ABSTRACT
BACKGROUND: The availability of a number of agents that are efficacious in patients with metastatic prostate cancer (mPC) has led to them being used sequentially, and this has prolonged patient survival. However, in order to maximize their efficacy, clinicians need to be able to obtain a reliable picture of disease evolution by means of monitoring procedures. METHODS: As the intensive monitoring protocols used in pivotal trials cannot be adopted in everyday clinical practice and there is no agreement among the available guidelines, a multidisciplinary panel of Italian experts met to develop recommendations for monitoring mPC patients using a modified Delphi method. RESULTS: The consensus project considered methods of clinically, radiographically, and biochemically monitoring patients with metastatic hormone-sensitive and metastatic castration-resistant prostate cancer undergoing chemotherapy and/or hormonal treatment. The panelists also considered the methods and timing of monitoring castration levels, bone health, and the metabolic syndrome during androgen deprivation therapy. CONCLUSIONS: The recommendations, which were drawn up by experts following a formal and validated consensus procedure, will help clinicians face the everyday challenges of monitoring metastatic prostate cancer patients.
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.
Subject(s)
Prostatic Hyperplasia , Quality of Life , Surveys and Questionnaires , Humans , Male , Middle Aged , Patient Satisfaction , Prostatic Hyperplasia/complications , Sickness Impact ProfileABSTRACT
OBJECTIVES: Prostate cancer (PC) is the most common neoplasia in men over 50 years of age in western countries. Nowadays, since there are several alternative medical-surgical treatments for this cancer, health-related quality of life (HQoL) evaluation has become very important. The present study deals with the development and the validation of a questionnaire (BSP-PC), considering the HQoL in prostate cancer patients. The BSP-PC items are mainly related to the subjects' satisfaction. As far as we know, it does not exist any disease specific instrument based on such aspect. MATERIALS AND METHODS: Questionnaire development: During three different meetings, with ten experts and twenty patients, we have defined the life aspects which are the most affected by prostate cancer. Subsequently we have created a first 40-item version of the BSP-PC. Patients were asked to fill in this particular questionnaire in addition to a generic and validated one (the EuroQol). A final 24 item questionnaire version, was finally achieved by other statistical analysis and meetings with experts. Questionnaire validation: the BSP-PC was filled in by 261 patients divided into 3 groups: "healthy" (57), "prostate cancer" (103), "other diseases" (100). RESULTS: Questionnaire development: participants' mean age was 59 years (N=71); 46% had prostate cancer, while 53% of the sample did not report notable diseases. The 24 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 PC), c) r>0.50, p<0.05 (correlation with EuroQol). Questionnaire validation: participants' mean age was 68 years (N=261). Four factors were identified: 1) satisfaction about physical functionality (Crombach alpha=0.95), 2) satisfaction about sexual functionality (alpha=0.94), 3) satisfaction about social functionality (alpha=0.77), 4) satisfaction about urinary functionality (alpha=0.89); total Crombach alpha was 0.94. CONCLUSIONS: The BSP-PC questionnaire can be used as an instrument in the evaluation of HQoL in PC patients by principally considering their subjective satisfaction.
