Development and testing of a multidimensional parent reported outcome measure for common presenting complaints of infancy: the UK infant questionnaire.

Abstract

Objectives: Patient reported outcome measures are recognized as important and valuable tools to monitor patient progress in healthcare. It is fundamental to clinical practice to understand whether the treated patient has improved or not. Despite the highest use of outpatient healthcare among all pediatric age groups, no age-appropriate outcome measures are available for the infant. Therefore, the objective of this study was to develop and test a new infant outcomes instrument for the most common presenting complaints of infancy. Methods: This was a multi-phase study designed to develop a questionnaire using maternal interviews and to test it for reliability and validity for use in well child clinical practice. After collecting the mother’s views, grounded theory and content analysis were used to derive themes and domains for the questionnaire. After achieving face validity, the instrument was evaluated for test-retest reliability, homogeneity and concurrent criterion validity. Subjects comprised a convenience sample of mothers who presented their infants to a university-affiliated chiropractic teaching clinic on the south coast of England. Results: Maternal interviews revealed mothers’ concerns about feeding, sleeping, crying and other aspects of infant activities of daily living resulting in construction of a 12 question instrument. The questionnaire showed excellent test-retest reliability (ICC = 0.96) and good internal consistency (Cronbach’s α = 0.8). In validity testing, ten questions showed positive correlation to a statistically significant degree against their established gold standard references. In all, 294 mother/infant dyads were involved in the research project. Conclusion: The UK Infant Questionnaire is the first parent reported outcome measure for use with the most common complaints of the infant patient based on maternal views. As such, this instrument meets the standard set by the UK National Health Service to involve the parent’s voice in their child’s care, and is therefore innovative in its field. Although further testing is indicated, and we make no claims that this instrument is comprehensive in all aspects of infant well-child care, it may be used by individual clinicians in routine daily practice to gain understanding of clinical progress of individual patients.