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Baer II W.H.,MercyHealth ClinXus LLC | Maini A.,Broward Health Medical Center | Jacobs I.,Pfizer
Pharmaceuticals | Year: 2014

Biologics such as rituximab are an important component of oncology treatment strategies, although access to such therapies is challenging in countries with limited resources. This study examined access to rituximab and identified potential barriers to its use in the United States, Mexico, Turkey, Russia, and Brazil. The study also examined whether availability of a biosimilar to rituximab would improve access to, and use of, rituximab. Overall, 450 hematologists and oncologists completed a survey examining their use of rituximab in patients with non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Less than 40% of physicians considered rituximab as easy to access from a cost perspective. Furthermore, many physicians chose not to treat, were unable to treat, or had to modify treatment with rituximab despite guidelines recommending its use in NHL and CLL patients. Insurance coverage, reimbursement, and cost to patient were commonly reported as barriers to the use of rituximab. Across all markets, over half of physicians reported that they would increase use of rituximab if a biosimilar was available. We conclude that rituximab use would increase across all therapy types and markets if a biosimilar was available, although a biosimilar would have the greatest impact in Brazil, Mexico, and Russia. © 2014 by the authors; licensee MDPI, Basel, Switzerland.

Mulchan S.S.,Nova Southeastern University | Valenzuela J.M.,Nova Southeastern University | Crosby L.E.,Cincinnati Childrens Hospital Medical Center | Diaz Pow Sang C.,Broward Health Medical Center
Journal of Pediatric Psychology | Year: 2016

Objectives This study aimed to examine the applicability of the Social-ecological Model of Adolescent and Young Adult Readiness to Transition (SMART) model for adolescents and young adults (AYA) with sickle-cell disease (SCD). Methods 14 AYA with SCD (14-24 years old) and 10 clinical experts (6-20 years of experience) completed semi-structured interviews. AYA completed brief questionnaires. Interviews were coded for themes, which were reviewed to determine their fit within the SMART model. Results Overall, most themes were consistent with the model (e.g., sociodemographics/culture, neurocognition/IQ, etc.). Factors related to race/culture, pain management, health-care navigation skills, societal stigma, and lack of awareness about SCD were salient for AYA with SCD. Conclusions Findings suggest the SMART model may be appropriate in SCD with the consideration of disease-related stigma. This study is a step toward developing a disease-specific model of transition readiness for SCD. Future directions include the development of a measure of transition readiness for this population. © 2015 The Author 2015.

Andersen B.L.,Ohio State University | DeRubeis R.J.,University of Pennsylvania | Berman B.S.,Broward Health Medical Center | Gruman J.,Center for Advancing Health | And 7 more authors.
Journal of Clinical Oncology | Year: 2014

Purpose: A Pan-Canadian Practice Guideline on Screening, Assessment, and Care of Psychosocial Distress (Depression, Anxiety) in Adults With Cancer was identified for adaptation. Methods: American Society of Clinical Oncology (ASCO) has a policy and set of procedures for adapting clinical practice guidelines developed by other organizations. The guideline was reviewed for developmental rigor and content applicability. Results On the basis of content review of the pan-Canadian guideline, the ASCO panel agreed that, in general, the recommendations were clear, thorough, based on the most relevant scientific evidence, and presented options that will be acceptable to patients. However, for some topics addressed in the pan-Canadian guideline, the ASCO panel formulated a set of adapted recommendations based on local context and practice beliefs of the ad hoc panel members. It is recommended that all patients with cancer be evaluated for symptoms of depression and anxiety at periodic times across the trajectory of care. Assessment should be performed using validated, published measures and procedures. Depending on levels of symptoms and supplementary information, differing treatment pathways are recommended. Failure to identify and treat anxiety and depression increases the risk for poor quality of life and potential disease-related morbidity and mortality. This guideline adaptation is part of a larger survivorship guideline series. Conclusion: Although clinicians may not be able to prevent some of the chronic or late medical effects of cancer, they have a vital role in mitigating the negative emotional and behavioral sequelae. Recognizing and treating effectively those who manifest symptoms of anxiety or depression will reduce the human cost of cancer. © 2014 by American Society of Clinical Oncology.

Cahn P.,Fundacion Huesped | Pozniak A.L.,Chelsea and Westminster Hospital NHS Foundation Trust | Mingrone H.,Fundacion IDEAA | Brites C.,Federal University of Bahia | And 16 more authors.
The Lancet | Year: 2013

Background Dolutegravir (GSK1349572), a once-daily HIV integrase inhibitor, has shown potent antiviral response and a favourable safety profile. We evaluated safety, efficacy, and emergent resistance in antiretroviral- experienced, integrase-inhibitor-naive adults with HIV-1 with at least two-class drug resistance. Methods ING111762 (SAILING) is a 48 week, phase 3, randomised, double-blind, active-controlled, non-inferiority study that began in October, 2010. Eligible patients had two consecutive plasma HIV-1 RNA assessments of 400 copies per mL or higher (unless >1000 copies per mL at screening), resistance to two or more classes of antiretroviral drugs, and had one to two fully active drugs for background therapy. Participants were randomly assigned (1:1) to once-daily dolutegravir 50 mg or twice-daily raltegravir 400 mg, with investigator-selected background therapy. Matching placebo was given, and study sites were masked to treatment assignment. The primary endpoint was the proportion of patients with plasma HIV-1 RNA less than 50 copies per mL at week 48, evaluated in all participants randomly assigned to treatment groups who received at least one dose of study drug, excluding participants at one site with violations of good clinical practice. Non-inferiority was prespecified with a 12% margin; if non-inferiority was established, then superiority would be tested per a prespecified sequential testing procedure. A key prespecified secondary endpoint was the proportion of patients with treatment-emergent integrase-inhibitor resistance. The trial is registered at ClinicalTrials.gov, NCT01231516. Findings Analysis included 715 patients (354 dolutegravir; 361 raltegravir). At week 48, 251 (71%) patients on dolutegravir had HIV-1 RNA less than 50 copies per mL versus 230 (64%) patients on raltegravir (adjusted difference 7·4%, 95% CI 0·7 to 14·2); superiority of dolutegravir versus raltegravir was then concluded (p=0·03). Significantly fewer patients had virological failure with treatment-emergent integrase-inhibitor resistance on dolutegravir (four vs 17 patients; adjusted difference -3·7%, 95% CI -6·1 to -1·2; p=0·003). Adverse event frequencies were similar across groups; the most commonly reported events for dolutegravir versus raltegravir were diarrhoea (71 [20%] vs 64 [18%] patients), upper respiratory tract infection (38 [11%] vs 29 [8%]), and headache (33 [9%] vs 31 [9%]). Safety events leading to discontinuation were infrequent in both groups (nine [3%] dolutegravir, 14 [4%] raltegravir). Interpretation Once-daily dolutegravir, in combination with up to two other antiretroviral drugs, is well tolerated with greater virological effect compared with twice-daily raltegravir in this treatment-experienced patient group. Funding ViiV Healthcare. © 2013 Elsevier Ltd.

Hsu A.R.,Rush University Medical Center | Gross C.E.,Rush University Medical Center | Lee S.,Rush University Medical Center | Carreira D.S.,Broward Health Medical Center
Journal of the American Academy of Orthopaedic Surgeons | Year: 2014

Advances in foot and ankle arthroscopy have allowed surgeons to diagnose and treat a broadening array of disorders that were previously limited to open procedures. Arthroscopy of the posterior ankle, subtalar joint, and first metatarsophalangeal joint and tendoscopy can be used to address common foot and ankle ailments, with the potential benefits of decreased pain, fast recovery, and low complication rates. Posterior ankle and subtalar arthroscopy can be used to manage impingement, arthrofibrosis, synovitis, arthritis, fractures, and osteochondral defects. First metatarsophalangeal joint arthroscopy can address osteophytes, chronic synovitis, osteochondral defects, and degenerative joint disease. Tendoscopy is a minimally invasive alternative for evaluation and débridement of the Achilles, posterior tibial, flexor hallucis longus, and peroneal tendons.

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