OBJECTIVES: The aim of our study was to construct the conceptual framework of the impact of ADPKD on patients to support the use or development of a HRQoL instrument in ADPKD. METHODS: Based on concepts identified from the literature and ADPKD physicians/researchers from North America, Europe, and Japan, patients were asked how ADPKD impacts their physical and social functioning, emotions, and urinary symptoms according to a pre-defined moderator guide.  Twenty focus groups (FGs) were conducted across 11 sites: three cities in North America (n=42), six cities in Europe (n=64), and two cities in Japan (n=11).  FGs were moderated by native speakers and overseen onsite by a US-based scientist.  A saturation table was developed to summarize concepts discussed in the FGs; saturation was achieved once no new concepts were identified.  Concepts were identified based on themes mentioned by ≥2 participants within a FG. RESULTS: Concepts generated from the literature and ADPKD physicians/researchers discussions were endorsed by ADPKD patients.  Agreement of concepts between genders across all countries was observed.  Twenty-eight concepts were identified and categorized into: Physical Impact (impact on work/housework, limited functioning with mild/moderate exertion, self-care, diminish sex/intimacy, pain/discomfort in extremities/core, pain affecting work/housework, pain occurring with activity, modifications in lifestyle), Emotional Impact (fatigue, depression, anxiety, guilt of passing it to children, acceptance/self-education), Urinary Concerns (urgency, frequency, nocturia).  Other concepts identified by patients include effect on diet, concern over body image, thirst, and disruption of social/leisure activities.  Fifty-seven percent of these concepts were identified in the first FG; 100% saturation was achieved in the fifth FG.   CONCLUSIONS: Identified concepts were universally applicable and their strength is evident by the achievement of complete saturation after 25% of the FGs.  The completion of this conceptual framework using an iterative process provides a strong basis to develop an ADPKD-specific HRQoL instrument.