OBJECTIVE: The purpose of this study was to develop and test a unique, new pelvic floor surgery complication scale and compare it with an existing validated measure. STUDY DESIGN: Surgeons from 2 clinical trials networks rated complications based on perceived patient bother, severity, and duration of disability to develop a pelvic floor complication scale (PFCS). PFCS scores were calculated for subjects in 2 multicenter pelvic floor surgical trials. The PFCS and modified Clavien-Dindo scores were evaluated for associations with length of hospitalization, satisfaction, and quality-of-life measures (health utilities index, short form-36, urogenital distress inventory, and incontinence impact questionnaire). RESULTS: We calculated PFCS scores for 977 subjects. Higher PFCS and Clavien-Dindo scores similarly were associated with longer length of hospitalization (P < .01), lower satisfaction (P < .01), lower Health Utilities Index scores (P = .02), lower short form-36 scores (P = .02), higher urogenital distress Inventory scores (P < .01), and incontinence impact questionnaire scores (P < .01) at 3 months. No associations were present at 1 year. CONCLUSION: The PFCS compares favorably to the validated modified Clavien-Dindo instrument.
OBJECTIVE: The purpose of this study was to develop and test a unique, new pelvic floor surgery complication scale and compare it with an existing validated measure. STUDY DESIGN: Surgeons from 2 clinical trials networks rated complications based on perceived patient bother, severity, and duration of disability to develop a pelvic floor complication scale (PFCS). PFCS scores were calculated for subjects in 2 multicenter pelvic floor surgical trials. The PFCS and modified Clavien-Dindo scores were evaluated for associations with length of hospitalization, satisfaction, and quality-of-life measures (health utilities index, short form-36, urogenital distress inventory, and incontinence impact questionnaire). RESULTS: We calculated PFCS scores for 977 subjects. Higher PFCS and Clavien-Dindo scores similarly were associated with longer length of hospitalization (P < .01), lower satisfaction (P < .01), lower Health Utilities Index scores (P = .02), lower short form-36 scores (P = .02), higher urogenital distress Inventory scores (P < .01), and incontinence impact questionnaire scores (P < .01) at 3 months. No associations were present at 1 year. CONCLUSION: The PFCS compares favorably to the validated modified Clavien-Dindo instrument.
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