Development and validation of the BSP-BPH (Bononian Satisfaction Profile--Benign Prostatic Hyperplasia) a "disease-specific" questionnaire for the evaluation of health related quality of life in patients with benign prostatic hyperplasia

Abstract OBJECTIVES: Lower Urinary Tract Symptoms (LUTS) associated to Benign Prostatic Hyperplasia (BPH) are very common in middle aged and older men. Since BPH, and the related therapies have a significant impact on a patient's Quality of Life (QoL), the health related quality of life (HQoL) evaluation is becoming an important aspect to be considered. The present study deals with the development and validation of a BPH disease specific questionnaire (Bononian Satisfaction Profile - BSP-BPH), considering HQoL in patients seeking medical help for BPH. The innovation of this questionnaire is that the patients' scores achieved are related to their subjective satisfaction. MATERIALS AND METHODS: Questionnaire development: On the base of our previous experience with BSP-PC (a disease specific questionnaire assessing HQoL in prostate Cancer patients), of a careful review of other available instruments (SAT-P, SF-36, ICS-QoL, BPH-HqoL) and of three subsequent meetings with experts (10) and patients (20), we defined the ten life aspects mostly impaired by BPH. We created a first 72-item version of the BSP-BPH. Ten patients cross matched for age end education to our study population were asked to fill in the questionnaire. A 31 item questionnaire version, together with EuroQoL, an already generic validated instrument, was administered to 121 patients as well. Further meetings and statistical analysis defined the 18 items of the BSP- BPH. Questionnaire validation: the BSP-BPH was filled in by 435 patients enrolled in a campaign for detection of prostatic diseases held among the male population of Bologna. RESULTS: Questionnaire development: the participants' mean age was 63 years (N = 121); 47.1% had BPH. The 18 items were selected on the basis of the following criteria: a) r > 0.50, p < 0.05 (correlation test re-test); b) p < 0.05 (ANOVA presence vs absence of BPH); c) r > 0.50, p < 0.05 (correlation with EuroQol). Questionnaire validation: the participants' mean age was 63 years (N = 436). 16 patients with a history of neoplasia were excluded from our study. 21 were missing data. 45% of the sample had BPH. Principal component analysis identified 5 components: 1) satisfaction about sexual functionality (Cronbach alpha = 0.94); 2) satisfaction about social functionality (alpha = 0.80); 3) satisfaction about cognitive/emotional functionality (alpha = 0.82); 4) satisfaction about urinary functionality (alpha = 0.87); 5) satisfaction about physical functionality (alpha = 0.66); total Cronbach alpha was 0.88. CONCLUSIONS: The 18 items version of BSP-BPH questionnaire can be used as an instrument for HQoL evaluation in patients with BPH focusing on patients' subjective satisfaction. At the moment only the Italian version is available.