OBJECTIVES: To understand the patient/caregiver experience of participating in a clinical outcomes assessment (COA) qualitative interview study to inform future study design.

METHODS: Participants in COA studies in various diseases (e.g. inflammatory, infectious, rare), in the US, Germany, Japan and China, from 2018 to 2023 completed a brief, optional feedback form after their concept elicitation and/or cognitive debriefing interview. Free text questions were analyzed using qualitative content analysis and multiple-choice questions were analyzed descriptively.

RESULTS: Feedback forms from 106 patients (n=89) and caregivers (n=13 of children/adolescents; n=4 of adults) who participated in a remote (online/telephone; n=59) or face-to-face (n=47) interview lasting 90- (n=77), 75- (n=1) 60- (n=19), 45- (n=3) or 30-minutes (n=6) were analyzed.

Free-text responses indicated participants felt positive about their overall interview experience. The invitation and interview processes were described as good, easy, comfortable and professional; some participants commended their interviewer for being considerate in handling sensitive topics. Positive feelings and nervousness or curiosity were felt before participation and, afterwards, participants felt happy to have contributed to research. Problems and suggestions for improvements were few and varied but predominantly related to methodology (e.g. less repetition, technical difficulties with video conferencing) and accommodations for children (e.g. simplifying questions).

Multiple-choice responses revealed that participants felt their interview format and length was appropriate (88% and 80%, respectively). Participants would most like to be interviewed by a researcher (56%) over their doctor/nurse or a patient/caregiver peer (1-8%) or had no interviewer preference (31%). Most (76%) participants reported being very likely to participate in other research interviews based on their experience.

CONCLUSIONS: Participants were happy with their interview and valued contributing to research. Additional explanation regarding COA interview methodology (e.g. importance of item-by-item debriefing and thus the potential for repetitive questioning) and mitigating potential remote interview technical difficulties may be beneficial and appreciated.