Critique of Exclusion Criteria and Inter-Rater Reliability in Bell Palsy Study

Reference: Babl et al. Efficacy of prednisolone for bell palsy in children: a randomized, double-blind, placebo-controlled, multicenter trial (BellPIC). Neurology 2022 Date: January 3, 2023 Guest Skeptic: Dr. Jennifer Harmon is an MD, Ph.D at Children’s National Hospital in Washington, DC. She is a board-certified pediatric neurologist and completing another fellowship in medical genetics. Dr. Jennifer Harmon Case: A 9-year-old girl shows up at your emergency department (ED) with unilateral facial paralysis. Her parents noticed that one side of her face looked abnormal when she woke up in the morning. She has no other medical conditions and has not had any recent fevers, ear pain, or trauma. On exam, she is alert and active, but you note that the entire left side of her face does not move when you ask her to smile or raise her eyebrows. The remainder of her exam is unremarkable. You make a clinical diagnosis of Bell palsy, and the parents ask you, “Is there anything you can give her to help her recover faster?” Background: Bell palsy is a common cause of unilateral facial 7th nerve palsy in children. The differential diagnoses for this presentation can include trauma, otitis media, viral infections (herpes, varicella, CMV, EBV, etc), brain lesions or stroke, and acute leukemia. If the 7th nerve palsy is known to be caused by the herpes virus it is called Ramsay Hunt syndrome (herpes zoster oticus) [1]. It is important to perform a careful history and physical before ultimately arriving at the diagnosis of Bell palsy. While many children spontaneously recover, the clinical manifestations of Bell palsy may significantly impact a child functionally and emotionally.  There have been studies in adults regarding the treatment of Bell palsy that have demonstrated that treatment with corticosteroids provide significant benefit (NNT 10) [2].  The SGEM covered the use of steroids and antivirals for Bell Palsy in SGEM#14. Unfortunately, the data for the use of steroids in treatment of pediatric Bell Palsy is still lacking [3]. Clinical Question: Does prednisolone improve the proportion of children with Bell palsy with complete recovery at one month?  Reference: Babl et al. Efficacy of prednisolone for bell palsy in children: a randomized, double-blind, placebo-controlled, multicenter trial (BellPIC). Neurology 2022 Population: Children 6 months to 18 years presenting to multiple emergency departments in Australia with Bell Palsy diagnosed by a senior clinician with onset of symptoms less than 72 hours prior to evaluation. Excluded: There were a lot of exclusion criteria that we will list in the show notes. Contraindication to prednisolone (active/latent tuberculosis, systemic fungal infection, hypersensitivity, diminished cardiac function, diabetes mellitus, peptic ulcer disease, chronic renal failure, multiple sclerosis, recent active herpes zoster or chickenpox) Use of any systemic or inhaled steroid within 2 weeks prior to onset of symptoms Current or past oncological diagnosis Pregnant or breastfeeding Receiving concomitant medications in which prednisolone is contraindicated Immunization with a live vaccine within previous one month Requirement for live vaccine within 6 weeks of first dose of study drug Signs of upper motor VII nerve weakness Acute otitis media concurrently or within 1 week prior to onset of symptoms Vesicles at ear suggestive of Ramsay-Hunt syndrome Known facial trauma within 1 week prior to symptom onset Any other condition at risk of being influence by the study treatment or might affect completion of study Any concern about ability to comply with the study protocol Prior episode of Bell palsy Intervention: Prednisolone 1 mg/kg (max 50 mg) for 10 days, with no taper. Comparison: Placebo Outcome:  Primary Outcome: Complete recovery of facial function at 1 month defined by a House-Brackmann score of 1.