{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,6]],"date-time":"2026-06-06T15:11:25Z","timestamp":1780758685859,"version":"3.54.1"},"reference-count":21,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2024,8,6]],"date-time":"2024-08-06T00:00:00Z","timestamp":1722902400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Pfizer Inc (New York, NY","award":["CP36103-B2361001"],"award-info":[{"award-number":["CP36103-B2361001"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,5,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Pediatric-specific safety data are required during development of pharmaceutical agents. Retrospective studies can leverage real-world data to assess safety and effectiveness in children where prospective, controlled studies are not feasible. A retrospective cohort study combined data from Pediatric Health Information Systems (PHIS) and medical records to evaluate the safety and effectiveness of piperacillin\/tazobactam (P\/T) in pediatric patients with hospital-acquired pneumonia (HAP). After identifying 407 patients diagnosed with HAP receiving P\/T (n\u00a0=\u00a0140) or comparator (n\u00a0=\u00a0267) HAP-appropriate antibiotics between 2003-2016 across 7 pediatric institutions, we evaluated comparative risk of a serious adverse event (SAE). Clinical improvement 14\u00a0days after therapy initiation was studied as a secondary outcome. Incidence rate ratios (IRRs) were calculated to compare between exposure groups using inverse probability-weighted Poisson regression models. The unadjusted and adjusted IRRs with 95% CIs for SAEs were 1.26 (0.66-2.39) and 1.24 (0.65-2.35). The unadjusted and adjusted ORs with 95% CIs for clinical improvement were 1.14 (0.56-2.34) and 1.50 (0.67-3.38). Point estimates from this retrospective analysis suggest similar safety and clinical effectiveness of P\/T and comparator antibiotics for treating HAP. However, due to wide CIs, actual between-group differences cannot be excluded. Existing real-world data can be utilized to inform pediatric-specific safety and effectiveness of medications used in off-label settings.<\/jats:p>\n               <jats:p>This article is part of a Special Collection on Pharmacoepidemiology.<\/jats:p>","DOI":"10.1093\/aje\/kwae251","type":"journal-article","created":{"date-parts":[[2024,8,8]],"date-time":"2024-08-08T00:18:38Z","timestamp":1723076318000},"page":"1426-1435","source":"Crossref","is-referenced-by-count":1,"title":["Leveraging real-world data from administrative claims and medical records to inform safety and effectiveness of piperacillin-tazobactam in the management of pediatric hospital\u2013acquired pneumonia"],"prefix":"10.1093","volume":"194","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7185-0705","authenticated-orcid":false,"given":"Jesse A","family":"Blumenstock","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases, Department of Pediatrics, Children\u2019s Hospital of Philadelphia (CHOP), Philadelphia , PA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer A","family":"Faerber","sequence":"additional","affiliation":[{"name":"Department of Biomedical and Health Informatics, The Children's Hospital of Philadelphia , Philadelphia, PA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muida","family":"Menon","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Pediatrics, Children\u2019s Hospital of Philadelphia (CHOP), Philadelphia , PA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rasheeda","family":"Lawler","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Pediatrics, Children\u2019s Hospital of Philadelphia (CHOP), Philadelphia , PA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin J","family":"Downes","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Pediatrics, Children\u2019s Hospital of Philadelphia (CHOP), Philadelphia , PA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellen","family":"Kratz","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Pediatrics, Children\u2019s Hospital of Philadelphia (CHOP), Philadelphia , PA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelley","family":"Erickson","sequence":"additional","affiliation":[{"name":"Cancer and Blood Disorders Center, Oncology, Seattle Children's, Seattle , WA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brittany","family":"Haltzman-Cassenti","sequence":"additional","affiliation":[{"name":"Patient Services, MDGroup, Durham , NC,","place":["United 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K","family":"Sederdahl","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Emory University , Atlanta, GA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Hahn","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Children's National Hospital , Washington, DC ,","place":["United States"]},{"name":"Center for Genetic Medicine Research, Children's National Research Institute , Washington, DC ,","place":["United States"]},{"name":"Department of Pediatrics, George Washington University School of Medicine and Health Sciences , Washington, DC ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanna","family":"Thomson","sequence":"additional","affiliation":[{"name":"Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center , Cincinnati, OH ,","place":["United States"]},{"name":"Department of Pediatrics, University of Cincinnati , Cincinnati, OH ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason","family":"Newland","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Washington University School of Medicine , St. Louis, St. Louis, MO ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cindy","family":"Terrill","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Washington University School of Medicine , St. Louis, St. Louis, MO ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Bradley","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Division of Infectious Diseases, University of California at San Diego La Jolla , CA ,","place":["United States"]},{"name":"Division of Infectious Diseases, Rady Children\u2019s Hospital San Diego, San Diego , CA ,","place":["United 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