%0 Journal Article
%T Construct validation of patient global impression of severity (PGI-S) and improvement (PGI-I) questionnaires in the treatment of men with lower urinary tract symptoms secondary to benign prostatic hyperplasia
%A Lars Viktrup
%A Risa P Hayes
%A Ping Wang
%A Wei Shen
%J BMC Urology
%D 2012
%I BioMed Central
%R 10.1186/1471-2490-12-30
%X This was a secondary analysis of data from 4 randomized placebo-controlled 12-week trials evaluating tadalafil for the treatment of BPH-LUTS (N=1694). Visit 2 (V2 [beginning of a 4-week placebo lead-in period]) and endpoint assessments included International Prostate Symptom Score (IPSS), IPSS Quality of Life Index (IPSS-QoL), BPH Impact Index (BII), and peak urine flow (Qmax). PGI-S was only administered at V2 and PGI-I only at endpoint. Associations between the PGI-S or the PGI-I and the other assessments were analyzed by calculating Spearman rank correlation coefficients and performing analysis of variance (ANOVA).Spearman correlation coefficients were 0.43, 0.43, 0.53, and £¿0.09, between the PGI-S and IPSS, IPSS-QoL, BII, and Qmax baseline results (all P<0.001). Similar results were seen across race, ethnicity, and baseline severity (moderate LUTS versus severe LUTS). IPSS, IPSS-QoL, BII baseline scores (P <0.001) and Qmax values (P=0.003) were significantly different among the 4 PGI-S severity levels. Spearman correlation coefficients were 0.56, 0.53, 0.47 and £¿0.15 between the PGI-I and change in IPSS, IPSS-QoL, BII scores, and Qmax values from baseline to endpoint (all P<0.001). Similar results were seen across race, ethnicity, and baseline severity. Change in IPSS, IPSS-QoL, BII scores, and Qmax values (P<0.001) were significantly different among the PGI-I levels (i.e., patient perception of change in urinary symptoms).This study demonstrated patients¡¯ overall perceptions of their severity and change in BPH-LUTS can be captured in a way that is simple, valid, and easily administered in a research setting or clinical practice. Clinical parameters are weakly associated with patients¡¯ perception of urinary symptoms, emphasizing the importance of a patient-reported assessment in the evaluation of BPH-LUTS treatment benefit.Lower urinary tract symptoms (LUTS), often associated with benign prostatic hyperplasia (BPH), are common in aging men worldwide with a sever
%K Patient global impression scale
%K Lower urinary tract symptoms
%K Construct validity
%U http://www.biomedcentral.com/1471-2490/12/30