Construct validation of patient global impression of severity questionnaires in the treatment of men with lower urinary tract symptoms secondary to benign prostatic hyperplasia

Background Lower urinary tract symptoms (LUTS) in aging men are often associated with benign prostatic hyperplasia (BPH). While regulatory evaluations of treatment benefit require an assessment of specific symptoms, a simpler approach to measuring patients' perceptions of severity and symptom c...

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Bibliographic Details
Published in:BMC urology 2012-11, Vol.12
Main Authors: Viktrup, Lars, Hayes, Risa P, Wang, Ping, Shen, Wei
Format: Article
Language:English
Subjects:
Analysis
Care and treatment
Hypertrophy
Medical research
Medicine, Experimental
Prostate
Questionnaires
Renal manifestations of general diseases
Surveys
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Summary:Background Lower urinary tract symptoms (LUTS) in aging men are often associated with benign prostatic hyperplasia (BPH). While regulatory evaluations of treatment benefit require an assessment of specific symptoms, a simpler approach to measuring patients' perceptions of severity and symptom change may be particularly useful for clinical practice. The aim of this study was to provide evidence of the validity of the 1-item Patient Global Impression of Severity (PGI-S) and Improvement (PGI-I) questionnaires for use as outcome measures in the treatment of BPH-LUTS. Methods 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). Results 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
ISSN:1471-2490
1471-2490
DOI:10.1186/1471-2490-12-30