The psychometric validation of a US English satisfaction measure for patients with benign prostatic hyperplasia and lowe
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BioMed Central
Open Access
Research
The psychometric validation of a US English satisfaction measure for patients with benign prostatic hyperplasia and lower urinary tract symptoms Libby Black*1, Alyson Grove2 and Betsy Morrill1 Address: 1GlaxoSmithKline, Research Triangle Park, NC, USA and 2Roundpeg Research, Abingdon, Oxon, UK Email: Libby Black* - [email protected]; Alyson Grove - [email protected]; Betsy Morrill - [email protected] * Corresponding author
Published: 19 June 2009 Health and Quality of Life Outcomes 2009, 7:55
doi:10.1186/1477-7525-7-55
Received: 20 August 2008 Accepted: 19 June 2009
This article is available from: http://www.hqlo.com/content/7/1/55 © 2009 Black et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract Background: The purpose of the current study was to validate the US English Patient Perception of Study Medication (PPSM) questionnaire, which measures patient satisfaction with Benign Prostatic Hyperplasia (BPH) treatment and was administered to men with BPH lower urinary tract symptoms (LUTS) enrolled in a multi-national clinical trial. Methods: Patients with moderate to severe BPH symptoms completed three disease-specific measures: The International Prostate Symptom Score (IPSS), the BPH Impact Index (BII) and the PPSM, at baseline (after completion of the placebo run-in period) and at every 13-week clinic visit thereafter for the duration of the study treatment period. The PPSM was analysed to assess its variability, reliability and validity. Results: There were 879 patients included in the analyses, with a mean age of 66.7 years. The PPSM was found to comprise two factors – PPSM-Global and PPSM-Pain, with a Total Score ranging from 7 to 49. It demonstrated good internal consistency (Cronbach's alpha ranged from .95 to .97) and also demonstrated convergent validity through significant correlations with the IPSS (.48 to .58), IPSS Quality of Life (QoL) item (.41 to .63) and BII (.31 to .45) and known-groups validity against the IPSS, IPSS QoL item and BII. Conclusion: Results support the use of the PPSM as a measure of satisfaction in BPH patient groups.
Background Benign Prostatic Hyperplasia (BPH) is the most common benign neoplasm in the ageing male population with pathological changes found in 88% of men in their ninth decade and symptoms reported in nearly 50% of men aged ≥ 50 years in the general population [1]. The known proximal cause of BPH is age-related prostate growth that is stimulated primarily by the presence of dihydrotesto-
sterone (DHT). DHT is formed when testosterone is reduced through the activity of the 5 α-reductase enzymes type 1 and type 2, although type 2 is considered primarily responsible for this conversion in the prostate. Prostatic growth may lead to urethral
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