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Quinn D.I.,University of Southern California | Tangen C.M.,Statistical Center | Hussain M.,University of Michigan | Lara P.N.,University of California at Davis | And 12 more authors.
The Lancet Oncology | Year: 2013

Background: The endothelin pathway has a role in bone metastases, which are characteristic of advanced prostate cancer. Atrasentan, an endothelin receptor antagonist, has shown activity in prostate cancer. We therefore assessed its effect on survival in patients with castration-resistant prostate cancer with bone metastases. Methods: In a double-blind phase 3 trial, men with metastatic castration-resistant prostate cancer, stratified for progression type (prostate-specific antigen or radiological), baseline pain, extraskeletal metastases, and bisphosphonate use, were randomly assigned in a 1:1 ratio to docetaxel (75 mg/m2 every 21 days, intravenously) with atrasentan (10 mg/day, orally) or placebo for up to 12 cycles and treated until disease progression or unacceptable toxicity. Patients who did not progress on treatment were permitted to continue atrasentan or placebo for up to 52 weeks. Coprimary endpoints were progression-free survival (PFS) and overall survival. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00134056. Findings: 498 patients were randomly assigned to the atrasentan group and 496 to the placebo group. The trial was halted early for futility in April, 2011, after a planned interim analysis. Median PFS was 9·2 months (95% CI 8·5-9·9) in the atrasentan group and 9·1 months (8·4-10·2) in the placebo group (hazard ratio 1·02, 0·89-1·16; p=0·81). Median overall survival was 17·8 months (16·4-19·8) in the atrasentan group versus 17·6 months (16·4-20·1) in the placebo group (1·04, 0·90-1·19; p=0·64). 278 (57%) of 492 patients in the atrasentan group had grade 3 and greater toxicity compared with 294 (60%) of 486 in the placebo group (p=0·22). Three deaths in the atrasentan group and seven in the placebo group were judged to be possibly or probably due to protocol treatment. Interpretation: Atrasentan, when added to docetaxel, does not improve overall survival or PFS in men with castration-resistant prostate cancer and bone metastases; therefore, single-agent docetaxel should remain as one of the standard treatments. Funded: National Cancer Institute, Sanofi-Aventis, and Abbott Laboratories. © 2013 Elsevier Ltd.

Ahern D.K.,Harvard University | Ahern D.K.,Brigham and Womens Hospital | Woods S.S.,Oregon Health And Science University | Woods S.S.,Portland Veterans Administration Medical Center | And 4 more authors.
American Journal of Preventive Medicine | Year: 2011

Patients are using healthcare technologies for a variety of reasons. Recently, the Meaningful-Use rule was released by the Centers for Medicare and Medicaid Services, providing some initial guidance for patient-facing technologies. There needs to be more of an understanding of patients' needs and how these technologies can be utilized effectively. This article provides a framework for organizing patient-facing technologies into categories of meaningful use, and how these technologies can improve healthcare quality, safety, and population health. Barriers to achieving meaningful use of HIT and unintended consequences of patient-facing technologies are discussed. The success of healthcare reform is predicated on achieving improved health outcomes and reduced costs, which can be accomplished only by activating patients to become more engaged in their own care. Patient-facing technologies are likely to play a critical role in supporting patients to become more informed and activated and may also improve efficiencies. Further research is needed to identify the most useful and effective technologies for patients. © 2011 American Journal of Preventive Medicine.

Tadros N.N.,Oregon Health And Science University | Bland L.,Oregon Health And Science University | Legg E.,Oregon Health And Science University | Olyaei A.,Oregon Health And Science University | Conlin M.J.,Portland Veterans Administration Medical Center
BJU International | Year: 2013

Objectives: To determine the incidence of severe pain after ureteric stent removal. To evaluate the efficacy of a single dose of a non-steroidal anti-inflammatory drug (NSAID) in preventing this complication. Patients and Methods: A prospective, randomised, double-blind, placebo-controlled trial was performed at our institution. Adults with an indwelling ureteric stent after ureteroscopy were randomised to receive either a single dose of placebo or an NSAID (rofecoxib 50 mg) before ureteric stent removal. Pain was measured using a visual analogue scale (VAS) just before and 24 h after stent removal Pain medication use after ureteric stent removal was measured using morphine equivalents. Results: In all, 22 patients were enrolled and randomised into the study before ending the study after interim analysis showed significant decrease in pain level in the NSAID group. The most common indication for ureteroscopy was urolithiasis (14 patients). The proportion of patients with severe pain (VAS score of ≥7) during the 24 h after ureteric stent removal was six of 11 (55%) in the placebo group and it was zero of 10 in the NSAID group (P < 0.01). There were no complications related to the use of rofecoxib. Conclusions: We found a 55% incidence of severe pain after ureteric stent removal. A single dose of a NSAID before stent removal prevents severe pain after ureteric stent removal. © 2012 BJU International.

Wolff F.,MaineHealth Center for Tobacco Independence | Hughes J.R.,University of Vermont | Woods S.S.,Portland Veterans Administration Medical Center
Journal of Smoking Cessation | Year: 2013

Tobacco dependence is characterised as a chronic, relapsing disorder that typically requires multiple quit attempts before successful, long-term abstinence is achieved (Steinberg, Foulds, Richardson, Burke, & Shah, 2006). Best practice, evidence-based treatment includes multiple-session counselling and pharmacotherapy, or the combination of both (Fiore et al., 2008). The field has moved past the notion that tobacco dependence is simply a bad habit, a vice, or a moral deficiency that can be overcome by willpower or education alone (Mars & Ling, 2008). However, the language used in discussing treatment has not always been consistent with this evidence. Some words and phrases used lend themselves to varied meanings, and could lead to significant misunderstanding not only among professionals in the field, but also among the general public (O'Brien, 2010; Davis, 1992; Perkins, 1999; Hughes, 2013). In this paper, we discuss some commonly used, problematic terminology, and suggest more appropriate terms (Table 1). © The Author(s), published by Cambridge University Press on behalf of Australian Academic Press Pty Ltd 2013.

Maier M.M.,Oregon Health And Science University | He H.,Program Design and Evaluation Service | Schafer S.D.,HIV STD TB Program | Ward T.T.,Portland Veterans Administration Medical Center | Zaman A.,Oregon Health And Science University
AIDS Care - Psychological and Socio-Medical Aspects of AIDS/HIV | Year: 2014

Approximately 287,000 individuals in the USA are coinfected with HIV and hepatitis C. Recently, new hepatitis C regimens have become available, increasing rates of sustained virologic response in the monoinfected, with studies evaluating their success in the coinfected under way. Previous investigators estimated eligibility for hepatitis C therapy among the coinfected patients, but all had significant methodological limitations. Our study is the first to use a multi-year, statewide, population-based sample to estimate treatment eligibility, and the first to estimate eligibility in the setting of an interferon-free regimen. In a population-based sample of 161 patients infected with HIV and hepatitis C living in Oregon during 2007-2010, 21% were eligible for hepatitis C therapy. Despite the anticipation surrounding an interferon-sparing regimen, eligibility assuming an interferon-free regimen increased only to 26%, largely due to multiple simultaneous contraindications. Obesity was described for the first time as being associated with decreased eligibility (OR: 0.11). Active alcohol abuse was the most common contraindication (24%); uncontrolled mental health (22%), recent injection drug use (21%), poor antiretroviral adherence (22%), and infection (21%) were also common excluding conditions. When active drug or alcohol abuse was excluded as contraindications to therapy, the eligibility rate was 34%, a 62% increase. Assuming an interferon-free regimen and the exclusion of active drug or alcohol abuse as contraindications to therapy, the eligibility rate increased to 42%. Despite the availability of direct-acting anti-viral regimens, eligibility rates in HIV-hepatitis C virus (HCV) coinfection are modest. Many factors precluding hepatitis C therapy are reversible, and targeted interventions could result in increased eligibility. © 2014 © 2014 Taylor & Francis.

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