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Item Effect of introducing the mucosal atomization device for fentanyl use in out-of-hospital pediatric trauma patients(Cambridge Journals, 2013-10) O'Donnell, Daniel; Schafer, Luke; Stevens, Andrew; Weinstein, Elizabeth; Miramonti, Charles; Kozak, Mary AnnBackground: Pain associated with pediatric trauma is often under-assessed and undertreated in the out-of-hospital setting. Administering an opioid such as fentanyl via the intranasal route is a safe and efficacious alternative to traditional routes of analgesic delivery and could potentially improve pain management in pediatric trauma patients. Objective: The study sought to examine the effect of introducing the mucosal atomization device (MAD) on analgesia administration as an alternative to intravenous fentanyl delivery in pediatric trauma patients. The hypothesis for the study is that the introduction of the MAD would increase the administration of fentanyl in pediatric trauma patients. Methods: The research utilized a 2-group design (pre-MAD and post-MAD) to study 946 pediatric trauma patients (age ,16) transported by a large, urban EMS agency to one of eight hospitals in Marion County, which is located in Indianapolis Indiana. Two emergency medicine physicians independently determined whether the patient met criteria for pain medication receipt and a third reviewer resolved any disagreements. A comparison of the rates of fentanyl administration in both groups was then conducted. Results: There was no statistically significant difference in the rate of fentanyl administration between the pre-MAD (30.4%) and post-MAD groups (37.8%) (P5.238). A subgroup analysis showed that age and mechanism of injury were stronger predictors of fentanyl administration. Conclusion: Contrary to the hypothesis, the addition of the MAD device did not increase fentanyl administration rates in pediatric trauma patients. Future research is needed to address the barriers to analgesia administration in pediatric trauma patients.Item Improvement in Kansas City Cardiomyopathy Questionnaire Scores After a Self-Care Intervention in Patients With Acute Heart Failure Discharged From the Emergency Department(American Heart Association, 2021) Stubblefield, William B.; Jenkins, Cathy A.; Liu, Dandan; Storrow, Alan B.; Spertus, John A.; Pang, Peter S.; Levy, Phillip D.; Butler, Javed; Chang, Anna Marie; Char, Douglas; Diercks, Deborah B.; Fermann, Gregory J.; Han, Jin H.; Hiestand, Brian C.; Hogan, Christopher J.; Khan, Yosef; Lee, Sangil; Lindenfeld, JoAnn M.; McNaughton, Candace D.; Miller, Karen; Peacock, W. Frank; Schrock, Jon W.; Self, Wesley H.; Singer, Adam J.; Sterling, Sarah A.; Collins, Sean P.; Emergency Medicine, School of MedicineBackground: We conducted a secondary analysis of changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 over 30 days in a randomized trial of self-care coaching versus structured usual care in patients with acute heart failure who were discharged from the emergency department. Methods: Patients in 15 emergency departments completed the KCCQ-12 at emergency department discharge and at 30 days. We compared change in KCCQ-12 scores between the intervention and usual care arms, adjusted for enrollment KCCQ-12 and demographic characteristics. We used linear regression to describe changes in KCCQ-12 summary scores and logistic regression to characterize clinically meaningful KCCQ-12 subdomain changes at 30 days. Results: There were 350 patients with both enrollment and 30-day KCCQ summary scores available; 166 allocated to usual care and 184 to the intervention arm. Median age was 64 years (interquartile range, 55-70), 37% were female participants, 63% were Black, median KCCQ-12 summary score at enrollment was 47 (interquartile range, 33-64). Self-care coaching resulted in significantly greater improvement in health status compared with structured usual care (5.4-point greater improvement, 95% CI, 1.12-9.68; P=0.01). Improvements in health status in the intervention arm were driven by improvements within the symptom frequency (adjusted odds ratio, 1.62 [95% CI, 1.01-2.59]) and quality of life (adjusted odds ratio, 2.39 [95% CI, 1.46-3.90]) subdomains. Conclusions: In this secondary analysis, patients with acute heart failure who received a tailored, self-care intervention after emergency department discharge had clinically significant improvements in health status at 30 days compared with structured usual care largely due to improvements within the symptom frequency and quality of life subdomains of the KCCQ-12.Item Relevant academic literature, applicable federal regulations for the protection of human subjects on emergency research involving artificial/substitute blood products (including PolyHeme)(Indiana University Center for Bioethics, 2006-03-27) Brown, BrandonFederal oversight of research involving human subjects is found in two regulatory regimes within the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA). 21 CFR 50, 56 - the Office of Human Research Protections (OHRP), and 45 CFR 46. Generally, any research that is testing a drug, device, or other product that will be submitted for FDA approval must follow their regulations (21 CFR 50/56), while research that is supported by federal funds (e.g., an NIH grant) must also comply at a minimum with 45 CFR 46 Subpart A (the federal policy for the protection of human subjects, also known as the Common Rule), and with Subparts B,C,D as appropriate. While most of the FDA and OHRP regulations are similar (or substantially overlap), there are a number of areas in which they differ. Further, all institutions supported by federal funds must negotiate a Federalwide Assurance with OHRP that provides for all research within an institution to be subject to the Common Rule, regardless of whether the research is federally funded.Item SHEA statement on antibiotic stewardship in hospitals during public health emergencies(Cambridge University Press, 2022) Barlam, Tamar F.; Al Mohajer, Mayar; Al-Tawfiq, Jaffar A.; Auguste, Antonie J.; Cunha, Cheston B.; Forrest, Graeme N.; Gross, Alan E.; Lee, Rachael A.; Seo, Susan K.; Suh, Kathryn N.; Volk, Stacy; Schaffzin, Joshua K.; Medicine, School of Medicine