Original Research Parent-Reported Outcome Questionnaire for Swallowing Dysfunction in Healthy Infants and Toddlers: Construction and Content Validation Otolaryngology– Head and Neck Surgery 1–9 Ó American Academy of Otolaryngology–Head and Neck Surgery Foundation 2020 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0194599820970950 http://otojournal.org Abdulsalam Baqays, MD, MSc 1,2 , Wendy Johannsen, M-SLP, S-LP, R-SLP 3 , Marghalara Rashid, PhD 4 , Hussein Jaffal, MD 1 , Anne Hicks, MD, PhD, FRCSC 5 , Caroline Jeffery, MD, MPH, FRCSC 1 , Hadi Seikaly, MD, FRCSC 1 , and Hamdy El-Hakim, MBChB, FRCS 1 Abstract 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 instru- mental 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 estab- lished the content validity of the items using a modified Delphi technique. Results. We achieved information saturation after interview- ing 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 instru- ment 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 swallowing dysfunction, dysphagia, deglutition, otherwise healthy infants and toddlers, parent-reported outcomes Received June 17, 2020; accepted October 13, 2020. T here is increasing evidence that swallowing dysfunc- tion (SwD) may be more prevalent in children than once believed. One survey restricted to children aged 3 to 17 years estimated that 500,000 children are affected annually by SwD in the United States. 1 It is well known that the prevalence is particularly high and well documented in some craniofacial syndromes and neurologically impaired children. 2-6 By contrast, literature sources regarding this con- dition in otherwise healthy children are scant, are poorly documented, and vary by the level of care where data were collected. However, there is a 21.3% to 74.8% prevalence of abnormalities on instrumental swallowing assessments in otherwise healthy infants and toddlers (OHITs) who were studied for recurring respiratory symptoms, gastroesophageal 1 Division of Otolaryngology, University of Alberta, Edmonton, Alberta, Canada 2 Division of Otolaryngology, King Saud University, Riyadh, Saudi Arabia 3 Department of Pediatric Speech Language Pathology, Stollery Children’s Hospital, Edmonton, Alberta, Canada 4 Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada 5 Department of Pediatrics, Division of Pediatric Respiratory Medicine, University of Alberta, Edmonton, Alberta, Canada Corresponding Author: Hamdy El-Hakim, MBChB, FRCS, Division of Otolaryngology, University of Alberta, 2C3. 57 Walter MacKenzie Center, Edmonton, AB T6H0R3, Canada. Email: helhakim@icloud.com