Hacetttepe University
Ankara, 06100, Turkey (Türkiye)
NCT Number: NCT02909127
There is no dysphagia spesific and patient/parent centered outcome instrument in the pediatric population. The purpose of this investigation is to develop the Pediatric version of the Eating Assessment Tool (PEDI-EAT-10) and investigate its validity and reliability.
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Notify Me18 month and older
All sexes
Observational
Ankara, 06100, Turkey (Türkiye)
The evaluation of pediatric swallowing disorders includes clinical and instrumental techniques. The clinical evaluation is important for clinical decision-making and to assess the need for an instrumental evaluation of swallowing. A recent systematic review suggested that the currently available non-instrumental assessments for clinicians to evaluate swallowing and feeding function in the pediatric population have wide variations in design, assessment domains, and target groups. It was concluded that there is a significant need for standardized assessment tools with good psychometric properties in the pediatric population. The existing instruments measure the presence or absence and frequency of challenges related to eating/feeding problems in pediatrics, they do not comprehensively measure oropharyngeal phase swallowing problems or do not reflect the severity of oropharyngeal dysphagia symptoms. The 10-item Eating Assessment Tool (EAT-10), which was designed for adult patients, is a good model for this current research. It has proven highly successful in quantifying initial dysphagia symptom severity and in monitoring treatment efficacy in a vast array of dysphagia etiologies. Although the EAT-10 is a symptom survey, it has been able to predict objective evidence of swallowing dysfunction. There is no dysphagia spesific and patient/parent centered outcome instrument in the pediatric population such as the EAT-10. The purpose of this investigation is to develop the Pediatric version of the Eating Assessment Tool (PEDI-EAT-10) and investigate its validity and reliability.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
The inclusion criteria are:
The exclusion criteria are:
Swallowing function of the CP patients will be imaged and recorded with Videofluoroscopic Swallowing Study (VFSS). The oral cavity, pharynx, larynx and just below the upper esophageal sphincter are visible. 3 trials of 3 ml of liquids will be used and the worst score will be considered for calculation. The Penetration-Aspiration Scale (PAS) will be used to assess dysphagia severity. The PAS is an ordinal scale consisting of eight scores. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled.
The Functional Independence Measure for Children (Wee-FIM) will be used to assess the functional independence level of the CP children. The Wee-FIM is developed to emphasize habilitative and developmental aspects of children with special health care needs, genetic disorders, developmental disabilities, and acquired disabilities.
The PEDI-EAT-10 will also be administered.
Time frame: 10 days
A comprehensive pediatric dysphagia literature review and the validated items from the other scales will be used to create the items of the PEDI-EAT-10. The PEDI-EAT-10 was designed as a parent-report measure of dysphagia symptom severity. Content validity will also be investigated because it is the first stage of instrument development. An expert panel with Delphi rounds will be convened to determine the initial content validity. The experts will be scored each item of the scale as ''necessary'', ''insufficent'' or ''unnecessary'' and the content validity index (CVI) will be calculated.
Time frame: 6 MONTHS
The PEDI-EAT-10 will be administered to the primary feeders of the CP children on two separate occasions separated by at least 48 hours to evaluate test-retest reliability. The criterion-related validity of the PEDI-EAT-10 will be assessed by the correlation between the PEDI-EAT-10 and swallowing evaluation results.
Hacettepe University
Other
The Development of the Pediatric Eating Assessment Tool (PEDI-EAT-10)
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