Two iterative rounds of in-depth interviews were conducted during two RSV seasons (2017–2018 and 2018–2019) to elicit comprehensive descriptions of symptoms and impacts of RSV infection (concept elicitation) as well as to refine the draft RSV-iiiQ item set (cognitive debriefing). Interviews lasted no more than 60 min. Approximately 20 min were allotted for concept elicitation, and 40 min were allotted for cognitive debriefing. The study protocol was reviewed and approved by the University of Michigan Institutional Review Board (Federalwide Assurance No. 4969) and RTI International Institutional Review Board (Federalwide Assurance No. 3331).
Participants were recruited through the University of Michigan (in Ann Arbor, Michigan) and the Global Market Research Group (headquartered in Carlsbad, California). Prospectively identified participants were invited at the time of the study office visit. Clinical sites also reviewed medical records and, within 45 days of the date of diagnosis, invited patients with a positive RSV polymerase chain reaction (PCR) test. Retrospectively identified participants were invited to participate via telephone call or email. Study sites attempted to recruit participants as soon as possible after confirmation of an RSV diagnosis by PCR and when the patient self-reported feeling well enough to participate in the interview. Individuals were eligible to participate if they had acute RSV infection confirmed by a PCR assay within 45 days of being contacted to participate in the qualitative interview. Individuals were excluded if they presented with a comorbid respiratory condition, received supplemental oxygen therapy for a condition other than RSV, had chemotherapy administered in the previous 12 months, or received an investigational medicinal product in the previous 30 days. Informed consent was obtained from each participant prior to the interview.
Interviews were conducted using standardized qualitative research methods [11 , 12 (link)] and began with open-ended questions to ascertain participants’ experiences with RSV and its impact on their lives. These general questions were followed by targeted probes intended to evaluate the course of RSV symptoms and what symptoms were considered the most bothersome or concerning. Following this concept elicitation component, the draft RSV-iiiQ items were reviewed with participants for their input and endorsement of symptom and impact concepts included in the instrument. During this cognitive debriefing portion of the interview, participants were asked to “think aloud” by describing their thought processes as they reviewed the draft RSV-iiiQ items. Participants were also asked to provide feedback to confirm the relevance of each item and identify any problems with item wording or response options. Follow-up questions were also asked to help better understand how participants interpreted and responded to each of the draft RSV-iiiQ items.
All interviews were audio recorded, transcribed, and verified for accuracy. Analysis of the qualitative data was conducted using the typed transcripts, and detailed field notes were collected during the interviews. Thematic analysis was conducted through the identification of dominant concepts in each interview, which were compared across other interviews to generate themes or patterns in the ways participants described their experiences [12 (link)]. Participants also provided feedback on draft items. Results incorporated representative participant quotes, selected to illustrate participants’ perspectives using their own words. Concept saturation (i.e., the point at which no new information is captured [13 (link)]) was documented using a saturation grid.
Participants were recruited through the University of Michigan (in Ann Arbor, Michigan) and the Global Market Research Group (headquartered in Carlsbad, California). Prospectively identified participants were invited at the time of the study office visit. Clinical sites also reviewed medical records and, within 45 days of the date of diagnosis, invited patients with a positive RSV polymerase chain reaction (PCR) test. Retrospectively identified participants were invited to participate via telephone call or email. Study sites attempted to recruit participants as soon as possible after confirmation of an RSV diagnosis by PCR and when the patient self-reported feeling well enough to participate in the interview. Individuals were eligible to participate if they had acute RSV infection confirmed by a PCR assay within 45 days of being contacted to participate in the qualitative interview. Individuals were excluded if they presented with a comorbid respiratory condition, received supplemental oxygen therapy for a condition other than RSV, had chemotherapy administered in the previous 12 months, or received an investigational medicinal product in the previous 30 days. Informed consent was obtained from each participant prior to the interview.
Interviews were conducted using standardized qualitative research methods [11 , 12 (link)] and began with open-ended questions to ascertain participants’ experiences with RSV and its impact on their lives. These general questions were followed by targeted probes intended to evaluate the course of RSV symptoms and what symptoms were considered the most bothersome or concerning. Following this concept elicitation component, the draft RSV-iiiQ items were reviewed with participants for their input and endorsement of symptom and impact concepts included in the instrument. During this cognitive debriefing portion of the interview, participants were asked to “think aloud” by describing their thought processes as they reviewed the draft RSV-iiiQ items. Participants were also asked to provide feedback to confirm the relevance of each item and identify any problems with item wording or response options. Follow-up questions were also asked to help better understand how participants interpreted and responded to each of the draft RSV-iiiQ items.
All interviews were audio recorded, transcribed, and verified for accuracy. Analysis of the qualitative data was conducted using the typed transcripts, and detailed field notes were collected during the interviews. Thematic analysis was conducted through the identification of dominant concepts in each interview, which were compared across other interviews to generate themes or patterns in the ways participants described their experiences [12 (link)]. Participants also provided feedback on draft items. Results incorporated representative participant quotes, selected to illustrate participants’ perspectives using their own words. Concept saturation (i.e., the point at which no new information is captured [13 (link)]) was documented using a saturation grid.
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