IMPROVED SEVERITY AND QUALITY-OF-LIFE MEASURES FOR FECAL INCONTINENCE: DEVELOPMENT OF THE MINNESOTA (MiNi)-FISI AND MiNi-FI-QOL.

BACKGROUND AND AIMS: Among patients with fecal incontinence (FI), the 29-item quality-of-life (FI-QoL) instrument is widely used but lengthy and only modestly correlated with symptom severity. We devised and evaluated revised symptom severity and FI-QoL instruments. METHODS: Among 822 individuals with FI from a multicenter FI-QoL cohort (n=118), community (n=170), pelvic floor clinic (n=423), and clinical trials (n=111), FI severity was assessed using the Fecal Incontinence Severity Index (FISI), the Fecal Incontinence Symptom Severity scale, and a derived combined instrument, the Minnesota FISI (MiNi-FISI). FI specific-QoL was assessed with the 29-item FI-QoL, a new Minnesota FI-QoL (MiNi-FI-QoL) and SF-36 instruments. Associations between FI severity and QoL and the validity of the MiNi-FI-QoL were examined; findings were validated in a separate trial (n=260). RESULTS: Among 1082 patients, FI symptoms and QoL impact were worse in clinic and trial patients than community participants (P<.001). FISI scores explained 26% of FI-QoL variance, increasing to 60% when staying near a toilet to prevent FI was included (P<.001). For a given FISI score, FI-QoL declined as time spent near a toilet increased. Iterative reduction yielded a new 11-item Minnesota (MiNi) FI-QoL score, which captured 97% of the variance in the 29-item FI-QoL and correlated with SF36 scores. A revised 7-item Minnesota FISI (MiNi-FISI) explained 46% of FI-QoL variance vs 36% for the original FISI. CONCLUSIONS: The MiNi-FISI and MiNi-FI-QoL are concise, psychometrically derived short forms with strong performance across diverse cohorts. Further validation, including direct patient input to confirm content validity, is warranted.