Abstract
Background
RSV prophylaxis with palivizumab is restricted to evidence-based indications in infants at relatively higher hospital admission risk. The RSV Program’s criteria follow CPS and AAP guidelines, but adjudication is needed in conditions of questionable efficacy or in infants who have a moderate risk of contracting RSV. In 2015–16, a blinded simple-majority Panel-of-Three adjudication (PoTA) process was implemented where adjudicators are from different specialities (e.g. neonatology, Peds ID, etc.) and are neither caregivers nor have funding that can be traced to the manufacturer/vendor for conflict of interest (COI) and bias avoidance.
Objectives
To review adjudications across 3 RSV seasons (2015–2018) and determine the benefits and challenges associated with the PoTA structure.
Design/Methods
All cases of PoTAs were reviewed and categorized based on age of infant, season, and diagnosis. Seasonal admissions with RSV & LRTI were ascertained provincially using 7 RSV-related acute respiratory infection ICD-10 codes, and cross-checked using the Program’s palivizumab database. The reliability of agreement within PoTAs during each season was measured with average pairwise percent agreement (APPA) and Fleiss kappa.
Results
In the 2015–16, 2016–17, and 2018-18 seasons, 67/467 applications (14.2%), 64/416 (15.4%), and 64/452 (13.9%) were adjudicated, with overall approval rates of 51%, 42% and 33% respectively. There was a trend towards lower approval rates from 2015–16 (range: 42–60%) to 2017–18 (25–38%), with a median approval turnaround time of 3 days. Infants with “exceptional conditions” (e.g. progressive neuromuscular and central nervous system disorders) comprised the largest category of applicants undergoing PoTA, followed by infants with significant pulmonary disabilities. Infants with immunodeficiencies were consistently approved in >80% of cases. In 2015–16, 2016–17 and 2017–18, the APPA and Fleiss kappa were found to be 78.1% and 0.57, 76.0% and 0.51 (moderate agreements) and 83.3% and 0.63 (moderate-to-substantial agreement). Unanimous decisions were reached in 46%, 47%, and 48% of cases amongst 3 adjudicators, for each season, respectively. Hospitalization rates were 20/82 (5 RSV+) in approved, and 3/113 (2 RSV+) in non-approved cases over 3 seasons.
Conclusion
We describe an adjudication process that balances transparency and independence of adjudicators from one another. Timely decisions were reached in most cases, and the rates of hospitalized infants in the non-approved category remained small. The PoTA reached agreement in the adjudication decision in most cases and the low hospitalization rates in non-approved infants suggest that the decision process is both safe and efficient.