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Item Association of Nonoperative Management Using Antibiotic Therapy vs Laparoscopic Appendectomy With Treatment Success and Disability Days in Children With Uncomplicated Appendicitis(American Medical Association, 2020-08) Minneci, Peter C.; Hade, Erinn M.; Lawrence, Amy E.; Sebastião, Yuri V.; Saito, Jacqueline M.; Mak, Grace Z.; Fox, Christa; Hirschl, Ronald B.; Gadepalli, Samir; Helmrath, Michael A.; Kohler, Jonathan E.; Leys, Charles M.; Sato, Thomas T.; Lal, Dave R.; Landman, Matthew P.; Kabre, Rashmi; Fallat, Mary E.; Cooper, Jennifer N.; Deans, Katherine J.; Surgery, School of MedicineImportance: 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.Item Can Fecal Continence be Predicted in Patients Born with Anorectal Malformations?(Elsevier, 2019) Minneci, Peter C.; Kabre, Rashmi S.; Mak, Grace Z.; Halleran, Devin R.; Cooper, Jennifer N.; Afrazi, Amin; Calkins, Casey M.; Corkum, Kristine; Downard, Cynthia D.; Ehrlich, Peter; Fraser, Jason D.; Gadepalli, Samir K.; Helmrath, Michael A.; Kohler, Jonathan E.; Landisch, Rachel; Landman, Matthew P.; Lee, Constance; Leys, Charles M.; Lodwick, Daniel L.; McLeod, Jennifer; Mon, Rodrigo; McClure, Beth; Rymeski, Beth; Saito, Jacqueline M.; Sato, Thomas T.; St. Peter, Shawn D.; Wood, Richard; Levitt, Marc A.; Deans, Katherine J.; Surgery, School of MedicinePurpose The purpose of this study was to identify factors associated with attaining fecal continence in children with anorectal malformations (ARM). Methods We performed a multi-institutional cohort study of children born with ARM in 2007–2011 who had spinal and sacral imaging. Questions from the Baylor Social Continence Scale were used to assess fecal continence at the age of ≥ 4 years. Factors present at birth that predicted continence were identified using multivariable logistic regression. Results Among 144 ARM patients with a median age of 7 years (IQR 6–8), 58 (40%) were continent. The rate of fecal continence varied by ARM subtype (p = 0.002) with the highest rate of continence in patients with perineal fistula (60%). Spinal anomalies and the lateral sacral ratio were not associated with continence. On multivariable analysis, patients with less severe ARM subtypes (perineal fistula, recto-bulbar fistula, recto-vestibular fistula, no fistula, rectal stenosis) were more likely to be continent (OR = 7.4, p = 0.001). Conclusion Type of ARM was the only factor that predicted fecal continence in children with ARM. The high degree of incontinence, even in the least severe subtypes, highlights that predicting fecal continence is difficult at birth and supports the need for long-term follow-up and bowel management programs for children with ARM.Item Changing the Paradigm for Management of Pediatric Primary Spontaneous Pneumothorax: A Simple Aspiration Test Predicts Need for Operation(Elsevier, 2019) Leys, Charles M.; Hirschl, Ronald B.; Kohler, Jonathan E.; Cherney-Stafford, Linda; Marka, Nicholas; Fallat, Mary E.; Gadepalli, Samir K.; Fraser, Jason D.; Grabowski, Julia; Burns, R. Cartland; Downard, Cynthia D.; Foley, David S.; Halleran, Devin R.; Helmrath, Michael A.; Kabre, Rashmi; Knezevich, Michellle S.; Lal, Dave R.; Landman, Matthew P.; Lawrence, Amy E.; Mak, Grace Z.; Minneci, Peter C.; Musili, Ninette; Rymeski, Beth; Saito, Jacqueline M.; Sato, Thomas T.; St. Peter, Shawn D.; Warner, Brad W.; Ostlie, Daniel J.; Surgery, School of MedicinePurpose Chest tube (CT) management for pediatric primary spontaneous pneumothorax (PSP) is associated with long hospital stays and high recurrence rates. To streamline management, we explored simple aspiration as a test to predict need for surgery. Methods A multi-institution, prospective pilot study of patients with first presentation for PSP at 9 children’s hospitals was performed. Aspiration was performed through a pigtail catheter, followed by 6 h observation with CT clamped. If pneumothorax recurred during observation, the aspiration test failed and subsequent management was per surgeon discretion. Results Thirty-three patients were managed with simple aspiration. Aspiration was successful in 16 of 33 (48%), while 17 (52%) failed the aspiration test and required hospitalization. Twelve who failed aspiration underwent CT management, of which 10 (83%) failed CT management owing to either persistent air leak requiring VATS or subsequent PSP recurrence. Recurrence rate was significantly greater in the group that failed aspiration compared to the group that passed aspiration [10/12 (83%) vs 7/16 (44%), respectively, P = 0.028]. Conclusion Simple aspiration test upon presentation with PSP predicts chest tube failure with 83% positive predictive value. We recommend changing the PSP management algorithm to include an initial simple aspiration test, and if that fails, proceed directly to VATS.Item Demographic and Clinical Characteristics Associated With the Failure of Nonoperative Management of Uncomplicated Appendicitis in Children: Secondary Analysis of a Nonrandomized Clinical Trial(JAMA, 2022-05-02) Minneci, Peter C.; Hade, Erinn M.; Gil, Lindsay A.; Metzger, Gregory A.; Saito, Jacqueline M.; Mak, Grace Z.; Hirschl, Ronald B.; Gadepalli, Samir; Helmrath, Michael A.; Leys, Charles M.; Sato, Thomas T.; Lal, Dave R.; Landman, Matthew P.; Kabre, Rashmi; Fallat, Mary E.; Cooper, Jennifer N.; Deans, Katherine J.; Midwest Pediatric Surgery Consortium; Surgery, School of MedicineImportance: The factors associated with the failure of nonoperative management of appendicitis and the differences in patient-reported outcomes between successful and unsuccessful nonoperative management remain unknown. Objectives: To investigate factors associated with the failure of nonoperative management of appendicitis and compare patient-reported outcomes between patients whose treatment succeeded and those whose treatment failed. Design, setting, and participants: This study was a planned subgroup secondary analysis conducted in 10 children's hospitals that included 370 children aged 7 to 17 years with uncomplicated appendicitis enrolled in a prospective, nonrandomized clinical trial between May 1, 2015, and October 31, 2018, with 1-year follow-up comparing nonoperative management with antibiotics vs surgery for uncomplicated appendicitis. Statistical analysis was performed from November 1, 2019, to February 12, 2022. Interventions: Nonoperative management with antibiotics vs surgery. Main outcomes and measures: Failure of nonoperative management and patient-reported outcomes. The relative risk (RR) of failure based on sociodemographic and clinical characteristics was calculated. Patient-reported outcomes were compared based on the success or failure of nonoperative management. Results: Of 370 patients (34.6% of 1068 total patients; 229 boys [61.9%]; median age, 12.3 years [IQR, 10.0-14.6 years]) enrolled in the nonoperative group, treatment failure occurred for 125 patients (33.8%) at 1 year, with 53 patients (14.3%) undergoing appendectomy during initial hospitalization and 72 patients (19.5%) experiencing delayed treatment failure after hospital discharge. Higher patient-reported pain at presentation was associated with increased risk of in-hospital treatment failure (RR, 2.1 [95% CI, 1.0-4.4]) but not delayed treatment failure (RR, 1.3 [95% CI, 0.7-2.3]) or overall treatment failure at 1 year (RR, 1.5 [95% CI, 1.0-2.2]). Pain duration greater than 24 hours was associated with decreased risk of delayed treatment failure (RR, 0.3 [95% CI, 0.1-1.0]) but not in-hospital treatment failure (RR, 1.2 [95% CI, 0.5-2.7]) or treatment failure at 1 year (RR, 0.7 [95% CI, 0.4-1.2]). There was no increased risk of treatment failure associated with age, white blood cell count, sex, race, ethnicity, primary language, insurance status, transfer status, symptoms at presentation, or imaging results. Health care satisfaction at 30 days and patient-reported, health-related quality of life at 30 days and 1 year were not different. Satisfaction with the decision was higher with successful nonoperative management at 30 days (28.0 vs 27.0; difference, 1.0 [95% CI, 0.01-2.0]) and 1 year (28.1 vs 27.0; difference, 1.1 [95% CI, 0.2-2.0]). Conclusions and relevance: This analysis suggests that a higher pain level at presentation was associated with a higher risk of initial failure of nonoperative management and that a longer duration of pain was associated with lower risk of delayed treatment failure. Although satisfaction was high in both groups, satisfaction with the treatment decision was higher among patients with successful nonoperative management at 1 year.Item Evaluating the Regional Differences in Pediatric Injury Patterns During the COVID-19 Pandemic(Elsevier, 2023) Collings, Amelia T.; Farazi, Manzur; Van Arendonk, Kyle J.; Fallat, Mary E.; Minneci, Peter C.; Sato, Thomas T.; Speck, K. Elizabeth; Gadepalli, Samir; Deans, Katherine J.; Falcone, Richard A., Jr.; Foley, David S.; Fraser, Jason D.; Keller, Martin S.; Kotagal, Meera; Landman, Matthew P.; Leys, Charles M.; Markel, Troy; Rubalcava, Nathan; St. Peter, Shawn D.; Flynn-O'Brien, Katherine T.; Midwest Pediatric Surgery Consortium; Surgery, School of MedicineIntroduction: Reports of pediatric injury patterns during the COVID-19 pandemic are conflicting and lack the granularity to explore differences across regions. We hypothesized there would be considerable variation in injury patterns across pediatric trauma centers in the United States. Materials and methods: A multicenter, retrospective study evaluating patients <18 y old with traumatic injuries meeting National Trauma Data Bank criteria was performed. Patients injured after stay-at-home orders through September 2020 ("COVID" cohort) were compared to "Historical" controls from an averaged period of equivalent dates in 2016-2019. Differences in injury type, intent, and mechanism were explored at the site level. Results: 47,385 pediatric trauma patients were included. Overall trauma volume increased during the COVID cohort compared to the Historical (COVID 7068 patients versus Historical 5891 patients); however, some sites demonstrated a decrease in overall trauma of 25% while others had an increase of over 33%. Bicycle injuries increased at every site, with a range in percent change from 24% to 135% increase. Although the greatest net increase was due to blunt injuries, there was a greater relative increase in penetrating injuries at 7/9 sites, with a range in percent change from a 110% increase to a 69% decrease. Conclusions: There was considerable discrepancy in pediatric injury patterns at the individual site level, perhaps suggesting a variable impact of the specific sociopolitical climate and pandemic policies of each catchment area. Investigation of the unique response of the community during times of stress at pediatric trauma centers is warranted to be better prepared for future environmental stressors.Item Impact of “Stay-at-Home”orders on non-accidental trauma: A multi-institutional study(Elsevier, 2022) Collings, Amelia T.; Farazi, Manzur; Van Arendonk, Kyle; Fallat, Mary E.; Minneci, Peter C.; Sato, Thomas T.; Speck, K. Elizabeth; Deans, Katherine J.; Falcone, Richard A.; Foley, David S.; Fraser, Jason D.; Keller, Martin S.; Kotagal, Meera; Landman, Matthew P.; Leys, Charles M.; Markel, Troy; Rubalcava, Nathan; St. Peter, Shawn D.; Flynn-O’Brien, Katherine T.; Midwest Pediatric Surgery Consortium; Surgery, School of MedicineBackground: It is unclear how Stay-at-Home Orders (SHO) of the COVID-19 pandemic impacted the welfare of children and rates of non-accidental trauma (NAT). We hypothesized that NAT would initially decrease during the SHO as children did not have access to mandatory reporters, and then increase as physicians' offices and schools reopened. Methods: A multicenter study evaluating patients <18 years with ICD-10 Diagnosis and/or External Cause of Injury codes meeting criteria for NAT. "Historical" controls from an averaged period of March-September 2016-2019 were compared to patients injured March-September 2020, after the implementation of SHO ("COVID" cohort). An interrupted time series analysis was utilized to evaluate the effects of SHO implementation. Results: Nine Level I pediatric trauma centers contributed 2064 patients meeting NAT criteria. During initial SHO, NAT rates dropped below what was expected based on historical trends; however, thereafter the rate increased above the expected. The COVID cohort experienced a significant increase in the proportion of NAT patients age ≥5 years, minority children, and least resourced as determined by social vulnerability index (SVI). Conclusions: The COVID-19 pandemic affected the presentation of children with NAT to the hospital. In times of public health crisis, maintaining systems of protection for children remain essential.Item Infants with esophageal atresia and right aortic arch: Characteristics and outcomes from the Midwest Pediatric Surgery Consortium(Elsevier, 2018) Lal, Dave R.; Gadepalli, Samir K.; Downard, Cynthia D.; Minneci, Peter C.; Knezevich, Michelle; Chelius, Thomas H.; Rapp, Cooper T.; Bilmire, Deborah; Bruch, Steven; Burns, R. Carland; Deans, Katherine J.; Fallat, Mary E.; Fraser, Jason D.; Grabowski, Julia; Hebel, Ferdynand; Helmrath, Michael A.; Hirschl, Ronald B.; Kabre, Rashmi; Kohler, Jonathan; Landman, Matthew P.; Leys, Charles M.; Mak, Grace Z.; Ostlie, Daniel J.; Raque, Jessica; Rymeski, Beth; Saito, Jacqueline M.; St. Peter, Shawn D.; von Allmen, Daniel; Warner, Brad W.; Sato, Thomas T.; Surgery, School of MedicinePurpose Right sided aortic arch (RAA) is a rare anatomic finding in infants with esophageal atresia with or without tracheoesophageal fistula (EA/TEF). In the presence of RAA, significant controversy exists regarding optimal side for thoracotomy in repair of the EA/TEF. The purpose of this study was to characterize the incidence, demographics, surgical approach, and outcomes of patients with RAA and EA/TEF. Methods A multi-institutional, IRB approved, retrospective cohort study of infants with EA/TEF treated at 11 children's hospitals in the United States over a 5-year period (2009 to 2014) was performed. All patients had a minimum of one-year follow-up. Results In a cohort of 396 infants with esophageal atresia, 20 (5%) had RAA, with 18 having EA with a distal TEF and 2 with pure EA. Compared to infants with left sided arch (LAA), RAA infants had a lower median birth weight, (1.96 kg (IQR 1.54–2.65) vs. 2.57 kg (2.00–3.03), p = 0.01), earlier gestational age (34.5 weeks (IQR 32–37) vs. 37 weeks (35–39), p = 0.01), and a higher incidence of congenital heart disease (90% vs. 32%, p < 0.0001). The most common cardiac lesions in the RAA group were ventricular septal defect (7), tetralogy of Fallot (7) and vascular ring (5). Seventeen infants with RAA underwent successful EA repair, 12 (71%) via right thoracotomy and 5 (29%) through left thoracotomy. Anastomotic strictures trended toward a difference in RAA patients undergoing right thoracotomy for primary repair of their EA/TEF compared to left thoracotomy (50% vs. 0%, p = 0.1). Side of thoracotomy in RAA patients undergoing EA/TEF repair was not significantly associated with mortality, anastomotic leak, recurrent laryngeal nerve injury, recurrent fistula, or esophageal dehiscence (all p > 0.29). Conclusion RAA in infants with EA/TEF is rare with an incidence of 5%. Compared to infants with EA/TEF and LAA, infants with EA/TEF and RAA are more severely ill with lower birth weight and higher rates of prematurity and complex congenital heart disease. In neonates with RAA, surgical repair of the EA/TEF is technically feasible via thoracotomy from either chest. A higher incidence of anastomotic strictures may occur with a right-sided approach.Item Multi-institutional trial of non-operative management and surgery for uncomplicated appendicitis in children: Design and rationale(Elsevier, 2019-08-01) Minneci, Peter C.; Hade, Erinn M.; Lawrence, Amy E.; Saito, Jacqueline M.; Mak, Grace Z.; Hirschl, Ronald B.; Gadepalli, Samir; Helmrath, Michael A.; Leys, Charles M.; Sato, Thomas T.; Lal, Dave R.; Landman, Matthew P.; Kabre, Rashmi; Fallat, Mary E.; Fischer, Beth A.; Cooper, Jennifer N.; Deans, Katherine J.; Surgery, School of MedicineTraditionally, children presenting with appendicitis are referred for urgent appendectomy. Recent improvements in the quality and availability of diagnostic imaging allow for better pre-operative characterization of appendicitis, including severity of inflammation; size of the appendix; and presence of extra-luminal inflammation, phlegmon, or abscess. These imaging advances, in conjunction with the availability of broad spectrum oral antibiotics, allow for the identification of a subset of patients with uncomplicated appendicitis that can be successfully treated with antibiotics alone. Recent studies demonstrated that antibiotics alone are a safe and efficacious treatment alternative for patents with uncomplicated appendicitis. The objective of this study is to perform a multi-institutional trial to examine the effectiveness of non-operative management of uncomplicated pediatric appendicitis across a group of large children’s hospitals. A prospective patient choice design was chosen to compare non-operative management to surgery in order to assess effectiveness in a broad population representative of clinical practice in which non-operative management is offered as an alternative to surgery. The risks and benefits of each treatment are very different and a “successful” treatment depends on which risks and benefits are most important to each patient and his/her family. The patient-choice design allows for alignment of preferences with treatment. Patients meeting eligibility criteria are offered a choice of non-operative management or appendectomy. Primary outcomes include determining the success rate of non-operative management and comparing differences in disability days, and secondarily, complication rates, quality of life, and healthcare satisfaction, between patients choosing non-operative management and those choosing appendectomy.Item The COVID-19 pandemic and associated rise in pediatric firearm injuries: A multi-institutional study(Elsevier, 2022) Collings, Amelia T.; Farazi, Manzur; Van Arendonk, Kyle J.; Fallat, Mary E.; Minneci, Peter C.; Sato, Thomas T.; Speck, K. Elizabeth; Deans, Katherine J.; Falcone, Richard A., Jr.; Foley, David S.; Fraser, Jason D.; Gadepalli, Samir K.; Keller, Martin S.; Kotagal, Meera; Landman, Matthew P.; Leys, Charles M.; Markel, Troy A.; Rubalcava, Nathan; St. Peter, Shawn D.; Flynn-O’Brien, Katherine T.; Midwest Pediatric Surgery Consortium; Surgery, School of MedicineBackground: Firearm sales in the United States (U.S.) markedly increased during the COVID-19 pandemic. Our objective was to determine if firearm injuries in children were associated with stay-at-home orders (SHO) during the COVID-19 pandemic. We hypothesized there would be an increase in pediatric firearm injuries during SHO. Methods: This was a multi institutional, retrospective study of institutional trauma registries. Patients <18 years with traumatic injuries meeting National Trauma Data Bank (NTDB) criteria were included. A "COVID" cohort, defined as time from initiation of state SHO through September 30, 2020 was compared to "Historical" controls from an averaged period of corresponding dates in 2016-2019. An interrupted time series analysis (ITSA) was utilized to evaluate the association of the U.S. declaration of a national state of emergency with pediatric firearm injuries. Results: Nine Level I pediatric trauma centers were included, contributing 48,111 pediatric trauma patients, of which 1,090 patients (2.3%) suffered firearm injuries. There was a significant increase in the proportion of firearm injuries in the COVID cohort (COVID 3.04% vs. Historical 1.83%; p < 0.001). There was an increased cumulative burden of firearm injuries in 2020 compared to a historical average. ITSA showed an 87% increase in the observed rate of firearm injuries above expected after the declaration of a nationwide emergency (p < 0.001). Conclusion: The proportion of firearm injuries affecting children increased during the COVID-19 pandemic. The pandemic was associated with an increase in pediatric firearm injuries above expected rates based on historical patterns.Item Understanding the Value of Tumor Markers in Pediatric Ovarian Neoplasms(Elsevier, 2019) Lawrence, Amy E.; Fallat, Mary E.; Hewitt, Geri; Hertweck, Paige; Onwuka, Amanda; Afrazi, Amin; Bence, Christina; Burns, Robert C.; Corkum, Kristine S.; Dillon, Patrick A.; Ehrlich, Peter F.; Fraser, Jason D.; Gonzalez, Dani O.; Grabowski, Julia E.; Kabre, Rashmi; Lal, Dave R.; Landman, Matthew P.; Leys, Charles M.; Mak, Grace Z.; Overman, R. Elliott; Rademacher, Brooks L.; Raiji, Manish T.; Sato, Thomas T.; Scannell, Madeline; Sujka, Joseph A.; Wright, Tiffany; Minneci, Peter C.; Deans, Katherine J.; Aldrink, Jennifer H.; Surgery, School of MedicinePurpose The purpose of this study was to determine the diagnostic accuracy of tumor markers for malignancy in girls with ovarian neoplasms. Methods A retrospective review of girls 2–21 years who presented for surgical management of an ovarian neoplasm across 10 children's hospitals between 2010 and 2016 was performed. Patients who had at least one concerning feature on imaging and had tumor marker testing were included in the study. Sensitivity, specificity, and negative and positive predictive values (PPV) of tumor markers were calculated. Results Our cohort included 401 patients; 22.4% had a malignancy. Testing for tumor markers was inconsistent. AFP had high specificity (98%) and low sensitivity (42%) with a PPV of 86%. The sensitivity, specificity, and PPV of beta-hCG was 44%, 76%, and 32%, respectively. LDH had high sensitivity (95%) and Inhibin A and Inhibin B had high specificity (97% and 92%, respectively). Conclusions Tumor marker testing is helpful in preoperative risk stratification of ovarian neoplasms for malignancy. Given the variety of potential tumor types, no single marker provides enough reliability, and therefore a panel of tumor marker testing is recommended if there is concern for malignancy. Prospective studies may help further elucidate the predictive value of tumor markers in a pediatric ovarian neoplasm population.