The PKD Daily: Development and Content Validation of a Hybrid Diary for Tracking Urinary Events in Adults with...

For patients with autosomal dominant polycystic kidney disease (ADPKD), the only approved treatment is tolvaptan, a twice-daily medication that works to slow kidney function decline. Patients on tolvaptan report a considerable burden related to the drug's aquaretic effects which can intensify immediately following a dose of the medication.

A targeted literature review and individual concept elicitation (CE) interviews with nephrologists and adult patients with ADPKD taking tolvaptan were conducted to inform the development of a hybrid diary, programmed as a smartphone application. A sample of adults with ADPKD taking tolvaptan tested the diary for 7 days; a subset also participated in cognitive debriefing (CD) interviews. The diary was then revised and finalized.

CE interviews confirmed the importance of tracking urinary frequency and urgency and timing of tolvaptan doses in real time. Results from the usability/feasibility test and CD interviews confirmed the understandability and relevance of the diary and provided critical insights to improve its content and functionality. The resulting PKD Daily includes two daily entries to report dose timing, overnight urination, and daily impacts of frequent/urgent urination; real-time entries to capture frequency/urgency of daytime urination; and reminders to encourage regular data entry.

Originally developed for use in a clinical trial, the PKD Daily can also provide valuable information to clinicians and patients to support treatment decisions and inform dose selection in clinical practice, becoming a valuable part of a clinician's toolbox. Further, the development of the PKD Daily can serve as a case study for the successful creation of a hybrid diary.