1209 eligible patients approached, 1068 enrolled in the study.Interventions: Patient and family selection of nonoperative management with antibiotics alone (nonoperative group, n = 370) or urgent (≤12 hours of admission) laparoscopic appendectomy (surgery group, n = 698).Main Outcomes and Measures: The 2 primary outcomes assessed at 1 year were disability days, defined as the total number of days the child was not able to participate in all of his/her normal activities secondary to appendicitis-related care (expected difference, 5 days), and success rate of nonoperative management, defined as the proportion of patients initially managed nonoperatively who did not undergo appendectomy by 1 year (lowest acceptable success rate, ≥70%). Inverse probability of treatment weighting (IPTW) was used to adjust for differences between treatment groups for all outcome assessments.Results: Among 1068 patients who were enrolled (median age, 12.4 years; 38% girls), 370 (35%) chose nonoperative management and 698 (65%) chose surgery. A total of 806 (75%) had complete follow-up: 284 (77%) in the nonoperative group; 522 (75%) in the surgery group. Patients in the nonoperative group were more often younger (median age, 12.3 years vs 12.5 years), Black (9.6% vs 4.9%) or other race (14.6% vs 8.7%), had caregivers with a bachelor's degree (29.8% vs 23.5%), and underwent diagnostic ultrasound (79.7% vs 74.5%). After IPTW, the success rate of nonoperative management at 1 year was 67.1% (96% CI, 61.5%-72.31%; P = .86). Nonoperative management was associated with significantly fewer patient disability days at 1 year than did surgery (adjusted mean, 6.6 vs 10.9 days; mean difference, -4.3 days (99% CI, -6.17 to -2.43; P < .001). Of 16 other prespecified secondary end points, 10 showed no significant difference.Conclusion and Relevance: Among children with uncomplicated appendicitis, an initial nonoperative management strategy with antibiotics alone had a success rate of 67.1% and, compared with urgent surgery, was associated with statistically significantly fewer disability days at 1 year. However, there was substantial loss to follow-up, the comparison with the prespecified threshold for an acceptable success rate of nonoperative management was not statistically significant, and the hypothesized difference in disability days was not met.Trial Registration: ClinicalTrials.gov Identifier: NCT02271932. [ABSTRACT FROM AUTHOR]

Statistics plays an essential role in clinical research by providing a framework for making inferences about a population of interest. In order to interpret research datasets, clinicians involved in clinical research should have an understanding of statistical methodology. This article provides a brief overview of statistical methods that are frequently used in clinical research studies. Descriptive and inferential methods, including regression modeling and propensity scores, are discussed, with focus on the rationale, assumptions, strengths, and limitations to their application. [ABSTRACT FROM AUTHOR]

Background: Accurate identification of Plasmodium infections in community surveys is essential to successful malaria control. Microscopy and rapid diagnostic tests (RDTs) are the main techniques used to diagnose malaria in field-based surveys. While microscopy is still considered the gold standard, RDTs are growing in popularity as they allow for rapid and inexpensive diagnosis. Using data from a prevalence survey conducted in north-western Angola in 2010, the authors aimed to compare the performance of microscopy and RDTs in identifying Plasmodium falciparum infections, using polymerase chain reaction (PCR) as the gold standard. Methods: Results from 3,307 subjects (1,225 preschool-aged children (zero to five year olds), 1,134 school-aged children (six to 15 year olds) and 948 mothers/caregivers (>15 years of age)), tested for P. falciparum infections, were utilized. The sensitivity, specificity, positive, and negative predictive values (PPV and NPV) of microscopy and Paracheck-Pf® were compared using the McNemar's test and the weighted generalized score Chi-squared test for paired data. Results: The prevalence of P. falciparum infections determined by PCR and microscopy was 15.9% and by Paracheck- Pf® was 16.3%. Compared to microscopy, Paracheck-Pf® had significantly higher sensitivity (72.8% versus 60%), specificity (94.3% versus 92.5%), PPV (70.7% versus 60%) and NPV (94.8% versus 92.5%). Both tests had significantly lower sensitivity in mothers (36.8% for microscopy and 43.7% for Paracheck-Pf®) than in their children (68.4% in zero to five years-old and 60.6% in six to 15 years-old for microscopy and 80.4% in zero to five year-olds and 76.5% in six to 15 year-olds for Paracheck-Pf®). Conclusion: Both microscopy and RDTs performed suboptimally when compared to PCR. False negativity could be associated with the low parasite density profile of the samples. False positivity may be related to the well-described limitations of those techniques such as level of expertise of microscopists or persistent antigenicity from previous infections in the case of RDTs. Nevertheless, RDTs had enhanced performance comparatively to microscopy in detecting malaria infections, favouring their use in community cross-sectional malaria surveys, where expert performance of microscopy is hard to accomplish. [ABSTRACT FROM AUTHOR]

Abstract Background Recurrence rates of pilonidal disease have been reported to be high as 30%. Patients with recurrent pilonidal disease often develop chronic wounds and draining sinuses that incur long-term morbidity, disability, and decreased quality of life. The aim of this study was to characterize rates of recurrence in patients with pilonidal disease treated by pediatric surgeons. Methods A single center retrospective review of patients with pilonidal disease evaluated by pediatric surgeons from 2010 to 2015 was performed. Recurrence of pilonidal disease was defined as an episode of active pilonidal disease that required medical or surgical intervention >30 days from the preceding treatment. Repeated events proportional hazards regression modeling was performed to identify factors associated with time to recurrence. Results Among 307 patients treated for pilonidal disease, nearly 50% were male, and the median age at initial evaluation was 16 years (IQR 15-17). Approximately 45% were obese (BMI ≥ 95th percentile). The initial treatment during the study period was surgical excision in two-thirds and incision and drainage and/or antibiotics in one-third. The overall recurrence rate was 33%, with the majority of recurrences (80%) occurring within the first year. On multivariable analysis, obese BMI was the only factor independently associated with time to disease recurrence. Conclusions Pilonidal disease has a substantial recurrence rate even after surgical excision. Future studies investigating treatments that can prevent disease recurrence are needed. [ABSTRACT FROM AUTHOR]