By Joanna Lyford, Senior medwireNews Reporter
UK researchers in collaboration with patients and clinicians have developed a new diary to be used to record lower urinary tract symptoms (LUTS).
The so-called International Consultations on Incontinence Questionnaire (ICIQ) Bladder Diary is designed to be used by adult men and women and has been shown to be valid and responsive to changes in symptoms.
The ICIQ Bladder Diary was developed by Elizabeth Bright (Bristol Urological Institute, Southmead Hospital) and colleagues, who have previously reported the initial phase of data-gathering and testing of different versions of the diary.
In this paper, they describe further validation of the diary using the psychometric validation protocol required by regulatory authorities; this encompasses tests of construct validity, criterion validity, reliability, responsiveness and optimum diary duration.
The researchers recruited 400 consecutive patients attending either the urodynamic or the uroflowmetry clinic, all of whom completed the diary and a gender-specific LUTS questionnaire prior to attendance. In all, 264 (66%) patients returned a completed diary; their mean age was 60.5 years and there were 123 women.
In terms of construct validity, significantly more women than men reported urinary incontinence and patients reporting nocturia were significantly older than their non-nocturic counterparts. The expected increase in the prevalence of incontinence with age was not seen, however, with an odds ratio of 1.0036 per 1-year increment.
There was a strong statistical association between diary and questionnaire responses with regard to nocturia, and weak but significant correlations for incontinence and urgency.
The entire 4-day diary was completed by 81% of patients. The first 3 days, 2 days and 1 day explained at least 94%, 88%, and 71% of the total variance of the 4-day diary, respectively. Noting that the 3-day diary was “almost as reliable” as the 4-day version, as well as reducing patient burden, the researchers say that the shorter version appears “optimal” and is recommended for future use.
With regard to reliability, levels of test–retest agreement varied from fair to excellent for bladder sensation, urgency and incontinence. In all, 20 patients underwent sacral nerve stimulation; diary scores revealed a statistically significant reduction in 24-hour frequency, daytime frequency, nocturia and incontinence episodes after treatment.
Writing in European Urology, Bright and co-authors say: “The inclusion of the diary in current national research studies will provide ongoing evidence of validation, as well as the external validity of the diary.”
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