CHARACTERIZING THE PATIENT EXPERIENCE OF COGNITIVE IMPAIRMENT ASSOCIATED WITH BIPOLAR DISORDER: A QUALITATIVE INTERVIEW STUDY
Author(s)
Claudia Hastedt, Dr. phil.1, Simona Sgarbi, MSc2, Stella Karantzoulis, PhD3, Ashna Alladin, PhD4.
1Boehringer Ingelheim International GmbH, Ingelheim, Germany, 2IQVIA, Madrid, Spain, 3IQVIA, New York, NY, USA, 4IQVIA Commercial GmbH & Co. OHG, Munich, Germany.
1Boehringer Ingelheim International GmbH, Ingelheim, Germany, 2IQVIA, Madrid, Spain, 3IQVIA, New York, NY, USA, 4IQVIA Commercial GmbH & Co. OHG, Munich, Germany.
OBJECTIVES: People living with bipolar disorder (BD) can experience cognitive symptoms even in the stable (euthymic) phase of the disease. The objective of this study was to identify the most relevant and impactful concepts of cognitive impairment (CI), to support the selection / development of patient-centered clinical outcome assessments (COAs) for use in clinical trials.
METHODS: A non-interventional qualitative interview study was conducted in the United States. Adults living with BD with confirmed CI (based on clinician impression) associated with their BD (CIABD) and caregivers participated in semi-structured, one-to-one concept elicitation interviews exploring patient-reported and caregiver-observed symptoms, impacts, and patient experience with CIABD. Transcripts were analyzed using a combined deductive and inductive coding approach. Concept saturation was assessed across interview waves.
RESULTS: A total of 35 participants were interviewed (26 patients and 9 caregivers). Seven CI concepts were identified across six DSM‑5 neurocognitive domains: attention, executive functioning, memory, learning, language, social cognition, and perceptual motor function. Problems with attention and executive functioning were reported by all participants (100%), followed by language (89%) and memory (86%). Difficulties with attention - particularly concentration and sustained attention - were frequently described and rated as bothersome (mean rating 7/10). Participants reported that CI impacts multiple aspects of daily life, including day-to-day functioning, emotional wellbeing, work or school performance, and social relationships, highlighting the broad and multidimensional burden of CIABD. Caregivers reported similar observations and described additional impacts related to caregiving and their own emotional burden. Concept saturation was achieved for symptom and impact concepts .
CONCLUSIONS: This study provides novel patient-centered evidence for CIABD that described salient symptoms and impact domains relevant to those living with the condition. The findings support the evaluation of the most suitable COAs that reflect concepts that are relevant and meaningful to patients in line with patient-focused drug development efforts in CIABD.
METHODS: A non-interventional qualitative interview study was conducted in the United States. Adults living with BD with confirmed CI (based on clinician impression) associated with their BD (CIABD) and caregivers participated in semi-structured, one-to-one concept elicitation interviews exploring patient-reported and caregiver-observed symptoms, impacts, and patient experience with CIABD. Transcripts were analyzed using a combined deductive and inductive coding approach. Concept saturation was assessed across interview waves.
RESULTS: A total of 35 participants were interviewed (26 patients and 9 caregivers). Seven CI concepts were identified across six DSM‑5 neurocognitive domains: attention, executive functioning, memory, learning, language, social cognition, and perceptual motor function. Problems with attention and executive functioning were reported by all participants (100%), followed by language (89%) and memory (86%). Difficulties with attention - particularly concentration and sustained attention - were frequently described and rated as bothersome (mean rating 7/10). Participants reported that CI impacts multiple aspects of daily life, including day-to-day functioning, emotional wellbeing, work or school performance, and social relationships, highlighting the broad and multidimensional burden of CIABD. Caregivers reported similar observations and described additional impacts related to caregiving and their own emotional burden. Concept saturation was achieved for symptom and impact concepts .
CONCLUSIONS: This study provides novel patient-centered evidence for CIABD that described salient symptoms and impact domains relevant to those living with the condition. The findings support the evaluation of the most suitable COAs that reflect concepts that are relevant and meaningful to patients in line with patient-focused drug development efforts in CIABD.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
P1
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Mental Health (including addiction)