Development of an observer-reported outcome measure to capture the signs and impact of fever distress symptoms in infants and young children.

Abstract

This qualitative study aimed to construct an observer-reported outcome measure (ObsRO) to evaluate fever distress in young children. A literature review was conducted to identify fever-related concepts. Clinical experts were interviewed for feedback on these concepts. Parents of young children were interviewed to identify behaviours the child exhibited during a recent fever episode. Fever sign and behaviour concepts endorsed by ≥ 20% parents were used to create items for the draft ObsRO. Parents of young children who recently had fever completed the ObsRO and gave feedback during two successive rounds of cognitive interviews. Twenty-five parents participated in the concept elicitation. Mean child age was 2.7years (range: 0.6-5.8years). Fever sign and behaviour concepts endorsed by ≥ 20% participants were high temperature (80%), skin hot to touch (32%), skin redness/flushing (32%), reduced appetite/drink (96%), needy/clingy/irritable (48-92%), less active/interactive (68-84%) and lethargic (64-88%). Eighteen items, four in the Fever Signs Module and 14 in the Fever Behaviours Module, were developed for the draft ObsRO. Chosen recall period was 24h. Thirty participants (Round 1: n = 17; Round 2: n = 13), participated in cognitive interviews. Mean child age was 2.4years (range 0.3-5.8). Round 1 feedback resulted in two Fever Signs items being combined. Three Fever Behaviour items were deleted, six revised and four unchanged. No changes were made following Round 2 feedback. Most participants understood all aspects of the ObsRO and found it user-friendly. The ObsRO will undergo further development in validation studies testing measurement properties of each item.