Validating copyrighted scales

One such instrument is the International Prostate Symptom Score (IPSS) which is commonly used to assess therapeutic efficacy of BPH therapy While the IPSS questionnaire is accepted as a critical component in BPH-LUTS research, the IPSS-Qo L and BII (assessments of symptom burden and impact) are less frequently used.In light of the need for a simple and easy-to-use validated questionnaire to assess patients' overall perception of their condition, the Patient's Global Impressions of Severity (PGI-S) and Patient's Global Impressions of Improvement (PGI-I) questionnaires were included in several tadalafil BPH-LUTS clinical studies conducted worldwide.In the next sections, we will explain our rationale for the new measure, describe its main components, which are derived from major theories of well-being [12, 13], and justify these components.The concept and measurement of well-being have been studied from various perspectives.The scale includes eleven items related to different domains of remembered well-being (general, hedonic, eudaimonic, and social well-being) and ten items related to experienced well-being (i.e., positive and negative emotional events that possibly happened the day before); the sum of these items produces a combined well-being index.A distinctive characteristic of this study is that to construct the scale, an initial pool of items, covering the remembered and experienced well-being domains, were subjected to a complete selection and validation process.

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Several validated questionnaires have been developed in collaboration with The American Urology Association (AUA) to assess the severity and treatment effect in men with BPH-LUTS.

The PGI-S and PGI-I respectively are 1-item questionnaires that ask an individual patient to rate the severity of a specific condition (single-state scales) at baseline and or to rate at endpoint the perceived change in his/her condition in response to therapy (transition scales).

The aim of this study was to provide evidence that supports the validity of these two 1-item questionnaires for LUTS suggestive of BPH by correlating them with other subjective and objective measures of symptom severity or changes in severity in tadalafil placebo-controlled studies.

**: p Asian: from the 2 studies conducted in Asia; Caucasian: from the 2 studies conducted outside Asia.

PGI-S: Patient Global Impression of Severity; IPSS: International Prostate Symptom Scores; IPSS Qo L: IPSS-Quality of Life (Qo L), BII – Benign Prostatic Hyperplasia Impact Index; Qmax: peak urine flow rate; LUTS: Lower Urinary Tract Symptoms; n: number of patients.

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