Pediatric Functional Constipation Questionnaire-Parent Report (PedFCQuest-PR): development and validation

Objective: Developing and validating a disease-specific instrument in the Brazilian Portuguese language to assess the Health-Related Quality of Life of children with functional constipation, applied to parents/caregivers. Methods: The process of developing the questionnaire was carried out in the following steps: items generation concerning functional constipation; elaboration of the preliminary questionnaire; assessment by health professionals; identifying problems or inconsistencies by the researchers; improvement of the questions; obtaining a final questionnaire named Pediatric Functional Constipation Questionnaire-Parent Form (PedFCQuest-PR) with 26 questions divided into four domains. Responses options use a Likert scale based on the events of the last four weeks. The process of validation was an observational, cross-sectional study in a sample of 87 parents/caregivers of children from 5 to 15 years of age diagnosed with Functional constipation according to the Rome IV Criteria. The questionnaire was applied simultaneously to the Pediatric Quality of Life Inventory 4.0 (PedsQL TM 4.0) as a control. Results: The questionnaire validation included 87 parents/caregivers. The children's median age was 8.2 years, with a long time of constipation symptoms associated with fecal incontinence in approximately two-thirds. Internal consistency reliability for the Total Scale Score of PedFCQuest-PR by Coefficient Alpha of Cronbach score was 0.86. Convergent and divergent validity of PedFCQuest-PR was demonstrated by correlating the domains of both questionnaires. Conclusion: This study provides evidence that PedFCQuest-PR is a reliable instrument. The results showed a high degree of internal consistency and validity of the instrument for future applications. (C) 2021 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda.

Automated summary

The objective of this study was to develop and validate a disease-specific questionnaire in Brazilian Portuguese language for assessing the Health-Related Quality of Life of children with functional constipation, applied to parents/caregivers. The questionnaire, named as Pediatric Functional Constipation Questionnaire-Parent Form (PedFCQuest-PR), was developed through a process of items generation, preliminary questionnaire elaboration, assessment by health professionals, identification of problems or inconsistencies, and improvement of the questions. The validation process involved 87 parents/caregivers and demonstrated strong internal consistency and validity of the PedFCQuest-PR.