Burch D.,Maternal and Reproductive Health Unit |
Hill W.C.,Sarasota Memorial Hospital |
Delke I.,Florida College
Seminars in Perinatology | Year: 2012
At the beginning of the 20th century, maternal mortality was a leading cause of death for women of reproductive age in the United States. Obstetrical care was not standardized, and there was a lack of universal systems for monitoring maternal deaths. Public health efforts of surveillance, along with advances in medicine and sanitation, resulted in a significant decrease in maternal deaths by the early 1980s. Today, maternal death is considered to be a rare event; however, the rates of maternal mortality have not improved in almost 3 decades. There is growing evidence that many maternal deaths can still be prevented through enhanced surveillance that influences improvements in overall health and delivery of care. This paper describes the experience of establishing and maintaining a pregnancy-associated mortality surveillance system in Florida. Emphasis is placed on the process and importance of a statewide review and the value of engagement with the medical community. © 2012 Elsevier Inc.
Wills A.-M.,Neurological Clinical Research Institute |
Wills A.-M.,Harvard University |
Hubbard J.,Massachusetts General Hospital |
Macklin E.A.,Biostatistics Center |
And 18 more authors.
The Lancet | Year: 2014
Background: Amyotrophic lateral sclerosis is a fatal neurodegenerative disease with few therapeutic options. Mild obesity is associated with greater survival in patients with the disease, and calorie-dense diets increased survival in a mouse model. We aimed to assess the safety and tolerability of two hypercaloric diets in patients with amyotrophic lateral sclerosis receiving enteral nutrition. Methods: In this double-blind, placebo-controlled, randomised phase 2 clinical trial, we enrolled adults with amyotrophic lateral sclerosis from participating centres in the USA. Eligible participants were aged 18 years or older with no history of diabetes or liver or cardiovascular disease, and who were already receiving percutaneous enteral nutrition. We randomly assigned participants (1:1:1) using a computer-generated list of random numbers to one of three dietary interventions: replacement calories using an isocaloric tube-fed diet (control), a high-carbohydrate hypercaloric tube-fed diet (HC/HC), or a high-fat hypercaloric tube-fed diet (HF/HC). Participants received the intervention diets for 4 months and were followed up for 5 months. The primary outcomes were safety and tolerability, analysed in all patients who began their study diet. This trial is registered with ClinicalTrials.gov, number NCT00983983. Findings: Between Dec 14, 2009, and Nov 2, 2012, we enrolled 24 participants, of whom 20 started their study diet (six in the control group, eight in the HC/HC group, and six in the HF/HC group). One patient in the control group, one in the HC/HC group, and two in the HF/HC group withdrew consent before receiving the intervention. Participants who received the HC/HC diet had a smaller total number of adverse events than did those in the other groups (23 in the HC/HC group vs 42 in the control group vs 48 in the HF/HC group; overall, p=0·06; HC/HC vs control, p=0·06) and significantly fewer serious adverse events than did those on the control diet (none vs nine; p=0·0005). Fewer patients in the HC/HC group discontinued their study diet due to adverse events (none [0%] of eight in the HC/HC group vs three [50%] of six in the control group). During the 5 month follow-up, no deaths occurred in the nine patients assigned to the HC/HC diet compared with three deaths (43%) in the seven patients assigned to the control diet (log-rank p=0·03). Adverse events, tolerability, deaths, and disease progression did not differ significantly between the HF/HC group and the control group. Interpretation: Our results provide preliminary evidence that hypercaloric enteral nutrition is safe and tolerable in patients with amyotrophic lateral sclerosis, and support the study of nutritional interventions in larger randomised controlled trials at earlier stages of the disease. Funding: Muscular Dystrophy Association, National Center for Research Resources, National Institutes of Health, and Harvard NeuroDiscovery Center.
Extermann M.,University of South Florida |
Boler I.,University of South Florida |
Reich R.R.,University of South Florida |
Lyman G.H.,Duke University |
And 7 more authors.
Cancer | Year: 2012
BACKGROUND: Tools are lacking to assess the individual risk of severe toxicity from chemotherapy. Such tools would be especially useful for older patients, who vary considerably in terms of health status and functional reserve. METHODS: The authors conducted a prospective, multicentric study of patients aged ≥70 years who were starting chemotherapy. Grade 4 hematologic (H) or grade 3/4 nonhematologic (NH) toxicity according to version 3.0 of the Common Terminology Criteria for Adverse Events was defined as severe. Twenty-four parameters were assessed. Toxicity of the regimen (Chemotox) was adjusted using an index to estimate the average per-patient risk of chemotherapy toxicity (the MAX2 index). In total, 562 patients were accrued, and 518 patients were evaluable and were split randomly (2:1 ratio) into a derivation cohort and a validation cohort. RESULTS: Severe toxicity was observed in 64% of patients. The Chemotherapy Risk Assessment Scale for High-Age Patients (CRASH) score was constructed along 2 subscores: H toxicity and NH toxicity. Predictors of H toxicity were lymphocytes, aspartate aminotransferase level, Instrumental Activities of Daily Living score, lactate dehydrogenase level, diastolic blood pressure, and Chemotox. The best model included the 4 latter predictors (risk categories: low, 7%; medium-low, 23%; medium-high, 54%; and high, 100%, respectively; P trend <.001). Predictors of NH toxicity were hemoglobin, creatinine clearance, albumin, self-rated health, Eastern Cooperative Oncology Group performance, Mini-Mental Status score, Mini-Nutritional Assessment score, and Chemotox. The 4 latter predictors provided the best model (risk categories: 33%, 46%, 67%, and 93%, respectively; P trend <.001). The combined risk categories were 50%, 58%, 77%, and 79%, respectively; P trend <.001). Bootstrap internal validation and independent sample validation demonstrated stable risk categorization and P trend <.001. CONCLUSIONS: The CRASH score distinguished several risk levels of severe toxicity. The split score discriminated better than the combined score. To the authors' knowledge, this is the first score systematically integrating both chemotherapy and patient risk for older patients and has a potential for future clinical application. © 2011 American Cancer Society.
Clauson K.A.,Nova Southeastern University |
Elkins J.,Nova Southeastern University |
Goncz C.E.,Sarasota Memorial Hospital
American Journal of Health-System Pharmacy | Year: 2010
Purpose. The characteristics of pharmacist blogs were examined. Methods. Internet search engines, blog aggregators, and blog rolls were used to identify pharmacist blogs. Six categories were developed to evaluate blogs, including practice-based topics, identifying information, positive language, critical language, professionalism, and miscellaneous. The most recent five posts on each pharmacist blog were reviewed. Descriptive statistics were used to characterize the results. Results. A total of 117 blogs were identified, 44 of which were designated as pharmacist blogs. No blogs contained patient-identifying information. Anonymity was maintained by 68.2% of bloggers. Bloggers practiced in community (43.1%) and noncommunity (43.1%) settings. Pharmacists most commonly used positive language to describe the profession (32%), other health care professionals (25%), and patients (25%). The highest rates of critical language were found in descriptions of patients (57%) and other health care professionals (44%). Almost half of pharmacist blogs contained explicit or unprofessional language. Overall, community practitioner blogs were substantially more likely than noncommunity practitioner blogs to use unprofessional and critical language. Twenty-five percent of pharmacist bloggers also maintained a microblog (e.g., Twitter) account. Conclusion. A search using Internet search engines, blog aggregators, and blog rolls identified 117 blogs, 44 of which met the study criteria for designation as pharmacist blogs. The majority of pharmacist blogs included some type of discussion of pharmacologic therapies. Pharmacists most commonly used positive language to describe the profession, other health care professionals, and patients. The highest rates of critical language were found in descriptions of patients and other health care professionals. Copyright © 2010, American Society of Health-System Pharmacists, Inc. All rights reserved.
Baksh K.,Sarasota Memorial Hospital
American Journal of Clinical Oncology: Cancer Clinical Trials | Year: 2015
PURPOSE:: To investigate whether positron emission tomography/computed tomography (PET/CT) initial and restaging imaging predicts for pathologic response measured by tumor regression grade (TRG) after preoperative chemoradiotherapy (CRT) in patients with locally advanced esophageal cancer. METHODS:: A retrospective review of 220 patients with stage II-III esophageal cancer treated with neoadjuvant CRT followed by surgery was performed. In total, 187 patients were eligible for statistical analysis. Pretreatment and posttreatment PET/CT scans were reviewed. Maximum standard uptake value (SUV) at the site of the primary tumor was recorded before and 6 weeks after neoadjuvant therapy. Upon completion of surgery, TRG was determined by a specialized site-specific gastrointestinal pathologist. Spearman correlation was used to compare pre, post, and change in maximum SUV, TRG, and overall survival. RESULTS:: The median follow-up was 24 months. Although no significant correlation was found between pretreatment SUV and TRG (r=0.073, P=0.32), post-CRT SUV, however, showed a significant positive correlation with TRG (r=0.374, P<0.01). There was no significant correlation between the absolute change in fluorodeoxyglucose uptake after CRT and TRG (r=0.057, P=0.44); however, the rate of SUV change showed a significant correlation with TRG (r=0.178, P=0.017). Similar to previous studies, our study showed a significant difference in overall survival between TRG groups (log-rank test, P=0.019). Patients with TRG 3 showed prominently worse survival with median survival of 27.4 months. Patients with favorable pathologic responses were those whose scans demonstrated a metabolic response defined as a decrease in SUV≥70%. CONCLUSIONS:: Changes in SUV uptake on PET/CT scans after CRT have prognostic value in predicting pathologic response of esophageal cancer after neoadjuvant therapy. Further studies are needed to validate the integration of PET/CT as a decision-making tool. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.