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Miami, FL, United States

Tamariz L.,University of Miami | Tamariz L.,Veterans Affairs Medical Center | Palacio A.,University of Miami | Palacio A.,Veterans Affairs Medical Center | And 3 more authors.
Journal of General Internal Medicine | Year: 2013

Background: Inadequate health literacy may impair research subjects' ability to participate adequately in the informed consent (IC) process. Our aim is to evaluate the evidence supporting interventions, to improve comprehension of the IC process in low literacy subjects. Methods: We performed a MEDLINE database search (1966 to November 2011) supplemented by manual searches of bibliographies of key relevant articles. We selected all studies in which a modification of the IC was tested to improve comprehension in low literacy populations. Study design, quality criteria, population, interventions and outcomes for each trial were extracted. The main outcome evaluated was comprehension, measured using a written test or verbal comprehension. Results: Our search strategy yielded 281 studies, of which only six met our eligibility criteria. The six studies included 1620 research participants. The studies predominantly included populations that were older (median age 61, range 48-64), ethnic minority, and with literacy level of 8th grade or below. Only one study had a randomized design. The specific intervention differed in each study. Two of the studies included the teach-back method or teach to goal method and achieved the highest level of comprehension. Two studies changed the readability level of the IC and resulted in the lowest comprehension among study subjects. CONCLUSIONS: The evidence supporting interventions to improve the informed consent process in low literacy populations is extremely limited. Among the interventions evaluated, having a study team member spend more time talking one-on-one to study participants was the most effective strategy for improving informed consent understanding; however, this finding is based on the results of a single study. © 2012 Society of General Internal Medicine. Source


Newman R.G.,Sylvester Comprehensive Cancer Center | Newman R.G.,University of Miami | Dee M.J.,University of Miami | Malek T.R.,University of Miami | And 2 more authors.
Blood | Year: 2014

Tumor relapse is the primary cause of mortality in patients with hematologic cancers following autologous hematopoietic stem cell transplantation (HSCT). Vaccination early after HSCT can exploit both the state of lymphopenia and minimal residual disease for generating antitumor immunity. Here, multiple vaccinations using lymphoma cells engineered to secrete heat shock protein fusion gp96-Ig within 2 weeks of T cell-replete syngeneic HSCT led to cross-presentation and increased survival of lymphoma-bearing mice. To enhance vaccine efficacy, interleukin (IL)-2 was directed to predominantly memory phenotype CD8+ T lymphocytes and natural killer (NK) cells via administration bound to anti-IL-2 monoclonal antibody clone S4B6 (IL-2 S4B6). Combination therapy with gp96-Ig vaccination and coordinated infusions of IL-2S4B6 resulted in marked prolongation of survival, which directly correlated with ∼500% increase in effector CD8+ T-cell numbers. Notably, this dual regimen elicited large increases in both donor CD8+ T and NK cells, but not CD4+ T lymphocytes; the former 2 populations are essential for both vaccine efficacy and protection against opportunistic infections after HSCT. Indeed, IL-2S4B6-treated HSCT recipients infected with Listeria monocytogenes exhibited decreased bacterial levels. These preclinical studies validate a new strategy particularly well suited to the post-HSCT environment, which may augment adaptive and innate immune function in patients with malignant disease receiving autologous HSCT. © 2014 by The American Society of Hematology. Source


Principal goals of therapy for women with hormone receptor (HR)-positive metastatic breast cancer (MBC) are to maintain a good quality of life and to prolong survival; another important goal is to delay initiation of chemotherapy. Most women with tumors that are estrogen receptor (ER)-positive, progesterone receptor (PR)-positive, or both are treated initially with endocrine therapy because of its effectiveness and relatively low toxicity. Several classes of single-agent endocrine therapies are available for postmenopausal women, including the nonsteroidal aromatase inhibitors (AIs), steroidal AIs, selective ER modulators, selective ER downregulators, progestins, androgens, and high-dose estrogen. In addition, combination therapy, either with 2 different endocrine agents or with endocrine therapy plus newer targeted therapies, provides some relatively new strategies for the treatment of these patients. Nevertheless, disease resistance ultimately develops with each endocrine regimen, and many questions remain regarding the optimal timing and sequencing of these treatments. This article reviews the efficacy and safety of endocrine therapy regimens in women with HR-positive MBC, and it addresses the effect of prior endocrine therapies and the mechanisms of action of the different endocrine regimens within the context of overall treatment goals. © 2014 Elsevier Inc. All rights reserved. Source


McKenzie N.D.,University of Miami | Kobetz E.N.,University of Miami | Hnatyszyn J.,Sylvester Comprehensive Cancer Center | Twiggs L.B.,University of Miami | Lucci III J.A.,University of Miami
Gynecologic Oncology | Year: 2010

Objective: To review and summarize evidence from clinical, translational and epidemiologic studies which have examined the clinically relevant aspects of HPV type prevalence and cervical dysplasia in HIV-infected women. Methods: Relevant studies were identified through a MEDLINE search. References of identified reports were also used to identify additional published articles for review. Results: HIV-infected women in different geographic regions (such as Zambia, Brazil, Rochester NY) appear to be infected with less prevalent types of HR-HPV as compared to the general population who, across all continents, are more commonly infected with types 16 and 18. Secondly, integration of HPV DNA into the host genome is no longer thought to be a necessary cause of malignant transformation of cervical cells. However, rate of integration appears to differ by the type of HPV. In fact, the types of HPV which appear to be more common in cervical dysplasia of HIV-infected women are the same types which are more likely to require integration for malignant transformation. Finally, HPV types found in HIV-infected women are relatively common and likely to persist. The most common among these types belong to the alpha-9 and -7 species which are the most carcinogenic species. Conclusion: Given that current vaccines target HR-HPV-16/18, the findings from the above mentioned studies may have important implications for the design of HPV vaccines that target the types of HPV associated with disease risk in HIV-infected women. HPV typing and assessment of the physical state (whether it is integrated or episomal) appear to be two valuable parameters for the prognostic evaluation of dysplastic lesions of the uterine cervix. This, however, has not yet been assessed in HIV-infected women. Recent data about the immune response in HPV/HIV co-infection may lead to understanding potential mechanisms for less virulent HPV causing malignant transformation in HIV-infected women. © 2009 Elsevier Inc. All rights reserved. Source


Carcas L.P.,Sylvester Comprehensive Cancer Center
Current Colorectal Cancer Reports | Year: 2014

Colorectal cancer is a leading cause of cancer-related mortality in the USA. Although recent years have brought significant advances in treatment in the metastatic setting, the last major advance in the adjuvant setting was the addition of oxaliplatin to fluorouracil and leucovorin in the treatment of stage III disease. The benefit of adjuvant therapy in patients with stage II disease is not as clear. Prognostic and predictive markers help stratify patient risk and thereby indentify patients who may benefit from adjuvant therapy. The goal of this review is to help define the prognostic markers and molecular predictors that should be considered when attempting to personalize adjuvant therapy. © 2013 Springer Science+Business Media. Source

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