Zobrazeno 1 - 10
of 80
pro vyhledávání: '"Margaret, Rothman"'
Publikováno v:
Value in Health. 18(1):1-4
We report a panel designed to open a dialog between pharmaceutical sponsors, regulatory reviewers, and other stakeholders regarding the use of social media to collect data to support the content validity of patient-reported outcome instruments in the
Autor:
Scott North, J.S. de Bono, C. M. Haqq, Cora N. Sternberg, Yanni Hao, Karim Fizazi, Dennis D. Gagnon, Margaret Rothman, Thian Kheoh, Howard I. Scher, Charles S. Cleeland, Arturo Molina, Paul N. Mainwaring
Publikováno v:
Annals of Oncology. 24:1017-1025
Fatigue is a common, debilitating side-effect of prostate cancer and its treatment. Patient-reported fatigue was evaluated as part of COU-AA-301, a randomized, placebo-controlled, phase III trial of abiraterone acetate and prednisone versus placebo a
Autor:
Joseph W. Aquilina, Fisseha Tesfaye, Raymond C. Rosen, Stanley E. Althof, Gerald B. Brock, David L. Rowland, Scott Bull, Margaret Rothman
Publikováno v:
The Journal of Sexual Medicine. 7:2243-2252
Introduction The Clinical Global Impression of Change (CGIC) measures have high utility in clinical practice. However, it is unknown whether the CGIC is valued for assessing premature ejaculation (PE) symptoms and/or the relationship between CGIC and
Autor:
Margaret Rothman, Pierluigi Morosini, Donald L. Patrick, Tom Burns, Dennis D. Gagnon, Ines Adriaenssen
Publikováno v:
Clinical Therapeutics. 32:275-292
BACKGROUND: The safety and efficacy of paliperidone extended-release tablets (paliperidone ER) in patients with acute symptoms of schizophrenia have been described in 3 randomized, double-blind, 6-week, placebo-controlled, fixed-dose, Phase III clini
Autor:
Fisseha Tesfaye, Joseph W. Aquilina, Margaret Rothman, Chin-pao Chang, Chris McMahon, Sae Woong Kim, David Rivas, Nam Cheol Park
Publikováno v:
The Journal of Sexual Medicine. 7:256-268
Introduction Dapoxetine is a short-acting selective serotonin reuptake inhibitor that was recently approved for the on-demand treatment of premature ejaculation (PE). Aim To evaluate the efficacy and safety of dapoxetine 30 mg and 60 mg on demand (pr
Autor:
Charles D. Petrie, Laurie B. Burke, Nancy Kline Leidy, Donald L. Patrick, Margaret Rothman, Pennifer Erickson
Publikováno v:
Value in Health. 12(8):1075-1083
Background: Patient-reported outcome (PRO) instruments are used to evaluate the effect of medical products on how patients feel or function. This article presents the results of an ISPOR task force convened to address good clinical research practices
Publikováno v:
Current Medical Research and Opinion. 25:1433-1443
To assess the validity of the patient global assessment (PGA) of the method of pain control, a single-item patient-reported outcome measure of a method of pain control for patients experiencing postoperative pain.Content validity of the PGA of the me
Publikováno v:
European Urology. 55:957-968
Dapoxetine is being developed for the on-demand treatment of premature ejaculation (PE). Previous clinical trials have demonstrated its safety and efficacy.To evaluate the long-term efficacy and safety of dapoxetine in men with PE.This randomized, do
Autor:
François Giuliano, Kai Fai Ho, Dennis D. Gagnon, Donald L. Patrick, Pauline McNulty, Margaret Rothman
Publikováno v:
BJU International. 103:358-364
OBJECTIVE To evaluate the reliability and validity of the Premature Ejaculation Profile (PEP), a self-reported outcome instrument for evaluating domains of PE and its treatment, comprised of four single-item measures, a profile, and an index score. S
Autor:
Nicholas Bellamy, Joseph F. Heyse, Joseph W. Stauffer, Nathaniel P. Katz, Penney Cowan, Julie Chandler, Donald C. Manning, Gary W. Jay, Charles S. Cleeland, Richard E. White, Michael P. McDermott, Rozalina Dimitrova, Susan Martin, Dennis C. Turk, Ola Svensson, Dennis A. Revicki, Robert H. Dworkin, John T. Farrar, Steve Quessy, Mitchell B. Max, Smriti Iyengar, Bob A. Rappaport, Margaret Rothman, Laurie B. Burke, John A. Jermano, Sharon Hertz, James Witter, Patrick J. McGrath, Alejandro R. Jadad, Henry J McQuay
Publikováno v:
Pain. 139:485-493
The increasing complexity of randomized clinical trials and the practice of obtaining a wide variety of measurements from study participants have made the consideration of multiple endpoints a critically important issue in the design, analysis, and i