Table 3 Cognitive Interview Recommendations by COA type
Process | Patient-reported outcome measure (PRO) | Observer-reported outcome measure (ObsRO) | Performance outcome measure (PerfO) | Clinician-reported outcome measure (ClinRO) |
|---|---|---|---|---|
Performing individual interviews with subjects to complete item-by-item cognitive debriefing of the COA translation | Yes | Yes | Yes (for patient-facing text contained within the PerfO measure) | Yes (for patient-facing text contained within the ClinRO measure) |
Interviewing in-country patients drawn from the target population | Yes | No | Yes (for patient-facing text contained within the PerfO measure) | Yes (for patient-facing text contained within the ClinRO measure) |
Interviewing native-speaking clinicians who specialize in the condition being studied | No | No | No | An acceptable but not mandatory approach. Clinician review of the text is an acceptable alternative. Interviews with clinicians may be useful in cases where complexity and content of the ClinRO measure presents a vulnerability to varied interpretations. |
Interviewing in-country observers of the patients drawn from the target population (patient not in the room during interview) | No | Yes | No | No |
Selection of interview subjects based on observer type (parent, caregiver, teacher) required as well as disease population | No | Yes, although selection of observers may vary depending on the type most likely to be included in future trials and their availability for such interviews. Flexibility is recommended. | No | No |
Pilot testing including patients performing specific tasks | No | No | Yes | No |