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Dimond E.P.,U.S. National Cancer Institute | St. Germain D.,U.S. National Cancer Institute | Nacpil L.M.,St Joseph Hospital | Swanson S.M.,Mercy Medical Center | And 8 more authors.
Clinical Trials

Background The value of community-based cancer research has long been recognized. In addition to the National Cancer Institute's Community Clinical and Minority-Based Oncology Programs established in 1983, and 1991 respectively, the National Cancer Institute established the National Cancer Institute Community Cancer Centers Program in 2007 with an aim of enhancing access to high-quality cancer care and clinical research in the community setting where most cancer patients receive their treatment. This article discusses strategies utilized by the National Cancer Institute Community Cancer Centers Program to build research capacity and create a more entrenched culture of research at the community hospitals participating in the program over a 7-year period. Methods To facilitate development of a research culture at the community hospitals, the National Cancer Institute Community Cancer Centers Program required leadership or chief executive officer engagement; utilized a collaborative learning structure where best practices, successes, and challenges could be shared; promoted site-to-site mentoring to foster faster learning within and between sites; required research program assessments that spanned clinical trial portfolio, accrual barriers, and outreach; increased identification and use of metrics; and, finally, encouraged research team engagement across hospital departments (navigation, multidisciplinary care, pathology, and disparities) to replace the traditionally siloed approach to clinical trials. Limitations The health-care environment is rapidly changing while complexity in research increases. Successful research efforts are impacted by numerous factors (e.g. institutional review board reviews, physician interest, and trial availability). The National Cancer Institute Community Cancer Centers Program sites, as program participants, had access to the required resources and support to develop and implement the strategies described. Metrics are an important component yet often challenging to identify and collect. The model requires a strong emphasis on outreach that challenges hospitals to improve and expand their reach, particularly into underrepresented populations and catchment areas. These efforts build on trust and a referral pipeline within the community which take time and significant commitment to establish. Conclusion The National Cancer Institute Community Cancer Centers Program experience provides a relevant model to broadly address creating a culture of research in community hospitals that are increasingly networked via systems and consortiums. The strategies used align well with the National Cancer Institute?American Society of Clinical Oncology Accrual Symposium recommendations for patient-/community-, physician-/provider-, and site-/organizationallevel approaches to clinical trials; they helped sites achieve organizational culture shifts that enhanced their cancer research programs. The National Cancer Institute Community Cancer Centers Program hospitals reported that the strategies were challenging to implement yet proved valuable as they provided useful metrics for programmatic assessment, planning, reporting, and growth. While focused on oncology trials, these concepts may be useful within other disease-focused research as well. © The Author(s) 2015. Source

Katz P.O.,Albert Einstein Healthcare Network | Rex D.K.,Indiana University | Epstein M.,Annapolis flyer cab | Grandhi N.K.,Gastroenterology Research Consultants of Greater Cincinnati | And 4 more authors.
American Journal of Gastroenterology

OBJECTIVES:Optimal bowel preparation is vital for the efficacy and safety of colonoscopy. The inconvenience, discomfort, required consumption of large volumes of product, and potential adverse effects associated with some bowel preparations deter patients from colonoscopy and may provide inadequate cleansing. A dual-action, non-phosphate, natural orange-flavored, low-volume preparation containing sodium picosulfate and magnesium citrate (P/MC) is currently being reviewed for bowel cleansing.METHODS:This was a phase 3, randomized, multicenter, assessor-blinded, prespecified non-inferiority, head-to-head study to investigate the efficacy, safety, and tolerability of day-before administration of P/MC vs. 2L polyethylene glycol solution and two 5-mg bisacodyl tablets (2L PEG-3350 and bisacodyl tablets (HalfLytely and Bisacodyl Tablets Bowel Prep Kit)) in adult patients preparing for colonoscopy (SEE CLEAR II Study). The primary objective of the study was to demonstrate the non-inferiority of P/MC to 2L PEG-3350 and bisacodyl tablets in overall colon cleansing using a modified Aronchick scale. In addition, efficacy in the ascending, mid (transverse and descending), and recto-sigmoid segments of colon was evaluated using a modified Ottawa scale. Patient acceptability and tolerability of the bowel preparations were assessed via a standard questionnaire. Safety was assessed based on the monitoring of adverse events (AEs) and meaningful findings on clinical evaluations including physical examinations, vital sign measurements, and electrocardiograms (ECGs).RESULTS:A total of 603 patients were randomized to receive either P/MC (n=300) or 2L PEG-3350 and bisacodyl tablets (n=303). Based on the Aronchick scale, successful overall cleansing was similar in patients receiving P/MC (83.0%) and patients receiving 2L PEG-3350 and bisacodyl tablets (79.7%). P/MC demonstrated non-inferiority to 2L PEG-3350 and bisacodyl tablets in overall cleansing of the colon, as measured by the Aronchick scale. Similarly, the efficacy of P/MC, as measured by the Ottawa scale, was non-inferior to 2L PEG-3350 and bisacodyl tablets in cleansing the ascending, mid, and recto-sigmoid segments of the colon. Patient-reported acceptability and tolerability for each item examined on the questionnaire was significantly greater for P/MC compared with 2L PEG-3350 and bisacodyl tablets (P<0.0001).Treatment-emergent AEs related to the bowel preparation reported by 1% of patients receiving P/MC or 2L PEG-3350 and bisacodyl tablets were nausea (3.0% vs. 4.3%), vomiting (1.4% vs. 2.0%), and headache (2.7% vs. 1.7%). No clinically meaningful changes were noted in either treatment arm in data collected from physical examinations, vital sign measurements, and ECGs.CONCLUSIONS:When administered as a day-before dose, the bowel cleansing effects of P/MC were non-inferior compared with 2L PEG-3350 and bisacodyl tablets using the clinician-rated Aronchick and Ottawa scales. Treatment acceptability was significantly more favorable in patients receiving P/MC than in patients receiving 2L PEG-3350 and bisacodyl tablets. Source

Rex D.K.,Indiana University | Katz P.O.,Albert Einstein Healthcare Network | Bertiger G.,Hillmont GI | Vanner S.,Queens University | And 3 more authors.
Gastrointestinal Endoscopy

Background: New bowel cleansers for colonoscopy that lead to improved efficacy, safety, and tolerability are needed. Objective: This study evaluated a nonphosphate, dual-action, low-volume, orange-flavored preparation containing sodium picosulfate and magnesium citrate (P/MC). Design: Multicenter, assessor-blinded, randomized, noninferiority study. Setting: University hospitals, academic medical centers, and private clinics across the United States. Patients: Adults preparing for colonoscopy. Interventions: P/MC versus 2 L of polyethylene glycol solution (2L PEG-3350) and two 5-mg bisacodyl tablets. Main Outcome Measurements: This phase 3 study investigated the efficacy, safety, and tolerability of split-dose administration of P/MC versus day-before dosing of 2L PEG-3350 and two 5-mg bisacodyl tablets (SEE CLEAR I study). Efficacy was evaluated by using the Aronchick and Ottawa scales; noninferiority and superiority analyses were performed. Safety was assessed by monitoring adverse events (AEs). Tolerability was measured via a patient questionnaire. Results: The intent-to-treat population consisted of 601 patients who self-administered P/MC (n = 304) or 2L PEG-3350 and bisacodyl tablets (n = 297). P/MC was superior to 2L PEG-3350 and bisacodyl tablets in overall colon cleansing (84.2% vs 74.4%; 1-sided 97.5% confidence interval [CI], 3.4) (Aronchick scores of excellent or good) and in cleansing of the ascending (89.5% vs 78.8%; 1-sided 97.5% CI, 4.9), mid (transverse and descending) (92.4% vs 85.9%; 1-sided 97.5% CI, 1.6), and rectosigmoid (92.4% vs 87.2%; 1-sided 97.5% CI, 0.4) segments of the colon (Ottawa scores of excellent, good, or fair). Commonly reported AEs related to the bowel preparations were nausea, vomiting, headache, and chills. Patient-reported tolerability, including ease of consumption and taste, was significantly higher for P/MC than 2L PEG-3350 and bisacodyl tablets (P <.0001). Limitations: Because of differences in administration and volume of the bowel preparations, the study was designed to be a single-assessor, blinded study. Conclusions: The bowel-cleansing effects and patient acceptability of split-dose P/MC were superior to day-before dosing with 2L PEG-3350 and bisacodyl tablets. © 2013 by the American Society for Gastrointestinal Endoscopy. Source

Bellon J.R.,Dana-Farber Cancer Institute | Golshan M.,Dana-Farber Cancer Institute | Solin L.J.,Albert Einstein Healthcare Network
Annals of Surgical Oncology

Multiple randomized trials, as well as a meta-analysis of these studies, have confirmed the equivalence of breast-conservation and mastectomy. In addition, in unselected populations, adjuvant radiation therapy following lumpectomy has been shown to decrease in-breast recurrence and improve overall survival. However, radiation has morbidity, and is costly and inconvenient. Multiple efforts to minimize treatment have been studied, including omitting radiation in low-risk populations, as well as in those with significant competing risks. Central to these efforts has been an increased awareness of the inherent biology, allowing treatment to be more precisely tailored to the risks posed by each individual patient’s disease. In addition, an improved understanding of the radio-responsiveness of both tumor and adjacent normal tissue has permitted safe use of short-course (hypofractionated) radiation. Studies are ongoing to determine the most appropriate candidates for both hypofractionated treatment and omission of radiation entirely. The optimal management of ductal carcinoma in situ is also a subject of intense study. Multiple trials have attempted to identify patients who can safely forego radiation and, more recently, molecular predictors of recurrence have been developed to further fine-tune this low-risk population. © 2015, Society of Surgical Oncology. Source

Furin M.,Albert Einstein Healthcare Network | Kohn M.,Albert Einstein Healthcare Network | Overberger R.,Albert Einstein Healthcare Network | Jaslow D.,Philadelphia University
Western Journal of Emergency Medicine

Introduction: Pennsylvania, among other states, includes surgical airway management, or cricothyrotomy, within the paramedic scope of practice. However, there is scant literature that evaluates paramedic perception of clinical competency in cricothyrotomy. The goal of this project is to assess clinical exposure, education and self-perceived competency of ground paramedics in cricothyrotomy. Methods: Eighty-six paramedics employed by four ground emergency medical services agencies completed a 22-question written survey that assessed surgical airway attempts, training, skills verification, and perceptions about procedural competency. Descriptive statistics were used to evaluate responses. Results: Only 20% (17/86, 95% CI [11-28%]) of paramedics had attempted cricothyrotomy, most (13/17 or 76%, 95% CI [53-90%]) of whom had greater than 10 years experience. Most subjects (63/86 or 73%, 95% CI [64-82%]) did not reply that they are well-trained to perform cricothyrotomy and less than half (34/86 or 40%, 95% CI [30-50%]) felt they could correctly perform cricothyrotomy on their first attempt. Among subjects with five or more years of experience, 39/70 (56%, 95% CI [44-68%]) reported 0-1 hours per year of practical cricothyrotomy training within the last five years. Half of the subjects who were able to recall (40/80, 50% 95% CI [39-61%]) reported having proficiency verification for cricothyrotomy within the past five years. Conclusion: Paramedics surveyed indicated that cricothyrotomy is rarely performed, even among those with years of experience. Many paramedics felt that their training in this area is inadequate and did not feel confident to perform the procedure. Further study to determine whether to modify paramedic scope of practice and/or to develop improved educational and testing methods is warranted. © 2016 Koenig et al. Source

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