Demographic characteristics of the caregivers and demographic and clinical characteristics of infants in the study are provided in Table 1. The mean age of the caregiver sample was 36.5 years, which included a greater proportion of females (n = 16; 76.2%) than males (n = 5; 23.8%). The majority were parents of the infants (61.9% mothers, 19.1% fathers), with the remainder being grandparents. Most caregivers were of a Black/African American (n = 10; 47.6%) or White (n = 9; 42.9%), with one Hispanic/ Latino caregiver (4.8%).
Clinicians confirmed that no infants described in the study were born prematurely, had any additional diseases, or were receiving treatment for another medical condition. The majority of infants were treated in the emergency room (n = 19; 90%), while eleven patients (52.4%) also received treatment as an inpatient either in the hospital ward (n = 8; 38.1%) or intensive care unit (n = 3; 14.3%). Of the eleven patients that stayed overnight in hospital and were treated as inpatients, the typical length of stay was one to three nights (n = 9; 42.9%), with one patient hospitalized for four to seven nights (4.8%) and one patient hospitalized for more than seven nights (4.8%). Clinicians rated the majority of infants as having ‘moderate’ or ‘severe’ RSV disease (47.6% and 23.8%, respectively).
Concept elicitation results
Figure 1 displays the conceptual model based on the results of the study. The conceptual model displays the number of caregivers that reported each sign and impact of RSV, and provides an indication of how important or relevant each concept is to most caregivers’ experiences of their child having RSV disease.
Respiratory or “cold” signs, dehydration, and gastrointestinal problems were described by caregivers as the physical signs of RSV disease. All caregivers reported that their child had been coughing (n = 21/21, 100%) and had difficulty breathing (n = 21/21, 100%), with most reporting the child having a fever (n = 18/21, 90%) and making noises while breathing (n = 17/21, 81%). The most frequently reported behavioral signs in these infants included eating/drinking less than usual (n = 18/21, 86%), decreased activity level (n = 13/21, 62%), crying more than usual (n = 11/21, 52%) and not appearing the be their ‘usual self’ (n = 11/21, 52%). Sub-group analysis for many signs revealed that infants classified by the clinician as having had ‘severe’ or ‘moderate’ RSV disease (47.6% and 23.8%, respectively) were more likely to exhibit some of the more severe signs of RSV, such as wheezing, head bobbing, sweating (indicating a fever), vomiting, and signs of dehydration. However, given the small sample size in the subgroup analysis, findings should be treated with caution.
RSV disease affected children’s ability to sleep (n = 17/21, 81%) and physical signs such as losing weight and appearing to be hungry and uncomfortable (n = 4/21, 19%). Long-term complications of RSV infection were also experienced (n = 6/21, 29%) including pneumonia, asthma, and RSV disease signs that persisted, such as coughing and nasal congestion. Further insight into the descriptions and observations of key signs of RSV identified by caregivers during the interviews is provided in Additional file 3.
Conceptual saturation was achieved with no new concepts regarding RSV diseases severity emerging in the final set of interviews.
Findings across the market research studies were broadly consistent with findings from the primary qualitative study and no notable differences were identified across findings from the US, Brazil and China. With the exception of three gastro-intestinal signs, including gassiness, diarrhea, and constipation, all concepts identified in the market research studies across each country were also identified in the primary qualitative study.
A gap analysis was completed to determine whether the PRESORS ObsRO captured concepts discussed by the caregivers in both the market research studies and primary research study (Table 2). The findings confirm that the PRESORS ObsRO captures 23 of the 26 key concepts discussed by caregivers across all studies. Signs described by caregivers that were not captured by the PRESORS ObsRO included behavioral signs; specifically the infant not being his/her usual self or being irritable and/or clingy. The infant not being their usual self is a difficult sign to conceptualize as it is related to many other concepts, however revisions to the PRESORS ObsRO based on these research findings have incorporated other behavioral signs described by caregivers. Additional signs described that were not captured by the original PRESORS ObsRO included breathing sounds such as rattling, cracking, and whinnying are now reflected in the PRESORS items about noisy breathing. Gastrointestinal signs of “gassy,” diarrhea and constipation, and eye signs have not been included as they are not clearly related to a respiratory infection. However, all of the signs that were not in the original PRESORS were reported by less than four caregivers in the primary content validation study and therefore were not considered key signs.
Cognitive debriefing results
Overall, 16/19 (84%) items in the PRESORS ObsRO were well understood by all caregivers (Figs. 2, 3) and were reported to be relevant by the majority of caregivers during cognitive debriefing interviews (Fig. 4).
Three items were not well-understood by four caregivers, three of whom had received tertiary education and one of whom had completed high school. These three items required the caregivers to count the number of breaths the child takes, the number of heartbeats, and the number of hours caregivers were unable to do their normal activities. Quotes from the interviews show the difficulties caregivers had with these three questions.
- Confusion about breath counts:
[interviewer] would you count the breathing in and out as one breath or two breaths?
[caregiver] I counted that as two breaths.” (S-18-T-Mo)
- Confusion about heartbeat counts:
“I’m sort of confused on this one. Does it mean when the stomach goes in and out or just the heartbeats?” (M-5-HS-Gm)
“are we counting the double beat as one or one, two, three, four” (S-3-T-Fa)
- What are usual activities:
“Well I don’t really have no activities besides work. But they said in the last 24 h, so, um, I’m going to skip that question.” (M-4-T-Fa)
Items considered indicative of more severe breathing difficulties associated with RSV were found to be less relevant for some caregivers. These included:
Item assessing lips, skin or fingernails turning blue (n = 12/21, 57%)
Item assessing intercostal retractions (skin between ribs being sucked in when breathing in [n = 14/21, 67%]) and supraclavicular retractions (skin between ribs being sucked in when breathing in [n = 8/21, 38%])
Item assessing nasal flaring (n = 7/21, 33%) and head bobbing (n = 7/21, 33%)
Most signs of dehydration were also observed by few caregivers. Whilst just over half of caregivers reported observing dry skin or lips (n = 11/21, 52.4%), only four caregivers reported observing sunken eyes (n = 4/21, 19%), and no caregivers reported observing a sunken fontanelle.
Revisions to the PRESORS ObsRO were proposed to enhance content validity, including removing the heartbeat count, revising the breath count, and clarifying the hours missed from usual activities item. No key concepts were reported to be missing from the questionnaire by caregivers.
Ease of use
All caregivers stated completing PRESORS ObsRO in the smartphone application was easy to do; no usability problems were reported. Four caregivers suggested usability would be easier on a tablet computer (n = 3) or as an application they could download on their own mobile phone (n = 1).
Just over half of caregivers (n = 12/21, 57%) discussed how feasible it would have been for them to complete the PRESORS ObsRO shortly after their infant was admitted to hospital. The majority of caregivers (n = 8/12, 67%) stated they would have been able to complete the PRESORS upon the infant’s admission to hospital, as it would have provided a welcomed distraction and would be have been helpful: “I mean I would want whatever physician to know this information. This is pertinent to them and for her. So if it was there I would definitely be like, okay. That’s something I could do while they’re working on her. That’s keeping me calm, you know, and having something to do.” (M-6-T-Gm-a).
However, some caregivers (n = 4/12, 33%) felt it would have been too challenging to complete the PRESORS when the infant was first admitted to hospital, given the caregivers’ emotional state at the time: “probably a little frustrated, um, didn’t want to fill out no paperwork at the time.” (VS-5-T-Mo).
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