Objectives: Management of spontaneous pneumomediastinum in the pediatric population is highly variable. There are limited data on the use of diagnostic tests and the need for admission. Our objectives were to characterize the management of pediatric spontaneous pneumomediastinum, determine the diagnostic yield of advanced imaging, and describe the patients' outcomes.Methods: This is a retrospective cohort study of all patients presenting to a single tertiary pediatric emergency department between January 2008 and February 2015 diagnosed with pneumomediastinum. Patients were identified using 2 complementary strategies: International Classification of Diseases, Ninth Revision billing codes and a keyword search of the hospital radiology database. Results:We identified 183 patients with spontaneous pneumomediastinum.The mean age was 12.8 ± 4.8 years. Diagnosis was established by chest radiograph (CXR) in 165 (90%) patients, chest computed tomography in 15 (8%), neck imaging in 2 (1%), and abdominal imaging in 1. After diagnosis, many patients underwent additional studies: repeat CXR (99, 54%), chest computed tomography (53, 29%), esophagram (45, 25%), and laryngoscopy (15, 8%). Seventy-eight percent of patients (n = 142) were admitted with a median length of stay of 27 hours (18.4-45.6 hours). Six patients returned to the emergency department within 96 hours for persistent chest pain; 2 were admitted, and 1 was found to have worsening pneumomediastinum on CXR. We performed a secondary analysis on 3 key subgroups: primary spontaneous pneumomediastinum (64, 35%), secondary gastrointestinalassociated pneumomediastinum (31, 17%), and secondary respiratoryassociated pneumomediastinum (88, 48%). No patients in the study received an invasive intervention for pneumomediastinum. In all patients, further studies did not yield additional diagnostic information.Conclusions: Our data suggest that patients with spontaneous pneumomediastinum who are clinically well appearing can be managed conservatively with clinical observation, avoiding exposure to radiation and invasive procedures.
Due to the widely-dispersed small number of patients with a given rare disease (RD), there is generally a lack of validated biomarkers and endpoints in RDs. This poses a major challenge for generating clinical data for healthcare decision-making in RD. Registries can provide a rich source of real-world evidence to aid healthcare providers, payers, and regulators in decision making. This review aimed to identify and assess key characteristics of the RD registries reporting data from EU5 countries. MethOds: Registries were identified through a systematic search of MEDLINE® and EMBASE® databases for the last 15 years. Any data on RD patients from EU5 countries were included. Registry publications (English language only) and websites were assessed for information on patient demographics and disease characteristics, epidemiology, disease management, resource use, patientreported outcomes (PROs) and funding agency. Results: The review identified 52 registries reporting data for RDs. Six were multinational, while 46 were national. Twenty registries collected data from the UK, 15 from France, 12 from Germany, 10 from Italy, and nine from Spain; 31 registries collected data for a specific RD, while 21 registries collected data for various RDs. The number of included patients varied from 61 to 12,500. Of these registries, 41% were initiated during the last 10 years and 14% were industry-funded, 55% were non-industry-funded, while funding information was unclear for 31% registries. Data were available for baseline demographics (in 96% of registries), patient and disease-related characteristics (96%), incidence/prevalence (77%), mortality (69%), treatment-related information (42%), PROs (6%), and cost/resource use (4%). A dedicated website was available for 62% of registries; however, information on data accessibility was not clearly available for most of these registries. cOnclusiOns: Our review demonstrates that registries can provide valuable real-world information on patients with RD, supplementing the limited findings from clinical trials, to inform health-care decision-making.
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