Comparison of physician and patient assessments of incontinence severity and improvement.

Compare the subjective and objective assessment of stress urinary incontinence (SUI) severity and improvement with treatment using patient- and clinician-rated global impression of severity (PGI-S, CGI-S) and improvement (PGI-I, CGI-I) scales. Five hundred fifty-three women with mild SUI were recruited via media advertising into a placebo-controlled duloxetine trial. PGI-S and CGI-S (normal, mild, moderate, severe) were administered at baseline and PGI-I and CGI-I (seven responses from "very much worse" to "very much better") during treatment. Incontinence episode frequency (IEF) was determined from diaries. Agreements between clinician and patient ratings were assessed using Kappa and degree of association with Spearman's correlation. There was only a slight agreement regarding severity, with 53% of ratings being different (Kappa = 0.14; 95%CI = 0.08, 0.20). When ratings differed, clinicians rated severity worse in 72% of cases than did patients. Agreement regarding improvement was moderate, with 42% of ratings being different (Kappa = 0.45; 95%CI = 0.39, 0.50). When ratings differed, clinicians rated improvement greater than did patients in 54% of cases. Patients' assessments of severity correlated better with IEF (0.33) than did the clinicians' (0.15). The correlations of PGI-I and CGI-I with IEF changes were similar (0.46 and 0.44). In this study, the subjective (patient) and objective (clinician) assessments of SUI improvement with treatment appear to be more closely aligned than are the assessments of initial SUI severity.

RCT Entities:   Population Interventions Outcomes