Cognitive debriefing and content validation of patient-reported outcomes measurement information system cognitive function abilities-subset short form 6a Version 2.0 (PROMIS-CF)

One Sentence Summary: This qualitative study provides evidence of the content validity of the Patient-Reported Outcomes Measurement Information System® v2.0 Cognitive Function Abilities Short Form 6a (PROMIS-CF-SF6a) in adults with migraine and establishes patient-defined meaningful change thresholds, supporting its use in clinical trials in migraine to measure treatment-related changes in cognitive function. Background: Cognitive dysfunction, including reduced mental acuity, concentration, and memory, is a common symptom associated with migraine attacks. The PROMIS-CF-SF6a evaluates positive selfassessments of 6 cognitive functioning concepts over a 7-day recall period, utilizing a 5-point scale ranging from “Not at all” to “Very much”. This study evaluated the content validity of the PROMIS-CF-SF6a in adults with migraine through cognitive debriefing interviews, assessing its suitability for measuring cognitive function in the target population and the potential impact of migraine treatment. It also aimed to establish patient-defined meaningful change thresholds to complement statistical methods and enhance the interpretability of clinical trial results. Methods: U.S. adults with self-reported migraine headache frequency of ≥ 4 attacks per month were recruited through an online research platform. Semi-structured interviews queried the interpretability, clarity, and relevance of the PROMIS-CF-SF6a. Participants were also asked to define the smallest item-level change they considered meaningful improvement. Results are reported for all participants with evaluable data. Results: A total of 40 participants (mean age 43.1 years; 87.5% [35/40] female) were included (Table 1) completed study interviews. At least 92.3% (36/39) of participants interpreted all 6 items as intended, and at least 85.3% (29/34) found each item clear. All participants (38/38) understood the 7-day recall period as intended. Most participants 90.6% (29/32) interpreted each response option as intended, and at least 81.5% (22/27) found them clear. For all PROMIS-CF-SF6a items, at least 92.1% (35/38) reported experiencing each concept (Table 2). Most participants considered a 1-point improvement per item to be meaningful. Conclusion: These qualitative data support the content validity of the PROMIS-CF-SF6a in adults with migraine and suggest it may be fit for purpose to measure cognitive function in a clinical trial setting. A participant-defined 1-point item-level improvement was widely considered meaningful, offering a practical threshold that can complement those derived from statistical methods (eg, anchor-based and distribution-based analyses). a Three participants identified as American Indian or Alaska Native and White. b Participant selected other and specified: “unsure.” Of note, this participant also selected White. c Participants selected other specified: “some grad school” (n= 1) and “J.D. (law school)” (n=1 ). n, number of responders; N, total sample size; SD, standard deviation.