DEVELOPING A PATIENT-REPORTED OUTCOME (PRO) MEASURE FOR JAPANESE PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER (NMCRPC)
Author(s)
Kazuo Nishimura, MD, PhD1, Takahiro Kimura, MD, PhD2, Dianne Athene Ledesma, MPH, PhD, MD3, Jessica Smith, MA4, Ana Martinez, MPH4, Laura DiGiovanni, MA4, Naoyuki Mita, MPH3;
1Osaka International Cancer Institute, Osaka, Japan, 2The Jikei University School of Medicine, Tokyo, Japan, 3Bayer Yakuhin, Ltd., Tokyo, Japan, 4OPEN Health, New York, NY, USA
1Osaka International Cancer Institute, Osaka, Japan, 2The Jikei University School of Medicine, Tokyo, Japan, 3Bayer Yakuhin, Ltd., Tokyo, Japan, 4OPEN Health, New York, NY, USA
OBJECTIVES: To develop a new PRO with potential utility in clinical practice among Japanese urologists to better assess the effects of nmCRPC and treatment and for patients to better understand their health-related quality of life (HRQOL).
METHODS: Cognitive debriefing interviews were conducted in Japanese with 19 nmCRPC patients (median age [range]: 77 [70-93] years) to assess patient comprehension, perceived relevance, and appropriateness of a 14-item draft PRO instrument and 12-item checklist across 4 iterative waves of interviews. All interviews were recorded, transcribed, and coded for analysis using ATLAS.ti.
RESULTS: The draft PRO instructions were well understood (overall comprehension rate: 89%). Participants reported minimal difficulty with the 7-day recall period. Comprehension of individual items was high (84%-100%). Participants reported minimal difficulty in answering most items. Item 5 (sexual function) posed challenges in Waves 1-3 for participants experiencing a total loss of sexual function, but this was resolved with refined response options in Wave 4. The most reported symptoms were urinary frequency (UF)-waking hours (100%; relevance: 79%) and -night (89%; relevance: 74%) and difficulty urinating (89%; relevance: 74%). All 14 draft PRO items were retained across symptoms (Pain, Hot flashes/unexpected sweating, Fatigue/tiredness, Leg weakness, Sexual function, Difficulty urinating, UF-waking hours, UF-night, Urinary incontinence) and impacts (Worry, UF-impact on activities, Sleep difficulty, Social relationships, Leisure activities). The final checklist retained items that were commonly reported and considered relevant by participants: Loose stools/diarrhea, Constipation, Thoughts of death or dying, Uncertainty related to PC progression, Use of incontinence pads or adult diapers, and Changes in weight.
CONCLUSIONS: The study results support the content validity of the draft PRO, which captures key symptoms, impacts, and HRQOL aspects relevant to Japanese nmCRPC patients. The findings support integration into clinical settings to enhance patient-centered evaluation of nmCRPC and patient-clinician communication.
METHODS: Cognitive debriefing interviews were conducted in Japanese with 19 nmCRPC patients (median age [range]: 77 [70-93] years) to assess patient comprehension, perceived relevance, and appropriateness of a 14-item draft PRO instrument and 12-item checklist across 4 iterative waves of interviews. All interviews were recorded, transcribed, and coded for analysis using ATLAS.ti.
RESULTS: The draft PRO instructions were well understood (overall comprehension rate: 89%). Participants reported minimal difficulty with the 7-day recall period. Comprehension of individual items was high (84%-100%). Participants reported minimal difficulty in answering most items. Item 5 (sexual function) posed challenges in Waves 1-3 for participants experiencing a total loss of sexual function, but this was resolved with refined response options in Wave 4. The most reported symptoms were urinary frequency (UF)-waking hours (100%; relevance: 79%) and -night (89%; relevance: 74%) and difficulty urinating (89%; relevance: 74%). All 14 draft PRO items were retained across symptoms (Pain, Hot flashes/unexpected sweating, Fatigue/tiredness, Leg weakness, Sexual function, Difficulty urinating, UF-waking hours, UF-night, Urinary incontinence) and impacts (Worry, UF-impact on activities, Sleep difficulty, Social relationships, Leisure activities). The final checklist retained items that were commonly reported and considered relevant by participants: Loose stools/diarrhea, Constipation, Thoughts of death or dying, Uncertainty related to PC progression, Use of incontinence pads or adult diapers, and Changes in weight.
CONCLUSIONS: The study results support the content validity of the draft PRO, which captures key symptoms, impacts, and HRQOL aspects relevant to Japanese nmCRPC patients. The findings support integration into clinical settings to enhance patient-centered evaluation of nmCRPC and patient-clinician communication.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PCR56
Topic
Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Oncology