Content validation of a caregiver diary to monitor severity and recovery of pediatric patients with respiratory syncytial virus infection

Journal of Patient-Reported Outcomes

Table 2 Gap analysis of key concepts discussed in caregiver interviews against concepts captured in caregiver PRESORS ObsRO v4.0

Concepts	Concepts identified through caregiver qualitative research		Concepts measured in the PRESORS ObsRO v4.0	Concepts measured in revised PRESORS ObsRO following COA study
Concepts	Market research studies	COA study	Concepts measured in the PRESORS ObsRO v4.0
Respiratory signs
Difficulty breathing	✓	✓	✓	✓
Cough	✓	✓	✓	✓
Breathing sounds	✓	✓	✓	✓
Wheezing	✓	✓	✓	✓
Grunting	X	✓	✓	✓
Descriptions of retractions	✓	✓	✓	✓
Change in respiratory rate	✓	✓	✓	✓
Blue skin	✓	✓	✓	✓
Choking/gagging	✓	✓	✓	✓
Nostrils flaring	✓	✓	✓	✓
Gastrointestinal signs
Vomiting	✓	✓	✓	✓
Spitting-up	✓	✓	✓	✓
Signs of a cold
Fever	✓	✓	✓	✓
Runny nose	✓	✓	✓	✓
Congestion	✓	✓	✓	✓
Cold-signs unspecified	✓	✓	✓	✓
Signs of dehydration
Dehydration*	✓	✓	✓	✓
Not eating/drinking	✓	✓	✓	✓
Behavioural signs
Reduction in eating or drinking	✓	✓	✓	✓
Low activity	✓	✓	✓	✓
Tiredness**	✓	✓	✓	✓
Crying	✓	✓	✓	✓
Not usual self	✓	✓	X	X
Irritable/fussy/cranky	✓	✓	X	✓¹
Unresponsive to surroundings	X	✓	X	✓²
Clingy	X	✓	X	X

Only the signs described by more than four caregivers are reported unless considered a key sign
*Observations of dehydration included pale skin, not eating or drinking as usual, having to change diapers less frequently, and the infant not sweating
**Observations of tiredness included the infant sleeping more than usual and appearing restless or drowsy
Revisions to concepts assessed:
¹Concepts of ‘irritable/fussy/cranky’ were added as these were reported by caregivers in all studies
²An item assessing the infant being ‘unresponsive to surroundings’ was added as this was reported by caregivers in the COA study
The following four items were added: two items assessing sleep during the day and night, an item assessing whether the infant’s heart was beating faster (via a yes/no response), an item assessing whether the infant was receiving liquids other than medicine through tubes in the nose, mouth or stomach, and a return to normal health item. The item assessing the infant’s heartbeat via counting was removed
Source of patient journey study data: Nielsen US, 2015; Segmedica US, 2016; Neolite Agency China, 2017; Segmedica Brazil, 2017