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Browsing by Author "Lawrence, Amy E."
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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 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 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 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.