Developing a validated urinary diary: phase 1.

AIMS: To develop and validate a urinary diary, using the psychometric validation protocol applied to all International Consultation on Incontinence Questionnaire (ICIQ) modules.
METHODS: Patient and clinician opinion was sought on diary content, format, and duration using interviews and questionnaires. Content deemed essential for inclusion were incorporated into four draft diary formats (Phase 1a). Four rounds of content validation using patient-completed diaries or patient interviews and one round of clinician opinion were undertaken, before a consensus was achieved (Phase 1b).
RESULTS: Phase 1a: 27 patients were interviewed and 30 clinicians returned a questionnaire regarding diary content, format and duration. Content deemed essential for inclusion was identified. Patients reported no format preference but preferred a diary of ≤7 days. Clinicians preferred a 3-day diary in single sheet format. Phase 1b: 75 of 200 (37.5%) patients returned completed draft diaries. Equal preference for the two portrait format diaries was expressed. Twenty-six clinicians returned a questionnaire regarding their preference for either of these two options, with 69% (18/26) selecting the one with a printed 24-hr clock. Optimal diary duration was 4 days. Frequency, voided volume, fluid intake (amount, time and type), time of incontinence episode, and bladder sensation were supported for inclusion in the final diary.
CONCLUSIONS: Diary content, format, and duration deemed essential by both patients and clinicians have been identified in this preliminary phase, allowing the formation of a draft urinary diary. Further tests of diary validity, reliability and responsiveness will be evaluated in Phase 2 of the study.