Developing and validating the International Consultation on Incontinence Questionnaire bladder diary.

BACKGROUND Despite the common use of urinary diaries to assess lower urinary tract symptoms (LUTS), a standardised validated diary does not exist. OBJECTIVE To develop a validated urinary diary, using the psychometric validation protocol used in previous International Consultation on Incontinence Questionnaire (ICIQ) modules. DESIGN, SETTING, AND PARTICIPANTS We invited 400 consecutive patients attending the urology department for assessment of LUTS to complete a urinary diary (developed and validated for content in a previous study), and the ICIQ Male or Female LUTS questionnaire. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS To establish construct validity, the urinary diary was compared with known theories from published literature; to establish criterion validity, the diary was compared with questionnaire responses and/or urodynamic observations. Optimal diary duration was tested by comparing the 4-d diary against shorter durations. Patients completed a second diary after 2-3 wk for test-retest analysis, and a subset receiving sacral nerve stimulation completed the diary before and after treatment for analysis of responsiveness. A variety of statistical tests were used for different stages of the study. RESULTS AND LIMITATIONS The urinary diaries and ICIQ LUTS questionnaires were completed by 264 patients. Construct validity was established for two of three tested hypotheses. Criterion testing showed good agreement between questionnaire and diary recordings of nocturia (κ=0.653; p<0.001; 92.2%) and incontinence (κ=0.351; p<0.001; 64.5%), whereas good agreement (κ=0.378; p<0.001; 69.2%) was observed between urodynamically proven incontinence and diary reports (n=104). Diary recordings of urgency showed weak agreement with questionnaire responses (κ=-0.215; p<0.001; 36%) and urodynamic observations (κ=-0.105; p=0.256; 43.7%). The 3-d diary explained at least 94% of the total variance of the 4-d diary. A second diary for test-retest analysis was returned by 59 patients, demonstrating fair to excellent agreement (Spearman correlations: 0.49-0.88). Pre- and post-treatment analysis, on pilot testing, showed that the diary is responsive to change. CONCLUSIONS Using the ICIQ psychometric validation methodology, a bladder diary was developed for the assessment of LUTS and shown to be valid, reliable, and responsive to change. The 3-d diary has been accepted as the ICIQ bladder diary. PATIENT SUMMARY In this study, patients and clinicians developed and tested a diary in which patients can record their urinary symptoms. The resulting 3-d diary is called the ICIQ bladder diary and is available for adult men and women with urinary symptoms.