Objectives: There is limited epidemiological information on swallowing dysfunction (SwD) in otherwise healthy infants and toddlers (OHITs). Cost, invasiveness, expertise, and resources constrain the repeatability and utility of instrumental diagnostic tests. A parent-reported outcomes (PRO) tool has the potential to mitigate these disadvantages. Hence, we set out to develop and validate a novel PRO tool to assess SwD in OHITs.
Study design: A mixed-method study.
Setting: Tertiary pediatric center.
Methods: We recruited parents of OHITs with SwD and excluded those with a confounding diagnosis (syndromes or neurological impairment). Interviews were conducted and thematically analyzed to extract the relevant domains and items. A similar analytical method was performed on the reports from a systematic review and literature search. Four verification sessions of parents and experts were conducted to maintain rigor. A panel of experts assessed and established the content validity of the items using a modified Delphi technique.
Results: We achieved information saturation after interviewing 10 parents and generated 7 domains with 72 items. Over the course of 3 rounds of modified Delphi content validation, the domains were reduced to 3 (swallowing, breathing, and illness) containing 21 items; a content validity index of 82.1% was achieved.
Conclusion: We validated the content of a new PRO instrument to assess SwD in OHITs. The instrument is composed of 3 primary domains representing 21 items. This tool has the potential to screen for swallowing dysfunction and can assess management outcomes specifically for this population at a community level.
Keywords: deglutition; dysphagia; otherwise healthy infants and toddlers; parent-reported outcomes; swallowing dysfunction.