Assessment of the Severity of Infant Crying and Its Impact on Parents: Development and Validation of the ColiQ Questionnaire in France.

Objectives: The purpose of this study was to develop and validate a questionnaire that comprehensively assesses symptoms and severity of crying, symptoms suggesting infant functional gastrointestinal discomfort, and its impact on parents' quality of life: the Infant Colic Questionnaire (ColiQ(C)). For the first time, parents had access to a web application to follow their infants' evolving symptoms with a daily questionnaire. Methods: The ColiQ was developed with a board of clinical experts (physicians and psychologists) based on extensive parent input. A longitudinal, observational study was conducted in France for 3 months. ColiQ assessments were collected online at six different time points. Psychometric testing demonstrated that ColiQ has acceptable psychometric properties (reliability, internal consistency, construct validity, and responsiveness). Results: The ColiQ is a 16-question instrument developed in French including ten questions describing symptoms (Infant score) and six questions describing impacts (Parent score). The ColiQ demonstrated good test-retest reliability (ICC > 0.70), internal consistency for both the Symptom and Impact subscale scores (Cronbach's alpha > 0.70), and construct validity. Responsiveness was good; the ColiQ was able to detect significant improvement in the target population as early as 1 month (p < 0.05). The global ColiQ score discriminated between severity levels (mild, medium, severe). Conclusions: The ColiQ was developed with input from parents and healthcare professionals and has shown validity, reliably, and responsiveness to change. Parents can use the web application to follow how their infants' symptoms evolve. The ColiQ can help parents quantify and verbalize their concerns during consultations, and provides an opportunity to facilitate conversations between the physician and parents. (C) 2021 The Authors. Published by Elsevier Masson SAS on behalf of French Society of Pediatrics.