@article{74048f28ae4346cdb28f4117cf3e8d13,
title = "Relationships among participant international prostate symptom score, benign prostatic hyperplasia impact index changes and global ratings of change in a trial of phytotherapy in men with lower urinary tract symptoms",
abstract = "Purpose: We related changes in American Urological Association symptom index scores with bother measures and global ratings of change in men with lower urinary tract symptoms who were enrolled in a saw palmetto trial. Materials and Methods: To be eligible for study men were 45 years old or older, and had a peak uroflow of 4 ml per second or greater and an American Urological Association symptom index score of 8 to 24. Participants self-administered the American Urological Association symptom index, International Prostate Symptom Score quality of life item, Benign Prostatic Hyperplasia Impact Index and 2 global change questions at baseline, and at 24, 48 and 72 weeks. Results: In 357 participants global ratings of a little better were associated with a mean decrease in American Urological Association symptom index scores from 2.8 to 4.1 points across 3 time points. The analogous range for mean decreases in Benign Prostatic Hyperplasia Impact Index scores was 1.0 to 1.7 points and for the International Prostate Symptom Score quality of life item it was 0.5 to 0.8 points. At 72 weeks for the first global change question each change measure discriminated between participants who rated themselves at least a little better vs unchanged or worse 70% to 72% of the time. A multivariate model increased discrimination to 77%. For the second global change question each change measure correctly discriminated ratings of at least a little better vs unchanged or worse 69% to 74% of the time and a multivariate model increased discrimination to 79%. Conclusions: Changes in American Urological Association symptom index scores could discriminate between participants rating themselves at least a little better vs unchanged or worse. Our findings support the practice of powering studies to detect group mean differences in American Urological Association symptom index scores of at least 3 points.",
keywords = "health status index, lower urinary tract symptoms, prostate, prostatic hyperplasia, psychometrics",
author = "Barry, {Michael J.} and Alan Cantor and Claus Roehrborn",
note = "Funding Information: Dr. Michael J. Barry, steering committee chair, Massachusetts General Hospital; Dr. O. Dale Williams, director, Dr. Sreeletha Meleth, associate director and Dr. Alan Cantor, Data Coordinating Center, University of Alabama at Birmingham; clinical sites: Dr. Andrew McCullough, principal investigator (through December 3, 2010), Dr. Christopher Kelly, principal investigator (as of December 3, 2010), Brianne Goodwin and Laurie Mantor, study coordinators, and Artrit Butuci, research data associate, New York University; Drs. Andrew L. Avins and Harley Goldberg, co-investigators, Luisa Hamilton, study coordinator and Cynthia Huynh, research associate, Northern California Kaiser Permanente; Dr. Kevin T. McVary, principal investigator, Dr. Robert Brannigan, co-investigator, Dr. Brian Helfand, consultant, Maria Velez, study coordinator and Nancy Schoenecker, clinical research coordinator, Northwestern University Feinberg School of Medicine; Dr. J. Curtis Nickel, principal investigator, Alvaro Morales and Dr. D. Robert Siemens, co-investigators, and Joe Downey and Janet Clark-Pereira, study coordinators, Queens University; Dr. E. David Crawford, principal investigator, Drs. Shandra S. Wilson and Paul D. Maroni, co-investigators, and Patricia DeVore and Cliff Jones, clinical research coordinators, University of Colorado-Denver; Dr. Karl J. Kreder, principal investigator, Dr. Victoria Sharp, co-investigator, and Diane Meyerholz and Mary Eno, study coordinators, University of Iowa; Dr. Michael J. Naslund, principal investigator and Ganine Markowitz-Chrystal, study coordinator, University of Maryland; Dr. Claus G. Roehrborn, principal investigator, Brad Hornberger, co-investigator, Allison Beaver, study coordinator and Suzie Carter, data manager, University of Texas Southwestern Medical Center; Dr. Gerald L. Andriole, principal investigator, Vivien Gardner, study coordinator and Karen Whitmore, supervisor patient services, Washington University School of Medicine; Dr. Steven A. Kaplan, principal investigator, Dr. Alexis E. Te, co-investigator, Noreen Buckley, study coordinator and Maritza Rodriquez, medical assistant, Weill Cornell Medical College; Dr. Harris E. Foster, Jr., principal investigator, Dr. John W. Colberg, co-investigator and Karen Stavris, study coordinator, Yale University School of Medicine; biostatistics consultant: Dr. Jeannette Y. Lee, University of Arkansas for Medical Sciences; National Institutes of Health: Drs. John W. Kusek and Leroy M. Nyberg, (through September 2, 2009), National Institute of Diabetes, Digestive and Kidney Diseases; Dr. Catherine M. Meyers, National Center for Complementary and Alternative Medicine; Dr. Joseph M. Betz, Office of Dietary Supplements; and Data Safety Monitoring Board: Dr. Timothy J. Wilt, chair, University of Minnesota Veterans Affairs Medical Center; Dr. Harry H.S. Fong, University of Illinois at Chicago; Dr. Glenn S. Gerber, University of Chicago; Dr. Mikel Gray, University of Virginia; Dr. Freddie Ann Hoffman, HeteroGeneity LLC; Dr. Gary Koch, University of North Carolina; Dr. Mark Litwin, University of California-Los Angeles; Dr. Warren E. Lux, United States Environmental Protection Agency; Dr. Michael P. O'Leary, Harvard Medical School; Col (Ret.) James E. Williams, Jr., Intercultural Cancer Council; and Dr. Domenic Reda, Hines Veterans Affairs Hospital Cooperative Studies Program Coordinating Center. ",
year = "2013",
month = mar,
doi = "10.1016/j.juro.2012.08.257",
language = "English (US)",
volume = "189",
pages = "987--992",
journal = "Journal of Urology",
issn = "0022-5347",
publisher = "Elsevier Inc.",
number = "3",
}