The clinical validation of a new short faecal measure for epidemiological and outcomes research (poster)
Hypothesis / aims of study
The Revised Faecal Incontinence Scale (RFIS) contains three items from the Wexner Faecal Continence Grading Scale (WFCGS) and two other faecal incontinence items (1). All items were administered in a large community survey (N=2915) (2).
The community survey data indicated the internal consistency reliability of the RFIS = 0.85 and the RFIS had superior measurement properties compared with the WFCGS (2). This suggested the RFIS would be useful for evaluation and epidemiological research but further validation would be required in clinical settings. This study reports an interim validation of the RFIS in clinical settings for incontinence treatment.
Study design, materials and methods
Patients were recruited consecutively from 11 continence clinics (specialist and community) across 4 Australian States. The study examined clinical and patient definitions of incontinence status, treatment outcomes and success across 4 treatment types (Continence Advising, Physiotherapy, Surgery and Combined Treatments).
Based on baseline (recruitment, pre-treatment) and follow up (3 months post treatment), and an assumed effect size of 0.5 on the RFIS, where the test size was 0.05, power set at 0.80, the calculated sample size was 84 cases. This paper reports an interim analysis on the first 56 cases with complete baseline data and 27 faecal incontinence participants with full data (pre-post) available.
The study protocols contain the RFIS, other urinary incontinence items and questionnaires (e.g. WFCGS; St Marks (3)), incontinence impact and health related quality of life measures, and patient global ratings of severity and improvement.
Baseline: for all 56 cases the mean RFIS score was 9.59 (SD = 4.94). When examined by patient rating of the severity of faecal incontinence the means for those in a normal/mild state 7.14 (SD = 4.00, N = 22) and for those with moderate/severe incontinence 11.38 (SD = 4.88, N = 32) (F = 11.32, df = 1, 52, p<0.01). When examined by a general item on health status there were no significant differences between those in Excellent/Very Good, Good, or Fair/Poor Health; similarly there were no statistically significant associations by gender, education level, age group or BMI.
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