Observer-Reported Outcome Measure for Distress in Paediatric Fever
Research type
Research Study
Full title
Develop an Observer-Reported Outcome (ObsRO) Measure to Capture the Signs and Impacts of Fever Symptoms in Infants and Young Children (≥3 months to <6 years)
IRAS ID
249111
Contact name
Hayley Syrad
Contact email
Sponsor organisation
Reckitt Benckiser Health Ltd.
Duration of Study in the UK
0 years, 6 months, 7 days
Research summary
Fever is a common paediatric presentation, which usually indicates an underlying infection, and is often a cause of concern among parents and caregivers. Fever, however, is not the primary illness but the body’s mechanism that has positive benefits for fighting infection. Parents and caregivers often believe that fever needs to be treated, which can lead to unscheduled physician visits and wide use of over-the-counter antipyretics.\nNICE (2013/17) recommends that the primary goal of treating the feverish child is to improve the child’s overall comfort rather than focus on the normalisation of body temperature. There is currently no instrument available to measure distress in children experiencing fever. There is therefore a need to develop a parent or caregiver report (also referred to as “observer-report” or ObsRO) to determine the level of distress and behaviours associated with fever in the infant and young child. The ObsRO will focus on indicators of distress only (e.g. appetite loss, agitation/apathy, etc) in order to detect and quantify signs of distress, and be used in future clinical studies.\n\nThis is a cross-sectional, non-interventional study.\n\nThe study will be conducted in two stages, with specific objectives at each stage:\nStage 1: Plan and conduct telephone concept elicitation (CE) interviews with parents/caregivers to explore signs of fever and the associated impacts on the child.\nStage 2: Conduct telephone (Round 1) and face-to-face (Round 2 and 3) cognitive interviews (CI) with parents/caregivers to assess comprehension of the ObsRO. Usability testing will also take place to understand parent/caregiver use of the electronic format of the ObsRO measure.\n
REC name
South West - Central Bristol Research Ethics Committee
REC reference
18/SW/0165
Date of REC Opinion
18 Jul 2018
REC opinion
Further Information Favourable Opinion