Abstract
BackgroundDeveloping age-appropriate medications remains a challenge in particular for the population of infants and toddlers, as they are not able to reliably self-report if they would accept and consequently take an oral medicine. Therefore, it is common to use caregivers as proxies when assessing medicine acceptance. The outcome measures used in this research field differ and most importantly lack validation, implying a persisting gap in knowledge and controversy in the field. The newly developed Caregiver-administered Children’s Acceptance Tool (CareCAT) is based on a 5-point nominal scale, with descriptors of medication acceptance behavior. This cross-sectional study assessed the measurement properties of the tool with regards to the user’s understanding and its intra- and inter-rater reliability.MethodsParticipating caregivers were enrolled at a primary healthcare facility where their children (median age 6 months) had been prescribed oral antibiotics. Caregivers, trained observers and the tool developer observed and scored on the CareCAT tool what behavior children exhibited when receiving the medicine (n = 104). The video-records of this process served as replicate observations (n = 69). After using the tool caregivers were asked to explain their observations and the tool descriptors in their own words. The tool’s reliability was assessed by percentage agreement and Cohen’s unweighted kappa coefficients of agreement for nominal scales.ResultsThe study found that caregivers using CareCAT had a satisfactory understanding of the tool’s descriptors. Using its dichotomized scores the tool reliably was strong for acceptance behavior (agreement inter-rater 84–88%, kappa 0.66–0.76; intra-rater 87–89%, kappa 0.68–0.72) and completeness of medicine ingestion (agreement inter-rater 82–86%, kappa 0.59–0.67; intra-rater 85–93%, kappa 0.50–0.70).ConclusionsThe CareCAT is a low-cost, easy-to-use and reliable instrument, which is relevant to assess acceptance behavior and completeness of medicine ingestion, both of which are of significant importance for developing age-appropriate medications in infants and toddlers.
Highlights
Developing age-appropriate medications remains a challenge in particular for the population of infants and toddlers, as they are not able to reliably self-report if they would accept and take an oral medicine
There is a move towards patient-centered development of formulations for pediatric oral medicines, reflected in legislation from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA)
We have explored the measurement properties of the Caregiver-administered Children’s Acceptance Tool (CareCAT) tool, a newly developed informant-reported outcome instrument used for scoring behaviors that infants and young children display while receiving oral antibiotics
Summary
Developing age-appropriate medications remains a challenge in particular for the population of infants and toddlers, as they are not able to reliably self-report if they would accept and take an oral medicine. The newly developed Caregiver-administered Children’s Acceptance Tool (CareCAT) is based on a 5-point nominal scale, with descriptors of medication acceptance behavior. This crosssectional study assessed the measurement properties of the tool with regards to the user’s understanding and its intra- and inter-rater reliability. Regulators have been criticized for not providing evidence-based guidance on the acceptability aspects [3] This area is still evolving, and there is a need to provide evidence on perceptions of the relevant stakeholders, i.e. the children and their caregivers as the end-users of oral medicines. In pediatric practice worldwide, prescriptions of oral medicines for the youngest children remain to be driven by the availability of formulations [8], rather than by considering any age-specific preference or needs of the children
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