Understanding Clinical vs. Statistical Significance in Pediatric Care

Reference:  Shaikh N, et al. Identifying children likely to benefit from antibiotics for acute sinusitis: a randomized clinical trial. JAMA July 2023 Date: October 17, 2023 Dr. Alasdair Munro Guest Skeptic: Dr. Alasdair Munro is a clinical research fellow specializing in pediatric infectious disease at the University of Southampton. He is currently involved with clinical trials of vaccines and antibiotics. Case: A 4-year-old girl presents to your emergency department (ED) with fever and nasal drainage. Her vaccinations are all up to date. Symptoms have been present for the past 12 days. She initially had some cough and congestion which was diagnosed as a viral upper respiratory infection by her primary care doctor. Her symptoms have persisted and yesterday she developed fever (temperature of 38.3°C) and nasal drainage. On physical examination, she has nasal congestion with yellow-colored nasal discharge. The family says to you, “She’s been sick for almost 2 weeks and the color of her nasal drainage changed to yellow. Does this mean she has a bacterial infection that needs antibiotics?” Background: Distinguishing between sinusitis and viral upper respiratory infections in children is challenging. The symptoms often overlap. The latest clinical practice guidelines from the American Academy of Pediatrics (AAP) on the diagnosis and management of acute bacterial sinusitis in children was published in 2013 [1]. Based on those guidelines, a presumptive diagnosis of bacterial sinusitis can be made when a child with URI symptoms has: persistent illness (nasal discharge, daytime cough) lasting more than 10 days without improvement worsening course (new or worsening nasal discharge, daytime cough, or fever after initial improvement) severe onset (fever ≥39°C, purulent nasal discharge for at least 3 consecutive days) This recommendation only has an evidence quality of B. We don’t routinely perform sinus aspiration on children, but it is thought that the most common pathogens involved in sinusitis include Streptococcus pneumoniae Hemophilus influenzae, or Moraxella catarrhalis. Untreated sinusitis is associated with complications such as pre septal cellulitis, orbital cellulitis. In bad cases, there can be intracranial involvement that includes cavernous venous thrombosis, osteomyelitis, meningitis, or intracranial abscess. However, in the interest of antibiotic stewardship. We also do not want to be prescribing antibiotics for viral illnesses. This issue was covered on SGEM #263. We should be thinking about implementing strategies to reduce the unnecessary prescribing of antibiotics in the emergency department. Clinical Question: What are the potential benefits and harms of antibiotic treatment for children diagnosed with acute sinusitis and does it depend on bacterial pathogen colonization or color of nasal discharge? Population: Children aged 2 to 11 years with persistent or worsening acute sinusitis (as per AAP practice guideline) and symptom score of => 9 on Pediatric Rhinosinusitis Scale (PRSS) [2]. This scale ranges from 0-40 with higher scores representing more severe symptoms. Persistent = nasal symptoms, cough or both for 11 - 30 days without improvement. Worsening = period of improvement followed by worsening nasal symptoms or daytime cough, or new onset fever on days 6 - 10. Exclusion: severe presentation (presence of both colored nasal discharge and fever ≥39°C for 3 or more consecutive days, history of asthma, active wheezing, solely cough, history of allergic rhinitis, immotile cilia syndrome, cystic fibrosis, immunodeficiency, allergy to study medications, concurrent infections, systemic antibiotic use within the previous 15 days, prior sinus surgery, families did not have access to phone or were not English/Spanish speaking Intervention: 10 days of Amoxicillin/Clavulanic acid Comparison: Matching placebo Outcome: